ibuprofen 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
anti-inflammatory agents, ibuprofen derivatives 1407 15687-27-1

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • ibuprofen lysine
  • ibuprofen lysinate
  • ibuprofen lysine salt
  • soluphene
  • solufenum
  • neoprofen
  • ibuprofen
  • ibuprofen sodium
A nonsteroidal anti-inflammatory agent with analgesic properties used in the treatment of RHEUMATISM and ARTHRITIS. Concerns that anti-inflammatory drugs such as ibuprofen may worsen COVID-19 circulated widely in the early months of the pandemic. FDA has stated that it is not aware of scientific evidence connecting the use of NSAIAs, such as ibuprofen, with worsening COVID-19 symptoms and will communicate publicly when more information is available.
  • Molecular weight: 206.29
  • Formula: C13H18O2
  • CLOGP: 3.68
  • LIPINSKI: 0
  • HAC: 2
  • HDO: 1
  • TPSA: 37.30
  • ALOGS: -3.48
  • ROTB: 4
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
30 mg P
1.20 g O
1.20 g P
1.20 g R

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.04 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 0.50 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 193.90 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 85 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.15 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 0.82 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.01 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 1.60 hours Lombardo F, Berellini G, Obach RS

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 0.959 High 1
caco2-efflux Caco-2 efflux ratio (BA/AB) 0.254 High 1
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 157.036 10^-6 cm/s High 1
dh-clint Dog hepatocyte intrinsic clearance 12.023 uL/min/10^6 cells High 1
dppb Dog plasma protein binding (% unbound) 1.220 % High 1
fcs-ppb Fetal calf serum protein binding (% unbound) 2.730 % High 1
herg hERG pIC50 4.095 pIC50 High 1
hh-clint Human hepatocyte intrinsic clearance 13.932 uL/min/10^6 cells High 1
hlm-clint Human liver microsomal intrinsic clearance 4.111 uL/min/mg protein High 1
hppb Human plasma protein binding (% unbound) 1.140 % High 1
kinase-safety-class ACVR2A,ACVR2B,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK5,CDK9,DDR1,DYRK1B,EGFR,EIF2AK3,ERBB2,GRK2,IKBKB,ITK,MAP2K6,MAP3K21,MAP3K7,MAPK7,MAPKAPK2,NTRK2,PDK1,PDK2,PDK4,PIK3CB,PIK3CG,PRKDC,SIK2,STK33,SYK,TEK,TGFBR1,ZAP70 36
kinase-selectivity-class AXL,EIF2AK3,GRK2 3
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 0.504 High 1
mh-clint Mouse hepatocyte intrinsic clearance 137.721 High 1
mppb Mouse plasma protein binding (% unbound) 6.060 High 1
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 0.134 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pld-class Phospholipidosis risk class (1 = positive, 0 = negative) 0 High 1
pppb Pig plasma protein binding (% unbound) 1.720 % High 1
rh-clint Rat hepatocyte intrinsic clearance 51.642 uL/min/10^6 cells High 1
rh-fuinc Rat hepatocyte fraction unbound in incubation 89.220 % High 1
rppb Rat plasma protein binding (% unbound) 1.380 % High 1
solubility-dd Solubility at pH 7.4 in DMSO 816.582 uM High 1

Approvals:

DateAgencyCompanyOrphan
Jan. 19, 2018 PMDA Senju Pharmaceutical Co., Ltd.
Sept. 19, 1974 FDA

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Toxicity to various agents 4449.63 10.32 10453 1100447 277393 89240154
Completed suicide 3066.41 10.32 5986 1104914 139072 89378475
Intentional overdose 2954.00 10.32 4616 1106284 89218 89428329
Exposure to toxic agent 1754.57 10.32 1138 1109762 6829 89510718
Overdose 1277.49 10.32 4546 1106354 153163 89364384
Suicide attempt 1220.52 10.32 2792 1108108 72607 89444940
Acute hepatic failure 1139.60 10.32 1395 1109505 21166 89496381
Metabolic acidosis 786.76 10.32 1956 1108944 53720 89463827
Hepatic cytolysis 592.71 10.32 1226 1109674 29690 89487857
Poisoning deliberate 525.18 10.32 816 1110084 15670 89501877
Drug ineffective 487.82 10.32 13092 1097808 1371206 88146341
Intentional product misuse 474.75 10.32 2267 1108633 87337 89430210
Analgesic drug level increased 463.60 10.32 341 1110559 2578 89514969
Angioedema 423.57 10.32 1747 1109153 63129 89454418
Injection site pain 360.55 10.32 1018 1109882 172681 89344866
Cholecystitis chronic 333.64 10.32 501 1110399 9325 89508222
Suspected suicide 298.38 10.32 469 1110431 9099 89508448
Malignant neoplasm progression 292.59 10.32 539 1110361 106331 89411216
Suspected suicide attempt 292.22 10.32 165 1110735 736 89516811
Blood pressure fluctuation 292.16 10.32 1346 1109554 51067 89466480
Myelosuppression 285.49 10.32 150 1110750 53441 89464106
Diarrhoea 280.18 10.32 9079 1101821 930111 88587436
Product dose omission issue 279.96 10.32 2259 1108641 289428 89228119
Disease progression 272.53 10.32 993 1109907 155622 89361925
Infusion related reaction 261.85 10.32 6825 1104075 409955 89107592
Cardiac failure congestive 246.72 10.32 525 1110375 98169 89419378
Depressed level of consciousness 240.58 10.32 1623 1109277 71161 89446386
Anion gap 224.52 10.32 152 1110748 990 89516557
Coagulopathy 208.05 10.32 694 1110206 22595 89494952
Sinusitis 207.49 10.32 5591 1105309 337497 89180050
Wrong technique in product usage process 203.06 10.32 353 1110547 71218 89446329
Neutropenia 202.53 10.32 1771 1109129 223133 89294414
Throat irritation 199.87 10.32 1148 1109752 47547 89470000
Lip oedema 199.74 10.32 265 1110635 4374 89513173
Hospitalisation 199.39 10.32 849 1110051 127251 89390296
Rheumatoid arthritis 198.33 10.32 5834 1105066 356780 89160767
Pyroglutamic acidosis 197.60 10.32 147 1110753 1133 89516414
Device expulsion 197.16 10.32 129 1110771 40757 89476790
Hepatotoxicity 196.91 10.32 1094 1109806 44748 89472799
Medication error 196.30 10.32 1738 1109162 82914 89434633
Lower respiratory tract infection 192.92 10.32 4222 1106678 246437 89271110
Cardiac failure 187.34 10.32 699 1110201 108797 89408750
Oligohydramnios 176.58 10.32 317 1110583 6884 89510663
Anaemia 165.99 10.32 3185 1107715 349617 89167930
Neuropathy peripheral 162.03 10.32 998 1109902 135972 89381575
Muscle injury 157.42 10.32 3041 1107859 173613 89343934
Aspirin-exacerbated respiratory disease 155.47 10.32 100 1110800 590 89516957
Coma 154.10 10.32 1463 1109437 71169 89446378
Hepatic failure 153.60 10.32 922 1109978 38806 89478741
Tubulointerstitial nephritis 152.62 10.32 666 1110234 24677 89492870
Drug resistance 149.65 10.32 94 1110806 30355 89487192
Folliculitis 146.82 10.32 3409 1107491 200944 89316603
Interstitial lung disease 145.38 10.32 466 1110434 75939 89441608
Drug abuse 144.30 10.32 1595 1109305 80752 89436795
Prothrombin time ratio decreased 137.57 10.32 107 1110793 888 89516659
Fixed eruption 136.10 10.32 135 1110765 1595 89515952
Irritable bowel syndrome 135.55 10.32 3416 1107484 204032 89313515
Poisoning 135.52 10.32 453 1110447 14764 89502783
White blood cell count decreased 134.89 10.32 1352 1109548 165757 89351790
Body temperature increased 134.81 10.32 975 1109925 43735 89473812
Injection site erythema 133.70 10.32 686 1110214 97816 89419731
Emotional distress 132.39 10.32 836 1110064 35826 89481721
Pneumonia 130.90 10.32 6439 1104461 631620 88885927
Injury 130.80 10.32 3256 1107644 194093 89323454
Red blood cell sedimentation rate abnormal 130.02 10.32 67 1110833 24137 89493410
Blister 127.89 10.32 4060 1106840 250938 89266609
Ill-defined disorder 123.88 10.32 3055 1107845 181836 89335711
Meningitis aseptic 122.14 10.32 262 1110638 6511 89511036
Intentional self-injury 121.97 10.32 694 1110206 28640 89488907
Acute lung injury 121.76 10.32 119 1110781 1379 89516168
Muscle spasticity 121.74 10.32 796 1110104 34526 89483021
Toxic epidermal necrolysis 120.12 10.32 746 1110154 31782 89485765
Sleep disorder due to general medical condition, insomnia type 119.28 10.32 2229 1108671 126465 89391082
Nasopharyngitis 118.15 10.32 6112 1104788 400992 89116555
Ear pruritus 117.93 10.32 259 1110641 6544 89511003
Platelet count decreased 116.51 10.32 1094 1109806 135875 89381672
Myocardial infarction 116.23 10.32 790 1110110 105182 89412365
Urticaria 115.66 10.32 4811 1106089 307923 89209624
Off label use 113.48 10.32 11808 1099092 1090444 88427103
Therapy interrupted 111.19 10.32 284 1110616 49824 89467723
Renal impairment 111.14 10.32 795 1110105 104626 89412921
Deafness transitory 109.15 10.32 130 1110770 1913 89515634
Impaired healing 108.70 10.32 3695 1107205 230504 89287043
Hepatitis acute 106.80 10.32 335 1110565 10552 89506995
Gastrointestinal disorder 104.24 10.32 3989 1106911 252698 89264849
Abdominal pain upper 104.02 10.32 5031 1105869 327643 89189904
Stevens-Johnson syndrome 103.07 10.32 665 1110235 28711 89488836
Duodenal ulcer perforation 102.87 10.32 3492 1107408 217796 89299751
Blood pressure systolic abnormal 102.52 10.32 492 1110408 18986 89498561
Injection site pruritus 100.56 10.32 331 1110569 53503 89464044
Face oedema 100.48 10.32 557 1110343 22761 89494786
Pancytopenia 100.39 10.32 965 1109935 119298 89398249
Self-medication 97.87 10.32 156 1110744 3064 89514483
Unevaluable event 97.85 10.32 344 1110556 54504 89463043
Atrial fibrillation 97.31 10.32 1107 1109793 132504 89385043
Somnolence 95.82 10.32 3294 1107606 205790 89311757
Renal tubular acidosis 93.21 10.32 128 1110772 2187 89515360
Blood pressure diastolic abnormal 93.20 10.32 486 1110414 19395 89498152
Cardio-respiratory arrest 92.13 10.32 1181 1109719 61959 89455588
Hepatic necrosis 91.77 10.32 227 1110673 6211 89511336
Hypersensitivity 91.43 10.32 6610 1104290 448067 89069480
Neoplasm progression 90.56 10.32 263 1110637 44223 89473324
Diabetes mellitus 89.63 10.32 449 1110451 64426 89453121
Fall 89.40 10.32 4911 1105989 476899 89040648
Gastric ulcer perforation 88.74 10.32 96 1110804 1264 89516283
Bone marrow failure 86.84 10.32 164 1110736 32057 89485490
Injection site swelling 86.82 10.32 407 1110493 59432 89458115
Myelodysplastic syndrome 86.67 10.32 77 1110823 20826 89496721
Haematemesis 86.36 10.32 708 1110192 33018 89484529
Respiratory arrest 85.14 10.32 699 1110201 32612 89484935
Accidental overdose 84.91 10.32 616 1110284 27657 89489890
Biliary dyskinesia 84.68 10.32 130 1110770 2469 89515078
Helicobacter infection 84.32 10.32 3492 1107408 223358 89294189
Ductus arteriosus stenosis foetal 83.97 10.32 46 1110854 191 89517356
Hypocalcaemia 83.70 10.32 254 1110646 42114 89475433
Medication overuse headache 82.66 10.32 97 1110803 1404 89516143
Posterior reversible encephalopathy syndrome 82.59 10.32 91 1110809 22248 89495299
Cholelithiasis 82.58 10.32 996 1109904 51510 89466037
Full blood count abnormal 82.30 10.32 206 1110694 36391 89481156
Joint swelling 81.53 10.32 7196 1103704 496104 89021443
Device malfunction 81.43 10.32 82 1110818 20895 89496652
Uterine perforation 81.18 10.32 240 1110660 7314 89510233
Alanine aminotransferase increased 80.33 10.32 1959 1108941 116379 89401168
Respiratory failure 80.13 10.32 997 1109903 117421 89400126
Ductus arteriosus premature closure 79.95 10.32 55 1110845 369 89517178
Vomiting 79.56 10.32 10923 1099977 777370 88740177
Gastric ulcer 78.99 10.32 592 1110308 26856 89490691
Respiratory depression 78.81 10.32 389 1110511 15186 89502361
Dyspnoea exertional 78.71 10.32 540 1110360 71748 89445799
Dehydration 78.52 10.32 1799 1109101 192648 89324899
Sepsis 77.95 10.32 1645 1109255 178169 89339378
Therapy cessation 76.20 10.32 212 1110688 36149 89481398
Cytomegalovirus infection 75.63 10.32 131 1110769 26471 89491076
Plasma cell myeloma 75.59 10.32 252 1110648 40576 89476971
Pneumocystis jirovecii pneumonia 74.61 10.32 93 1110807 21523 89496024
Brain death 74.19 10.32 157 1110743 3864 89513683
Drug-induced liver injury 74.13 10.32 1536 1109364 88782 89428765
Pulmonary hypertension 73.66 10.32 270 1110630 42253 89475294
Transplant rejection 73.62 10.32 32 1110868 12726 89504821
Therapeutic product effect incomplete 73.56 10.32 1811 1109089 192085 89325462
Blood pressure diastolic decreased 72.97 10.32 571 1110329 26255 89491292
Acute generalised exanthematous pustulosis 72.03 10.32 346 1110554 13357 89504190
Blood pressure systolic increased 71.94 10.32 1059 1109841 57286 89460261
Duodenal ulcer 71.85 10.32 269 1110631 9283 89508264
Cardiac disorder 71.67 10.32 406 1110494 56466 89461081
Thrombotic microangiopathy 71.49 10.32 53 1110847 15690 89501857
Acute kidney injury 71.39 10.32 4698 1106202 315689 89201858
Osteonecrosis of jaw 71.27 10.32 243 1110657 38860 89478687
Drug dose omission by device 70.56 10.32 19 1110881 10212 89507335
Gallbladder disorder 70.53 10.32 450 1110450 19353 89498194
Upper gastrointestinal haemorrhage 70.39 10.32 503 1110397 22473 89495074
Product substitution issue 70.35 10.32 70 1110830 17938 89499609
Neurotoxicity 70.35 10.32 96 1110804 21371 89496176
Death 69.30 10.32 4741 1106159 451810 89065737
Full blood count decreased 69.22 10.32 164 1110736 29525 89488022
Product storage error 68.91 10.32 88 1110812 20153 89497394
Hypothermia 67.75 10.32 373 1110527 15202 89502345
Metastases to bone 67.70 10.32 131 1110769 25374 89492173
Multiple-drug resistance 67.50 10.32 8 1110892 7768 89509779
Bezoar 66.58 10.32 120 1110780 2614 89514933
Hepatic enzyme increased 66.36 10.32 5208 1105692 355528 89162019
Pulmonary arterial hypertension 65.67 10.32 139 1110761 26048 89491499
Breast cancer 64.97 10.32 389 1110511 53372 89464175
Peritonsillar abscess 64.71 10.32 56 1110844 548 89516999
Pyroglutamate increased 64.25 10.32 45 1110855 312 89517235
Unintentional medical device removal 64.19 10.32 6 1110894 7024 89510523
Acute myeloid leukaemia 63.98 10.32 96 1110804 20544 89497003
Hypocoagulable state 63.76 10.32 88 1110812 1511 89516036
Papillary muscle rupture 63.64 10.32 21 1110879 10 89517537
Heart rate decreased 62.80 10.32 963 1109937 52542 89465005
Eyelid oedema 62.64 10.32 294 1110606 11240 89506307
Femur fracture 62.48 10.32 321 1110579 45761 89471786
Product use in unapproved indication 62.33 10.32 3427 1107473 332809 89184738
Pharyngeal paraesthesia 60.98 10.32 126 1110774 3048 89514499
Cerebrovascular accident 60.85 10.32 1106 1109794 122427 89395120
Post transplant lymphoproliferative disorder 60.69 10.32 7 1110893 6942 89510605
Neutrophil count decreased 60.53 10.32 572 1110328 70960 89446587
Metastases to liver 60.33 10.32 168 1110732 28639 89488908
Thrombocytopenia 60.31 10.32 2024 1108876 206701 89310846
Leukopenia 60.12 10.32 870 1110030 99840 89417707
Pathogen resistance 60.02 10.32 13 1110887 8102 89509445
Anion gap abnormal 59.88 10.32 44 1110856 332 89517215
Haematotoxicity 59.82 10.32 40 1110860 12495 89505052
Ear pain 59.31 10.32 1016 1109884 56686 89460861
Injection site bruising 58.81 10.32 387 1110513 51920 89465627
Pericarditis 58.67 10.32 3953 1106947 266198 89251349
Hypomagnesaemia 58.39 10.32 231 1110669 35357 89482190
Palmar-plantar erythrodysaesthesia syndrome 58.27 10.32 164 1110736 27859 89489688
Urinary tract infection 57.95 10.32 3108 1107792 302524 89215023
Right ventricular failure 57.93 10.32 91 1110809 19114 89498433
Exposure via ingestion 57.38 10.32 111 1110789 2556 89514991
Confusional state 57.35 10.32 5488 1105412 380717 89136830
Pruritus 57.29 10.32 7526 1103374 533999 88983548
Sedation complication 57.27 10.32 380 1110520 16564 89500983
Cytopenia 57.21 10.32 78 1110822 17371 89500176
Gallbladder injury 56.84 10.32 75 1110825 1231 89516316
Mucosal inflammation 56.70 10.32 443 1110457 57182 89460365
Alopecia 55.85 10.32 5266 1105634 489805 89027742
Blood glucose increased 55.74 10.32 826 1110074 94420 89423127
Creatinine renal clearance decreased 55.17 10.32 409 1110491 18490 89499057
Anti-cyclic citrullinated peptide antibody positive 55.01 10.32 3480 1107420 232953 89284594
Drug use disorder 54.69 10.32 225 1110675 8118 89509429
Brain oedema 54.07 10.32 382 1110518 17003 89500544
Metastases to lung 53.94 10.32 70 1110830 15921 89501626
Premature delivery 53.69 10.32 268 1110632 38494 89479053
Liver injury 52.71 10.32 2577 1108323 167990 89349557
Septic shock 52.37 10.32 721 1110179 83439 89434108
Hepatitis cholestatic 52.32 10.32 226 1110674 8335 89509212
Hypothyroidism 52.01 10.32 409 1110491 52718 89464829
Prothrombin time shortened 51.72 10.32 97 1110803 2181 89515366
Therapy partial responder 51.20 10.32 122 1110778 21921 89495626
Pleural effusion 51.05 10.32 1016 1109884 110975 89406572
Acidosis 50.78 10.32 298 1110602 12438 89505109
Feeling abnormal 50.60 10.32 1612 1109288 165623 89351924
Fluid retention 50.50 10.32 767 1110133 87324 89430223
Hypervolaemia 50.39 10.32 218 1110682 32539 89485008
Transient ischaemic attack 49.79 10.32 317 1110583 42859 89474688
Breast cancer female 49.36 10.32 66 1110834 14820 89502727
Infusion site pain 49.27 10.32 412 1110488 19326 89498221
Schizoaffective disorder 49.23 10.32 157 1110743 4990 89512557
Underdose 49.17 10.32 424 1110476 53593 89463954
Hepatic encephalopathy 49.07 10.32 313 1110587 13459 89504088
Infusion site pruritus 48.81 10.32 188 1110712 6577 89510970
Intentional product use issue 48.74 10.32 3183 1107717 213709 89303838
Diabetic ketoacidosis 48.44 10.32 146 1110754 24261 89493286
Ascites 48.39 10.32 364 1110536 47376 89470171
Breast cancer stage I 48.28 10.32 29 1110871 9595 89507952
Cardiac failure acute 48.20 10.32 45 1110855 11884 89505663
Cytokine release syndrome 48.16 10.32 540 1110360 27433 89490114
Tardive dyskinesia 48.10 10.32 38 1110862 10892 89506655
Jejunal ulcer 47.30 10.32 25 1110875 95 89517452
Dry skin 47.08 10.32 777 1110123 87296 89430251
Second primary malignancy 47.05 10.32 35 1110865 10343 89507204
Infusion site swelling 46.58 10.32 274 1110626 11446 89506101
No adverse event 46.12 10.32 572 1110328 67410 89450137
Wound closure 46.08 10.32 27 1110873 131 89517416
Treatment failure 46.08 10.32 3156 1107744 300772 89216775
Accidental exposure to product 45.86 10.32 317 1110583 42049 89475498
Stomatitis 45.85 10.32 3937 1106963 270761 89246786
Disease recurrence 45.73 10.32 272 1110628 37381 89480166
Bone pain 45.72 10.32 512 1110388 61471 89456076
Decreased appetite 45.65 10.32 3983 1106917 372557 89144990
Aspergillus infection 44.71 10.32 40 1110860 10783 89506764
Renal papillary necrosis 44.70 10.32 33 1110867 251 89517296
Periorbital oedema 44.28 10.32 183 1110717 6616 89510931
Tongue oedema 43.89 10.32 157 1110743 5297 89512250
Discomfort 43.80 10.32 3919 1106981 270416 89247131
Hyponatraemia 43.64 10.32 1274 1109626 132264 89385283
Loss of personal independence in daily activities 43.60 10.32 1302 1109598 134803 89382744
Forced expiratory volume decreased 43.58 10.32 9 1110891 5799 89511748
Pharyngitis 43.08 10.32 435 1110465 21512 89496035
Brain empyema 42.87 10.32 14 1110886 6 89517541
Clostridium difficile infection 42.36 10.32 265 1110635 35980 89481567
Visual acuity reduced 42.31 10.32 146 1110754 23264 89494283
Ovarian hyperstimulation syndrome 42.14 10.32 10 1110890 5852 89511695
Hepatitis fulminant 42.07 10.32 125 1110775 3820 89513727
Oral pruritus 42.01 10.32 104 1110796 2847 89514700
Kounis syndrome 41.79 10.32 95 1110805 2458 89515089
Injection site reaction 41.78 10.32 836 1110064 91244 89426303
Chronic obstructive pulmonary disease 41.57 10.32 645 1110255 73184 89444363
Anaphylactic reaction 41.34 10.32 1384 1109516 86140 89431407
Heart rate increased 41.01 10.32 1734 1109166 111168 89406379
Haemoglobin decreased 40.99 10.32 1596 1109304 160360 89357187
Melaena 40.72 10.32 626 1110274 34171 89483376
Cardiotoxicity 40.36 10.32 48 1110852 11341 89506206
Hip fracture 40.14 10.32 239 1110661 32838 89484709
Gastrointestinal pain 40.12 10.32 255 1110645 10951 89506596
Oedema peripheral 39.95 10.32 2673 1108227 255242 89262305
Dyskinesia 39.72 10.32 273 1110627 36261 89481286
Staphylococcal infection 39.43 10.32 391 1110509 48048 89469499
Infusion site erythema 39.43 10.32 295 1110605 13375 89504172
Chronic graft versus host disease 39.25 10.32 3 1110897 4136 89513411
Cognitive disorder 39.01 10.32 1121 1109779 68286 89449261
Tachycardia 38.93 10.32 2333 1108567 155340 89362207
Treatment noncompliance 38.66 10.32 426 1110474 51301 89466246
Epistaxis 38.57 10.32 773 1110127 84352 89433195
Blood calcium decreased 38.46 10.32 551 1110349 29631 89487916
Extrapyramidal disorder 38.05 10.32 90 1110810 16213 89501334
Therapeutic response decreased 37.95 10.32 824 1110076 88905 89428642
Intestinal diaphragm disease 37.93 10.32 24 1110876 137 89517410
Hypoaldosteronism 37.89 10.32 33 1110867 326 89517221
Drug level increased 37.87 10.32 513 1110387 27249 89490298
Coronary artery disease 37.68 10.32 249 1110651 33374 89484173
Jaundice cholestatic 37.50 10.32 231 1110669 9812 89507735
Abdominal pain 37.17 10.32 5462 1105438 390259 89127288
Osteotomy 37.00 10.32 30 1110870 266 89517281
Blood pressure diastolic increased 36.93 10.32 278 1110622 12628 89504919
Hypomania 36.66 10.32 210 1110690 8687 89508860
Cytomegalovirus viraemia 36.48 10.32 24 1110876 7562 89509985
Sleep disorder due to a general medical condition 36.47 10.32 361 1110539 44377 89473170
Product quality issue 36.34 10.32 719 1110181 78606 89438941
Neonatal cardiac failure 36.17 10.32 12 1110888 6 89517541
Oesophageal obstruction 36.16 10.32 44 1110856 663 89516884
Acute graft versus host disease 36.15 10.32 11 1110889 5457 89512090
Osteonecrosis 36.02 10.32 182 1110718 26059 89491488
Renal disorder 35.88 10.32 294 1110606 37565 89479982
Seizure 35.86 10.32 1517 1109383 151112 89366435
Mydriasis 35.71 10.32 310 1110590 14702 89502845
Device leakage 35.52 10.32 42 1110858 9949 89507598
Joint destruction 35.48 10.32 68 1110832 13219 89504328
Surgery 35.43 10.32 365 1110535 44522 89473025
Device difficult to use 35.38 10.32 104 1110796 17421 89500126
Bronchopulmonary aspergillosis 35.34 10.32 53 1110847 11345 89506202
Blood iron abnormal 35.23 10.32 4 1110896 4016 89513531
Injection site haemorrhage 35.23 10.32 203 1110697 28115 89489432
Foreign body in throat 35.22 10.32 36 1110864 442 89517105
Aspartate aminotransferase increased 35.17 10.32 1571 1109329 101366 89416181
Exposure via skin contact 34.95 10.32 48 1110852 10657 89506890
Pain in jaw 34.75 10.32 398 1110502 47587 89469960
Injection site rash 34.72 10.32 165 1110735 24008 89493539
Cerebral infarction 34.53 10.32 188 1110712 26408 89491139
Cholestasis 34.40 10.32 631 1110269 35668 89481879
Injection site urticaria 34.15 10.32 110 1110790 17901 89499646
Dissociation 34.02 10.32 20 1110880 6695 89510852
Blood pressure increased 33.91 10.32 2833 1108067 194384 89323163
Electric shock 33.84 10.32 69 1110831 1653 89515894
Device related infection 33.63 10.32 182 1110718 25604 89491943
Jaundice 33.58 10.32 573 1110327 31944 89485603
Asthma 33.38 10.32 2535 1108365 239625 89277922
Foetal acidosis 33.29 10.32 12 1110888 11 89517536
Muscle spasms 33.13 10.32 2647 1108253 249236 89268311
Pulmonary infarction 33.12 10.32 94 1110806 2798 89514749
Weight increased 32.81 10.32 5712 1105188 412215 89105332
Lip swelling 32.45 10.32 659 1110241 37951 89479596
Urinary sediment present 32.42 10.32 78 1110822 2096 89515451
Hepatitis B reactivation 32.33 10.32 5 1110895 3969 89513578
Hypokalaemia 32.33 10.32 1296 1109604 129820 89387727
Left ventricular dysfunction 31.88 10.32 84 1110816 14585 89502962
Injection site warmth 31.81 10.32 109 1110791 17406 89500141
Infusion site extravasation 31.57 10.32 226 1110674 10102 89507445
Transaminases increased 31.33 10.32 635 1110265 36557 89480990
Cardiac failure chronic 31.27 10.32 15 1110885 5631 89511916
Renal failure 31.22 10.32 1300 1109600 129707 89387840
Lymphoproliferative disorder 31.17 10.32 7 1110893 4255 89513292
Dyspnoea 31.12 10.32 9993 1100907 870962 88646585
Transplant dysfunction 30.88 10.32 13 1110887 5269 89512278
Hypotension 30.86 10.32 4494 1106406 320903 89196644
Crystal urine present 30.83 10.32 61 1110839 1429 89516118
Acute graft versus host disease in skin 30.67 10.32 10 1110890 4746 89512801
Electrocardiogram QRS complex prolonged 30.65 10.32 174 1110726 7174 89510373
White blood cells urine positive 30.56 10.32 159 1110741 6339 89511208
Sopor 30.47 10.32 177 1110723 24467 89493080
Cellulitis 30.44 10.32 869 1110031 90468 89427079
Graft versus host disease 30.30 10.32 33 1110867 8111 89509436
Pneumonia aspiration 30.26 10.32 338 1110562 40602 89476945
Spinal stenosis 29.94 10.32 111 1110789 17313 89500234
Psoriasis 29.78 10.32 1493 1109407 146261 89371286
Diffuse large B-cell lymphoma recurrent 29.70 10.32 4 1110896 3522 89514025
Allergy test negative 29.58 10.32 24 1110876 213 89517334
Osteoporosis 29.54 10.32 929 1109971 95602 89421945
Schizophrenia 29.46 10.32 296 1110604 14618 89502929
Colorectal cancer 29.28 10.32 6 1110894 3887 89513660
Blood immunoglobulin E increased 29.08 10.32 9 1110891 4416 89513131
Malaise 28.92 10.32 6550 1104350 579436 88938111
Haemophagocytic lymphohistiocytosis 28.90 10.32 95 1110805 15364 89502183
Acute myocardial infarction 28.66 10.32 281 1110619 34609 89482938
Deep vein thrombosis 28.66 10.32 1386 1109514 90234 89427313
Cytomegalovirus infection reactivation 28.59 10.32 32 1110868 7768 89509779
Mucormycosis 28.51 10.32 6 1110894 3815 89513732
Injection site discolouration 28.26 10.32 44 1110856 9276 89508271
Duodenal ulcer haemorrhage 28.23 10.32 82 1110818 2474 89515073
Anion gap increased 28.19 10.32 76 1110824 2194 89515353
Peripheral swelling 28.18 10.32 5606 1105294 407500 89110047
Heart rate irregular 28.17 10.32 436 1110464 23832 89493715
Laryngeal discomfort 28.09 10.32 31 1110869 418 89517129
Laryngeal oedema 28.08 10.32 162 1110738 6719 89510828
Catatonia 28.01 10.32 20 1110880 6036 89511511
Gallbladder cholesterolosis 27.93 10.32 41 1110859 747 89516800
Drug ineffective for unapproved indication 27.90 10.32 613 1110287 66031 89451516
Abortion incomplete 27.84 10.32 3 1110897 3137 89514410
Analgesic drug level above therapeutic 27.74 10.32 20 1110880 146 89517401
Systemic candida 27.74 10.32 13 1110887 4946 89512601
Urine leukocyte esterase positive 27.73 10.32 96 1110804 3186 89514361
Injection site mass 27.67 10.32 158 1110742 21932 89495615
Mania 27.66 10.32 85 1110815 14039 89503508
Pericardial effusion 27.66 10.32 303 1110597 36530 89481017
Adrenal insufficiency 27.61 10.32 234 1110666 29687 89487860
Maternal exposure during pregnancy 27.50 10.32 3931 1106969 356132 89161415
SJS-TEN overlap 27.45 10.32 49 1110851 1059 89516488
Glomerulonephritis minimal lesion 27.38 10.32 28 1110872 344 89517203
Haemorrhage 27.36 10.32 644 1110256 68725 89448822
Body temperature decreased 27.31 10.32 427 1110473 23389 89494158
Infection 27.12 10.32 4937 1105963 357157 89160390
Graft versus host disease in gastrointestinal tract 26.96 10.32 10 1110890 4378 89513169
Device dislocation 26.95 10.32 251 1110649 31231 89486316
Blood potassium decreased 26.86 10.32 417 1110483 47310 89470237
Eye pruritus 26.79 10.32 227 1110673 28800 89488747
Skin cancer 26.74 10.32 81 1110819 13438 89504109
Paradoxical drug reaction 26.72 10.32 19 1110881 5747 89511800
Tubulointerstitial nephritis and uveitis syndrome 26.71 10.32 24 1110876 248 89517299
Endophthalmitis 26.64 10.32 12 1110888 4673 89512874
Open globe injury 26.60 10.32 13 1110887 40 89517507
Immunosuppressant drug level increased 26.59 10.32 12 1110888 4668 89512879
Drug tolerance 26.49 10.32 121 1110779 17795 89499752
Lemierre syndrome 26.47 10.32 17 1110883 100 89517447
Urine abnormality 26.44 10.32 174 1110726 7563 89509984
Respiratory disorder 26.44 10.32 1008 1109892 63808 89453739
Toxic shock syndrome streptococcal 26.17 10.32 25 1110875 281 89517266
Generalised bullous fixed drug eruption 26.13 10.32 27 1110873 336 89517211
Intestinal obstruction 26.10 10.32 310 1110590 36821 89480726
Complication associated with device 26.07 10.32 136 1110764 19313 89498234
Polyneuropathy 26.06 10.32 135 1110765 19206 89498341
Device use error 26.06 10.32 30 1110870 7191 89510356
Congestive cardiomyopathy 26.06 10.32 31 1110869 7323 89510224
Throat tightness 26.04 10.32 507 1110393 28977 89488570
Product complaint 25.91 10.32 82 1110818 13418 89504129
Herpes zoster 25.87 10.32 924 1109976 93720 89423827
Hyperglycaemia 25.83 10.32 454 1110446 50516 89467031
Stress cardiomyopathy 25.71 10.32 81 1110819 13274 89504273
Renal failure neonatal 25.57 10.32 21 1110879 190 89517357
Night sweats 25.46 10.32 1870 1109030 126896 89390651
Chronic kidney disease 25.45 10.32 447 1110453 49744 89467803
Blood pH decreased 25.36 10.32 79 1110821 2479 89515068
Eczema 25.20 10.32 476 1110424 52394 89465153
Gastritis 25.04 10.32 680 1110220 41073 89476474
Metastases to central nervous system 25.04 10.32 120 1110780 17422 89500125
Anticipatory anxiety 24.94 10.32 50 1110850 1183 89516364
Hepatic cirrhosis 24.73 10.32 588 1110312 62665 89454882
Impaired quality of life 24.64 10.32 174 1110726 22970 89494577
Mitral valve incompetence 24.64 10.32 168 1110732 22356 89495191
Gastrooesophageal reflux disease 24.56 10.32 1731 1109169 164606 89352941
Hyperkalaemia 24.55 10.32 607 1110293 64357 89453190
Perichondritis 24.53 10.32 14 1110886 64 89517483
Cardiomyopathy 24.52 10.32 146 1110754 20060 89497487
Tremor 24.46 10.32 1583 1109317 151590 89365957
Dermo-hypodermitis 24.39 10.32 39 1110861 768 89516779
Human herpesvirus 6 infection 24.38 10.32 6 1110894 3426 89514121
Visual impairment 24.32 10.32 1350 1109550 131015 89386532
Coagulation factor decreased 24.17 10.32 20 1110880 183 89517364
Hallucination, auditory 24.16 10.32 107 1110793 15868 89501679
Myopathy 23.96 10.32 85 1110815 13433 89504114
Anticholinergic syndrome 23.84 10.32 81 1110819 2662 89514885
Multiple organ dysfunction syndrome 23.83 10.32 646 1110254 67690 89449857
Cholesterosis 23.83 10.32 29 1110871 437 89517110
Hypoglycaemic coma 23.79 10.32 4 1110896 2986 89514561
Oxygen saturation decreased 23.70 10.32 1575 1109325 105908 89411639
Administration site swelling 23.68 10.32 55 1110845 1444 89516103
Ageusia 23.52 10.32 109 1110791 15967 89501580
Anosognosia 23.44 10.32 7 1110893 3515 89514032
Epstein-Barr virus infection 23.43 10.32 58 1110842 10286 89507261
Blood creatine increased 23.39 10.32 156 1110744 6811 89510736
Accidental exposure to product by child 23.39 10.32 51 1110849 1282 89516265
Necrotising fasciitis 23.39 10.32 102 1110798 3778 89513769
Cholecystitis acute 23.32 10.32 196 1110704 9208 89508339
Cystitis haemorrhagic 23.23 10.32 20 1110880 5493 89512054
JC virus infection 23.11 10.32 3 1110897 2716 89514831
Skin discolouration 23.01 10.32 393 1110507 43922 89473625
Aplasia pure red cell 22.93 10.32 18 1110882 5176 89512371
Serum sickness-like reaction 22.91 10.32 32 1110868 556 89516991
Ventricular tachycardia 22.91 10.32 193 1110707 24515 89493032
Acute respiratory failure 22.81 10.32 379 1110521 42539 89475008
Incorrect dose administered by device 22.76 10.32 22 1110878 5715 89511832
Carpal tunnel syndrome 22.59 10.32 186 1110714 23742 89493805
Gallbladder hypofunction 22.57 10.32 29 1110871 463 89517084
Kidney transplant rejection 22.51 10.32 16 1110884 4841 89512706
Needle issue 22.51 10.32 91 1110809 13843 89503704
Musculoskeletal stiffness 22.50 10.32 4046 1106854 292486 89225061
Cerebral haemorrhage 22.47 10.32 293 1110607 34229 89483318
Lymphoma 22.43 10.32 88 1110812 13503 89504044
Renal tubular necrosis 22.40 10.32 275 1110625 14280 89503267
Vanishing bile duct syndrome 22.40 10.32 51 1110849 1321 89516226
Foreign body in gastrointestinal tract 22.36 10.32 13 1110887 62 89517485
Fear of disease 22.06 10.32 53 1110847 1423 89516124
Respiratory rate increased 21.96 10.32 296 1110604 15705 89501842
BK virus infection 21.95 10.32 14 1110886 4484 89513063
Varicella zoster virus infection 21.94 10.32 10 1110890 3867 89513680
Gastric perforation 21.71 10.32 64 1110836 1947 89515600
Anhedonia 21.69 10.32 225 1110675 11206 89506341
Biliary colic 21.65 10.32 103 1110797 3960 89513587
Vision blurred 21.55 10.32 1118 1109782 109175 89408372
Laryngospasm 21.51 10.32 7 1110893 3326 89514221
Nocardiosis 21.45 10.32 3 1110897 2567 89514980
Immune reconstitution inflammatory syndrome 21.42 10.32 33 1110867 6986 89510561
Pancreatic carcinoma 21.40 10.32 44 1110856 8333 89509214
Lymphocyte count decreased 21.35 10.32 572 1110328 34478 89483069
Gastritis erosive 21.34 10.32 149 1110751 6606 89510941
Head injury 21.31 10.32 262 1110638 30926 89486621
Coma hepatic 21.26 10.32 33 1110867 633 89516914
Systemic lupus erythematosus rash 21.17 10.32 71 1110829 2318 89515229
Loss of consciousness 21.10 10.32 1457 1109443 138781 89378766
Cystic fibrosis 21.03 10.32 11 1110889 3930 89513617
Duodenitis haemorrhagic 20.95 10.32 8 1110892 10 89517537
Transfusion 20.88 10.32 127 1110773 17361 89500186
Palatal oedema 20.78 10.32 33 1110867 646 89516901
Clostridium test positive 20.65 10.32 125 1110775 5276 89512271
Product preparation error 20.64 10.32 61 1110839 10200 89507347
Glomerulonephritis membranous 20.58 10.32 34 1110866 689 89516858
Akathisia 20.57 10.32 69 1110831 11090 89506457
Polyomavirus-associated nephropathy 20.56 10.32 3 1110897 2487 89515060
Genital odour 20.48 10.32 6 1110894 0 89517547
Specific gravity urine decreased 20.46 10.32 36 1110864 769 89516778
Infusion site rash 20.43 10.32 72 1110828 2411 89515136
Coagulation factor X level decreased 20.36 10.32 12 1110888 59 89517488
Prothrombin time prolonged 20.30 10.32 196 1110704 9576 89507971
Dry eye 20.11 10.32 548 1110352 57383 89460164
Sinus node dysfunction 20.06 10.32 22 1110878 5390 89512157
Substance abuse 19.97 10.32 124 1110776 5282 89512265
Torsade de pointes 19.88 10.32 107 1110793 15075 89502472
Pharyngeal abscess 19.65 10.32 25 1110875 395 89517152
Hepatic function abnormal 19.59 10.32 425 1110475 45863 89471684
Malnutrition 19.52 10.32 140 1110760 18418 89499129
Lymphocyte percentage decreased 19.46 10.32 83 1110817 3044 89514503
Ear infection 19.45 10.32 1044 1109856 68731 89448816
Myalgia 19.38 10.32 1865 1109035 173260 89344287
Thinking abnormal 19.34 10.32 76 1110824 11656 89505891
Synovitis 19.34 10.32 4443 1106457 325309 89192238
Spinal compression fracture 19.31 10.32 108 1110792 15070 89502477
Stent placement 19.28 10.32 14 1110886 4189 89513358
Oedema 19.19 10.32 2155 1108745 198140 89319407
Electrolyte imbalance 19.19 10.32 192 1110708 23553 89493994
Blood bilirubin increased 19.17 10.32 682 1110218 42788 89474759
Drug screen positive 19.12 10.32 94 1110806 3663 89513884
Miosis 19.11 10.32 189 1110711 9295 89508252
Type I hypersensitivity 19.08 10.32 101 1110799 4054 89513493
Eye irritation 19.07 10.32 297 1110603 33681 89483866
Sleep apnoea syndrome 19.03 10.32 274 1110626 31473 89486074
Leukoencephalopathy 18.97 10.32 19 1110881 4854 89512693
Liver transplant 18.91 10.32 67 1110833 2250 89515297
Atypical femur fracture 18.82 10.32 31 1110869 6390 89511157
Hepatitis toxic 18.82 10.32 93 1110807 3632 89513915
Headache 18.80 10.32 11209 1099691 851537 88666010
Swelling 18.77 10.32 5581 1105319 413477 89104070
Uterine cancer 18.76 10.32 23 1110877 5362 89512185
Klebsiella infection 18.76 10.32 64 1110836 10233 89507314
Blood magnesium decreased 18.72 10.32 114 1110786 15579 89501968
Therapy non-responder 18.67 10.32 1432 1109468 135272 89382275
Breast cancer recurrent 18.65 10.32 24 1110876 5479 89512068
Catheterisation cardiac 18.53 10.32 20 1110880 4936 89512611
Therapeutic product effect decreased 18.53 10.32 3763 1107137 273808 89243739
Metabolic disorder 18.44 10.32 40 1110860 7430 89510117
Diffuse large B-cell lymphoma 18.41 10.32 50 1110850 8595 89508952
Glutathione decreased 18.35 10.32 9 1110891 28 89517519
Unresponsive to stimuli 18.30 10.32 604 1110296 37517 89480030
Shoulder arthroplasty 18.27 10.32 100 1110800 4066 89513481
Blood prolactin increased 18.19 10.32 11 1110889 3626 89513921
International normalised ratio increased 18.16 10.32 731 1110169 46585 89470962
Dizziness 18.14 10.32 6719 1104181 582565 88934982
Low turnover osteopathy 18.14 10.32 15 1110885 4203 89513344
Ceruloplasmin decreased 18.09 10.32 6 1110894 3 89517544
Paraesthesia ear 18.00 10.32 25 1110875 432 89517115
Intracranial pressure increased 17.99 10.32 144 1110756 6667 89510880
Unintended pregnancy 17.95 10.32 42 1110858 7595 89509952
Cryopyrin associated periodic syndrome 17.93 10.32 28 1110872 540 89517007
Glucose tolerance impaired 17.91 10.32 45 1110855 7940 89509607
Infusion site bruising 17.89 10.32 103 1110797 4269 89513278
Multiple drug therapy 17.87 10.32 147 1110753 6862 89510685
Thyroid cancer 17.81 10.32 31 1110869 6253 89511294
Inappropriate antidiuretic hormone secretion 17.79 10.32 153 1110747 19352 89498195
Lupus-like syndrome 17.76 10.32 459 1110441 48387 89469160
Neonatal hypoxia 17.69 10.32 32 1110868 699 89516848
Aorto-oesophageal fistula 17.68 10.32 9 1110891 31 89517516
Poor venous access 17.66 10.32 337 1110563 19190 89498357
Drug hypersensitivity 17.63 10.32 6135 1104765 457474 89060073
Metastases to peritoneum 17.60 10.32 15 1110885 4140 89513407
Prothrombin level decreased 17.59 10.32 31 1110869 663 89516884
Enterococcal infection 17.59 10.32 63 1110837 9928 89507619
Ischaemic stroke 17.59 10.32 180 1110720 21986 89495561
Nodule 17.55 10.32 226 1110674 26460 89491087
Leukocytosis 17.54 10.32 501 1110399 30489 89487058
Hypertransaminasaemia 17.50 10.32 282 1110618 15543 89502004
Ludwig angina 17.49 10.32 11 1110889 62 89517485
Bronchitis 17.43 10.32 1625 1109275 151302 89366245
Obstructive airways disorder 17.41 10.32 218 1110682 25651 89491896
Contusion 17.40 10.32 3412 1107488 247804 89269743
Functional gastrointestinal disorder 17.39 10.32 114 1110786 4948 89512599
Neutrophil percentage increased 17.38 10.32 78 1110822 2925 89514622
Memory impairment 17.38 10.32 2134 1108766 195110 89322437
Ulcer 17.36 10.32 527 1110373 32355 89485192
Red blood cells urine positive 17.36 10.32 82 1110818 3143 89514404
Dysmorphism 17.28 10.32 5 1110895 2563 89514984
Bacterial test 17.27 10.32 41 1110859 1092 89516455
Bundle branch block left 17.25 10.32 45 1110855 7840 89509707
Aortic valve stenosis 17.12 10.32 16 1110884 4224 89513323
Mycobacterium avium complex infection 17.10 10.32 15 1110885 4083 89513464
Brain stem glioma 17.09 10.32 16 1110884 175 89517372
Viral parotitis 17.07 10.32 5 1110895 0 89517547
Glycosylated haemoglobin increased 17.06 10.32 116 1110784 15446 89502101
Cardiac operation 17.04 10.32 14 1110886 3935 89513612
Administration site pain 17.03 10.32 42 1110858 1147 89516400
Red blood cell count decreased 17.00 10.32 435 1110465 45916 89471631
Occupational exposure to product 16.90 10.32 5 1110895 2526 89515021
Weight decreased 16.86 10.32 4267 1106633 375643 89141904
Polycystic ovaries 16.85 10.32 27 1110873 5627 89511920
Body tinea 16.81 10.32 3 1110897 2145 89515402
Lung adenocarcinoma stage IV 16.81 10.32 24 1110876 426 89517121
Status epilepticus 16.80 10.32 149 1110751 18725 89498822
Rash maculo-papular 16.79 10.32 637 1110263 40296 89477251
Pancreatitis acute 16.77 10.32 514 1110386 31601 89485946
Fatigue 16.66 10.32 13469 1097431 1140554 88376993
Product administration error 16.61 10.32 433 1110467 25990 89491557
Skin exfoliation 16.58 10.32 672 1110228 67241 89450306
Epstein-Barr virus associated lymphoproliferative disorder 16.52 10.32 6 1110894 2661 89514886
Ankle arthroplasty 16.50 10.32 7 1110893 2824 89514723
Oropharyngeal discomfort 16.49 10.32 156 1110744 7579 89509968
Ejection fraction abnormal 16.49 10.32 5 1110895 2486 89515061
Hypertensive crisis 16.45 10.32 139 1110761 17645 89499902
Loss of employment 16.45 10.32 8 1110892 2979 89514568
Choluria 16.41 10.32 18 1110882 241 89517306
Enthesopathy 16.40 10.32 182 1110718 9222 89508325
Food interaction 16.39 10.32 43 1110857 1221 89516326
Mixed liver injury 16.39 10.32 154 1110746 7469 89510078
Eosinophilic oesophagitis 16.33 10.32 34 1110866 827 89516720
Intervertebral discitis 16.27 10.32 103 1110797 4417 89513130
Rheumatic fever 16.25 10.32 2129 1108771 150992 89366555
Galactorrhoea 16.23 10.32 20 1110880 4652 89512895
Condition aggravated 16.11 10.32 6822 1104078 588723 88928824
Febrile bone marrow aplasia 16.11 10.32 63 1110837 9675 89507872
Hepatitis B 16.06 10.32 19 1110881 4500 89513047
Lung transplant 16.04 10.32 13 1110887 3679 89513868
Nephritis allergic 16.01 10.32 20 1110880 310 89517237
Large intestine polyp 15.99 10.32 60 1110840 9326 89508221
Osmolar gap 15.98 10.32 12 1110888 94 89517453
Menstrual discomfort 15.93 10.32 6 1110894 7 89517540
Weight fluctuation 15.91 10.32 335 1110565 19414 89498133
Injection site induration 15.90 10.32 70 1110830 10398 89507149
Wheelchair user 15.86 10.32 46 1110854 7739 89509808
Hyperlipidaemia 15.85 10.32 192 1110708 22724 89494823
Acute myeloid leukaemia recurrent 15.83 10.32 3 1110897 2054 89515493
Blood lactic acid increased 15.82 10.32 171 1110729 8607 89508940
Dystonia 15.76 10.32 131 1110769 16688 89500859
Pulmonary alveolar haemorrhage 15.75 10.32 31 1110869 5967 89511580
Multiple sclerosis 15.74 10.32 450 1110450 27390 89490157
Ventricular fibrillation 15.74 10.32 104 1110796 13940 89503607
Cyanosis neonatal 15.63 10.32 23 1110877 420 89517127
Injury associated with device 15.62 10.32 19 1110881 4445 89513102
Drug provocation test 15.62 10.32 8 1110892 28 89517519
Thrombosis 15.57 10.32 736 1110164 72515 89445032
Bone erosion 15.57 10.32 513 1110387 52508 89465039
Blood glucose decreased 15.56 10.32 198 1110702 23231 89494316
Pulmonary arterial pressure increased 15.55 10.32 15 1110885 3901 89513646
Allodynia 15.55 10.32 37 1110863 987 89516560
Caesarean section 15.52 10.32 149 1110751 18428 89499119
Gout 15.49 10.32 132 1110768 16727 89500820
Mayer-Rokitansky-Kuster-Hauser syndrome 15.48 10.32 7 1110893 17 89517530
Vasoplegia syndrome 15.48 10.32 72 1110828 2742 89514805
Catheter management 15.44 10.32 9 1110891 3027 89514520
Tachypnoea 15.44 10.32 356 1110544 20953 89496594
Coma scale abnormal 15.44 10.32 120 1110780 5506 89512041
Osteopenia 15.42 10.32 194 1110706 22808 89494739
Specific gravity urine abnormal 15.40 10.32 11 1110889 79 89517468
Coagulation factor VII level decreased 15.40 10.32 11 1110889 79 89517468
Erythema multiforme 15.38 10.32 223 1110677 12023 89505524
Speech disorder 15.36 10.32 433 1110467 45152 89472395
Rebound effect 15.34 10.32 61 1110839 9323 89508224
Ocular hyperaemia 15.28 10.32 307 1110593 33491 89484056
Hyperthyroidism 15.24 10.32 147 1110753 18163 89499384
Infusion site urticaria 15.22 10.32 51 1110849 1664 89515883
Distichiasis 15.21 10.32 8 1110892 30 89517517
Mobility decreased 15.14 10.32 3383 1107517 247351 89270196
Peritonitis bacterial 15.13 10.32 25 1110875 5146 89512401
Lung neoplasm malignant 15.08 10.32 208 1110692 24065 89493482
Scleroderma 15.07 10.32 34 1110866 6227 89511320
Sinus tachycardia 15.06 10.32 457 1110443 28056 89489491
Asthenia 15.06 10.32 6105 1104795 527646 88989901
Chondritis 15.03 10.32 10 1110890 63 89517484
Amniotic cavity disorder 15.03 10.32 10 1110890 63 89517484
Genital tract inflammation 14.97 10.32 11 1110889 83 89517464
Ovarian germ cell teratoma benign 14.96 10.32 14 1110886 153 89517394
Low density lipoprotein increased 14.90 10.32 50 1110850 8035 89509512
Substance abuser 14.81 10.32 15 1110885 182 89517365
Diabetic metabolic decompensation 14.75 10.32 3 1110897 1954 89515593
Small intestine ulcer 14.70 10.32 21 1110879 373 89517174
Nasal pruritus 14.68 10.32 30 1110870 720 89516827
Body temperature fluctuation 14.63 10.32 61 1110839 2214 89515333
Peripheral sensory neuropathy 14.57 10.32 61 1110839 9189 89508358
Catheter site pruritus 14.57 10.32 5 1110895 2297 89515250
Drug withdrawal headache 14.56 10.32 9 1110891 49 89517498
Renal cancer 14.54 10.32 32 1110868 5913 89511634
Fracture 14.50 10.32 187 1110713 21889 89495658
Product dose omission in error 14.48 10.32 171 1110729 20332 89497215
Poor quality device used 14.47 10.32 5 1110895 2288 89515259
Hepatic infiltration eosinophilic 14.45 10.32 7 1110893 21 89517526
Physical deconditioning 14.43 10.32 60 1110840 2175 89515372
Tumour lysis syndrome 14.38 10.32 79 1110821 11073 89506474
Bladder cancer 14.37 10.32 31 1110869 5770 89511777
Cutaneous vasculitis 14.32 10.32 143 1110757 7050 89510497
Infusion site mass 14.32 10.32 59 1110841 2130 89515417
Dermatitis 14.31 10.32 189 1110711 22031 89495516
Delusion 14.27 10.32 105 1110795 13735 89503812
Sexual dysfunction 14.26 10.32 23 1110877 4781 89512766
Urosepsis 14.26 10.32 179 1110721 21053 89496494
Pneumonia streptococcal 14.24 10.32 58 1110842 2083 89515464
Drug withdrawal syndrome 14.19 10.32 257 1110643 28466 89489081
Sputum culture positive 14.17 10.32 60 1110840 2193 89515354
Orbital compartment syndrome 14.17 10.32 11 1110889 91 89517456
Nasal necrosis 14.15 10.32 12 1110888 114 89517433
Renal cortical necrosis 14.12 10.32 18 1110882 285 89517262
Amenorrhoea 14.06 10.32 85 1110815 11637 89505910
Tonsillar erythema 14.04 10.32 6 1110894 12 89517535
Pineal gland cyst 14.01 10.32 15 1110885 195 89517352
Product adhesion issue 14.01 10.32 26 1110874 5116 89512431
Enzyme induction 14.01 10.32 9 1110891 53 89517494
Metabolic myopathy 13.98 10.32 12 1110888 116 89517431
Febrile neutropenia 13.97 10.32 1713 1109187 156636 89360911
Acute lymphocytic leukaemia recurrent 13.93 10.32 8 1110892 2713 89514834
Neonatal respiratory acidosis 13.93 10.32 17 1110883 257 89517290
Grief reaction 13.93 10.32 17 1110883 257 89517290
Ejection fraction decreased 13.90 10.32 232 1110668 26021 89491526
Magnesium deficiency 13.86 10.32 29 1110871 708 89516839
Adenovirus infection 13.85 10.32 22 1110878 4600 89512947
Pneumatosis intestinalis 13.85 10.32 13 1110887 3424 89514123
Pulmonary function test decreased 13.84 10.32 21 1110879 4473 89513074
Syncope 13.81 10.32 1419 1109481 131244 89386303
Soft tissue disorder 13.77 10.32 95 1110805 4195 89513352
Polyarthritis 13.76 10.32 151 1110749 18199 89499348
Neuroblastoma recurrent 13.75 10.32 14 1110886 171 89517376
Tenosynovitis 13.73 10.32 253 1110647 14314 89503233
Allergy test positive 13.72 10.32 29 1110871 713 89516834
Infective pulmonary exacerbation of cystic fibrosis 13.71 10.32 72 1110828 10207 89507340
Eosinophil percentage increased 13.67 10.32 35 1110865 979 89516568
Parapharyngeal space infection 13.67 10.32 5 1110895 5 89517542
Skin adhesion 13.66 10.32 4 1110896 0 89517547
Shoulder injury related to vaccine administration 13.66 10.32 4 1110896 0 89517547
Barbiturates positive 13.66 10.32 4 1110896 0 89517547
Breast cancer stage IV 13.65 10.32 4 1110896 2034 89515513
Application site pain 13.64 10.32 23 1110877 4697 89512850
Autoimmune hepatitis 13.60 10.32 190 1110710 10161 89507386
Tumour marker increased 13.60 10.32 32 1110868 5775 89511772
Post cholecystectomy syndrome 13.56 10.32 32 1110868 849 89516698
Oesophageal discomfort 13.53 10.32 18 1110882 298 89517249
Blood glucose abnormal 13.51 10.32 65 1110835 9427 89508120
Substance use disorder 13.47 10.32 4 1110896 2016 89515531
Alpha 1 microglobulin increased 13.47 10.32 8 1110892 40 89517507
Abdominal distension 13.45 10.32 1398 1109502 129203 89388344
Device issue 13.44 10.32 268 1110632 29269 89488278
Acute haemorrhagic oedema of infancy 13.43 10.32 6 1110894 14 89517533
Potentiating drug interaction 13.42 10.32 31 1110869 5631 89511916
Carcinoembryonic antigen increased 13.39 10.32 6 1110894 2344 89515203
Vitamin K deficiency 13.38 10.32 23 1110877 482 89517065
H1N1 influenza 13.37 10.32 4 1110896 2006 89515541
Electrocardiogram U-wave abnormality 13.36 10.32 7 1110893 26 89517521
Hand deformity 13.35 10.32 3948 1106952 292414 89225133
Squamous cell carcinoma 13.33 10.32 71 1110829 10030 89507517
Gastric ulcer haemorrhage 13.33 10.32 111 1110789 5200 89512347
Pre-eclampsia 13.31 10.32 80 1110820 10968 89506579
Local anaesthetic systemic toxicity 13.22 10.32 14 1110886 3486 89514061
Body height below normal 13.22 10.32 5 1110895 2163 89515384
Device deployment issue 13.22 10.32 25 1110875 4884 89512663
Macular oedema 13.22 10.32 25 1110875 4884 89512663
Blood copper decreased 13.20 10.32 5 1110895 6 89517541
Spinal fracture 13.20 10.32 190 1110710 21826 89495721
Eye haemorrhage 13.19 10.32 72 1110828 10108 89507439
Injection site hyperaesthesia 13.13 10.32 9 1110891 60 89517487
Blood bicarbonate decreased 13.10 10.32 74 1110826 3045 89514502
Granulocyte count increased 13.07 10.32 45 1110855 1489 89516058
Nutritional supplementation 13.02 10.32 8 1110892 43 89517504
Infusion site haemorrhage 13.01 10.32 112 1110788 5299 89512248
Periorbital swelling 12.98 10.32 102 1110798 4696 89512851
Cardiac dysfunction 12.92 10.32 15 1110885 3582 89513965
Thrombophlebitis septic 12.88 10.32 17 1110883 279 89517268
pH body fluid decreased 12.88 10.32 6 1110894 16 89517531
Administration site bruise 12.87 10.32 22 1110878 459 89517088
Harlequin syndrome 12.74 10.32 15 1110885 218 89517329
Band neutrophil count increased 12.69 10.32 20 1110880 389 89517158
Vital capacity decreased 12.68 10.32 50 1110850 1769 89515778
Infected dermal cyst 12.67 10.32 22 1110878 465 89517082
Upper limb fracture 12.66 10.32 187 1110713 21391 89496156
Infection reactivation 12.65 10.32 4 1110896 1936 89515611
Escherichia infection 12.65 10.32 129 1110771 15766 89501781
Eastern Cooperative Oncology Group performance status worsened 12.64 10.32 4 1110896 1935 89515612
Hepatocellular carcinoma 12.63 10.32 7 1110893 2421 89515126
Product administered to patient of inappropriate age 12.63 10.32 99 1110801 4554 89512993
Angina unstable 12.61 10.32 45 1110855 7098 89510449
Gait disturbance 12.60 10.32 2914 1107986 257582 89259965
Pneumonitis 12.58 10.32 429 1110471 43741 89473806
Antidepressant drug level above therapeutic 12.57 10.32 22 1110878 468 89517079
Costovertebral angle tenderness 12.45 10.32 13 1110887 164 89517383
Skin toxicity 12.44 10.32 42 1110858 6737 89510810
Therapy change 12.43 10.32 56 1110844 8266 89509281
Supraventricular tachycardia 12.42 10.32 134 1110766 16202 89501345
Bleeding time abnormal 12.39 10.32 5 1110895 8 89517539
Metastases to lymph nodes 12.39 10.32 88 1110812 11601 89505946
Haemorrhage subcutaneous 12.37 10.32 14 1110886 3382 89514165
Pelvic venous thrombosis 12.36 10.32 53 1110847 1948 89515599
Coronary arterial stent insertion 12.34 10.32 10 1110890 2830 89514717
Blood urine present 12.31 10.32 288 1110612 16990 89500557
Cough 12.29 10.32 4194 1106706 364768 89152779
Colon cancer 12.29 10.32 81 1110819 10863 89506684
Osteomyelitis 12.27 10.32 254 1110646 27592 89489955
Corneal oedema 12.25 10.32 4 1110896 1897 89515650
Neurological examination normal 12.20 10.32 8 1110892 49 89517498
Inflammation 12.20 10.32 2424 1108476 176168 89341379
Ketoacidosis 12.19 10.32 32 1110868 5563 89511984
Cervicogenic headache 12.18 10.32 14 1110886 198 89517349
Sensitivity to weather change 12.13 10.32 62 1110838 8852 89508695
Flank pain 12.08 10.32 315 1110585 18907 89498640
Consciousness fluctuating 12.08 10.32 32 1110868 914 89516633
Corneal leukoma 12.08 10.32 8 1110892 50 89517497
Oral discomfort 12.07 10.32 77 1110823 10406 89507141
Ventricular extrasystoles 12.06 10.32 104 1110796 13146 89504401
Mycobacterial infection 12.05 10.32 6 1110894 2204 89515343
Spondylolysis 12.02 10.32 12 1110888 143 89517404
General physical health deterioration 11.97 10.32 4679 1106221 350436 89167111
Base excess 11.95 10.32 8 1110892 51 89517496
Gingival hypertrophy 11.95 10.32 6 1110894 2194 89515353
Dementia 11.94 10.32 213 1110687 23648 89493899
Enanthema 11.93 10.32 22 1110878 488 89517059
Transfusion-related acute lung injury 11.91 10.32 13 1110887 173 89517374
Pelvic fracture 11.91 10.32 124 1110776 15095 89502452
Productive cough 11.86 10.32 799 1110101 76264 89441283
Plasma cell myeloma recurrent 11.86 10.32 21 1110879 4207 89513340
Hepatic cyst 11.84 10.32 41 1110859 6527 89511020
Cardiac arrest 11.76 10.32 1464 1109436 103471 89414076
Subacute cutaneous lupus erythematosus 11.76 10.32 16 1110884 3566 89513981
Hyporesponsive to stimuli 11.72 10.32 45 1110855 1572 89515975
Toxicologic test abnormal 11.72 10.32 27 1110873 705 89516842
Streptococcal endocarditis 11.70 10.32 12 1110888 148 89517399
Cachexia 11.70 10.32 44 1110856 6834 89510713
Subdural haematoma 11.69 10.32 139 1110761 16506 89501041
Intramedullary rod insertion 11.68 10.32 6 1110894 2166 89515381
Haemorrhage intracranial 11.68 10.32 124 1110776 15038 89502509
Hypertensive emergency 11.67 10.32 56 1110844 2161 89515386
Coagulation factor V level decreased 11.64 10.32 18 1110882 344 89517203
Gastroenteritis viral 11.64 10.32 283 1110617 30072 89487475
Adjacent segment degeneration 11.63 10.32 7 1110893 36 89517511
Foreign body sensation in eyes 11.60 10.32 14 1110886 3286 89514261
Recurrent cancer 11.53 10.32 8 1110892 2451 89515096
Blindness 11.52 10.32 243 1110657 26325 89491222
Wrong technique in device usage process 11.51 10.32 35 1110865 5800 89511747
Psychogenic tremor 11.51 10.32 6 1110894 22 89517525
Urine analysis abnormal 11.49 10.32 106 1110794 5115 89512432
Gastric cancer 11.48 10.32 29 1110871 5107 89512440
Incorrect drug administration rate 11.47 10.32 106 1110794 5117 89512430
Exostosis 11.47 10.32 533 1110367 52601 89464946
Endocarditis enterococcal 11.47 10.32 15 1110885 244 89517303
Urobilinogen urine increased 11.45 10.32 16 1110884 278 89517269
Salivary gland cyst 11.45 10.32 4 1110896 3 89517544
Arthrodesis 11.43 10.32 12 1110888 3000 89514547
Pulmonary oedema 11.43 10.32 633 1110267 61447 89456100
Product residue present 11.42 10.32 22 1110878 4269 89513278
Cells in urine 11.41 10.32 13 1110887 182 89517365
Atrial flutter 11.39 10.32 81 1110819 10677 89506870
Post-traumatic stress disorder 11.39 10.32 131 1110769 6697 89510850
Metastases to skin 11.38 10.32 6 1110894 2134 89515413
Dysphoria 11.38 10.32 38 1110862 6116 89511431
Shock 11.37 10.32 446 1110454 28332 89489215
Selenium deficiency 11.36 10.32 8 1110892 56 89517491
Frostbite 11.35 10.32 14 1110886 214 89517333
Candida infection 11.35 10.32 324 1110576 33733 89483814
Hepatic cancer 11.35 10.32 27 1110873 4854 89512693
Mean cell haemoglobin concentration increased 11.33 10.32 24 1110876 591 89516956
Henoch-Schonlein purpura nephritis 11.31 10.32 6 1110894 23 89517524
Transplant failure 11.26 10.32 5 1110895 1964 89515583
Atypical mycobacterial infection 11.25 10.32 3 1110897 1623 89515924
Hypertriglyceridaemia 11.24 10.32 54 1110846 7835 89509712
Bronchitis chronic 11.22 10.32 26 1110874 4717 89512830
Acute fatty liver of pregnancy 11.20 10.32 7 1110893 39 89517508
Gastrointestinal mucosal exfoliation 11.15 10.32 11 1110889 129 89517418
Accident at home 11.15 10.32 12 1110888 157 89517390
Frequent bowel movements 11.14 10.32 577 1110323 56358 89461189
Continuous haemodiafiltration 11.14 10.32 31 1110869 912 89516635
Cardiogenic shock 11.14 10.32 222 1110678 24246 89493301
Fungal rhinitis 11.12 10.32 6 1110894 24 89517523
Post procedural pulmonary embolism 11.11 10.32 14 1110886 219 89517328
Orthostatic hypotension 11.10 10.32 623 1110277 41204 89476343
Blood thromboplastin decreased 11.10 10.32 5 1110895 12 89517535
Genital pain 11.09 10.32 27 1110873 731 89516816
Venoocclusive liver disease 11.09 10.32 37 1110863 5956 89511591
Gestational diabetes 11.05 10.32 80 1110820 10502 89507045
Pulmonary tuberculosis 11.03 10.32 27 1110873 4807 89512740
Peptic ulcer perforation 11.02 10.32 20 1110880 438 89517109
Fanconi syndrome 11.01 10.32 5 1110895 1938 89515609
Strongyloidiasis 11.00 10.32 3 1110897 1599 89515948
Duodenal perforation 10.97 10.32 34 1110866 1064 89516483
Tuberculin test positive 10.91 10.32 18 1110882 3707 89513840
Laboratory test abnormal 10.90 10.32 411 1110489 41443 89476104
Malignant melanoma 10.88 10.32 100 1110800 12476 89505071
Ovarian cancer recurrent 10.88 10.32 3 1110897 1587 89515960
Abnormal dreams 10.86 10.32 87 1110813 11170 89506377
Cardioactive drug level increased 10.86 10.32 8 1110892 2376 89515171
Mental impairment 10.85 10.32 142 1110758 16578 89500969
Gastric haemorrhage 10.84 10.32 134 1110766 6969 89510578
Internal injury 10.84 10.32 17 1110883 329 89517218
Chronic myeloid leukaemia 10.82 10.32 10 1110890 2654 89514893
Accidental poisoning 10.80 10.32 31 1110869 929 89516618
Effusion 10.79 10.32 52 1110848 2010 89515537
Medical diet 10.76 10.32 6 1110894 26 89517521
Platelet aggregation decreased 10.76 10.32 6 1110894 26 89517521
Partial seizures 10.75 10.32 49 1110851 7211 89510336
Pubic pain 10.75 10.32 12 1110888 164 89517383
Staphylococcal bacteraemia 10.71 10.32 51 1110849 7418 89510129
Epilepsy 10.62 10.32 865 1110035 81341 89436206
Oral pain 10.62 10.32 312 1110588 32371 89485176
Pneumothorax 10.60 10.32 168 1110732 18999 89498548
Migraine with aura 10.59 10.32 72 1110828 3164 89514383
Pyrexia 10.59 10.32 8512 1102388 651973 88865574
Alcohol poisoning 10.58 10.32 49 1110851 1863 89515684
Disseminated tuberculosis 10.56 10.32 15 1110885 3284 89514263
Vaginal haemorrhage 10.55 10.32 297 1110603 30974 89486573
Lung adenocarcinoma 10.54 10.32 34 1110866 5531 89512016
Cataract 10.51 10.32 751 1110149 71341 89446206
Aphthous ulcer 10.50 10.32 282 1110618 17005 89500542
Metastases to pleura 10.48 10.32 6 1110894 2038 89515509
Muscle tone disorder 10.46 10.32 11 1110889 140 89517407
Bone disorder 10.45 10.32 210 1110690 22910 89494637
Intraocular pressure increased 10.43 10.32 48 1110852 7045 89510502
Systemic lupus erythematosus 10.42 10.32 4136 1106764 357760 89159787
Mediastinal abscess 10.42 10.32 6 1110894 28 89517519
Arteriosclerosis 10.41 10.32 84 1110816 10769 89506778
Antipsychotic drug level increased 10.39 10.32 19 1110881 3760 89513787
Body height decreased 10.34 10.32 95 1110805 11854 89505693
Drug dependence 10.33 10.32 449 1110451 28878 89488669

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Toxicity to various agents 1927.19 11.31 5785 414602 223351 41977597
Completed suicide 1602.39 11.31 3170 417217 93295 42107653
Intentional overdose 1288.81 11.31 2026 418361 49430 42151518
Exposure to toxic agent 1103.90 11.31 661 419726 4343 42196605
Overdose 826.97 11.31 2599 417788 102665 42098283
Suicide attempt 626.82 11.31 1397 418990 44703 42156245
Acute hepatic failure 543.61 11.31 753 419634 16320 42184628
Intentional product misuse 426.93 11.31 1463 418924 60437 42140511
Angioedema 412.73 11.31 1132 419255 41345 42159603
Metabolic acidosis 383.59 11.31 1255 419132 50603 42150345
Drug ineffective 322.13 11.31 4337 416050 625860 41575088
Infusion related reaction 268.24 11.31 1250 419137 59556 42141392
Hepatic cytolysis 250.43 11.31 705 419682 26139 42174809
Anaphylactic reaction 247.82 11.31 955 419432 41788 42159160
Blood pressure fluctuation 240.64 11.31 696 419691 26212 42174736
Analgesic drug level increased 238.24 11.31 144 420243 964 42199984
Haematemesis 229.69 11.31 738 419649 29461 42171487
Fixed eruption 225.73 11.31 190 420197 2264 42198684
Suspected suicide 224.20 11.31 291 420096 5908 42195040
Lip oedema 220.47 11.31 210 420177 2974 42197974
Urticaria 218.95 11.31 1364 419023 72672 42128276
Drug resistance 196.24 11.31 48 420339 34200 42166748
Cardiac failure congestive 190.85 11.31 345 420042 85257 42115691
Poisoning deliberate 184.91 11.31 347 420040 9787 42191161
Aspirin-exacerbated respiratory disease 183.48 11.31 80 420307 233 42200715
Drug hypersensitivity 182.18 11.31 1635 418752 97754 42103194
Disease progression 176.62 11.31 772 419615 142884 42058064
Tubulointerstitial nephritis 171.63 11.31 691 419696 30857 42170091
Myelosuppression 170.73 11.31 93 420294 40368 42160580
Gastric ulcer 169.72 11.31 479 419908 17783 42183165
Upper gastrointestinal haemorrhage 163.51 11.31 662 419725 29637 42171311
Cardiac failure 161.33 11.31 528 419859 106328 42094620
Medication error 156.15 11.31 695 419692 32459 42168489
Toxic epidermal necrolysis 156.10 11.31 599 419788 26151 42174797
Duodenal ulcer 155.55 11.31 362 420025 11917 42189031
Glomerulonephritis minimal lesion 154.88 11.31 92 420295 594 42200354
Myocardial infarction 152.05 11.31 667 419720 123342 42077606
Melaena 150.36 11.31 768 419619 37978 42162970
Death 147.85 11.31 3531 416856 467654 41733294
Interstitial lung disease 146.38 11.31 350 420037 78112 42122836
Malignant neoplasm progression 140.94 11.31 570 419817 107830 42093118
Diarrhoea 133.32 11.31 3495 416892 457354 41743594
Liver injury 131.39 11.31 452 419935 18696 42182252
Pneumonia 131.08 11.31 3168 417219 418981 41781967
Pyroglutamic acidosis 128.80 11.31 86 420301 699 42200249
Acute kidney injury 128.71 11.31 4626 415761 362711 41838237
Vomiting 125.52 11.31 3742 416645 285981 41914967
Stevens-Johnson syndrome 124.82 11.31 491 419896 21687 42179261
Self-medication 122.32 11.31 156 420231 3110 42197838
Gastric haemorrhage 117.14 11.31 295 420092 10220 42190728
Cytokine release syndrome 111.98 11.31 788 419599 43739 42157209
Accidental overdose 107.44 11.31 558 419829 27772 42173176
Suspected suicide attempt 106.94 11.31 59 420328 324 42200624
Face oedema 105.74 11.31 336 420051 13330 42187618
Product dose omission issue 105.47 11.31 993 419394 153372 42047576
Hospitalisation 104.23 11.31 379 420008 73951 42126997
Pancytopenia 103.70 11.31 707 419680 117036 42083912
Gastric ulcer perforation 100.87 11.31 84 420303 985 42199963
Ankylosing spondylitis 98.26 11.31 216 420171 6840 42194108
Peptic ulcer 97.55 11.31 143 420244 3269 42197679
Poisoning 95.68 11.31 341 420046 14358 42186590
Gastritis 95.23 11.31 478 419909 23469 42177479
Heart rate decreased 94.49 11.31 651 419736 35881 42165067
Full blood count abnormal 93.32 11.31 94 420293 29782 42171166
Anion gap 92.50 11.31 72 420315 761 42200187
Coma 90.98 11.31 867 419520 52687 42148261
Duodenal ulcer perforation 89.99 11.31 99 420288 1677 42199271
Wrong technique in product usage process 89.56 11.31 178 420209 42457 42158491
Therapeutic product effect incomplete 89.06 11.31 378 420009 70561 42130387
Neuropathy peripheral 88.98 11.31 613 419774 101240 42099708
Hepatitis acute 88.92 11.31 241 420146 8734 42192214
Meningitis aseptic 84.93 11.31 156 420231 4326 42196622
Platelet count decreased 84.87 11.31 915 419472 137666 42063282
Drug-induced liver injury 84.65 11.31 657 419730 37616 42163332
Treatment failure 82.81 11.31 327 420060 62297 42138651
Cytomegalovirus infection 81.50 11.31 120 420267 32186 42168762
Acute generalised exanthematous pustulosis 78.45 11.31 224 420163 8371 42192577
Renal papillary necrosis 76.90 11.31 36 420351 130 42200818
Eyelid oedema 74.44 11.31 170 420217 5525 42195423
Neutropenia 73.94 11.31 1454 418933 197977 42002971
Intestinal diaphragm disease 73.35 11.31 43 420344 270 42200678
Coagulopathy 72.92 11.31 420 419967 21742 42179206
Palatal oedema 71.78 11.31 68 420319 956 42199992
Generalised bullous fixed drug eruption 71.02 11.31 48 420339 399 42200549
Renal tubular acidosis 69.74 11.31 109 420278 2641 42198307
Inspiratory capacity decreased 68.94 11.31 113 420274 2854 42198094
Bone marrow failure 67.94 11.31 140 420247 32953 42167995
Duodenal ulcer haemorrhage 66.85 11.31 165 420222 5643 42195305
Hepatitis fulminant 65.90 11.31 149 420238 4810 42196138
Blood pressure increased 63.59 11.31 1383 419004 100545 42100403
Abdominal pain 62.64 11.31 2383 418004 188088 42012860
Renal tubular necrosis 61.15 11.31 349 420038 18005 42182943
Off label use 60.45 11.31 5450 414937 632885 41568063
Renal impairment 60.37 11.31 746 419641 109482 42091466
Graft versus host disease 60.16 11.31 26 420361 12899 42188049
Osteotomy 59.64 11.31 24 420363 53 42200895
Chills 58.89 11.31 1277 419110 92789 42108159
Gastritis erosive 58.88 11.31 169 420218 6334 42194614
Wound closure 58.18 11.31 24 420363 58 42200890
Blood pressure diastolic abnormal 58.17 11.31 162 420225 5966 42194982
Sleep disorder due to a general medical condition 57.91 11.31 52 420335 17401 42183547
Erythema multiforme 57.85 11.31 223 420164 9754 42191194
BK virus infection 57.27 11.31 9 420378 8775 42192173
Asthenia 56.04 11.31 2233 418154 278560 41922388
Vanishing bile duct syndrome 55.80 11.31 80 420307 1791 42199157
Blood glucose increased 55.60 11.31 462 419925 73237 42127711
Injection site pain 55.46 11.31 338 420049 57460 42143488
Anaemia 55.27 11.31 2232 418155 278046 41922902
Pathogen resistance 54.96 11.31 22 420365 11428 42189520
Peritonsillar abscess 54.82 11.31 43 420344 460 42200488
Tongue oedema 53.86 11.31 108 420279 3202 42197746
Post transplant lymphoproliferative disorder 53.79 11.31 12 420375 9108 42191840
Type I hypersensitivity 53.75 11.31 85 420302 2081 42198867
Pulmonary alveolar haemorrhage 53.04 11.31 41 420346 14775 42186173
Haematotoxicity 52.90 11.31 21 420366 10964 42189984
Cytopenia 52.45 11.31 57 420330 17440 42183508
Methaemoglobinaemia 52.23 11.31 150 420237 5624 42195324
Tachycardia 52.15 11.31 1336 419051 99751 42101197
Drug abuse 51.82 11.31 1377 419010 103394 42097554
Thrombocytopenia 51.62 11.31 1455 418932 188824 42012124
Gastric ulcer haemorrhage 51.44 11.31 155 420232 5972 42194976
Lip swelling 51.33 11.31 343 420044 18710 42182238
Cerebral infarction 51.27 11.31 148 420239 31021 42169927
Brain empyema 50.93 11.31 15 420372 4 42200944
Venoocclusive liver disease 50.76 11.31 19 420368 10283 42190665
Medication overuse headache 50.47 11.31 30 420357 194 42200754
Throat irritation 50.28 11.31 258 420129 12778 42188170
Blood pressure systolic increased 50.10 11.31 458 419929 27510 42173438
Cerebrovascular accident 50.07 11.31 666 419721 96494 42104454
Ductus arteriosus premature closure 49.83 11.31 31 420356 220 42200728
Pulmonary vasculitis 49.73 11.31 3 420384 6263 42194685
Dermo-hypodermitis 49.37 11.31 47 420340 665 42200283
Atrial fibrillation 48.63 11.31 1028 419359 138565 42062383
Transplant rejection 48.14 11.31 38 420349 13550 42187398
Progressive multifocal leukoencephalopathy 47.95 11.31 27 420360 11509 42189439
Bladder cancer 47.37 11.31 59 420328 16988 42183960
Prostate cancer 47.17 11.31 253 420134 44390 42156558
Prothrombin time ratio decreased 46.90 11.31 42 420345 547 42200401
Faeces discoloured 46.87 11.31 308 420079 16706 42184242
Decreased appetite 46.66 11.31 1500 418887 191637 42009311
Hepatotoxicity 46.54 11.31 415 419972 24752 42176196
Gastrointestinal haemorrhage 46.21 11.31 1277 419110 96449 42104499
Transaminases increased 45.66 11.31 511 419876 32374 42168574
Depressed level of consciousness 45.44 11.31 695 419692 47275 42153673
Syringe issue 45.25 11.31 14 420373 8542 42192406
White blood cell count decreased 45.17 11.31 791 419596 109605 42091343
Aspergillus infection 44.86 11.31 54 420333 15783 42185165
Full blood count decreased 44.77 11.31 84 420303 20476 42180472
Akathisia 44.11 11.31 24 420363 10427 42190521
Body temperature decreased 44.10 11.31 268 420119 14145 42186803
Blood pressure diastolic increased 43.76 11.31 151 420236 6254 42194694
Myelodysplastic syndrome 43.56 11.31 100 420287 22645 42178303
Cytomegalovirus viraemia 43.55 11.31 24 420363 10353 42190595
Bronchopulmonary aspergillosis 43.54 11.31 78 420309 19351 42181597
Drug reaction with eosinophilia and systemic symptoms 43.14 11.31 618 419769 41457 42159491
Hypothermia 43.03 11.31 240 420147 12275 42188673
Therapeutic response decreased 42.96 11.31 203 420184 36809 42164139
Abdominal pain upper 42.95 11.31 1093 419294 81516 42119432
Cardiac failure chronic 42.08 11.31 21 420366 9580 42191368
Hyperhidrosis 41.75 11.31 1179 419208 89333 42111615
Therapy partial responder 41.69 11.31 84 420303 19937 42181011
Hepatic function abnormal 41.32 11.31 318 420069 51249 42149699
Acidosis 41.24 11.31 234 420153 12045 42188903
Dust allergy 41.00 11.31 3 420384 5329 42195619
Acute myeloid leukaemia 40.91 11.31 100 420287 22156 42178792
Discoloured vomit 40.80 11.31 44 420343 728 42200220
Hypothyroidism 40.23 11.31 171 420216 31913 42169035
Blood pressure systolic abnormal 40.13 11.31 133 420254 5395 42195553
Fall 39.71 11.31 1899 418488 232621 41968327
IgM nephropathy 39.56 11.31 22 420365 123 42200825
Peptic ulcer perforation 39.50 11.31 31 420356 332 42200616
Cerebral haemorrhage 39.43 11.31 224 420163 38742 42162206
Substance abuse 39.18 11.31 183 420204 8722 42192226
Inadequate analgesia 39.12 11.31 93 420294 3104 42197844
Acute graft versus host disease 39.08 11.31 16 420371 8199 42192749
Infusion site extravasation 39.01 11.31 131 420256 5350 42195598
Alanine aminotransferase increased 38.69 11.31 1144 419243 87262 42113686
Mite allergy 38.35 11.31 3 420384 5043 42195905
Ventricular tachycardia 38.27 11.31 160 420227 30000 42170948
Drug ineffective for unapproved indication 37.77 11.31 283 420104 45880 42155068
Acute graft versus host disease in skin 37.76 11.31 13 420374 7411 42193537
Immune reconstitution inflammatory syndrome 37.69 11.31 27 420360 10116 42190832
Headache 37.54 11.31 2793 417594 236576 41964372
Chronic graft versus host disease 37.46 11.31 7 420380 6018 42194930
Plantar fasciitis 37.24 11.31 89 420298 2981 42197967
Septic shock 37.13 11.31 658 419729 91014 42109934
Fractional exhaled nitric oxide increased 37.01 11.31 61 420326 1548 42199400
Cystitis haemorrhagic 36.99 11.31 13 420374 7316 42193632
Mycotic allergy 36.91 11.31 3 420384 4888 42196060
Therapy cessation 36.72 11.31 93 420294 20357 42180591
Musculoskeletal stiffness 36.39 11.31 785 419602 56980 42143968
Low birth weight baby 36.34 11.31 27 420360 9928 42191020
Cholestatic liver injury 36.15 11.31 99 420288 3610 42197338
Nightmare 35.79 11.31 391 419996 24621 42176327
Hepatic necrosis 35.73 11.31 102 420285 3811 42197137
Periorbital oedema 35.57 11.31 114 420273 4543 42196405
Plasma cell myeloma 35.54 11.31 299 420088 47279 42153669
Symmetrical drug-related intertriginous and flexural exanthema 34.96 11.31 43 420344 825 42200123
Pharyngeal paraesthesia 34.96 11.31 44 420343 865 42200083
Renal cortical necrosis 34.95 11.31 23 420364 182 42200766
Device leakage 34.90 11.31 30 420357 10255 42190693
Intentional product use issue 34.90 11.31 942 419445 70891 42130057
Tubulointerstitial nephritis and uveitis syndrome 34.78 11.31 19 420368 102 42200846
Chronic obstructive pulmonary disease 34.59 11.31 427 419960 62687 42138261
Nocardiosis 34.56 11.31 5 420382 5185 42195763
Prothrombin time abnormal 34.37 11.31 43 420344 840 42200108
Pulmonary fibrosis 34.20 11.31 141 420246 26540 42174408
Therapy interrupted 34.19 11.31 109 420278 22141 42178807
Graft versus host disease in gastrointestinal tract 34.14 11.31 5 420382 5138 42195810
No adverse event 33.97 11.31 235 420152 38786 42162162
Respiratory depression 33.80 11.31 309 420078 18559 42182389
Lung neoplasm malignant 33.67 11.31 88 420299 19059 42181889
Stomatitis 33.36 11.31 326 420061 50003 42150945
Oesophageal carcinoma 33.25 11.31 28 420359 9668 42191280
Glomerulonephritis membranous 33.11 11.31 55 420332 1405 42199543
Hepatic failure 33.06 11.31 544 419843 37556 42163392
Nipple swelling 32.98 11.31 29 420358 368 42200580
Forced expiratory volume decreased 32.97 11.31 17 420370 7613 42193335
Body temperature increased 32.80 11.31 326 420061 20032 42180916
Sepsis 32.76 11.31 1619 418768 197715 42003233
Head discomfort 32.75 11.31 119 420268 5058 42195890
Chronic gastrointestinal bleeding 32.74 11.31 27 420360 312 42200636
Glycosylated haemoglobin increased 32.60 11.31 48 420339 12876 42188072
Product use in unapproved indication 32.53 11.31 1487 418900 182969 42017979
Somnolence 32.38 11.31 1702 418685 139403 42061545
Oedema peripheral 32.32 11.31 1059 419328 135017 42065931
Pneumocystis jirovecii pneumonia 32.32 11.31 133 420254 25048 42175900
Enthesopathy 32.27 11.31 113 420274 4715 42196233
Dyspnoea 32.05 11.31 3850 416537 438771 41762177
Prostatic specific antigen increased 31.94 11.31 75 420312 16850 42184098
Carnitine palmitoyltransferase deficiency 31.92 11.31 11 420376 12 42200936
Infection masked 31.67 11.31 15 420372 56 42200892
Lymphocyte count abnormal 31.65 11.31 68 420319 2119 42198829
Throat tightness 31.63 11.31 182 420205 9417 42191531
Hepatocellular carcinoma 31.52 11.31 21 420366 8173 42192775
Jejunal ulcer perforation 31.32 11.31 16 420371 73 42200875
Diabetes mellitus 31.26 11.31 411 419976 59676 42141272
Aplasia pure red cell 30.92 11.31 16 420371 7150 42193798
Heart rate irregular 30.89 11.31 267 420120 15783 42185165
Hypersensitivity 30.72 11.31 933 419454 71437 42129511
Conjunctivitis allergic 30.67 11.31 10 420377 5901 42195047
Drug dose omission by device 30.47 11.31 10 420377 5876 42195072
Graft versus host disease in skin 30.45 11.31 7 420380 5205 42195743
Hypomagnesaemia 30.34 11.31 161 420226 28327 42172621
Tropical infectious disease 30.28 11.31 13 420374 36 42200912
Sinusitis 30.21 11.31 644 419743 46648 42154300
Mixed liver injury 30.15 11.31 105 420282 4369 42196579
Tongue disorder 30.14 11.31 119 420268 5264 42195684
Sensation of foreign body 29.95 11.31 91 420296 3522 42197426
Foreign body in throat 29.93 11.31 32 420355 524 42200424
Intentional self-injury 29.84 11.31 254 420133 14948 42186000
Respiratory failure 29.29 11.31 1002 419385 127130 42073818
Therapeutic product effect decreased 29.25 11.31 246 420141 38904 42162044
Scleroderma renal crisis 28.98 11.31 28 420359 404 42200544
Aspartate aminotransferase increased 28.89 11.31 980 419407 76183 42124765
Virologic failure 28.67 11.31 3 420384 3991 42196957
Oxygen saturation decreased 28.55 11.31 838 419549 63849 42137099
Swelling face 28.36 11.31 405 419982 27149 42173799
Poor venous access 28.29 11.31 144 420243 7108 42193840
Purpura fulminans 28.12 11.31 20 420367 182 42200766
Thrombosis 27.97 11.31 491 419896 68020 42132928
Incorrect dosage administered 27.89 11.31 56 420331 1662 42199286
Endophthalmitis 27.88 11.31 5 420382 4428 42196520
Second primary malignancy 27.81 11.31 32 420355 9543 42191405
Diffuse large B-cell lymphoma recurrent 27.69 11.31 7 420380 4879 42196069
Myopathy 27.58 11.31 59 420328 13702 42187246
Diabetic ketoacidosis 27.56 11.31 120 420267 22247 42178701
Oesophagitis 27.46 11.31 250 420137 14997 42185951
Hyperaesthesia 27.43 11.31 124 420263 5828 42195120
Respiratory arrest 27.37 11.31 413 419974 28011 42172937
Cytomegalovirus chorioretinitis 27.33 11.31 6 420381 4605 42196343
Meningitis pneumococcal 27.19 11.31 22 420365 247 42200701
Ejection fraction decreased 26.91 11.31 119 420268 21968 42178980
Infusion site pain 26.84 11.31 115 420272 5280 42195668
Cytomegalovirus infection reactivation 26.77 11.31 43 420344 11135 42189813
Pyloric stenosis 26.68 11.31 39 420348 889 42200059
Candida infection 26.58 11.31 116 420271 21494 42179454
Nasal septum perforation 26.45 11.31 21 420366 229 42200719
Therapy non-responder 26.31 11.31 369 420018 52990 42147958
Nasal disorder 26.29 11.31 60 420327 1949 42198999
Nasal obstruction 25.84 11.31 40 420347 961 42199987
Obstructive airways disorder 25.77 11.31 141 420246 24618 42176330
Dry skin 25.75 11.31 329 420058 48009 42152939
Exostosis 25.72 11.31 117 420270 5514 42195434
Cerebral artery thrombosis 25.62 11.31 45 420342 1204 42199744
Delusion of grandeur 25.45 11.31 59 420328 1937 42199011
Cellulitis pharyngeal 25.40 11.31 7 420380 0 42200948
Kidney transplant rejection 25.24 11.31 29 420358 8654 42192294
Exposure via ingestion 25.18 11.31 61 420326 2061 42198887
Inappropriate schedule of product administration 25.15 11.31 1172 419215 94730 42106218
Laryngeal dyspnoea 24.99 11.31 15 420372 99 42200849
Beta haemolytic streptococcal infection 24.66 11.31 37 420350 864 42200084
Pharyngeal abscess 24.60 11.31 27 420360 456 42200492
Pulmonary arterial hypertension 24.57 11.31 39 420348 10148 42190800
Immunosuppressant drug level increased 24.51 11.31 24 420363 7707 42193241
Kounis syndrome 24.42 11.31 81 420306 3287 42197661
Renal cancer 24.42 11.31 27 420360 8197 42192751
Acute respiratory failure 24.38 11.31 255 420132 38603 42162345
Allergy test negative 24.33 11.31 17 420370 150 42200798
Dactylitis 24.30 11.31 42 420345 1109 42199839
Deep vein thrombosis 24.14 11.31 576 419811 76381 42124567
Intraocular pressure increased 24.06 11.31 17 420370 6416 42194532
Psychiatric decompensation 24.02 11.31 6 420381 4216 42196732
Cytomegalovirus colitis 23.96 11.31 5 420382 3976 42196972
Torsade de pointes 23.61 11.31 30 420357 8564 42192384
Strongyloidiasis 23.57 11.31 3 420384 3428 42197520
Shock 23.51 11.31 411 419976 28710 42172238
Electrocardiogram QT prolonged 23.48 11.31 332 420055 47613 42153335
Tenosynovitis 23.30 11.31 100 420287 4595 42196353
Thymoma benign 23.28 11.31 12 420375 56 42200892
Leukocytosis 23.18 11.31 417 419970 29291 42171657
Mucocutaneous disorder 23.01 11.31 17 420370 165 42200783
Complications of transplanted kidney 23.00 11.31 12 420375 5338 42195610
Visual acuity reduced 22.96 11.31 92 420295 17458 42183490
Nasopharyngitis 22.78 11.31 1030 419357 82966 42117982
Rash maculo-papular 22.77 11.31 507 419880 36996 42163952
Macrocephaly 22.71 11.31 26 420361 461 42200487
Conjunctival hyperaemia 22.69 11.31 76 420311 3100 42197848
Reversible cerebral vasoconstriction syndrome 22.60 11.31 32 420355 708 42200240
Pulmonary embolism 22.56 11.31 957 419430 118655 42082293
Dysmorphism 22.54 11.31 3 420384 3313 42197635
Allergic respiratory disease 22.46 11.31 11 420376 45 42200903
Oral pruritus 22.40 11.31 27 420360 507 42200441
Tuberculosis 22.22 11.31 41 420346 10058 42190890
Dehydration 22.20 11.31 1157 419230 140610 42060338
Underdose 22.03 11.31 87 420300 16579 42184369
Coronary arterial stent insertion 22.03 11.31 6 420381 3979 42196969
Nodal rhythm 21.95 11.31 49 420338 1568 42199380
Rhinalgia 21.88 11.31 53 420334 1791 42199157
Cardio-respiratory arrest 21.77 11.31 744 419643 57892 42143056
Blood ethanol increased 21.76 11.31 25 420362 445 42200503
Acute graft versus host disease in intestine 21.75 11.31 6 420381 3945 42197003
Mucormycosis 21.71 11.31 23 420364 7120 42193828
Apparent death 21.63 11.31 5 420382 3703 42197245
Injection site swelling 21.56 11.31 90 420297 16883 42184065
Unevaluable event 21.52 11.31 225 420162 34063 42166885
Oesophageal oedema 21.44 11.31 8 420379 13 42200935
Unintentional medical device removal 21.42 11.31 3 420384 3188 42197760
Alcohol poisoning 21.40 11.31 138 420249 7436 42193512
Erythema 21.39 11.31 1294 419093 107499 42093449
Normochromic normocytic anaemia 21.38 11.31 35 420352 8996 42191952
Helicobacter test positive 21.37 11.31 33 420354 791 42200157
Body temperature fluctuation 21.34 11.31 49 420338 1598 42199350
Paradoxical drug reaction 21.32 11.31 10 420377 4728 42196220
Monocyte chemotactic protein-1 increased 21.27 11.31 22 420365 346 42200602
Alpha tumour necrosis factor increased 21.02 11.31 22 420365 351 42200597
Atrioventricular block complete 20.93 11.31 51 420336 11313 42189635
Parkinsonism 20.92 11.31 46 420341 10577 42190371
Polyomavirus-associated nephropathy 20.79 11.31 15 420372 5600 42195348
Duodenitis 20.76 11.31 109 420278 5447 42195501
Neurological symptom 20.73 11.31 42 420345 9949 42190999
Neutrophil percentage increased 20.72 11.31 54 420333 1911 42199037
Epidermolysis 20.67 11.31 25 420362 471 42200477
Nephrolithiasis 20.53 11.31 492 419895 36338 42164610
Viral mutation identified 20.43 11.31 4 420383 3327 42197621
Pyroglutamate increased 20.35 11.31 20 420367 295 42200653
Cognitive disorder 20.34 11.31 227 420160 33945 42167003
Thrombotic microangiopathy 20.29 11.31 76 420311 14706 42186242
Respiratory rate increased 20.24 11.31 182 420205 10880 42190068
Peritonitis bacterial 20.21 11.31 23 420364 6892 42194056
Parvimonas micra infection 20.14 11.31 11 420376 59 42200889
Gastric cancer 20.13 11.31 23 420364 6880 42194068
Psoriatic arthropathy 20.02 11.31 352 420035 24615 42176333
Pemphigus 20.00 11.31 54 420333 1952 42198996
Infusion site pruritus 19.96 11.31 39 420348 1134 42199814
Hepatitis B 19.96 11.31 22 420365 6689 42194259
Pneumatosis intestinalis 19.93 11.31 11 420376 4741 42196207
Epistaxis 19.91 11.31 504 419883 66322 42134626
Clostridium test positive 19.88 11.31 107 420280 5398 42195550
Metastases to liver 19.86 11.31 88 420299 16238 42184710
Hypertriglyceridaemia 19.81 11.31 44 420343 10082 42190866
Ear pruritus 19.80 11.31 30 420357 707 42200241
Urine sodium decreased 19.78 11.31 15 420372 152 42200796
JC virus infection 19.76 11.31 3 420384 3001 42197947
Dermatitis bullous 19.72 11.31 147 420240 8309 42192639
Blood pressure diastolic decreased 19.65 11.31 172 420215 10203 42190745
Fluid retention 19.63 11.31 208 420179 31411 42169537
Nodule 19.54 11.31 61 420326 12473 42188475
Device issue 19.51 11.31 68 420319 13441 42187507
Lipodystrophy acquired 19.44 11.31 5 420382 3445 42197503
Cardiac failure acute 19.43 11.31 69 420318 13564 42187384
Dyspnoea exertional 19.33 11.31 363 420024 49785 42151163
Fatigue 19.30 11.31 3898 416489 431743 41769205
Device use error 19.28 11.31 4 420383 3193 42197755
Eye swelling 19.26 11.31 191 420196 11729 42189219
Erosive oesophagitis 19.24 11.31 45 420342 1486 42199462
Peripheral swelling 19.23 11.31 712 419675 89558 42111390
Neuroblastoma recurrent 19.22 11.31 22 420365 390 42200558
Memory impairment 19.22 11.31 364 420023 49858 42151090
Blood pH decreased 19.16 11.31 58 420329 2240 42198708
Oesophageal rupture 19.11 11.31 23 420364 431 42200517
Fungal infection 19.09 11.31 115 420272 19607 42181341
Perforated ulcer 19.06 11.31 18 420369 252 42200696
Transplant failure 19.04 11.31 8 420379 4036 42196912
Post concussion syndrome 18.93 11.31 15 420372 163 42200785
Adulterated product 18.92 11.31 30 420357 736 42200212
Alcohol interaction 18.86 11.31 55 420332 2080 42198868
Agitation 18.85 11.31 795 419592 63519 42137429
Pharyngeal swelling 18.82 11.31 75 420312 3332 42197616
Hypervolaemia 18.80 11.31 142 420245 22983 42177965
Productive cough 18.75 11.31 377 420010 51190 42149758
Myoglobin blood increased 18.72 11.31 79 420308 3603 42197345
Infusion site erythema 18.63 11.31 78 420309 3544 42197404
Therapeutic product effect variable 18.52 11.31 4 420383 3105 42197843
Physical deconditioning 18.48 11.31 59 420328 2346 42198602
Alcohol use 18.47 11.31 66 420321 2782 42198166
Asphyxia 18.44 11.31 143 420244 8183 42192765
Leukopenia 18.38 11.31 579 419808 74167 42126781
Tonsillitis 18.38 11.31 65 420322 2726 42198222
Tunnel vision 18.37 11.31 26 420361 575 42200373
Hypervitaminosis D 18.34 11.31 9 420378 37 42200911
Lactic acidosis 18.27 11.31 580 419807 44681 42156267
Leukaemia 18.21 11.31 18 420369 5754 42195194
Retinal haemorrhage 18.19 11.31 18 420369 5752 42195196
Haemophilia 18.19 11.31 6 420381 5 42200943
Neutrophil count decreased 18.17 11.31 481 419906 62934 42138014
Kawasaki's disease 18.14 11.31 5 420382 0 42200948
Abscess of eyelid 18.14 11.31 5 420382 0 42200948
Pleural infection bacterial 18.14 11.31 5 420382 0 42200948
Parapharyngeal space infection 18.14 11.31 5 420382 0 42200948
Benign familial pemphigus 18.14 11.31 5 420382 0 42200948
Respiratory symptom 18.07 11.31 53 420334 11053 42189895
Cardiac disorder 18.01 11.31 357 420030 48575 42152373
Hepatic cirrhosis 17.97 11.31 117 420270 19585 42181363
Prothrombin time prolonged 17.95 11.31 157 420230 9312 42191636
Sedation 17.87 11.31 410 419977 30065 42170883
Ductus arteriosus stenosis foetal 17.87 11.31 15 420372 178 42200770
Disinhibition 17.87 11.31 8 420379 3887 42197061
Hepatitis 17.83 11.31 373 420014 26927 42174021
Hypotension 17.83 11.31 2847 417540 254784 41946164
Tobacco abuse 17.75 11.31 26 420361 594 42200354
Cardiomyopathy 17.56 11.31 114 420273 19096 42181852
Major depression 17.56 11.31 102 420285 5296 42195652
Pelvic haematoma 17.52 11.31 16 420371 214 42200734
Mast cell activation syndrome 17.40 11.31 19 420368 319 42200629
Antipsychotic drug level below therapeutic 17.38 11.31 5 420382 3199 42197749
Hepatic cancer 17.30 11.31 36 420351 8444 42192504
Drug interaction 17.22 11.31 2339 418048 264660 41936288
Pain 17.20 11.31 2708 417679 242140 41958808
Status epilepticus 17.17 11.31 87 420300 15491 42185457
Heart rate increased 17.15 11.31 665 419722 52590 42148358
Accidental death 17.14 11.31 68 420319 3015 42197933
Transient ischaemic attack 17.10 11.31 232 420155 33507 42167441
Intervertebral discitis 17.05 11.31 68 420319 3022 42197926
Infusion site swelling 17.02 11.31 71 420316 3221 42197727
Gastric perforation 17.01 11.31 68 420319 3025 42197923
Injection site haemorrhage 17.00 11.31 59 420328 11677 42189271
Product used for unknown indication 16.99 11.31 37 420350 1164 42199784
Osteolysis 16.98 11.31 7 420380 3573 42197375
Osteonecrosis of jaw 16.93 11.31 114 420273 18935 42182013
Lung disorder 16.93 11.31 352 420035 47571 42153377
Laboratory test abnormal 16.89 11.31 145 420242 22833 42178115
Right ventricle outflow tract obstruction 16.82 11.31 9 420378 46 42200902
Drug screen positive 16.80 11.31 83 420304 4048 42196900
Treatment noncompliance 16.68 11.31 266 420121 37406 42163542
Acquired epidermolysis bullosa 16.66 11.31 8 420379 31 42200917
Hepatitis cholestatic 16.65 11.31 159 420228 9665 42191283
Gastritis haemorrhagic 16.63 11.31 45 420342 1629 42199319
Abdominal tenderness 16.57 11.31 92 420295 4697 42196251
Anion gap abnormal 16.57 11.31 21 420366 416 42200532
Dementia 16.53 11.31 95 420292 16385 42184563
Ascites 16.47 11.31 429 419958 56249 42144699
Mucosal inflammation 16.47 11.31 366 420021 49008 42151940
Pigment nephropathy 16.47 11.31 8 420379 32 42200916
Posthaemorrhagic hydrocephalus 16.45 11.31 12 420375 114 42200834
Ear infection 16.45 11.31 196 420191 12608 42188340
Cerebral atrophy congenital 16.42 11.31 10 420377 68 42200880
Posterior reversible encephalopathy syndrome 16.27 11.31 68 420319 12753 42188195
Rhinitis 16.12 11.31 185 420202 11792 42189156
Behaviour disorder 16.09 11.31 28 420359 7026 42193922
Hepatitis C 16.02 11.31 49 420338 10084 42190864
Pleural effusion 15.97 11.31 789 419598 96377 42104571
Food intolerance 15.94 11.31 44 420343 1612 42199336
Lemierre syndrome 15.91 11.31 7 420380 21 42200927
Unresponsive to stimuli 15.87 11.31 414 419973 30989 42169959
Abnormal clotting factor 15.85 11.31 10 420377 73 42200875
Tympanic membrane hyperaemia 15.82 11.31 5 420382 3 42200945
Prepyloric stenosis 15.82 11.31 5 420382 3 42200945
Blood triglycerides increased 15.75 11.31 92 420295 15804 42185144
Back pain 15.74 11.31 1613 418774 140163 42060785
Immunoglobulin G4 related disease 15.65 11.31 16 420371 248 42200700
Blood creatine phosphokinase increased 15.65 11.31 360 420027 47978 42152970
Embolic stroke 15.57 11.31 16 420371 5024 42195924
Colorectal cancer 15.56 11.31 16 420371 5022 42195926
Increased upper airway secretion 15.54 11.31 58 420329 2498 42198450
Postoperative delirium 15.52 11.31 24 420363 576 42200372
Myocardial fibrosis 15.51 11.31 37 420350 1238 42199710
Prescribed underdose 15.36 11.31 51 420336 10231 42190717
Coronavirus infection 15.35 11.31 96 420291 5118 42195830
Ocular icterus 15.35 11.31 66 420321 3035 42197913
Social anxiety disorder 15.34 11.31 24 420363 582 42200366
Neurotoxicity 15.33 11.31 154 420233 23497 42177451
Dizziness 15.31 11.31 2190 418197 247064 41953884
Portal vein phlebitis 15.30 11.31 6 420381 12 42200936
Interleukin level increased 15.18 11.31 30 420357 880 42200068
Gynaecomastia 15.13 11.31 68 420319 12499 42188449
Disease recurrence 15.07 11.31 204 420183 29474 42171474
Cholestasis 15.07 11.31 428 419959 32451 42168497
Pulmonary toxicity 15.05 11.31 40 420347 8615 42192333
Adrenal insufficiency 15.01 11.31 117 420270 18807 42182141
Pulmonary thrombosis 14.96 11.31 38 420349 8310 42192638
Skin toxicity 14.94 11.31 26 420361 6523 42194425
Acute myeloid leukaemia recurrent 14.92 11.31 8 420379 3504 42197444
Haemoptysis 14.90 11.31 344 420043 45823 42155125
Product substitution issue 14.88 11.31 59 420328 11231 42189717
Anion gap increased 14.86 11.31 50 420337 2044 42198904
Atrial thrombosis 14.86 11.31 3 420384 2441 42198507
Increased appetite 14.85 11.31 42 420345 8864 42192084
Patient uncooperative 14.85 11.31 25 420362 646 42200302
Peripheral arterial occlusive disease 14.83 11.31 28 420359 6810 42194138
Oedema 14.75 11.31 395 419992 51606 42149342
Mononeuropathy 14.73 11.31 16 420371 267 42200681
Coma scale abnormal 14.68 11.31 86 420301 4479 42196469
Bilirubin urine present 14.66 11.31 13 420374 167 42200781
Epstein-Barr virus infection 14.66 11.31 48 420339 9670 42191278
Apnoea 14.59 11.31 129 420258 7674 42193274
Enterococcal infection 14.58 11.31 65 420322 11974 42188974
Asthma 14.53 11.31 486 419901 61828 42139120
Pneumonia necrotising 14.52 11.31 33 420354 1069 42199879
Burn oral cavity 14.52 11.31 4 420383 0 42200948
Asthmatic crisis 14.50 11.31 22 420365 519 42200429
Renal disorder 14.43 11.31 200 420187 28780 42172168
Skin cancer 14.42 11.31 61 420326 11401 42189547
Dental operation 14.41 11.31 20 420367 434 42200514
Intestinal obstruction 14.40 11.31 185 420202 26973 42173975
Lymphocyte percentage decreased 14.35 11.31 52 420335 2207 42198741
Vascular stent thrombosis 14.34 11.31 7 420380 3235 42197713
Hyponatraemic seizure 14.29 11.31 13 420374 173 42200775
Mallory-Weiss syndrome 14.23 11.31 40 420347 1481 42199467
Congenital megacolon 14.23 11.31 9 420378 66 42200882
Palmar-plantar erythrodysaesthesia syndrome 14.20 11.31 132 420255 20450 42180498
Product storage error 14.19 11.31 59 420328 11081 42189867
Oesophagitis ulcerative 14.17 11.31 30 420357 925 42200023
Pneumococcal infection 14.11 11.31 22 420365 532 42200416
Muscle swelling 14.07 11.31 20 420367 444 42200504
Cardiac dysfunction 14.06 11.31 8 420379 3391 42197557
Myocardial oedema 14.06 11.31 15 420372 245 42200703
Brain scan abnormal 14.05 11.31 35 420352 1204 42199744
Dermatitis acneiform 14.04 11.31 35 420352 7704 42193244
Bronchial dysplasia 14.04 11.31 7 420380 30 42200918
Flushing 14.04 11.31 471 419916 36557 42164391
Haematochezia 14.02 11.31 708 419679 57728 42143220
Migraine 14.01 11.31 339 420048 25075 42175873
Myocardial ischaemia 14.00 11.31 110 420277 17652 42183296
Gastrointestinal injury 13.99 11.31 33 420354 1096 42199852
Gastrointestinal hypermotility 13.92 11.31 12 420375 148 42200800
Tremor 13.88 11.31 798 419589 96131 42104817
Klebsiella infection 13.83 11.31 61 420326 11271 42189677
Pemphigoid 13.83 11.31 62 420325 11405 42189543
Long QT syndrome 13.77 11.31 7 420380 3160 42197788
Acute phase reaction 13.73 11.31 12 420375 151 42200797
Organising pneumonia 13.72 11.31 34 420353 7498 42193450
Periportal oedema 13.70 11.31 9 420378 71 42200877
Dyspnoea at rest 13.69 11.31 13 420374 4236 42196712
Electrocardiogram T wave peaked 13.69 11.31 26 420361 740 42200208
Hypoglycaemia 13.68 11.31 468 419919 59386 42141562
Transplant dysfunction 13.64 11.31 8 420379 3335 42197613
Conjunctivitis 13.64 11.31 191 420196 12748 42188200
Hepatitis B reactivation 13.63 11.31 15 420372 4563 42196385
Transfusion-related circulatory overload 13.62 11.31 26 420361 743 42200205
Ventricular septal defect 13.59 11.31 82 420305 4317 42196631
Bone erosion 13.58 11.31 14 420373 4389 42196559
Pulmonary sequestration 13.55 11.31 8 420379 51 42200897
Genital lesion 13.55 11.31 15 420372 256 42200692
Colitis microscopic 13.51 11.31 7 420380 3126 42197822
Macrophages increased 13.48 11.31 12 420375 155 42200793
Pericarditis adhesive 13.45 11.31 5 420382 8 42200940
White coat hypertension 13.40 11.31 17 420370 337 42200611
Hypocalcaemia 13.37 11.31 213 420174 29960 42170988
Mental fatigue 13.37 11.31 15 420372 260 42200688
Atrial septal defect 13.34 11.31 128 420259 7791 42193157
Pulmonary tuberculosis 13.33 11.31 21 420366 5480 42195468
Injection site erythema 13.30 11.31 131 420256 20064 42180884
Balance disorder 13.23 11.31 363 420024 47282 42153666
Palmoplantar keratoderma 13.22 11.31 3 420384 2251 42198697
Renal hypoplasia 13.22 11.31 10 420377 101 42200847
Prostatic pain 13.21 11.31 17 420370 342 42200606
Sulphaemoglobinaemia 13.21 11.31 7 420380 35 42200913
SJS-TEN overlap 13.18 11.31 24 420363 661 42200287
Duodenal stenosis 13.17 11.31 17 420370 343 42200605
Prothrombin time shortened 13.15 11.31 40 420347 1549 42199399
Colon cancer 13.14 11.31 50 420337 9631 42191317
Appendicolith 13.14 11.31 196 420191 13260 42187688
Mucosal erosion 13.14 11.31 30 420357 975 42199973
Hallucination, tactile 13.13 11.31 22 420365 566 42200382
Intracranial pressure increased 13.11 11.31 85 420302 4589 42196359
Nasal turbinate hypertrophy 13.11 11.31 13 420374 194 42200754
Neoplasm progression 13.09 11.31 204 420183 28796 42172152
Photophobia 13.07 11.31 130 420257 7989 42192959
Urinary tract infection 13.05 11.31 824 419563 98460 42102488
Cerebral ischaemia 13.00 11.31 31 420356 6928 42194020
Obstruction gastric 13.00 11.31 31 420356 1037 42199911
Mycoplasma test positive 12.98 11.31 10 420377 104 42200844
Hypocoagulable state 12.98 11.31 30 420357 983 42199965
Pneumocystis jirovecii infection 12.92 11.31 6 420381 2854 42198094
Injection site bruising 12.91 11.31 64 420323 11461 42189487
Rebound effect 12.91 11.31 34 420353 7345 42193603
Angular cheilitis 12.90 11.31 13 420374 198 42200750
Epilepsy 12.89 11.31 181 420206 25990 42174958
Vascular pseudoaneurysm 12.87 11.31 57 420330 2655 42198293
Pneumonia cytomegaloviral 12.86 11.31 13 420374 4113 42196835
Oropharyngeal blistering 12.85 11.31 13 420374 199 42200749
Neglect of personal appearance 12.81 11.31 17 420370 353 42200595
Tooth injury 12.80 11.31 34 420353 1217 42199731
Hand deformity 12.77 11.31 11 420376 3757 42197191
Product dispensing error 12.76 11.31 36 420351 7603 42193345
Ventricular tachyarrhythmia 12.75 11.31 18 420369 397 42200551
Gait inability 12.68 11.31 154 420233 22679 42178269
Pallor 12.68 11.31 374 420013 28512 42172436
Device difficult to use 12.67 11.31 16 420371 4580 42196368
Teething 12.65 11.31 9 420378 82 42200866
Nipple pain 12.64 11.31 31 420356 1056 42199892
Transposition of the great vessels 12.59 11.31 19 420368 446 42200502
Oedematous pancreatitis 12.59 11.31 25 420362 736 42200212
Influenza like illness 12.58 11.31 407 419980 31433 42169515
Arrhythmia 12.57 11.31 302 420085 40015 42160933
Right ventricular failure 12.55 11.31 50 420337 9505 42191443
Adverse event 12.55 11.31 161 420226 23479 42177469
Intervertebral disc compression 12.52 11.31 17 420370 361 42200587
Coagulation factor V level decreased 12.51 11.31 14 420373 242 42200706
Injection site pruritus 12.49 11.31 49 420338 9356 42191592
Varicella zoster virus infection 12.48 11.31 5 420382 2596 42198352
Psychomotor skills impaired 12.48 11.31 20 420367 5184 42195764
Viral load increased 12.48 11.31 7 420380 2990 42197958
Systemic mycosis 12.45 11.31 4 420383 2383 42198565
Bezoar 12.38 11.31 34 420353 1242 42199706
Streptococcal infection 12.32 11.31 103 420284 6029 42194919
Microbiology test abnormal 12.31 11.31 4 420383 3 42200945
Reticulocyte percentage increased 12.31 11.31 4 420383 3 42200945
Pain in jaw 12.29 11.31 88 420299 14414 42186534
Antineutrophil cytoplasmic antibody positive 12.24 11.31 15 420372 4350 42196598
Analgesic therapy 12.24 11.31 29 420358 6495 42194453
Mucosal necrosis 12.21 11.31 9 420378 87 42200861
Muscular weakness 12.21 11.31 686 419701 82812 42118136
Carotid artery occlusion 12.20 11.31 14 420373 4180 42196768
Type IV hypersensitivity reaction 12.16 11.31 52 420335 2385 42198563
Osteonecrosis 12.16 11.31 99 420288 15766 42185182
Aminoaciduria 12.15 11.31 14 420373 250 42200698
Diffuse large B-cell lymphoma 12.09 11.31 50 420337 9404 42191544
Renal arteriosclerosis 12.07 11.31 15 420372 291 42200657
Conjunctival scar 12.07 11.31 15 420372 291 42200657
Sacroiliitis 12.07 11.31 45 420342 1937 42199011
Vaccination site pain 12.06 11.31 7 420380 43 42200905
Anti-erythrocyte antibody positive 12.06 11.31 7 420380 43 42200905
Carotid arteriosclerosis 12.01 11.31 4 420383 2328 42198620
Phonophobia 11.99 11.31 15 420372 293 42200655
Infusion site bruising 11.98 11.31 28 420359 924 42200024
Suprapubic pain 11.96 11.31 19 420368 467 42200481
Bronchospasm 11.93 11.31 186 420201 12699 42188249
Croup infectious 11.93 11.31 20 420367 515 42200433
Specific gravity urine decreased 11.88 11.31 8 420379 66 42200882
Thymoma malignant 11.87 11.31 5 420382 13 42200935
Device malfunction 11.86 11.31 72 420315 12255 42188693
Meningitis cryptococcal 11.86 11.31 9 420378 3274 42197674
Nasal inflammation 11.85 11.31 18 420369 425 42200523
Partial seizures 11.84 11.31 25 420362 5834 42195114
Epiglottic oedema 11.84 11.31 12 420375 184 42200764
Injection site mass 11.83 11.31 44 420343 8531 42192417
Dissociation 11.80 11.31 12 420375 3786 42197162
Duodenal obstruction 11.79 11.31 12 420375 185 42200763
Blood bilirubin unconjugated 11.78 11.31 4 420383 4 42200944
Pericardial mesothelioma malignant 11.78 11.31 4 420383 4 42200944
Cardiotoxicity 11.77 11.31 36 420351 7409 42193539
Febrile bone marrow aplasia 11.72 11.31 56 420331 10125 42190823
Infusion site discomfort 11.71 11.31 17 420370 385 42200563
Confusion postoperative 11.70 11.31 11 420376 153 42200795
Neck pain 11.69 11.31 383 420004 29631 42171317
Appendicitis 11.68 11.31 276 420111 20337 42180611
Retinopathy 11.59 11.31 4 420383 2277 42198671
Brain injury 11.57 11.31 121 420266 7534 42193414
Pneumonia bacterial 11.54 11.31 99 420288 15593 42185355
Dependent personality disorder 11.50 11.31 8 420379 70 42200878
Venoocclusive disease 11.46 11.31 13 420374 3902 42197046
Foreign body aspiration 11.46 11.31 15 420372 307 42200641
Neuroblastoma 11.43 11.31 15 420372 308 42200640
Symblepharon 11.39 11.31 12 420375 193 42200755
Febrile convulsion 11.38 11.31 23 420364 686 42200262
Anterior interosseous syndrome 11.36 11.31 5 420382 15 42200933
Gastric mucosal lesion 11.35 11.31 23 420364 687 42200261
Respiratory syncytial virus bronchitis 11.35 11.31 9 420378 98 42200850
Urinary incontinence 11.34 11.31 148 420239 21520 42179428
Product label issue 11.32 11.31 15 420372 311 42200637

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Toxicity to various agents 4938.59 10.65 14584 1283892 465971 108824852
Completed suicide 4687.92 10.65 9395 1289081 232986 109057837
Intentional overdose 3973.63 10.65 6227 1292249 126274 109164549
Exposure to toxic agent 2783.52 10.65 1788 1296688 11070 109279753
Suicide attempt 1663.23 10.65 3721 1294755 99673 109191150
Overdose 1429.91 10.65 5986 1292490 227808 109063015
Acute hepatic failure 1423.21 10.65 1942 1296534 34526 109256297
Angioedema 1127.38 10.65 3113 1295363 95387 109195436
Metabolic acidosis 980.25 10.65 2985 1295491 96759 109194064
Intentional product misuse 917.62 10.65 3535 1294941 129369 109161454
Hepatic cytolysis 744.38 10.65 1852 1296624 53201 109237622
Analgesic drug level increased 656.10 10.65 466 1298010 3480 109287343
Poisoning deliberate 642.72 10.65 1129 1297347 25202 109265621
Blood pressure fluctuation 525.95 10.65 2002 1296474 72822 109218001
Myelosuppression 507.08 10.65 236 1298240 94104 109196719
Suspected suicide 496.78 10.65 744 1297732 14455 109276368
Drug ineffective 484.30 10.65 13884 1284592 1506656 107784167
Infusion related reaction 431.38 10.65 6575 1291901 374587 108916236
Cardiac failure congestive 401.85 10.65 723 1297753 150277 109140546
Lip oedema 396.86 10.65 468 1298008 7132 109283691
Disease progression 377.95 10.65 1527 1296949 242507 109048316
Malignant neoplasm progression 368.07 10.65 952 1297524 173615 109117208
Cardiac failure 360.06 10.65 1071 1297405 186555 109104268
Urticaria 355.15 10.65 5486 1292990 313371 108977452
Drug resistance 347.51 10.65 114 1298362 56260 109234563
Injection site pain 335.39 10.65 1024 1297452 176898 109113925
Medication error 329.14 10.65 2243 1296233 103123 109187700
Interstitial lung disease 321.28 10.65 725 1297751 138609 109152214
Diarrhoea 318.31 10.65 10582 1287894 1128923 108161900
Pyroglutamic acidosis 318.19 10.65 233 1298243 1835 109288988
Aspirin-exacerbated respiratory disease 307.30 10.65 171 1298305 777 109290046
Fixed eruption 305.43 10.65 309 1298167 3923 109286900
Neutropenia 304.08 10.65 2870 1295606 371750 108919073
Cholecystitis chronic 296.27 10.65 455 1298021 9045 109281778
Product dose omission issue 294.89 10.65 2389 1296087 319393 108971430
Throat irritation 293.10 10.65 1327 1297149 52225 109238598
Anion gap 292.72 10.65 218 1298258 1767 109289056
Tubulointerstitial nephritis 269.15 10.65 1307 1297169 52977 109237846
Myocardial infarction 267.44 10.65 1251 1297225 190832 109099991
Coagulopathy 259.48 10.65 1060 1297416 39851 109250972
Depressed level of consciousness 256.64 10.65 2222 1296254 110056 109180767
Cross sensitivity reaction 252.07 10.65 319 1298157 5248 109285575
Rheumatoid arthritis 249.39 10.65 4921 1293555 294692 108996131
Pneumonia 248.54 10.65 8124 1290352 868590 108422233
Wrong technique in product usage process 247.24 10.65 402 1298074 86946 109203877
Haematemesis 239.77 10.65 1346 1297130 57762 109233061
Anaphylactic reaction 238.19 10.65 2217 1296259 112083 109178740
Pancytopenia 231.37 10.65 1475 1297001 208138 109082685
Toxic epidermal necrolysis 227.61 10.65 1288 1297188 55439 109235384
Anaemia 225.78 10.65 4801 1293675 542285 108748538
Hepatotoxicity 225.09 10.65 1394 1297082 62006 109228817
Coma 224.32 10.65 2243 1296233 115626 109175197
Poisoning 206.34 10.65 781 1297695 28324 109262499
Platelet count decreased 201.46 10.65 1732 1296744 228711 109062112
Hospitalisation 201.30 10.65 923 1297553 141570 109149253
Gastric ulcer 200.38 10.65 963 1297513 38864 109251959
Duodenal ulcer 200.08 10.65 593 1297883 18921 109271902
Face oedema 198.82 10.65 850 1297626 32619 109258204
Self-medication 192.26 10.65 297 1298179 5935 109284888
Vomiting 189.22 10.65 12757 1285719 897918 108392905
Upper gastrointestinal haemorrhage 183.21 10.65 1110 1297366 48986 109241837
Renal impairment 181.87 10.65 1379 1297097 187066 109103757
Stevens-Johnson syndrome 181.67 10.65 1055 1297421 45846 109244977
Cytomegalovirus infection 177.29 10.65 227 1298249 54217 109236606
Neuropathy peripheral 175.82 10.65 1306 1297170 177971 109112852
Hepatitis acute 174.41 10.65 551 1297925 18215 109272608
Meningitis aseptic 173.12 10.65 368 1298108 9502 109281321
Gastric ulcer perforation 170.52 10.65 170 1298306 2118 109288705
Accidental overdose 169.98 10.65 1117 1297359 50717 109240106
Bone marrow failure 167.70 10.65 262 1298214 57586 109233237
Renal tubular acidosis 165.93 10.65 239 1298237 4476 109286347
Prothrombin time ratio decreased 164.63 10.65 142 1298334 1450 109289373
Glomerulonephritis minimal lesion 163.53 10.65 121 1298355 970 109289853
Heart rate decreased 158.01 10.65 1576 1296900 81180 109209643
Full blood count abnormal 155.80 10.65 261 1298215 55791 109235032
Atrial fibrillation 152.74 10.65 1842 1296634 227800 109063023
Hepatic failure 150.65 10.65 1348 1297128 67391 109223432
Injection site erythema 149.05 10.65 584 1297892 93592 109197231
Drug hypersensitivity 147.27 10.65 6630 1291846 447460 108843363
Thrombocytopenia 143.36 10.65 3063 1295413 345822 108945001
Ear pruritus 143.04 10.65 284 1298192 6976 109283847
White blood cell count decreased 142.82 10.65 1866 1296610 227524 109063299
Blood pressure diastolic abnormal 142.23 10.65 641 1297835 25174 109265649
Melaena 139.40 10.65 1326 1297150 67431 109223392
Blood pressure systolic abnormal 139.13 10.65 620 1297856 24230 109266593
Off label use 138.62 10.65 15465 1283011 1484720 107806103
Abdominal pain upper 138.29 10.65 5207 1293269 343904 108946919
Duodenal ulcer perforation 137.26 10.65 2887 1295589 174813 109116010
Injury 135.97 10.65 2877 1295599 174388 109116435
Drug-induced liver injury 135.46 10.65 2071 1296405 117996 109172827
Respiratory failure 135.39 10.65 1748 1296728 213584 109077239
Intentional self-injury 134.76 10.65 826 1297650 36603 109254220
Eyelid oedema 134.47 10.65 440 1298036 14822 109276001
Hepatic necrosis 131.16 10.65 331 1298145 9591 109281232
Sepsis 125.59 10.65 2905 1295571 324441 108966382
Red blood cell sedimentation rate abnormal 124.60 10.65 66 1298410 24443 109266380
Myelodysplastic syndrome 124.43 10.65 154 1298322 37330 109253493
Acute myeloid leukaemia 123.98 10.65 159 1298317 37951 109252872
Medication overuse headache 121.81 10.65 119 1298357 1444 109289379
Post transplant lymphoproliferative disorder 121.26 10.65 19 1298457 15594 109275229
Multiple-drug resistance 120.77 10.65 9 1298467 13226 109277597
Blood pressure systolic increased 119.87 10.65 1496 1296980 81495 109209328
Acute generalised exanthematous pustulosis 119.40 10.65 538 1297938 21126 109269697
Transplant rejection 119.35 10.65 70 1298406 24497 109266326
Device expulsion 119.12 10.65 112 1298364 30779 109260044
Septic shock 117.96 10.65 1230 1297246 156298 109134525
Cytokine release syndrome 117.79 10.65 1304 1297172 69002 109221821
Pathogen resistance 117.57 10.65 31 1298445 17641 109273182
Somnolence 116.70 10.65 4432 1294044 293017 108997806
Therapy interrupted 116.64 10.65 257 1298219 49565 109241258
Drug abuse 116.54 10.65 2817 1295659 174594 109116229
Cerebral infarction 116.01 10.65 274 1298202 51564 109239259
Product use in unapproved indication 112.01 10.65 4208 1294268 443169 108847654
Intestinal diaphragm disease 111.36 10.65 69 1298407 397 109290426
Haematotoxicity 111.33 10.65 54 1298422 21028 109269795
Aspergillus infection 110.92 10.65 83 1298393 25533 109265290
Peritonsillar abscess 110.69 10.65 95 1298381 963 109289860
Cytopenia 110.58 10.65 114 1298362 30002 109260821
Blood pressure increased 109.66 10.65 3884 1294592 254489 109036334
Body temperature increased 109.35 10.65 1052 1297424 53661 109237162
Pulmonary hypertension 108.93 10.65 311 1298165 54909 109235914
Pneumocystis jirovecii pneumonia 108.89 10.65 210 1298266 42525 109248298
Emotional distress 107.96 10.65 898 1297578 43949 109246874
Sinusitis 107.56 10.65 4383 1294093 292305 108998518
Diabetes mellitus 106.72 10.65 705 1297771 98676 109192147
Renal papillary necrosis 106.07 10.65 66 1298410 383 109290440
Nasopharyngitis 106.03 10.65 5654 1292822 388707 108902116
Muscle injury 105.94 10.65 2279 1296197 138528 109152295
Dyspnoea exertional 104.43 10.65 753 1297723 103307 109187516
Liver injury 103.57 10.65 2404 1296072 148009 109142814
Wound closure 103.49 10.65 51 1298425 170 109290653
Fall 103.06 10.65 5915 1292561 597567 108693256
Uterine perforation 100.88 10.65 238 1298238 6602 109284221
Acute kidney injury 99.78 10.65 8710 1289766 626720 108664103
Cardio-respiratory arrest 99.78 10.65 1913 1296563 113923 109176900
Cytomegalovirus viraemia 99.28 10.65 42 1298434 17722 109273101
Dehydration 99.09 10.65 2510 1295966 277001 109013822
Abdominal pain 98.49 10.65 7142 1291334 505847 108784976
Hypothyroidism 97.78 10.65 481 1297995 72418 109218405
Hypomagnesaemia 97.68 10.65 371 1298105 59999 109230824
Posterior reversible encephalopathy syndrome 97.54 10.65 154 1298322 33707 109257116
Injection site swelling 97.24 10.65 384 1298092 61406 109229417
Therapeutic product effect incomplete 97.15 10.65 1947 1296529 221858 109068965
Graft versus host disease 96.56 10.65 50 1298426 18756 109272067
Thrombotic microangiopathy 96.50 10.65 120 1298356 29029 109261794
Pulmonary arterial hypertension 95.84 10.65 146 1298330 32422 109258401
Injection site pruritus 95.83 10.65 296 1298180 50962 109239861
Bronchopulmonary aspergillosis 95.70 10.65 126 1298350 29737 109261086
Respiratory depression 95.62 10.65 674 1297802 31327 109259496
Acute lung injury 95.57 10.65 149 1298327 3002 109287821
Lower respiratory tract infection 95.50 10.65 3623 1294853 239483 109051340
Respiratory arrest 95.25 10.65 1076 1297400 57223 109233600
Hypersensitivity 95.18 10.65 5723 1292753 398275 108892548
Hypocalcaemia 93.73 10.65 421 1298055 64945 109225878
Drug dose omission by device 93.70 10.65 27 1298449 14489 109276334
Blood pressure diastolic decreased 93.69 10.65 732 1297744 35153 109255670
Osteotomy 92.60 10.65 54 1298422 273 109290550
Pharyngeal paraesthesia 91.69 10.65 170 1298306 3962 109286861
Therapy cessation 91.18 10.65 249 1298227 44608 109246215
Neoplasm progression 90.85 10.65 419 1298057 64176 109226647
Hepatitis fulminant 90.51 10.65 263 1298213 8297 109282526
Gastritis 89.96 10.65 996 1297480 52703 109238120
Generalised bullous fixed drug eruption 89.88 10.65 75 1298401 729 109290094
Gastric haemorrhage 89.04 10.65 397 1298079 15518 109275305
Neutrophil count decreased 88.24 10.65 950 1297526 119991 109170832
Pulmonary alveolar haemorrhage 87.63 10.65 65 1298411 20085 109270738
Blood glucose increased 87.21 10.65 1065 1297411 131431 109159392
BK virus infection 87.17 10.65 23 1298453 13083 109277740
Folliculitis 86.31 10.65 2579 1295897 165074 109125749
Neurotoxicity 86.01 10.65 234 1298242 41973 109248850
Hypothermia 85.75 10.65 566 1297910 25736 109265087
Helicobacter infection 85.74 10.65 2768 1295708 179109 109111714
Plasma cell myeloma 85.72 10.65 413 1298063 62523 109228300
Irritable bowel syndrome 85.60 10.65 2530 1295946 161685 109129138
Therapy partial responder 85.26 10.65 193 1298283 36868 109253955
Unevaluable event 85.20 10.65 381 1298095 58846 109231977
Decreased appetite 84.10 10.65 4648 1293828 471198 108819625
Tongue oedema 83.80 10.65 250 1298226 8006 109282817
Cerebrovascular accident 83.27 10.65 1562 1296914 179722 109111101
Acute graft versus host disease 83.07 10.65 24 1298452 12857 109277966
Prostate cancer 82.61 10.65 201 1298275 37440 109253383
Mucosal inflammation 82.45 10.65 726 1297750 95415 109195408
Forced expiratory volume decreased 82.34 10.65 26 1298450 13150 109277673
Dyspnoea 82.20 10.65 11569 1286907 1095303 108195520
Brain empyema 81.98 10.65 29 1298447 26 109290797
Alanine aminotransferase increased 81.30 10.65 2776 1295700 180997 109109826
Biliary dyskinesia 81.25 10.65 120 1298356 2301 109288522
Sleep disorder due to general medical condition, insomnia type 80.79 10.65 1714 1296762 103929 109186894
Osteonecrosis of jaw 80.36 10.65 291 1298185 47726 109243097
Second primary malignancy 80.24 10.65 57 1298419 18011 109272812
Cardiac failure chronic 79.88 10.65 31 1298445 13780 109277043
Leukopenia 79.66 10.65 1247 1297229 147544 109143279
Peptic ulcer 79.51 10.65 233 1298243 7386 109283437
Drug ineffective for unapproved indication 79.44 10.65 797 1297679 102041 109188782
Drug interaction 79.39 10.65 4936 1293540 495247 108795576
Blister 79.17 10.65 3345 1295131 224031 109066792
Hepatic function abnormal 78.94 10.65 669 1297807 88626 109202197
Eosinophilic granulomatosis with polyangiitis 78.61 10.65 15 1298461 10671 109280152
Bladder cancer 77.74 10.65 74 1298402 20218 109270605
Periorbital oedema 77.70 10.65 280 1298196 9912 109280911
Chronic graft versus host disease 76.97 10.65 10 1298466 9447 109281376
Discomfort 75.97 10.65 3164 1295312 211543 109079280
Diabetic ketoacidosis 75.73 10.65 247 1298229 41811 109249012
Ascites 75.60 10.65 710 1297766 92098 109198725
Cerebral haemorrhage 75.36 10.65 450 1298026 64518 109226305
Acute graft versus host disease in skin 75.04 10.65 17 1298459 10723 109280100
Palatal oedema 74.74 10.65 96 1298380 1604 109289219
Intentional product use issue 74.53 10.65 3593 1294883 244313 109046510
Ventricular tachycardia 74.18 10.65 318 1298158 49691 109241132
Exposure via ingestion 73.90 10.65 172 1298304 4728 109286095
Tachycardia 73.74 10.65 3311 1295165 223334 109067489
Unintentional medical device removal 73.68 10.65 9 1298467 8914 109281909
Oesophageal carcinoma 73.35 10.65 22 1298454 11502 109279321
Duodenal ulcer haemorrhage 72.88 10.65 234 1298242 7803 109283020
Hypervolaemia 72.46 10.65 316 1298160 49144 109241679
Lip swelling 72.16 10.65 911 1297565 49756 109241067
Blood pressure diastolic increased 72.15 10.65 422 1298054 18385 109272438
Acidosis 71.73 10.65 482 1297994 22049 109268774
Full blood count decreased 71.56 10.65 170 1298306 31929 109258894
Bezoar 70.93 10.65 151 1298325 3903 109286920
Cardiac failure acute 70.79 10.65 108 1298368 23970 109266853
Gallbladder disorder 70.67 10.65 456 1298020 20573 109270250
Hepatic enzyme increased 70.58 10.65 4519 1293957 316373 108974450
Device leakage 69.49 10.65 52 1298424 15996 109274827
Chronic obstructive pulmonary disease 69.36 10.65 884 1297592 108274 109182549
Right ventricular failure 69.25 10.65 124 1298352 25830 109264993
Hypocoagulable state 68.89 10.65 116 1298360 2499 109288324
Immune reconstitution inflammatory syndrome 68.44 10.65 54 1298422 16172 109274651
Pleural effusion 68.39 10.65 1576 1296900 176133 109114690
Muscle spasticity 68.07 10.65 683 1297793 35232 109255591
Cystitis haemorrhagic 68.01 10.65 29 1298447 12180 109278643
Metastases to liver 67.82 10.65 202 1298274 35184 109255639
Device malfunction 67.40 10.65 123 1298353 25435 109265388
Pyroglutamate increased 67.26 10.65 58 1298418 592 109290231
Intercepted product preparation error 67.23 10.65 3 1298473 6817 109284006
Gastritis erosive 66.88 10.65 299 1298177 11701 109279122
Transient ischaemic attack 66.63 10.65 458 1298018 63524 109227299
Graft versus host disease in skin 66.53 10.65 9 1298467 8245 109282578
Palmar-plantar erythrodysaesthesia syndrome 66.45 10.65 252 1298224 40773 109250050
Anion gap abnormal 65.81 10.65 64 1298412 772 109290051
Heart rate irregular 65.06 10.65 652 1297824 33622 109257201
Venoocclusive liver disease 64.92 10.65 50 1298426 15157 109275666
Sleep disorder due to a general medical condition 64.73 10.65 353 1298123 51759 109239064
Cardiac disorder 64.53 10.65 578 1297898 75702 109215121
Fluid retention 63.98 10.65 753 1297723 93554 109197269
Brain death 63.86 10.65 196 1298280 6377 109284446
Ill-defined disorder 63.83 10.65 2347 1296129 154506 109136317
Dermo-hypodermitis 63.81 10.65 83 1298393 1405 109289418
Nocardiosis 63.19 10.65 7 1298469 7479 109283344
Joint swelling 62.71 10.65 6026 1292450 436819 108854004
Obstructive airways disorder 62.17 10.65 304 1298172 45845 109244978
Acute respiratory failure 61.62 10.65 575 1297901 74685 109216138
Cytomegalovirus infection reactivation 61.19 10.65 75 1298401 18258 109272565
Graft versus host disease in gastrointestinal tract 61.07 10.65 15 1298461 8953 109281870
Heart rate increased 60.44 10.65 2160 1296316 141674 109149149
Electrocardiogram QT prolonged 60.43 10.65 907 1297569 108053 109182770
Transaminases increased 60.20 10.65 1063 1297413 62327 109228496
Foreign body in throat 59.76 10.65 68 1298408 995 109289828
Epistaxis 59.34 10.65 1125 1297351 129247 109161576
Body temperature decreased 59.11 10.65 679 1297797 36256 109254567
Impaired healing 58.67 10.65 2849 1295627 193868 109096955
Oral pruritus 58.48 10.65 124 1298352 3196 109287627
Kounis syndrome 57.86 10.65 177 1298299 5748 109285075
Renal tubular necrosis 57.50 10.65 579 1297897 29896 109260927
Product substitution issue 57.30 10.65 115 1298361 22946 109267877
Underdose 57.14 10.65 474 1298002 63080 109227743
Disease recurrence 57.10 10.65 448 1298028 60336 109230487
Gallbladder injury 57.04 10.65 73 1298403 1215 109289608
Pain 57.03 10.65 12357 1286119 942598 108348225
Tubulointerstitial nephritis and uveitis syndrome 56.35 10.65 43 1298433 363 109290460
Oedema peripheral 56.24 10.65 3220 1295256 325440 108965383
Immunosuppressant drug level increased 56.12 10.65 34 1298442 11690 109279133
Prothrombin time shortened 56.11 10.65 129 1298347 3517 109287306
Product storage error 56.03 10.65 106 1298370 21622 109269201
Visual acuity reduced 55.83 10.65 192 1298284 31981 109258842
Anti-cyclic citrullinated peptide antibody positive 55.40 10.65 2641 1295835 179343 109111480
Dry skin 55.36 10.65 909 1297567 106744 109184079
Gastrointestinal disorder 55.14 10.65 3418 1295058 238534 109052289
Throat tightness 55.11 10.65 619 1297857 32870 109257953
Mucormycosis 54.95 10.65 28 1298448 10600 109280223
Myopathy 53.43 10.65 135 1298341 24825 109265998
Endophthalmitis 53.27 10.65 15 1298461 8172 109282651
Vanishing bile duct syndrome 53.13 10.65 116 1298360 3052 109287771
Sedation complication 52.93 10.65 407 1298069 19448 109271375
Cholelithiasis 52.77 10.65 1042 1297434 62380 109228443
Pericarditis 52.67 10.65 3110 1295366 216004 109074819
Injection site bruising 52.37 10.65 369 1298107 50894 109239929
Metastases to lung 52.33 10.65 121 1298355 22942 109267881
Kidney transplant rejection 51.70 10.65 39 1298437 11948 109278875
Allergy test negative 51.64 10.65 41 1298435 369 109290454
Therapeutic response decreased 51.56 10.65 809 1297667 95690 109195133
Treatment noncompliance 51.38 10.65 578 1297898 72412 109218411
Loss of personal independence in daily activities 51.31 10.65 1354 1297122 148666 109142157
Staphylococcal infection 51.18 10.65 549 1297927 69395 109221428
Hepatocellular carcinoma 51.12 10.65 26 1298450 9854 109280969
Musculoskeletal stiffness 51.11 10.65 3881 1294595 275941 109014882
Transplant dysfunction 51.04 10.65 17 1298459 8311 109282512
Breast cancer stage I 51.00 10.65 12 1298464 7375 109283448
Substance abuse 50.66 10.65 284 1298192 12179 109278644
Renal cancer 50.56 10.65 47 1298429 12987 109277836
Colorectal cancer 50.21 10.65 22 1298454 9092 109281731
Urinary tract infection 49.96 10.65 3230 1295246 323052 108967771
Dissociation 49.31 10.65 27 1298449 9815 109281008
Osteonecrosis 49.16 10.65 216 1298260 33525 109257298
Paradoxical drug reaction 49.08 10.65 27 1298449 9790 109281033
Pulmonary vasculitis 48.70 10.65 9 1298467 6551 109284272
Epstein-Barr virus infection 48.68 10.65 91 1298385 18647 109272176
Pain in jaw 48.63 10.65 376 1298100 50801 109240022
Hepatitis cholestatic 48.47 10.65 363 1298113 17203 109273620
Polyomavirus-associated nephropathy 48.11 10.65 18 1298458 8183 109282640
Pneumatosis intestinalis 47.93 10.65 20 1298456 8509 109282314
Erythema multiforme 47.91 10.65 417 1298059 20680 109270143
Creatinine renal clearance decreased 47.89 10.65 428 1298048 21387 109269436
Glomerulonephritis membranous 47.73 10.65 85 1298391 1918 109288905
Acute myocardial infarction 47.62 10.65 694 1297782 83083 109207740
Infusion site pruritus 47.42 10.65 148 1298328 4860 109285963
Ductus arteriosus stenosis foetal 47.35 10.65 25 1298451 100 109290723
Gastric cancer 47.24 10.65 36 1298440 10972 109279851
Clostridium difficile infection 47.22 10.65 388 1298088 51741 109239082
Asthenia 47.13 10.65 7235 1291241 681764 108609059
Inspiratory capacity decreased 46.96 10.65 98 1298378 2497 109288326
Mycotic allergy 46.80 10.65 7 1298469 5947 109284876
Coronary arterial stent insertion 46.39 10.65 7 1298469 5908 109284915
Death 46.32 10.65 7352 1291124 691517 108599306
Type I hypersensitivity 45.68 10.65 172 1298304 6221 109284602
Hyperkalaemia 45.56 10.65 1229 1297247 134567 109156256
Neuritis 45.53 10.65 15 1298461 7384 109283439
Aplasia pure red cell 45.53 10.65 28 1298448 9550 109281273
Hyponatraemia 45.53 10.65 2089 1296387 215564 109075259
Treatment failure 45.48 10.65 2727 1295749 274507 109016316
Renal disorder 45.41 10.65 367 1298109 49112 109241711
Ear pain 45.13 10.65 877 1297599 52349 109238474
Hand deformity 45.12 10.65 3061 1295415 215445 109075378
Status epilepticus 44.86 10.65 204 1298272 31367 109259456
Metastases to bone 44.41 10.65 203 1298273 31169 109259654
Device use error 44.01 10.65 26 1298450 9063 109281760
Cardiotoxicity 43.84 10.65 82 1298394 16799 109274024
Lymphoproliferative disorder 43.78 10.65 15 1298461 7203 109283620
Virologic failure 43.44 10.65 4 1298472 4948 109285875
Torsade de pointes 43.32 10.65 129 1298347 22471 109268352
Mydriasis 43.27 10.65 424 1298052 21733 109269090
Injection site haemorrhage 43.10 10.65 220 1298256 32808 109258015
Glycosylated haemoglobin increased 43.02 10.65 138 1298338 23481 109267342
Peptic ulcer perforation 43.00 10.65 51 1298425 782 109290041
Hepatitis B reactivation 42.95 10.65 17 1298459 7467 109283356
Cytomegalovirus chorioretinitis 42.91 10.65 15 1298461 7113 109283710
Premature delivery 42.89 10.65 199 1298277 30433 109260390
Left ventricular dysfunction 42.27 10.65 138 1298338 23355 109267468
Diffuse large B-cell lymphoma recurrent 42.00 10.65 11 1298465 6288 109284535
Candida infection 41.84 10.65 361 1298115 47648 109243175
Breast cancer female 41.62 10.65 51 1298425 12417 109278406
Device related infection 41.59 10.65 282 1298194 39237 109251586
Aspartate aminotransferase increased 41.12 10.65 2284 1296192 157652 109133171
Coronary artery disease 41.05 10.65 593 1297883 71097 109219726
Renal cortical necrosis 41.03 10.65 40 1298436 484 109290339
Conjunctivitis allergic 41.02 10.65 15 1298461 6916 109283907
Oxygen saturation decreased 40.98 10.65 2245 1296231 154737 109136086
Congestive cardiomyopathy 40.64 10.65 65 1298411 14154 109276669
Gastric ulcer haemorrhage 40.36 10.65 229 1298247 9865 109280958
Viral mutation identified 40.34 10.65 3 1298473 4416 109286407
Needle issue 40.15 10.65 94 1298382 17746 109273077
Pruritus 40.05 10.65 7579 1290897 573981 108716842
Sopor 39.86 10.65 258 1298218 36288 109254535
JC virus infection 39.83 10.65 7 1298469 5283 109285540
Injection site warmth 39.74 10.65 91 1298385 17314 109273509
Dyskinesia 39.60 10.65 399 1298077 51047 109239776
Hypotension 39.38 10.65 6858 1291618 516991 108773832
Acute graft versus host disease in intestine 39.25 10.65 9 1298467 5630 109285193
Enterococcal infection 39.22 10.65 116 1298360 20250 109270573
Cardiomyopathy 38.99 10.65 232 1298244 33293 109257530
Thrombosis 38.95 10.65 974 1297502 107688 109183135
Strongyloidiasis 38.88 10.65 6 1298470 4980 109285843
Progressive multifocal leukoencephalopathy 38.69 10.65 156 1298320 24800 109266023
Akathisia 38.65 10.65 90 1298386 17023 109273800
Exposure via skin contact 38.62 10.65 59 1298417 13088 109277735
White blood cells urine positive 38.62 10.65 183 1298293 7341 109283482
Haemoglobin decreased 38.11 10.65 2462 1296014 246265 109044558
Oesophageal obstruction 38.01 10.65 59 1298417 1184 109289639
Pemphigus 38.01 10.65 2969 1295507 211601 109079222
Methaemoglobinaemia 37.99 10.65 210 1298266 8958 109281865
Tardive dyskinesia 37.94 10.65 63 1298413 13516 109277307
Pharyngeal abscess 37.91 10.65 49 1298427 824 109289999
Deafness transitory 37.88 10.65 55 1298421 1038 109289785
Lemierre syndrome 37.81 10.65 24 1298452 145 109290678
Disturbance in social behaviour 37.42 10.65 7 1298469 5051 109285772
Cytomegalovirus colitis 37.42 10.65 18 1298458 7043 109283780
Pneumonia aspiration 37.26 10.65 700 1297776 80533 109210290
Blood pH decreased 37.07 10.65 130 1298346 4539 109286284
Hepatitis B 36.88 10.65 35 1298441 9577 109281246
Hepatic encephalopathy 36.87 10.65 500 1297976 27756 109263067
Urine abnormality 36.79 10.65 207 1298269 8889 109281934
Ankylosing spondylitis 36.72 10.65 311 1298165 15301 109275522
Ovarian hyperstimulation syndrome 36.43 10.65 9 1298467 5351 109285472
Mixed liver injury 36.43 10.65 255 1298221 11824 109278999
Klebsiella infection 36.38 10.65 117 1298359 19892 109270931
Nasal disorder 36.35 10.65 121 1298355 4113 109286710
Peritonitis bacterial 36.32 10.65 42 1298434 10491 109280332
Anion gap increased 36.28 10.65 123 1298353 4221 109286602
Hypoaldosteronism 36.27 10.65 42 1298434 627 109290196
Crystal urine present 36.25 10.65 75 1298401 1899 109288924
Breast cancer 36.23 10.65 284 1298192 38258 109252565
Syringe issue 36.18 10.65 35 1298441 9490 109281333
Lung neoplasm malignant 35.86 10.65 241 1298235 33601 109257222
Drug use disorder 35.85 10.65 347 1298129 17727 109273096
Neutrophil percentage increased 35.79 10.65 133 1298343 4780 109286043
Respiratory rate increased 35.72 10.65 451 1298025 24632 109266191
Renal failure 35.52 10.65 2238 1296238 224336 109066487
Subdural haematoma 35.50 10.65 266 1298210 36188 109254635
Electric shock 35.40 10.65 71 1298405 1757 109289066
SJS-TEN overlap 35.36 10.65 72 1298404 1802 109289021
Mite allergy 35.30 10.65 12 1298464 5791 109285032
Hypomania 35.30 10.65 223 1298253 9987 109280836
IgM nephropathy 35.18 10.65 22 1298454 129 109290694
Complications of transplanted kidney 35.04 10.65 22 1298454 7420 109283403
Skin toxicity 34.50 10.65 53 1298423 11730 109279093
Drug screen positive 34.44 10.65 158 1298318 6252 109284571
Polyneuropathy 34.40 10.65 227 1298249 31785 109259038
Laryngeal oedema 34.40 10.65 215 1298261 9592 109281231
Pulmonary tuberculosis 34.23 10.65 34 1298442 9105 109281718
Acute myeloid leukaemia recurrent 34.22 10.65 9 1298467 5130 109285693
Leukocytosis 34.20 10.65 851 1297625 52977 109237846
Intestinal obstruction 34.20 10.65 430 1298046 52797 109238026
Infusion site erythema 34.06 10.65 249 1298227 11710 109279113
Blood immunoglobulin E increased 34.03 10.65 23 1298453 7459 109283364
Diffuse large B-cell lymphoma 34.02 10.65 86 1298390 15812 109275011
Blood calcium decreased 34.00 10.65 601 1297875 35244 109255579
Infection reactivation 33.99 10.65 4 1298472 4077 109286746
Pericardial effusion 33.92 10.65 470 1298006 56747 109234076
Nodule 33.77 10.65 234 1298242 32397 109258426
Pancreatic carcinoma 33.76 10.65 78 1298398 14794 109276029
Gastrointestinal haemorrhage 33.68 10.65 2316 1296160 163202 109127621
Device difficult to use 33.47 10.65 111 1298365 18694 109272129
Clostridium test positive 33.47 10.65 231 1298245 10662 109280161
Jejunal ulcer 33.37 10.65 26 1298450 227 109290596
Productive cough 33.20 10.65 1055 1297421 113250 109177573
Skin cancer 33.02 10.65 103 1298373 17681 109273142
Infusion site pain 32.89 10.65 331 1298145 17088 109273735
Swelling face 32.75 10.65 1361 1297115 90960 109199863
Glossodynia 32.58 10.65 3029 1295447 218975 109071848
Symmetrical drug-related intertriginous and flexural exanthema 32.43 10.65 70 1298406 1827 109288996
Dust allergy 32.26 10.65 15 1298461 5986 109284837
No adverse event 32.12 10.65 642 1297834 73197 109217626
Adrenal insufficiency 32.12 10.65 330 1298146 42060 109248763
Injection site mass 32.09 10.65 164 1298312 24449 109266374
Systemic candida 32.04 10.65 42 1298434 9932 109280891
Urinary sediment present 32.03 10.65 83 1298393 2445 109288378
Incorrect dosage administered 31.90 10.65 110 1298366 3808 109287015
Extrapyramidal disorder 31.89 10.65 203 1298273 28664 109262159
Hepatic cancer 31.88 10.65 51 1298425 11105 109279718
Respiratory symptom 31.86 10.65 81 1298395 14864 109275959
Body temperature fluctuation 31.66 10.65 107 1298369 3666 109287157
Lymphocyte percentage decreased 31.65 10.65 135 1298341 5175 109285648
Human herpesvirus 6 infection 31.62 10.65 19 1298457 6562 109284261
Urine leukocyte esterase positive 31.44 10.65 107 1298369 3679 109287144
Prostatic specific antigen increased 31.42 10.65 62 1298414 12449 109278374
Headache 31.40 10.65 11174 1287302 871203 108419620
Femur fracture 31.35 10.65 352 1298124 44117 109246706
Leukoencephalopathy 31.34 10.65 37 1298439 9158 109281665
Hepatic cirrhosis 31.25 10.65 582 1297894 67044 109223779
Jaundice cholestatic 31.25 10.65 285 1298191 14323 109276500
Oropharyngeal discomfort 31.14 10.65 218 1298258 10109 109280714
Hypertriglyceridaemia 31.11 10.65 92 1298384 16062 109274761
Local anaesthetic systemic toxicity 31.09 10.65 13 1298463 5524 109285299
Herpes zoster 31.07 10.65 1002 1297474 107377 109183446
Cryptococcosis 31.04 10.65 8 1298468 4623 109286200
Rebound effect 30.99 10.65 81 1298395 14725 109276098
Chronic kidney disease 30.93 10.65 671 1297805 75620 109215203
Epstein-Barr virus associated lymphoproliferative disorder 30.87 10.65 9 1298467 4793 109286030
Mycobacterial infection 30.84 10.65 7 1298469 4410 109286413
Seizure 30.61 10.65 2209 1296267 218976 109071847
Parapharyngeal space infection 30.57 10.65 10 1298466 5 109290818
Injection site rash 30.56 10.65 156 1298320 23263 109267560
Toxic shock syndrome streptococcal 30.52 10.65 27 1298449 286 109290537
Stress cardiomyopathy 30.46 10.65 90 1298386 15716 109275107
Poor venous access 30.40 10.65 430 1298046 24092 109266731
Mania 30.38 10.65 133 1298343 20663 109270160
Intervertebral discitis 30.23 10.65 162 1298314 6828 109283995
Mobility decreased 30.13 10.65 3207 1295269 234215 109056608
Head injury 30.13 10.65 341 1298135 42676 109248147
Parkinsonism 29.98 10.65 146 1298330 22041 109268782
Syncope 29.96 10.65 2011 1296465 200525 109090298
Jaundice 29.87 10.65 909 1297567 58327 109232496
Haemorrhage 29.73 10.65 990 1297486 105702 109185121
Therapy non-responder 29.71 10.65 1526 1296950 155781 109135042
Brain oedema 29.71 10.65 522 1297954 30576 109260247
Incorrect dose administered by device 29.60 10.65 22 1298454 6792 109284031
Unresponsive to stimuli 29.57 10.65 969 1297507 62821 109228002
Laryngeal dyspnoea 29.43 10.65 28 1298448 328 109290495
Analgesic drug level above therapeutic 29.36 10.65 33 1298443 476 109290347
Prothrombin time prolonged 29.29 10.65 321 1298155 16940 109273883
Asthma 29.17 10.65 2535 1295941 247756 109043067
Viral haemorrhagic cystitis 29.15 10.65 3 1298473 3396 109287427
Spinal stenosis 28.99 10.65 120 1298356 18936 109271887
Accidental poisoning 28.83 10.65 79 1298397 2408 109288415
Haemoptysis 28.80 10.65 628 1297848 70726 109220097
Blood creatine phosphokinase increased 28.69 10.65 646 1297830 72431 109218392
Nipple swelling 28.67 10.65 29 1298447 368 109290455
Faeces discoloured 28.66 10.65 559 1297917 33389 109257434
Ejection fraction decreased 28.66 10.65 324 1298152 40556 109250267
Tenosynovitis 28.65 10.65 305 1298171 15978 109274845
Infusion site extravasation 28.56 10.65 234 1298242 11400 109279423
Aggression 28.48 10.65 506 1297970 58704 109232119
Specific gravity urine decreased 28.43 10.65 43 1298433 843 109289980
Anticipatory anxiety 28.28 10.65 52 1298424 1204 109289619
Squamous cell carcinoma 28.25 10.65 116 1298360 18347 109272476
Pseudomonas infection 28.20 10.65 201 1298275 27652 109263171
Infection masked 28.18 10.65 19 1298457 129 109290694
Tropical infectious disease 28.11 10.65 13 1298463 36 109290787
Metastases to central nervous system 28.09 10.65 155 1298321 22662 109268161
Wound 27.86 10.65 3153 1295323 231284 109059539
Serum sickness-like reaction 27.81 10.65 40 1298436 748 109290075
Ischaemic stroke 27.78 10.65 330 1298146 40933 109249890
Neuroblastoma recurrent 27.78 10.65 33 1298443 507 109290316
Mucocutaneous disorder 27.62 10.65 22 1298454 199 109290624
Cholestasis 27.61 10.65 971 1297505 63547 109227276
Tumour lysis syndrome 27.56 10.65 230 1298246 30571 109260252
Hyperglycaemia 27.53 10.65 774 1297702 84316 109206507
B-cell lymphoma 27.51 10.65 26 1298450 7128 109283695
Tremor 27.45 10.65 2023 1296453 200209 109090614
Discoloured vomit 27.41 10.65 68 1298408 1949 109288874
Swelling 27.38 10.65 4605 1293871 346436 108944387
Synovitis 27.32 10.65 3646 1294830 270446 109020377
Febrile bone marrow aplasia 27.18 10.65 109 1298367 17356 109273467
Allergic respiratory disease 27.17 10.65 19 1298457 138 109290685
Cardiac dysfunction 27.16 10.65 20 1298456 6203 109284620
Feeling abnormal 27.12 10.65 1792 1296684 178919 109111904
Accidental exposure to product by child 27.10 10.65 91 1298385 3107 109287716
Leukaemia 26.99 10.65 29 1298447 7489 109283334
Enthesopathy 26.97 10.65 244 1298232 12234 109278589
Aortic valve stenosis 26.95 10.65 21 1298455 6329 109284494
Carnitine palmitoyltransferase deficiency 26.82 10.65 10 1298466 12 109290811
Dystonia 26.73 10.65 185 1298291 25620 109265203
Tongue disorder 26.66 10.65 271 1298205 14027 109276796
Infusion site swelling 26.63 10.65 203 1298273 9674 109281149
Injection site discolouration 26.60 10.65 41 1298435 9062 109281761
Laryngeal discomfort 26.55 10.65 39 1298437 744 109290079
Hypoglycaemic coma 26.55 10.65 16 1298460 5517 109285306
Blood potassium decreased 26.49 10.65 461 1298015 53653 109237170
Intracranial pressure increased 26.46 10.65 213 1298263 10322 109280501
Red blood cell count decreased 26.09 10.65 582 1297894 65341 109225482
Transplant failure 26.06 10.65 17 1298459 5618 109285205
Colon cancer 25.99 10.65 102 1298374 16341 109274482
Catatonia 25.87 10.65 59 1298417 11241 109279582
Mitral valve incompetence 25.86 10.65 258 1298218 33071 109257752
Retinal haemorrhage 25.70 10.65 45 1298431 9456 109281367
Ductus arteriosus premature closure 25.69 10.65 16 1298460 93 109290730
Histoplasmosis disseminated 25.64 10.65 7 1298469 3892 109286931
Oedema 25.61 10.65 2119 1296357 207857 109082966
Abortion incomplete 25.61 10.65 3 1298473 3069 109287754
Arthropathy 25.54 10.65 3799 1294677 283723 109007100
Multiple organ dysfunction syndrome 25.45 10.65 1489 1296987 150221 109140602
Device occlusion 25.43 10.65 92 1298384 15093 109275730
Tricuspid valve incompetence 25.30 10.65 170 1298306 23703 109267120
Bacterial test 25.24 10.65 48 1298428 1141 109289682
Actinic keratosis 25.24 10.65 27 1298449 6986 109283837
Squamous cell carcinoma of skin 25.14 10.65 110 1298366 17093 109273730
Bundle branch block left 25.11 10.65 73 1298403 12815 109278008
Eczema 25.10 10.65 651 1297825 71642 109219181
Systemic mycosis 24.94 10.65 7 1298469 3822 109287001
Rash maculo-papular 24.93 10.65 1088 1297388 73134 109217689
Hip fracture 24.88 10.65 278 1298198 34873 109255950
Spinal compression fracture 24.86 10.65 121 1298355 18271 109272552
Glutathione decreased 24.81 10.65 13 1298463 51 109290772
Stent placement 24.78 10.65 29 1298447 7205 109283618
Pneumonia cytomegaloviral 24.77 10.65 27 1298449 6927 109283896
Product preparation error 24.74 10.65 57 1298419 10822 109280001
Cerebral ischaemia 24.74 10.65 67 1298409 12037 109278786
Intraocular pressure increased 24.72 10.65 57 1298419 10819 109280004
Injection site reaction 24.70 10.65 827 1297649 88243 109202580
Adenovirus infection 24.69 10.65 58 1298418 10936 109279887
Gastric perforation 24.66 10.65 119 1298357 4810 109286013
Varicella zoster virus infection 24.66 10.65 23 1298453 6345 109284478
Inappropriate schedule of product administration 24.64 10.65 2742 1295734 200895 109089928
Haematuria 24.61 10.65 764 1297712 82241 109208582
Injection site urticaria 24.60 10.65 111 1298365 17104 109273719
Sensitisation 24.54 10.65 9 1298467 4142 109286681
Ejection fraction 24.35 10.65 3 1298473 2952 109287871
Sudden infant death syndrome 24.31 10.65 25 1298451 324 109290499
Drug effective for unapproved indication 24.28 10.65 85 1298391 14082 109276741
Visual impairment 24.26 10.65 1310 1297166 133118 109157705
Mycobacterium avium complex infection 24.24 10.65 20 1298456 5857 109284966
Surgery 24.16 10.65 340 1298136 40943 109249880
Analgesic therapy 24.10 10.65 30 1298446 7254 109283569
Embolic stroke 24.03 10.65 41 1298435 8702 109282121
Pneumonia bacterial 24.00 10.65 195 1298281 26066 109264757
Cardiac operation 23.99 10.65 21 1298455 5974 109284849
Pneumonia fungal 23.65 10.65 91 1298385 14663 109276160
Glucose tolerance impaired 23.64 10.65 50 1298426 9787 109281036
Jejunal ulcer perforation 23.58 10.65 16 1298460 110 109290713
Escherichia infection 23.57 10.65 173 1298303 23643 109267180
Coma scale abnormal 23.54 10.65 195 1298281 9531 109281292
Loss of consciousness 23.50 10.65 1984 1296492 194322 109096501
Sexual dysfunction 23.44 10.65 40 1298436 8490 109282333
Chronic gastrointestinal bleeding 23.38 10.65 29 1298447 467 109290356
Metastases to lymph nodes 23.28 10.65 94 1298382 14938 109275885
Lipodystrophy acquired 23.27 10.65 12 1298464 4512 109286311
Catheterisation cardiac 23.23 10.65 23 1298453 6168 109284655
Rheumatic fever 23.18 10.65 1705 1296771 120874 109169949
Secondary immunodeficiency 23.18 10.65 13 1298463 4663 109286160
Disseminated tuberculosis 23.16 10.65 16 1298460 5130 109285693
Bilirubin urine present 23.16 10.65 24 1298452 314 109290509
Metabolic disorder 23.16 10.65 56 1298420 10454 109280369
Conjunctival hyperaemia 23.12 10.65 132 1298344 5699 109285124
Substance use disorder 23.11 10.65 31 1298445 7259 109283564
Allergy test positive 23.07 10.65 40 1298436 883 109289940
Condition aggravated 23.06 10.65 8007 1290469 726829 108563994
Lung transplant 23.05 10.65 17 1298459 5269 109285554
Gingival hypertrophy 23.01 10.65 11 1298465 4320 109286503
Vascular stent thrombosis 22.99 10.65 10 1298466 4151 109286672
Ulcer 22.92 10.65 666 1297810 42450 109248373
Stenotrophomonas infection 22.87 10.65 21 1298455 5837 109284986
Sedation 22.86 10.65 1019 1297457 68664 109222159
Shock 22.81 10.65 806 1297670 52782 109238041
Prothrombin time abnormal 22.72 10.65 48 1298428 1234 109289589
Weight fluctuation 22.71 10.65 376 1298100 21769 109269054
Epstein-Barr viraemia 22.48 10.65 7 1298469 3572 109287251
Drug reaction with eosinophilia and systemic symptoms 22.41 10.65 1179 1297297 80916 109209907
Cutaneous T-cell lymphoma 22.39 10.65 6 1298470 3378 109287445
Partial seizures 22.32 10.65 64 1298412 11285 109279538
Urine analysis abnormal 22.23 10.65 148 1298328 6749 109284074
Corneal oedema 22.21 10.65 5 1298471 3168 109287655
Inadequate analgesia 22.19 10.65 118 1298358 4959 109285864
Gynaecomastia 22.17 10.65 49 1298427 9441 109281382
Post-traumatic stress disorder 22.14 10.65 143 1298333 6453 109284370
Beta haemolytic streptococcal infection 22.12 10.65 81 1298395 2890 109287933
Psychiatric decompensation 22.11 10.65 21 1298455 5744 109285079
Electrocardiogram QRS complex prolonged 22.03 10.65 242 1298234 12779 109278044
Sinus node dysfunction 21.73 10.65 46 1298430 9001 109281822
Macular oedema 21.70 10.65 30 1298446 6936 109283887
Arteriosclerosis 21.68 10.65 186 1298290 24581 109266242
Purpura fulminans 21.63 10.65 24 1298452 341 109290482
Perforated ulcer 21.55 10.65 35 1298441 731 109290092
Interleukin level increased 21.35 10.65 54 1298422 1567 109289256
Eye pruritus 21.35 10.65 264 1298212 32511 109258312
Osteolysis 21.32 10.65 20 1298456 5503 109285320
Atrioventricular block complete 21.28 10.65 143 1298333 19939 109270884
Nasal pruritus 21.27 10.65 39 1298437 901 109289922
Infective pulmonary exacerbation of cystic fibrosis 21.25 10.65 95 1298381 14676 109276147
Product complaint 21.24 10.65 88 1298388 13884 109276939
Ventricular extrasystoles 21.20 10.65 167 1298309 22474 109268349
Disseminated cryptococcosis 21.17 10.65 3 1298473 2654 109288169
Bronchitis 21.12 10.65 1572 1296904 155460 109135363
Fear of disease 21.07 10.65 49 1298427 1346 109289477
Weight decreased 20.93 10.65 5024 1293452 463033 108827790
Alpha tumour necrosis factor increased 20.90 10.65 25 1298451 387 109290436
Pulmonary nocardiosis 20.88 10.65 3 1298473 2626 109288197
Organising pneumonia 20.86 10.65 91 1298385 14152 109276671
Eyelid ptosis 20.85 10.65 83 1298393 13244 109277579
Osmolar gap 20.81 10.65 17 1298459 160 109290663
Chronic graft versus host disease in skin 20.77 10.65 3 1298473 2616 109288207
Genital odour 20.74 10.65 6 1298470 0 109290823
Product dispensing error 20.69 10.65 110 1298366 16235 109274588
Pulmonary mass 20.50 10.65 311 1298165 36990 109253833
Hyperthyroidism 20.48 10.65 232 1298244 29029 109261794
Fracture 20.45 10.65 189 1298287 24599 109266224
Neurological symptom 20.35 10.65 104 1298372 15504 109275319
Inflammation 20.33 10.65 2579 1295897 190659 109100164
Dementia 20.30 10.65 256 1298220 31417 109259406
Lymphoma 20.21 10.65 146 1298330 20025 109270798
Osteomyelitis 20.17 10.65 305 1298171 36295 109254528
Peripheral sensory neuropathy 20.16 10.65 114 1298362 16566 109274257
Infusion site mass 20.14 10.65 55 1298421 1673 109289150
Night sweats 20.09 10.65 1831 1296645 132152 109158671
Systemic lupus erythematosus rash 20.07 10.65 61 1298415 1974 109288849
Galactorrhoea 19.96 10.65 12 1298464 4143 109286680
Cellulitis pharyngeal 19.93 10.65 7 1298469 6 109290817
Abnormal clotting factor 19.91 10.65 17 1298459 171 109290652
Haemophagocytic lymphohistiocytosis 19.88 10.65 256 1298220 31303 109259520
Disseminated intravascular coagulation 19.80 10.65 353 1298123 40933 109249890
Ketoacidosis 19.75 10.65 57 1298419 10030 109280793
Neuroleptic malignant syndrome 19.75 10.65 281 1298195 33778 109257045
Schizophrenia 19.66 10.65 363 1298113 21463 109269360
Hepatitis toxic 19.65 10.65 128 1298348 5793 109285030
Device issue 19.65 10.65 286 1298190 34249 109256574
Atypical mycobacterial infection 19.61 10.65 4 1298472 2714 109288109
Brain stem glioma 19.53 10.65 18 1298458 202 109290621
Product used for unknown indication 19.51 10.65 59 1298417 1904 109288919
Viraemia 19.49 10.65 12 1298464 4090 109286733
Apparent death 19.48 10.65 5 1298471 2897 109287926
Bone pain 19.43 10.65 599 1297877 64534 109226289
Eye swelling 19.40 10.65 517 1297959 32531 109258292
Plasma cell myeloma recurrent 19.37 10.65 33 1298443 7009 109283814
Osteoporosis 19.33 10.65 831 1297645 86321 109204502
Electrolyte imbalance 19.25 10.65 312 1298164 36716 109254107
Nasal septum perforation 19.24 10.65 37 1298439 887 109289936
Hepatitis C 19.23 10.65 79 1298397 12494 109278329
Toxoplasmosis 19.18 10.65 7 1298469 3232 109287591
Left ventricular hypertrophy 19.16 10.65 85 1298391 13159 109277664
Tuberculosis 19.12 10.65 126 1298350 17648 109273175
Catheter management 19.07 10.65 10 1298466 3725 109287098
Blood triglycerides increased 19.07 10.65 184 1298292 23742 109267081
Scedosporium infection 19.07 10.65 3 1298473 2455 109288368
Hypertensive emergency 19.06 10.65 84 1298392 3267 109287556
Abdominal tenderness 19.04 10.65 227 1298249 12230 109278593
Diabetic metabolic decompensation 19.01 10.65 11 1298465 3878 109286945
Systemic lupus erythematosus 19.00 10.65 3329 1295147 251009 109039814
Neoplasm recurrence 18.99 10.65 20 1298456 5212 109285611
Chills 18.97 10.65 2535 1295941 188045 109102778
Malaise 18.90 10.65 7350 1291126 664469 108626354
Delusion 18.80 10.65 183 1298293 23572 109267251
Helicobacter test positive 18.79 10.65 46 1298430 1307 109289516
Adenocarcinoma of colon 18.78 10.65 27 1298449 6141 109284682
H1N1 influenza 18.78 10.65 6 1298470 3012 109287811
Granulocytopenia 18.77 10.65 81 1298395 12634 109278189
Atrial flutter 18.74 10.65 188 1298288 24074 109266749
Carcinoembryonic antigen increased 18.70 10.65 5 1298471 2819 109288004
Photophobia 18.69 10.65 415 1298061 25356 109265467
Product dose omission in error 18.66 10.65 181 1298295 23331 109267492
Paraesthesia ear 18.65 10.65 27 1298449 508 109290315
Eosinophilic oesophagitis 18.64 10.65 45 1298431 1267 109289556
Staphylococcal sepsis 18.64 10.65 124 1298352 17330 109273493
Fanconi syndrome 18.60 10.65 9 1298467 3510 109287313
Pulmonary infarction 18.50 10.65 97 1298379 4054 109286769
Peripheral arterial occlusive disease 18.50 10.65 52 1298424 9228 109281595
Euglycaemic diabetic ketoacidosis 18.43 10.65 72 1298404 11551 109279272
Injection site induration 18.38 10.65 70 1298406 11313 109279510
Necrotising fasciitis 18.27 10.65 152 1298324 7439 109283384
White coat hypertension 18.22 10.65 45 1298431 1286 109289537
Speech disorder 18.18 10.65 567 1297909 61002 109229821
Immunosuppressant drug level decreased 18.17 10.65 5 1298471 2766 109288057
Meningitis pneumococcal 18.16 10.65 32 1298444 716 109290107
Monocyte chemotactic protein-1 increased 18.13 10.65 22 1298454 346 109290477
Ejection fraction abnormal 18.06 10.65 9 1298467 3451 109287372
Fungal infection 18.04 10.65 456 1298020 50350 109240473
Acute graft versus host disease in liver 18.03 10.65 3 1298473 2356 109288467
Thinking abnormal 18.02 10.65 104 1298372 15036 109275787
Impaired quality of life 18.00 10.65 246 1298230 29771 109261052
Concomitant disease progression 17.94 10.65 10 1298466 3600 109287223
Anosognosia 17.90 10.65 13 1298463 4061 109286762
Haemorrhage intracranial 17.88 10.65 236 1298240 28733 109262090
Coronary artery bypass 17.86 10.65 27 1298449 6015 109284808
Pharyngeal swelling 17.84 10.65 218 1298258 11814 109279009
Foreign body in gastrointestinal tract 17.81 10.65 14 1298462 124 109290699
Nephrogenic systemic fibrosis 17.71 10.65 23 1298453 5460 109285363
Sinus tachycardia 17.66 10.65 664 1297812 43829 109246994
Blood ethanol increased 17.64 10.65 29 1298447 612 109290211
Weight increased 17.63 10.65 5349 1293127 414295 108876528
Flank pain 17.59 10.65 375 1298101 22755 109268068
Infusion site rash 17.55 10.65 64 1298412 2279 109288544
Acute coronary syndrome 17.48 10.65 180 1298296 22932 109267891
Ventricular hypokinesia 17.44 10.65 70 1298406 11144 109279679
Cholesterosis 17.43 10.65 22 1298454 361 109290462
Viral load increased 17.42 10.65 9 1298467 3381 109287442
Pleurothotonus 17.36 10.65 4 1298472 2494 109288329
Escherichia sepsis 17.35 10.65 62 1298414 10210 109280613
Ceruloplasmin decreased 17.35 10.65 7 1298469 12 109290811
Oesophageal candidiasis 17.32 10.65 73 1298403 11461 109279362
Gallbladder cholesterolosis 17.31 10.65 29 1298447 622 109290201
Consciousness fluctuating 17.31 10.65 61 1298415 2135 109288688
Abscess of eyelid 17.28 10.65 5 1298471 0 109290823
Poor quality device used 17.28 10.65 6 1298470 2857 109287966
Arthralgia 17.27 10.65 9720 1288756 769912 108520911
Renal transplant failure 17.27 10.65 5 1298471 2675 109288148
Dyspnoea at rest 17.21 10.65 46 1298430 8300 109282523
Thyroid cancer 17.21 10.65 29 1298447 6185 109284638
Abdominal pain lower 17.19 10.65 566 1297910 36717 109254106
Lip dry 17.08 10.65 1381 1297095 98702 109192121
Periorbital swelling 17.07 10.65 117 1298359 5388 109285435
Immune-mediated myositis 17.01 10.65 29 1298447 6157 109284666
Duodenitis 17.00 10.65 174 1298302 9022 109281801
Bleeding time abnormal 17.00 10.65 7 1298469 13 109290810
Supraventricular tachycardia 16.95 10.65 194 1298282 24228 109266595
Malnutrition 16.92 10.65 222 1298254 27057 109263766
Hallucination 16.92 10.65 996 1297480 100436 109190387
Hepatitis 16.92 10.65 1252 1297224 88802 109202021
Pneumonitis 16.92 10.65 730 1297746 75801 109215022
Pneumocystis jirovecii infection 16.91 10.65 16 1298460 4384 109286439
Dysphoria 16.89 10.65 31 1298445 6397 109284426
Cryopyrin associated periodic syndrome 16.83 10.65 28 1298448 597 109290226
Pemphigoid 16.81 10.65 149 1298327 19558 109271265
Coagulation factor X level decreased 16.75 10.65 12 1298464 91 109290732
Injection site discomfort 16.69 10.65 35 1298441 6872 109283951
Polycystic ovaries 16.67 10.65 19 1298457 4777 109286046
Carotid artery occlusion 16.65 10.65 57 1298419 9508 109281315
Metastases to peritoneum 16.65 10.65 25 1298451 5585 109285238
Hypokalaemia 16.64 10.65 1881 1296595 180567 109110256
Hyperaesthesia 16.59 10.65 254 1298222 14473 109276350
Multiple sclerosis 16.54 10.65 407 1298069 25291 109265532
Hypertransaminasaemia 16.48 10.65 387 1298089 23868 109266955
Genital tract inflammation 16.46 10.65 14 1298462 140 109290683
Therapy change 16.45 10.65 61 1298415 9936 109280887
Urosepsis 16.44 10.65 257 1298219 30418 109260405
Mycoplasma test positive 16.43 10.65 18 1298458 252 109290571
Choluria 16.41 10.65 24 1298452 456 109290367
Skin exfoliation 16.41 10.65 851 1297625 86800 109204023
Distichiasis 16.38 10.65 8 1298468 26 109290797
Inflammatory marker increased 16.37 10.65 101 1298375 14368 109276455
Dizziness 16.36 10.65 7687 1290789 690506 108600317
Eye disorder 16.34 10.65 450 1298026 28456 109262367
Delusion of grandeur 16.31 10.65 61 1298415 2199 109288624
Coagulation factor V level decreased 16.30 10.65 29 1298447 654 109290169
Product administered to patient of inappropriate age 16.29 10.65 155 1298321 7881 109282942
Gastritis haemorrhagic 16.16 10.65 77 1298399 3096 109287727
Thyroiditis 16.14 10.65 33 1298443 6540 109284283
Pre-eclampsia 16.13 10.65 50 1298426 8600 109282223
Portal hypertension 16.05 10.65 50 1298426 8587 109282236
Acute lymphocytic leukaemia recurrent 16.03 10.65 27 1298449 5760 109285063
Drug provocation test 15.95 10.65 8 1298468 28 109290795
Parvimonas micra infection 15.94 10.65 11 1298465 78 109290745
Left ventricular failure 15.94 10.65 74 1298402 11315 109279508
Eye irritation 15.73 10.65 287 1298189 33165 109257658
Food intolerance 15.73 10.65 99 1298377 4428 109286395
Exposure to SARS-CoV-2 15.72 10.65 72 1298404 2847 109287976
Type IV hypersensitivity reaction 15.71 10.65 123 1298353 5910 109284913
Allodynia 15.69 10.65 57 1298419 2026 109288797
Cerebral artery thrombosis 15.52 10.65 49 1298427 1619 109289204
Thymoma benign 15.51 10.65 9 1298467 45 109290778
Acute haemorrhagic oedema of infancy 15.51 10.65 9 1298467 45 109290778
Flushing 15.50 10.65 1430 1297046 103306 109187517
Device use issue 15.45 10.65 13 1298463 3771 109287052
Catheter site pruritus 15.43 10.65 4 1298472 2302 109288521
Nasal necrosis 15.42 10.65 15 1298461 181 109290642
Cerebral aspergillosis 15.39 10.65 4 1298472 2298 109288525
Normochromic normocytic anaemia 15.37 10.65 90 1298386 12967 109277856
Blood copper decreased 15.35 10.65 6 1298470 9 109290814
Lymphangiosis carcinomatosa 15.33 10.65 5 1298471 2477 109288346
Myalgia 15.28 10.65 2334 1296142 220047 109070776
Anaemia macrocytic 15.25 10.65 40 1298436 7263 109283560
Terminal state 15.19 10.65 27 1298449 5640 109285183
Graft versus host disease in liver 15.16 10.65 5 1298471 2460 109288363
Renal cell carcinoma 15.15 10.65 42 1298434 7488 109283335
Diplopia 15.15 10.65 375 1298101 41519 109249304
Accidental exposure to product 15.14 10.65 459 1298017 49549 109241274
Cachexia 15.12 10.65 90 1298386 12915 109277908
Cystic fibrosis 15.12 10.65 20 1298456 4711 109286112
Liver transplant 15.11 10.65 99 1298377 4490 109286333
Uterine cancer 15.10 10.65 16 1298460 4158 109286665
Substance abuser 15.09 10.65 23 1298453 454 109290369
Pulmonary arterial pressure increased 15.07 10.65 23 1298453 5104 109285719
Cyanosis neonatal 15.06 10.65 10 1298466 66 109290757
Pulmonary thrombosis 15.05 10.65 98 1298378 13765 109277058
Steroid diabetes 15.03 10.65 24 1298452 5230 109285593
Pancreatic carcinoma metastatic 15.02 10.65 16 1298460 4148 109286675
Urine bilirubin decreased 14.98 10.65 13 1298463 134 109290689
Viral parotitis 14.97 10.65 5 1298471 3 109290820
Prescribed underdose 14.97 10.65 619 1297857 64555 109226268
Product quality issue 14.95 10.65 748 1297728 76551 109214272
Duodenal obstruction 14.95 10.65 23 1298453 458 109290365
Joint range of motion decreased 14.94 10.65 1642 1296834 120190 109170633
Urinary retention 14.93 10.65 667 1297809 69016 109221807
Product administration error 14.92 10.65 556 1297920 36661 109254162
Blood lactic acid increased 14.91 10.65 265 1298211 15556 109275267
Epidermal necrosis 14.80 10.65 73 1298403 2977 109287846
Joint destruction 14.79 10.65 72 1298404 10871 109279952
Fusarium infection 14.78 10.65 7 1298469 2764 109288059
Acute febrile neutrophilic dermatosis 14.77 10.65 104 1298372 4832 109285991
Mononeuropathy 14.76 10.65 20 1298456 353 109290470
Frequent bowel movements 14.75 10.65 686 1297790 70704 109220119
Gallbladder hypofunction 14.75 10.65 24 1298452 502 109290321
Miosis 14.70 10.65 350 1298126 21633 109269190
Oropharyngeal pain 14.68 10.65 1809 1296667 133467 109157356
Abortion spontaneous 14.63 10.65 299 1298177 33983 109256840
Magnesium deficiency 14.62 10.65 30 1298446 755 109290068
Pulmonary oedema 14.62 10.65 1001 1297475 99658 109191165
Blood magnesium decreased 14.61 10.65 157 1298319 19839 109270984
Angina unstable 14.57 10.65 123 1298353 16309 109274514
Cognitive disorder 14.53 10.65 1205 1297271 86306 109204517
Lung adenocarcinoma 14.51 10.65 60 1298416 9471 109281352
Coagulation factor decreased 14.50 10.65 19 1298457 324 109290499
Anticholinergic syndrome 14.50 10.65 93 1298383 4187 109286636
Akinesia 14.49 10.65 13 1298463 3654 109287169
Atrial tachycardia 14.46 10.65 57 1298419 9121 109281702
Carotid arteriosclerosis 14.44 10.65 9 1298467 3048 109287775
Therapeutic response unexpected 14.44 10.65 195 1298281 23648 109267175
Head discomfort 14.43 10.65 308 1298168 18692 109272131
Duodenal stenosis 14.41 10.65 34 1298442 943 109289880
Diabetic nephropathy 14.39 10.65 12 1298464 3496 109287327
Muscle disorder 14.35 10.65 36 1298440 6636 109284187
Cardiac pacemaker insertion 14.34 10.65 33 1298443 6268 109284555
Breast cancer stage IV 14.34 10.65 3 1298473 2000 109288823
Tympanic membrane hyperaemia 14.29 10.65 6 1298470 12 109290811
Wrong technique in device usage process 14.26 10.65 38 1298438 6863 109283960
Acquired epidermolysis bullosa 14.22 10.65 11 1298465 95 109290728
Erythema 14.20 10.65 3738 1294738 287709 109003114
Catheter site erythema 14.19 10.65 31 1298445 5997 109284826
Contusion 14.17 10.65 3023 1295453 230338 109060485
Lymphopenia 14.14 10.65 361 1298115 39809 109251014
Colitis 14.13 10.65 1022 1297454 101301 109189522
Calciphylaxis 14.11 10.65 17 1298459 4170 109286653
Hepatitis E 14.10 10.65 19 1298457 4440 109286383
Alcohol poisoning 14.07 10.65 165 1298311 8855 109281968
Post cholecystectomy syndrome 14.07 10.65 31 1298445 821 109290002
Ageusia 14.05 10.65 155 1298321 19490 109271333
Forced vital capacity decreased 14.00 10.65 3 1298473 1967 109288856
Medical device discomfort 13.98 10.65 53 1298423 1923 109288900
Eye haemorrhage 13.95 10.65 81 1298395 11693 109279130
Low density lipoprotein increased 13.94 10.65 71 1298405 10595 109280228
Dermatitis bullous 13.92 10.65 286 1298190 17243 109273580
Meningoencephalitis bacterial 13.87 10.65 22 1298454 450 109290373
Therapeutic response shortened 13.87 10.65 450 1298026 29133 109261690
Blood glucose decreased 13.86 10.65 253 1298223 29235 109261588
Hyperacusis 13.86 10.65 70 1298406 2882 109287941
Venoocclusive disease 13.86 10.65 34 1298442 6316 109284507
pH body fluid decreased 13.85 10.65 7 1298469 25 109290798
Potentiating drug interaction 13.84 10.65 80 1298396 11563 109279260
Concomitant disease aggravated 13.84 10.65 124 1298352 16240 109274583
Shoulder injury related to vaccine administration 13.83 10.65 4 1298472 0 109290823
Salivary gland cyst 13.83 10.65 4 1298472 0 109290823
Atypical femur fracture 13.81 10.65 33 1298443 6186 109284637
Febrile neutropenia 13.80 10.65 3404 1295072 313363 108977460
Muscle spasms 13.77 10.65 2971 1295505 275186 109015637
Antineutrophil cytoplasmic antibody positive 13.77 10.65 24 1298452 5052 109285771
Patient uncooperative 13.72 10.65 33 1298443 927 109289896
Chronic myeloid leukaemia 13.72 10.65 18 1298458 4255 109286568
Device delivery system issue 13.71 10.65 4 1298472 2129 109288694
Drug withdrawal headache 13.68 10.65 11 1298465 101 109290722
Injection site hyperaesthesia 13.63 10.65 10 1298466 79 109290744
Vascular graft 13.63 10.65 4 1298472 2121 109288702
Polyhydramnios 13.63 10.65 3 1298473 1930 109288893
Alcohol use 13.62 10.65 89 1298387 4033 109286790
Multiple drug therapy 13.58 10.65 149 1298327 7865 109282958
Cerebellar syndrome 13.56 10.65 34 1298442 6268 109284555
Arrhythmia 13.50 10.65 673 1297803 68902 109221921
Sinus arrest 13.49 10.65 18 1298458 4224 109286599
Feeling cold 13.44 10.65 507 1297969 33480 109257343
Ileus 13.42 10.65 267 1298209 30462 109260361
Ocular icterus 13.41 10.65 119 1298357 5934 109284889
Meningitis cryptococcal 13.39 10.65 22 1298454 4740 109286083
Diabetic neuropathy 13.38 10.65 40 1298436 6959 109283864
Cutaneous vasculitis 13.38 10.65 217 1298259 12512 109278311
Cervicogenic headache 13.37 10.65 15 1298461 216 109290607
Dental operation 13.35 10.65 43 1298433 1436 109289387
Prostatic pain 13.33 10.65 17 1298459 282 109290541
Blood glucose fluctuation 13.32 10.65 46 1298430 7652 109283171
Extremity necrosis 13.28 10.65 15 1298461 3787 109287036
Metabolic myopathy 13.28 10.65 12 1298464 131 109290692
Swollen joint count increased 13.26 10.65 1148 1297328 82513 109208310
Spondylolysis 13.26 10.65 15 1298461 218 109290605
Sudden cardiac death 13.26 10.65 29 1298447 5608 109285215
Acute promyelocytic leukaemia 13.25 10.65 3 1298473 1893 109288930
Pulmonary function test abnormal 13.24 10.65 24 1298452 4976 109285847
Specific gravity urine abnormal 13.24 10.65 10 1298466 83 109290740
Nephritis allergic 13.24 10.65 35 1298441 1044 109289779
Body height below normal 13.23 10.65 4 1298472 2080 109288743
Tachyarrhythmia 13.21 10.65 51 1298425 8210 109282613
Bradycardia 13.20 10.65 1611 1296865 153906 109136917
Sputum increased 13.19 10.65 30 1298446 5721 109285102
Cells in urine 13.17 10.65 14 1298462 189 109290634
Dermatitis acneiform 13.15 10.65 91 1298385 12604 109278219
Blood thromboplastin decreased 13.13 10.65 6 1298470 16 109290807
Orbital compartment syndrome 13.10 10.65 11 1298465 108 109290715
Tendonitis 13.08 10.65 400 1298076 25683 109265140
Trichiasis 13.07 10.65 12 1298464 134 109290689
Alcoholic coma 13.05 10.65 10 1298466 85 109290738
Scleroderma 13.04 10.65 35 1298441 6306 109284517
Prepyloric stenosis 12.99 10.65 5 1298471 7 109290816
Kawasaki's disease 12.99 10.65 5 1298471 7 109290816
Streptococcal sepsis 12.98 10.65 103 1298373 4969 109285854
Nutritional supplementation 12.92 10.65 8 1298468 46 109290777
Autoimmune hepatitis 12.92 10.65 245 1298231 14559 109276264
Alpha 1 microglobulin increased 12.92 10.65 8 1298468 46 109290777
Neonatal respiratory acidosis 12.91 10.65 9 1298467 65 109290758
Lymphocyte count decreased 12.90 10.65 808 1297668 56435 109234388
Blood creatinine decreased 12.89 10.65 164 1298312 8973 109281850
Alveolar rhabdomyosarcoma 12.88 10.65 6 1298470 17 109290806
Pulmonary fibrosis 12.86 10.65 1027 1297449 101015 109189808
Lung carcinoma cell type unspecified stage IV 12.83 10.65 5 1298471 2217 109288606
Administration site swelling 12.81 10.65 25 1298451 606 109290217
Fungal rhinitis 12.77 10.65 10 1298466 88 109290735
Blood urine present 12.75 10.65 374 1298102 23871 109266952
Medical device pain 12.74 10.65 41 1298435 1369 109289454
Toxicologic test abnormal 12.72 10.65 39 1298437 1268 109289555
Blood glucose abnormal 12.69 10.65 94 1298382 12822 109278001
Nipple pain 12.69 10.65 36 1298440 1120 109289703
Obstruction gastric 12.67 10.65 52 1298424 1959 109288864
Abnormal behaviour 12.65 10.65 355 1298121 38684 109252139
Pineal gland cyst 12.65 10.65 15 1298461 230 109290593
Amniotic cavity disorder 12.65 10.65 8 1298468 48 109290775
Salivary hypersecretion 12.64 10.65 137 1298339 17284 109273539
Haemorrhage subcutaneous 12.62 10.65 29 1298447 5510 109285313
Metastasis 12.61 10.65 52 1298424 8215 109282608
Delayed graft function 12.61 10.65 19 1298457 4238 109286585
Pericarditis adhesive 12.60 10.65 5 1298471 8 109290815
Polydipsia 12.60 10.65 47 1298429 7641 109283182
Postoperative delirium 12.59 10.65 31 1298445 884 109289939
Anti-erythrocyte antibody positive 12.59 10.65 9 1298467 68 109290755
Incorrect drug administration rate 12.57 10.65 109 1298367 5399 109285424
Agitation 12.56 10.65 1514 1296962 111537 109179286
Platelet function test abnormal 12.55 10.65 13 1298463 170 109290653
Fractional exhaled nitric oxide increased 12.55 10.65 28 1298448 748 109290075
Duodenal perforation 12.53 10.65 65 1298411 2705 109288118
Infusion site urticaria 12.51 10.65 37 1298439 1179 109289644
Coronavirus infection 12.49 10.65 169 1298307 9376 109281447
Leukaemia recurrent 12.49 10.65 11 1298465 3120 109287703
Polycythaemia 12.48 10.65 12 1298464 3263 109287560
Blood potassium increased 12.47 10.65 296 1298180 32953 109257870
Blindness 12.47 10.65 328 1298148 36031 109254792
N-terminal prohormone brain natriuretic peptide increased 12.42 10.65 34 1298442 6087 109284736
Haemorrhagic erosive gastritis 12.40 10.65 28 1298448 754 109290069
Gastrointestinal pain 12.39 10.65 202 1298274 11658 109279165
Selenium deficiency 12.38 10.65 9 1298467 70 109290753
Rhabdomyolysis 12.36 10.65 1231 1297245 119170 109171653
Restrictive pulmonary disease 12.35 10.65 12 1298464 3247 109287576
Phonophobia 12.34 10.65 26 1298450 667 109290156
Epstein-Barr virus infection reactivation 12.32 10.65 18 1298458 4066 109286757
Asphyxia 12.32 10.65 235 1298241 13980 109276843
Sleep apnoea syndrome 12.31 10.65 371 1298105 40076 109250747
Migraine 12.30 10.65 2242 1296234 169410 109121413
Vitritis 12.28 10.65 8 1298468 2645 109288178
Urobilinogen urine increased 12.27 10.65 25 1298451 626 109290197
Sputum culture positive 12.26 10.65 83 1298393 3806 109287017
Pubic pain 12.26 10.65 15 1298461 238 109290585
Swollen tongue 12.16 10.65 844 1297632 59518 109231305
Suspected suicide attempt 12.16 10.65 18 1298458 346 109290477
Severe invasive streptococcal infection 12.14 10.65 8 1298468 52 109290771
Hyperlipidaemia 12.13 10.65 324 1298152 35524 109255299
Tongue biting 12.12 10.65 10 1298466 2929 109287894
Immune-mediated hepatic disorder 12.11 10.65 21 1298455 4429 109286394
Pulmonary mucormycosis 12.08 10.65 5 1298471 2138 109288685
Pharyngitis 12.08 10.65 383 1298093 24715 109266108
Gait disturbance 12.08 10.65 2990 1295486 275218 109015605
Liver transplant rejection 12.08 10.65 17 1298459 3901 109286922
Neuroblastoma 12.08 10.65 18 1298458 348 109290475
Pleuritic pain 12.05 10.65 261 1298215 15879 109274944
Grief reaction 12.05 10.65 17 1298459 312 109290511
Thrombosis in device 12.04 10.65 28 1298448 5299 109285524
Heavy menstrual bleeding 12.02 10.65 264 1298212 16101 109274722
Neutropenic sepsis 12.01 10.65 272 1298204 30474 109260349
Large intestine perforation 11.97 10.65 131 1298345 16498 109274325
Insulin-like growth factor increased 11.94 10.65 6 1298470 2290 109288533
Chronic allograft nephropathy 11.92 10.65 5 1298471 2121 109288702
Orthopnoea 11.92 10.65 78 1298398 10943 109279880
Loss of employment 11.89 10.65 13 1298463 3331 109287492
Duodenal ulcer repair 11.89 10.65 9 1298467 75 109290748
Gastric mucosa erythema 11.89 10.65 22 1298454 512 109290311
Symblepharon 11.88 10.65 21 1298455 471 109290352
Blood bicarbonate decreased 11.85 10.65 112 1298364 5685 109285138
Brain scan abnormal 11.84 10.65 43 1298433 1528 109289295
Nephrogenic diabetes insipidus 11.83 10.65 7 1298469 2438 109288385
Drug abuser 11.81 10.65 106 1298370 5303 109285520
Tooth injury 11.80 10.65 55 1298421 2191 109288632
Corneal leukoma 11.79 10.65 8 1298468 55 109290768
Clostridium difficile colitis 11.78 10.65 408 1298068 43370 109247453
Psychogenic tremor 11.75 10.65 6 1298470 22 109290801
Infusion site bruising 11.74 10.65 79 1298397 3615 109287208
Aplasia 11.71 10.65 50 1298426 7823 109283000
Base excess 11.67 10.65 8 1298468 56 109290767
Eosinophil percentage increased 11.67 10.65 43 1298433 1539 109289284
Tri-iodothyronine free increased 11.66 10.65 15 1298461 251 109290572
Skin discolouration 11.65 10.65 464 1298012 48582 109242241
Febrile convulsion 11.64 10.65 34 1298442 1076 109289747
Nail bed inflammation 11.63 10.65 51 1298425 1979 109288844
Antipsychotic drug level below therapeutic 11.63 10.65 3 1298473 1732 109289091
Plasmacytoma 11.62 10.65 28 1298448 5234 109285589
Borrelia test positive 11.62 10.65 4 1298472 3 109290820
Microbiology test abnormal 11.62 10.65 4 1298472 3 109290820
Testis discomfort 11.62 10.65 4 1298472 3 109290820
Sphincter of Oddi dysfunction 11.58 10.65 23 1298453 565 109290258
Xanthelasma 11.58 10.65 12 1298464 157 109290666
Oesophageal oedema 11.56 10.65 8 1298468 57 109290766
Hypercapnia 11.56 10.65 80 1298396 11079 109279744
Caesarean section 11.55 10.65 105 1298371 13712 109277111
Wheelchair user 11.55 10.65 50 1298426 7792 109283031
Transfusion 11.52 10.65 220 1298256 25252 109265571
Skin ulcer 11.52 10.65 620 1297856 63025 109227798
Granulocyte count decreased 11.52 10.65 18 1298458 3956 109286867
Epilepsy 11.51 10.65 1016 1297460 99193 109191630
Hyperglycaemic hyperosmolar nonketotic syndrome 11.50 10.65 11 1298465 2998 109287825
Tooth infection 11.49 10.65 342 1298134 21874 109268949
Acute fatty liver of pregnancy 11.47 10.65 7 1298469 39 109290784
Periportal oedema 11.46 10.65 12 1298464 159 109290664
Aplastic anaemia 11.46 10.65 370 1298106 23938 109266885
Administration site bruise 11.45 10.65 14 1298462 222 109290601
Cogwheel rigidity 11.45 10.65 16 1298460 3682 109287141
Harlequin syndrome 11.44 10.65 15 1298461 256 109290567
Recurrent cancer 11.43 10.65 14 1298462 3409 109287414
Transfusion-related circulatory overload 11.43 10.65 30 1298446 891 109289932
Cerebral toxoplasmosis 11.42 10.65 12 1298464 3130 109287693
Respiratory tract oedema 11.39 10.65 34 1298442 1089 109289734
Ankle arthroplasty 11.39 10.65 8 1298468 2543 109288280
Scleroderma renal crisis 11.38 10.65 30 1298446 893 109289930
Device defective 11.37 10.65 17 1298459 3805 109287018
Drug-disease interaction 11.37 10.65 49 1298427 1887 109288936
Carotid artery stenosis 11.36 10.65 63 1298413 9200 109281623
Arterial haemorrhage 11.35 10.65 17 1298459 3802 109287021
Renal failure neonatal 11.34 10.65 9 1298467 81 109290742
Bursitis 11.33 10.65 1715 1296761 128203 109162620
Osteoporotic fracture 11.32 10.65 29 1298447 5308 109285515
Intestinal haemorrhage 11.31 10.65 46 1298430 7295 109283528
Blood cholesterol increased 11.24 10.65 2394 1296082 182391 109108432
Erosive duodenitis 11.24 10.65 55 1298421 2236 109288587
Marasmus 11.19 10.65 3 1298473 1688 109289135
Inappropriate antidiuretic hormone secretion 11.18 10.65 307 1298169 33544 109257279
Allergic sinusitis 11.18 10.65 46 1298430 1735 109289088
Bone lesion 11.18 10.65 44 1298432 7043 109283780
Dactylitis 11.17 10.65 85 1298391 4048 109286775
Gastrointestinal fistula 11.17 10.65 31 1298445 952 109289871
Erectile dysfunction 11.15 10.65 152 1298324 18404 109272419
Right ventricle outflow tract obstruction 11.13 10.65 8 1298468 61 109290762
Blood bilirubin unconjugated 11.10 10.65 4 1298472 4 109290819
Bradycardia neonatal 11.08 10.65 9 1298467 84 109290739
Vital capacity decreased 11.07 10.65 51 1298425 2022 109288801
Bacterial infection 11.05 10.65 435 1298041 45601 109245222
Oesophagitis 11.03 10.65 427 1298049 28288 109262535
Basal cell carcinoma 11.03 10.65 427 1298049 44843 109245980
Lymphocyte count abnormal 11.03 10.65 57 1298419 2369 109288454
Malignant melanoma 11.02 10.65 136 1298340 16755 109274068
Breath sounds abnormal 11.01 10.65 221 1298255 25183 109265640
Pleural infection bacterial 11 10.65 6 1298470 26 109290797
Neurosis 11.00 10.65 23 1298453 587 109290236
Uterine pain 10.98 10.65 13 1298463 199 109290624
Hypotensive crisis 10.95 10.65 12 1298464 168 109290655
Hyperhidrosis 10.95 10.65 2422 1296054 184876 109105947
Fracture pain 10.94 10.65 34 1298442 1114 109289709
Osteopenia 10.93 10.65 189 1298287 22020 109268803
PCO2 decreased 10.90 10.65 69 1298407 3092 109287731
COVID-19 10.89 10.65 3131 1295345 241929 109048894
Aortitis 10.89 10.65 5 1298471 2010 109288813
Hyporesponsive to stimuli 10.86 10.65 64 1298412 2796 109288027
Retinal deposits 10.85 10.65 11 1298465 140 109290683
Adulterated product 10.81 10.65 34 1298442 1121 109289702
Visual evoked potentials abnormal 10.81 10.65 7 1298469 44 109290779
Injury associated with device 10.81 10.65 22 1298454 4367 109286456
Psoriatic arthropathy 10.80 10.65 2537 1295939 194224 109096599
Enteritis 10.77 10.65 159 1298317 18997 109271826
Portal vein phlebitis 10.77 10.65 5 1298471 14 109290809
Specific gravity urine increased 10.77 10.65 21 1298455 509 109290314
Oesophagitis haemorrhagic 10.76 10.65 24 1298452 641 109290182
Aortic valve incompetence 10.75 10.65 80 1298396 10901 109279922
Tonsillar erythema 10.73 10.65 8 1298468 65 109290758
Epiglottic oedema 10.72 10.65 19 1298457 427 109290396
Pancreatic steatosis 10.69 10.65 4 1298472 1818 109289005
Band neutrophil count increased 10.68 10.65 25 1298451 690 109290133
Vitreous haemorrhage 10.68 10.65 24 1298452 4596 109286227
Dermatitis 10.66 10.65 247 1298229 27590 109263233
Nail ridging 10.66 10.65 22 1298454 556 109290267
Peripheral artery occlusion 10.66 10.65 11 1298465 2894 109287929
Hyperuricaemia 10.65 10.65 114 1298362 14417 109276406

FDA Adverse Event Reporting System (Pediatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Intestinal perforation 41.50 15.46 23 1460 92 112378
Oliguria 31.62 15.46 11 1472 7 112463
Gastrointestinal haemorrhage 24.19 15.46 13 1470 48 112422
Urine output decreased 23.12 15.46 11 1472 29 112441
Upper gastrointestinal haemorrhage 20.14 15.46 6 1477 0 112470
Intraventricular haemorrhage 19.59 15.46 15 1468 114 112356
Pulmonary arterial hypertension 18.99 15.46 10 1473 35 112435
Nasal congestion 18.58 15.46 9 1474 25 112445
Pulmonary hypertension 18.40 15.46 22 1461 307 112163
Off label use 17.87 15.46 49 1434 1358 111112
Incorrect route of product administration 17.83 15.46 7 1476 9 112461
Abdominal distension 17.81 15.46 13 1470 91 112379
Gastric haemorrhage 17.75 15.46 6 1477 3 112467
Prothrombin time prolonged 16.67 15.46 7 1476 12 112458
Premature baby 16.50 15.46 25 1458 4949 107521
Posthaemorrhagic hydrocephalus 15.76 15.46 11 1472 71 112399
Pulmonary oedema 15.66 15.46 9 1474 39 112431
Accidental overdose 15.58 15.46 14 1469 136 112334

Pharmacologic Action:

SourceCodeDescription
ATC C01EB16 CARDIOVASCULAR SYSTEM
CARDIAC THERAPY
OTHER CARDIAC PREPARATIONS
Other cardiac preparations
ATC G02CC01 GENITO URINARY SYSTEM AND SEX HORMONES
OTHER GYNECOLOGICALS
OTHER GYNECOLOGICALS
Antiinflammatory products for vaginal administration
ATC M01AE01 MUSCULO-SKELETAL SYSTEM
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
Propionic acid derivatives
ATC M01AE51 MUSCULO-SKELETAL SYSTEM
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
Propionic acid derivatives
ATC M02AA13 MUSCULO-SKELETAL SYSTEM
TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
Antiinflammatory preparations, non-steroids for topical use
ATC N02AJ08 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Opioids in combination with non-opioid analgesics
ATC N02AJ19 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Opioids in combination with non-opioid analgesics
ATC N02AJ23 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Opioids in combination with non-opioid analgesics
ATC R02AX02 RESPIRATORY SYSTEM
THROAT PREPARATIONS
THROAT PREPARATIONS
Other throat preparations
FDA CS M0001335 Anti-Inflammatory Agents, Non-Steroidal
FDA MoA N0000000160 Cyclooxygenase Inhibitors
MeSH PA D000700 Analgesics
MeSH PA D000893 Anti-Inflammatory Agents
MeSH PA D000894 Anti-Inflammatory Agents, Non-Steroidal
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D016861 Cyclooxygenase Inhibitors
MeSH PA D018501 Antirheumatic Agents
MeSH PA D018689 Sensory System Agents
MeSH PA D018712 Analgesics, Non-Narcotic
CHEBI has role CHEBI:22587 antiviral agent
CHEBI has role CHEBI:33231 antitubercular agent
CHEBI has role CHEBI:33282 antibacterial agent
CHEBI has role CHEBI:35441 antiinfective agent
CHEBI has role CHEBI:35469 antidepressant
CHEBI has role CHEBI:35475 non-steroidal anti-inflammatory drug
CHEBI has role CHEBI:35476 antipsychotic agent
CHEBI has role CHEBI:35480 analgesic
CHEBI has role CHEBI:35481 non-narcotic analgesic
CHEBI has role CHEBI:35493 antipyretic
CHEBI has role CHEBI:35526 hypoglycemic agent
CHEBI has role CHEBI:35554 cardiovascular drug
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:35623 anticonvulsant
CHEBI has role CHEBI:35674 antihypertensive agent
CHEBI has role CHEBI:35703 xenobiotic
CHEBI has role CHEBI:35705 immunosuppressive agent
CHEBI has role CHEBI:35842 antirheumatic drug
CHEBI has role CHEBI:38068 antimalarial
CHEBI has role CHEBI:48578 radical scavenger
CHEBI has role CHEBI:49201 anti-ulcer drug
CHEBI has role CHEBI:50514 vasoconstrictor agent
CHEBI has role CHEBI:50629 cyclooxygenase 2 inhibitor
CHEBI has role CHEBI:50630 cyclooxygenase 1 inhibitor
CHEBI has role CHEBI:64946 anti-HIV agent
CHEBI has role CHEBI:67079 anti-inflammatory agent
CHEBI has role CHEBI:73336 vulnerary
CHEBI has role CHEBI:78298 environmental contaminant
CHEBI has role CHEBI:88188 drug allergen
CHEBI has role CHEBI:176497 geroprotector
CHEBI has role CHEBI:231911 renoprotective agent
FDA EPC N0000175722 Nonsteroidal Anti-inflammatory Drug

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Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Sinus headache indication 4969004
Pain indication 22253000
Rheumatoid arthritis indication 69896004 DOID:7148
Severe pain indication 76948002
Patent ductus arteriosus indication 83330001 DOID:13832
Headache disorder indication 230461009
Dysmenorrhea indication 266599000
Influenza-like symptoms indication 315642008
Fever indication 386661006
Osteoarthritis indication 396275006
Juvenile rheumatoid arthritis indication 410795001
Acute postoperative pain indication 107401000119105
Necrotizing enterocolitis in fetus OR newborn contraindication 2707005
Ocular hypertension contraindication 4210003 DOID:9282
Suicidal thoughts contraindication 6471006
Dependent drug abuse contraindication 6525002
Alcoholism contraindication 7200002
Alcohol withdrawal delirium contraindication 8635005
Peptic ulcer contraindication 13200003 DOID:750
Chronic obstructive lung disease contraindication 13645005 DOID:3083
Asthenia contraindication 13791008
Constipation contraindication 14760008 DOID:2089
Mood swings contraindication 18963009
Myocardial infarction contraindication 22298006 DOID:5844
Inflammatory bowel disease contraindication 24526004 DOID:0050589
Alcohol intoxication contraindication 25702006
Shock contraindication 27942005
Hypercapnia contraindication 29596007
Dehydration contraindication 34095006
Hyperthyroidism contraindication 34486009 DOID:7998
Hypertensive disorder contraindication 38341003 DOID:10763
Disorder of gallbladder contraindication 39621005 DOID:0060262
Gastrointestinal ulcer contraindication 40845000
Hypothyroidism contraindication 40930008 DOID:1459
Hypokalemia contraindication 43339004
Body fluid retention contraindication 43498006
Conduction disorder of the heart contraindication 44808001
Low blood pressure contraindication 45007003
Chronic heart failure contraindication 48447003
Bradycardia contraindication 48867003
Gastrointestinal perforation contraindication 51875005
Gastrectomy contraindication 53442002
Coronary arteriosclerosis contraindication 53741008 DOID:3393
Systemic lupus erythematosus contraindication 55464009 DOID:9074
Leber's optic atrophy contraindication 58610003 DOID:705
Hepatic failure contraindication 59927004
Ulcerative colitis contraindication 64766004 DOID:8577
Blood coagulation disorder contraindication 64779008 DOID:1247
Substance abuse contraindication 66214007
Benign intracranial hypertension contraindication 68267002 DOID:11459
Agoraphobia contraindication 70691001 DOID:593
Diabetes mellitus contraindication 73211009 DOID:9351
Gastrointestinal hemorrhage contraindication 74474003
Urethral stricture contraindication 76618002
Decreased respiratory function contraindication 80954004
Injury of head contraindication 82271004
Chronic idiopathic constipation contraindication 82934008
Cor pulmonale contraindication 83291003 DOID:8515
Atrophic gastritis contraindication 84568007 DOID:8929
Pulmonary emphysema contraindication 87433001
Kidney disease contraindication 90708001 DOID:557
Acute abdominal pain contraindication 116290004
Gastrointestinal obstruction contraindication 126765001
Neoplasm of brain contraindication 126952004 DOID:1319
Seizure disorder contraindication 128613002
Liver function tests abnormal contraindication 166603001
Drug-induced psychosis contraindication 191483003 DOID:1742
Obsessive-compulsive disorder contraindication 191736004 DOID:10933
Impaired renal function disorder contraindication 197663003
Cerebrovascular accident contraindication 230690007
Coronary artery bypass graft contraindication 232717009
Disease of liver contraindication 235856003 DOID:409
Bladder outflow obstruction contraindication 236645006
Morbid obesity contraindication 238136002 DOID:11981
Benign prostatic hyperplasia contraindication 266569009
Retention of urine contraindication 267064002
Anemia contraindication 271737000 DOID:2355
Exacerbation of asthma contraindication 281239006
Pregnancy, function contraindication 289908002
Lesion of brain contraindication 301766008
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Thromboembolic disorder contraindication 371039008
Panic disorder contraindication 371631005 DOID:594
Coma contraindication 371632003
Primary adrenocortical insufficiency contraindication 373662000
Operation on gastrointestinal tract contraindication 386621005
Hypoxia contraindication 389086002
Angle-closure glaucoma contraindication 392291006 DOID:13550
Cardiovascular event risk contraindication 395112001
Myocardial ischemia contraindication 414795007 DOID:3393
Myocardial infarction in recovery phase contraindication 418044006
Central nervous system depression contraindication 418072004
Dysfunction of sphincter of Oddi contraindication 430887001
Hypertensive urgency contraindication 443482000
Smokes tobacco daily contraindication 449868002
Significant Bleeding contraindication
Acute Thromboembolic Stroke contraindication




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 4.37 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
26.6MG;800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** DUEXIS HORIZON N022519 April 23, 2011 DISCN TABLET ORAL 8067451 July 18, 2026 RELIEF OF SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS AND OSTEOARTHRITIS AND TO DECREASE RISK OF DEVELOPING UPPER GASTROINTESTINAL ULCERS IN PATIENTS WHO ARE TAKING IBUPROFEN FOR THOSE INDICATIONS
26.6MG;800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** DUEXIS HORIZON N022519 April 23, 2011 DISCN TABLET ORAL 8501228 July 18, 2026 RELIEF OF SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS AND OSTEOARTHRITIS AND TO DECREASE RISK OF DEVELOPING UPPER GASTROINTESTINAL ULCERS IN PATIENTS WHO ARE TAKING IBUPROFEN FOR THOSE INDICATIONS
800MG/200ML (4MG/ML) CALDOLOR CUMBERLAND PHARMS N022348 Jan. 25, 2019 RX SOLUTION INTRAVENOUS 8735452 Sept. 30, 2029 MANAGEMENT OF MILD TO MODERATE PAIN, MANAGEMENT OF MODERATE TO SEVERE PAIN AS AN ADJUNCT TO OPIOID ANALGESICS, REDUCTION IN FEVER THROUGH ANTI-INFLAMMATORY, ANALGESIC, AND ANTIPYRETIC ACTIVITY
800MG/200ML (4MG/ML) CALDOLOR CUMBERLAND PHARMS N022348 Jan. 25, 2019 RX SOLUTION INTRAVENOUS 8871810 Sept. 30, 2029 MANAGEMENT OF MILD TO MODERATE PAIN, MANAGEMENT OF MODERATE TO SEVERE PAIN AS AN ADJUNCT TO OPIOID ANALGESICS, REDUCTION IN FEVER THROUGH ANTI-INFLAMMATORY, ANALGESIC, AND ANTIPYRETIC ACTIVITY
800MG/8ML (100MG/ML) CALDOLOR CUMBERLAND PHARMS N022348 June 11, 2009 RX SOLUTION INTRAVENOUS 8735452 Sept. 30, 2029 MANAGEMENT OF MILD TO MODERATE PAIN, MANAGEMENT OF MODERATE TO SEVERE PAIN AS AN ADJUNCT TO OPIOID ANALGESICS, REDUCTION IN FEVER THROUGH ANTI-INFLAMMATORY, ANALGESIC, AND ANTIPYRETIC ACTIVITY
800MG/8ML (100MG/ML) CALDOLOR CUMBERLAND PHARMS N022348 June 11, 2009 RX SOLUTION INTRAVENOUS 8871810 Sept. 30, 2029 MANAGEMENT OF MILD TO MODERATE PAIN, MANAGEMENT OF MODERATE TO SEVERE PAIN AS AN ADJUNCT TO OPIOID ANALGESICS, REDUCTION IN FEVER THROUGH ANTI-INFLAMMATORY, ANALGESIC, AND ANTIPYRETIC ACTIVITY
800MG/8ML (100MG/ML) CALDOLOR CUMBERLAND PHARMS N022348 June 11, 2009 RX SOLUTION INTRAVENOUS 9114068 Sept. 30, 2029 METHODS OF TREATING PAIN, INFLAMMATION AND/OR FEVER WITH INTRAVENOUS IBUPROFEN SUCH THAT MEAN ARTERIAL BLOOD PRESSURE DOES NOT INCREASE THE DOSAGE INTERVAL
800MG/8ML (100MG/ML) CALDOLOR CUMBERLAND PHARMS N022348 June 11, 2009 RX SOLUTION INTRAVENOUS 9138404 Sept. 30, 2029 METHODS OF TREATING PAIN, INFLAMMATION AND/OR FEVER IN A CRITICALLY ILL PATIENT WITH INTRAVENOUS IBUPROFEN IN NEED THEREOF
800MG/8ML (100MG/ML) CALDOLOR CUMBERLAND PHARMS N022348 June 11, 2009 RX SOLUTION INTRAVENOUS 9295639 Sept. 30, 2029 METHODS OF TREATING PAIN, INFLAMMATION AND/OR FEVER IN A CRITICALLY ILL PATIENT WITH INTRAVENOUS IBUPROFEN IN NEED THEREOF
800MG/8ML (100MG/ML) CALDOLOR CUMBERLAND PHARMS N022348 June 11, 2009 RX SOLUTION INTRAVENOUS 9649284 Sept. 30, 2029 MANAGEMENT OF MILD TO MODERATE PAIN, MANAGEMENT OF MODERATE TO SEVERE PAIN AS AN ADJUNCT TO OPIOID ANALGESICS IN A CRITICALLY ILL PATIENT WITH INTRAVENOUS IBUPROFEN IN NEED THEREOF
800MG/200ML (4MG/ML) CALDOLOR CUMBERLAND PHARMS N022348 Jan. 25, 2019 RX SOLUTION INTRAVENOUS 9012508 Sept. 14, 2030 MANAGEMENT OF MILD TO MODERATE PAIN, MANAGEMENT OF MODERATE TO SEVERE PAIN AS AN ADJUNCT TO OPIOID ANALGESICS, REDUCTION IN FEVER THROUGH ANTI-INFLAMMATORY, ANALGESIC, AND ANTIPYRETIC ACTIVITY
800MG/8ML (100MG/ML) CALDOLOR CUMBERLAND PHARMS N022348 June 11, 2009 RX SOLUTION INTRAVENOUS 9012508 Sept. 14, 2030 MANAGEMENT OF MILD TO MODERATE PAIN, MANAGEMENT OF MODERATE TO SEVERE PAIN AS AN ADJUNCT TO OPIOID ANALGESICS, REDUCTION IN FEVER THROUGH ANTI-INFLAMMATORY, ANALGESIC, AND ANTIPYRETIC ACTIVITY
1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML) COMBOGESIC IV HIKMA N215320 Oct. 17, 2023 RX SOLUTION INTRAVENOUS 11446266 Oct. 26, 2031 METHOD OF TREATING MILD TO MODERATE PAIN IN ADULTS
1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML) COMBOGESIC IV HIKMA N215320 Oct. 17, 2023 RX SOLUTION INTRAVENOUS 11446266 Oct. 26, 2031 METHOD OF TREATING MODERATE TO SEVERE PAIN IN ADULTS AS AN ADJUNCT TO OPIOID ANALGESICS
1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML) COMBOGESIC IV HIKMA N215320 Oct. 17, 2023 RX SOLUTION INTRAVENOUS 11896567 Oct. 26, 2031 METHOD OF TREATING MILD TO MODERATE PAIN IN ADULTS
1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML) COMBOGESIC IV HIKMA N215320 Oct. 17, 2023 RX SOLUTION INTRAVENOUS 11896567 Oct. 26, 2031 METHOD OF TREATING MODERATE TO SEVERE PAIN IN ADULTS AS AN ADJUNCT TO OPIOID ANALGESICS
1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML) COMBOGESIC IV HIKMA N215320 Oct. 17, 2023 RX SOLUTION INTRAVENOUS 12220392 Oct. 26, 2031 METHOD OF TREATING MILD TO MODERATE PAIN (SURGICAL) IN ADULTS
1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML) COMBOGESIC IV HIKMA N215320 Oct. 17, 2023 RX SOLUTION INTRAVENOUS 12220392 Oct. 26, 2031 METHOD OF TREATING MODERATE TO SEVERE PAIN (SURGICAL) IN ADULTS AS AN ADJUNCT TO OPIOID ANALGESICS
800MG/200ML (4MG/ML) CALDOLOR CUMBERLAND PHARMS N022348 Jan. 25, 2019 RX SOLUTION INTRAVENOUS 11806400 March 16, 2032 METHODS OF MAKING AQUEOUS COMPOSITION AND TREATING PAIN, INFLAMMATION, FEVER, PATENT DUCTUS ATERIOSIS WITH AQUEOUS COMPOSITION
800MG/200ML (4MG/ML) CALDOLOR CUMBERLAND PHARMS N022348 Jan. 25, 2019 RX SOLUTION INTRAVENOUS 9072661 March 16, 2032 METHODS OF TREATING PAIN, INFLAMMATION, FEVER, PATENT DUCTUS ARTERIOSIS WITH AQUEOUS COMPOSITION
800MG/200ML (4MG/ML) CALDOLOR CUMBERLAND PHARMS N022348 Jan. 25, 2019 RX SOLUTION INTRAVENOUS 9072710 March 16, 2032 METHODS OF MAKING AQUEOUS COMPOSITION AND TREATING PAIN, INFLAMMATION, FEVER, PATENT DUCTUS ARTERIOSIS WITH AQUEOUS COMPOSITION
800MG/8ML (100MG/ML) CALDOLOR CUMBERLAND PHARMS N022348 June 11, 2009 RX SOLUTION INTRAVENOUS 11806400 March 16, 2032 METHODS OF MAKING AQUEOUS COMPOSITION AND TREATING PAIN, INFLAMMATION, FEVER, PATENT DUCTUS ATERIOSIS WITH AQUEOUS COMPOSITION
1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML) COMBOGESIC IV HIKMA N215320 Oct. 17, 2023 RX SOLUTION INTRAVENOUS 12083087 July 17, 2035 METHOD OF TREATING MILD TO MODERATE PAIN IN ADULTS
1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML) COMBOGESIC IV HIKMA N215320 Oct. 17, 2023 RX SOLUTION INTRAVENOUS 12083087 July 17, 2035 METHOD OF TREATING MODERATE TO SEVERE PAIN IN ADULTS AS AN ADJUNCT TO OPIOID ANALGESICS
325MG;97.5MG COMBOGESIC AFT PHARMS US N209471 March 1, 2023 RX TABLET ORAL 11197830 Feb. 27, 2039 A METHOD OF TREATING MILD TO MODERATE ACUTE PAIN IN ADULTS BY ADMINISTERING 975-1000 MG OF ACETAMINOPHEN AND 292.5-300 MG OF IBUPROFEN IN A SINGLE ADMINISTRATION
325MG;97.5MG COMBOGESIC AFT PHARMS US N209471 March 1, 2023 RX TABLET ORAL 11534407 Feb. 27, 2039 A METHOD OF TREATING MILD TO MODERATE ACUTE PAIN IN ADULTS BY ADMINISTERING 975-1000 MG OF ACETAMINOPHEN AND 292.5-300 MG OF IBUPROFEN IN A SINGLE ADMINISTRATION

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
325MG;97.5MG COMBOGESIC AFT PHARMS US N209471 March 1, 2023 RX TABLET ORAL March 1, 2026 NEW PRODUCT
400MG/4ML (100MG/ML) CALDOLOR CUMBERLAND PHARMS N022348 June 11, 2009 DISCN SOLUTION INTRAVENOUS May 11, 2026 NEW PATIENT POPULATION
800MG/200ML (4MG/ML) CALDOLOR CUMBERLAND PHARMS N022348 Jan. 25, 2019 RX SOLUTION INTRAVENOUS May 11, 2026 NEW PATIENT POPULATION
800MG/8ML (100MG/ML) CALDOLOR CUMBERLAND PHARMS N022348 June 11, 2009 RX SOLUTION INTRAVENOUS May 11, 2026 NEW PATIENT POPULATION
1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML) COMBOGESIC IV HIKMA N215320 Oct. 17, 2023 RX SOLUTION INTRAVENOUS Oct. 17, 2026 NEW PRODUCT

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Prostaglandin G/H synthase 2 Enzyme INHIBITOR IC50 5.14 WOMBAT-PK CHEMBL
Prostaglandin G/H synthase 1 Enzyme INHIBITOR IC50 5.12 WOMBAT-PK CHEMBL
Cytochrome P450 2C9 Enzyme Ki 4.30 WOMBAT-PK
Aldo-keto reductase family 1 member C2 Enzyme IC50 4.37 CHEMBL
Aldo-keto reductase family 1 member C3 Enzyme IC50 4.48 CHEMBL
Arachidonate 5-lipoxygenase Enzyme WOMBAT-PK
Serum albumin Secreted Kd 4.14 CHEMBL
Interleukin-8 Cytokine IC50 7.30 CHEMBL
Sodium-coupled monocarboxylate transporter 1 Transporter INHIBITOR IC50 4.20 IUPHAR
Acid-sensing ion channel 1 Ion channel BLOCKER IC50 3.53 SCIENTIFIC LITERATURE
Fatty acid-binding protein, liver Cytosolic other Ki 4.32 CHEMBL
Prostaglandin G/H synthase 2 Enzyme IC50 6.07 CHEMBL
Prostaglandin G/H synthase 1 Enzyme Ki 5.05 CHEMBL
Prostaglandin G/H synthase 2 Enzyme IC50 5.96 CHEMBL
Prostaglandin-H2 D-isomerase Enzyme IC50 4.89 CHEMBL
Prostaglandin G/H synthase 2 Enzyme Ki 5.05 CHEMBL
Serum albumin Secreted IC50 5.52 CHEMBL
Solute carrier family 22 member 6 Transporter Ki 5.33 CHEMBL
Prostaglandin G/H synthase 1 Enzyme IC50 5.54 CHEMBL
Solute carrier family 22 member 20 Transporter Ki 5.96 CHEMBL
Cyclooxygenase Enzyme IC50 5.70 CHEMBL
Dehydrogenase/reductase SDR family member 9 Enzyme IC50 4 CHEMBL

External reference:

IDSource
4032936 VUID
N0000189536 NUI
D00126 KEGG_DRUG
57469-77-9 SECONDARY_CAS_RN
4017840 VANDF
4032936 VANDF
C0020740 UMLSCUI
CHEBI:5855 CHEBI
IBP PDB_CHEM_ID
CHEMBL521 ChEMBL_ID
DB01050 DRUGBANK_ID
CHEMBL1201141 ChEMBL_ID
CHEMBL3989408 ChEMBL_ID
D007052 MESH_DESCRIPTOR_UI
3672 PUBCHEM_CID
2713 IUPHAR_LIGAND_ID
C016106 MESH_SUPPLEMENTAL_RECORD_UI
2118 INN_ID
527688-20-6 SECONDARY_CAS_RN
WK2XYI10QM UNII
1429044 RXNORM
2133 MMSL
240518 MMSL
32273 MMSL
4862 MMSL
7027 MMSL
82565 MMSL
d00015 MMSL
002377 NDDF
006088 NDDF
006232 NDDF
38268001 SNOMEDCT_US
387207008 SNOMEDCT_US
425516000 SNOMEDCT_US
725863000 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Good Sense Infants Ibuprofen HUMAN OTC DRUG LABEL 1 0113-0040 SUSPENSION/ DROPS 50 mg ORAL ANDA 15 sections
good sense ibuprofen pm HUMAN OTC DRUG LABEL 2 0113-0050 TABLET, FILM COATED 200 mg ORAL ANDA 16 sections
Good Sense ibuprofeninfants HUMAN OTC DRUG LABEL 1 0113-0057 SUSPENSION 50 mg ORAL ANDA 15 sections
good sense ibuprofenchildrens HUMAN OTC DRUG LABEL 1 0113-0166 SUSPENSION 100 mg ORAL ANDA 15 sections
good sense ibuprofen HUMAN OTC DRUG LABEL 1 0113-0298 CAPSULE, LIQUID FILLED 200 mg ORAL ANDA 16 sections
Good Sense ibuprofen HUMAN OTC DRUG LABEL 1 0113-0517 TABLET, FILM COATED 200 mg ORAL ANDA 16 sections
good sense ibuprofen HUMAN OTC DRUG LABEL 1 0113-0604 TABLET, FILM COATED 200 mg ORAL ANDA 16 sections
good sense ibuprofen HUMAN OTC DRUG LABEL 1 0113-0647 TABLET, FILM COATED 200 mg ORAL ANDA 16 sections
Good Sense IbuprofenChildrens HUMAN OTC DRUG LABEL 1 0113-0660 SUSPENSION 100 mg ORAL ANDA 15 sections
Good Sense Ibuprofen HUMAN OTC DRUG LABEL 1 0113-0685 SUSPENSION 100 mg ORAL ANDA 15 sections
good sense ibuprofenchildrens HUMAN OTC DRUG LABEL 1 0113-0897 SUSPENSION 100 mg ORAL ANDA 15 sections
Good Sense Ibuprofen HUMAN OTC DRUG LABEL 1 0113-1212 TABLET, FILM COATED 200 mg ORAL ANDA 16 sections
Good Sense Childrens Ibuprofen HUMAN OTC DRUG LABEL 1 0113-2461 TABLET, CHEWABLE 100 mg ORAL ANDA 15 sections
good sense ibuprofen HUMAN OTC DRUG LABEL 1 0113-4501 CAPSULE, LIQUID FILLED 200 mg ORAL ANDA 16 sections
Good Sense Dual Action Back Pain HUMAN OTC DRUG LABEL 2 0113-5299 TABLET, FILM COATED 125 mg ORAL ANDA 16 sections
good sense dual action HUMAN OTC DRUG LABEL 2 0113-5300 TABLET, FILM COATED 125 mg ORAL ANDA 16 sections
good sense childrens ibuprofen HUMAN OTC DRUG LABEL 1 0113-6040 TABLET, CHEWABLE 100 mg ORAL ANDA 15 sections
GOOD SENSE CHILDRENS IBUPROFEN HUMAN OTC DRUG LABEL 1 0113-7366 TABLET, CHEWABLE 100 mg ORAL ANDA 15 sections
Childrens Ibuprofen Oral Suspension HUMAN OTC DRUG LABEL 1 0121-0833 SUSPENSION 100 mg ORAL ANDA 16 sections
Childrens Ibuprofen Oral Suspension HUMAN OTC DRUG LABEL 1 0121-0914 SUSPENSION 100 mg ORAL ANDA 16 sections
Dye Free Childrens Ibuprofen HUMAN OTC DRUG LABEL 1 0121-1022 SUSPENSION 100 mg ORAL ANDA 15 sections
Childrens Ibuprofen Oral Suspension HUMAN OTC DRUG LABEL 1 0121-1666 SUSPENSION 200 mg ORAL ANDA 16 sections
Childrens Ibuprofen Oral Suspension HUMAN OTC DRUG LABEL 1 0121-1828 SUSPENSION 100 mg ORAL ANDA 16 sections
Dye Free Childrens Ibuprofen HUMAN OTC DRUG LABEL 1 0121-2044 SUSPENSION 200 mg ORAL ANDA 15 sections
COMBOGESIC IV HUMAN PRESCRIPTION DRUG LABEL 2 0143-9150 INJECTION 300 mg INTRAVENOUS NDA 30 sections
Combogesic HUMAN PRESCRIPTION DRUG LABEL 2 0143-9432 TABLET, FILM COATED 97.50 mg ORAL NDA 34 sections
IBUPROFEN Human OTC Drug Label 1 0363-0003 CAPSULE, LIQUID FILLED 200 mg ORAL ANDA 16 sections
Ibuprofen PM HUMAN OTC DRUG LABEL 2 0363-0050 TABLET, FILM COATED 200 mg ORAL ANDA 16 sections
Dye-Free Ibuprofen 200 HUMAN OTC DRUG LABEL 1 0363-0103 CAPSULE, LIQUID FILLED 200 mg ORAL ANDA 17 sections
ibuprofenchildrens HUMAN OTC DRUG LABEL 1 0363-0166 SUSPENSION 100 mg ORAL ANDA 15 sections