ibuprofen ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | 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 ยตM/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

Approvals:

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

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
Intentional overdose 825.51 9.72 1413 305927 61091 50236693
Cholecystitis chronic 525.36 9.72 450 306890 9219 50288565
Muscle injury 503.00 9.72 849 306491 36262 50261522
Angioedema 492.28 9.72 848 306492 36828 50260956
Folliculitis 480.28 9.72 858 306482 38367 50259417
Injury 475.49 9.72 970 306370 47955 50249829
Irritable bowel syndrome 469.63 9.72 994 306346 50447 50247337
Lower respiratory tract infection 373.91 9.72 1350 305990 93851 50203933
Death 353.82 9.72 921 306419 324458 49973326
Sleep disorder due to general medical condition, insomnia type 333.76 9.72 647 306693 30800 50266984
Blister 322.51 9.72 1196 306144 84222 50213562
Impaired healing 295.81 9.72 1015 306325 68771 50229013
Abdominal pain upper 288.59 9.72 1804 305536 157505 50140279
Urticaria 285.25 9.72 1545 305795 128016 50169768
Off label use 283.48 9.72 1706 305634 472720 49825064
Emotional distress 282.81 9.72 572 306768 28091 50269693
Pneumonia 276.06 9.72 1271 306069 377130 49920654
Pruritus 268.04 9.72 2765 304575 280803 50016981
Gastrointestinal disorder 255.52 9.72 1194 306146 93262 50204522
Suicide attempt 254.83 9.72 792 306548 50940 50246844
Muscle spasticity 240.60 9.72 399 306941 16785 50280999
Sinusitis 239.81 9.72 1815 305525 168743 50129041
Ill-defined disorder 232.52 9.72 796 306544 53858 50243926
Drug hypersensitivity 232.09 9.72 2437 304903 248573 50049211
Uterine perforation 219.17 9.72 231 307109 6184 50291600
Tubulointerstitial nephritis 218.09 9.72 357 306983 14854 50282930
Ear pain 205.10 9.72 499 306841 27784 50270000
Overdose 187.13 9.72 1140 306200 98587 50199197
Aspirin-exacerbated respiratory disease 184.36 9.72 95 307245 779 50297005
Deep vein thrombosis 176.21 9.72 896 306444 72408 50225376
Deafness transitory 173.91 9.72 118 307222 1678 50296106
Renal tubular acidosis 173.36 9.72 111 307229 1423 50296361
Stomatitis 173.07 9.72 1131 306209 100213 50197571
Gallbladder disorder 172.19 9.72 340 307000 16402 50281382
Peripheral swelling 161.78 9.72 1937 305403 203999 50093785
Duodenal ulcer perforation 158.33 9.72 622 306718 44989 50252795
Febrile neutropenia 152.23 9.72 223 307117 97444 50200340
Cardiac failure 143.29 9.72 150 307190 75890 50221894
Biliary dyskinesia 143.26 9.72 121 307219 2429 50295355
Fall 138.57 9.72 1333 306007 333599 49964185
Completed suicide 137.82 9.72 1314 306026 130575 50167209
Toxicity to various agents 136.33 9.72 1926 305414 210573 50087211
Cardiac failure congestive 136.12 9.72 188 307152 84194 50213590
Interstitial lung disease 135.66 9.72 77 307263 53099 50244685
Body temperature increased 135.48 9.72 459 306881 30882 50266902
Lip oedema 131.09 9.72 127 307213 3066 50294718
Night sweats 129.03 9.72 473 306867 33101 50264683
Gastrointestinal pain 124.97 9.72 196 307144 7860 50289924
Haematemesis 123.35 9.72 410 306930 27315 50270469
Treatment failure 123.03 9.72 426 306914 137211 50160573
Respiratory disorder 122.07 9.72 442 306898 30745 50267039
Drug ineffective 119.91 9.72 3932 303408 815401 49482383
Metabolic acidosis 118.58 9.72 509 306831 38316 50259468
Helicobacter infection 117.65 9.72 605 306735 49097 50248687
Cholelithiasis 116.11 9.72 498 306842 37475 50260309
Gastric ulcer 113.14 9.72 335 307005 20970 50276814
Malignant neoplasm progression 112.68 9.72 149 307191 67975 50229809
Neutropenia 105.76 9.72 500 306840 147465 50150319
Intentional self-injury 104.79 9.72 344 306996 22768 50275016
Oligohydramnios 103.57 9.72 150 307190 5600 50292184
Kounis syndrome 99.27 9.72 71 307269 1104 50296680
Stevens-Johnson syndrome 97.94 9.72 323 307017 21429 50276355
Atrial fibrillation 95.63 9.72 308 307032 101437 50196347
Nasopharyngitis 94.97 9.72 1673 305667 191254 50106530
Pulmonary embolism 93.04 9.72 986 306354 100718 50197066
Hospitalisation 91.96 9.72 170 307170 67767 50230017
Sepsis 88.76 9.72 460 306880 132465 50165319
Vomiting 87.28 9.72 3522 303818 457236 49840548
Toxic epidermal necrolysis 85.12 9.72 301 307039 20691 50277093
Platelet count decreased 83.88 9.72 321 307019 100405 50197379
Meningitis aseptic 81.72 9.72 113 307227 4039 50293745
Hypersensitivity 81.03 9.72 1792 305548 213369 50084415
Hypervolaemia 80.73 9.72 27 307313 25472 50272312
Foreign body in throat 80.51 9.72 29 307311 83 50297701
Joint swelling 78.98 9.72 1999 305341 243287 50054497
Infection 78.84 9.72 1482 305858 171472 50126312
Pain 78.77 9.72 4281 303059 574622 49723162
Thrombocytopenia 76.95 9.72 457 306883 127216 50170568
Disease progression 76.33 9.72 311 307029 95555 50202229
Acute kidney injury 76.21 9.72 1868 305472 226190 50071594
Gallbladder injury 76.00 9.72 63 307277 1231 50296553
Anhedonia 75.50 9.72 174 307166 9350 50288434
Gastric ulcer perforation 75.12 9.72 58 307282 1019 50296765
Renal impairment 74.65 9.72 224 307116 75437 50222347
Eyelid oedema 74.00 9.72 172 307168 9294 50288490
Fixed eruption 73.89 9.72 52 307288 787 50296997
Peritonsillar abscess 73.45 9.72 43 307297 464 50297320
Anaemia 72.33 9.72 1088 306252 251368 50046416
Drug resistance 71.82 9.72 14 307326 18975 50278809
Diarrhoea 71.28 9.72 2888 304452 585588 49712196
Upper gastrointestinal haemorrhage 70.31 9.72 236 307104 15799 50281985
Face oedema 69.95 9.72 253 307087 17586 50280198
Wound closure 69.41 9.72 26 307314 86 50297698
Pharyngitis 68.43 9.72 248 307092 17255 50280529
Duodenal ulcer 67.75 9.72 136 307204 6639 50291145
Bezoar 67.70 9.72 60 307280 1288 50296496
Therapeutic product effect decreased 64.83 9.72 1174 306166 134876 50162908
Vanishing bile duct syndrome 64.43 9.72 43 307297 594 50297190
Red blood cell sedimentation rate abnormal 64.07 9.72 11 307329 16332 50281452
Hypoaldosteronism 64.06 9.72 27 307313 131 50297653
Lip swelling 63.40 9.72 308 307032 24428 50273356
Femur fracture 61.88 9.72 82 307258 37382 50260402
Confusional state 61.79 9.72 1522 305818 184406 50113378
Plasma cell myeloma 61.02 9.72 60 307280 31262 50266522
Enthesopathy 61.02 9.72 135 307205 7058 50290726
Haemoglobin decreased 60.53 9.72 488 306852 126728 50171056
Anxiety 59.36 9.72 1455 305885 176151 50121633
Malaise 58.18 9.72 1572 305768 333960 49963824
Gastritis 58.01 9.72 371 306969 32612 50265172
Herpes zoster 57.37 9.72 228 307112 70558 50227226
Osteotomy 57.32 9.72 27 307313 178 50297606
Weight increased 57.09 9.72 1618 305722 200273 50097511
Cytomegalovirus infection 56.90 9.72 19 307321 17943 50279841
Orthostatic hypotension 56.83 9.72 57 307283 29424 50268360
Fluid retention 56.66 9.72 141 307199 50508 50247276
Myocardial infarction 56.13 9.72 314 307026 88713 50209071
Sleep disorder 55.99 9.72 563 306777 56720 50241064
Urinary tract infection 55.38 9.72 992 306348 223028 50074756
Oesophageal obstruction 55.15 9.72 34 307306 406 50297378
Wrong technique in product usage process 55.00 9.72 164 307176 55346 50242438
Melaena 54.77 9.72 314 307026 26550 50271234
Analgesic drug level increased 53.29 9.72 59 307281 1672 50296112
Chronic obstructive pulmonary disease 52.85 9.72 158 307182 53277 50244507
Osteoporosis 51.73 9.72 123 307217 44756 50253028
White blood cell count decreased 51.36 9.72 457 306883 116265 50181519
Cardiac disorder 50.98 9.72 116 307224 42863 50254921
Gastrointestinal haemorrhage 50.75 9.72 674 306666 72647 50225137
Clostridium difficile infection 50.41 9.72 48 307292 25391 50272393
Biliary colic 50.15 9.72 79 307261 3180 50294604
Product use issue 50.01 9.72 624 306716 148851 50148933
Bone marrow failure 49.26 9.72 57 307283 27567 50270217
Product prescribing error 48.78 9.72 254 307086 20707 50277077
Pulmonary infarction 48.30 9.72 66 307274 2332 50295452
Pulmonary arterial hypertension 48.23 9.72 32 307308 20287 50277497
Oxygen saturation decreased 48.01 9.72 255 307085 72993 50224791
Gallbladder cholesterolosis 47.98 9.72 38 307302 694 50297090
Ear infection 47.46 9.72 295 307045 25675 50272109
Acute lung injury 47.30 9.72 50 307290 1343 50296441
Neuropathy peripheral 47.01 9.72 369 306971 96388 50201396
Transplant rejection 46.46 9.72 3 307337 9606 50288178
Pancytopenia 45.87 9.72 310 307030 83720 50214064
Pleural effusion 45.72 9.72 298 307042 81156 50216628
Neutrophil count decreased 45.58 9.72 136 307204 45890 50251894
Ductus arteriosus premature closure 45.53 9.72 27 307313 299 50297485
Self-medication 44.39 9.72 62 307278 2237 50295547
Hypomagnesaemia 44.37 9.72 45 307295 23111 50274673
Shoulder arthroplasty 44.21 9.72 77 307263 3371 50294413
Pneumonia aspiration 43.36 9.72 76 307264 30928 50266856
Septic shock 43.32 9.72 189 307151 56986 50240798
Jejunal ulcer 43.27 9.72 18 307322 84 50297700
Acute myeloid leukaemia 42.68 9.72 19 307321 15055 50282729
Embedded device 42.59 9.72 68 307272 2769 50295015
Macular degeneration 42.56 9.72 17 307323 14371 50283413
Dementia 42.49 9.72 22 307318 15975 50281809
Contusion 42.37 9.72 935 306405 111248 50186536
Swelling 42.23 9.72 1554 305786 199318 50098466
Insomnia 42.06 9.72 1374 305966 173491 50124293
Red blood cell sedimentation rate 42.03 9.72 77 307263 3509 50294275
Medication overuse headache 41.70 9.72 33 307307 602 50297182
Acute hepatic failure 41.47 9.72 197 307143 15480 50282304
Bone erosion 41.39 9.72 10 307330 11677 50286107
Medical device discomfort 41.34 9.72 51 307289 1626 50296158
Heavy menstrual bleeding 40.92 9.72 195 307145 15342 50282442
Rash 40.86 9.72 3134 304206 434337 49863447
Pneumocystis jirovecii pneumonia 40.71 9.72 19 307321 14644 50283140
Tenosynovitis 40.71 9.72 149 307191 10416 50287368
Gastric perforation 40.00 9.72 47 307293 1423 50296361
Myelodysplastic syndrome 39.91 9.72 21 307319 15111 50282673
Cholecystitis acute 39.90 9.72 114 307226 6992 50290792
Bradycardia 39.65 9.72 229 307111 64197 50233587
Functional gastrointestinal disorder 39.20 9.72 73 307267 3369 50294415
Pulmonary hypertension 38.98 9.72 91 307249 33326 50264458
Pelvic pain 38.96 9.72 153 307187 11060 50286724
Leukopenia 38.94 9.72 245 307095 67283 50230501
Abdominal pain lower 38.43 9.72 245 307095 21511 50276273
Neurotoxicity 38.08 9.72 21 307319 14719 50283065
Device related infection 37.82 9.72 42 307298 20693 50277091
Hyponatraemia 37.78 9.72 387 306953 95752 50202032
Foetal acidosis 37.65 9.72 11 307329 11 50297773
Productive cough 37.64 9.72 178 307162 52516 50245268
Foot operation 37.59 9.72 95 307245 5415 50292369
Lemierre syndrome 37.42 9.72 16 307324 81 50297703
Abdominal pain 37.27 9.72 1773 305567 234455 50063329
Respiratory failure 37.10 9.72 364 306976 90817 50206967
Dehydration 37.03 9.72 677 306663 151772 50146012
Pelvic venous thrombosis 36.88 9.72 43 307297 1291 50296493
Premature delivery 36.87 9.72 54 307286 23609 50274175
Duodenal ulcer haemorrhage 36.84 9.72 55 307285 2111 50295673
Cough 36.81 9.72 1150 306190 240114 50057670
Tendonitis 36.54 9.72 199 307141 16506 50281278
Cholesterosis 35.88 9.72 26 307314 413 50297371
Blood pressure increased 35.62 9.72 581 306759 132551 50165233
General physical health deterioration 35.49 9.72 1124 306216 141310 50156474
Hypocalcaemia 35.49 9.72 68 307272 26748 50271036
Dyspnoea exertional 35.47 9.72 175 307165 51058 50246726
Right ventricular failure 35.13 9.72 27 307313 15866 50281918
Bronchitis 35.13 9.72 434 306906 103725 50194059
Tongue disorder 34.69 9.72 129 307211 9087 50288697
Alopecia 34.54 9.72 1180 306160 243867 50053917
Multiple organ dysfunction syndrome 34.24 9.72 173 307167 50164 50247620
Diabetes mellitus 34.23 9.72 167 307173 48866 50248918
Hepatitis cholestatic 34.22 9.72 98 307242 6019 50291765
Hip fracture 34.10 9.72 66 307274 25865 50271919
Transfusion 33.90 9.72 18 307322 12887 50284897
Acute generalised exanthematous pustulosis 33.55 9.72 125 307215 8813 50288971
Oedema peripheral 32.80 9.72 720 306620 157241 50140543
Hypoglycaemia 32.67 9.72 191 307149 53390 50244394
Product dose omission issue 32.66 9.72 858 306482 182980 50114804
Tongue oedema 32.50 9.72 72 307268 3767 50294017
Open globe injury 32.43 9.72 12 307328 38 50297746
Laryngeal oedema 32.29 9.72 85 307255 4968 50292816
Sedation complication 32.04 9.72 7 307333 8759 50289025
Eosinophilic oesophagitis 32.01 9.72 20 307320 245 50297539
Ankylosing spondylitis 31.90 9.72 106 307234 7059 50290725
Hypotension 31.78 9.72 1140 306200 234329 50063455
Pharyngeal abscess 31.66 9.72 20 307320 250 50297534
Suspected suicide 31.11 9.72 87 307253 5270 50292514
Rheumatoid factor positive 30.26 9.72 178 307162 49681 50248103
Pain in jaw 29.74 9.72 126 307214 38302 50259482
Foreign body in gastrointestinal tract 29.68 9.72 11 307329 35 50297749
Ascites 29.37 9.72 115 307225 35746 50262038
Renal papillary necrosis 29.34 9.72 18 307322 213 50297571
Exposure during pregnancy 29.19 9.72 538 306802 120477 50177307
Poisoning 29.19 9.72 151 307189 12278 50285506
Headache 29.00 9.72 3506 303834 503029 49794755
Condition aggravated 28.49 9.72 1494 305846 295564 50002220
Neonatal cardiac failure 28.44 9.72 8 307332 6 50297778
Multiple sclerosis 28.11 9.72 217 307123 20276 50277508
Therapeutic product effect incomplete 28.04 9.72 389 306951 91126 50206658
Musculoskeletal disorder 27.99 9.72 191 307149 17158 50280626
Brain death 27.99 9.72 56 307284 2727 50295057
Device expulsion 27.94 9.72 86 307254 28736 50269048
Duodenitis haemorrhagic 27.89 9.72 8 307332 7 50297777
Bronchopulmonary aspergillosis 27.88 9.72 6 307334 7586 50290198
Mucosal inflammation 27.85 9.72 137 307203 40005 50257779
Gallbladder hypofunction 27.63 9.72 24 307316 501 50297283
Injection site pain 27.59 9.72 491 306849 110533 50187251
Intestinal obstruction 27.56 9.72 76 307264 26307 50271477
Gastritis erosive 27.51 9.72 81 307259 5053 50292731
Serotonin syndrome 27.48 9.72 69 307271 24644 50273140
Maternal exposure during pregnancy 27.25 9.72 750 306590 159028 50138756
Glomerulonephritis membranous 26.93 9.72 24 307316 519 50297265
Corneal leukoma 26.90 9.72 8 307332 9 50297775
Protein-losing gastroenteropathy 26.69 9.72 16 307324 181 50297603
Palatal oedema 26.62 9.72 22 307318 428 50297356
Brain empyema 26.29 9.72 7 307333 3 50297781
Constipation 26.21 9.72 894 306446 184814 50112970
Thyroid disorder 26.21 9.72 23 307317 12654 50285130
Myelosuppression 26.20 9.72 26 307314 13491 50284293
Pericarditis 26.05 9.72 644 306696 78045 50219739
Cytokine release syndrome 25.87 9.72 10 307330 8624 50289160
Cerebrovascular accident 25.71 9.72 412 306928 94268 50203516
Distichiasis 25.62 9.72 8 307332 12 50297772
Cholecystitis 25.62 9.72 158 307182 13713 50284071
Unevaluable event 25.60 9.72 169 307171 45897 50251887
Rheumatoid nodule 25.40 9.72 148 307192 12587 50285197
Posterior reversible encephalopathy syndrome 25.34 9.72 32 307308 14896 50282888
Drug-induced liver injury 25.02 9.72 271 307069 27824 50269960
Multiple sclerosis relapse 24.94 9.72 383 306957 42581 50255203
Systemic lupus erythematosus 24.78 9.72 657 306683 139965 50157819
Genital odour 24.66 9.72 6 307334 0 50297784
Tonsillar erythema 24.66 9.72 6 307334 0 50297784
Blood parathyroid hormone decreased 24.66 9.72 97 307243 7017 50290767
Blood magnesium decreased 24.62 9.72 19 307321 11141 50286643
Hunger 24.53 9.72 69 307271 4194 50293590
Infected dermal cyst 24.39 9.72 21 307319 433 50297351
Toxic shock syndrome streptococcal 24.30 9.72 12 307328 89 50297695
Medical device pain 24.21 9.72 37 307303 1450 50296334
Hepatic function abnormal 24.17 9.72 109 307231 32572 50265212
Haematochezia 24.11 9.72 358 306982 39524 50258260
Psychological trauma 23.99 9.72 30 307310 970 50296814
Cardiac failure acute 23.99 9.72 10 307330 8240 50289544
Heart rate decreased 23.94 9.72 127 307213 36370 50261414
Knee arthroplasty 23.92 9.72 124 307216 35722 50262062
Pneumonia viral 23.90 9.72 6 307334 6828 50290956
Serum sickness-like reaction 23.73 9.72 21 307319 450 50297334
Pulmonary fibrosis 23.63 9.72 73 307267 24364 50273420
Laryngeal discomfort 23.62 9.72 17 307323 267 50297517
Hypertension 23.62 9.72 1045 306295 210158 50087626
Cataract 23.61 9.72 179 307161 47121 50250663
Arthralgia 23.59 9.72 3025 304315 435677 49862107
Dysmenorrhoea 23.56 9.72 58 307282 3252 50294532
Back pain 23.50 9.72 1594 305746 218436 50079348
Ductus arteriosus stenosis foetal 23.46 9.72 14 307326 157 50297627
Cytopenia 23.41 9.72 12 307328 8763 50289021
Bronchiectasis 23.34 9.72 17 307323 10266 50287518
Tumour lysis syndrome 23.24 9.72 8 307332 7413 50290371
Genital haemorrhage 23.08 9.72 90 307250 6484 50291300
Kidney enlargement 23.02 9.72 22 307318 522 50297262
Pneumonia streptococcal 23.00 9.72 38 307302 1593 50296191
Full blood count decreased 22.87 9.72 65 307275 22281 50275503
Embolism arterial 22.76 9.72 27 307313 826 50296958
Scar 22.70 9.72 136 307204 11682 50286102
Torsade de pointes 22.67 9.72 23 307317 11812 50285972
Blood glucose increased 22.63 9.72 301 307039 71023 50226761
Chondritis 22.62 9.72 7 307333 10 50297774
Red blood cell count decreased 22.61 9.72 117 307223 33718 50264066
Panniculitis 22.60 9.72 107 307233 8396 50289388
Cerebral venous sinus thrombosis 22.37 9.72 38 307302 1630 50296154
Drug level decreased 22.35 9.72 6 307334 6527 50291257
Underdose 22.25 9.72 57 307283 20221 50277563
Jaundice 22.19 9.72 252 307088 26177 50271607
Pathogen resistance 21.93 9.72 4 307336 5685 50292099
Cholecystectomy 21.83 9.72 113 307227 9190 50288594
Genital tract inflammation 21.70 9.72 8 307332 25 50297759
Discomfort 21.67 9.72 834 306506 107546 50190238
Disease recurrence 21.61 9.72 57 307283 20024 50277760
Fear of disease 21.55 9.72 27 307313 875 50296909
Granuloma skin 21.54 9.72 81 307259 5737 50292047
Nasal disorder 21.51 9.72 45 307295 2263 50295521
Anaphylactic reaction 21.50 9.72 454 306886 53601 50244183
Hypertensive emergency 21.48 9.72 36 307304 1527 50296257
Frequent bowel movements 21.45 9.72 32 307308 13886 50283898
Internal injury 21.26 9.72 17 307323 315 50297469
Cushingoid 21.10 9.72 7 307333 6638 50291146
Beta haemolytic streptococcal infection 21.07 9.72 39 307301 1791 50295993
Infertility female 21.05 9.72 21 307319 526 50297258
Fear 21.04 9.72 156 307184 14393 50283391
Systemic lupus erythematosus rash 20.97 9.72 38 307302 1717 50296067
Necrosis ischaemic 20.84 9.72 25 307315 774 50297010
Second primary malignancy 20.73 9.72 8 307332 6906 50290878
Creatinine renal clearance decreased 20.66 9.72 25 307315 11856 50285928
Thrombotic microangiopathy 20.65 9.72 14 307326 8777 50289007
Diabetic ketoacidosis 20.58 9.72 49 307291 17823 50279961
Viral parotitis 20.55 9.72 5 307335 0 50297784
Hyperglycaemia 20.51 9.72 133 307207 36272 50261512
Inappropriate schedule of product administration 20.37 9.72 310 307030 71521 50226263
Sedation 20.36 9.72 106 307234 30504 50267280
Aspergillus infection 20.27 9.72 8 307332 6813 50290971
Extrapyramidal disorder 20.22 9.72 25 307315 11745 50286039
Metastases to bone 20.20 9.72 50 307290 17945 50279839
SJS-TEN overlap 20.17 9.72 14 307326 207 50297577
Progressive multifocal leukoencephalopathy 20.04 9.72 24 307316 11433 50286351
Enzyme induction 19.94 9.72 9 307331 53 50297731
Epilepsy 19.75 9.72 66 307274 21501 50276283
Pericardial effusion 19.74 9.72 84 307256 25505 50272279
Pemphigus 19.73 9.72 567 306773 119599 50178185
Breast cancer 19.71 9.72 166 307174 42724 50255060
Psoriatic arthropathy 19.69 9.72 398 306942 46634 50251150
Dermo-hypodermitis 19.67 9.72 14 307326 216 50297568
Pulmonary oedema 19.63 9.72 196 307144 48742 50249042
Ceruloplasmin decreased 19.62 9.72 6 307334 8 50297776
Food refusal 19.59 9.72 16 307324 306 50297478
Renal tubular necrosis 19.52 9.72 117 307223 10051 50287733
Genital pain 19.50 9.72 16 307324 308 50297476
Mediastinal abscess 19.22 9.72 6 307334 9 50297775
Anti-cyclic citrullinated peptide antibody positive 19.16 9.72 563 306777 70024 50227760
Therapeutic response decreased 19.01 9.72 189 307151 47042 50250742
Coma scale abnormal 18.99 9.72 68 307272 4703 50293081
Injection site extravasation 18.93 9.72 11 307329 7490 50290294
Dyskinesia 18.81 9.72 96 307244 27765 50270019
Poor venous access 18.80 9.72 21 307319 10319 50287465
Tinnitus 18.79 9.72 257 307083 27875 50269909
Metastases to liver 18.77 9.72 61 307279 20043 50277741
No adverse event 18.75 9.72 123 307217 33455 50264329
Bacteraemia 18.75 9.72 37 307303 14396 50283388
Procedural pain 18.71 9.72 146 307194 13686 50284098
COVID-19 18.67 9.72 187 307153 46475 50251309
Staphylococcal infection 18.63 9.72 133 307207 35483 50262301
Electrocardiogram QRS complex prolonged 18.63 9.72 73 307267 5271 50292513
Device malfunction 18.59 9.72 40 307300 15081 50282703
Hepatic necrosis 18.55 9.72 72 307268 5176 50292608
Full blood count abnormal 18.52 9.72 76 307264 23312 50274472
Liver disorder 18.51 9.72 141 307199 37081 50260703
Perichondritis 18.50 9.72 7 307333 24 50297760
Skin papilloma 18.33 9.72 62 307278 4167 50293617
Electrocardiogram U-wave abnormality 18.28 9.72 7 307333 25 50297759
Effusion 18.26 9.72 34 307306 1569 50296215
Blood pressure fluctuation 18.15 9.72 135 307205 35688 50262096
Drug abuse 18.11 9.72 484 306856 59362 50238422
Ulcer 18.06 9.72 195 307145 20005 50277779
Loss of personal independence in daily activities 17.97 9.72 308 307032 69742 50228042
Necrotising fasciitis 17.87 9.72 45 307295 2559 50295225
Labelled drug-food interaction medication error 17.87 9.72 7 307333 27 50297757
Acute pulmonary oedema 17.85 9.72 11 307329 7256 50290528
Muscle rigidity 17.83 9.72 20 307320 9809 50287975
Flushing 17.73 9.72 293 307047 66722 50231062
Intestinal diaphragm disease 17.73 9.72 10 307330 100 50297684
Brain injury 17.71 9.72 78 307262 5936 50291848
Balance disorder 17.59 9.72 312 307028 70278 50227506
Acute haemorrhagic oedema of infancy 17.52 9.72 6 307334 14 50297770
Dyspareunia 17.48 9.72 40 307300 2139 50295645
Hypothermia 17.47 9.72 129 307211 11887 50285897
Lung neoplasm malignant 17.40 9.72 43 307297 15441 50282343
Hepatic cirrhosis 17.35 9.72 52 307288 17525 50280259
Blood pressure decreased 17.35 9.72 237 307103 55672 50242112
Ludwig angina 17.34 9.72 8 307332 50 50297734
Osteonecrosis 17.32 9.72 74 307266 22443 50275341
Glaucoma 17.28 9.72 44 307296 15642 50282142
Osteonecrosis of jaw 17.24 9.72 121 307219 32405 50265379
Myoclonus 17.20 9.72 39 307301 14431 50283353
Tendon disorder 17.20 9.72 71 307269 5251 50292533
Deafness 17.19 9.72 158 307182 15533 50282251
Parkinsonism 17.17 9.72 17 307323 8830 50288954
Product use in unapproved indication 17.16 9.72 554 306786 115265 50182519
Accidental exposure to product by child 17.11 9.72 26 307314 1014 50296770
Periorbital oedema 17.10 9.72 68 307272 4944 50292840
Chromaturia 17.05 9.72 149 307191 14441 50283343
Vulval ulceration 16.86 9.72 13 307327 228 50297556
Hepatitis acute 16.85 9.72 94 307246 7867 50289917
Intentional product misuse 16.84 9.72 387 306953 46347 50251437
Drug withdrawal headache 16.83 9.72 8 307332 54 50297730
Electrocardiogram QT prolonged 16.81 9.72 218 307122 51668 50246116
Glomerulonephritis minimal lesion 16.81 9.72 13 307327 229 50297555
Staphylococcal sepsis 16.81 9.72 11 307329 7025 50290759
Immunodeficiency 16.80 9.72 41 307299 14787 50282997
Cardiotoxicity 16.77 9.72 11 307329 7016 50290768
Swelling face 16.68 9.72 428 306912 52167 50245617
Superior sagittal sinus thrombosis 16.63 9.72 21 307319 686 50297098
Uterine leiomyoma 16.58 9.72 93 307247 7798 50289986
Tardive dyskinesia 16.56 9.72 12 307328 7267 50290517
Posthaemorrhagic hydrocephalus 16.45 9.72 6 307334 18 50297766
Shoulder injury related to vaccine administration 16.44 9.72 4 307336 0 50297784
Photophobia 16.36 9.72 150 307190 14737 50283047
Trichiasis 16.35 9.72 8 307332 58 50297726
Diffuse large B-cell lymphoma 16.25 9.72 7 307333 5655 50292129
Aplasia pure red cell 16.17 9.72 3 307337 4212 50293572
Erosive duodenitis 16.16 9.72 16 307324 397 50297387
Muscle tone disorder 16.11 9.72 10 307330 121 50297663
Spinal compression fracture 15.96 9.72 33 307307 12623 50285161
Mania 15.96 9.72 26 307314 10890 50286894
Pulmonary mass 15.95 9.72 59 307281 18646 50279138
Anal haemorrhage 15.78 9.72 33 307307 1659 50296125
Oesophageal discomfort 15.77 9.72 11 307329 164 50297620
Hepatic infiltration eosinophilic 15.76 9.72 6 307334 21 50297763
Pituitary tumour benign 15.76 9.72 34 307306 1747 50296037
Obstructive airways disorder 15.67 9.72 46 307294 15606 50282178
Cerebral haemorrhage 15.67 9.72 98 307242 26954 50270830
Tremor neonatal 15.62 9.72 9 307331 94 50297690
Psychogenic tremor 15.55 9.72 6 307334 22 50297762
Alanine aminotransferase abnormal 15.50 9.72 58 307282 4098 50293686
Blood pressure systolic increased 15.49 9.72 139 307201 35310 50262474
Blood copper decreased 15.46 9.72 5 307335 9 50297775
Small intestinal stenosis 15.43 9.72 17 307323 479 50297305
Depression 15.35 9.72 1185 306155 164238 50133546
Pancreatitis acute 15.28 9.72 216 307124 23596 50274188
Myopathy 15.09 9.72 20 307320 9119 50288665
Anoxia 15.07 9.72 12 307328 221 50297563
Paraesthesia 15.00 9.72 883 306457 119360 50178424
Nodule 14.92 9.72 53 307287 16950 50280834
Evans syndrome 14.90 9.72 11 307329 180 50297604
Hypogammaglobulinaemia 14.90 9.72 8 307332 5691 50292093
Therapy partial responder 14.82 9.72 11 307329 6580 50291204
Normochromic anaemia 14.79 9.72 13 307327 276 50297508
Abdominal tenderness 14.77 9.72 85 307255 7195 50290589
Injection site hyperaesthesia 14.75 9.72 7 307333 47 50297737
Laryngeal dyspnoea 14.63 9.72 10 307330 144 50297640
Schizophrenia 14.60 9.72 14 307326 7383 50290401
Urogenital haemorrhage 14.58 9.72 12 307328 232 50297552
Hypertonia neonatal 14.58 9.72 12 307328 232 50297552
Allergy test positive 14.58 9.72 15 307325 390 50297394
Cystitis 14.52 9.72 187 307153 44377 50253407
Thrombophlebitis septic 14.51 9.72 10 307330 146 50297638
Left ventricular dysfunction 14.47 9.72 26 307314 10480 50287304
Blood potassium increased 14.46 9.72 51 307289 16347 50281437
Abnormal loss of weight 14.40 9.72 65 307275 4999 50292785
Haematotoxicity 14.39 9.72 16 307324 7879 50289905
Stress cardiomyopathy 14.36 9.72 16 307324 7871 50289913
Hyperventilation 14.33 9.72 68 307272 5341 50292443
Temperature regulation disorder 14.24 9.72 4 307336 4223 50293561
Salivary gland cyst 14.22 9.72 4 307336 3 50297781
Chemical burn 14.15 9.72 14 307326 347 50297437
Drug intolerance 14.12 9.72 1142 306198 217962 50079822
Neonatal hypoxia 14.08 9.72 16 307324 467 50297317
Anion gap 14.07 9.72 25 307315 1112 50296672
Bunion operation 14.07 9.72 25 307315 1112 50296672
Congestive cardiomyopathy 14.05 9.72 8 307332 5510 50292274
Acquired haemophilia 14.05 9.72 22 307318 881 50296903
Hypoxia 14.03 9.72 222 307118 50901 50246883
Gastric infection 13.98 9.72 45 307295 2947 50294837
Visual snow syndrome 13.96 9.72 5 307335 14 50297770
Duodenal ulcer repair 13.94 9.72 7 307333 54 50297730
Blood glucose decreased 13.91 9.72 60 307280 18151 50279633
Allodynia 13.87 9.72 19 307321 673 50297111
Alanine aminotransferase increased 13.86 9.72 663 306677 87696 50210088
Staphylococcal scalded skin syndrome 13.82 9.72 9 307331 119 50297665
Influenza 13.82 9.72 426 306914 89112 50208672
Prescribed underdose 13.80 9.72 50 307290 15899 50281885
Neoplasm progression 13.78 9.72 112 307228 29045 50268739
Substance abuser 13.71 9.72 5 307335 15 50297769
Vulvovaginitis trichomonal 13.71 9.72 5 307335 15 50297769
Urosepsis 13.71 9.72 48 307292 15417 50282367
Upper gastrointestinal perforation 13.69 9.72 4 307336 4 50297780
Scleroderma 13.67 9.72 6 307334 4795 50292989
Pregnancy with contraceptive device 13.64 9.72 55 307285 4024 50293760
Asphyxia 13.63 9.72 8 307332 5419 50292365
Diabetes mellitus inadequate control 13.63 9.72 38 307302 13107 50284677
Splenic vein thrombosis 13.62 9.72 13 307327 308 50297476
Swollen tongue 13.59 9.72 247 307093 28383 50269401
Acute myocardial infarction 13.58 9.72 113 307227 29160 50268624
Fear of injection 13.55 9.72 73 307267 6030 50291754
Suicidal ideation 13.50 9.72 436 306904 54949 50242835
Tachycardia 13.49 9.72 738 306602 99025 50198759
Alveolar rhabdomyosarcoma 13.47 9.72 5 307335 16 50297768
Total bile acids increased 13.44 9.72 9 307331 125 50297659
Oral candidiasis 13.37 9.72 55 307285 16860 50280924
Respiratory tract infection 13.36 9.72 127 307213 31890 50265894
Allergic respiratory disease 13.34 9.72 6 307334 35 50297749
Throat tightness 13.34 9.72 189 307151 20658 50277126
Pneumoperitoneum 13.32 9.72 26 307314 1243 50296541
Intestinal cyst 13.31 9.72 8 307332 91 50297693
Renal failure 13.30 9.72 521 306819 106112 50191672
Abortion spontaneous 13.26 9.72 340 307000 41432 50256352
Alpha 1 microglobulin increased 13.23 9.72 7 307333 61 50297723
Hyperuricaemia 13.09 9.72 6 307334 4674 50293110
Small intestine ulcer 13.08 9.72 13 307327 324 50297460
Hyperchromic anaemia 13.07 9.72 6 307334 37 50297747
Blood creatine phosphokinase increased 13.06 9.72 100 307240 26267 50271517
Henoch-Schonlein purpura nephritis 13.03 9.72 5 307335 18 50297766
Cellulitis 12.93 9.72 329 307011 70469 50227315
Benzodiazepine drug level increased 12.89 9.72 10 307330 177 50297607
Renal disorder 12.84 9.72 106 307234 27399 50270385
Pulmonary valve disease 12.82 9.72 5 307335 19 50297765
pH body fluid decreased 12.82 9.72 5 307335 19 50297765
Lice infestation 12.81 9.72 4 307336 6 50297778
Pasteurella infection 12.76 9.72 7 307333 66 50297718
Therapy interrupted 12.73 9.72 71 307269 20081 50277703
Skin necrosis 12.71 9.72 111 307229 10756 50287028
Hyperlactacidaemia 12.67 9.72 38 307302 2395 50295389
Cerebral infarction 12.65 9.72 78 307262 21526 50276258
Nuchal rigidity 12.63 9.72 17 307323 592 50297192
Foetal exposure during pregnancy 12.52 9.72 106 307234 27253 50270531
Erythema multiforme 12.50 9.72 96 307244 8954 50288830
Anti-thyroid antibody positive 12.50 9.72 14 307326 402 50297382
Deformity 12.49 9.72 18 307322 7922 50289862
Papillitis 12.43 9.72 5 307335 21 50297763
Neuroleptic malignant syndrome 12.43 9.72 31 307309 11099 50286685
Treatment noncompliance 12.41 9.72 120 307220 30030 50267754
Pseudomonas infection 12.40 9.72 24 307316 9406 50288378
Left ventricular failure 12.36 9.72 7 307333 4834 50292950
Rash maculo-papular 12.35 9.72 229 307111 26412 50271372
Gastric ulcer haemorrhage 12.34 9.72 57 307283 4427 50293357
Anastomotic ulcer perforation 12.33 9.72 3 307337 0 50297784
Laryngeal web 12.33 9.72 3 307337 0 50297784
Microsleep 12.33 9.72 3 307337 0 50297784
Ultrasound antenatal screen 12.33 9.72 3 307337 0 50297784
Corrosive gastritis 12.33 9.72 3 307337 0 50297784
Foetal non-stress test 12.33 9.72 3 307337 0 50297784
Uraemic gastropathy 12.33 9.72 3 307337 0 50297784
Autoimmune hepatitis 12.26 9.72 83 307257 7436 50290348
Monoplegia 12.24 9.72 41 307299 2742 50295042
Polymenorrhagia 12.21 9.72 6 307334 44 50297740
Chest wall abscess 12.21 9.72 6 307334 44 50297740
Listless 12.14 9.72 37 307303 2353 50295431
Substance dependence 12.12 9.72 10 307330 194 50297590
Disturbance in attention 12.10 9.72 261 307079 30925 50266859
Medication error 12.10 9.72 296 307044 35808 50261976
Narrow anterior chamber angle 12.09 9.72 6 307334 45 50297739
Metastases to lung 12.07 9.72 31 307309 10989 50286795
Vulval disorder 12.03 9.72 18 307322 692 50297092
Systemic mastocytosis 12.01 9.72 9 307331 151 50297633
Base excess 12.00 9.72 7 307333 75 50297709
Facial spasm 11.99 9.72 17 307323 622 50297162
Xanthoma 11.98 9.72 6 307334 46 50297738
Dystonia 11.98 9.72 35 307305 11891 50285893
Carotid artery dissection 11.96 9.72 9 307331 152 50297632
Haemorrhage intracranial 11.94 9.72 37 307303 12337 50285447
Abscess rupture 11.90 9.72 11 307329 250 50297534
Duodenogastric reflux 11.87 9.72 6 307334 47 50297737
Hyperkalaemia 11.83 9.72 213 307127 47876 50249908
Escherichia infection 11.82 9.72 31 307309 10910 50286874
Product administered to patient of inappropriate age 11.79 9.72 39 307301 2591 50295193
Abnormal clotting factor 11.78 9.72 8 307332 114 50297670
Rales 11.77 9.72 27 307313 9951 50287833
Thyroid stimulating immunoglobulin increased 11.77 9.72 7 307333 78 50297706
Device leakage 11.75 9.72 11 307329 5867 50291917
Strawberry tongue 11.74 9.72 5 307335 25 50297759
Drug interaction 11.73 9.72 1048 306292 198573 50099211
Acidosis 11.72 9.72 104 307236 10123 50287661
Upper limb fracture 11.70 9.72 53 307287 15820 50281964
Necrotising colitis 11.64 9.72 15 307325 500 50297284
Helicobacter test positive 11.64 9.72 13 307327 372 50297412
Psychotic disorder 11.63 9.72 81 307259 21731 50276053
Grief reaction 11.62 9.72 10 307330 206 50297578
Coagulopathy 11.61 9.72 163 307177 17781 50280003
Blood pressure systolic abnormal 11.60 9.72 18 307322 7688 50290096
Platelet aggregation decreased 11.59 9.72 5 307335 26 50297758
Catheterisation cardiac 11.58 9.72 5 307335 4035 50293749
Cystitis haemorrhagic 11.58 9.72 4 307336 3698 50294086
Ventricular tachycardia 11.56 9.72 53 307287 15768 50282016
Glomerulonephropathy 11.54 9.72 7 307333 81 50297703
Peritonitis bacterial 11.53 9.72 7 307333 4654 50293130
Coeliac disease 11.51 9.72 22 307318 8663 50289121
Anti-transglutaminase antibody 11.49 9.72 4 307336 10 50297774
Clostridium difficile colitis 11.49 9.72 62 307278 17680 50280104
Blood iron abnormal 11.48 9.72 3 307337 3323 50294461
Spinal fracture 11.48 9.72 52 307288 15521 50282263
Product storage error 11.48 9.72 37 307303 12187 50285597
Pulseless electrical activity 11.45 9.72 76 307264 6765 50291019
Transverse sinus thrombosis 11.44 9.72 15 307325 509 50297275
Pneumonia fungal 11.39 9.72 6 307334 4314 50293470
Tuberculosis 11.33 9.72 28 307312 10055 50287729
Blood pressure diastolic abnormal 11.31 9.72 25 307315 9336 50288448
Haemoptysis 11.29 9.72 100 307240 25473 50272311
Product administration error 11.20 9.72 175 307165 19524 50278260
Sacroiliitis 11.19 9.72 38 307302 2559 50295225
Lip erythema 11.10 9.72 8 307332 126 50297658
Oedema genital 11.07 9.72 9 307331 171 50297613
Disseminated intravascular coagulation 11.03 9.72 60 307280 17075 50280709
Basal ganglion degeneration 11.03 9.72 13 307327 395 50297389
Muscle tightness 11.00 9.72 103 307237 10177 50287607
Blood calcium decreased 10.99 9.72 77 307263 20629 50277155
Genitourinary symptom 10.99 9.72 6 307334 56 50297728
Malnutrition 10.99 9.72 42 307298 13147 50284637
Hepatobiliary scan abnormal 10.99 9.72 6 307334 56 50297728
Rash pruritic 10.98 9.72 374 306966 47472 50250312
Orthopnoea 10.96 9.72 11 307329 5678 50292106
Needle issue 10.95 9.72 17 307323 7258 50290526
Atrial flutter 10.93 9.72 23 307317 8740 50289044
Duodenitis 10.88 9.72 44 307296 3224 50294560
Prothrombin time ratio decreased 10.82 9.72 13 307327 403 50297381
Disorientation 10.80 9.72 151 307189 35333 50262451
Fistula 10.73 9.72 21 307319 8197 50289587
Vertebral artery occlusion 10.72 9.72 7 307333 93 50297691
Human papilloma virus test positive 10.70 9.72 14 307326 474 50297310
Accidental exposure to product 10.70 9.72 89 307251 22968 50274816
Osteoarthritis 10.68 9.72 326 307014 68280 50229504
Epistaxis 10.68 9.72 301 307039 63653 50234131
Colon cancer 10.68 9.72 23 307317 8668 50289116
Skin cancer 10.62 9.72 26 307314 9368 50288416
Hip arthroplasty 10.55 9.72 126 307214 30303 50267481
Lung disorder 10.53 9.72 200 307140 44599 50253185
Product communication issue 10.46 9.72 12 307328 354 50297430
Gait deviation 10.39 9.72 6 307334 63 50297721
International normalised ratio increased 10.35 9.72 192 307148 42960 50254824
Coronary artery disease 10.34 9.72 123 307217 29603 50268181
Forced expiratory volume decreased 10.32 9.72 7 307333 4387 50293397
Secondary adrenocortical insufficiency 10.32 9.72 22 307318 1121 50296663
Blindness transient 10.31 9.72 43 307297 3195 50294589
Peripheral sensory neuropathy 10.31 9.72 15 307325 6576 50291208
Limbal stem cell deficiency 10.30 9.72 4 307336 15 50297769
Erythema nodosum 10.29 9.72 49 307291 3854 50293930
Coma 10.28 9.72 433 306907 56446 50241338
Meconium ileus 10.27 9.72 3 307337 3 50297781
Pharyngeal lesion 10.27 9.72 3 307337 3 50297781
Ejection fraction decreased 10.26 9.72 68 307272 18452 50279332
Toxic encephalopathy 10.25 9.72 11 307329 5504 50292280
Faeces discoloured 10.24 9.72 146 307194 15978 50281806
Asthma 10.18 9.72 441 306899 88896 50208888
Retroplacental haematoma 10.15 9.72 8 307332 145 50297639
Epiglottic oedema 10.13 9.72 5 307335 37 50297747
Gastrointestinal ulcer 10.13 9.72 29 307311 1781 50296003
Breath sounds abnormal 10.10 9.72 20 307320 7772 50290012
Myoglobin urine 10.10 9.72 4 307336 16 50297768
Scleral oedema 10.10 9.72 4 307336 16 50297768
Quadriparesis 10.10 9.72 28 307312 1688 50296096
Post cholecystectomy syndrome 10.07 9.72 6 307334 67 50297717
Atypical femur fracture 10.06 9.72 9 307331 4907 50292877
Syncope 10.04 9.72 517 306823 102485 50195299
Glycosylated haemoglobin increased 10.03 9.72 32 307308 10574 50287210
Pleural fibrosis 10.01 9.72 4 307336 3380 50294404
Neutropenic sepsis 9.98 9.72 48 307292 14099 50283685
Atrioventricular block complete 9.95 9.72 18 307322 7237 50290547
Superficial vein prominence 9.92 9.72 6 307334 69 50297715
Bladder irritation 9.86 9.72 9 307331 201 50297583
Mallory-Weiss syndrome 9.86 9.72 24 307316 1336 50296448
Haemorrhage 9.85 9.72 248 307092 53193 50244591
Murphy's sign positive 9.81 9.72 3 307337 4 50297780
Heart rate irregular 9.79 9.72 73 307267 19287 50278497
Gastrointestinal toxicity 9.75 9.72 55 307285 4622 50293162
Pelvic adhesions 9.73 9.72 11 307329 319 50297465

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
Angioedema 540.45 10.22 702 136318 31213 29406294
Intentional overdose 371.95 10.22 652 136368 37876 29399631
Haematemesis 311.36 10.22 471 136549 24155 29413352
Drug hypersensitivity 301.61 10.22 845 136175 67561 29369946
Suicide attempt 274.74 10.22 534 136486 33576 29403931
Melaena 243.71 10.22 482 136538 30694 29406813
Aspirin-exacerbated respiratory disease 241.65 10.22 83 136937 283 29437224
Death 218.81 10.22 832 136188 341252 29096255
Urticaria 218.42 10.22 652 136368 54008 29383499
Febrile neutropenia 210.35 10.22 130 136890 112110 29325397
Completed suicide 205.87 10.22 896 136124 89350 29348157
Gastric haemorrhage 201.85 10.22 232 136788 9065 29428442
Off label use 189.33 10.22 736 136284 300064 29137443
Gastric ulcer 184.91 10.22 274 136746 13787 29423720
Tubulointerstitial nephritis 175.90 10.22 303 136717 17340 29420167
Duodenal ulcer 173.33 10.22 214 136806 9024 29428483
Lip oedema 171.30 10.22 114 136906 2090 29435417
Glomerulonephritis minimal lesion 170.24 10.22 66 136954 343 29437164
Acute kidney injury 154.46 10.22 1891 135129 263376 29174131
Pneumonia 152.70 10.22 866 136154 319306 29118201
Upper gastrointestinal haemorrhage 147.91 10.22 319 136701 21595 29415912
Overdose 142.24 10.22 738 136282 79081 29358426
Interstitial lung disease 138.87 10.22 47 136973 57671 29379836
Anaphylactic reaction 134.75 10.22 354 136666 27219 29410288
Gastrointestinal haemorrhage 123.27 10.22 708 136312 78825 29358682
Neutropenia 122.96 10.22 267 136753 131444 29306063
Meningitis aseptic 116.49 10.22 93 136927 2283 29435224
Gastritis 115.90 10.22 270 136750 19247 29418260
Platelet count decreased 115.37 10.22 192 136828 104480 29333027
Duodenal ulcer haemorrhage 111.37 10.22 120 136900 4359 29433148
Peptic ulcer 108.67 10.22 91 136929 2394 29435113
Palatal oedema 107.32 10.22 57 136963 674 29436833
Gastric ulcer perforation 100.08 10.22 58 136962 822 29436685
Abdominal pain upper 97.78 10.22 548 136472 60445 29377062
Duodenal ulcer perforation 96.10 10.22 69 136951 1437 29436070
Cardiac failure 95.41 10.22 137 136883 79150 29358357
Ankylosing spondylitis 95.37 10.22 107 136913 4069 29433438
Toxicity to various agents 93.50 10.22 1221 135799 172440 29265067
Sepsis 92.07 10.22 345 136675 142337 29295170
Renal papillary necrosis 81.58 10.22 30 136990 131 29437376
Face oedema 81.52 10.22 160 136860 10123 29427384
Metabolic acidosis 79.75 10.22 366 136654 37296 29400211
Cardiac failure congestive 79.32 10.22 146 136874 76435 29361072
Enthesopathy 78.88 10.22 92 136928 3651 29433856
Eyelid oedema 78.41 10.22 102 136918 4534 29432973
Wound closure 77.68 10.22 24 136996 52 29437455
Pancytopenia 77.21 10.22 169 136851 82999 29354508
Gastric ulcer haemorrhage 76.78 10.22 104 136916 4810 29432697
Osteotomy 76.47 10.22 24 136996 56 29437451
Stevens-Johnson syndrome 73.75 10.22 205 136815 16292 29421215
Intentional product misuse 72.76 10.22 336 136684 34325 29403182
Peritonsillar abscess 72.70 10.22 34 136986 299 29437208
Thrombocytopenia 71.03 10.22 352 136668 134471 29303036
Gastritis erosive 67.90 10.22 103 136917 5290 29432217
Cytomegalovirus infection 67.12 10.22 13 137007 23202 29414305
Headache 64.75 10.22 1149 135871 172858 29264649
Vomiting 64.54 10.22 1359 135661 210901 29226606
Psoriatic arthropathy 64.14 10.22 181 136839 14510 29422997
Renal tubular acidosis 62.75 10.22 58 136962 1745 29435762
Nasal obstruction 61.70 10.22 36 136984 517 29436990
Self-medication 61.24 10.22 62 136958 2092 29435415
Glomerulonephritis membranous 60.84 10.22 44 136976 927 29436580
Tongue oedema 60.75 10.22 67 136953 2499 29435008
Hypersensitivity 60.36 10.22 436 136584 52467 29385040
Intestinal diaphragm disease 59.29 10.22 27 136993 222 29437285
Disease progression 58.89 10.22 189 136831 81727 29355780
Malignant neoplasm progression 58.43 10.22 163 136857 73696 29363811
Drug resistance 58.33 10.22 14 137006 21526 29415981
Tenosynovitis 58.31 10.22 79 136941 3654 29433853
Hepatic function abnormal 56.52 10.22 59 136961 39200 29398307
White blood cell count decreased 54.73 10.22 200 136820 83162 29354345
Lip swelling 53.30 10.22 152 136868 12258 29425249
Faeces discoloured 53.00 10.22 159 136861 13192 29424315
Suspected suicide 52.35 10.22 78 136942 3942 29433565
Tongue disorder 50.69 10.22 83 136937 4553 29432954
Swelling face 50.12 10.22 207 136813 20143 29417364
Septic shock 49.52 10.22 138 136882 62422 29375085
Tendonitis 49.31 10.22 112 136908 7849 29429658
Toxic epidermal necrolysis 48.18 10.22 189 136831 17964 29419543
Ascites 45.29 10.22 62 136958 36557 29400950
Atrial fibrillation 45.23 10.22 295 136725 105351 29332156
Pyloric stenosis 44.76 10.22 33 136987 717 29436790
Hospitalisation 44.70 10.22 91 136929 45897 29391610
Hyperhidrosis 44.43 10.22 476 136544 64064 29373443
Acute hepatic failure 44.33 10.22 139 136881 11813 29425694
Neutrophil count decreased 43.38 10.22 85 136935 43482 29394025
Coronavirus infection 43.11 10.22 64 136956 3224 29434283
Pruritus 41.42 10.22 766 136254 116083 29321424
Jejunal ulcer perforation 41.25 10.22 15 137005 63 29437444
Bone marrow failure 40.93 10.22 40 136980 27409 29410098
Macrocephaly 40.61 10.22 25 136995 398 29437109
Haematochezia 40.57 10.22 302 136718 36681 29400826
Conjunctivitis 40.40 10.22 104 136916 7894 29429613
Encephalopathy 38.95 10.22 52 136968 30991 29406516
Fixed eruption 38.64 10.22 37 136983 1165 29436342
Discoloured vomit 38.39 10.22 25 136995 441 29437066
Erythema multiforme 37.60 10.22 99 136921 7618 29429889
Pain 37.59 10.22 1050 135970 170382 29267125
Mast cell activation syndrome 37.57 10.22 18 137002 168 29437339
Mucocutaneous disorder 37.44 10.22 16 137004 111 29437396
Hypoglycaemia 37.26 10.22 108 136912 48238 29389269
Laryngeal dyspnoea 37.20 10.22 15 137005 88 29437419
Tropical infectious disease 36.08 10.22 12 137008 36 29437471
Duodenitis 36.05 10.22 67 136953 4068 29433439
Erosive oesophagitis 35.96 10.22 38 136982 1349 29436158
Respiratory failure 35.85 10.22 283 136737 96848 29340659
Hypoxia 35.67 10.22 107 136913 47272 29390235
Medication overuse headache 34.51 10.22 15 137005 109 29437398
Graft versus host disease 33.52 10.22 3 137017 9625 29427882
Neuropathy peripheral 33.16 10.22 193 136827 70834 29366673
Hypomagnesaemia 32.99 10.22 20 137000 17448 29420059
Renal cortical necrosis 32.79 10.22 16 137004 156 29437351
Myocardial infarction 32.59 10.22 340 136680 109956 29327551
Type I hypersensitivity 32.59 10.22 32 136988 1040 29436467
Gastritis haemorrhagic 32.13 10.22 34 136986 1209 29436298
Acute generalised exanthematous pustulosis 31.79 10.22 76 136944 5507 29432000
Renal tubular necrosis 31.69 10.22 141 136879 14174 29423333
Pharyngeal abscess 31.60 10.22 21 136999 384 29437123
Eye swelling 31.48 10.22 100 136920 8557 29428950
Alanine aminotransferase abnormal 31.07 10.22 52 136968 2905 29434602
Pneumocystis jirovecii pneumonia 30.60 10.22 20 137000 16759 29420748
Myelodysplastic syndrome 30.09 10.22 23 136997 17771 29419736
Musculoskeletal stiffness 29.97 10.22 285 136735 37173 29400334
Clostridium difficile infection 29.76 10.22 19 137001 16122 29421385
Cytopenia 29.62 10.22 5 137015 9854 29427653
Ventricular tachyarrhythmia 29.60 10.22 18 137002 280 29437227
Blood glucose increased 29.31 10.22 157 136863 58827 29378680
Cerebral infarction 29.29 10.22 43 136977 24632 29412875
Muscle swelling 29.28 10.22 19 137001 333 29437174
Analgesic drug level increased 28.65 10.22 23 136997 569 29436938
Plasma cell myeloma 28.53 10.22 83 136937 37032 29400475
Conjunctival hyperaemia 28.48 10.22 42 136978 2103 29435404
Brain empyema 28.17 10.22 7 137013 3 29437504
Arthralgia 27.53 10.22 844 136176 138773 29298734
Diarrhoea 27.50 10.22 1261 135759 331437 29106070
Poisoning 27.29 10.22 105 136915 9888 29427619
Full blood count abnormal 27.23 10.22 18 137002 14995 29422512
Confusional state 27.05 10.22 423 136597 127454 29310053
Joint swelling 27.03 10.22 350 136670 49280 29388227
Intervertebral disc protrusion 26.96 10.22 95 136925 8575 29428932
Milk-alkali syndrome 26.81 10.22 21 136999 501 29437006
Erysipelas 26.79 10.22 60 136960 4165 29433342
Periorbital oedema 26.78 10.22 52 136968 3263 29434244
Bronchopulmonary aspergillosis 26.46 10.22 12 137008 12332 29425175
Beta haemolytic streptococcal infection 26.30 10.22 20 137000 456 29437051
Synovitis 26.20 10.22 110 136910 10780 29426727
C-reactive protein abnormal 26.09 10.22 78 136942 6458 29431049
Lemierre syndrome 25.84 10.22 7 137013 7 29437500
Erosive duodenitis 25.68 10.22 31 136989 1276 29436231
Peptic ulcer perforation 25.54 10.22 14 137006 177 29437330
Dactylitis 25.47 10.22 23 136997 671 29436836
Wrong technique in product usage process 25.10 10.22 69 136951 31359 29406148
Meningitis pneumococcal 25.06 10.22 13 137007 146 29437361
Tonsillitis 24.97 10.22 38 136982 1957 29435550
Transplant rejection 24.91 10.22 6 137014 9206 29428301
Cerebral atrophy congenital 24.89 10.22 10 137010 58 29437449
Weight increased 24.87 10.22 231 136789 76436 29361071
Transposition of the great vessels 24.70 10.22 19 137001 441 29437066
Neuroleptic malignant syndrome 24.70 10.22 23 136997 16125 29421382
Obstruction gastric 24.66 10.22 25 136995 845 29436662
Perforated ulcer 24.53 10.22 13 137007 153 29437354
Swelling of eyelid 24.43 10.22 21 136999 573 29436934
Drug-induced liver injury 24.40 10.22 178 136842 21477 29416030
Drug ineffective 24.37 10.22 1406 135614 361764 29075743
Ulcer 24.33 10.22 80 136940 6971 29430536
Sacroiliitis 24.25 10.22 28 136992 1099 29436408
Oral pruritus 24.03 10.22 15 137005 245 29437262
Dermo-hypodermitis 23.98 10.22 15 137005 246 29437261
Back pain 23.95 10.22 632 136388 101652 29335855
Febrile bone marrow aplasia 23.77 10.22 3 137017 7348 29430159
Intentional product use issue 23.47 10.22 109 136911 42389 29395118
Multiple sclerosis relapse 23.44 10.22 110 136910 11309 29426198
Fluid retention 23.42 10.22 46 136974 23514 29413993
Renal impairment 23.09 10.22 253 136767 81080 29356427
Tobacco abuse 22.76 10.22 17 137003 377 29437130
Chronic obstructive pulmonary disease 22.64 10.22 105 136915 40850 29396657
Vanishing bile duct syndrome 22.60 10.22 20 137000 568 29436939
Dermatomyositis 22.49 10.22 26 136994 1022 29436485
Helicobacter test positive 22.47 10.22 21 136999 641 29436866
Liver injury 22.32 10.22 117 136903 12573 29424934
Sebaceous gland disorder 22.14 10.22 6 137014 6 29437501
Red blood cell count decreased 22.14 10.22 54 136966 25548 29411959
Gastrointestinal injury 22.09 10.22 16 137004 338 29437169
Prepyloric stenosis 21.90 10.22 5 137015 0 29437507
Kawasaki's disease 21.90 10.22 5 137015 0 29437507
Benign familial pemphigus 21.90 10.22 5 137015 0 29437507
Pulmonary arterial hypertension 21.90 10.22 4 137016 7445 29430062
Angular cheilitis 21.74 10.22 12 137008 154 29437353
Lymphocyte count decreased 21.52 10.22 35 136985 19236 29418271
Migraine 21.45 10.22 114 136906 12316 29425191
Hypervolaemia 21.39 10.22 30 136990 17515 29419992
Flank pain 21.36 10.22 68 136952 5825 29431682
Fractional exhaled nitric oxide increased 21.22 10.22 16 137004 360 29437147
Macrophages increased 21.15 10.22 12 137008 163 29437344
Abdominal pain 21.04 10.22 796 136224 134561 29302946
Oxygen saturation decreased 21.02 10.22 122 136898 44815 29392692
Anosmia 20.90 10.22 35 136985 1956 29435551
Hypoaldosteronism 20.90 10.22 12 137008 167 29437340
Oesophageal rupture 20.81 10.22 16 137004 371 29437136
Symmetrical drug-related intertriginous and flexural exanthema 20.64 10.22 13 137007 216 29437291
Pathogen resistance 20.59 10.22 6 137014 8110 29429397
Heart rate decreased 20.42 10.22 54 136966 24858 29412649
Nasal disorder 20.15 10.22 29 136991 1420 29436087
Kidney transplant rejection 20.08 10.22 4 137016 7001 29430506
Psoriasis 20.02 10.22 233 136787 31994 29405513
Pulmonary oedema 20.00 10.22 116 136904 42619 29394888
Ocular icterus 19.89 10.22 40 136980 2575 29434932
Tumour lysis syndrome 19.82 10.22 21 136999 13863 29423644
Diabetes mellitus 19.79 10.22 106 136914 39725 29397782
Secondary amyloidosis 19.76 10.22 9 137011 74 29437433
Nasal turbinate hypertrophy 19.66 10.22 9 137011 75 29437432
Hypotension 19.55 10.22 720 136300 193634 29243873
Cytomegalovirus viraemia 19.45 10.22 3 137017 6317 29431190
Alcohol use 19.32 10.22 44 136976 3088 29434419
Streptococcal infection 19.30 10.22 55 136965 4433 29433074
Post concussion syndrome 19.22 10.22 10 137010 113 29437394
Anaemia 19.20 10.22 749 136271 200202 29237305
Erythema 19.10 10.22 472 136548 75134 29362373
Duodenal obstruction 19.03 10.22 11 137009 155 29437352
Haemophilia 18.98 10.22 5 137015 4 29437503
Necrotising soft tissue infection 18.90 10.22 8 137012 54 29437453
Nausea 18.87 10.22 1570 135450 287685 29149822
Clostridium difficile colitis 18.85 10.22 20 137000 13192 29424315
Neutropenic sepsis 18.78 10.22 16 137004 11711 29425796
Gastrointestinal hypermotility 18.77 10.22 10 137010 119 29437388
Xyphoid retraction 18.61 10.22 11 137009 162 29437345
Meningitis streptococcal 18.61 10.22 7 137013 33 29437474
Epidermolysis 18.60 10.22 13 137007 259 29437248
Implant site extravasation 18.49 10.22 15 137005 377 29437130
Atrioventricular block complete 18.44 10.22 7 137013 8004 29429503
Phonophobia 18.44 10.22 11 137009 165 29437342
Food intolerance 18.37 10.22 24 136996 1071 29436436
Plantar fasciitis 18.35 10.22 26 136994 1255 29436252
Pleural effusion 18.35 10.22 229 136791 71679 29365828
Pulmonary embolism 18.32 10.22 247 136773 76287 29361220
Head discomfort 18.31 10.22 44 136976 3198 29434309
Hepatocellular carcinoma 18.24 10.22 5 137015 7033 29430474
Acute respiratory failure 18.21 10.22 62 136958 26340 29411167
Oropharyngeal blistering 18.15 10.22 11 137009 170 29437337
Otitis media acute 18.12 10.22 16 137004 453 29437054
Mucosal necrosis 18.08 10.22 8 137012 61 29437446
Posthaemorrhagic hydrocephalus 18.08 10.22 9 137011 92 29437415
Intestinal obstruction 18.01 10.22 39 136981 19238 29418269
Epistaxis 17.98 10.22 153 136867 51551 29385956
Oesophagitis haemorrhagic 17.89 10.22 12 137008 223 29437284
Neurotoxicity 17.80 10.22 25 136995 14588 29422919
Cardiac arrest 17.79 10.22 284 136736 85307 29352200
Cerebral haemorrhage 17.71 10.22 80 136940 31346 29406161
Influenza like illness 17.54 10.22 182 136838 24288 29413219
Tympanic membrane hyperaemia 17.52 10.22 4 137016 0 29437507
Fall 17.45 10.22 658 136362 176520 29260987
Intervertebral disc disorder 17.42 10.22 30 136990 1715 29435792
COVID-19 17.26 10.22 97 136923 35917 29401590
Duodenal stenosis 17.24 10.22 11 137009 187 29437320
Angiocardiogram 17.14 10.22 11 137009 189 29437318
Cerebrovascular accident 17.07 10.22 252 136768 76659 29360848
Energy increased 17.00 10.22 24 136996 1154 29436353
Cardiogenic shock 16.97 10.22 40 136980 19150 29418357
International normalised ratio increased 16.95 10.22 128 136892 44244 29393263
Crying 16.95 10.22 59 136961 5292 29432215
Mallory-Weiss syndrome 16.95 10.22 25 136995 1252 29436255
Lip erosion 16.91 10.22 16 137004 496 29437011
Asthenia 16.90 10.22 820 136200 214430 29223077
Delirium 16.84 10.22 110 136910 39287 29398220
Acute myeloid leukaemia 16.62 10.22 32 136988 16481 29421026
Extra dose administered 16.57 10.22 41 136979 3036 29434471
Herbal interaction 16.57 10.22 13 137007 311 29437196
Deep vein thrombosis 16.50 10.22 178 136842 57221 29380286
Transaminases increased 16.45 10.22 169 136851 22493 29415014
Exostosis 16.43 10.22 45 136975 3544 29433963
Cytokine release syndrome 16.43 10.22 22 136998 13097 29424410
Coma scale abnormal 16.39 10.22 44 136976 3425 29434082
Neoplasm progression 16.29 10.22 39 136981 18573 29418934
Onychomycosis 16.24 10.22 32 136988 2030 29435477
Dyspepsia 16.21 10.22 212 136808 29913 29407594
Intentional self-injury 16.15 10.22 106 136914 12355 29425152
Gastrointestinal ulcer 16.13 10.22 28 136992 1611 29435896
Hypothermia 16.12 10.22 85 136935 9154 29428353
Neck pain 16.08 10.22 161 136859 21286 29416221
Inadequate analgesia 16.06 10.22 37 136983 2617 29434890
Congenital skin dimples 16.04 10.22 10 137010 163 29437344
Post transplant lymphoproliferative disorder 16.04 10.22 3 137017 5490 29432017
Thrombosis mesenteric vessel 15.97 10.22 7 137013 52 29437455
Epiglottic oedema 15.93 10.22 10 137010 165 29437342
Ankle deformity 15.92 10.22 11 137009 215 29437292
Infection masked 15.86 10.22 7 137013 53 29437454
Portal vein phlebitis 15.83 10.22 5 137015 12 29437495
Acquired epidermolysis bullosa 15.83 10.22 5 137015 12 29437495
Cataract 15.81 10.22 52 136968 22326 29415181
Cervicobrachial syndrome 15.80 10.22 12 137008 273 29437234
Incorrect route of product administration 15.80 10.22 16 137004 10785 29426722
Spinal pain 15.73 10.22 54 136966 4810 29432697
Superinfection 15.69 10.22 31 136989 1970 29435537
Skin texture abnormal 15.66 10.22 6 137014 30 29437477
Urticaria chronic 15.56 10.22 8 137012 88 29437419
Aortic bruit 15.48 10.22 10 137010 174 29437333
Hepatitis acute 15.33 10.22 65 136955 6397 29431110
Subdural abscess 15.29 10.22 4 137016 3 29437504
Diffuse large B-cell lymphoma 15.28 10.22 5 137015 6271 29431236
Full blood count decreased 15.23 10.22 32 136988 15960 29421547
Orthostatic intolerance 15.18 10.22 17 137003 645 29436862
Haematotoxicity 15.18 10.22 6 137014 6693 29430814
Hypertensive emergency 15.09 10.22 19 137001 817 29436690
Progressive multifocal leukoencephalopathy 15.09 10.22 11 137009 8708 29428799
Peritonitis bacterial 15.08 10.22 4 137016 5752 29431755
Gastric mucosa erythema 15.08 10.22 11 137009 235 29437272
Dental operation 15.05 10.22 13 137007 357 29437150
Carbohydrate antigen 19-9 increased 15.04 10.22 10 137010 183 29437324
Torsade de pointes 15.04 10.22 6 137014 6655 29430852
Anterior interosseous syndrome 15.03 10.22 5 137015 15 29437492
Retinopathy of prematurity 15.03 10.22 8 137012 95 29437412
Disease recurrence 15.03 10.22 32 136988 15882 29421625
Gastric perforation 14.94 10.22 32 136988 2154 29435353
SJS-TEN overlap 14.84 10.22 11 137009 241 29437266
Eye oedema 14.81 10.22 17 137003 663 29436844
Blood bilirubin unconjugated 14.76 10.22 4 137016 4 29437503
Allergy test negative 14.76 10.22 4 137016 4 29437503
Facet joint syndrome 14.69 10.22 11 137009 245 29437262
Tongue injury 14.68 10.22 8 137012 100 29437407
Respiratory fatigue 14.64 10.22 7 137013 65 29437442
Oesophagitis 14.60 10.22 100 136920 11823 29425684
Spinal cord infection 14.58 10.22 9 137011 144 29437363
Bradycardia 14.57 10.22 215 136805 65414 29372093
Asthma 14.54 10.22 229 136791 33620 29403887
Gastritis bacterial 14.45 10.22 10 137010 196 29437311
Musculoskeletal pain 14.45 10.22 201 136819 28752 29408755
Pruritus genital 14.37 10.22 15 137005 525 29436982
Pneumonitis 14.28 10.22 74 136946 27970 29409537
Parkinsonism 14.21 10.22 8 137012 7270 29430237
Blood pressure fluctuation 14.21 10.22 46 136974 19848 29417659
Costochondritis 14.21 10.22 14 137006 457 29437050
Anuria 14.14 10.22 84 136936 9457 29428050
Hepatitis B 14.07 10.22 4 137016 5493 29432014
Depression 14.01 10.22 504 136516 84643 29352864
Photophobia 13.99 10.22 60 136960 5935 29431572
Lower gastrointestinal haemorrhage 13.95 10.22 75 136945 8138 29429369
Multiple organ dysfunction syndrome 13.93 10.22 207 136813 62909 29374598
Paraesthesia oral 13.92 10.22 42 136978 3495 29434012
Oesophageal infection 13.88 10.22 11 137009 267 29437240
Microbiology test abnormal 13.88 10.22 4 137016 6 29437501
Coating in mouth 13.78 10.22 7 137013 75 29437432
Meningoencephalitis bacterial 13.77 10.22 8 137012 114 29437393
Purpura fulminans 13.70 10.22 7 137013 76 29437431
Ulcer haemorrhage 13.65 10.22 33 136987 2408 29435099
Staphylococcal abscess 13.63 10.22 15 137005 558 29436949
Asthmatic crisis 13.61 10.22 13 137007 408 29437099
Right ventricular failure 13.60 10.22 10 137010 7880 29429627
Exposure to toxic agent 13.54 10.22 34 136986 2541 29434966
Hyperglycaemia 13.53 10.22 98 136922 34189 29403318
Conjunctival erosion 13.50 10.22 4 137016 7 29437500
Osteomyelitis blastomyces 13.50 10.22 4 137016 7 29437500
Posterior reversible encephalopathy syndrome 13.47 10.22 13 137007 8963 29428544
Apnoea 13.43 10.22 60 136960 6042 29431465
Severe acute respiratory syndrome 13.42 10.22 6 137014 47 29437460
Presbyopia 13.38 10.22 9 137011 168 29437339
Candida infection 13.25 10.22 32 136988 15193 29422314
Elbow operation 13.24 10.22 8 137012 123 29437384
Bronchospasm 13.23 10.22 83 136937 9526 29427981
Tubulointerstitial nephritis and uveitis syndrome 13.16 10.22 7 137013 83 29437424
Joint effusion 13.14 10.22 46 136974 4138 29433369
Burn oral cavity 13.14 10.22 3 137017 0 29437507
Pigment nephropathy 13.14 10.22 3 137017 0 29437507
Vestibular ataxia 13.14 10.22 3 137017 0 29437507
Atrio-oesophageal fistula 13.14 10.22 3 137017 0 29437507
Pneumonia aspiration 13.09 10.22 108 136912 36629 29400878
Nasal septum deviation 13.05 10.22 19 137001 940 29436567
Spondylitis 13.04 10.22 20 137000 1037 29436470
Mesenteric panniculitis 13.02 10.22 8 137012 127 29437380
Aspergillus infection 12.99 10.22 18 137002 10563 29426944
Cardiomyopathy 12.93 10.22 31 136989 14756 29422751
Bacteraemia 12.91 10.22 36 136984 16287 29421220
Allergic respiratory disease 12.89 10.22 5 137015 26 29437481
Ear canal stenosis 12.84 10.22 4 137016 9 29437498
Urinary tract infection 12.82 10.22 247 136773 72107 29365400
Neutrophil Pelger-Huet anomaly present 12.79 10.22 10 137010 238 29437269
Gastrooesophageal reflux disease 12.75 10.22 211 136809 31285 29406222
Vascular pseudoaneurysm 12.72 10.22 28 136992 1921 29435586
Blood pressure systolic increased 12.70 10.22 38 136982 16807 29420700
Nephrolithiasis 12.69 10.22 176 136844 25158 29412349
Inflammation 12.67 10.22 161 136859 22567 29414940
Drug reaction with eosinophilia and systemic symptoms 12.65 10.22 191 136829 27801 29409706
Febrile convulsion 12.51 10.22 14 137006 531 29436976
Tremor 12.43 10.22 253 136767 73285 29364222
Acid-base balance disorder mixed 12.43 10.22 6 137014 57 29437450
Orbital oedema 12.39 10.22 8 137012 139 29437368
Product use in unapproved indication 12.38 10.22 307 136713 86568 29350939
Subdural haematoma 12.35 10.22 43 136977 18150 29419357
Akathisia 12.34 10.22 8 137012 6734 29430773
Escherichia pyelonephritis 12.34 10.22 6 137014 58 29437449
Product dose omission issue 12.32 10.22 346 136674 96037 29341470
Dermatitis acneiform 12.31 10.22 5 137015 5486 29432021
Electrocardiogram QT shortened 12.29 10.22 8 137012 141 29437366
Hypogammaglobulinaemia 12.26 10.22 6 137014 5901 29431606
Ear injury 12.17 10.22 5 137015 31 29437476
Thrombosis 12.16 10.22 134 136886 42911 29394596
Liver disorder 12.10 10.22 77 136943 27672 29409835
Anhidrosis 12.09 10.22 7 137013 99 29437408
Bone disorder 12.08 10.22 56 136964 5727 29431780
Foreign body in throat 12.08 10.22 6 137014 61 29437446
Ischaemic stroke 12.08 10.22 36 136984 15941 29421566
Immune reconstitution inflammatory syndrome 12.06 10.22 11 137009 7791 29429716
Coma 12.05 10.22 253 136767 39197 29398310
Complement factor C4 decreased 12.03 10.22 4 137016 12 29437495
Sensation of foreign body 12.00 10.22 26 136994 1764 29435743
Paranasal sinus mucosal hypertrophy 12.00 10.22 6 137014 62 29437445
Anaphylactic shock 11.95 10.22 104 136916 13232 29424275
Oral mucosa erosion 11.94 10.22 17 137003 824 29436683
Blood ethanol increased 11.94 10.22 13 137007 478 29437029
Pelvic fluid collection 11.91 10.22 7 137013 102 29437405
Capillary nail refill test abnormal 11.91 10.22 5 137015 33 29437474
Focal segmental glomerulosclerosis 11.84 10.22 26 136994 1781 29435726
Hemiplegia 11.83 10.22 8 137012 6586 29430921
Ventricular tachycardia 11.82 10.22 59 136961 22515 29414992
Pneumonia fungal 11.80 10.22 6 137014 5771 29431736
Bladder discomfort 11.79 10.22 7 137013 104 29437403
Muscle injury 11.75 10.22 20 137000 1133 29436374
Hereditary angioedema 11.73 10.22 16 137004 745 29436762
Colonic abscess 11.68 10.22 12 137008 412 29437095
Mucosal inflammation 11.67 10.22 92 136928 31503 29406004
Arrhythmia 11.64 10.22 91 136929 31222 29406285
Respiratory tract oedema 11.63 10.22 11 137009 341 29437166
Ureteric obstruction 11.62 10.22 20 137000 1143 29436364
Blood pressure increased 11.58 10.22 257 136763 73546 29363961
Alcohol poisoning 11.52 10.22 36 136984 3053 29434454
Stomatitis 11.52 10.22 113 136907 37000 29400507
Therapy non-responder 11.42 10.22 90 136930 30821 29406686
Agitation 11.42 10.22 315 136705 50989 29386518
Hyperammonaemia 11.39 10.22 6 137014 5657 29431850
Fusobacterium infection 11.37 10.22 6 137014 70 29437437
Pneumonia bacterial 11.37 10.22 16 137004 9327 29428180
Orthostatic hypotension 11.36 10.22 60 136960 22569 29414938
Hepatic cancer 11.36 10.22 8 137012 6448 29431059
Rash macular 11.35 10.22 85 136935 10340 29427167
Medication error 11.30 10.22 149 136871 21062 29416445
Myelosuppression 11.20 10.22 25 136995 12202 29425305
Anxiety 11.17 10.22 493 136527 84872 29352635
Lung neoplasm malignant 11.11 10.22 32 136988 14325 29423182
Pharyngeal erythema 11.08 10.22 13 137007 519 29436988
Spinal meningeal cyst 11.07 10.22 3 137017 3 29437504
Peritonsillitis 11.07 10.22 3 137017 3 29437504
Oculoauriculovertebral dysplasia 11.07 10.22 3 137017 3 29437504
Vertebral artery hypoplasia 11.07 10.22 3 137017 3 29437504
Kernicterus 11.07 10.22 3 137017 3 29437504
Multiple sclerosis 11.03 10.22 53 136967 5501 29432006
Colostomy closure 10.99 10.22 5 137015 41 29437466
Ligament injury 10.98 10.22 10 137010 295 29437212
Social anxiety disorder 10.97 10.22 9 137011 230 29437277
Antineutrophil cytoplasmic antibody 10.96 10.22 4 137016 17 29437490
Transmission of an infectious agent via product 10.96 10.22 8 137012 171 29437336
Meniscus injury 10.94 10.22 26 136994 1877 29435630
Heat stroke 10.93 10.22 17 137003 892 29436615
Cardiac failure acute 10.93 10.22 16 137004 9176 29428331
Generalised oedema 10.92 10.22 22 136998 11143 29426364
Mycoplasma infection 10.90 10.22 10 137010 298 29437209
Accidental overdose 10.84 10.22 127 136893 17466 29420041
Gastrointestinal erosion 10.82 10.22 11 137009 373 29437134
Oropharyngeal swelling 10.76 10.22 12 137008 453 29437054
Dermatitis bullous 10.76 10.22 55 136965 5851 29431656
Emotional distress 10.75 10.22 105 136915 13790 29423717
Mediastinitis 10.68 10.22 14 137006 627 29436880
Congestive cardiomyopathy 10.67 10.22 9 137011 6621 29430886
Red blood cell sedimentation rate 10.66 10.22 13 137007 541 29436966
Klebsiella infection 10.62 10.22 11 137009 7338 29430169
Anxiety disorder due to a general medical condition 10.61 10.22 3 137017 4 29437503
Hepatic cirrhosis 10.59 10.22 33 136987 14411 29423096
Pyrexia 10.58 10.22 1169 135851 286453 29151054
Tension headache 10.57 10.22 21 136999 1340 29436167
Lumbar radiculopathy 10.55 10.22 15 137005 726 29436781
Dementia 10.55 10.22 24 136996 11634 29425873
Kounis syndrome 10.52 10.22 25 136995 1804 29435703
Allergy to chemicals 10.50 10.22 5 137015 46 29437461
Iritis 10.49 10.22 20 137000 1238 29436269
Mental fatigue 10.48 10.22 6 137014 83 29437424
Cross sensitivity reaction 10.44 10.22 20 137000 1242 29436265
Axillary pain 10.44 10.22 10 137010 315 29437192
Metatarsalgia 10.42 10.22 6 137014 84 29437423
Circumoral oedema 10.41 10.22 5 137015 47 29437460
Hiatus hernia 10.36 10.22 60 136960 6692 29430815
Haemorrhoids thrombosed 10.35 10.22 8 137012 187 29437320
Bladder neck obstruction 10.35 10.22 7 137013 132 29437375
Application site haematoma 10.23 10.22 5 137015 49 29437458

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
Angioedema 1077.69 9.79 1521 359878 60300 64077033
Intentional overdose 1067.48 9.79 1854 359545 88090 64049243
Drug hypersensitivity 594.62 9.79 2773 358626 235042 63902291
Injury 467.80 9.79 995 360404 54997 64082336
Cholecystitis chronic 461.90 9.79 397 361002 8890 64128443
Off label use 459.11 9.79 1908 359491 630898 63506435
Urticaria 457.00 9.79 1834 359565 145483 63991850
Suicide attempt 439.83 9.79 1122 360277 69885 64067448
Aspirin-exacerbated respiratory disease 388.16 9.79 169 361230 991 64136342
Haematemesis 380.87 9.79 825 360574 46174 64091159
Pneumonia 368.76 9.79 1748 359651 557828 63579505
Febrile neutropenia 357.54 9.79 315 361084 187342 63949991
Tubulointerstitial nephritis 357.02 9.79 630 360769 30279 64107054
Death 349.79 9.79 1455 359944 481250 63656083
Abdominal pain upper 337.74 9.79 1899 359500 173131 63964202
Overdose 313.64 9.79 1740 359659 157826 63979507
Muscle injury 302.94 9.79 537 360862 25900 64111433
Completed suicide 301.22 9.79 2221 359178 222193 63915140
Lip oedema 297.83 9.79 241 361158 4948 64132385
Duodenal ulcer perforation 292.26 9.79 618 360781 34007 64103326
Emotional distress 284.46 9.79 626 360773 35412 64101921
Interstitial lung disease 279.56 9.79 99 361300 97633 64039700
Irritable bowel syndrome 270.30 9.79 627 360772 36742 64100591
Melaena 258.89 9.79 773 360626 52775 64084558
Gastric ulcer 256.76 9.79 541 360858 29693 64107640
Uterine perforation 251.96 9.79 230 361169 5590 64131743
Renal tubular acidosis 245.93 9.79 172 361227 2807 64134526
Folliculitis 244.83 9.79 529 360870 29548 64107785
Sleep disorder due to general medical condition, insomnia type 243.05 9.79 487 360912 25783 64111550
Cardiac failure 225.67 9.79 245 361154 132128 64005205
Duodenal ulcer 222.05 9.79 335 361064 14100 64123233
Neutropenia 221.79 9.79 650 360749 238974 63898359
Toxicity to various agents 221.31 9.79 3054 358345 360459 63776874
Pruritus 204.69 9.79 2660 358739 309740 63827593
Cardiac failure congestive 191.80 9.79 271 361128 130309 64007024
Upper gastrointestinal haemorrhage 190.11 9.79 529 360870 34691 64102642
Metabolic acidosis 184.67 9.79 838 360561 70120 64067213
Acute kidney injury 181.63 9.79 3528 357871 445712 63691621
Platelet count decreased 180.25 9.79 422 360977 167289 63970044
Blister 178.78 9.79 912 360487 80055 64057278
Pain 176.95 9.79 4201 357198 549310 63588023
Meningitis aseptic 176.41 9.79 188 361211 5542 64131791
Helicobacter infection 176.23 9.79 544 360855 37818 64099515
Glomerulonephritis minimal lesion 165.92 9.79 80 361319 613 64136720
Gallbladder disorder 165.12 9.79 322 361077 16708 64120625
Sepsis 158.60 9.79 707 360692 229634 63907699
Face oedema 157.11 9.79 395 361004 24366 64112967
Gastric haemorrhage 154.64 9.79 274 361125 13207 64124126
Gastric ulcer perforation 153.82 9.79 106 361293 1687 64135646
Thrombocytopenia 153.44 9.79 688 360711 223113 63914220
Malignant neoplasm progression 153.42 9.79 247 361152 112624 64024709
Wound closure 149.28 9.79 50 361349 119 64137214
Eyelid oedema 149.22 9.79 256 361143 12023 64125310
Stevens-Johnson syndrome 147.52 9.79 475 360924 33774 64103559
Gastrointestinal haemorrhage 146.83 9.79 1254 360145 131058 64006275
Drug resistance 143.13 9.79 15 361384 35087 64102246
Vomiting 141.20 9.79 4063 357336 547054 63590279
Osteotomy 140.09 9.79 51 361348 169 64137164
Lower respiratory tract infection 137.47 9.79 955 360444 93659 64043674
Peritonsillar abscess 136.92 9.79 73 361326 707 64136626
Gastritis 136.29 9.79 536 360863 42082 64095251
Biliary dyskinesia 135.78 9.79 110 361289 2262 64135071
Sinusitis 132.62 9.79 1325 360074 144603 63992730
Impaired healing 131.97 9.79 679 360720 59794 64077539
Muscle spasticity 126.40 9.79 285 361114 16384 64120949
Cytomegalovirus infection 124.27 9.79 28 361371 37171 64100162
Duodenal ulcer haemorrhage 124.25 9.79 165 361234 6160 64131173
Atrial fibrillation 123.30 9.79 516 360883 170573 63966760
Toxic epidermal necrolysis 121.74 9.79 471 360928 36695 64100638
Hypersensitivity 119.46 9.79 1651 359748 194801 63942532
Lip swelling 119.30 9.79 422 360977 31485 64105848
Fall 118.91 9.79 1633 359766 415193 63722140
Ear pain 117.82 9.79 359 361040 24777 64112556
Pancytopenia 114.93 9.79 414 360985 142895 63994438
Anaphylactic reaction 110.52 9.79 711 360688 67953 64069380
Palatal oedema 110.38 9.79 74 361325 1123 64136210
Disease progression 109.88 9.79 415 360984 141265 63996068
Enthesopathy 101.79 9.79 189 361210 9449 64127884
Renal papillary necrosis 99.37 9.79 46 361353 318 64137015
Discomfort 97.97 9.79 782 360617 80096 64057237
Hypervolaemia 94.69 9.79 48 361351 38237 64099096
Gastrointestinal disorder 94.67 9.79 841 360558 88868 64048465
Deep vein thrombosis 93.10 9.79 950 360449 104232 64033101
Intentional self-injury 92.62 9.79 365 361034 28679 64108654
Septic shock 91.73 9.79 294 361105 105143 64032190
Hospitalisation 90.95 9.79 177 361222 75030 64062303
Self-medication 90.61 9.79 114 361285 4031 64133302
Bone marrow failure 89.41 9.79 82 361317 47870 64089463
Renal impairment 88.93 9.79 421 360978 134596 64002737
Kounis syndrome 87.43 9.79 96 361303 2929 64134404
Glomerulonephritis membranous 87.16 9.79 67 361332 1273 64136060
Myocardial infarction 86.29 9.79 559 360840 165262 63972071
Foreign body in throat 85.41 9.79 35 361364 172 64137161
Fixed eruption 85.12 9.79 81 361318 2078 64135255
Ascites 84.86 9.79 135 361264 61866 64075467
Neutrophil count decreased 84.68 9.79 192 361207 77004 64060329
Plasma cell myeloma 84.49 9.79 80 361319 45995 64091338
Gastritis erosive 84.14 9.79 174 361225 9421 64127912
Respiratory failure 84.06 9.79 543 360856 160640 63976693
Tongue oedema 83.71 9.79 133 361266 5857 64131476
White blood cell count decreased 83.19 9.79 530 360869 157307 63980026
Cholelithiasis 83.18 9.79 487 360912 45019 64092314
Tenosynovitis 82.77 9.79 196 361203 11637 64125696
Fluid retention 82.33 9.79 129 361270 59477 64077856
Suspected suicide 80.72 9.79 161 361238 8493 64128840
Diarrhoea 79.91 9.79 3276 358123 719428 63417905
Analgesic drug level increased 79.84 9.79 80 361319 2190 64135143
Joint swelling 78.29 9.79 1666 359733 213716 63923617
Clostridium difficile infection 77.25 9.79 54 361345 36109 64101224
Hepatic function abnormal 77.21 9.79 152 361247 64161 64073172
Pericarditis 77.09 9.79 607 360792 61909 64075424
Psoriatic arthropathy 77.06 9.79 460 360939 42821 64094512
Vanishing bile duct syndrome 76.88 9.79 61 361338 1216 64136117
Intestinal diaphragm disease 76.60 9.79 38 361361 312 64137021
Ill-defined disorder 75.76 9.79 464 360935 43588 64093745
Hypomagnesaemia 75.71 9.79 59 361340 37317 64100016
Anxiety 75.11 9.79 1572 359827 201077 63936256
Acute hepatic failure 74.45 9.79 317 361082 25795 64111538
Hypoglycaemia 73.17 9.79 258 361141 89634 64047699
Tendonitis 73.04 9.79 265 361134 20017 64117316
Tongue disorder 72.78 9.79 189 361210 11891 64125442
Orthostatic hypotension 72.64 9.79 93 361306 46645 64090688
Wrong technique in product usage process 72.58 9.79 160 361239 64814 64072519
Abdominal pain 71.65 9.79 2273 359126 310102 63827231
Ankylosing spondylitis 70.66 9.79 148 361251 8086 64129247
Intentional product misuse 70.31 9.79 666 360733 71629 64065704
Night sweats 69.97 9.79 392 361007 35654 64101679
Hypoaldosteronism 69.67 9.79 35 361364 296 64137037
Oxygen saturation decreased 69.51 9.79 336 361063 106840 64030493
Transplant rejection 69.51 9.79 8 361391 17393 64119940
Pulmonary arterial hypertension 68.67 9.79 28 361371 25339 64111994
Neuropathy peripheral 68.60 9.79 382 361017 117143 64020190
Pneumocystis jirovecii pneumonia 66.34 9.79 36 361363 27598 64109735
Pulmonary hypertension 65.85 9.79 87 361312 43052 64094281
Anaemia 65.83 9.79 1617 359782 377063 63760270
Anti-cyclic citrullinated peptide antibody positive 65.44 9.79 489 360910 49073 64088260
Peptic ulcer 65.41 9.79 112 361287 5251 64132082
Chronic obstructive pulmonary disease 64.70 9.79 194 361205 70854 64066479
Swelling 64.37 9.79 1258 360141 158960 63978373
Medication overuse headache 63.34 9.79 43 361356 667 64136666
Gallbladder injury 63.11 9.79 52 361347 1096 64136237
Acute myeloid leukaemia 62.75 9.79 38 361361 27425 64109908
Haematochezia 62.35 9.79 607 360792 65766 64071567
Pleural effusion 62.15 9.79 434 360965 126125 64011208
Graft versus host disease 61.55 9.79 4 361395 13809 64123524
Gastric ulcer haemorrhage 61.48 9.79 139 361260 8004 64129329
Drug ineffective 61.21 9.79 3974 357425 836273 63301060
Red blood cell sedimentation rate abnormal 59.25 9.79 10 361389 16296 64121037
Myelodysplastic syndrome 59.15 9.79 41 361358 27538 64109795
Lemierre syndrome 59.11 9.79 23 361376 96 64137237
Herpes zoster 58.77 9.79 236 361163 78951 64058382
Acute generalised exanthematous pustulosis 58.75 9.79 193 361206 13865 64123468
Rash 58.19 9.79 3133 358266 455416 63681917
Bronchopulmonary aspergillosis 56.87 9.79 18 361381 19067 64118266
Anhedonia 56.23 9.79 187 361212 13519 64123814
Pharyngeal abscess 56.05 9.79 38 361361 588 64136745
Neurotoxicity 55.84 9.79 43 361356 27361 64109972
Headache 55.48 9.79 3556 357843 525911 63611422
Pneumonia aspiration 55.30 9.79 160 361239 59111 64078222
Hypoxia 55.06 9.79 280 361119 87869 64049464
Swelling face 55.04 9.79 540 360859 58626 64078707
Peripheral swelling 54.40 9.79 1546 359853 207607 63929726
Faeces discoloured 54.11 9.79 286 361113 25443 64111890
Brain empyema 53.70 9.79 14 361385 6 64137327
Abdominal pain lower 53.48 9.79 291 361108 26178 64111155
Diabetes mellitus 53.28 9.79 192 361207 66282 64071051
Deafness transitory 53.20 9.79 41 361358 782 64136551
Respiratory disorder 52.71 9.79 365 361034 35746 64101587
Osteoporosis 52.65 9.79 97 361302 41983 64095350
Gastrointestinal pain 52.48 9.79 125 361274 7449 64129884
Nasal disorder 51.74 9.79 72 361327 2812 64134521
Hyponatraemia 51.33 9.79 557 360842 147782 63989551
Blood pressure increased 51.24 9.79 670 360729 171882 63965451
Bradycardia 50.67 9.79 421 360978 117798 64019535
Product prescribing error 50.60 9.79 355 361044 34914 64102419
Body temperature increased 50.25 9.79 365 361034 36301 64101032
Product use in unapproved indication 50.19 9.79 692 360707 175926 63961407
Right ventricular failure 50.06 9.79 29 361370 21442 64115891
Heavy menstrual bleeding 49.75 9.79 165 361234 11912 64125421
Multiple organ dysfunction syndrome 49.67 9.79 348 361051 101065 64036268
Febrile bone marrow aplasia 48.04 9.79 4 361395 11251 64126082
Laryngeal dyspnoea 47.25 9.79 25 361374 238 64137095
Red blood cell sedimentation rate 47.20 9.79 79 361320 3635 64133698
Oesophageal obstruction 46.92 9.79 38 361361 781 64136552
Medical device discomfort 46.24 9.79 50 361349 1499 64135834
Mucosal inflammation 46.13 9.79 187 361212 62397 64074936
Cytokine release syndrome 45.97 9.79 30 361369 20799 64116534
Cytomegalovirus viraemia 45.80 9.79 4 361395 10824 64126509
Tumour lysis syndrome 45.69 9.79 26 361373 19414 64117919
Glossodynia 45.67 9.79 559 360840 64137 64073196
Bezoar 45.65 9.79 59 361340 2144 64135189
Hypotension 45.39 9.79 1711 359688 379263 63758070
Cytopenia 45.38 9.79 15 361384 15456 64121877
Haematotoxicity 44.52 9.79 9 361390 12887 64124446
Device related infection 44.50 9.79 64 361335 30562 64106771
Cerebral infarction 44.27 9.79 103 361296 40941 64096392
Pelvic pain 44.00 9.79 148 361251 10762 64126571
Neuroleptic malignant syndrome 43.98 9.79 45 361354 24951 64112382
Embedded device 43.94 9.79 65 361334 2687 64134646
Heart rate decreased 43.51 9.79 160 361239 54907 64082426
Haemoglobin decreased 43.46 9.79 800 360599 194263 63943070
Dementia 43.06 9.79 32 361367 20734 64116599
Cardiac disorder 42.91 9.79 164 361235 55652 64081681
Stomatitis 42.79 9.79 857 360542 108748 64028585
Alanine aminotransferase abnormal 42.77 9.79 109 361290 6779 64130554
Leukopenia 42.72 9.79 362 361037 100880 64036453
Encephalopathy 42.57 9.79 177 361222 58642 64078691
Post transplant lymphoproliferative disorder 41.84 9.79 3 361396 9541 64127792
Kidney transplant rejection 41.66 9.79 3 361396 9508 64127825
Coronavirus infection 41.31 9.79 94 361305 5436 64131897
Synovitis 41.12 9.79 782 360617 98308 64039025
Pathogen resistance 40.79 9.79 10 361389 12533 64124800
Pulmonary oedema 39.99 9.79 267 361132 78407 64058926
Urinary tract infection 39.62 9.79 991 360408 230605 63906728
Posterior reversible encephalopathy syndrome 39.59 9.79 42 361357 22904 64114429
Dermo-hypodermitis 39.52 9.79 29 361370 512 64136821
Blood glucose increased 39.46 9.79 355 361044 97718 64039615
Drug-induced liver injury 39.16 9.79 424 360975 47219 64090114
Nasopharyngitis 38.86 9.79 1403 359996 194670 63942663
Periorbital oedema 38.66 9.79 110 361289 7304 64130029
Poisoning 38.60 9.79 232 361167 21647 64115686
Bone erosion 38.18 9.79 9 361390 11586 64125747
Ulcer 38.17 9.79 240 361159 22750 64114583
Cerebral haemorrhage 38.07 9.79 152 361247 50938 64086395
Arthropathy 38.05 9.79 917 360482 120050 64017283
Red blood cell count decreased 37.96 9.79 141 361258 48245 64089088
Productive cough 37.43 9.79 248 361151 72955 64064378
Hypocalcaemia 37.30 9.79 115 361284 41638 64095695
Dyspnoea exertional 37.09 9.79 251 361148 73479 64063854
Aspergillus infection 36.95 9.79 23 361376 16356 64120977
Obstruction gastric 36.87 9.79 43 361356 1403 64135930
Pulmonary embolism 36.70 9.79 1077 360322 145279 63992054
Renal cortical necrosis 36.60 9.79 22 361377 273 64137060
Blood pressure decreased 36.46 9.79 308 361091 85891 64051442
Genital haemorrhage 35.98 9.79 89 361310 5433 64131900
Jejunal ulcer 35.90 9.79 19 361380 181 64137152
Bronchitis 35.76 9.79 413 360986 108330 64029003
Renal tubular necrosis 35.59 9.79 229 361170 21881 64115452
Cardiac failure acute 35.45 9.79 24 361375 16320 64121013
Conjunctivitis 35.38 9.79 215 361184 20139 64117194
Hypertensive emergency 35.26 9.79 53 361346 2223 64135110
COVID-19 35.19 9.79 217 361182 64923 64072410
Multiple sclerosis relapse 35.17 9.79 369 361030 40766 64096567
Beta haemolytic streptococcal infection 35.06 9.79 48 361351 1846 64135487
Pulmonary infarction 35.05 9.79 64 361335 3158 64134175
Arthralgia 34.61 9.79 2902 358497 439358 63697975
Coma scale abnormal 34.54 9.79 109 361290 7665 64129668
Cataract 34.22 9.79 159 361240 51103 64086230
Diffuse large B-cell lymphoma 34.20 9.79 8 361391 10353 64126980
Duodenitis 34.17 9.79 99 361300 6642 64130691
Sedation complication 34.17 9.79 8 361391 10346 64126987
Disease recurrence 34.04 9.79 79 361320 31431 64105902
Nasal obstruction 33.97 9.79 40 361359 1319 64136014
Discoloured vomit 33.93 9.79 37 361362 1120 64136213
Product dose omission issue 33.93 9.79 831 360568 193916 63943417
Tropical infectious disease 33.85 9.79 12 361387 36 64137297
Hyperglycaemia 33.51 9.79 202 361197 60766 64076567
Myelosuppression 33.45 9.79 51 361348 23779 64113554
Blood pressure fluctuation 33.40 9.79 163 361236 51708 64085625
SJS-TEN overlap 33.38 9.79 25 361374 456 64136877
Erythema multiforme 33.34 9.79 175 361224 15526 64121807
Erosive duodenitis 33.31 9.79 44 361355 1634 64135699
Mucocutaneous disorder 33.25 9.79 16 361383 122 64137211
Biliary colic 33.24 9.79 65 361334 3379 64133954
Progressive multifocal leukoencephalopathy 33.02 9.79 32 361367 18200 64119133
Photophobia 32.85 9.79 187 361212 17106 64120227
Bacteraemia 32.82 9.79 63 361336 26848 64110485
Pemphigus 32.81 9.79 500 360899 60201 64077132
Jejunal ulcer perforation 32.49 9.79 15 361384 103 64137230
Serotonin syndrome 32.45 9.79 112 361287 39170 64098163
Gastric perforation 32.21 9.79 65 361334 3458 64133875
Obstructive airways disorder 32.18 9.79 50 361349 23135 64114198
Transfusion 32.11 9.79 32 361367 17962 64119371
Torsade de pointes 32 9.79 30 361369 17333 64120000
Gallbladder cholesterolosis 32.00 9.79 26 361373 537 64136796
Liver disorder 31.89 9.79 172 361227 53179 64084154
Full blood count abnormal 31.83 9.79 75 361324 29682 64107651
Intestinal obstruction 31.67 9.79 101 361298 36185 64101148
Rheumatoid arthritis 31.67 9.79 1172 360227 163122 63974211
Hand deformity 31.26 9.79 510 360889 62261 64075072
Conjunctival hyperaemia 31.06 9.79 68 361331 3831 64133502
Metastases to liver 31.02 9.79 54 361345 23887 64113446
Distichiasis 30.99 9.79 8 361391 3 64137330
Cystitis haemorrhagic 30.94 9.79 4 361395 7952 64129381
Medical device pain 30.77 9.79 38 361361 1318 64136015
Pain in jaw 30.52 9.79 121 361278 40634 64096699
Femur fracture 30.50 9.79 94 361305 34041 64103292
Musculoskeletal stiffness 30.43 9.79 905 360494 122301 64015032
Laryngeal discomfort 30.39 9.79 24 361375 475 64136858
Hypothermia 30.35 9.79 203 361196 19653 64117680
Malaise 30.25 9.79 1865 359534 394382 63742951
Laryngeal oedema 30.03 9.79 98 361301 7015 64130318
Premature delivery 29.92 9.79 36 361363 18553 64118780
Hepatitis B 29.86 9.79 4 361395 7741 64129592
Cholecystectomy 29.82 9.79 106 361293 7926 64129407
Back pain 29.62 9.79 1699 359700 248472 63888861
Treatment failure 29.59 9.79 468 360931 116348 64020985
Cross sensitivity reaction 29.45 9.79 61 361338 3306 64134027
Constipation 29.30 9.79 1021 360378 228316 63909017
Throat tightness 29.16 9.79 226 361173 22934 64114399
Hepatitis acute 28.96 9.79 150 361249 13239 64124094
Blood parathyroid hormone decreased 28.89 9.79 99 361300 7267 64130066
Epilepsy 28.80 9.79 94 361305 33437 64103896
Hepatocellular carcinoma 28.73 9.79 6 361393 8397 64128936
Parkinsonism 28.72 9.79 23 361376 14350 64122983
International normalised ratio increased 28.69 9.79 294 361105 78873 64058460
Aplasia pure red cell 28.59 9.79 3 361396 7011 64130322
Migraine 28.57 9.79 502 360897 62175 64075158
Corneal leukoma 28.53 9.79 8 361391 7 64137326
Therapeutic product effect decreased 28.41 9.79 847 360552 114504 64022829
Serum sickness-like reaction 28.34 9.79 24 361375 526 64136807
Toxic shock syndrome streptococcal 28.31 9.79 13 361386 88 64137245
Acute lung injury 28.15 9.79 53 361346 2678 64134655
Milk-alkali syndrome 27.99 9.79 34 361365 1159 64136174
Helicobacter test positive 27.98 9.79 32 361367 1022 64136311
Cerebrovascular accident 27.67 9.79 574 360825 137009 64000324
Depression 27.65 9.79 1274 360125 182017 63955316
Eosinophilic oesophagitis 27.58 9.79 22 361377 442 64136891
Medication error 27.56 9.79 413 360986 49553 64087780
Rheumatoid nodule 27.55 9.79 142 361257 12509 64124824
Flank pain 27.50 9.79 170 361229 16019 64121314
Allergic respiratory disease 27.36 9.79 11 361388 51 64137282
Open globe injury 27.33 9.79 12 361387 72 64137261
Musculoskeletal disorder 27.33 9.79 183 361216 17723 64119610
Eye swelling 27.27 9.79 216 361183 22065 64115268
Pelvic venous thrombosis 27.06 9.79 41 361358 1732 64135601
Catatonia 26.98 9.79 5 361394 7615 64129718
Second primary malignancy 26.91 9.79 18 361381 12319 64125014
Blood magnesium decreased 26.86 9.79 23 361376 13882 64123451
Abdominal discomfort 26.59 9.79 1263 360136 181059 63956274
Bronchiectasis 26.57 9.79 24 361375 14116 64123217
Clostridium difficile colitis 26.49 9.79 72 361327 27151 64110182
Oedema peripheral 26.47 9.79 938 360461 209379 63927954
Neutropenic sepsis 26.24 9.79 57 361342 23215 64114118
Foreign body in gastrointestinal tract 26.22 9.79 11 361388 58 64137275
Peritonitis bacterial 26.12 9.79 9 361390 9034 64128299
Coma 26.00 9.79 659 360740 86956 64050377
Gastritis haemorrhagic 25.97 9.79 46 361353 2216 64135117
Hunger 25.81 9.79 67 361332 4214 64133119
Blood creatine phosphokinase increased 25.78 9.79 207 361192 58351 64078982
Blood pressure systolic increased 25.55 9.79 167 361232 49286 64088047
Scar 25.53 9.79 145 361254 13253 64124080
Congestive cardiomyopathy 25.53 9.79 13 361386 10331 64127002
Ventricular tachycardia 25.49 9.79 102 361297 34163 64103170
General physical health deterioration 25.49 9.79 1395 360004 203030 63934303
Pericardial effusion 25.47 9.79 123 361276 39131 64098202
Lung neoplasm malignant 25.47 9.79 51 361348 21397 64115936
Panniculitis 25.47 9.79 108 361291 8771 64128562
Cholesterosis 25.40 9.79 19 361380 346 64136987
Pneumonia fungal 25.36 9.79 9 361390 8868 64128465
Liver injury 25.35 9.79 268 361131 29664 64107669
Hypogammaglobulinaemia 25.33 9.79 13 361386 10286 64127047
Atrioventricular block complete 25.31 9.79 26 361373 14392 64122941
Electrocardiogram QT prolonged 25.24 9.79 304 361095 79144 64058189
Genital odour 25.14 9.79 6 361393 0 64137333
Cardiogenic shock 25.10 9.79 95 361304 32332 64105001
Granuloma skin 25.03 9.79 83 361316 5991 64131342
Pregnancy with contraceptive device 24.88 9.79 55 361344 3119 64134214
Systemic lupus erythematosus rash 24.71 9.79 35 361364 1390 64135943
Extrapyramidal disorder 24.52 9.79 45 361354 19507 64117826
Hepatic cirrhosis 24.52 9.79 71 361328 26227 64111106
Cough 24.29 9.79 1415 359984 300733 63836600
Nausea 24.24 9.79 4870 356529 780930 63356403
Immunodeficiency 24.12 9.79 33 361366 16091 64121242
Pneumonitis 24.08 9.79 174 361225 50191 64087142
Psychological trauma 23.98 9.79 32 361367 1200 64136133
Metastases to bone 23.92 9.79 49 361350 20386 64116947
Insomnia 23.87 9.79 1346 360053 196490 63940843
Subdural haematoma 23.85 9.79 79 361320 27975 64109358
Delirium 23.84 9.79 260 361139 68934 64068399
Erosive oesophagitis 23.73 9.79 48 361351 2558 64134775
Aplasia 23.70 9.79 5 361394 6948 64130385
Hyperkalaemia 23.69 9.79 411 360988 100718 64036615
Disseminated intravascular coagulation 23.62 9.79 97 361302 32251 64105082
Dehydration 23.49 9.79 984 360415 215779 63921554
Neoplasm progression 23.42 9.79 134 361265 40830 64096503
Myoclonus 23.28 9.79 68 361331 25050 64112283
Tonsillar erythema 23.18 9.79 7 361392 10 64137323
Intentional product use issue 23.17 9.79 385 361014 94979 64042354
Dyskinesia 22.98 9.79 128 361271 39260 64098073
Cerebral venous sinus thrombosis 22.97 9.79 39 361360 1816 64135517
Unevaluable event 22.91 9.79 177 361222 50312 64087021
Dyspareunia 22.85 9.79 38 361361 1739 64135594
Mast cell activation syndrome 22.85 9.79 18 361381 355 64136978
Multiple sclerosis 22.84 9.79 183 361216 18758 64118575
Allergy test negative 22.78 9.79 7 361392 11 64137322
Paraesthesia 22.71 9.79 946 360453 133576 64003757
Sleep disorder 22.67 9.79 465 360934 59244 64078089
Epistaxis 22.61 9.79 400 360999 97731 64039602
Acute pulmonary oedema 22.60 9.79 23 361376 12786 64124547
Diabetes mellitus inadequate control 22.59 9.79 54 361345 21267 64116066
Hip fracture 22.56 9.79 77 361322 27022 64110311
Swollen tongue 22.53 9.79 297 361102 34657 64102676
Full blood count decreased 22.52 9.79 59 361340 22523 64114810
Hemiplegia 22.45 9.79 23 361376 12745 64124588
Meningitis pneumococcal 22.43 9.79 18 361381 365 64136968
Wound 22.33 9.79 574 360825 75903 64061430
Therapeutic response decreased 22.28 9.79 186 361213 52002 64085331
Infertility female 22.27 9.79 19 361380 421 64136912
Tendon disorder 22.18 9.79 82 361317 6250 64131083
Dental operation 22.12 9.79 27 361372 925 64136408
Thrombotic microangiopathy 22.10 9.79 37 361362 16618 64120715
Genital tract inflammation 22.09 9.79 8 361391 26 64137307
Creatinine renal clearance decreased 22.09 9.79 29 361370 14392 64122941
Coronary arterial stent insertion 21.80 9.79 3 361396 5689 64131644
Decreased appetite 21.78 9.79 1322 360077 279967 63857366
Pseudomonas infection 21.69 9.79 42 361357 17841 64119492
Dysmenorrhoea 21.56 9.79 45 361354 2452 64134881
Pulmonary mass 21.55 9.79 66 361333 23950 64113383
Gallbladder hypofunction 21.46 9.79 19 361380 443 64136890
Contraindicated product administered 21.44 9.79 772 360627 107057 64030276
Cardiac failure chronic 21.38 9.79 12 361387 9029 64128304
Frequent bowel movements 21.33 9.79 44 361355 18261 64119072
Epiglottic oedema 21.28 9.79 15 361384 248 64137085
Cushingoid 21.22 9.79 8 361391 7595 64129738
Head discomfort 21.20 9.79 126 361273 11708 64125625
Drug interaction 21.11 9.79 1744 359655 360339 63776994
Systemic lupus erythematosus 21.07 9.79 577 360822 77035 64060298
Contusion 20.99 9.79 809 360590 113156 64024177
Oesophagitis haemorrhagic 20.95 9.79 21 361378 575 64136758
Viral parotitis 20.95 9.79 5 361394 0 64137333
Pulmonary fibrosis 20.95 9.79 91 361308 29787 64107546
Psychotic disorder 20.93 9.79 111 361288 34467 64102866
Internal injury 20.88 9.79 17 361382 352 64136981
Diabetic ketoacidosis 20.86 9.79 91 361308 29754 64107579
Staphylococcal sepsis 20.74 9.79 25 361374 12874 64124459
Embolism arterial 20.65 9.79 30 361369 1220 64136113
Thyroid disorder 20.62 9.79 21 361378 11671 64125662
Dystonia 20.62 9.79 47 361352 18818 64118515
Pneumonia viral 20.58 9.79 9 361390 7813 64129520
Staphylococcal infection 20.57 9.79 183 361216 50495 64086838
Peripheral sensory neuropathy 20.57 9.79 20 361379 11358 64125975
Respiratory tract infection 20.52 9.79 124 361275 37283 64100050
Genital pain 20.46 9.79 18 361381 416 64136917
Peptic ulcer perforation 20.45 9.79 17 361382 363 64136970
Underdose 20.43 9.79 75 361324 25754 64111579
Perforated ulcer 20.40 9.79 21 361378 594 64136739
Muscle rigidity 20.36 9.79 42 361357 17431 64119902
Urosepsis 20.35 9.79 60 361339 22034 64115299
Vulval ulceration 20.31 9.79 12 361387 144 64137189
Intervertebral disc disorder 20.27 9.79 63 361336 4394 64132939
Uterine leiomyoma 20.05 9.79 71 361328 5298 64132035
Injection site pain 20.04 9.79 473 360926 110935 64026398
Poor venous access 20.03 9.79 24 361375 12393 64124940
Acute respiratory failure 19.97 9.79 181 361218 49753 64087580
Systemic candida 19.97 9.79 3 361396 5326 64132007
Procedural pain 19.90 9.79 152 361247 15356 64121977
Escherichia infection 19.84 9.79 34 361365 15134 64122199
Jaundice 19.82 9.79 382 361017 48130 64089203
Haemorrhage intracranial 19.79 9.79 68 361331 23816 64113517
Candida infection 19.50 9.79 100 361299 31319 64106014
Hyperventilation 19.46 9.79 83 361316 6757 64130576
Mallory-Weiss syndrome 19.40 9.79 44 361355 2539 64134794
Foot operation 19.39 9.79 60 361339 4175 64133158
Metastases to lung 19.26 9.79 35 361364 15229 64122104
Bunion operation 19.26 9.79 23 361376 770 64136563
Toxic encephalopathy 19.24 9.79 16 361383 9799 64127534
Shoulder arthroplasty 19.08 9.79 45 361354 2664 64134669
Sacroiliitis 19.05 9.79 48 361351 2964 64134369
Bladder cancer 19.03 9.79 20 361379 10954 64126379
Hepatitis cholestatic 19.02 9.79 125 361274 12030 64125303
Protein-losing gastroenteropathy 18.91 9.79 19 361380 522 64136811
Tinnitus 18.77 9.79 282 361117 33851 64103482
Left ventricular failure 18.74 9.79 12 361387 8405 64128928
Gastritis bacterial 18.70 9.79 15 361384 304 64137029
Cardiotoxicity 18.64 9.79 18 361381 10256 64127077
Prepyloric stenosis 18.62 9.79 5 361394 3 64137330
Anhidrosis 18.54 9.79 13 361386 213 64137120
Head injury 18.47 9.79 108 361291 32734 64104599
Chromaturia 18.47 9.79 201 361198 22410 64114923
Duodenal stenosis 18.45 9.79 21 361378 667 64136666
Poisoning deliberate 18.45 9.79 134 361265 13324 64124009
Duodenal ulcer repair 18.45 9.79 9 361390 71 64137262
Trichiasis 18.45 9.79 9 361390 71 64137262
Gastrointestinal ulcer 18.41 9.79 48 361351 3027 64134306
Pneumonia streptococcal 18.41 9.79 41 361358 2337 64134996
Fear of disease 18.38 9.79 24 361375 881 64136452
Acidosis 18.33 9.79 166 361233 17629 64119704
Atrial flutter 18.31 9.79 52 361347 19328 64118005
Rales 18.27 9.79 36 361363 15193 64122140
Stress cardiomyopathy 18.26 9.79 15 361384 9242 64128091
Ischaemic stroke 18.25 9.79 92 361307 28943 64108390
Weight decreased 18.24 9.79 1366 360033 284373 63852960
Oropharyngeal blistering 18.21 9.79 21 361378 677 64136656
Duodenal obstruction 18.08 9.79 16 361383 373 64136960
Pulmonary tuberculosis 18.03 9.79 9 361390 7235 64130098
Prescribed underdose 18.02 9.79 47 361352 17968 64119365
Dactylitis 18.01 9.79 36 361363 1902 64135431
Dyspepsia 17.99 9.79 583 360816 79729 64057604
Infection 17.89 9.79 1234 360165 183646 63953687
Fear of injection 17.81 9.79 73 361326 5839 64131494
Food refusal 17.80 9.79 17 361382 438 64136895
Chemical burn 17.74 9.79 17 361382 440 64136893
Sinus node dysfunction 17.74 9.79 8 361391 6820 64130513
Blood glucose decreased 17.73 9.79 68 361331 23055 64114278
Anoxia 17.67 9.79 15 361384 330 64137003
Glaucoma 17.65 9.79 41 361358 16307 64121026
Cervicobrachial syndrome 17.63 9.79 25 361374 994 64136339
Malnutrition 17.57 9.79 52 361347 19073 64118260
Functional gastrointestinal disorder 17.52 9.79 57 361342 4074 64133259
Hepatic cancer 17.45 9.79 10 361389 7438 64129895
Muscle swelling 17.45 9.79 21 361378 709 64136624
Skin cancer 17.42 9.79 25 361374 11949 64125384
Macrophages increased 17.31 9.79 12 361387 193 64137140
Nocardiosis 17.15 9.79 3 361396 4764 64132569
Rash maculo-papular 17.12 9.79 364 361035 46662 64090671
Needle issue 17.11 9.79 16 361383 9256 64128077
Necrotising fasciitis 17.03 9.79 67 361332 5259 64132074
Myopathy 17.02 9.79 47 361352 17633 64119700
Pasteurella infection 16.98 9.79 7 361392 35 64137298
Kidney enlargement 16.94 9.79 25 361374 1031 64136302
Device malfunction 16.89 9.79 47 361352 17586 64119747
Leukoencephalopathy 16.83 9.79 9 361390 6958 64130375
Device leakage 16.80 9.79 13 361386 8253 64129080
Muscle tone disorder 16.78 9.79 10 361389 122 64137211
Shoulder injury related to vaccine administration 16.76 9.79 4 361395 0 64137333
Salivary gland cyst 16.76 9.79 4 361395 0 64137333
Lymphoproliferative disorder 16.73 9.79 4 361395 5099 64132234
Tobacco abuse 16.72 9.79 22 361377 814 64136519
Infection masked 16.71 9.79 10 361389 123 64137210
Xyphoid retraction 16.69 9.79 11 361388 162 64137171
Glycosylated haemoglobin increased 16.64 9.79 41 361358 15978 64121355
Gastric mucosa erythema 16.59 9.79 15 361384 360 64136973
B-cell lymphoma 16.52 9.79 5 361394 5452 64131881
Allergy test positive 16.51 9.79 16 361383 420 64136913
Suicidal ideation 16.48 9.79 489 360910 66053 64071280
Eosinophil count increased 16.38 9.79 34 361365 14078 64123255
Ejection fraction decreased 16.36 9.79 94 361305 28613 64108720
Hepatic necrosis 16.34 9.79 92 361307 8381 64128952
Nodule 16.34 9.79 49 361350 17898 64119435
Epstein-Barr virus infection 16.33 9.79 28 361371 12460 64124873
Therapeutic product effect incomplete 16.30 9.79 448 360951 103034 64034299
Electrocardiogram QRS complex prolonged 16.29 9.79 98 361301 9146 64128187
Organising pneumonia 16.27 9.79 16 361383 9039 64128294
Sedation 16.27 9.79 151 361248 41311 64096022
Ceruloplasmin decreased 16.23 9.79 6 361393 21 64137312
Rash pruritic 16.22 9.79 429 360970 56975 64080358
Oral mucosa erosion 16.21 9.79 32 361367 1675 64135658
Psoriasis 16.18 9.79 521 360878 71182 64066151
Device occlusion 16.16 9.79 19 361380 9894 64127439
Oral pruritus 16.14 9.79 33 361366 1772 64135561
Cardiomyopathy 16.13 9.79 80 361319 25276 64112057
Abdominal tenderness 16.13 9.79 99 361300 9306 64128027
Endophthalmitis 16.09 9.79 5 361394 5360 64131973
Injection site extravasation 16.08 9.79 13 361386 8073 64129260
Psychogenic tremor 16.02 9.79 6 361393 22 64137311
Pruritus genital 15.94 9.79 24 361375 1008 64136325
Benign familial pemphigus 15.85 9.79 5 361394 9 64137324
Respiratory tract oedema 15.83 9.79 20 361379 710 64136623
Meningoencephalitis bacterial 15.81 9.79 11 361388 178 64137155
Food intolerance 15.79 9.79 43 361356 2783 64134550
Febrile convulsion 15.61 9.79 21 361378 794 64136539
Superficial vein prominence 15.60 9.79 8 361391 71 64137262
Pharyngeal erythema 15.54 9.79 32 361367 1727 64135606
Pulmonary alveolar haemorrhage 15.52 9.79 19 361380 9719 64127614
Pneumatosis intestinalis 15.46 9.79 5 361394 5224 64132109
Fusobacterium infection 15.45 9.79 9 361390 105 64137228
Lung disorder 15.43 9.79 243 361156 60457 64076876
Listless 15.42 9.79 47 361352 3243 64134090
Dermatitis bullous 15.38 9.79 118 361281 11936 64125397
Necrosis ischaemic 15.38 9.79 23 361376 960 64136373
Colon cancer 15.38 9.79 30 361369 12709 64124624
Neutrophil Pelger-Huet anomaly present 15.38 9.79 14 361385 339 64136994
Enzyme induction 15.38 9.79 9 361390 106 64137227
Spondylitis 15.33 9.79 45 361354 3041 64134292
Glomerulonephropathy 15.27 9.79 13 361386 287 64137046
Adenovirus infection 15.27 9.79 11 361388 7244 64130089
Blood copper decreased 15.20 9.79 5 361394 11 64137322
Bradypnoea 15.13 9.79 5 361394 5154 64132179
Food craving 15.13 9.79 28 361371 1396 64135937
Exposure during pregnancy 15.04 9.79 326 361073 77349 64059984
Accidental overdose 15.02 9.79 268 361131 33289 64104044
Asthenia 15.01 9.79 2136 359263 425908 63711425
Tremor 14.99 9.79 678 360721 147552 63989781
Inappropriate schedule of product administration 14.93 9.79 398 361001 91888 64045445
Tympanic membrane hyperaemia 14.90 9.79 5 361394 12 64137321
Portal vein phlebitis 14.90 9.79 5 361394 12 64137321
Type I hypersensitivity 14.87 9.79 49 361350 3525 64133808
Necrotising soft tissue infection 14.86 9.79 11 361388 197 64137136
Rash macular 14.75 9.79 200 361199 23485 64113848
Secondary amyloidosis 14.68 9.79 9 361390 116 64137217
Therapy interrupted 14.68 9.79 60 361339 19976 64117357
Klebsiella infection 14.58 9.79 33 361366 13248 64124085
Angular cheilitis 14.58 9.79 16 361383 488 64136845
Infected dermal cyst 14.55 9.79 20 361379 772 64136561
Fear 14.54 9.79 175 361224 19996 64117337
Drug withdrawal headache 14.53 9.79 8 361391 83 64137250
Pemphigoid 14.48 9.79 32 361367 12954 64124379
Hyperacusis 14.46 9.79 33 361366 1912 64135421
Blood potassium increased 14.31 9.79 86 361313 25894 64111439
Aortic bruit 14.18 9.79 11 361388 212 64137121
Duodenitis haemorrhagic 14.17 9.79 9 361390 124 64137209
Pyrexia 14.10 9.79 2839 358560 555805 63581528
Vulvovaginitis trichomonal 14.10 9.79 5 361394 15 64137318
Superior sagittal sinus thrombosis 14.09 9.79 22 361377 954 64136379
Hyperammonaemia 14.09 9.79 21 361378 9883 64127450
Accidental exposure to product by child 14.08 9.79 38 361361 2447 64134886
Burn oral cavity 14.06 9.79 7 361392 58 64137275
Blood bilirubin unconjugated 14.01 9.79 4 361395 4 64137329
Swelling of eyelid 13.94 9.79 35 361364 2157 64135176
Pneumoperitoneum 13.92 9.79 40 361359 2671 64134662
Lung transplant 13.91 9.79 3 361396 4105 64133228
Product storage error 13.90 9.79 34 361365 13284 64124049
Asphyxia 13.89 9.79 20 361379 9546 64127787
Alveolar rhabdomyosarcoma 13.86 9.79 5 361394 16 64137317
Brain death 13.84 9.79 59 361340 4802 64132531
Balance disorder 13.82 9.79 361 361038 83565 64053768
Renal disorder 13.79 9.79 129 361270 35236 64102097
Staphylococcal bacteraemia 13.74 9.79 23 361376 10332 64127001
Generalised oedema 13.73 9.79 65 361334 20788 64116545
Pneumonia bacterial 13.72 9.79 41 361358 14994 64122339
Rhabdomyolysis 13.71 9.79 400 360999 91326 64046007
Spinal compression fracture 13.69 9.79 40 361359 14735 64122598
Immune reconstitution inflammatory syndrome 13.68 9.79 31 361368 12439 64124894
Complication of device removal 13.68 9.79 45 361354 3235 64134098
Escherichia sepsis 13.66 9.79 12 361387 7153 64130180
Lymphopenia 13.58 9.79 86 361313 25571 64111762
Scleroderma 13.57 9.79 5 361394 4813 64132520
Sebaceous gland disorder 13.53 9.79 6 361393 37 64137296
Bacterial infection 13.53 9.79 83 361316 24867 64112466
Abscess rupture 13.48 9.79 12 361387 282 64137051
Phonophobia 13.47 9.79 15 361384 465 64136868
Transverse sinus thrombosis 13.47 9.79 17 361382 603 64136730
Lymphoma 13.47 9.79 37 361362 13904 64123429
Otitis media acute 13.36 9.79 23 361376 1083 64136250
Angiocardiogram 13.34 9.79 11 361388 232 64137101
Pulmonary function test decreased 13.34 9.79 10 361389 6451 64130882
Mucosal necrosis 13.33 9.79 8 361391 99 64137234
Conjunctival erosion 13.33 9.79 8 361391 99 64137234
Erythema nodosum 13.32 9.79 51 361348 3953 64133380
Large intestine perforation 13.29 9.79 32 361367 12572 64124761
Herbal interaction 13.26 9.79 14 361385 408 64136925
Paradoxical drug reaction 13.25 9.79 9 361390 6111 64131222
Substance dependence 13.22 9.79 15 361384 475 64136858
Condition aggravated 13.22 9.79 1857 359542 370569 63766764
Exposure via partner 13.21 9.79 5 361394 19 64137314
Alpha 1 microglobulin increased 13.20 9.79 7 361392 67 64137266
Sleep disorder due to a general medical condition 13.19 9.79 16 361383 8218 64129115
Hyperuricaemia 13.19 9.79 23 361376 10168 64127165
Brain natriuretic peptide increased 13.14 9.79 14 361385 7619 64129714
Microbiology test abnormal 13.13 9.79 4 361395 6 64137327
Drug level decreased 13.11 9.79 28 361371 11475 64125858
Palmar-plantar erythrodysaesthesia syndrome 13.09 9.79 101 361298 28718 64108615
Nephrolithiasis 13.08 9.79 329 361070 43354 64093979
Tuberculosis 13.05 9.79 34 361365 13004 64124329
Oesophageal ulcer 13.04 9.79 69 361330 6141 64131192
Cephalo-pelvic disproportion 13.02 9.79 9 361390 144 64137189
Visual snow syndrome 13.02 9.79 5 361394 20 64137313
COVID-19 pneumonia 13.00 9.79 48 361351 16456 64120877
Cardiac arrest 13.00 9.79 718 360681 153346 63983987
Vulval disorder 12.99 9.79 15 361384 484 64136849
Pancreatic carcinoma 12.90 9.79 24 361375 10349 64126984
Cardiac pacemaker insertion 12.87 9.79 6 361393 5017 64132316
Necrotising fasciitis streptococcal 12.86 9.79 9 361390 147 64137186
Status asthmaticus 12.85 9.79 21 361378 947 64136386
Device dislocation 12.85 9.79 178 361221 21000 64116333
Cerebellar syndrome 12.84 9.79 6 361393 5010 64132323
Loss of control of legs 12.82 9.79 29 361370 1670 64135663
Hypoglycaemic coma 12.79 9.79 4 361395 4270 64133063
Polymenorrhagia 12.78 9.79 6 361393 43 64137290
Ductus arteriosus stenosis foetal 12.77 9.79 7 361392 72 64137261
Cholecystitis acute 12.75 9.79 108 361291 11252 64126081
Osteomyelitis blastomyces 12.75 9.79 4 361395 7 64137326
Oesophageal discomfort 12.73 9.79 11 361388 248 64137085
Abnormal clotting factor 12.73 9.79 8 361391 108 64137225
Subileus 12.67 9.79 6 361393 4971 64132362
Crying 12.65 9.79 170 361229 19920 64117413
Skin toxicity 12.65 9.79 11 361388 6591 64130742
Exposure to toxic agent 12.63 9.79 68 361331 6091 64131242
Mycoplasma test positive 12.62 9.79 10 361389 199 64137134
Nerve injury 12.62 9.79 80 361319 7605 64129728
Anastomotic ulcer perforation 12.57 9.79 3 361396 0 64137333
Corrosive gastritis 12.57 9.79 3 361396 0 64137333
Oculoauriculovertebral dysplasia 12.57 9.79 3 361396 0 64137333
Vestibular ataxia 12.57 9.79 3 361396 0 64137333
Ultrasound antenatal screen 12.57 9.79 3 361396 0 64137333
Foetal non-stress test 12.57 9.79 3 361396 0 64137333
Enterococcal infection 12.52 9.79 38 361361 13828 64123505
Hepatic enzyme increased 12.51 9.79 867 360532 129076 64008257
Temperature regulation disorder 12.50 9.79 4 361395 4207 64133126
Therapy partial responder 12.49 9.79 24 361375 10224 64127109
Mental disorder 12.48 9.79 213 361186 26232 64111101
Anterior interosseous syndrome 12.47 9.79 5 361394 23 64137310
Strawberry tongue 12.47 9.79 5 361394 23 64137310
Lymphocyte count decreased 12.44 9.79 157 361242 40542 64096791
Mycoplasma infection 12.43 9.79 17 361382 653 64136680
Foreign body reaction 12.42 9.79 8 361391 113 64137220
Small intestinal stenosis 12.41 9.79 17 361382 654 64136679
Monoplegia 12.41 9.79 45 361354 3398 64133935
Grief reaction 12.41 9.79 11 361388 257 64137076
Product used for unknown indication 12.39 9.79 19 361380 811 64136522
Fungaemia 12.34 9.79 3 361396 3782 64133551
Neurosis 12.31 9.79 13 361386 379 64136954
Status epilepticus 12.31 9.79 71 361328 21592 64115741
Cholecystitis 12.30 9.79 166 361233 19470 64117863
Enterocolitis 12.29 9.79 31 361368 11987 64125346
Hepatitis B reactivation 12.28 9.79 6 361393 4883 64132450
Left ventricular dysfunction 12.28 9.79 51 361348 16903 64120430
Hypocoagulable state 12.22 9.79 30 361369 1823 64135510
Tachycardia 12.21 9.79 985 360414 148594 63988739
Blood pressure diastolic decreased 12.19 9.79 74 361325 22227 64115106
Human papilloma virus test positive 12.15 9.79 14 361385 451 64136882
Henoch-Schonlein purpura nephritis 12.13 9.79 5 361394 25 64137308
Ear canal stenosis 12.10 9.79 4 361395 9 64137324
Anion gap 12.07 9.79 30 361369 1837 64135496
Benzodiazepine drug level increased 12.05 9.79 10 361389 213 64137120
Heparin-induced thrombocytopenia 12.04 9.79 18 361381 8461 64128872
Crepitations 12.04 9.79 16 361383 7899 64129434
Glucose tolerance impaired 12.03 9.79 11 361388 6432 64130901
Post cholecystectomy syndrome 12.02 9.79 6 361393 50 64137283
Breath sounds abnormal 12.01 9.79 30 361369 11639 64125694
Acidosis hyperchloraemic 12.00 9.79 17 361382 675 64136658
Menstruation irregular 12.00 9.79 53 361346 4382 64132951
Base excess 11.99 9.79 7 361392 82 64137251
Purpura fulminans 11.98 9.79 9 361390 165 64137168
Pituitary tumour benign 11.94 9.79 34 361365 2259 64135074
Mediastinal abscess 11.92 9.79 6 361393 51 64137282
Symmetrical drug-related intertriginous and flexural exanthema 11.89 9.79 16 361383 605 64136728
Tubulointerstitial nephritis and uveitis syndrome 11.86 9.79 11 361388 273 64137060
Injection site hyperaesthesia 11.82 9.79 6 361393 52 64137281
Kawasaki's disease 11.81 9.79 4 361395 10 64137323
Anti-transglutaminase antibody 11.81 9.79 4 361395 10 64137323
Symblepharon 11.75 9.79 9 361390 170 64137163
Pharyngeal oedema 11.75 9.79 136 361263 15395 64121938
Anti-thyroid antibody positive 11.74 9.79 14 361385 468 64136865
Orthostatic intolerance 11.73 9.79 27 361372 1573 64135760
Product use issue 11.73 9.79 713 360686 151002 63986331
Aortic stenosis 11.73 9.79 11 361388 6354 64130979
Emphysema 11.70 9.79 40 361359 14029 64123304
Uterine pain 11.66 9.79 9 361390 172 64137161
Euglycaemic diabetic ketoacidosis 11.66 9.79 8 361391 5402 64131931
Ileus 11.64 9.79 78 361321 22888 64114445
Facet joint syndrome 11.64 9.79 30 361369 1879 64135454
Haemoptysis 11.59 9.79 199 361200 48849 64088484
Drug screen positive 11.58 9.79 63 361336 5666 64131667
Thyroid stimulating immunoglobulin increased 11.57 9.79 7 361392 88 64137245
Pyloric stenosis 11.55 9.79 13 361386 408 64136925
Speech sound disorder 11.53 9.79 6 361393 55 64137278
Linear IgA disease 11.51 9.79 38 361361 2736 64134597
Pelvic adhesions 11.50 9.79 11 361388 284 64137049
Conjunctival scar 11.50 9.79 7 361392 89 64137244
Genital ulceration 11.46 9.79 16 361383 627 64136706
Lower gastrointestinal haemorrhage 11.43 9.79 124 361275 13815 64123518
Interleukin level increased 11.42 9.79 13 361386 413 64136920
Renal cancer 11.40 9.79 13 361386 6862 64130471
pH body fluid decreased 11.39 9.79 5 361394 30 64137303
Acute haemorrhagic oedema of infancy 11.35 9.79 6 361393 57 64137276
Upper gastrointestinal perforation 11.28 9.79 4 361395 12 64137321
Schizophrenia 11.27 9.79 29 361370 11139 64126194
Human herpesvirus 6 infection 11.26 9.79 6 361393 4648 64132685
Eye disorder 11.21 9.79 158 361241 18711 64118622
Urinary retention 11.19 9.79 201 361198 49000 64088333
Tension headache 11.18 9.79 43 361356 3340 64133993
Skin irritation 11.18 9.79 89 361310 9105 64128228
Mania 11.18 9.79 50 361349 16236 64121097
Prescription drug used without a prescription 11.14 9.79 36 361363 2564 64134769
Blood prolactin increased 11.11 9.79 3 361396 3525 64133808
Inadequate analgesia 11.11 9.79 48 361351 3930 64133403
Intestinal cyst 11.11 9.79 8 361391 137 64137196
Muscle tightness 11.10 9.79 103 361296 11012 64126321
Skin necrosis 11.07 9.79 126 361273 14203 64123130
Gastric cancer 11.07 9.79 12 361387 6481 64130852
Skin papilloma 11.05 9.79 58 361341 5145 64132188
Pathological fracture 11.05 9.79 21 361378 8984 64128349
Normochromic anaemia 11.03 9.79 13 361386 429 64136904
Catheter site haemorrhage 10.99 9.79 6 361393 4585 64132748
Bladder neck obstruction 10.98 9.79 7 361392 97 64137236
Increased upper airway secretion 10.98 9.79 44 361355 3483 64133850
Varicella 10.97 9.79 36 361363 2585 64134748
Tissue infiltration 10.93 9.79 15 361384 578 64136755
Gait deviation 10.92 9.79 6 361393 62 64137271
Osteosclerosis 10.91 9.79 3 361396 3483 64133850
Nasal pruritus 10.88 9.79 12 361387 368 64136965
Antineutrophil cytoplasmic antibody 10.87 9.79 5 361394 34 64137299
Delusion 10.80 9.79 58 361341 17956 64119377
Atrioventricular block 10.80 9.79 33 361366 11982 64125351
Cystitis 10.79 9.79 171 361228 42504 64094829
Device breakage 10.78 9.79 85 361314 8670 64128663
Catheterisation cardiac 10.78 9.79 7 361392 4866 64132467
Complication of device insertion 10.73 9.79 56 361343 4956 64132377
Epiglottitis 10.72 9.79 16 361383 667 64136666
Reaction to excipient 10.65 9.79 24 361375 1379 64135954
Blood test abnormal 10.62 9.79 37 361362 12906 64124427
Myeloma cast nephropathy 10.59 9.79 8 361391 148 64137185
Osteonecrosis 10.57 9.79 104 361295 28125 64109208
Streptococcal infection 10.56 9.79 75 361324 7404 64129929
Cystoscopy abnormal 10.51 9.79 3 361396 3 64137330
Circumoral swelling 10.51 9.79 3 361396 3 64137330
Vertebral artery hypoplasia 10.51 9.79 3 361396 3 64137330
Tongue injury 10.49 9.79 11 361388 318 64137015
Blood calcium decreased 10.49 9.79 92 361307 25462 64111871
Gastrointestinal perforation 10.44 9.79 9 361390 5415 64131918
Wrong patient received product 10.43 9.79 4 361395 3758 64133575
Nuchal rigidity 10.43 9.79 19 361380 936 64136397
Hyperhidrosis 10.42 9.79 824 360575 124096 64013237
Peritonsillitis 10.40 9.79 5 361394 38 64137295
Staphylococcal scalded skin syndrome 10.38 9.79 12 361387 388 64136945
Escherichia bacteraemia 10.36 9.79 9 361390 5394 64131939
Thrombophlebitis septic 10.35 9.79 11 361388 323 64137010
Drug ineffective for unapproved indication 10.32 9.79 118 361281 31015 64106318
Postoperative wound infection 10.31 9.79 27 361372 10309 64127024
Subacute hepatic failure 10.30 9.79 9 361390 206 64137127
Haemorrhoids thrombosed 10.30 9.79 9 361390 206 64137127
Catheter site infection 10.30 9.79 10 361389 5683 64131650
Catheter management 10.29 9.79 3 361396 3352 64133981
Maternal exposure timing unspecified 10.29 9.79 36 361363 2671 64134662
Thrombosis in device 10.28 9.79 8 361391 5063 64132270
Vulvitis 10.27 9.79 9 361390 207 64137126
Hypothyroidism 10.27 9.79 162 361237 40295 64097038
Viral mutation identified 10.25 9.79 3 361396 3343 64133990
Bradykinesia 10.25 9.79 13 361386 6547 64130786
Hypoaesthesia 10.24 9.79 909 360490 138199 63999134
Scleral oedema 10.22 9.79 4 361395 17 64137316
Spinal pain 10.22 9.79 112 361287 12509 64124824
Respiratory fatigue 10.20 9.79 9 361390 209 64137124
Drug eruption 10.19 9.79 270 361129 35866 64101467
Lip erythema 10.19 9.79 8 361391 157 64137176
Basal ganglion degeneration 10.18 9.79 12 361387 396 64136937
Cognitive disorder 10.15 9.79 233 361166 54854 64082479
Xanthelasma 10.15 9.79 8 361391 158 64137175
Pneumonia klebsiella 10.07 9.79 5 361394 4032 64133301
Effusion 10.07 9.79 29 361370 1939 64135394
Akathisia 10.07 9.79 32 361367 11478 64125855
Empyema 10.07 9.79 44 361355 3621 64133712
Thrombosis prophylaxis 10.04 9.79 4 361395 18 64137315
Protein urine present 10.04 9.79 22 361377 8934 64128399
Agranulocytosis 10.03 9.79 283 361116 37946 64099387
Erysipelas 10.02 9.79 86 361313 8995 64128338
Choluria 10.01 9.79 11 361388 336 64136997
Cerebral atrophy 9.84 9.79 16 361383 7269 64130064
Stent placement 9.83 9.79 10 361389 5561 64131772
White blood cell count increased 9.83 9.79 288 361111 65726 64071607
Joint injury 9.82 9.79 182 361217 22765 64114568
Chondromalacia 9.81 9.79 8 361391 166 64137167
Transaminases 9.81 9.79 6 361393 77 64137256
Allodynia 9.80 9.79 22 361377 1261 64136072

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 51.41 25.43 21 702 61 83894
Oliguria 34.00 25.43 9 714 0 83955
Intraventricular haemorrhage 30.61 25.43 18 705 136 83819
Product use in unapproved indication 30.00 25.43 10 713 12 83943
Product use issue 29.41 25.43 16 707 102 83853
Pulmonary arterial hypertension 27.30 25.43 10 713 19 83936

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 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 D018712 Analgesics, Non-Narcotic
MeSH PA D000893 Anti-Inflammatory Agents
MeSH PA D000894 Anti-Inflammatory Agents, Non-Steroidal
MeSH PA D018501 Antirheumatic Agents
MeSH PA D002491 Central Nervous System Agents
MeSH PA D016861 Cyclooxygenase Inhibitors
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D018689 Sensory System Agents
CHEBI has role CHEBI:35475 non-steroidal anti-inflammatory agent
CHEBI has role CHEBI:35493 anti-pyretic
CHEBI has role CHEBI:35703 Xenobiotic
CHEBI has role CHEBI:48578 free radical scavengers
CHEBI has role CHEBI:50629 COX-2 inhibitor
CHEBI has role CHEBI:50630 COX-1 inhibitor
CHEBI has role CHEBI:78298 environmental contaminants
CHEBI has role CHEBI:88188 allergenic drug
CHEBI has role CHEBI:176497 geroprotectors
FDA EPC N0000175722 Nonsteroidal Anti-inflammatory Drug

Drug Use (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




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ 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
25MG;EQ 200MG FREE ACID AND POTASSIUM SALT ADVIL PM GLAXOSMITHKLINE N021393 Dec. 21, 2005 OTC CAPSULE ORAL 8883849 Jan. 17, 2022 A METHOD OF TREATING A PATIENT SUFFERING FROM A PAIN ASSOCIATED SLEEP DISTURBANCE COMPRISING ADMINISTERING A LIQUID COMPOSITION FORMULATED INSIDE A SOFT GEL CAPSULE, AS CLAIMED, TO THE PATIENT
26.6MG;800MG DUEXIS HORIZON N022519 April 23, 2011 RX 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 DUEXIS HORIZON N022519 April 23, 2011 RX 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
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

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
250MG;125MG ADVIL DUAL ACTION WITH ACETAMINOPHEN GLAXOSMITHKLINE N211733 Feb. 28, 2020 OTC TABLET ORAL Feb. 28, 2023 NEW PRODUCT
400MG/4ML (100MG/ML) CALDOLOR CUMBERLAND PHARMS N022348 June 11, 2009 DISCN SOLUTION INTRAVENOUS Nov. 19, 2024 CLINICAL TRIAL STUDY RESULTS
800MG/200ML (4MG/ML) CALDOLOR CUMBERLAND PHARMS N022348 Jan. 25, 2019 RX SOLUTION INTRAVENOUS Nov. 19, 2024 CLINICAL TRIAL STUDY RESULTS
800MG/8ML (100MG/ML) CALDOLOR CUMBERLAND PHARMS N022348 June 11, 2009 RX SOLUTION INTRAVENOUS Nov. 19, 2024 CLINICAL TRIAL STUDY RESULTS

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
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 Unclassified 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
527688-20-6 SECONDARY_CAS_RN
4017840 VANDF
4032936 VANDF
C0020740 UMLSCUI
CHEBI:132922 CHEBI
IBP PDB_CHEM_ID
CHEMBL427526 ChEMBL_ID
CHEMBL521 ChEMBL_ID
DB01050 DRUGBANK_ID
CHEMBL1201141 ChEMBL_ID
CHEMBL175 ChEMBL_ID
D007052 MESH_DESCRIPTOR_UI
3672 PUBCHEM_CID
2118 INN_ID
C016106 MESH_SUPPLEMENTAL_RECORD_UI
2713 IUPHAR_LIGAND_ID
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
CHEMBL3989408 ChEMBL_ID
CHEMBL1241153 ChEMBL_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Ibuprofen and famotidine HUMAN PRESCRIPTION DRUG LABEL 2 0093-8107 TABLET, FILM COATED 800 mg ORAL ANDA 28 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 ibuprofen HUMAN OTC DRUG LABEL 1 0113-0074 TABLET, FILM COATED 200 mg ORAL ANDA 16 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 0113-0517 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
basic care childrens ibuprofen HUMAN OTC DRUG LABEL 1 0113-1461 TABLET, CHEWABLE 100 mg ORAL ANDA 15 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
basic care ibuprofen HUMAN OTC DRUG LABEL 1 0113-7131 CAPSULE, LIQUID FILLED 200 mg ORAL ANDA 16 sections
basic care ibuprofen HUMAN OTC DRUG LABEL 1 0113-7517 TABLET, FILM COATED 200 mg ORAL ANDA 16 sections
Basic Care Ibuprofen HUMAN OTC DRUG LABEL 1 0113-7604 TABLET, FILM COATED 200 mg ORAL ANDA 16 sections
basic care childrens ibuprofen HUMAN OTC DRUG LABEL 1 0113-7660 SUSPENSION 100 mg ORAL ANDA 15 sections
Basic Care childrens ibuprofen HUMAN OTC DRUG LABEL 1 0113-7897 SUSPENSION 100 mg ORAL ANDA 15 sections
Childrens Ibuprofen Oral Suspension HUMAN OTC DRUG LABEL 1 0121-0914 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
Childrens Ibuprofen HUMAN OTC DRUG LABEL 1 0121-0917 SUSPENSION 100 mg ORAL ANDA 15 sections
Ibuprofen HUMAN PRESCRIPTION DRUG LABEL 1 0121-0918 SUSPENSION 100 mg ORAL ANDA 27 sections
IBUPROFEN HUMAN PRESCRIPTION DRUG LABEL 1 0121-1548 SUSPENSION 100 mg ORAL ANDA 28 sections
Childrens Ibuprofen Oral Suspension HUMAN OTC DRUG LABEL 1 0121-1828 SUSPENSION 100 mg ORAL ANDA 16 sections
Childrens Ibuprofen Oral Suspension HUMAN OTC DRUG LABEL 1 0121-1828 SUSPENSION 100 mg ORAL ANDA 16 sections
Childrens Ibuprofen HUMAN OTC DRUG LABEL 1 0121-1836 SUSPENSION 100 mg ORAL ANDA 16 sections