paracetamol 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
52 103-90-2

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • acetaminophen
  • acetaminofen
  • aminofen
  • panadol
  • paracetamol
  • neopap
Analgesic antipyretic derivative of acetanilide. It has weak anti-inflammatory properties and is used as a common analgesic, but may cause liver, blood cell, and kidney damage.
  • Molecular weight: 151.17
  • Formula: C8H9NO2
  • CLOGP: 0.49
  • LIPINSKI: 0
  • HAC: 3
  • HDO: 2
  • TPSA: 49.33
  • ALOGS: -1.56
  • ROTB: 1
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
3 g O
3 g P
3 g R

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 23.70 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 3 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 330.76 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 88 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 1 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 5 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.52 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 2.50 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Nov. 7, 1968 FDA POLYMEDICA

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Toxicity to various agents 2566.35 11.16 8449 859254 216115 55208249
Intentional overdose 1308.57 11.16 3100 864603 65017 55359347
Completed suicide 1247.01 11.16 4712 862991 129121 55295243
Acute hepatic failure 1153.29 11.16 1350 866353 15228 55409136
Overdose 1064.41 11.16 3820 863883 102010 55322354
Analgesic drug level increased 893.71 11.16 474 867229 1348 55423016
Drug ineffective 780.73 11.16 9761 857942 909228 54515136
Hepatocellular injury 704.87 11.16 1377 866326 25137 55399227
Suicide attempt 593.31 11.16 2102 865601 55734 55368630
Poisoning deliberate 562.32 11.16 730 866973 9223 55415141
Metabolic acidosis 427.55 11.16 1485 866218 38969 55385395
Injection site pain 349.11 11.16 807 866896 116311 55308053
Product dose omission issue 334.68 11.16 1821 865882 202932 55221432
Device expulsion 326.08 11.16 42 867661 30407 55393957
Infusion related reaction 298.86 11.16 4701 863002 204230 55220134
Intentional product misuse 294.79 11.16 1570 866133 49934 55374430
Exposure to toxic agent 292.28 11.16 321 867382 3357 55421007
Cholestasis 285.27 11.16 989 866714 25924 55398440
Drug hypersensitivity 267.72 11.16 2830 864873 272375 55151989
Psoriasis 264.83 11.16 653 867050 92039 55332325
Rheumatoid arthritis 260.06 11.16 4240 863463 378364 55046000
Hepatic failure 241.14 11.16 1090 866613 32396 55391968
Injection site erythema 225.65 11.16 540 867163 76908 55347456
Hepatotoxicity 216.85 11.16 1004 866699 30149 55394215
Off label use 212.65 11.16 6744 860959 549436 54874928
Alopecia 206.58 11.16 3230 864473 290228 55134136
Blood pressure fluctuation 200.23 11.16 1184 866519 39176 55385188
Injection site reaction 183.03 11.16 338 867365 52909 55371455
Drug resistance 180.02 11.16 47 867656 20495 55403869
Sinusitis 175.43 11.16 4134 863569 193447 55230917
Coma 174.40 11.16 1541 866162 58114 55366250
Coagulopathy 166.56 11.16 650 867053 18066 55406298
Somnolence 166.48 11.16 3487 864216 159926 55264438
Anion gap 166.16 11.16 139 867564 1000 55423364
Therapeutic product effect incomplete 164.91 11.16 958 866745 105073 55319291
Wrong technique in product usage process 156.72 11.16 422 867281 57746 55366618
Cholecystitis chronic 151.86 11.16 410 867293 9338 55415026
Lower respiratory tract infection 151.26 11.16 2549 865154 112245 55312119
Treatment failure 147.49 11.16 1798 865905 168594 55255770
Confusional state 146.04 11.16 4222 863481 203933 55220431
Hospitalisation 142.57 11.16 632 867071 74368 55349996
Hepatitis 142.04 11.16 985 866718 34456 55389908
Psoriatic arthropathy 141.68 11.16 622 867081 73386 55350978
Abdominal discomfort 139.45 11.16 3232 864471 274042 55150322
International normalised ratio increased 138.87 11.16 1157 866546 42884 55381480
Accidental overdose 138.41 11.16 654 867049 19807 55404557
Depressed level of consciousness 136.27 11.16 1400 866303 55033 55369331
Hepatic cytolysis 135.48 11.16 423 867280 10483 55413881
Body temperature increased 129.84 11.16 939 866764 33303 55391061
Systemic lupus erythematosus 129.27 11.16 1974 865729 178104 55246260
Injection site swelling 129.18 11.16 301 867402 43277 55381087
Injection site pruritus 128.87 11.16 284 867419 41647 55382717
Folliculitis 126.19 11.16 1350 866353 53629 55370735
Muscle injury 121.83 11.16 1292 866411 51208 55373156
Hepatitis acute 121.76 11.16 343 867360 8014 55416350
Irritable bowel syndrome 112.78 11.16 1579 866124 66879 55357485
Pyroglutamate increased 112.76 11.16 74 867629 346 55424018
Maternal exposure during pregnancy 112.06 11.16 2152 865551 187401 55236963
Medication error 111.29 11.16 1069 866634 41266 55383098
Pemphigus 110.56 11.16 1730 865973 155482 55268882
Cardiac failure congestive 110.05 11.16 845 866858 86875 55337489
Drug abuse 109.99 11.16 1556 866147 66054 55358310
Injection site bruising 109.48 11.16 272 867431 38249 55386115
Hepatic necrosis 106.39 11.16 246 867457 5070 55419294
Hepatitis fulminant 106.09 11.16 183 867520 3021 55421343
Hepatitis cholestatic 105.21 11.16 275 867428 6139 55418225
Prothrombin time shortened 101.64 11.16 131 867572 1642 55422722
Abdominal pain 100.86 11.16 4917 862786 253888 55170476
Red blood cell sedimentation rate abnormal 97.96 11.16 86 867617 18587 55405777
Pyrexia 97.10 11.16 7602 860101 411171 55013193
Therapeutic response decreased 95.83 11.16 452 867251 52306 55372058
Therapy cessation 94.63 11.16 172 867531 27092 55397272
Vomiting 94.08 11.16 8907 858796 489321 54935043
Blister 92.19 11.16 2264 865439 106623 55317741
Disease progression 91.25 11.16 1109 866594 104064 55320300
Respiratory depression 91.18 11.16 407 867296 12028 55412336
Urine abnormality 90.88 11.16 268 867435 6431 55417933
Accidental exposure to product 88.70 11.16 152 867551 24495 55399869
Pyroglutamic acidosis 88.53 11.16 67 867636 409 55423955
Condition aggravated 87.32 11.16 4385 863318 340513 55083851
Intentional self-injury 84.97 11.16 668 867035 24324 55400040
Blood pressure diastolic abnormal 83.83 11.16 378 867325 11220 55413144
Urticaria 83.59 11.16 2867 864836 141809 55282555
Acute generalised exanthematous pustulosis 83.19 11.16 337 867366 9532 55414832
Transaminases increased 81.90 11.16 739 866964 28031 55396333
Contraindicated product administered 80.73 11.16 2219 865484 184067 55240297
Prothrombin time ratio decreased 78.94 11.16 60 867643 369 55423995
Therapy non-responder 78.85 11.16 587 867116 60768 55363596
Bradypnoea 78.69 11.16 161 867542 3042 55421322
Alanine aminotransferase increased 74.42 11.16 1931 865772 91731 55332633
Miosis 74.02 11.16 247 867456 6345 55418019
Toxic epidermal necrolysis 73.76 11.16 587 867116 21455 55402909
Therapy interrupted 73.56 11.16 180 867523 25445 55398919
Heart rate increased 73.36 11.16 1741 865962 81532 55342832
Urine leukocyte esterase positive 73.06 11.16 154 867549 2974 55421390
Poisoning 72.88 11.16 390 867313 12423 55411941
Lymphocyte count decreased 72.69 11.16 704 866999 27235 55397129
Diarrhoea 72.65 11.16 8677 859026 629830 54794534
Mixed liver injury 71.89 11.16 176 867527 3768 55420596
Oxygen saturation decreased 70.86 11.16 1657 866046 77410 55346954
Ill-defined disorder 70.15 11.16 1464 866239 67079 55357285
Bone marrow failure 69.74 11.16 214 867489 28072 55396292
Injection site warmth 68.41 11.16 71 867632 14172 55410192
Throat irritation 68.34 11.16 788 866915 31895 55392469
Breast cancer stage I 68.15 11.16 8 867695 6222 55418142
Blood pressure systolic abnormal 67.22 11.16 314 867389 9463 55414901
Sleep disorder due to general medical condition, insomnia type 67.14 11.16 989 866714 42349 55382015
Blood parathyroid hormone decreased 66.29 11.16 23 867680 8341 55416023
Glossodynia 66.05 11.16 1816 865887 150642 55273722
Granuloma skin 66 11.16 14 867689 7037 55417327
Pruritus 65.48 11.16 5699 862004 310924 55113440
Prothrombin time prolonged 65.27 11.16 295 867408 8765 55415599
Ductus arteriosus premature closure 64.83 11.16 48 867655 282 55424082
Surgery 64.63 11.16 269 867434 32217 55392147
Breast cancer female 64.51 11.16 57 867646 12281 55412083
Transplant rejection 63.58 11.16 37 867666 9897 55414467
Unintentional medical device removal 63.07 11.16 7 867696 5687 55418677
Hepatic encephalopathy 62.54 11.16 315 867388 9795 55414569
No adverse event 62.38 11.16 318 867385 36056 55388308
Cytomegalovirus infection 61.53 11.16 128 867575 19168 55405196
Product use in unapproved indication 61.36 11.16 1676 866027 139146 55285218
Malignant neoplasm progression 61.16 11.16 783 866920 72804 55351560
Pulmonary arterial hypertension 60.82 11.16 207 867496 26296 55398068
Rheumatoid nodule 59.78 11.16 85 867618 14772 55409592
Device dislocation 59.38 11.16 166 867537 22440 55401924
Myocardial infarction 59.31 11.16 1040 866663 91830 55332534
Product storage error 58.92 11.16 70 867633 13143 55411221
White blood cells urine positive 58.49 11.16 185 867518 4617 55419747
Device issue 58.45 11.16 151 867552 20955 55403409
Drug intolerance 58.17 11.16 3414 864289 261404 55162960
Myelosuppression 58.04 11.16 113 867590 17342 55407022
Neoplasm progression 57.72 11.16 275 867428 31741 55392623
Device malfunction 57.62 11.16 100 867603 16036 55408328
Heart rate decreased 57.02 11.16 908 866795 39519 55384845
Encephalopathy 56.24 11.16 810 866893 34515 55389849
Ear pain 56.01 11.16 725 866978 30165 55394199
Tachycardia 55.43 11.16 2075 865628 103801 55320563
Acute kidney injury 54.56 11.16 4364 863339 236399 55187965
Diabetes mellitus 53.71 11.16 536 867167 52199 55372165
Infusion site pain 53.67 11.16 380 867323 13382 55410982
Device difficult to use 53.56 11.16 52 867651 10709 55413655
Hypocoagulable state 53.42 11.16 73 867630 972 55423392
Product prescribing error 53.27 11.16 181 867522 23005 55401359
Crystal urine present 52.76 11.16 91 867612 1502 55422862
Haematotoxicity 52.56 11.16 32 867671 8351 55416013
Infusion site extravasation 52.34 11.16 258 867445 7952 55416412
Orthostatic hypotension 51.96 11.16 759 866944 32440 55391924
Cardiac failure 51.88 11.16 921 866782 81172 55343192
Acute lung injury 51.71 11.16 86 867617 1376 55422988
Post transplant lymphoproliferative disorder 51.11 11.16 6 867697 4666 55419698
Abortion spontaneous 50.93 11.16 430 867273 43323 55381041
Gallbladder injury 50.79 11.16 80 867623 1220 55423144
Product use issue 50.58 11.16 2347 865356 183694 55240670
Interstitial lung disease 50.50 11.16 599 867104 56464 55367900
Urinary sediment present 50.31 11.16 104 867599 1980 55422384
Infusion site swelling 49.84 11.16 248 867455 7673 55416691
Panniculitis 49.64 11.16 47 867656 9795 55414569
Bone erosion 48.87 11.16 98 867605 14876 55409488
Hypotension 48.67 11.16 4489 863214 246019 55178345
Blood pressure increased 48.52 11.16 2719 864984 142457 55281907
Respiratory arrest 48.27 11.16 701 867002 29924 55394440
Acidosis 48.22 11.16 302 867401 10199 55414165
Renal papillary necrosis 47.75 11.16 35 867668 202 55424162
Hypertransaminasaemia 47.31 11.16 170 867533 4537 55419827
Chills 47.20 11.16 1983 865720 100621 55323743
Arthropathy 47.03 11.16 2565 865138 197710 55226654
Breast cancer 46.60 11.16 504 867199 48329 55376035
Injection site haemorrhage 46.58 11.16 180 867523 22021 55402343
Blood pressure systolic increased 46.04 11.16 885 866818 39951 55384413
Myelodysplastic syndrome 45.72 11.16 117 867586 16289 55408075
Muscle spasticity 45.26 11.16 489 867214 19471 55404893
Cholelithiasis 45.09 11.16 857 866846 38607 55385757
Device use error 45.00 11.16 14 867689 5442 55418922
Injection site rash 44.93 11.16 124 867579 16834 55407530
Drug-induced liver injury 44.89 11.16 764 866939 33698 55390666
Red blood cells urine positive 44.71 11.16 123 867580 2833 55421531
Palmar-plantar erythrodysaesthesia syndrome 44.71 11.16 170 867533 20895 55403469
Loss of personal independence in daily activities 44.07 11.16 937 866766 80432 55343932
Metastases to liver 44.03 11.16 177 867526 21409 55402955
Skin necrosis 43.78 11.16 77 867626 12284 55412080
Cardio-respiratory arrest 43.76 11.16 1140 866563 54181 55370183
Pathogen resistance 43.42 11.16 19 867684 5981 55418383
Nasopharyngitis 42.98 11.16 3960 863743 216999 55207365
Infusion site erythema 42.71 11.16 274 867429 9332 55415032
Oligohydramnios 42.31 11.16 194 867509 5800 55418564
Stevens-Johnson syndrome 41.54 11.16 533 867170 22130 55402234
C-reactive protein abnormal 40.95 11.16 366 867337 36443 55387921
Injury 40.79 11.16 1210 866493 58641 55365723
Abdominal pain upper 40.68 11.16 3234 864469 175079 55249285
Rash maculo-papular 40.66 11.16 649 867054 28258 55396106
Genital haemorrhage 40.56 11.16 28 867675 6834 55417530
Creatinine renal clearance decreased 40.43 11.16 372 867331 14187 55410177
Lupus-like syndrome 39.99 11.16 82 867621 12345 55412019
Drug abuser 39.38 11.16 115 867588 2744 55421620
Injection site mass 39.33 11.16 130 867573 16663 55407701
Blood pressure diastolic decreased 39.11 11.16 463 867240 18860 55405504
Multiple-drug resistance 39.07 11.16 7 867696 3967 55420397
Injection site urticaria 38.93 11.16 87 867616 12696 55411668
Back pain 38.80 11.16 4200 863503 232970 55191394
Sedation complication 38.59 11.16 310 867393 11362 55413002
Posterior reversible encephalopathy syndrome 38.46 11.16 122 867581 15838 55408526
Unevaluable event 38.30 11.16 511 867192 47176 55377188
Emotional distress 38.10 11.16 658 867045 29105 55395259
Jaundice 38.10 11.16 612 867091 26682 55397682
Impaired healing 38.07 11.16 1670 866033 85171 55339193
Brain oedema 37.83 11.16 341 867362 12930 55411434
Drug level increased 37.81 11.16 487 867216 20238 55404126
Ear pruritus 37.70 11.16 115 867588 2813 55421551
Breast cancer stage II 37.49 11.16 21 867682 5737 55418627
Red blood cell sedimentation rate 37.48 11.16 10 867693 4298 55420066
Analgesic drug level above therapeutic 37.34 11.16 27 867676 152 55424212
Plasma cell myeloma 37.04 11.16 501 867202 46145 55378219
Abortion incomplete 36.87 11.16 3 867700 3124 55421240
Renal impairment 36.87 11.16 954 866749 79759 55344605
Liver transplant 36.81 11.16 96 867607 2140 55422224
Blood urine present 36.47 11.16 344 867359 13211 55411153
Metastases to bone 36.09 11.16 166 867537 19342 55405022
Exposure via ingestion 35.88 11.16 110 867593 2698 55421666
Disturbance in social behaviour 35.63 11.16 3 867700 3038 55421326
Second primary malignancy 35.43 11.16 37 867666 7365 55416999
Blood iron abnormal 35.34 11.16 5 867698 3372 55420992
Gastrointestinal disorder 35.18 11.16 2098 865605 110604 55313760
Aspartate aminotransferase increased 35.00 11.16 1583 866120 81019 55343345
Blood pressure diastolic increased 34.92 11.16 239 867464 8322 55416042
Metastases to lung 34.67 11.16 81 867622 11637 55412727
Transplant dysfunction 34.39 11.16 15 867688 4731 55419633
Infusion site pruritus 34.24 11.16 156 867547 4651 55419713
Red cell distribution width increased 34.18 11.16 254 867449 9086 55415278
Blood alkaline phosphatase increased 33.60 11.16 812 866891 38133 55386231
Underdose 33.60 11.16 221 867482 23536 55400828
Hepatitis toxic 33.49 11.16 111 867592 2841 55421523
Headache 33.40 11.16 9383 858320 549661 54874703
Liver injury 33.28 11.16 863 866840 40985 55383379
Gamma-glutamyltransferase increased 33.28 11.16 667 867036 30338 55394026
Adverse event 33.19 11.16 627 867076 54749 55369615
Injection site induration 32.99 11.16 51 867652 8564 55415800
Dermatitis atopic 32.88 11.16 48 867655 8251 55416113
Full blood count abnormal 32.66 11.16 256 867447 26206 55398158
Premature delivery 32.37 11.16 264 867439 26796 55397568
Hypothermia 32.33 11.16 314 867389 12156 55412208
Lymphocyte percentage decreased 32.10 11.16 107 867596 2747 55421617
Musculoskeletal disorder 31.92 11.16 169 867534 18978 55405386
Adverse drug reaction 31.87 11.16 762 866941 64370 55359994
Liver function test abnormal 31.85 11.16 926 866777 44745 55379619
Haemoglobin urine present 31.81 11.16 50 867653 761 55423603
Respiratory rate increased 31.66 11.16 308 867395 11929 55412435
Foot deformity 31.54 11.16 226 867477 23599 55400765
Chronic graft versus host disease 31.45 11.16 6 867697 3250 55421114
Mydriasis 31.31 11.16 284 867419 10787 55413577
Unresponsive to stimuli 31.28 11.16 674 867029 31051 55393313
Gallbladder disorder 30.65 11.16 405 867298 16929 55407435
Complication associated with device 30.59 11.16 127 867576 15223 55409141
Biliary dyskinesia 30.54 11.16 98 867605 2465 55421899
Temperature regulation disorder 30.35 11.16 143 867560 4325 55420039
Cerebrovascular accident 30.34 11.16 1236 866467 98034 55326330
Urine ketone body present 30.27 11.16 93 867610 2284 55422080
Blood calcium decreased 30.25 11.16 525 867178 23244 55401120
Meningitis aseptic 30.04 11.16 141 867562 4258 55420106
Complication of device removal 29.95 11.16 16 867687 4488 55419876
Asthma 29.76 11.16 1427 866276 111343 55313021
Visceral congestion 29.73 11.16 30 867673 282 55424082
Neuropathy peripheral 29.58 11.16 1290 866413 101603 55322761
Systemic infection 29.57 11.16 7 867696 3262 55421102
Cardiotoxicity 29.57 11.16 45 867658 7605 55416759
Congenital pulmonary hypertension 29.57 11.16 16 867687 48 55424316
Hypertensive crisis 29.32 11.16 114 867589 13922 55410442
Haemophagocytic lymphohistiocytosis 29.27 11.16 65 867638 9507 55414857
Duodenal ulcer perforation 29.01 11.16 1310 866393 67032 55357332
Dyspnoea exertional 28.96 11.16 632 867071 54057 55370307
Juvenile idiopathic arthritis 28.85 11.16 19 867684 4754 55419610
Coagulation factor VII level decreased 28.80 11.16 18 867685 76 55424288
Anion gap abnormal 28.67 11.16 31 867672 318 55424046
Poor venous access 28.61 11.16 303 867400 12003 55412361
Osteoporosis 28.59 11.16 598 867105 51454 55372910
Brain death 28.52 11.16 106 867597 2877 55421487
Urine analysis abnormal 28.49 11.16 146 867557 4571 55419793
Cerebral haematoma 28.43 11.16 114 867589 3209 55421155
Femur fracture 28.40 11.16 430 867273 38865 55385499
Chest discomfort 28.39 11.16 1827 865876 97030 55327334
White blood cell count decreased 28.37 11.16 1620 866083 124370 55299994
Product administration error 28.36 11.16 467 867236 20462 55403902
Blood bilirubin increased 28.35 11.16 694 867009 32660 55391704
Anaemia 28.18 11.16 3652 864051 263859 55160505
Night sweats 28.02 11.16 833 866870 40380 55383984
Osteonecrosis 27.99 11.16 226 867477 22989 55401375
Product substitution issue 27.74 11.16 123 867580 14476 55409888
Complication of device insertion 27.62 11.16 35 867668 6389 55417975
Fixed eruption 27.55 11.16 51 867652 892 55423472
Disease recurrence 27.54 11.16 235 867468 23625 55400739
Acute graft versus host disease 27.51 11.16 15 867688 4160 55420204
Respiratory disorder 27.51 11.16 702 867001 33255 55391109
Fear of injection 27.50 11.16 36 867667 6479 55417885
Stomatitis 27.36 11.16 2190 865513 118620 55305744
Toxic skin eruption 27.27 11.16 289 867414 11450 55412914
Helicobacter infection 27.21 11.16 1386 866317 71882 55352482
Basal cell carcinoma 27.09 11.16 253 867450 24968 55399396
Drug ineffective for unapproved indication 27.06 11.16 259 867444 25434 55398930
Coagulation factor V level decreased 27.05 11.16 28 867675 272 55424092
Mucormycosis 27.03 11.16 5 867698 2769 55421595
Osteonecrosis of jaw 26.95 11.16 357 867346 33001 55391363
Blood glucose increased 26.91 11.16 918 866785 74233 55350131
Anti-neutrophil cytoplasmic antibody positive vasculitis 26.62 11.16 4 867699 2579 55421785
Product quality issue 26.61 11.16 337 867366 31399 55392965
Product monitoring error 26.58 11.16 10 867693 3449 55420915
Mucosal inflammation 26.50 11.16 482 867221 42328 55382036
Diabetic ketoacidosis 26.46 11.16 176 867527 18695 55405669
Cytokine release syndrome 26.34 11.16 270 867433 10605 55413759
Device breakage 26.29 11.16 75 867628 10072 55414292
Colorectal cancer 26.21 11.16 10 867693 3419 55420945
Memory impairment 26.17 11.16 1079 866624 85478 55338886
Platelet count decreased 25.97 11.16 1357 866346 105026 55319338
Substance abuse 25.92 11.16 138 867565 4387 55419977
Drug dose omission by device 25.66 11.16 9 867694 3242 55421122
Knee arthroplasty 25.64 11.16 504 867199 43755 55380609
Thrombotic microangiopathy 25.55 11.16 68 867635 9343 55415021
Jaundice cholestatic 25.52 11.16 159 867544 5360 55419004
Culture urine positive 25.51 11.16 115 867588 3413 55420951
Joint stiffness 25.48 11.16 388 867315 35037 55389327
Musculoskeletal stiffness 25.44 11.16 2064 865639 153943 55270421
Neutropenia 25.42 11.16 2095 865608 156072 55268292
Flushing 25.40 11.16 1323 866380 68777 55355587
Medication overuse headache 25.39 11.16 42 867661 669 55423695
Bradycardia 25.28 11.16 1278 866425 66226 55358138
Cell death 25.25 11.16 86 867617 2233 55422131
Neutrophil percentage increased 25.22 11.16 98 867605 2718 55421646
Cognitive disorder 25.00 11.16 960 866743 48173 55376191
Seizure 24.97 11.16 1627 866076 123492 55300872
Body temperature fluctuation 24.94 11.16 80 867623 2012 55422352
Infusion site bruising 24.54 11.16 97 867606 2712 55421652
Electric shock 24.52 11.16 53 867650 1042 55423322
Ovarian hyperstimulation syndrome 24.38 11.16 13 867690 3651 55420713
Hyponatraemia 24.18 11.16 1858 865845 100281 55324083
Pulmonary hypertension 24.08 11.16 399 867304 35545 55388819
Feeling abnormal 24.07 11.16 1753 865950 131849 55292515
Wrong patient received product 24.07 11.16 81 867622 2090 55422274
Anion gap increased 23.92 11.16 65 867638 1486 55422878
Hyperbilirubinaemia 23.79 11.16 252 867451 9983 55414381
Sensitisation 23.66 11.16 4 867699 2364 55422000
Prothrombin level increased 23.51 11.16 24 867679 229 55424135
Neurotoxicity 23.33 11.16 145 867558 15650 55408714
Glycosylated haemoglobin increased 23.12 11.16 91 867612 11074 55413290
Intentional product use issue 22.91 11.16 1810 865893 97923 55326441
Varicella zoster virus infection 22.47 11.16 6 867697 2578 55421786
Hypothyroidism 22.42 11.16 434 867269 37762 55386602
Foot operation 22.23 11.16 39 867664 6228 55418136
Hyperthermia 22.16 11.16 210 867493 8075 55416289
Type I hypersensitivity 22.00 11.16 86 867617 2392 55421972
Acute myeloid leukaemia 21.98 11.16 162 867541 16810 55407554
Constipation 21.95 11.16 3489 864214 198454 55225910
Eosinophilia 21.91 11.16 433 867270 19644 55404720
Labelled drug-drug interaction medication error 21.78 11.16 98 867605 11488 55412876
Arthritis 21.56 11.16 1289 866414 98563 55325801
Forced expiratory volume decreased 21.52 11.16 24 867679 4636 55419728
Cholestatic liver injury 21.51 11.16 80 867623 2172 55422192
Drug eruption 21.44 11.16 274 867429 25489 55398875
Specific gravity urine decreased 21.40 11.16 40 867663 705 55423659
Subacute cutaneous lupus erythematosus 21.31 11.16 5 867698 2344 55422020
Lymphoproliferative disorder 21.27 11.16 10 867693 3018 55421346
Joint destruction 21.26 11.16 28 867675 5027 55419337
Coma scale abnormal 21.18 11.16 138 867565 4725 55419639
Administration site pain 21.06 11.16 40 867663 714 55423650
Drug reaction with eosinophilia and systemic symptoms 21.01 11.16 614 867089 29690 55394674
Hypoprothrombinaemia 20.94 11.16 24 867679 264 55424100
Graft versus host disease 20.77 11.16 46 867657 6735 55417629
Neutropenic sepsis 20.64 11.16 339 867364 14846 55409518
Neoplasm malignant 20.62 11.16 293 867410 26762 55397602
Heart rate irregular 20.60 11.16 440 867263 20239 55404125
Unintended pregnancy 20.59 11.16 30 867673 5161 55419203
Incorrect dose administered by device 20.55 11.16 17 867686 3783 55420581
Graft versus host disease in skin 20.51 11.16 8 867695 2699 55421665
Tardive dyskinesia 20.34 11.16 60 867643 7971 55416393
Pneumonia 20.29 11.16 5779 861924 401319 55023045
Epstein-Barr virus infection 20.20 11.16 54 867649 7409 55416955
Drug screen positive 20.08 11.16 106 867597 3358 55421006
Injection site discolouration 20.05 11.16 52 867651 7207 55417157
Hyperleukocytosis 20.00 11.16 32 867671 495 55423869
Breast cancer metastatic 19.86 11.16 148 867555 15321 55409043
Administration site swelling 19.81 11.16 49 867654 1056 55423308
Oedema 19.79 11.16 1046 866657 80874 55343490
Joint dislocation 19.74 11.16 152 867551 15621 55408743
Abortion induced 19.72 11.16 79 867624 9566 55414798
Biliary sepsis 19.71 11.16 43 867660 851 55423513
Decreased appetite 19.55 11.16 3023 864680 216208 55208156
Renal failure neonatal 19.54 11.16 19 867684 170 55424194
Respiratory acidosis 19.47 11.16 162 867541 6001 55418363
Brain stem glioma 19.45 11.16 21 867682 215 55424149
Upper gastrointestinal haemorrhage 19.36 11.16 370 867333 16684 55407680
Cardiomyopathy 19.27 11.16 159 867544 16099 55408265
Gait disturbance 19.26 11.16 2213 865490 161108 55263256
Retinitis 19.24 11.16 22 867681 4202 55420162
Nasal necrosis 19.20 11.16 14 867689 80 55424284
Metastases to lymph nodes 19.13 11.16 55 867648 7368 55416996
Infectious thyroiditis 19.08 11.16 9 867694 18 55424346
Prothrombin level decreased 19.03 11.16 32 867671 517 55423847
Acute graft versus host disease in skin 19.01 11.16 13 867690 3189 55421175
Polycystic ovaries 18.96 11.16 14 867689 3300 55421064
Bacterial test 18.94 11.16 50 867653 1123 55423241
Sedation 18.93 11.16 686 867017 34168 55390196
Ductus arteriosus stenosis foetal 18.86 11.16 18 867685 157 55424207
Hypercalcaemia 18.73 11.16 277 867426 25134 55399230
Product adhesion issue 18.69 11.16 25 867678 4458 55419906
Hepatitis B reactivation 18.64 11.16 7 867696 2417 55421947
Device deployment issue 18.64 11.16 17 867686 3607 55420757
Tenosynovitis 18.61 11.16 114 867589 12347 55412017
Right ventricular failure 18.60 11.16 162 867541 16217 55408147
Exposure during pregnancy 18.54 11.16 1829 865874 134513 55289851
Cholesterosis 18.53 11.16 28 867675 411 55423953
Lip oedema 18.53 11.16 104 867599 3374 55420990
Sexual dysfunction 18.51 11.16 15 867688 3373 55420991
Deep vein thrombosis 18.50 11.16 1402 866301 75575 55348789
Vitamin K deficiency 18.48 11.16 28 867675 412 55423952
Enthesopathy 18.48 11.16 63 867640 8000 55416364
Blood lactic acid increased 18.41 11.16 158 867545 5906 55418458
Therapy partial responder 18.41 11.16 60 867643 7725 55416639
Fracture 18.40 11.16 183 867520 17835 55406529
Incorrect drug administration rate 18.38 11.16 97 867606 3073 55421291
Haemorrhage 18.35 11.16 697 867006 55700 55368664
Akathisia 18.25 11.16 70 867633 8582 55415782
Congenital tricuspid valve incompetence 18.18 11.16 14 867689 88 55424276
Treatment noncompliance 18.15 11.16 374 867329 32249 55392115
Posturing 17.97 11.16 29 867674 452 55423912
Injury associated with device 17.91 11.16 15 867688 3318 55421046
Rash erythematous 17.71 11.16 722 866981 36499 55387865
Asphyxia 17.67 11.16 151 867552 5638 55418726
Agranulocytosis 17.64 11.16 466 867237 22193 55402171
Pulmonary embolism 17.62 11.16 1898 865805 105226 55319138
Device use issue 17.60 11.16 6 867697 2200 55422164
Truncus coeliacus thrombosis 17.57 11.16 7 867696 7 55424357
Pneumocystis jirovecii pneumonia 17.52 11.16 156 867547 15545 55408819
Disability 17.51 11.16 157 867546 15623 55408741
Hepatic enzyme increased 17.49 11.16 2951 864752 168433 55255931
Hallucination 17.48 11.16 926 866777 48223 55376141
Diffuse large B-cell lymphoma recurrent 17.48 11.16 3 867700 1754 55422610
JC virus infection 17.44 11.16 4 867699 1905 55422459
Graft versus host disease in gastrointestinal tract 17.36 11.16 12 867691 2927 55421437
Device leakage 17.35 11.16 46 867657 6329 55418035
Aspergillus infection 17.34 11.16 58 867645 7407 55416957
Septic shock 17.21 11.16 764 866939 60071 55364293
Human herpesvirus 6 infection 17.15 11.16 10 867693 2672 55421692
Cytomegalovirus viraemia 17.15 11.16 33 867670 5087 55419277
Inadequate analgesia 17.07 11.16 84 867619 2587 55421777
Hyperglycaemia 17.07 11.16 454 867249 37827 55386537
Endophthalmitis 17.07 11.16 14 867689 3129 55421235
Virologic failure 17.06 11.16 3 867700 1723 55422641
Caesarean section 17.03 11.16 162 867541 15929 55408435
Macular oedema 17.02 11.16 20 867683 3774 55420590
Leukocyturia 16.94 11.16 47 867656 1088 55423276
Amenorrhoea 16.90 11.16 76 867627 8910 55415454
Gallbladder cholesterolosis 16.88 11.16 36 867667 701 55423663
Angioedema 16.82 11.16 791 866912 40662 55383702
Infusion site discomfort 16.81 11.16 46 867657 1056 55423308
Sputum culture positive 16.80 11.16 62 867641 1677 55422687
Coagulation factor V level increased 16.74 11.16 6 867697 3 55424361
Hip arthroplasty 16.46 11.16 461 867242 38162 55386202
Bacterial test positive 16.45 11.16 132 867571 4836 55419528
Impaired quality of life 16.34 11.16 71 867632 8403 55415961
Delirium 16.34 11.16 807 866896 41710 55382654
Depression 16.24 11.16 2482 865221 177635 55246729
Shoulder arthroplasty 16.21 11.16 20 867683 3693 55420671
Dyspnoea at rest 16.16 11.16 21 867682 3792 55420572
Specific gravity urine increased 16.12 11.16 18 867685 192 55424172
Coagulation factor X level decreased 16.01 11.16 12 867691 72 55424292
Bursitis 16.00 11.16 547 867156 27035 55397329
Leukopenia 15.99 11.16 912 866791 70028 55354336
Abnormal clotting factor 15.99 11.16 14 867689 108 55424256
Galactorrhoea 15.95 11.16 22 867681 3873 55420491
Sensitivity to weather change 15.90 11.16 51 867652 6598 55417766
Oedema peripheral 15.88 11.16 2356 865347 168898 55255466
Nitrite urine present 15.75 11.16 43 867660 986 55423378
Self-medication 15.74 11.16 78 867625 2409 55421955
Biliary colic 15.72 11.16 98 867605 3304 55421060
Osmolar gap 15.70 11.16 13 867690 92 55424272
Blood pH decreased 15.63 11.16 78 867625 2416 55421948
Lung neoplasm malignant 15.62 11.16 182 867521 17214 55407150
Cystic fibrosis 15.62 11.16 18 867685 3426 55420938
Visual acuity reduced 15.60 11.16 225 867478 20501 55403863
Infusion site rash 15.58 11.16 57 867646 1535 55422829
Splenic vein thrombosis 15.56 11.16 22 867681 303 55424061
Peptic ulcer haemorrhage 15.54 11.16 43 867660 994 55423370
Ecchymosis 15.51 11.16 235 867468 10121 55414243
Blood creatinine decreased 15.37 11.16 134 867569 5032 55419332
Product preparation error 15.31 11.16 32 867671 4784 55419580
Respiratory failure 15.28 11.16 1259 866444 93803 55330561
Periorbital cellulitis 15.28 11.16 32 867671 615 55423749
Vulvar erosion 15.26 11.16 16 867687 158 55424206
Hepatic cirrhosis 15.25 11.16 233 867470 21030 55403334
Dilatation intrahepatic duct acquired 15.18 11.16 32 867671 618 55423746
Cardiac disorder 15.18 11.16 566 867137 45321 55379043
Acute haemorrhagic oedema of infancy 15.17 11.16 7 867696 13 55424351
Kidney transplant rejection 15.14 11.16 26 867677 4187 55420177
Anaphylactic reaction 15.11 11.16 1080 866623 57915 55366449
Bladder dilatation 15.11 11.16 36 867667 757 55423607
Pregnancy with contraceptive device 15.01 11.16 26 867677 4173 55420191
Cerebral infarction 15.01 11.16 250 867453 22255 55402109
Lethargy 15.00 11.16 952 866751 50489 55373875
Laboratory test abnormal 14.98 11.16 279 867424 24416 55399948
Syncope 14.91 11.16 1450 866253 106749 55317615
Impaired work ability 14.88 11.16 148 867555 14424 55409940
Coma hepatic 14.86 11.16 31 867672 594 55423770
Infusion site nodule 14.81 11.16 48 867655 1214 55423150
Epilepsy 14.71 11.16 287 867416 24944 55399420
Rheumatoid lung 14.69 11.16 16 867687 3124 55421240
Myopathy 14.53 11.16 90 867613 9722 55414642
Pregnancy 14.40 11.16 393 867310 32640 55391724
Polyomavirus-associated nephropathy 14.39 11.16 4 867699 1673 55422691
Red blood cell sedimentation rate increased 14.39 11.16 442 867261 36181 55388183
Pancreatic fibrosis 14.38 11.16 12 867691 86 55424278
Drug use disorder 14.36 11.16 122 867581 4547 55419817
Coronary artery disease 14.32 11.16 363 867340 30433 55393931
Hepatitis B 14.32 11.16 21 867682 3603 55420761
Fluid retention 14.32 11.16 684 867019 53394 55370970
Food allergy 14.31 11.16 203 867500 8621 55415743
Renal disorder 14.30 11.16 347 867356 29258 55395106
Creatinine urine decreased 14.24 11.16 16 867687 172 55424192
Glutathione decreased 14.24 11.16 7 867696 16 55424348
Sleep disorder due to a general medical condition 14.19 11.16 82 867621 9008 55415356
Blood copper decreased 14.17 11.16 6 867697 8 55424356
Gestational diabetes 14.11 11.16 70 867633 7994 55416370
Gastrooesophageal reflux disease 14.10 11.16 1098 866605 82159 55342205
Chronic kidney disease 14.08 11.16 518 867185 41538 55382826
Hepatectomy 14.06 11.16 11 867692 71 55424293
Anticholinergic syndrome 13.95 11.16 63 867640 1871 55422493
Open globe injury 13.89 11.16 9 867694 41 55424323
Gallbladder adenocarcinoma 13.86 11.16 12 867691 91 55424273
Spleen congestion 13.83 11.16 13 867690 111 55424253
Cholangitis acute 13.81 11.16 26 867677 461 55423903
Weight increased 13.78 11.16 3857 863846 225846 55198518
Blood thyroid stimulating hormone decreased 13.74 11.16 114 867589 4219 55420145
Ankylosing spondylitis 13.73 11.16 93 867610 9837 55414527
Autonomic dysreflexia 13.72 11.16 21 867682 312 55424052
Intervertebral discitis 13.69 11.16 82 867621 2725 55421639
Renal cancer 13.69 11.16 39 867664 5240 55419124
Blood phosphorus decreased 13.68 11.16 107 867596 3890 55420474
Dependence 13.63 11.16 64 867639 1933 55422431
Transverse sinus thrombosis 13.63 11.16 27 867676 498 55423866
Obstructive airways disorder 13.58 11.16 186 867517 17096 55407268
Hypoglycaemic coma 13.54 11.16 10 867693 2357 55422007
Gallbladder hypofunction 13.52 11.16 27 867676 501 55423863
Skin ulcer 13.50 11.16 473 867230 38135 55386229
Hyperlipidaemia 13.49 11.16 197 867506 17912 55406452
Anticipatory anxiety 13.49 11.16 41 867662 1001 55423363
Eosinophil percentage increased 13.46 11.16 40 867663 964 55423400
Serum sickness 13.42 11.16 78 867625 2564 55421800
Blood immunoglobulin E increased 13.35 11.16 16 867687 2993 55421371
Breast cancer stage IV 13.31 11.16 6 867697 1856 55422508
Cardiac steatosis 13.31 11.16 8 867695 31 55424333
General physical health deterioration 13.24 11.16 2362 865341 167648 55256716
Immune reconstitution inflammatory syndrome 13.23 11.16 44 867659 5630 55418734
Accidental exposure to product by child 13.21 11.16 44 867659 1129 55423235
Agitation 13.20 11.16 1019 866684 55017 55369347
Therapy change 13.19 11.16 42 867661 5446 55418918
Hand deformity 13.18 11.16 1844 865859 132648 55291716
Product tampering 13.08 11.16 17 867686 215 55424149
Allodynia 13.06 11.16 34 867669 757 55423607
Feeling hot 13.05 11.16 778 866925 41009 55383355
Migraine with aura 13.03 11.16 72 867631 2322 55422042
Fatigue 13 11.16 11601 856102 776951 54647413
Cholecystitis acute 13.00 11.16 173 867530 7243 55417121
Cytomegalovirus infection reactivation 12.95 11.16 18 867685 3158 55421206
Vaccination site swelling 12.94 11.16 8 867695 33 55424331
Acute myocardial infarction 12.89 11.16 363 867340 30030 55394334
BK virus infection 12.86 11.16 17 867686 3047 55421317
Diffuse axonal injury 12.85 11.16 11 867692 82 55424282
Dizziness 12.81 11.16 5418 862285 370722 55053642
Hyperprolactinaemia 12.79 11.16 23 867680 3638 55420726
Brain compression 12.76 11.16 21 867682 333 55424031
Analgesic drug level therapeutic 12.75 11.16 4 867699 0 55424364
Fibrin D dimer decreased 12.75 11.16 4 867699 0 55424364
Myocardial fibrosis 12.73 11.16 32 867671 697 55423667
Infusion site haemorrhage 12.69 11.16 99 867604 3596 55420768
Stent placement 12.68 11.16 22 867681 3529 55420835
Ascites 12.66 11.16 462 867241 37082 55387282
Pulmonary infarction 12.65 11.16 74 867629 2438 55421926
Infusion site mass 12.62 11.16 51 867652 1441 55422923
Pancreatic carcinoma 12.59 11.16 63 867640 7178 55417186
Vital capacity decreased 12.51 11.16 46 867657 1242 55423122
Balance disorder 12.47 11.16 1355 866348 75165 55349199
Coronary arterial stent insertion 12.47 11.16 14 867689 2696 55421668
Toxic shock syndrome streptococcal 12.46 11.16 12 867691 106 55424258
Suspected suicide 12.43 11.16 134 867569 5332 55419032
Rash pruritic 12.43 11.16 673 867030 51921 55372443
Neonatal respiratory acidosis 12.42 11.16 14 867689 151 55424213
Blood glucose decreased 12.42 11.16 213 867490 18874 55405490
Mediastinal abscess 12.41 11.16 6 867697 13 55424351
Exostosis 12.41 11.16 159 867544 14784 55409580
Palatal oedema 12.41 11.16 25 867678 467 55423897
Libido disorder 12.40 11.16 9 867694 51 55424313
Toxicologic test abnormal 12.39 11.16 31 867672 673 55423691
Dysphoria 12.39 11.16 36 867667 4806 55419558
Dose calculation error 12.20 11.16 12 867691 109 55424255
Vascular purpura 12.10 11.16 47 867656 1303 55423061
Pleural fibrosis 12.06 11.16 93 867610 3366 55420998
Full blood count decreased 12.02 11.16 271 867432 23078 55401286
Arthrodesis 12.02 11.16 14 867689 2652 55421712
Tonsillar inflammation 11.97 11.16 11 867692 91 55424273
Death 11.90 11.16 4914 862789 336512 55087852
Intestinal pseudo-obstruction 11.89 11.16 33 867670 764 55423600
Lip infection 11.88 11.16 11 867692 92 55424272
Lupus vasculitis 11.85 11.16 25 867678 483 55423881
Therapeutic response shortened 11.83 11.16 207 867496 9179 55415185
Granuloma 11.83 11.16 44 867659 5443 55418921
Cystitis haemorrhagic 11.82 11.16 27 867676 3910 55420454
Thrombosis 11.81 11.16 773 866930 58654 55365710
SJS-TEN overlap 11.78 11.16 17 867686 239 55424125
Cytopenia 11.74 11.16 95 867608 9660 55414704
Acute lymphocytic leukaemia recurrent 11.55 11.16 11 867692 2286 55422078
Sinus tachycardia 11.53 11.16 439 867264 22005 55402359
Bone disorder 11.48 11.16 222 867481 19321 55405043
Red blood cell spherocytes present 11.48 11.16 7 867696 28 55424336
Gene mutation 11.46 11.16 4 867699 1445 55422919
Bladder cancer 11.43 11.16 37 867666 4773 55419591
Breast cancer recurrent 11.40 11.16 29 867674 4046 55420318
Blood prolactin increased 11.37 11.16 21 867682 3288 55421076
Cardiogenic shock 11.34 11.16 180 867523 16145 55408219
Cholelithiasis obstructive 11.33 11.16 6 867697 17 55424347
Loss of employment 11.32 11.16 8 867695 1929 55422435
Haematoma muscle 11.32 11.16 37 867666 940 55423424
Congenital central hypoventilation syndrome 11.30 11.16 7 867696 29 55424335
Hernial eventration 11.29 11.16 5 867698 8 55424356
Schizoaffective disorder 11.25 11.16 81 867622 2868 55421496
Body temperature decreased 11.24 11.16 362 867341 17746 55406618
Eye irritation 11.23 11.16 216 867487 18812 55405552
Monocyte percentage increased 11.22 11.16 40 867663 1063 55423301
Throat tightness 11.20 11.16 437 867266 21970 55402394
Nocardiosis 11.20 11.16 7 867696 1801 55422563

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Toxicity to various agents 1046.70 11.85 4914 409089 176573 31106768
Drug ineffective 631.92 11.85 2843 411160 392730 30890611
Intentional overdose 563.37 11.85 1491 412512 39898 31243443
Overdose 555.96 11.85 2385 411618 82279 31201062
Acute hepatic failure 537.66 11.85 748 413255 12111 31271230
Infusion related reaction 509.25 11.85 1582 412421 46473 31236868
Completed suicide 422.09 11.85 2330 411673 89184 31194157
Hepatocellular injury 396.09 11.85 872 413131 20672 31262669
Analgesic drug level increased 360.52 11.85 176 413827 496 31282845
Poisoning deliberate 265.78 11.85 399 413604 6945 31276396
Product dose omission issue 183.31 11.85 733 413270 104853 31178488
Drug resistance 180.95 11.85 42 413961 23411 31259930
Suicide attempt 179.28 11.85 960 413043 36288 31247053
Intentional product misuse 175.83 11.85 968 413035 36983 31246358
Blood pressure fluctuation 171.48 11.85 669 413334 22067 31261274
Accidental overdose 153.35 11.85 558 413445 17792 31265549
Treatment failure 153.31 11.85 184 413819 40608 31242733
Exposure to toxic agent 151.14 11.85 178 413825 2417 31280924
Liver injury 137.09 11.85 438 413565 13054 31270287
Cholestasis 132.94 11.85 664 413339 24411 31258930
Chills 130.37 11.85 1512 412491 72638 31210703
Toxic epidermal necrolysis 122.52 11.85 543 413460 18981 31264360
Myocardial infarction 116.64 11.85 935 413068 112519 31170822
Hepatitis 115.34 11.85 582 413421 21484 31261857
Therapeutic product effect incomplete 109.60 11.85 256 413747 43440 31239901
Psoriasis 104.59 11.85 290 413713 46429 31236912
Cardiac failure congestive 104.56 11.85 608 413395 78779 31204562
Vomiting 104.48 11.85 3738 410265 220235 31063106
Urticaria 102.93 11.85 1177 412826 56340 31227001
Hepatitis acute 102.92 11.85 253 413750 6456 31276885
Hepatic cytolysis 99.80 11.85 340 413663 10483 31272858
Metabolic acidosis 96.38 11.85 863 413140 38714 31244627
Cardiac failure 88.93 11.85 707 413296 85246 31198095
Heart rate decreased 81.38 11.85 640 413363 27626 31255715
Drug interaction 81.26 11.85 2088 411915 206455 31076886
Hospitalisation 81.23 11.85 354 413649 49453 31233888
Coagulopathy 80.26 11.85 464 413539 18051 31265290
Somnolence 77.24 11.85 1771 412232 97674 31185667
Off label use 75.65 11.85 3737 410266 343537 30939804
Injection site pain 72.40 11.85 222 413781 34412 31248929
Hepatotoxicity 71.32 11.85 461 413542 18665 31264676
Wrong technique in product usage process 70.94 11.85 212 413791 33131 31250210
Oxygen saturation decreased 69.43 11.85 962 413041 48153 31235188
Hepatic necrosis 69.26 11.85 150 413853 3513 31279828
Product use in unapproved indication 68.52 11.85 898 413105 98273 31185068
Prostate cancer 67.10 11.85 258 413745 37343 31245998
Coma 66.95 11.85 827 413176 40323 31243018
Death 66.06 11.85 3947 410056 356622 30926719
Myelosuppression 65.40 11.85 59 413944 14861 31268480
Prothrombin time shortened 65.25 11.85 86 413917 1318 31282023
Pyroglutamic acidosis 65.14 11.85 46 413957 301 31283040
Hepatitis cholestatic 64.58 11.85 223 413780 6923 31276418
Abdominal pain 64.04 11.85 2420 411583 143532 31139809
Mixed liver injury 62.84 11.85 111 413892 2226 31281115
Anaphylactic reaction 62.27 11.85 625 413378 28928 31254413
Pyrexia 62.24 11.85 4688 409315 299152 30984189
Diarrhoea 61.32 11.85 3876 410127 348533 30934808
Fixed eruption 59.94 11.85 84 413919 1369 31281972
Blood pressure diastolic abnormal 59.92 11.85 149 413854 3830 31279511
Contraindicated product administered 59.68 11.85 104 413899 19668 31263673
Anion gap 59.42 11.85 60 413943 677 31282664
Haematotoxicity 58.72 11.85 11 413992 7126 31276215
Transaminases increased 57.32 11.85 527 413476 23814 31259527
Cytokine release syndrome 57.15 11.85 393 413610 16249 31267092
Bladder cancer 56.83 11.85 65 413938 14660 31268681
Therapy non-responder 56.54 11.85 238 413765 33573 31249768
Immune reconstitution inflammatory syndrome 55.02 11.85 19 413984 8159 31275182
Diabetes mellitus 54.89 11.85 328 413675 42228 31241113
Cytomegalovirus infection 53.34 11.85 156 413847 24551 31258790
Renal impairment 52.52 11.85 802 413201 85547 31197794
Loss of personal independence in daily activities 52.49 11.85 191 413812 28097 31255244
Blood pressure increased 51.31 11.85 1383 412620 78250 31205091
Pathogen resistance 50.80 11.85 25 413978 8676 31274665
Ductus arteriosus premature closure 50.71 11.85 34 413969 202 31283139
Psoriatic arthropathy 50.23 11.85 116 413887 19767 31263574
Disease progression 48.18 11.85 861 413142 89603 31193738
Hepatic failure 47.21 11.85 643 413360 32059 31251282
Plasma cell myeloma 46.70 11.85 492 413511 56039 31227302
Multiple-drug resistance 46.61 11.85 3 414000 4477 31278864
Confusional state 46.46 11.85 2158 411845 131176 31152165
Cerebral infarction 45.22 11.85 180 413823 25797 31257544
Hepatitis fulminant 45.00 11.85 129 413874 3617 31279724
International normalised ratio increased 44.80 11.85 835 413168 44388 31238953
Progressive multifocal leukoencephalopathy 44.65 11.85 33 413970 9180 31274161
Therapy partial responder 44.57 11.85 15 413988 6547 31276794
Drug ineffective for unapproved indication 43.97 11.85 105 413898 17685 31265656
Graft versus host disease 43.81 11.85 43 413960 10404 31272937
C-reactive protein abnormal 42.88 11.85 24 413979 7745 31275596
Blood pressure systolic abnormal 42.75 11.85 112 413891 2975 31280366
Oesophageal carcinoma 42.66 11.85 26 413977 8007 31275334
Stevens-Johnson syndrome 42.37 11.85 379 413624 16993 31266348
Liver function test abnormal 42.12 11.85 582 413421 29110 31254231
Methaemoglobinaemia 41.57 11.85 109 413894 2897 31280444
Post transplant lymphoproliferative disorder 41.08 11.85 14 413989 6062 31277279
Respiratory depression 40.91 11.85 327 413676 14183 31269158
Pyroglutamate increased 40.47 11.85 32 413971 254 31283087
Glycosylated haemoglobin increased 40.04 11.85 46 413957 10354 31272987
Cell death 39.82 11.85 86 413917 2010 31281331
Inadequate analgesia 39.67 11.85 100 413903 2593 31280748
Depressed level of consciousness 39.02 11.85 715 413288 37886 31245455
Blood glucose increased 38.97 11.85 562 413441 60521 31222820
Acute generalised exanthematous pustulosis 38.65 11.85 169 413834 5871 31277470
Back pain 38.13 11.85 1771 412232 107642 31175699
Infusion site extravasation 37.79 11.85 119 413884 3518 31279823
Alanine aminotransferase increased 37.66 11.85 1258 412745 73398 31209943
Prothrombin time ratio decreased 37.48 11.85 34 413969 332 31283009
Sinusitis 37.19 11.85 680 413323 36016 31247325
Therapeutic product effect decreased 37.04 11.85 251 413752 31371 31251970
Drug abuser 35.87 11.85 122 413881 3758 31279583
Body temperature increased 35.46 11.85 328 413675 14845 31268496
Venoocclusive liver disease 35.34 11.85 27 413976 7385 31275956
Jaundice 34.56 11.85 572 413431 29715 31253626
Medication error 34.21 11.85 451 413552 22321 31261020
BK virus infection 33.99 11.85 12 413991 5083 31278258
Apparent death 33.23 11.85 4 413999 3601 31279740
Throat tightness 33.10 11.85 192 413811 7477 31275864
Chronic graft versus host disease 31.70 11.85 9 413994 4383 31278958
Blood pressure diastolic increased 31.61 11.85 125 413878 4148 31279193
Drug-induced liver injury 31.16 11.85 469 413534 23894 31259447
Unresponsive to stimuli 30.83 11.85 491 413512 25309 31258032
Virologic failure 30.47 11.85 3 414000 3162 31280179
Body temperature decreased 30.37 11.85 260 413743 11510 31271831
Tachycardia 30.18 11.85 1250 412753 74957 31208384
Cerebrovascular accident 30.01 11.85 799 413204 78685 31204656
Treatment noncompliance 29.52 11.85 205 413798 25479 31257862
Renal papillary necrosis 29.43 11.85 21 413982 140 31283201
Labelled drug-drug interaction medication error 29.23 11.85 82 413921 13081 31270260
Coronary artery disease 29.05 11.85 425 413578 45662 31237679
Respiratory arrest 28.54 11.85 492 413511 25765 31257576
Blood pressure systolic increased 28.17 11.85 383 413620 19087 31264254
Substance abuse 27.59 11.85 174 413829 6984 31276357
Miosis 27.45 11.85 199 413804 8371 31274970
Infusion site swelling 27.40 11.85 75 413928 2046 31281295
Full blood count abnormal 27.37 11.85 115 413888 16232 31267109
Flushing 27.02 11.85 548 413455 29580 31253761
Dysmorphism 26.90 11.85 4 413999 3068 31280273
Renal cortical necrosis 26.83 11.85 22 413981 185 31283156
Fluid retention 26.56 11.85 202 413801 24600 31258741
Asthma 26.49 11.85 394 413609 42217 31241124
Therapeutic response decreased 26.49 11.85 220 413783 26289 31257052
Hepatocellular carcinoma 26.48 11.85 46 413957 8710 31274631
Renal cancer 26.40 11.85 37 413966 7642 31275699
Bone marrow failure 26.40 11.85 236 413767 27772 31255569
Hepatorenal failure 26.33 11.85 34 413969 510 31282831
Prescription form tampering 26.32 11.85 31 413972 421 31282920
Nasal necrosis 26.29 11.85 13 413990 38 31283303
Aspergillus infection 26.20 11.85 71 413932 11457 31271884
Rash maculo-papular 26.20 11.85 477 413526 25242 31258099
Hypotension 26.19 11.85 3054 410949 201564 31081777
Heart rate increased 26.18 11.85 713 413290 40397 31242944
Acute graft versus host disease 26.18 11.85 25 413978 6128 31277213
Viral mutation identified 25.70 11.85 3 414000 2766 31280575
Nocardiosis 25.66 11.85 7 413996 3500 31279841
Factor VIII inhibition 25.64 11.85 26 413977 295 31283046
Anaemia 25.57 11.85 2421 411582 211101 31072240
Headache 25.54 11.85 2756 411247 180896 31102445
Syringe issue 25.39 11.85 16 413987 4840 31278501
Bronchopulmonary aspergillosis 25.33 11.85 92 413911 13542 31269799
Drug intolerance 25.28 11.85 503 413500 51530 31231811
Acute graft versus host disease in skin 25.16 11.85 16 413987 4816 31278525
Infusion site pruritus 25.13 11.85 35 413968 567 31282774
Atrial fibrillation 25.09 11.85 1222 412781 112561 31170780
Aspartate aminotransferase increased 24.89 11.85 1029 412974 61690 31221651
Blood alkaline phosphatase increased 24.87 11.85 531 413472 28922 31254419
Infusion site pain 24.70 11.85 95 413908 3111 31280230
Agranulocytosis 24.51 11.85 402 413601 20845 31262496
Cardiac disorder 24.24 11.85 363 413640 38851 31244490
Device leakage 24.21 11.85 21 413982 5392 31277949
Livedo reticularis 24.12 11.85 72 413931 2066 31281275
Hyperhidrosis 23.92 11.85 1093 412910 66300 31217041
Injection site swelling 23.78 11.85 61 413942 10026 31273315
Constipation 23.75 11.85 1904 412099 122087 31161254
Neuropathy peripheral 23.21 11.85 782 413221 74867 31208474
Cardio-respiratory arrest 23.19 11.85 860 413143 50866 31232475
Product prescribing error 22.96 11.85 156 413847 19486 31263855
Oral pruritus 22.81 11.85 23 413980 259 31283082
Mucosal inflammation 22.57 11.85 315 413688 34112 31249229
Acute myocardial infarction 22.43 11.85 499 413504 50324 31233017
Cardiac failure chronic 22.42 11.85 38 413965 7265 31276076
Coagulation factor VII level decreased 22.15 11.85 16 413987 109 31283232
COVID-19 treatment 22.08 11.85 22 413981 244 31283097
Mydriasis 22.06 11.85 154 413849 6398 31276943
Mucocutaneous disorder 21.92 11.85 16 413987 111 31283230
Transplant rejection 21.91 11.85 60 413943 9648 31273693
Graft versus host disease in gastrointestinal tract 21.87 11.85 9 413994 3470 31279871
Psychotic disorder 21.83 11.85 186 413817 22107 31261234
Platelet count decreased 21.69 11.85 1200 412803 109235 31174106
Diffuse large B-cell lymphoma recurrent 21.65 11.85 6 413997 2969 31280372
Visual acuity reduced 21.54 11.85 115 413888 15228 31268113
Intracranial pressure increased 21.52 11.85 99 413904 3516 31279825
Vascular stent thrombosis 21.45 11.85 5 413998 2780 31280561
Angina pectoris 21.33 11.85 266 413737 29375 31253966
Prothrombin time prolonged 21.30 11.85 197 413806 8915 31274426
Interstitial lung disease 20.94 11.85 626 413377 60777 31222564
Anaphylactic shock 20.77 11.85 279 413724 13866 31269475
Therapy interrupted 20.69 11.85 70 413933 10526 31272815
Unintentional medical device removal 20.49 11.85 4 413999 2516 31280825
Kidney transplant rejection 20.47 11.85 40 413963 7242 31276099
Accidental exposure to product by child 20.30 11.85 54 413949 1448 31281893
General physical health deterioration 20.23 11.85 1244 412759 112191 31171150
Prothrombin time abnormal 20.23 11.85 32 413971 584 31282757
Sleep disorder due to a general medical condition 20.21 11.85 13 413990 3889 31279452
Endophthalmitis 20.20 11.85 11 413992 3605 31279736
Dizziness 20.16 11.85 2285 411718 196862 31086479
Prostate cancer stage IV 20.07 11.85 3 414000 2292 31281049
Therapy cessation 19.96 11.85 115 413888 14940 31268401
Acidosis 19.83 11.85 208 413795 9738 31273603
Maternal exposure before pregnancy 19.76 11.85 34 413969 667 31282674
Hepatitis C 19.57 11.85 72 413931 10558 31272783
Prostatic specific antigen increased 19.27 11.85 101 413902 13437 31269904
Injection site haemorrhage 19.15 11.85 58 413945 9027 31274314
Hyperlipasaemia 19.12 11.85 28 413975 476 31282865
Underdose 19.11 11.85 92 413911 12515 31270826
Body temperature fluctuation 19.06 11.85 55 413948 1548 31281793
Feeling hot 19.04 11.85 308 413695 15925 31267416
Colorectal cancer 18.98 11.85 21 413982 4808 31278533
Injection site bruising 18.98 11.85 48 413955 7927 31275414
Hand deformity 18.96 11.85 8 413995 3039 31280302
Neutropenic sepsis 18.94 11.85 246 413757 12133 31271208
Peripheral swelling 18.89 11.85 710 413293 67155 31216186
Schizophrenia 18.87 11.85 75 413928 10755 31272586
Obstructive airways disorder 18.86 11.85 93 413910 12571 31270770
Lip oedema 18.85 11.85 70 413933 2254 31281087
Intraocular pressure increased 18.85 11.85 24 413979 5163 31278178
Viral load increased 18.83 11.85 3 414000 2186 31281155
Sphincter of Oddi dysfunction 18.78 11.85 15 413988 121 31283220
Immunosuppressant drug level increased 18.64 11.85 25 413978 5260 31278081
Erythema 18.48 11.85 1253 412750 79152 31204189
Cryptococcosis 18.41 11.85 4 413999 2334 31281007
Pharyngeal paraesthesia 18.34 11.85 29 413974 529 31282812
No adverse event 18.22 11.85 166 413837 19459 31263882
Rheumatoid arthritis 18.19 11.85 480 413523 47329 31236012
Use of accessory respiratory muscles 18.10 11.85 24 413979 370 31282971
Drug reaction with eosinophilia and systemic symptoms 18.09 11.85 517 413486 29501 31253840
Hepatitis B 17.82 11.85 30 413973 5751 31277590
Ejection fraction decreased 17.73 11.85 144 413859 17290 31266051
Hypertransaminasaemia 17.45 11.85 106 413897 4198 31279143
Throat irritation 17.27 11.85 192 413811 9122 31274219
Eyelid ptosis 17.10 11.85 28 413975 5427 31277914
Cytomegalovirus chorioretinitis 16.97 11.85 12 413991 3416 31279925
Failure to suspend medication 16.91 11.85 24 413979 396 31282945
Tenosynovitis 16.89 11.85 18 413985 4192 31279149
Glucose-6-phosphate dehydrogenase deficiency 16.86 11.85 14 413989 120 31283221
Angioedema 16.81 11.85 566 413437 33052 31250289
Paradoxical drug reaction 16.79 11.85 10 413993 3119 31280222
Accidental exposure to product 16.79 11.85 85 413918 11410 31271931
Environmental exposure 16.70 11.85 19 413984 248 31283093
Haematemesis 16.64 11.85 446 413557 25207 31258134
Parkinsonism 16.64 11.85 48 413955 7588 31275753
Rebound effect 16.63 11.85 6 413997 2507 31280834
Band neutrophil percentage decreased 16.63 11.85 7 413996 12 31283329
Coronary artery bypass 16.62 11.85 23 413980 4776 31278565
Coronary arterial stent insertion 16.58 11.85 17 413986 4031 31279310
Rhinalgia 16.36 11.85 23 413980 376 31282965
Oedematous pancreatitis 16.33 11.85 25 413978 443 31282898
Dependent personality disorder 16.25 11.85 12 413991 85 31283256
Periportal oedema 16.25 11.85 10 413993 50 31283291
Intentional self-injury 16.13 11.85 254 413749 13061 31270280
Brain death 16.11 11.85 70 413933 2425 31280916
Condition aggravated 16.04 11.85 1886 412117 162123 31121218
Hypothermia 16.03 11.85 193 413810 9351 31273990
Myopathy 15.99 11.85 80 413923 10772 31272569
Injection site reaction 15.98 11.85 88 413915 11563 31271778
Heart rate irregular 15.98 11.85 269 413734 14020 31269321
Kidney fibrosis 15.84 11.85 4 413999 2106 31281235
Bezoar 15.83 11.85 36 413967 872 31282469
Nipple inflammation 15.80 11.85 10 413993 53 31283288
Rhabdomyolysis 15.79 11.85 674 413329 62907 31220434
Lymphocyte count abnormal 15.71 11.85 33 413970 756 31282585
Myelodysplastic syndrome 15.70 11.85 168 413835 19083 31264258
Poisoning 15.69 11.85 206 413797 10185 31273156
Self-medication 15.66 11.85 65 413938 2206 31281135
Synovitis 15.66 11.85 95 413908 12188 31271153
Gamma-glutamyltransferase increased 15.62 11.85 475 413528 27350 31255991
Posterior reversible encephalopathy syndrome 15.61 11.85 66 413937 9301 31274040
Blood pH decreased 15.59 11.85 63 413940 2112 31281229
Lower respiratory tract infection 15.57 11.85 481 413522 27756 31255585
Beta haemolytic streptococcal infection 15.47 11.85 25 413978 465 31282876
Neutrophil percentage increased 15.45 11.85 55 413948 1734 31281607
Dyspnoea at rest 15.43 11.85 14 413989 3517 31279824
Metastases to liver 15.42 11.85 100 413903 12627 31270714
Pneumonia cytomegaloviral 15.39 11.85 9 413994 2835 31280506
Pain 15.34 11.85 2717 411286 184042 31099299
Lymph node calcification 15.33 11.85 14 413989 138 31283203
Device issue 15.27 11.85 58 413945 8426 31274915
Hepatitis toxic 15.24 11.85 59 413944 1938 31281403
Disease recurrence 15.16 11.85 163 413840 18498 31264843
Respiratory rate increased 15.11 11.85 186 413817 9059 31274282
Cerebral atrophy congenital 15.10 11.85 10 413993 58 31283283
Febrile neutropenia 15.07 11.85 1815 412188 120034 31163307
Low birth weight baby 15.05 11.85 44 413959 6926 31276415
Tuberculosis 15.02 11.85 57 413946 8284 31275057
Angular cheilitis 15.01 11.85 15 413988 167 31283174
Product storage error 14.97 11.85 45 413958 7021 31276320
Generalised bullous fixed drug eruption 14.94 11.85 9 413994 43 31283298
Thrombotic microangiopathy 14.91 11.85 67 413936 9284 31274057
Aptyalism 14.87 11.85 19 413984 282 31283059
Graft versus host disease in skin 14.86 11.85 15 413988 3582 31279759
Cytomegalovirus viraemia 14.85 11.85 42 413961 6683 31276658
Gastric ulcer perforation 14.83 11.85 37 413966 953 31282388
Hepatic cirrhosis 14.80 11.85 132 413871 15542 31267799
Antipsychotic drug level below therapeutic 14.78 11.85 4 413999 2011 31281330
JC virus infection 14.55 11.85 4 413999 1990 31281351
Mucormycosis 14.47 11.85 32 413971 5538 31277803
Lymphoproliferative disorder 14.44 11.85 8 413995 2597 31280744
Duodenal ulcer perforation 14.43 11.85 49 413954 1508 31281833
Incision site complication 14.38 11.85 19 413984 292 31283049
Infection 14.34 11.85 900 413103 81031 31202310
Hyperbilirubinaemia 14.29 11.85 287 413716 15463 31267878
Bone erosion 14.28 11.85 14 413989 3389 31279952
Cryopyrin associated periodic syndrome 14.24 11.85 11 413992 84 31283257
Hypertriglyceridaemia 14.23 11.85 53 413950 7745 31275596
Pulmonary arterial hypertension 14.13 11.85 73 413930 9748 31273593
Hepatic cancer 14.09 11.85 53 413950 7722 31275619
Psychomotor retardation 14.08 11.85 13 413990 3239 31280102
Hepatic encephalopathy 14.08 11.85 254 413749 13417 31269924
Cystitis haemorrhagic 14.06 11.85 30 413973 5259 31278082
Agitation 14.05 11.85 853 413150 53316 31230025
Neuroleptic malignant syndrome 13.85 11.85 147 413856 16722 31266619
Nipple disorder 13.83 11.85 15 413988 185 31283156
Patent ductus arteriosus 13.82 11.85 80 413923 3113 31280228
Acute haemorrhagic oedema of infancy 13.81 11.85 8 413995 35 31283306
Product quality issue 13.80 11.85 139 413864 15972 31267369
Joint swelling 13.77 11.85 564 413439 52867 31230474
Ear injury 13.64 11.85 8 413995 36 31283305
Salivary gland calculus 13.62 11.85 9 413994 52 31283289
Chronic obstructive pulmonary disease 13.59 11.85 468 413535 44698 31238643
Feeling abnormal 13.59 11.85 607 413396 56395 31226946
Infusion site bruising 13.52 11.85 25 413978 520 31282821
Testicular infarction 13.48 11.85 9 413994 53 31283288
Fragile X syndrome 13.48 11.85 8 413995 37 31283304
Erythema multiforme 13.46 11.85 163 413840 7908 31275433
Pemphigus 13.45 11.85 45 413958 1374 31281967
Akathisia 13.43 11.85 49 413954 7204 31276137
Asthenia 13.35 11.85 2661 411342 222094 31061247
Ureteric obstruction 13.29 11.85 40 413963 1153 31282188
Aplasia pure red cell 13.29 11.85 35 413968 5702 31277639
Kussmaul respiration 13.27 11.85 11 413992 94 31283247
Coagulation factor V level decreased 13.27 11.85 16 413987 223 31283118
Noninfective encephalitis 13.22 11.85 9 413994 55 31283286
Poor venous access 13.22 11.85 95 413908 3985 31279356
Depression 13.18 11.85 1014 412989 89801 31193540
Electrocardiogram abnormal 13.16 11.85 57 413946 7979 31275362
Colour blindness acquired 13.09 11.85 10 413993 75 31283266
Thrombosis 13.09 11.85 470 413533 44681 31238660
Palmar-plantar erythrodysaesthesia syndrome 13.08 11.85 134 413869 15349 31267992
Oropharyngeal blistering 13.08 11.85 14 413989 170 31283171
Oedema peripheral 13.03 11.85 1246 412757 108593 31174748
Blood pressure diastolic decreased 13.01 11.85 161 413842 7852 31275489
Dose calculation error 13.00 11.85 8 413995 40 31283301
Dyspnoea exertional 12.97 11.85 397 413606 38440 31244901
Haemarthrosis 12.96 11.85 74 413929 2865 31280476
Oesophageal obstruction 12.92 11.85 23 413980 464 31282877
Pancreatic carcinoma 12.90 11.85 63 413940 8537 31274804
Infusion site rash 12.86 11.85 21 413982 394 31282947
Incorrect dose administered by device 12.86 11.85 3 414000 1667 31281674
Lip swelling 12.84 11.85 245 413758 13078 31270263
Cardiomyopathy 12.84 11.85 133 413870 15200 31268141
Coma scale abnormal 12.83 11.85 88 413915 3635 31279706
Vascular purpura 12.81 11.85 45 413958 1409 31281932
Blood lactic acid 12.81 11.85 19 413984 327 31283014
Blood ethanol increased 12.79 11.85 23 413980 468 31282873
Pneumococcal infection 12.79 11.85 21 413982 396 31282945
Mitochondrial toxicity 12.75 11.85 9 413994 2564 31280777
Jaundice cholestatic 12.74 11.85 101 413902 4369 31278972
Drug abuse 12.73 11.85 1321 412682 86437 31196904
Pleural thickening 12.73 11.85 18 413985 296 31283045
Haemolytic anaemia 12.69 11.85 189 413814 9607 31273734
Rhinitis allergic 12.68 11.85 72 413931 2782 31280559
Drug screen positive 12.66 11.85 90 413913 3762 31279579
Prostate cancer stage II 12.65 11.85 6 413997 2127 31281214
Mast cell activation syndrome 12.64 11.85 14 413989 177 31283164
Chondrocalcinosis 12.59 11.85 18 413985 299 31283042
Cytopenia 12.59 11.85 88 413915 10922 31272419
Hyperthermia 12.56 11.85 192 413811 9812 31273529
Rash macular 12.55 11.85 214 413789 11181 31272160
Hemiparesis 12.55 11.85 129 413874 14765 31268576
Pneumonia 12.54 11.85 4054 409949 331258 30952083
Enthesopathy 12.53 11.85 23 413980 4264 31279077
Electrocardiogram QT prolonged 12.52 11.85 389 413614 37598 31245743
Negative pressure pulmonary oedema 12.50 11.85 15 413988 208 31283133
Croup infectious 12.46 11.85 18 413985 302 31283039
Hypoxia 12.44 11.85 789 413214 49524 31233817
Allergic cough 12.37 11.85 7 413996 29 31283312
Systemic candida 12.36 11.85 14 413989 3172 31280169
Obsessive-compulsive disorder 12.31 11.85 29 413974 4908 31278433
Neck pain 12.30 11.85 389 413614 22521 31260820
Face oedema 12.29 11.85 201 413802 10415 31272926
Mycobacterial infection 12.28 11.85 7 413996 2236 31281105
Skin degenerative disorder 12.27 11.85 6 413997 17 31283324
Therapeutic product effect variable 12.20 11.85 5 413998 1933 31281408
Crystal urine present 12.07 11.85 21 413982 416 31282925
Injection site pruritus 12.04 11.85 41 413962 6153 31277188
Specific gravity urine decreased 12.02 11.85 10 413993 86 31283255
Dermo-hypodermitis 11.92 11.85 18 413985 315 31283026
Acute kidney injury 11.91 11.85 3951 410052 275763 31007578
Specific gravity urine increased 11.91 11.85 12 413991 135 31283206
Visual impairment 11.91 11.85 314 413689 30965 31252376
Macrophages increased 11.88 11.85 13 413990 162 31283179
Status epilepticus 11.85 11.85 101 413902 12005 31271336

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Toxicity to various agents 3326.71 11.15 12878 1047358 369294 69498914
Intentional overdose 1860.14 11.15 4368 1055868 94067 69774141
Completed suicide 1820.23 11.15 7466 1052770 219669 69648539
Acute hepatic failure 1611.00 11.15 2028 1058208 25644 69842564
Overdose 1401.34 11.15 5633 1054603 164112 69704096
Analgesic drug level increased 1220.85 11.15 637 1059599 1806 69866402
Hepatocellular injury 1045.45 11.15 2201 1058035 43890 69824318
Drug ineffective 913.05 11.15 9323 1050913 930429 68937779
Poisoning deliberate 766.21 11.15 1102 1059134 15958 69852250
Suicide attempt 720.76 11.15 2719 1057517 76791 69791417
Infusion related reaction 629.01 11.15 5076 1055160 192458 69675750
Intentional product misuse 526.23 11.15 2472 1057764 77123 69791085
Metabolic acidosis 424.59 11.15 2215 1058021 72131 69796077
Exposure to toxic agent 424.13 11.15 493 1059743 5701 69862507
Product dose omission issue 400.92 11.15 1778 1058458 215690 69652518
Cholestasis 367.02 11.15 1554 1058682 46318 69821890
Injection site pain 359.54 11.15 762 1059474 116857 69751351
Blood pressure fluctuation 357.08 11.15 1787 1058449 57225 69810983
Drug resistance 343.75 11.15 75 1060161 38115 69830093
Hepatotoxicity 288.36 11.15 1363 1058873 42623 69825585
Accidental overdose 269.13 11.15 1140 1059096 33981 69834227
Psoriasis 254.63 11.15 696 1059540 97737 69770471
Hepatitis 244.42 11.15 1428 1058808 48552 69819656
Off label use 235.79 11.15 8909 1051327 734151 69134057
Coagulopathy 231.00 11.15 1048 1059188 32201 69836007
Coma 230.35 11.15 2241 1057995 89603 69778605
Hepatic failure 229.30 11.15 1562 1058674 56063 69812145
Somnolence 225.76 11.15 4500 1055736 211106 69657102
Cardiac failure congestive 220.66 11.15 1157 1059079 134300 69733908
Injection site erythema 218.19 11.15 478 1059758 72446 69795762
Liver injury 217.50 11.15 1198 1059038 39837 69828371
Device expulsion 212.15 11.15 38 1060198 22208 69846000
Hepatic necrosis 209.02 11.15 424 1059812 8222 69859986
Anion gap 205.95 11.15 192 1060044 1678 69866530
Therapeutic product effect incomplete 202.60 11.15 1011 1059225 118871 69749337
Hepatic cytolysis 199.89 11.15 687 1059549 18505 69849703
Hepatitis acute 197.56 11.15 556 1059680 13406 69854802
Wrong technique in product usage process 196.03 11.15 462 1059774 68236 69799972
Vomiting 191.01 11.15 10760 1049476 582351 69285857
Myocardial infarction 174.29 11.15 1681 1058555 169964 69698244
Product use in unapproved indication 172.28 11.15 2128 1058108 205350 69662858
Toxic epidermal necrolysis 166.85 11.15 1088 1059148 38469 69829739
Drug hypersensitivity 164.21 11.15 2846 1057390 259613 69608595
Prothrombin time shortened 163.88 11.15 211 1060025 2731 69865477
Depressed level of consciousness 155.55 11.15 1994 1058242 85437 69782771
Injection site reaction 153.09 11.15 322 1059914 49530 69818678
Treatment failure 153.03 11.15 1396 1058840 142746 69725462
Hepatitis cholestatic 151.64 11.15 475 1059761 12175 69856033
Cardiac failure 149.87 11.15 1396 1058840 142145 69726063
Cholecystitis chronic 147.27 11.15 388 1059848 8988 69859220
Pyroglutamic acidosis 146.00 11.15 112 1060124 725 69867483
Urticaria 145.99 11.15 3327 1056909 159722 69708486
Abdominal pain 144.35 11.15 6373 1053863 335754 69532454
International normalised ratio increased 142.73 11.15 1839 1058397 78887 69789321
Injection site swelling 141.76 11.15 268 1059968 42889 69825319
Medication error 139.41 11.15 1382 1058854 55530 69812678
Pyroglutamate increased 137.57 11.15 99 1060137 573 69867635
Hospitalisation 136.81 11.15 701 1059535 81867 69786341
Disease progression 136.10 11.15 1591 1058645 155081 69713127
Heart rate decreased 134.44 11.15 1469 1058767 60546 69807662
Cytomegalovirus infection 134.04 11.15 243 1059993 39515 69828693
Confusional state 132.88 11.15 5355 1054881 279043 69589165
Hepatitis fulminant 130.67 11.15 298 1059938 6283 69861925
Blood pressure diastolic abnormal 129.62 11.15 517 1059719 14987 69853221
Transaminases increased 126.18 11.15 1164 1059072 45854 69822354
Myelosuppression 126.02 11.15 159 1060077 29986 69838222
Injection site pruritus 124.86 11.15 248 1059988 38962 69829246
Oxygen saturation decreased 120.38 11.15 2426 1057810 114003 69754205
Mixed liver injury 119.71 11.15 279 1059957 5970 69862238
Intentional self-injury 119.45 11.15 847 1059389 30803 69837405
Body temperature increased 116.58 11.15 1005 1059231 38829 69829379
Therapy non-responder 115.88 11.15 674 1059562 76241 69791967
Diarrhoea 110.66 11.15 10145 1050091 773196 69095012
Respiratory depression 109.66 11.15 691 1059545 24140 69844068
Chills 107.07 11.15 2879 1057357 141907 69726301
Prothrombin time ratio decreased 106.53 11.15 91 1060145 700 69867508
Blood pressure increased 105.69 11.15 3623 1056613 184894 69683314
Acute generalised exanthematous pustulosis 105.22 11.15 483 1059753 14914 69853294
Injection site bruising 104.36 11.15 261 1059975 37771 69830437
Heart rate increased 103.56 11.15 2193 1058043 103955 69764253
Blood pressure systolic abnormal 102.78 11.15 424 1059812 12485 69855723
Haematotoxicity 102.48 11.15 38 1060198 13636 69854572
Urine abnormality 102.08 11.15 303 1059933 7535 69860673
Bone marrow failure 100.61 11.15 384 1059852 48626 69819582
Drug interaction 100.26 11.15 4669 1055567 376772 69491436
Pathogen resistance 99.35 11.15 37 1060199 13242 69854966
Renal impairment 99.11 11.15 1533 1058703 142404 69725804
Red blood cell sedimentation rate abnormal 96.06 11.15 88 1060148 19215 69848993
Post transplant lymphoproliferative disorder 94.31 11.15 21 1060215 10524 69857684
Alanine aminotransferase increased 93.70 11.15 2877 1057359 144603 69723605
Condition aggravated 92.14 11.15 5341 1054895 422294 69445914
Prostate cancer 90.96 11.15 207 1060029 30956 69837252
Loss of personal independence in daily activities 88.07 11.15 827 1059409 84083 69784125
Psoriatic arthropathy 86.53 11.15 589 1059647 64182 69804026
Diabetes mellitus 85.91 11.15 674 1059562 71150 69797058
Throat irritation 84.37 11.15 853 1059383 34451 69833757
Therapy cessation 84.17 11.15 242 1059994 33434 69834774
Therapeutic response decreased 83.43 11.15 521 1059715 57932 69810276
Product prescribing error 83.35 11.15 300 1059936 38652 69829556
Plasma cell myeloma 82.93 11.15 697 1059539 72504 69795704
Multiple-drug resistance 80.98 11.15 8 1060228 7347 69860861
Lower respiratory tract infection 80.35 11.15 2217 1058019 109696 69758512
Interstitial lung disease 78.99 11.15 1095 1059141 103590 69764618
Transplant rejection 78.96 11.15 93 1060143 18078 69850130
Bladder cancer 78.46 11.15 85 1060151 17157 69851051
Miosis 78.31 11.15 417 1059819 13684 69854524
Tachycardia 76.90 11.15 2998 1057238 155548 69712660
Prothrombin time prolonged 76.83 11.15 459 1059777 15731 69852477
Fixed eruption 75.93 11.15 135 1060101 2361 69865847
Drug ineffective for unapproved indication 75.88 11.15 307 1059929 38231 69829977
Urine leukocyte esterase positive 75.67 11.15 168 1060068 3477 69864731
Graft versus host disease 75.34 11.15 68 1060168 14955 69853253
Pyrexia 74.43 11.15 10254 1049982 596698 69271510
Acute graft versus host disease 74.35 11.15 25 1060211 9537 69858671
Hepatic encephalopathy 73.85 11.15 575 1059661 21543 69846665
Liver function test abnormal 73.46 11.15 1304 1058932 59842 69808366
Rheumatoid arthritis 73.40 11.15 3588 1056648 288217 69579991
Drug-induced liver injury 73.33 11.15 1213 1059023 54900 69813308
Unintentional medical device removal 72.84 11.15 10 1060226 7114 69861094
Therapy interrupted 71.38 11.15 166 1060070 24636 69843572
Cardio-respiratory arrest 71.03 11.15 1990 1058246 98687 69769521
Blood pressure systolic increased 70.54 11.15 1226 1059010 56033 69812175
Granuloma skin 69.30 11.15 15 1060221 7667 69860541
Stevens-Johnson syndrome 69.03 11.15 831 1059405 35076 69833132
Pulmonary arterial hypertension 69.01 11.15 255 1059981 32600 69835608
Poisoning 68.96 11.15 576 1059660 22046 69846162
Anaemia 68.01 11.15 5150 1055086 398273 69469935
Renal papillary necrosis 67.83 11.15 51 1060185 319 69867889
Immune reconstitution inflammatory syndrome 67.32 11.15 57 1060179 12933 69855275
Device use error 67.06 11.15 10 1060226 6686 69861522
Oesophageal carcinoma 66.94 11.15 28 1060208 9338 69858870
Blood parathyroid hormone decreased 66.09 11.15 26 1060210 8998 69859210
Device issue 65.82 11.15 165 1060071 23860 69844348
C-reactive protein abnormal 64.76 11.15 326 1059910 38253 69829955
Drug intolerance 64.01 11.15 2739 1057497 222948 69645260
Breast cancer stage I 63.75 11.15 8 1060228 6094 69862114
Product monitoring error 63.70 11.15 12 1060224 6764 69861444
Respiratory arrest 63.66 11.15 1147 1059089 52786 69815422
Cerebral infarction 63.65 11.15 379 1059857 42630 69825578
Crystal urine present 63.33 11.15 112 1060124 1950 69866258
White blood cells urine positive 63.25 11.15 207 1060029 5433 69862775
Rheumatoid nodule 62.43 11.15 80 1060156 14987 69853221
Hypotension 62.25 11.15 6930 1053306 397451 69470757
Acidosis 62.21 11.15 477 1059759 17786 69850422
Accidental exposure to product 62.06 11.15 213 1060023 27838 69840370
Drug abuser 62.02 11.15 211 1060025 5653 69862555
Injection site warmth 61.98 11.15 69 1060167 13756 69854452
Drug abuse 61.94 11.15 2743 1057493 144513 69723695
Bradypnoea 61.80 11.15 201 1060035 5258 69862950
Myelodysplastic syndrome 61.37 11.15 233 1060003 29552 69838656
Blood pressure diastolic increased 61.19 11.15 355 1059881 12036 69856172
Product storage error 60.46 11.15 77 1060159 14464 69853744
Labelled drug-drug interaction medication error 59.85 11.15 174 1060062 23953 69844255
Cytokine release syndrome 58.76 11.15 630 1059606 25837 69842371
Bone erosion 58.39 11.15 85 1060151 15088 69853120
Posterior reversible encephalopathy syndrome 58.36 11.15 179 1060057 24223 69843985
Jaundice 58.21 11.15 1063 1059173 49045 69819163
Back pain 57.76 11.15 4755 1055481 266397 69601811
Aspergillus infection 57.76 11.15 112 1060124 17756 69850452
Neoplasm progression 57.60 11.15 417 1059819 44811 69823397
Chronic graft versus host disease 57.57 11.15 15 1060221 6755 69861453
Lymphocyte count decreased 57.56 11.15 943 1059293 42596 69825612
Sinusitis 57.39 11.15 3086 1057150 166109 69702099
Pneumonia 55.66 11.15 7939 1052297 588293 69279915
Mucosal inflammation 55.46 11.15 698 1059538 67152 69801056
Urinary sediment present 55.43 11.15 114 1060122 2233 69865975
Colorectal cancer 54.87 11.15 29 1060207 8441 69859767
Surgery 54.68 11.15 246 1059990 29743 69838465
Blood pressure diastolic decreased 54.63 11.15 608 1059628 25172 69843036
Rash maculo-papular 54.49 11.15 1060 1059176 49485 69818723
Therapy partial responder 54.03 11.15 64 1060172 12410 69855798
Anaphylactic reaction 54.01 11.15 1486 1058750 73488 69794720
Renal cancer 53.84 11.15 58 1060178 11738 69856470
Injection site haemorrhage 53.70 11.15 198 1060038 25329 69842879
Cell death 53.41 11.15 161 1060075 4039 69864169
Breast cancer female 53.14 11.15 47 1060189 10439 69857769
Flushing 52.69 11.15 1605 1058631 80567 69787641
Aspartate aminotransferase increased 52.24 11.15 2360 1057876 124618 69743590
Transplant dysfunction 52.11 11.15 19 1060217 6890 69861318
Acute graft versus host disease in skin 51.56 11.15 21 1060215 7116 69861092
General physical health deterioration 51.08 11.15 2946 1057290 233085 69635123
Muscle injury 50.98 11.15 834 1059402 37660 69830548
BK virus infection 50.81 11.15 28 1060208 7961 69860247
Mydriasis 50.69 11.15 414 1059822 15739 69852469
Blood alkaline phosphatase increased 50.42 11.15 1188 1059048 57333 69810875
Platelet count decreased 50.30 11.15 2164 1058072 176058 69692150
Pruritus 50.18 11.15 5900 1054336 339660 69528548
Acute myocardial infarction 49.90 11.15 777 1059459 72110 69796098
Injection site mass 49.46 11.15 127 1060109 18216 69849992
Full blood count abnormal 49.36 11.15 300 1059936 33578 69834630
Acute lung injury 49.06 11.15 121 1060115 2688 69865520
Device difficult to use 48.79 11.15 54 1060182 10795 69857413
Gallbladder injury 48.22 11.15 72 1060164 1080 69867128
Panniculitis 48.17 11.15 53 1060183 10623 69857585
Coagulation factor VII level decreased 48.16 11.15 34 1060202 190 69868018
Bronchopulmonary aspergillosis 48.16 11.15 157 1060079 20845 69847363
Infusion site extravasation 48.06 11.15 242 1059994 7766 69860442
Hypertransaminasaemia 47.99 11.15 262 1059974 8681 69859527
Glycosylated haemoglobin increased 47.98 11.15 119 1060117 17272 69850936
Palmar-plantar erythrodysaesthesia syndrome 47.74 11.15 261 1059975 29986 69838222
Blood glucose increased 47.33 11.15 1174 1059062 101808 69766400
Device malfunction 47.07 11.15 138 1060098 18946 69849262
Septic shock 46.78 11.15 1298 1058938 110960 69757248
Metastases to liver 46.75 11.15 213 1060023 25665 69842543
Cerebrovascular accident 46.54 11.15 1714 1058522 141756 69726452
Irritable bowel syndrome 46.20 11.15 1040 1059196 49810 69818398
Emotional distress 45.71 11.15 796 1059440 36392 69831816
Underdose 45.58 11.15 255 1059981 29128 69839080
Blood calcium decreased 45.55 11.15 644 1059592 28202 69840006
Asthma 45.26 11.15 1417 1058819 119376 69748832
Constipation 45.17 11.15 4371 1055865 248067 69620141
Unresponsive to stimuli 44.98 11.15 1055 1059181 50876 69817332
Substance abuse 44.84 11.15 276 1059960 9561 69858647
Abdominal pain upper 44.78 11.15 3417 1056819 190185 69678023
Second primary malignancy 44.68 11.15 79 1060157 12972 69855236
Folliculitis 44.62 11.15 889 1059347 41681 69826527
Blister 44.59 11.15 1883 1058353 98643 69769565
Hypocoagulable state 44.46 11.15 94 1060142 1879 69866329
Nocardiosis 44.31 11.15 11 1060225 5118 69863090
Thrombotic microangiopathy 44.06 11.15 129 1060107 17719 69850489
Strongyloidiasis 43.89 11.15 3 1060233 3720 69864488
Treatment noncompliance 43.55 11.15 465 1059771 46109 69822099
Neuropathy peripheral 43.20 11.15 1507 1058729 125389 69742819
Encephalopathy 42.97 11.15 1217 1059019 60444 69807764
Respiratory rate increased 42.16 11.15 465 1059771 19207 69849001
Lymphocyte percentage decreased 42.08 11.15 162 1060074 4617 69863591
Mucormycosis 41.73 11.15 35 1060201 7979 69860229
Cytomegalovirus viraemia 41.59 11.15 69 1060167 11616 69856592
Breast cancer stage II 41.53 11.15 14 1060222 5332 69862876
Lymphoproliferative disorder 41.32 11.15 14 1060222 5315 69862893
Ear pruritus 41.24 11.15 120 1060116 2950 69865258
Body temperature fluctuation 41.16 11.15 132 1060104 3427 69864781
Device leakage 41.13 11.15 47 1060189 9261 69858947
Heart rate irregular 41.11 11.15 649 1059587 29094 69839114
Vascular stent thrombosis 41.07 11.15 3 1060233 3520 69864688
Metastases to lung 40.80 11.15 119 1060117 16365 69851843
Hepatitis toxic 40.58 11.15 156 1060080 4443 69863765
Coronary artery disease 40.21 11.15 677 1059559 62059 69806149
Gamma-glutamyltransferase increased 40.08 11.15 1017 1059219 49668 69818540
Systemic infection 39.98 11.15 25 1060211 6632 69861576
Pulmonary hypertension 39.82 11.15 474 1059762 46062 69822146
Neutrophil percentage increased 39.21 11.15 153 1060083 4389 69863819
Kidney transplant rejection 39.13 11.15 55 1060181 9906 69858302
Disease recurrence 39.08 11.15 366 1059870 37237 69830971
Oedema peripheral 38.96 11.15 2908 1057328 225183 69643025
Skin necrosis 38.60 11.15 120 1060116 16171 69852037
Atrial fibrillation 38.60 11.15 2308 1057928 182040 69686168
Lipodystrophy acquired 38.51 11.15 8 1060228 4208 69864000
Immunosuppressant drug level increased 38.23 11.15 37 1060199 7870 69860338
Sedation complication 38.02 11.15 336 1059900 13074 69855134
Virologic failure 37.99 11.15 6 1060230 3844 69864364
Injection site induration 37.65 11.15 49 1060187 9119 69859089
Neurotoxicity 37.50 11.15 276 1059960 29550 69838658
Headache 37.37 11.15 9490 1050746 570915 69297293
Infusion site pain 37.16 11.15 298 1059938 11266 69856942
Dyspnoea exertional 37.16 11.15 890 1059346 77540 69790668
Coronary arterial stent insertion 36.91 11.15 21 1060215 5866 69862342
Myopathy 36.81 11.15 148 1060088 18464 69849744
Duodenal ulcer perforation 36.51 11.15 1012 1059224 50100 69818108
Venoocclusive liver disease 36.22 11.15 65 1060171 10613 69857595
Acute myeloid leukaemia 36.22 11.15 292 1059944 30648 69837560
Red blood cell sedimentation rate 36.20 11.15 14 1060222 4896 69863312
Graft versus host disease in gastrointestinal tract 36.14 11.15 22 1060214 5922 69862286
Drug tolerance decreased 35.99 11.15 57 1060179 9776 69858432
Exposure via ingestion 35.70 11.15 157 1060079 4758 69863450
Hepatocellular carcinoma 35.66 11.15 61 1060175 10147 69858061
Device dislocation 35.64 11.15 194 1060042 22313 69845895
Endophthalmitis 35.53 11.15 25 1060211 6230 69861978
Hypothermia 35.48 11.15 467 1059769 20127 69848081
Red cell distribution width increased 35.08 11.15 335 1059901 13322 69854886
Cardiac disorder 34.64 11.15 652 1059584 58763 69809445
Abortion incomplete 34.60 11.15 3 1060233 3059 69865149
Nasal necrosis 34.53 11.15 23 1060213 115 69868093
Coronary artery bypass 34.50 11.15 23 1060213 5897 69862311
Biliary dyskinesia 34.40 11.15 96 1060140 2303 69865905
Epstein-Barr virus infection 34.35 11.15 93 1060143 13105 69855103
Inadequate analgesia 34.09 11.15 137 1060099 3985 69864223
Blood urine present 33.81 11.15 440 1059796 18913 69849295
Osteonecrosis 33.77 11.15 276 1059960 28884 69839324
Incorrect dose administered by device 33.71 11.15 12 1060224 4417 69863791
Anion gap abnormal 33.71 11.15 41 1060195 499 69867709
Haematochezia 33.61 11.15 833 1059403 72248 69795960
Enthesopathy 33.53 11.15 70 1060166 10799 69857409
Urine analysis abnormal 33.50 11.15 181 1060055 5973 69862235
Creatinine renal clearance decreased 33.47 11.15 399 1059837 16801 69851407
Injection site rash 33.40 11.15 129 1060107 16281 69851927
Neutropenia 33.31 11.15 3350 1056886 253806 69614402
Sleep disorder due to general medical condition, insomnia type 33.15 11.15 733 1059503 34999 69833209
Poor venous access 33.06 11.15 356 1059880 14615 69853593
Brain death 32.87 11.15 159 1060077 5019 69863189
Graft versus host disease in skin 32.64 11.15 22 1060214 5608 69862600
Injection site urticaria 32.61 11.15 79 1060157 11559 69856649
Jaundice cholestatic 32.48 11.15 242 1059994 8942 69859266
Orthostatic hypotension 32.46 11.15 1008 1059228 50735 69817473
Tenosynovitis 32.38 11.15 104 1060132 13872 69854336
Feeling hot 32.37 11.15 955 1059281 47715 69820493
Decreased appetite 32.34 11.15 4025 1056211 300755 69567453
Hepatic enzyme increased 32.27 11.15 2746 1057490 154244 69713964
Oedema 32.13 11.15 1244 1058992 102337 69765871
Anosognosia 32.13 11.15 3 1060233 2882 69865326
Respiratory failure 32.12 11.15 2131 1058105 166604 69701604
JC virus infection 31.90 11.15 7 1060229 3544 69864664
Dyspnoea at rest 31.72 11.15 33 1060203 6786 69861422
Lip oedema 31.61 11.15 166 1060070 5417 69862791
Temperature regulation disorder 31.55 11.15 141 1060095 4303 69863905
Rash erythematous 31.26 11.15 1003 1059233 50715 69817493
Ear pain 31.18 11.15 583 1059653 27016 69841192
Drug dose omission by device 31.07 11.15 12 1060224 4200 69864008
Diabetic ketoacidosis 30.94 11.15 311 1059925 31201 69837007
Diffuse large B-cell lymphoma recurrent 30.93 11.15 7 1060229 3469 69864739
Red blood cells urine positive 30.91 11.15 146 1060090 4563 69863645
Basal cell carcinoma 30.88 11.15 338 1059898 33360 69834848
Status epilepticus 30.81 11.15 227 1060009 24299 69843909
Ascites 30.77 11.15 771 1059465 66776 69801432
Product administration error 30.76 11.15 616 1059620 28907 69839301
Cholelithiasis 30.70 11.15 926 1059310 46414 69821794
Accidental exposure to product by child 30.59 11.15 102 1060134 2704 69865504
Prothrombin level increased 30.55 11.15 35 1060201 398 69867810
Haemoglobin urine present 30.47 11.15 50 1060186 817 69867391
Meningitis aseptic 30.47 11.15 182 1060054 6237 69861971
Cytopenia 30.45 11.15 144 1060092 17179 69851029
Fluid retention 30.38 11.15 718 1059518 62667 69805541
Cardiomyopathy 30.37 11.15 250 1059986 26123 69842085
Injury 30.26 11.15 1228 1059008 64017 69804191
Agranulocytosis 30.24 11.15 803 1059433 39495 69828713
Specific gravity urine decreased 30.23 11.15 49 1060187 792 69867416
Coagulation factor V level decreased 30.18 11.15 41 1060195 561 69867647
Urine ketone body present 30.13 11.15 115 1060121 3264 69864944
Osteonecrosis of jaw 29.46 11.15 433 1059803 40569 69827639
Cystitis haemorrhagic 29.43 11.15 52 1060184 8541 69859667
Obstructive airways disorder 29.41 11.15 249 1059987 25864 69842344
Malignant neoplasm progression 29.37 11.15 1503 1058733 120236 69747972
Intentional product use issue 29.37 11.15 2130 1058106 118012 69750196
Electric shock 29.36 11.15 59 1060177 1136 69867072
Drug screen positive 29.28 11.15 168 1060068 5672 69862536
No adverse event 29.26 11.15 323 1059913 31830 69836378
Cytomegalovirus infection reactivation 29.15 11.15 35 1060201 6746 69861462
Gait disturbance 29.09 11.15 2376 1057860 182730 69685478
Contraindicated product administered 28.76 11.15 1682 1058554 132930 69735278
Infusion site pruritus 28.73 11.15 110 1060126 3127 69865081
Dyspnoea 28.69 11.15 10712 1049524 759348 69108860
Pulmonary alveolar haemorrhage 28.57 11.15 71 1060165 10298 69857910
Unevaluable event 28.33 11.15 578 1059658 51485 69816723
Livedo reticularis 28.10 11.15 122 1060114 3676 69864532
Metastases to lymph nodes 28.08 11.15 60 1060176 9178 69859030
Syncope 28.07 11.15 2114 1058122 163595 69704613
Specific gravity urine increased 28.06 11.15 34 1060202 412 69867796
Hepatitis B 27.88 11.15 49 1060187 8065 69860143
Body temperature decreased 27.82 11.15 592 1059644 28080 69840128
Hyperbilirubinaemia 27.71 11.15 483 1059753 22085 69846123
Hepatic cancer 27.71 11.15 65 1060171 9618 69858590
Coma scale abnormal 27.65 11.15 212 1060024 7904 69860304
Thrombosis 27.65 11.15 887 1059349 74518 69793690
Acute kidney injury 27.57 11.15 7727 1052509 466897 69401311
Memory impairment 27.57 11.15 1118 1059118 91523 69776685
Anion gap increased 27.49 11.15 108 1060128 3108 69865100
Chest discomfort 27.38 11.15 2187 1058049 122194 69746014
Cardiotoxicity 27.33 11.15 80 1060156 10990 69857218
Self-medication 27.18 11.15 135 1060101 4308 69863900
Neuroleptic malignant syndrome 27.08 11.15 253 1059983 25754 69842454
Liver transplant 27.08 11.15 131 1060105 4135 69864073
Visual acuity reduced 26.86 11.15 277 1059959 27653 69840555
Haemorrhage 26.79 11.15 1003 1059233 82812 69785396
Anti-neutrophil cytoplasmic antibody positive vasculitis 26.74 11.15 8 1060228 3289 69864919
Prostatic specific antigen increased 26.72 11.15 64 1060172 9402 69858806
Drug eruption 26.70 11.15 422 1059814 39074 69829134
Intracranial pressure increased 26.68 11.15 195 1060041 7161 69861047
Pneumocystis jirovecii pneumonia 26.67 11.15 304 1059932 29778 69838430
Gallbladder disorder 26.60 11.15 392 1059844 17320 69850888
Infusion site swelling 26.45 11.15 171 1060065 6027 69862181
Disturbance in social behaviour 26.24 11.15 14 1060222 4053 69864155
Brain oedema 26.22 11.15 494 1059742 22924 69845284
Forced expiratory volume decreased 26.21 11.15 43 1060193 7271 69860937
Neutropenic sepsis 26.18 11.15 519 1059717 24311 69843897
Dermatitis atopic 26.15 11.15 60 1060176 8947 69859261
Genital haemorrhage 26.09 11.15 29 1060207 5786 69862422
Fear of injection 26.05 11.15 37 1060199 6635 69861573
Juvenile idiopathic arthritis 25.94 11.15 29 1060207 5771 69862437
Agitation 25.91 11.15 1673 1058563 91702 69776506
Alopecia 25.79 11.15 2585 1057651 195905 69672303
Angina pectoris 25.77 11.15 539 1059697 47844 69820364
Ventricular tachycardia 25.70 11.15 386 1059850 36037 69832171
Subacute cutaneous lupus erythematosus 25.69 11.15 8 1060228 3205 69865003
Chronic kidney disease 25.68 11.15 705 1059531 60352 69807856
Blood bilirubin increased 25.65 11.15 1118 1059118 58783 69809425
Lung neoplasm malignant 25.64 11.15 241 1059995 24501 69843707
Mycobacterial infection 25.63 11.15 10 1060226 3478 69864730
Human herpesvirus 6 infection 25.58 11.15 21 1060215 4838 69863370
Drug reaction with eosinophilia and systemic symptoms 25.56 11.15 1086 1059150 56927 69811281
Ill-defined disorder 25.55 11.15 1031 1059205 53710 69814498
Methaemoglobinaemia 25.54 11.15 140 1060096 4646 69863562
Helicobacter infection 25.46 11.15 1046 1059190 54610 69813598
Culture urine positive 25.40 11.15 128 1060108 4109 69864099
Hepatitis C 25.22 11.15 102 1060134 12705 69855503
Hepatic cirrhosis 25.16 11.15 316 1059920 30415 69837793
Complications of transplanted kidney 25.11 11.15 31 1060205 5903 69862305
Hyperthermia 25.06 11.15 369 1059867 16302 69851906
Product substitution issue 24.89 11.15 168 1060068 18345 69849863
Leukopenia 24.87 11.15 1320 1058916 105240 69762968
Analgesic drug level above therapeutic 24.86 11.15 33 1060203 441 69867767
Sphincter of Oddi dysfunction 24.84 11.15 31 1060205 388 69867820
Feeling abnormal 24.84 11.15 1811 1058425 140508 69727700
Acute haemorrhagic oedema of infancy 24.73 11.15 14 1060222 49 69868159
Throat tightness 24.72 11.15 518 1059718 24504 69843704
Pain 24.70 11.15 10086 1050150 618730 69249478
Foot deformity 24.61 11.15 194 1060042 20461 69847747
Syringe issue 24.54 11.15 26 1060210 5302 69862906
Progressive multifocal leukoencephalopathy 24.54 11.15 177 1060059 19037 69849171
COVID-19 treatment 24.41 11.15 32 1060204 422 69867786
Neoplasm malignant 24.26 11.15 294 1059942 28480 69839728
Sexual dysfunction 24.20 11.15 39 1060197 6642 69861566
Seizure 24.19 11.15 2310 1057926 175652 69692556
Infusion site erythema 24.12 11.15 194 1060042 7341 69860867
Pancreatic carcinoma 24.04 11.15 105 1060131 12799 69855409
Nasopharyngitis 23.99 11.15 3728 1056508 218478 69649730
Right ventricular failure 23.93 11.15 215 1060021 22059 69846149
Bacterial test 23.86 11.15 55 1060181 1168 69867040
Lupus-like syndrome 23.77 11.15 90 1060146 11425 69856783
Renal cortical necrosis 23.76 11.15 27 1060209 304 69867904
Acute myeloid leukaemia recurrent 23.72 11.15 8 1060228 3046 69865162
Pulmonary fibrosis 23.39 11.15 366 1059870 33944 69834264
Hypertensive crisis 23.38 11.15 180 1060056 19082 69849126
Brain stem glioma 23.32 11.15 23 1060213 217 69867991
Hyperhidrosis 23.29 11.15 2277 1057959 129309 69738899
Blood pH decreased 23.26 11.15 130 1060106 4346 69863862
Chondrocalcinosis 23.26 11.15 41 1060195 712 69867496
Cytomegalovirus chorioretinitis 23.14 11.15 27 1060209 5271 69862937
Medication overuse headache 23.02 11.15 41 1060195 718 69867490
Cardiac failure acute 22.86 11.15 160 1060076 17327 69850881
Varicella zoster virus infection 22.70 11.15 17 1060219 4103 69864105
Pleurothotonus 22.65 11.15 4 1060232 2362 69865846
Gastric cancer 22.64 11.15 64 1060172 8891 69859317
Impaired work ability 22.61 11.15 147 1060089 16193 69852015
Osteoporosis 22.61 11.15 557 1059679 48350 69819858
Angioedema 22.58 11.15 1215 1059021 65395 69802813
Diffuse large B-cell lymphoma 22.55 11.15 112 1060124 13190 69855018
Renal disorder 22.19 11.15 417 1059819 37592 69830616
Systemic candida 22.10 11.15 34 1060202 5900 69862308
Therapeutic response shortened 22.06 11.15 291 1059945 12547 69855661
Cardiac failure chronic 22.03 11.15 79 1060157 10190 69858018
Polyomavirus-associated nephropathy 22.02 11.15 27 1060209 5156 69863052
Acute graft versus host disease in intestine 22.01 11.15 15 1060221 3801 69864407
Cryptococcosis 21.94 11.15 11 1060225 3299 69864909
Muscle spasticity 21.93 11.15 415 1059821 19274 69848934
Tuberculosis 21.88 11.15 131 1060105 14717 69853491
Candida infection 21.77 11.15 373 1059863 34100 69834108
Lethargy 21.74 11.15 1353 1058883 73897 69794311
Laboratory test abnormal 21.72 11.15 264 1059972 25559 69842649
Hepatitis B reactivation 21.60 11.15 29 1060207 5326 69862882
Maternal exposure during pregnancy 21.56 11.15 1459 1058777 113886 69754322
Sleep disorder due to a general medical condition 21.55 11.15 82 1060154 10394 69857814
Serum sickness 21.50 11.15 103 1060133 3238 69864970
Metastases to bone 21.49 11.15 222 1060014 22154 69846054
Fracture 21.21 11.15 193 1060043 19751 69848457
Ovarian hyperstimulation syndrome 21.13 11.15 11 1060225 3229 69864979
Monocyte percentage increased 21.12 11.15 73 1060163 1972 69866236
Leukocyturia 21.05 11.15 63 1060173 1574 69866634
Cholestatic liver injury 20.96 11.15 120 1060116 4048 69864160
Vascular purpura 20.93 11.15 89 1060147 2657 69865551
Sedation 20.86 11.15 876 1059360 45855 69822353
White blood cell count decreased 20.85 11.15 2225 1058011 167916 69700292
Eyelid ptosis 20.83 11.15 79 1060157 10023 69858185
Macular oedema 20.78 11.15 28 1060208 5134 69863074
Cognitive disorder 20.68 11.15 1112 1059124 59844 69808364
Epilepsy 20.68 11.15 432 1059804 38352 69829856
Retinitis 20.66 11.15 19 1060217 4141 69864067
Dose calculation error 20.65 11.15 19 1060217 163 69868045
Disability 20.63 11.15 135 1060101 14848 69853360
Hallucination 20.37 11.15 1362 1058874 74898 69793310
Adverse event 20.31 11.15 573 1059663 48888 69819320
Nipple disorder 20.30 11.15 19 1060217 167 69868041
Transplant failure 20.11 11.15 19 1060217 4088 69864120
Psychotic disorder 20.08 11.15 420 1059816 37281 69830927
Secondary immunodeficiency 20.07 11.15 9 1060227 2880 69865328
Hepatorenal failure 20.04 11.15 51 1060185 1156 69867052
Akathisia 20.00 11.15 105 1060131 12188 69856020
Infusion site discomfort 19.94 11.15 45 1060191 942 69867266
Bacterial test positive 19.84 11.15 176 1060060 6855 69861353
Accidental poisoning 19.80 11.15 61 1060175 1549 69866659
Hyponatraemia 19.68 11.15 2706 1057530 157381 69710827
Hypothyroidism 19.58 11.15 527 1059709 45228 69822980
Prothrombin time abnormal 19.49 11.15 43 1060193 886 69867322
Dizziness 19.27 11.15 6429 1053807 457712 69410496
Acquired gene mutation 19.12 11.15 4 1060232 2094 69866114
Hyperglycaemia 19.12 11.15 781 1059455 63891 69804317
Gallbladder cholesterolosis 19.03 11.15 32 1060204 534 69867674
Nitrite urine present 18.92 11.15 49 1060187 1123 69867085
Viral load increased 18.89 11.15 8 1060228 2648 69865560
C-reactive protein increased 18.85 11.15 1409 1058827 109108 69759100
Infection reactivation 18.81 11.15 6 1060230 2367 69865841
Mucocutaneous disorder 18.74 11.15 16 1060220 123 69868085
Red blood cell sedimentation rate increased 18.71 11.15 437 1059799 38205 69830003
Mycobacterium chelonae infection 18.70 11.15 6 1060230 2358 69865850
Rhabdomyolysis 18.62 11.15 1207 1059029 94553 69773655
Premature delivery 18.61 11.15 216 1060020 21088 69847120
Body height below normal 18.59 11.15 3 1060233 1892 69866316
Product quality issue 18.55 11.15 333 1059903 30228 69837980
Long QT syndrome 18.46 11.15 32 1060204 5295 69862913
Injection site discolouration 18.44 11.15 50 1060186 7042 69861166
Aplasia pure red cell 18.42 11.15 53 1060183 7321 69860887
Polycystic ovaries 18.36 11.15 10 1060226 2862 69865346
Infusion site bruising 18.34 11.15 68 1060168 1903 69866305
Sensitisation 18.32 11.15 7 1060229 2466 69865742
Pharyngeal paraesthesia 18.31 11.15 74 1060162 2158 69866050
Sopor 18.26 11.15 343 1059893 30924 69837284
Gestational diabetes 18.22 11.15 39 1060197 5962 69862246
Suspected suicide 18.11 11.15 207 1060029 8627 69859581
Pneumonia cytomegaloviral 18.10 11.15 25 1060211 4536 69863672
Faeces discoloured 18.09 11.15 527 1059709 26282 69841926
Lip swelling 17.94 11.15 650 1059586 33404 69834804
Kussmaul respiration 17.90 11.15 26 1060210 380 69867828
Type I hypersensitivity 17.83 11.15 106 1060130 3626 69864582
Abdominal discomfort 17.82 11.15 2877 1057359 211781 69656427
Concomitant disease aggravated 17.79 11.15 107 1060129 12007 69856201
Bursitis 17.63 11.15 523 1059713 26150 69842058
Skin cancer 17.62 11.15 124 1060112 13412 69854796
Wrong patient received product 17.55 11.15 121 1060115 4359 69863849
Oral pruritus 17.51 11.15 67 1060169 1904 69866304
Breast cancer 17.50 11.15 375 1059861 33174 69835034
Prescribed underdose 17.47 11.15 220 1060016 21165 69847043
Coagulation factor X level decreased 17.41 11.15 14 1060222 98 69868110
Truncus coeliacus thrombosis 17.31 11.15 7 1060229 8 69868200
Galactorrhoea 17.29 11.15 15 1060221 3363 69864845
Acute graft versus host disease in liver 17.22 11.15 3 1060233 1789 69866419
Device use issue 17.19 11.15 6 1060230 2236 69865972
Tardive dyskinesia 17.18 11.15 83 1060153 9846 69858362
Glutathione decreased 17.06 11.15 10 1060226 38 69868170
Oedematous pancreatitis 17.02 11.15 43 1060193 970 69867238
Cholesterosis 17.01 11.15 24 1060212 341 69867867
Prostate cancer stage II 16.94 11.15 5 1060231 2074 69866134
Complication of device removal 16.89 11.15 16 1060220 3438 69864770
Respiratory acidosis 16.83 11.15 231 1060005 10050 69858158
Pancytopenia 16.82 11.15 1989 1058247 149118 69719090
Needle issue 16.78 11.15 95 1060141 10820 69857388
Retinal haemorrhage 16.75 11.15 59 1060177 7651 69860557
Haemolysis 16.71 11.15 254 1059982 11297 69856911
Full blood count decreased 16.70 11.15 254 1059982 23664 69844544
Toxic skin eruption 16.67 11.15 407 1059829 19755 69848453
Neonatal respiratory acidosis 16.67 11.15 11 1060225 54 69868154
Abortion spontaneous 16.56 11.15 287 1059949 26192 69842016
Erythema 16.52 11.15 3302 1056934 196261 69671947
Ductus arteriosus stenosis foetal 16.47 11.15 12 1060224 71 69868137
Pulmonary tuberculosis 16.40 11.15 61 1060175 7784 69860424
Impaired quality of life 16.33 11.15 73 1060163 8843 69859365
Joint destruction 16.30 11.15 28 1060208 4650 69863558
Eosinophilia 16.27 11.15 748 1059488 39571 69828637
Palatal oedema 16.26 11.15 48 1060188 1190 69867018
Bilirubin urine present 16.24 11.15 23 1060213 328 69867880
Red blood cell spherocytes present 16.22 11.15 9 1060227 30 69868178
Apparent death 16.20 11.15 11 1060225 2793 69865415
Gene mutation 16.13 11.15 7 1060229 2284 69865924
Glucose-6-phosphate dehydrogenase deficiency 16.04 11.15 23 1060213 332 69867876
Granuloma 15.98 11.15 60 1060176 7635 69860573
Beta haemolytic streptococcal infection 15.97 11.15 65 1060171 1902 69866306
Drug effective for unapproved indication 15.92 11.15 28 1060208 4607 69863601
Complication of device insertion 15.90 11.15 35 1060201 5297 69862911
Pleural thickening 15.90 11.15 84 1060152 2748 69865460
Food allergy 15.83 11.15 196 1060040 8328 69859880
Systemic mycosis 15.81 11.15 9 1060227 2513 69865695
Rheumatoid lung 15.80 11.15 17 1060219 3442 69864766
Noninfective encephalitis 15.79 11.15 26 1060210 426 69867782
Vulvar erosion 15.75 11.15 16 1060220 157 69868051
Band neutrophil percentage decreased 15.72 11.15 7 1060229 12 69868196
Skin toxicity 15.69 11.15 55 1060181 7143 69861065
Dermo-hypodermitis 15.66 11.15 31 1060205 590 69867618
Pancreatic fibrosis 15.63 11.15 13 1060223 96 69868112
Acute lymphocytic leukaemia recurrent 15.63 11.15 31 1060205 4873 69863335
Factor VIII inhibition 15.62 11.15 22 1060214 312 69867896
Rash macular 15.59 11.15 496 1059740 25048 69843160
Haematemesis 15.54 11.15 885 1059351 47912 69820296
Intervertebral discitis 15.49 11.15 111 1060125 4050 69864158
Therapy change 15.49 11.15 50 1060186 6659 69861549
Anticipatory anxiety 15.37 11.15 41 1060195 957 69867251
Visual impairment 15.34 11.15 1013 1059223 79237 69788971
Environmental exposure 15.31 11.15 23 1060213 347 69867861
Failure of child resistant product closure 15.24 11.15 11 1060225 64 69868144
Skin ulcer 15.19 11.15 577 1059659 47568 69820640
Peritonitis bacterial 15.19 11.15 78 1060158 9106 69859102
Parkinsonism 15.15 11.15 151 1060085 15174 69853034
Stent placement 15.13 11.15 44 1060192 6057 69862151
Lactic acidosis 15.07 11.15 806 1059430 64218 69803990
Leukoencephalopathy 15.06 11.15 57 1060179 7237 69860971
Intraocular pressure increased 15.06 11.15 75 1060161 8826 69859382
Mania 15.05 11.15 174 1060062 17000 69851208
Generalised bullous fixed drug eruption 15.05 11.15 14 1060222 122 69868086
Nipple inflammation 15.01 11.15 10 1060226 50 69868158
Vitamin K deficiency 14.99 11.15 33 1060203 679 69867529
Orbital oedema 14.95 11.15 21 1060215 297 69867911
Post-traumatic stress disorder 14.95 11.15 115 1060121 4292 69863916
Torsade de pointes 14.94 11.15 186 1060050 17930 69850278
Haematuria 14.92 11.15 787 1059449 62786 69805422
Delirium 14.83 11.15 1302 1058934 73312 69794896
Gallbladder adenocarcinoma 14.83 11.15 13 1060223 104 69868104
Bezoar 14.78 11.15 71 1060165 2235 69865973
Chronic myeloid leukaemia 14.77 11.15 25 1060211 4176 69864032
Nephrogenic systemic fibrosis 14.75 11.15 44 1060192 6008 69862200
Injury associated with device 14.67 11.15 14 1060222 2998 69865210
Musculoskeletal disorder 14.66 11.15 210 1060026 19761 69848447
Obesity 14.62 11.15 297 1059939 26474 69841734
Gastrointestinal toxicity 14.60 11.15 48 1060188 6357 69861851
Blood creatinine decreased 14.53 11.15 171 1060065 7178 69861030
Hypertriglyceridaemia 14.51 11.15 110 1060126 11701 69856507
Gastric ulcer perforation 14.49 11.15 64 1060172 1943 69866265
Failure to suspend medication 14.47 11.15 25 1060211 427 69867781
Mean cell haemoglobin concentration decreased 14.44 11.15 108 1060128 3995 69864213
Oropharyngeal pain 14.42 11.15 1648 1058588 94662 69773546
Infusion site mass 14.40 11.15 45 1060191 1152 69867056
Hypoglycaemic coma 14.39 11.15 27 1060209 4334 69863874
SJS-TEN overlap 14.36 11.15 28 1060208 527 69867681
Congestive cardiomyopathy 14.27 11.15 100 1060136 10826 69857382
Dilatation intrahepatic duct acquired 14.27 11.15 32 1060204 667 69867541
Anaphylactic shock 14.26 11.15 608 1059628 31882 69836326
Blood immunoglobulin E increased 14.26 11.15 31 1060205 4713 69863495
Toxicologic test abnormal 14.25 11.15 48 1060188 1279 69866929
Renal failure neonatal 14.25 11.15 11 1060225 72 69868136
Histoplasmosis 14.20 11.15 7 1060229 2120 69866088
Erythema multiforme 14.18 11.15 336 1059900 16228 69851980
Toxoplasmosis 14.09 11.15 11 1060225 2599 69865609
Electrolyte imbalance 14.08 11.15 300 1059936 26561 69841647
Tongue disorder 14.06 11.15 128 1060108 13099 69855109
Depression 13.98 11.15 2691 1057545 196283 69671925
Osmolar gap 13.96 11.15 14 1060222 135 69868073
Fungal rhinitis 13.88 11.15 10 1060226 58 69868150
Gallbladder hypofunction 13.87 11.15 25 1060211 442 69867766
Multiple organ dysfunction syndrome 13.84 11.15 1415 1058821 107100 69761108
Left ventricular dysfunction 13.83 11.15 187 1060049 17770 69850438
Osteomyelitis 13.82 11.15 346 1059890 29972 69838236
Device deployment issue 13.77 11.15 14 1060222 2910 69865298
Tendonitis 13.76 11.15 240 1059996 21882 69846326
Euglycaemic diabetic ketoacidosis 13.71 11.15 45 1060191 5962 69862246
Diffuse axonal injury 13.69 11.15 12 1060224 96 69868112
Granulocytopenia 13.63 11.15 98 1060138 10549 69857659
Vascular graft 13.59 11.15 6 1060230 1938 69866270
Hemiparesis 13.58 11.15 362 1059874 31107 69837101
Dependent personality disorder 13.57 11.15 13 1060223 118 69868090
Migraine with aura 13.56 11.15 72 1060164 2360 69865848
Latent tuberculosis 13.53 11.15 16 1060220 3105 69865103
Histoplasmosis disseminated 13.52 11.15 7 1060229 2061 69866147
Psychotic symptom 13.51 11.15 10 1060226 2428 69865780
Use of accessory respiratory muscles 13.51 11.15 23 1060213 388 69867820
Gingival hypertrophy 13.51 11.15 14 1060222 2884 69865324
Pneumonia streptococcal 13.50 11.15 73 1060163 2410 69865798
Eosinophil percentage increased 13.47 11.15 50 1060186 1400 69866808
Enterococcal infection 13.46 11.15 146 1060090 14436 69853772
Biliary sepsis 13.37 11.15 51 1060185 1447 69866761
Transverse sinus thrombosis 13.29 11.15 29 1060207 593 69867615
Urine bilirubin decreased 13.28 11.15 14 1060222 144 69868064
Hypoprothrombinaemia 13.25 11.15 32 1060204 701 69867507
Delusion 13.22 11.15 204 1060032 18961 69849247
Thymus disorder 13.21 11.15 19 1060217 275 69867933
Hypercalcaemia 13.20 11.15 402 1059834 33983 69834225
Choluria 13.15 11.15 21 1060215 335 69867873
Strawberry tongue 13.14 11.15 7 1060229 21 69868187
Hyperprolactinaemia 13.13 11.15 29 1060207 4384 69863824
Chronic obstructive pulmonary disease 13.05 11.15 991 1059245 76650 69791558
White coat hypertension 13.05 11.15 31 1060205 672 69867536
Chronic graft versus host disease in skin 13.01 11.15 3 1060233 1468 69866740
Product tampering 12.98 11.15 17 1060219 224 69867984
Autonomic dysreflexia 12.94 11.15 23 1060213 402 69867806
Catatonia 12.93 11.15 70 1060166 8063 69860145
Colon cancer 12.90 11.15 144 1060092 14162 69854046
Analgesic drug level therapeutic 12.87 11.15 4 1060232 0 69868208
Neurone-specific enolase increased 12.87 11.15 4 1060232 0 69868208
Hepatitis non-A non-B 12.87 11.15 4 1060232 0 69868208
Murphy's sign positive 12.87 11.15 4 1060232 0 69868208
Arthritis 12.86 11.15 1275 1058961 96705 69771503
Hypermagnesaemia 12.72 11.15 43 1060193 1148 69867060
Respiratory alkalosis 12.70 11.15 104 1060132 3957 69864251
Knee arthroplasty 12.69 11.15 403 1059833 33898 69834310
Breast cancer stage III 12.67 11.15 54 1060182 6627 69861581
Vaccination site swelling 12.65 11.15 8 1060228 36 69868172
Hyperkalaemia 12.64 11.15 1397 1058839 105194 69763014
Splenic vein thrombosis 12.64 11.15 32 1060204 723 69867485
Joint stiffness 12.60 11.15 415 1059821 34761 69833447
Breast cancer stage IV 12.57 11.15 6 1060230 1851 69866357
Fibrin D dimer increased 12.54 11.15 167 1060069 7216 69860992
Dyslipidaemia 12.51 11.15 91 1060145 9769 69858439
Blood magnesium increased 12.48 11.15 89 1060147 3242 69864966
Immune-mediated myositis 12.44 11.15 17 1060219 3099 69865109
Pleural fibrosis 12.41 11.15 105 1060131 4034 69864174
Cyanosis neonatal 12.39 11.15 9 1060227 53 69868155
Testicular infarction 12.39 11.15 9 1060227 53 69868155
Cells in urine 12.37 11.15 16 1060220 208 69868000
Hyperlipidaemia 12.37 11.15 267 1059969 23596 69844612
Metabolic disorder 12.35 11.15 70 1060166 7970 69860238
Acute lymphocytic leukaemia 12.34 11.15 42 1060194 5503 69862705
Ductus arteriosus premature closure 12.32 11.15 8 1060228 38 69868170
B-cell lymphoma 12.30 11.15 50 1060186 6219 69861989
Abortion induced 12.28 11.15 54 1060182 6571 69861637
Viral haemorrhagic cystitis 12.26 11.15 6 1060230 1825 69866383
Urostomy complication 12.24 11.15 5 1060231 6 69868202
Sensitivity to weather change 12.18 11.15 63 1060173 7342 69860866
Disseminated tuberculosis 12.16 11.15 27 1060209 4073 69864135
Prescription form tampering 12.14 11.15 21 1060215 359 69867849
Bone disorder 12.12 11.15 186 1060050 17304 69850904
Infection 12.11 11.15 2879 1057357 207906 69660302
Abnormal clotting factor 12.09 11.15 13 1060223 137 69868071
Exercise tolerance decreased 12.03 11.15 73 1060163 8175 69860033
Vasoconstriction 12.02 11.15 29 1060207 635 69867573
Bradycardia neonatal 12.01 11.15 10 1060226 74 69868134
Hyperlipasaemia 11.97 11.15 39 1060197 1021 69867187
Pre-eclampsia 11.94 11.15 53 1060183 6432 69861776
Open globe injury 11.90 11.15 10 1060226 75 69868133
Cerebral haemorrhage 11.86 11.15 671 1059565 53193 69815015
Intestinal haemorrhage 11.82 11.15 48 1060188 5972 69862236
Osmolar gap abnormal 11.80 11.15 10 1060226 76 69868132
Pharyngeal disorder 11.80 11.15 59 1060177 1888 69866320
Upper gastrointestinal haemorrhage 11.80 11.15 679 1059557 36798 69831410
Vital capacity decreased 11.79 11.15 47 1060189 1362 69866846
Catheter management 11.78 11.15 21 1060215 3438 69864770
Leukaemia 11.76 11.15 41 1060195 5334 69862874
Cardiac operation 11.76 11.15 31 1060205 4408 69863800
Ejection fraction decreased 11.72 11.15 360 1059876 30402 69837806
Periportal oedema 11.72 11.15 11 1060225 97 69868111
Arrhythmia 11.72 11.15 703 1059533 55440 69812768
Periorbital cellulitis 11.71 11.15 33 1060203 796 69867412
Cardiac steatosis 11.71 11.15 8 1060228 42 69868166
Incorrect drug administration rate 11.69 11.15 84 1060152 3068 69865140
Urobilinogen urine increased 11.68 11.15 29 1060207 647 69867561
Adverse drug reaction 11.66 11.15 665 1059571 52679 69815529
Sputum culture positive 11.65 11.15 88 1060148 3266 69864942
Dermatitis bullous 11.61 11.15 261 1059975 12496 69855712
Consciousness fluctuating 11.61 11.15 55 1060181 1721 69866487
Cytomegalovirus colitis 11.59 11.15 29 1060207 4197 69864011
Acute promyelocytic leukaemia 11.55 11.15 4 1060232 1498 69866710
Face oedema 11.53 11.15 481 1059755 25158 69843050
Cyanosis 11.51 11.15 440 1059796 22766 69845442
Congenital central hypoventilation syndrome 11.50 11.15 7 1060229 29 69868179
Haemophagocytic lymphohistiocytosis 11.50 11.15 215 1060021 19397 69848811
Hyperleukocytosis 11.49 11.15 64 1060172 2137 69866071
Mycobacterium avium complex infection 11.47 11.15 30 1060206 4276 69863932
Capillary nail refill test abnormal 11.43 11.15 8 1060228 44 69868164
Dependence 11.42 11.15 66 1060170 2234 69865974
Metastases to central nervous system 11.42 11.15 157 1060079 14877 69853331
Proteinuria 11.38 11.15 343 1059893 29031 69839177
Visceral congestion 11.35 11.15 33 1060203 811 69867397
Herpes zoster 11.34 11.15 1108 1059128 84127 69784081
Lyme disease 11.30 11.15 16 1060220 2873 69865335
pH urine increased 11.28 11.15 22 1060214 414 69867794
Colitis ulcerative 11.27 11.15 404 1059832 33519 69834689
Starvation ketoacidosis 11.27 11.15 12 1060224 125 69868083
Partial seizures 11.26 11.15 74 1060162 8131 69860077
Hyperprolinaemia 11.26 11.15 6 1060230 18 69868190
Internal haemorrhage 11.24 11.15 73 1060163 8043 69860165
Overflow diarrhoea 11.22 11.15 11 1060225 103 69868105
Therapeutic product effect decreased 11.20 11.15 1923 1058313 141095 69727113
Hepatectomy 11.17 11.15 14 1060222 176 69868032
Creatinine urine decreased 11.15 11.15 16 1060220 231 69867977

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
Accidental overdose 30.99 13.82 17 894 90 88791
Analgesic drug level increased 25.23 13.82 7 904 0 88881
Overdose 16.94 13.82 9 902 44 88837
Incorrect dosage administered 15.15 13.82 6 905 12 88869

Pharmacologic Action:

SourceCodeDescription
ATC N02AJ01 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Opioids in combination with non-opioid analgesics
ATC N02AJ06 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Opioids in combination with non-opioid analgesics
ATC N02AJ13 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Opioids in combination with non-opioid analgesics
ATC N02AJ17 NERVOUS SYSTEM
ANALGESICS
OPIOIDS
Opioids in combination with non-opioid analgesics
ATC N02BE01 NERVOUS SYSTEM
ANALGESICS
OTHER ANALGESICS AND ANTIPYRETICS
Anilides
ATC N02BE51 NERVOUS SYSTEM
ANALGESICS
OTHER ANALGESICS AND ANTIPYRETICS
Anilides
ATC N02BE71 NERVOUS SYSTEM
ANALGESICS
OTHER ANALGESICS AND ANTIPYRETICS
Anilides
MeSH PA D000700 Analgesics
MeSH PA D018712 Analgesics, Non-Narcotic
MeSH PA D058633 Antipyretics
MeSH PA D002491 Central Nervous System Agents
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:50629 COX-2 inhibitor
CHEBI has role CHEBI:50630 COX-1 inhibitor
CHEBI has role CHEBI:50908 agente hepatotoxico
CHEBI has role CHEBI:73263 cyclooxygenase-3 inhibitors
CHEBI has role CHEBI:78298 environmental contaminants
CHEBI has role CHEBI:85234 human blood serum metabolites
CHEBI has role CHEBI:173085 ferroptosis inducers
CHEBI has role CHEBI:176497 geroprotectors

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

DiseaseRelationSNOMED_IDDOID
Sinus headache indication 4969004
Pain indication 22253000
Toothache indication 27355003
Migraine indication 37796009 DOID:6364
Joint pain indication 57676002
Allergic rhinitis indication 61582004
Common cold indication 82272006 DOID:10459
Backache indication 161891005
Headache disorder indication 230461009
Influenza-like symptoms indication 315642008
Fever indication 386661006
Tension-type headache indication 398057008
Arthritic Pain indication
Pain Treatment Adjunct indication
Vascular headache off-label use 128187005
Fibromyalgia off-label use 203082005 DOID:631
Hepatic encephalopathy contraindication 13920009 DOID:13413
Cirrhosis of liver contraindication 19943007 DOID:5082
Hepatic failure contraindication 59927004
Disease of liver contraindication 235856003 DOID:409




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 9.69 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
325MG;7.5MG XARTEMIS XR MALLINCKRODT INC N204031 March 11, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 7976870 June 1, 2027 METHOD OF TREATING PATIENTS WITH GASTRIC RETENTIVE DOSAGE FORM
1GM/100ML (10MG/ML) OFIRMEV MALLINCKRODT HOSP N022450 Nov. 2, 2010 DISCN SOLUTION INTRAVENOUS 10383834 Nov. 13, 2028 MODIFIED DOSING REGIMEN FOR THE MANAGEMENT OF MILD TO MODERATE PAIN
1GM/100ML (10MG/ML) OFIRMEV MALLINCKRODT HOSP N022450 Nov. 2, 2010 DISCN SOLUTION INTRAVENOUS 10383834 Nov. 13, 2028 MODIFIED DOSING REGIMEN FOR THE REDUCTION OF FEVER
1GM/100ML (10MG/ML) OFIRMEV MALLINCKRODT HOSP N022450 Nov. 2, 2010 DISCN SOLUTION INTRAVENOUS 9610265 Nov. 13, 2028 MODIFIED DOSING REGIMEN FOR THE MANAGEMENT OF MODERATE TO SEVERE PAIN WITH ADJUNCTIVE OPIOID ANALGESICS
1GM/100ML (10MG/ML) OFIRMEV MALLINCKRODT HOSP N022450 Nov. 2, 2010 DISCN SOLUTION INTRAVENOUS 9987238 Nov. 13, 2028 MODIFIED DOSING REGIMEN FOR THE MANAGEMENT OF MILD TO MODERATE PAIN OR MANAGEMENT OF MODERATE TO SEVERE PAIN AS AN ADJUNCT TO OPIOID ANALGESICS
325MG;7.5MG XARTEMIS XR MALLINCKRODT INC N204031 March 11, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 8372432 March 11, 2029 MANAGEMENT OF ACUTE PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA
325MG;7.5MG XARTEMIS XR MALLINCKRODT INC N204031 March 11, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 8668929 March 11, 2029 MANAGEMENT OF ACUTE PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA
325MG;7.5MG XARTEMIS XR MALLINCKRODT INC N204031 March 11, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 8377453 Nov. 19, 2029 MANAGEMENT OF ACUTE PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA
325MG;EQ 4.08MG BASE APADAZ KVK TECH INC N208653 Jan. 4, 2019 RX TABLET ORAL 9132125 July 1, 2030 MANAGEMENT OF ACUTE PAIN SEVERE ENOUGH TO REQUIRE AN OPIOID ANALGESIC AND FOR WHICH ALTERNATIVE TREATMENTS ARE INADEQUATE
325MG;EQ 6.12MG BASE APADAZ KVK TECH INC N208653 Feb. 23, 2018 RX TABLET ORAL 9132125 July 1, 2030 MANAGEMENT OF ACUTE PAIN SEVERE ENOUGH TO REQUIRE AN OPIOID ANALGESIC AND FOR WHICH ALTERNATIVE TREATMENTS ARE INADEQUATE
325MG;EQ 8.16MG BASE APADAZ KVK TECH INC N208653 Jan. 4, 2019 RX TABLET ORAL 9132125 July 1, 2030 MANAGEMENT OF ACUTE PAIN SEVERE ENOUGH TO REQUIRE AN OPIOID ANALGESIC AND FOR WHICH ALTERNATIVE TREATMENTS ARE INADEQUATE
1GM/100ML (10MG/ML) OFIRMEV MALLINCKRODT HOSP N022450 Nov. 2, 2010 DISCN SOLUTION INTRAVENOUS 9399012 Sept. 11, 2031 MODIFIED DOSING REGIMEN FOR THE MANAGEMENT OF MILD TO MODERATE PAIN OR MANAGEMENT OF MODERATE TO SEVERE PAIN AS AN ADJUNCT TO OPIOID ANALGESICS
1GM/100ML (10MG/ML) OFIRMEV MALLINCKRODT HOSP N022450 Nov. 2, 2010 DISCN SOLUTION INTRAVENOUS 9399012 Sept. 11, 2031 MODIFIED DOSING REGIMEN FOR THE REDUCTION OF FEVER
325MG;7.5MG XARTEMIS XR MALLINCKRODT INC N204031 March 11, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 8741885 May 16, 2032 MANAGEMENT OF ACUTE PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA
325MG;7.5MG XARTEMIS XR MALLINCKRODT INC N204031 March 11, 2014 DISCN TABLET, EXTENDED RELEASE ORAL 9468636 May 16, 2032 MANAGEMENT OF ACUTE PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA

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

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Prostaglandin G/H synthase 2 Enzyme INHIBITOR IC50 4.31 WOMBAT-PK CHEMBL
Transient receptor potential cation channel subfamily V member 1 Ion channel OPENER WOMBAT-PK CHEMBL
Cannabinoid receptor 1 GPCR AGONIST WOMBAT-PK SCIENTIFIC LITERATURE
Carbonic anhydrase 2 Enzyme Ki 5.21 CHEMBL
Carbonic anhydrase 1 Enzyme Ki 5 CHEMBL
Carbonic anhydrase 4 Enzyme Ki 4.94 CHEMBL
Carbonic anhydrase 9 Enzyme Ki 4.15 CHEMBL
Carbonic anhydrase 12 Enzyme Ki 5.39 CHEMBL
Carbonic anhydrase 7 Enzyme Ki 5.04 CHEMBL
Carbonic anhydrase 3 Enzyme Ki 5.15 CHEMBL
Carbonic anhydrase 14 Enzyme Ki 4.97 CHEMBL
Arachidonate 5-lipoxygenase-activating protein Cytosolic other IC50 4.36 CHEMBL
Myoglobin Unclassified IC50 5.64 CHEMBL
Nuclear receptor subfamily 1 group I member 3 Nuclear hormone receptor WOMBAT-PK
Arachidonate 15-lipoxygenase Enzyme IC50 4.55 DRUG MATRIX
Carbonic anhydrase 13 Enzyme Ki 4.52 CHEMBL
Carbonic anhydrase 15 Enzyme Ki 5.03 CHEMBL

External reference:

IDSource
4017513 VUID
N0000145898 NUI
D00217 KEGG_DRUG
161 RXNORM
C0000970 UMLSCUI
CHEBI:46195 CHEBI
NNS PDB_CHEM_ID
CHEMBL112 ChEMBL_ID
DB00316 DRUGBANK_ID
5239 IUPHAR_LIGAND_ID
362O9ITL9D UNII
1983 PUBCHEM_CID
001605 NDDF
D000082 MESH_DESCRIPTOR_UI
626 INN_ID
387517004 SNOMEDCT_US
90332006 SNOMEDCT_US
4017513 VANDF
4119 MMSL
4973 MMSL
4992 MMSL
5005 MMSL
52845 MMSL
97317 MMSL
d00049 MMSL

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Childrens Dimetapp Multi-Symptom Cold and Flu HUMAN OTC DRUG LABEL 3 0031-2249 LIQUID 320 mg ORAL Unapproved drug other 17 sections
Robitussin Maximum Strength Severe Multi-Symptom 7 in 1 Relief Nighttime HUMAN OTC DRUG LABEL 3 0031-8744 CAPSULE, LIQUID FILLED 325 mg ORAL OTC MONOGRAPH FINAL 17 sections
Robitussin Maximum Strength Severe Cough Plus Sore Throat HUMAN OTC DRUG LABEL 2 0031-8750 LIQUID 650 mg ORAL OTC monograph final 17 sections
Robitussin Severe Multi-Symptom Cough Cold Flu HUMAN OTC DRUG LABEL 4 0031-8751 LIQUID 650 mg ORAL OTC monograph final 17 sections
Robitussin Severe Multi-Symptom Cough Cold Flu Nighttime HUMAN OTC DRUG LABEL 3 0031-8752 SOLUTION 650 mg ORAL OTC monograph final 17 sections
Robitussin Severe Multi-Symptom Cough Cold Flu Nighttime HUMAN OTC DRUG LABEL 3 0031-8752 SOLUTION 650 mg ORAL OTC monograph final 17 sections
Robitussin Honey Severe Cough, Flu Plus Sore Throat Nighttime HUMAN OTC DRUG LABEL 2 0031-8770 SOLUTION 650 mg ORAL OTC MONOGRAPH FINAL 17 sections
Robitussin Honey Severe Cough, Flu Plus Sore Throat HUMAN OTC DRUG LABEL 2 0031-8771 SOLUTION 650 mg ORAL OTC MONOGRAPH FINAL 17 sections
Robitussin Direct Sore Throat Pain HUMAN OTC DRUG LABEL 1 0031-9301 TABLET, COATED 500 mg ORAL OTC monograph not final 15 sections
Butalbital, Acetaminophen, Caffeine and Codeine Phosphate HUMAN PRESCRIPTION DRUG LABEL 4 0054-0650 CAPSULE 300 mg ORAL ANDA 33 sections
Butalbital, Acetaminophen, Caffeine and Codeine Phosphate HUMAN PRESCRIPTION DRUG LABEL 4 0054-3000 CAPSULE 325 mg ORAL ANDA 33 sections
Roxicet HUMAN PRESCRIPTION DRUG LABEL 2 0054-3686 SOLUTION 325 mg ORAL ANDA 23 sections
Roxicet HUMAN PRESCRIPTION DRUG LABEL 2 0054-4650 TABLET 325 mg ORAL ANDA 23 sections
Roxicet HUMAN PRESCRIPTION DRUG LABEL 2 0054-8648 SOLUTION 325 mg ORAL ANDA 23 sections
Roxicet HUMAN PRESCRIPTION DRUG LABEL 2 0054-8650 TABLET 325 mg ORAL ANDA 23 sections
TheraFlu Cold and Flu HUMAN OTC DRUG LABEL 3 0067-0924 POWDER 325 mg ORAL Export only 10 sections
ExcedrinExtra Strength Pain Reliever HUMAN OTC DRUG LABEL 3 0067-2000 TABLET, FILM COATED 250 mg ORAL OTC monograph not final 13 sections
ExcedrinExtra Strength Pain Reliever HUMAN OTC DRUG LABEL 3 0067-2001 TABLET, FILM COATED 250 mg ORAL OTC monograph not final 15 sections
ExcedrinExtra Strength Geltabs HUMAN OTC DRUG LABEL 3 0067-2021 TABLET, COATED 250 mg ORAL OTC monograph not final 14 sections
ExcedrinMigraine Geltabs HUMAN OTC DRUG LABEL 3 0067-2035 TABLET, COATED 250 mg ORAL NDA 14 sections
EXCEDRINMIGRAINE HUMAN OTC DRUG LABEL 3 0067-2039 TABLET, FILM COATED 250 mg ORAL NDA 15 sections
ExcedrinMigraine HUMAN OTC DRUG LABEL 3 0067-2040 TABLET, FILM COATED 250 mg ORAL NDA 16 sections
Excedrin PM Triple Action Caplets HUMAN OTC DRUG LABEL 3 0067-2056 TABLET, COATED 250 mg ORAL OTC monograph not final 16 sections
Excedrin PM Triple Action Caplets HUMAN OTC DRUG LABEL 3 0067-2056 TABLET, COATED 250 mg ORAL OTC monograph not final 16 sections
TherafluPowerPods Daytime Severe Cold HUMAN OTC DRUG LABEL 3 0067-6094 POWDER, FOR SOLUTION 650 mg ORAL OTC monograph final 16 sections
THERAFLUPOWERPODS NIGHTTIME SEVERE COLD HUMAN OTC DRUG LABEL 3 0067-6095 POWDER, FOR SOLUTION 650 mg ORAL OTC monograph final 16 sections
THERAFLUMULTI-SYMPTOM SEVERE COLD HUMAN OTC DRUG LABEL 3 0067-6426 POWDER, FOR SOLUTION 500 mg ORAL OTC monograph final 17 sections
TherafluFlu and Sore Throat HUMAN OTC DRUG LABEL 3 0067-7916 POWDER, FOR SOLUTION 650 mg ORAL OTC monograph final 17 sections
TherafluDaytime Severe Cold and Cough HUMAN OTC DRUG LABEL 3 0067-7917 POWDER, FOR SOLUTION 650 mg ORAL OTC monograph final 16 sections
THERAFLUNIGHTTIME SEVERE COLD AND COUGH HUMAN OTC DRUG LABEL 3 0067-7918 POWDER, FOR SOLUTION 650 mg ORAL OTC monograph final 17 sections