paracetamol 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 ┬ÁM/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 2703.78 11.31 8763 776691 203003 45697605
Completed suicide 2656.65 11.31 6860 778594 139060 45761548
Intentional overdose 1035.28 11.31 2910 782544 62034 45838574
Overdose 984.42 11.31 3855 781599 98124 45802484
Acute hepatic failure 825.79 11.31 1125 784329 13596 45887012
Analgesic drug level increased 773.89 11.31 415 785039 1079 45899529
Drug ineffective 585.41 11.31 7972 777482 669866 45230742
Hepatocellular injury 563.63 11.31 1415 784039 28107 45872501
Poisoning deliberate 458.62 11.31 615 784839 7311 45893297
Suicide attempt 441.68 11.31 1967 783487 53069 45847539
Intentional product misuse 371.84 11.31 1676 783778 45452 45855156
Metabolic acidosis 357.62 11.31 1446 784008 37334 45863274
Device expulsion 318.26 11.31 43 785411 27499 45873109
Drug abuse 295.30 11.31 1953 783501 61455 45839153
Injection site pain 267.07 11.31 916 784538 106236 45794372
Infusion related reaction 256.96 11.31 2719 782735 98489 45802119
Cholestasis 226.19 11.31 975 784479 25918 45874690
Hepatotoxicity 207.50 11.31 903 784551 24106 45876502
Injection site erythema 207.36 11.31 605 784849 73822 45826786
Rheumatoid arthritis 183.81 11.31 2888 782566 237327 45663281
Off label use 182.40 11.31 4931 780523 374910 45525698
Pemphigus 178.60 11.31 304 785150 44970 45855638
Alopecia 176.69 11.31 1812 783642 160602 45740006
Treatment failure 175.14 11.31 887 784567 92200 45808408
Systemic lupus erythematosus 170.04 11.31 546 784908 64634 45835974
Somnolence 165.29 11.31 3618 781836 152903 45747705
Anion gap 164.83 11.31 140 785314 933 45899675
Maternal exposure during pregnancy 160.70 11.31 1037 784417 101512 45799096
Drug resistance 152.21 11.31 51 785403 17317 45883291
Coma 151.01 11.31 1574 783880 56775 45843833
Liver injury 150.15 11.31 600 784854 15401 45885207
Hepatic failure 149.95 11.31 1020 784434 32396 45868212
Injection site reaction 149.08 11.31 368 785086 47481 45853127
Cardiac failure congestive 139.10 11.31 937 784517 90813 45809795
Product dose omission issue 134.24 11.31 2010 783444 166510 45734098
Coagulopathy 134.14 11.31 642 784812 17857 45882751
Cardio-respiratory arrest 129.01 11.31 1558 783896 58311 45842297
Psoriasis 127.17 11.31 787 784667 77817 45822791
Drug dependence 123.48 11.31 661 784793 19240 45881368
Respiratory arrest 121.42 11.31 979 784475 32837 45867771
Exposure to toxic agent 120.70 11.31 159 785295 1855 45898753
Respiratory depression 117.82 11.31 446 785008 11154 45889454
Injection site pruritus 112.90 11.31 320 785134 39423 45861185
Cholecystitis chronic 110.24 11.31 408 785046 10091 45890517
Pyroglutamate increased 107.79 11.31 75 785379 354 45900254
Hepatitis 106.77 11.31 916 784538 31299 45869309
Wrong technique in product usage process 106.69 11.31 511 784943 53911 45846697
Injection site swelling 102.95 11.31 341 785113 39986 45860622
Accidental overdose 99.45 11.31 628 784826 19438 45881170
No adverse event 99.18 11.31 273 785181 33958 45866650
Contraindicated product administered 98.78 11.31 864 784590 79083 45821525
Abdominal discomfort 96.05 11.31 1878 783576 149287 45751321
Myocardial infarction 96.00 11.31 1113 784341 96415 45804193
Blood pressure fluctuation 94.30 11.31 853 784601 29595 45871013
Vomiting 93.68 11.31 8837 776617 443957 45456651
Depressed level of consciousness 93.52 11.31 1217 784237 46352 45854256
Bone marrow failure 93.33 11.31 227 785227 29442 45871166
Drug intolerance 90.67 11.31 1836 783618 145213 45755395
Suspected suicide 88.49 11.31 223 785231 4438 45896170
International normalised ratio increased 88.24 11.31 1190 784264 45693 45854915
Abdominal pain 85.24 11.31 4708 780746 225323 45675285
Glossodynia 85.03 11.31 420 785034 43953 45856655
Red blood cell sedimentation rate abnormal 83.88 11.31 64 785390 13585 45887023
Bradypnoea 81.81 11.31 167 785287 2872 45897736
Hepatic necrosis 81.44 11.31 243 785211 5358 45895250
Miosis 81.37 11.31 272 785182 6385 45894223
Confusional state 80.01 11.31 3371 782083 156521 45744087
Transplant rejection 79.30 11.31 31 785423 9565 45891043
Urine abnormality 76.93 11.31 238 785216 5356 45895252
Injury 75.79 11.31 1100 784354 42927 45857681
Therapy non-responder 75.17 11.31 396 785058 40756 45859852
Injection site bruising 73.16 11.31 329 785125 35307 45865301
Hepatitis fulminant 72.31 11.31 170 785284 3232 45897376
Cytomegalovirus infection 67.78 11.31 126 785328 18018 45882590
Injection site warmth 67.71 11.31 79 785375 13693 45886915
Cardiac failure 66.92 11.31 944 784510 79004 45821604
Therapeutic response decreased 66.67 11.31 438 785016 42707 45857901
Ductus arteriosus premature closure 66.30 11.31 51 785403 289 45900319
Abortion spontaneous 64.99 11.31 448 785006 43198 45857410
Asthma 64.76 11.31 1116 784338 90426 45810182
Hepatitis cholestatic 64.76 11.31 253 785201 6424 45894184
Hepatitis acute 64.65 11.31 292 785162 7922 45892686
Therapeutic product effect incomplete 64.29 11.31 926 784528 77227 45823381
Prothrombin time shortened 64.02 11.31 110 785344 1649 45898959
Unintentional medical device removal 63.88 11.31 3 785451 4550 45896058
Poisoning 63.87 11.31 429 785025 13565 45887043
Accidental exposure to product 61.91 11.31 167 785287 20914 45879694
Transaminases increased 61.78 11.31 727 784727 27034 45873574
Pyroglutamic acidosis 60.10 11.31 43 785411 214 45900394
Inadequate analgesia 59.90 11.31 141 785313 2683 45897925
Exposure via ingestion 59.79 11.31 160 785294 3307 45897301
Interstitial lung disease 59.35 11.31 600 784854 53349 45847259
Mixed liver injury 59.28 11.31 150 785304 2993 45897615
Product quality issue 57.58 11.31 357 785097 35291 45865317
Urine leukocyte esterase positive 55.33 11.31 128 785326 2407 45898201
Hospitalisation 54.62 11.31 744 784710 62641 45837967
Osteonecrosis 53.85 11.31 236 785218 25508 45875100
Intentional self-injury 53.84 11.31 633 784821 23533 45877075
Breast cancer 53.55 11.31 498 784956 45020 45855588
Haematotoxicity 53.14 11.31 25 785429 6908 45893700
Prothrombin time prolonged 53.06 11.31 309 785145 9287 45891321
Emotional distress 52.76 11.31 767 784687 29940 45870668
Acute lung injury 52.32 11.31 84 785370 1187 45899421
Substance abuse 51.59 11.31 171 785283 3996 45896612
C-reactive protein abnormal 51.48 11.31 184 785270 21086 45879522
Pathogen resistance 51.04 11.31 19 785435 6041 45894567
Hepatic encephalopathy 51.02 11.31 319 785135 9838 45890770
Infective pulmonary exacerbation of cystic fibrosis 51.00 11.31 64 785390 10743 45889865
Disease progression 50.42 11.31 1160 784294 90140 45810468
Psoriatic arthropathy 50.01 11.31 382 785072 35997 45864611
Hypertransaminasaemia 49.46 11.31 150 785304 3338 45897270
Synovitis 49.40 11.31 726 784728 60349 45840259
Crystal urine present 48.83 11.31 81 785373 1178 45899430
White blood cells urine positive 48.76 11.31 166 785288 3934 45896674
Medication error 48.43 11.31 760 784694 30151 45870457
Back pain 48.24 11.31 4132 781322 205907 45694701
Coronary artery disease 47.54 11.31 352 785102 33400 45867208
Pulmonary arterial hypertension 47.07 11.31 250 785204 25678 45874930
Acute generalised exanthematous pustulosis 47.00 11.31 295 785159 9110 45891498
Adverse event 46.97 11.31 359 785095 33825 45866783
Condition aggravated 46.78 11.31 3519 781935 241533 45659075
Peritonitis bacterial 46.59 11.31 46 785408 8607 45892001
Dyspnoea 46.26 11.31 7798 777656 507750 45392858
Myelodysplastic syndrome 44.98 11.31 126 785328 15585 45885023
Transplant dysfunction 44.19 11.31 12 785442 4670 45895938
Cerebrovascular accident 43.86 11.31 1329 784125 99710 45800898
Urinary sediment present 43.18 11.31 95 785359 1725 45898883
Femur fracture 42.14 11.31 408 785046 36589 45864019
Injection site haemorrhage 42.02 11.31 192 785262 20517 45880091
Blood iron abnormal 41.70 11.31 3 785451 3167 45897441
Diabetes mellitus 41.23 11.31 593 784861 49472 45851136
Encephalopathy 41.16 11.31 794 784660 32795 45867813
Granuloma skin 41.09 11.31 5 785449 3465 45897143
Pregnancy 40.66 11.31 278 785176 26859 45873749
Abortion incomplete 40.44 11.31 4 785450 3260 45897348
Acute kidney injury 40.40 11.31 4546 780908 231309 45669299
Post transplant lymphoproliferative disorder 40.13 11.31 8 785446 3848 45896760
Forced expiratory volume decreased 39.75 11.31 18 785436 5086 45895522
Body temperature increased 39.61 11.31 613 784841 24248 45876360
Exposure during pregnancy 39.30 11.31 1456 783998 106756 45793852
Drug-induced liver injury 39.09 11.31 622 784832 24746 45875862
Product use in unapproved indication 39.03 11.31 1188 784266 89085 45811523
Renal papillary necrosis 38.62 11.31 33 785421 222 45900386
Bone erosion 38.54 11.31 62 785392 9381 45891227
Oligohydramnios 38.42 11.31 188 785266 5277 45895331
Diarrhoea 38.23 11.31 8584 776870 551018 45349590
Blood parathyroid hormone decreased 38.15 11.31 13 785441 4368 45896240
Injection site rash 38.13 11.31 137 785317 15676 45884932
Prothrombin time ratio decreased 37.99 11.31 41 785413 381 45900227
Anaemia 37.81 11.31 3747 781707 252032 45648576
Disease recurrence 37.62 11.31 171 785283 18300 45882308
Palmar-plantar erythrodysaesthesia syndrome 37.23 11.31 197 785257 20254 45880354
Lymphocyte count decreased 37.04 11.31 621 784833 24968 45875640
Arthropathy 37.03 11.31 1113 784341 83587 45817021
Hypertensive crisis 36.94 11.31 112 785342 13503 45887105
Constipation 36.88 11.31 3405 782049 170692 45729916
Medication overuse headache 36.84 11.31 43 785411 439 45900169
Product storage error 36.47 11.31 91 785363 11701 45888907
Dependence 36.26 11.31 92 785362 1839 45898769
Caesarean section 36.08 11.31 150 785304 16453 45884155
Product prescribing error 36.00 11.31 194 785260 19853 45880755
Analgesic drug level above therapeutic 35.57 11.31 28 785426 165 45900443
Neurotoxicity 34.99 11.31 116 785338 13601 45887007
Haemophagocytic lymphohistiocytosis 34.78 11.31 54 785400 8288 45892320
Malignant neoplasm progression 34.15 11.31 831 784623 64095 45836513
Red blood cells urine positive 34.09 11.31 109 785345 2498 45898110
Meningitis aseptic 34.00 11.31 147 785307 3912 45896696
Myelosuppression 33.93 11.31 48 785406 7655 45892953
Unresponsive to stimuli 33.65 11.31 743 784711 31431 45869177
Hypothermia 33.58 11.31 333 785121 11850 45888758
Renal impairment 33.58 11.31 973 784481 73399 45827209
Drug abuser 33.41 11.31 125 785329 3108 45897500
Dyspnoea exertional 33.36 11.31 620 784834 49669 45850939
Acute graft versus host disease 33.33 11.31 13 785441 4017 45896591
Blood glucose increased 33.30 11.31 939 784515 71074 45829534
Peritonitis 33.16 11.31 208 785246 20506 45880102
Device malfunction 32.83 11.31 115 785339 13259 45887349
Hand deformity 32.67 11.31 398 785056 34176 45866432
Blood pressure diastolic abnormal 32.44 11.31 199 785255 6095 45894513
Tachycardia 32.24 11.31 2015 783439 97607 45803001
Metastases to liver 32.22 11.31 195 785259 19390 45881218
Posterior reversible encephalopathy syndrome 32.15 11.31 138 785316 15003 45885605
Acidosis 32.06 11.31 308 785146 10866 45889742
Mucosal inflammation 31.97 11.31 462 784992 38514 45862094
Leukopenia 31.90 11.31 890 784564 67453 45833155
Gallbladder injury 31.79 11.31 71 785383 1303 45899305
Osteoporosis 31.70 11.31 486 784968 40122 45860486
Device dislocation 31.37 11.31 226 785228 21576 45879032
Migraine 31.15 11.31 1459 783995 68567 45832041
Glycosylated haemoglobin increased 30.57 11.31 88 785366 10788 45889820
Abdominal pain upper 30.32 11.31 2839 782615 142466 45758142
Anion gap abnormal 30.00 11.31 33 785421 314 45900294
Panniculitis 29.94 11.31 31 785423 5673 45894935
Obstructive airways disorder 29.88 11.31 120 785334 13292 45887316
Chronic graft versus host disease 29.77 11.31 5 785449 2720 45897888
Pain 29.72 11.31 8721 776733 468227 45432381
Multiple-drug resistance 29.64 11.31 4 785450 2561 45898047
Drug screen positive 29.64 11.31 137 785317 3754 45896854
Gallbladder disorder 29.64 11.31 436 785018 17062 45883546
Device adhesion issue 29.61 11.31 3 785451 2399 45898209
Neutropenia 29.46 11.31 2043 783411 141161 45759447
Prescription form tampering 29.45 11.31 46 785408 634 45899974
Injection site induration 29.39 11.31 57 785397 8022 45892586
Complication associated with device 29.09 11.31 147 785307 15294 45885314
Pulmonary hypertension 29.05 11.31 428 785026 35565 45865043
Thrombotic microangiopathy 29.02 11.31 60 785394 8246 45892362
Liver transplant 28.87 11.31 98 785356 2319 45898289
Chills 28.65 11.31 1929 783525 94103 45806505
General physical health deterioration 28.60 11.31 1624 783830 114145 45786463
Blood urine present 28.38 11.31 324 785130 11958 45888650
Therapeutic product effect decreased 28.31 11.31 1119 784335 81482 45819126
Infusion site pain 28.22 11.31 277 785177 9830 45890778
Osteonecrosis of jaw 28.14 11.31 408 785046 33994 45866614
Mucormycosis 27.90 11.31 3 785451 2289 45898319
Infection 27.79 11.31 1904 783550 131688 45768920
Toxic epidermal necrolysis 27.76 11.31 528 784926 21750 45878858
Acute myocardial infarction 27.75 11.31 374 785080 31550 45869058
Alanine aminotransferase increased 27.70 11.31 1784 783670 86667 45813941
Pneumocystis jirovecii pneumonia 27.69 11.31 147 785307 15101 45885507
Acute myeloid leukaemia 27.61 11.31 154 785300 15624 45884984
Uterine perforation 27.51 11.31 213 785241 7054 45893554
Haemoglobin urine present 27.39 11.31 44 785410 622 45899986
Juvenile idiopathic arthritis 27.20 11.31 18 785436 4114 45896494
Premature delivery 27.02 11.31 239 785215 21830 45878778
Cholelithiasis 27.02 11.31 847 784607 37834 45862774
Oedema peripheral 26.96 11.31 2316 783138 157390 45743218
Blood pressure systolic abnormal 26.92 11.31 172 785282 5345 45895263
Cerebral infarction 26.90 11.31 257 785197 23109 45877499
Wrong patient received product 26.83 11.31 77 785377 1660 45898948
Device breakage 26.82 11.31 79 785375 9613 45890995
Abortion induced 26.70 11.31 86 785368 10174 45890434
Neuralgia 26.37 11.31 506 784948 20877 45879731
Drug withdrawal syndrome 26.04 11.31 624 784830 26760 45873848
Oxygen saturation decreased 26.02 11.31 1418 784036 67746 45832862
Red cell distribution width increased 26.01 11.31 220 785234 7484 45893124
Infusion site extravasation 25.73 11.31 164 785290 5092 45895516
Upper gastrointestinal haemorrhage 25.63 11.31 410 785044 16328 45884280
Throat irritation 25.52 11.31 652 784802 28249 45872359
Injection site urticaria 25.46 11.31 109 785345 11858 45888750
Graft versus host disease 25.28 11.31 45 785409 6543 45894065
Peritoneal dialysis complication 25.25 11.31 7 785447 2687 45897921
Low turnover osteopathy 25.24 11.31 21 785433 4268 45896340
Device use error 25.14 11.31 29 785425 5052 45895556
Hallucination 25.13 11.31 1054 784400 48897 45851711
Visceral congestion 25.10 11.31 28 785426 271 45900337
Urticaria 24.98 11.31 2306 783148 115586 45785022
Heart rate decreased 24.96 11.31 705 784749 31018 45869590
Congenital pulmonary hypertension 24.95 11.31 16 785438 64 45900544
Kidney transplant rejection 24.43 11.31 20 785434 4098 45896510
Drug use disorder 24.42 11.31 101 785353 2634 45897974
Galactorrhoea 24.38 11.31 17 785437 3780 45896828
Myocardial depression 24.31 11.31 36 785418 472 45900136
Septic shock 24.25 11.31 765 784689 57128 45843480
Virologic failure 24.24 11.31 3 785451 2052 45898556
Hypocoagulable state 24.11 11.31 54 785400 993 45899615
Rheumatoid factor positive 24.00 11.31 224 785230 20237 45880371
Ovarian hyperstimulation syndrome 23.72 11.31 12 785442 3180 45897428
Cardiac arrest 23.72 11.31 1797 783657 88602 45812006
Complication of device insertion 23.62 11.31 29 785425 4915 45895693
Cerebral haematoma 23.57 11.31 115 785339 3224 45897384
Body temperature fluctuation 23.46 11.31 76 785378 1754 45898854
Posturing 23.26 11.31 35 785419 466 45900142
Toxic anterior segment syndrome 23.17 11.31 4 785450 2133 45898475
Coma scale abnormal 23.16 11.31 154 785300 4852 45895756
Metastases to lung 23.01 11.31 97 785357 10599 45890009
Nasal necrosis 22.97 11.31 17 785437 90 45900518
Arrhythmia 22.96 11.31 430 785024 34411 45866197
Pneumonia 22.86 11.31 5803 779651 370517 45530091
Atrial fibrillation 22.78 11.31 1469 783985 102121 45798487
Platelet count decreased 22.76 11.31 1414 784040 98610 45801998
Respiratory failure 22.70 11.31 1334 784120 93482 45807126
Porphyria acute 22.65 11.31 30 785424 352 45900256
Second primary malignancy 22.63 11.31 48 785406 6536 45894072
Right ventricular failure 22.58 11.31 168 785286 15925 45884683
Urine analysis abnormal 22.57 11.31 134 785320 4056 45896552
Prothrombin level increased 22.57 11.31 24 785430 219 45900389
Varicella zoster virus infection 22.13 11.31 6 785448 2337 45898271
Lethargy 22.08 11.31 1063 784391 50108 45850500
Metastases to bone 21.95 11.31 188 785266 17288 45883320
Coagulation factor V level decreased 21.87 11.31 28 785426 317 45900291
Lower respiratory tract infection 21.83 11.31 1135 784319 53954 45846654
Hepatitis toxic 21.66 11.31 104 785350 2896 45897712
Orthostatic hypotension 21.40 11.31 555 784899 24103 45876505
Fear of injection 21.25 11.31 23 785431 4124 45896484
Headache 21.21 11.31 8636 776818 469716 45430892
Cardiogenic shock 21.15 11.31 175 785279 16209 45884399
Injection site mass 21.11 11.31 157 785297 14883 45885725
Skin necrosis 21.11 11.31 74 785380 8530 45892078
Ear pruritus 21.11 11.31 81 785373 2039 45898569
Hyperhidrosis 21.10 11.31 1761 783693 87547 45813061
Anion gap increased 21.03 11.31 64 785390 1427 45899181
Acute graft versus host disease in skin 21.01 11.31 12 785442 2970 45897638
Accidental poisoning 20.93 11.31 37 785417 568 45900040
Hyperthermia 20.63 11.31 216 785238 7798 45892810
Drug level increased 20.61 11.31 430 785024 18011 45882597
Cardiomyopathy 20.60 11.31 172 785282 15901 45884707
Treatment noncompliance 20.51 11.31 364 785090 29367 45871241
Heart rate increased 20.51 11.31 1492 783962 73299 45827309
Brain death 20.48 11.31 98 785356 2725 45897883
Stevens-Johnson syndrome 20.40 11.31 525 784929 22772 45877836
Drug detoxification 20.30 11.31 21 785433 185 45900423
Knee arthroplasty 20.30 11.31 278 785176 23387 45877221
Duodenal stenosis 20.22 11.31 36 785418 556 45900052
Anti-neutrophil cytoplasmic antibody positive vasculitis 20.17 11.31 4 785450 1931 45898677
Cardiotoxicity 19.93 11.31 53 785401 6669 45893939
Aspergillus infection 19.92 11.31 55 785399 6835 45893773
Urine ketone body present 19.84 11.31 80 785374 2062 45898546
Temperature regulation disorder 19.76 11.31 110 785344 3250 45897358
Congenital tricuspid valve incompetence 19.67 11.31 14 785440 69 45900539
Neonatal respiratory acidosis 19.48 11.31 12 785442 44 45900564
Renal failure neonatal 19.38 11.31 17 785437 119 45900489
Blood pressure diastolic increased 19.33 11.31 169 785285 5805 45894803
Disturbance in social behaviour 19.30 11.31 3 785451 1728 45898880
Ascites 19.30 11.31 468 784986 36116 45864492
Cell death 19.27 11.31 83 785371 2205 45898403
Gastrooesophageal reflux disease 19.25 11.31 1038 784416 73306 45827302
Hyperlipidaemia 19.24 11.31 209 785245 18330 45882278
Fixed eruption 19.24 11.31 44 785410 821 45899787
Syncope 19.16 11.31 1510 783944 103293 45797315
Akathisia 19.16 11.31 66 785388 7648 45892960
Epstein-Barr virus infection 18.99 11.31 55 785399 6729 45893879
Swelling 18.92 11.31 1820 783634 122691 45777917
Pancytopenia 18.91 11.31 1205 784249 83853 45816755
Adverse drug reaction 18.87 11.31 585 784869 43777 45856831
Infusion site swelling 18.85 11.31 162 785292 5537 45895071
Myopathy 18.82 11.31 81 785373 8800 45891808
Infusion site erythema 18.75 11.31 204 785250 7438 45893170
Lymphoproliferative disorder 18.72 11.31 11 785443 2681 45897927
Hyperleukocytosis 18.70 11.31 29 785425 397 45900211
Biliary sepsis 18.67 11.31 34 785420 535 45900073
Underdose 18.53 11.31 225 785229 19333 45881275
Sinusitis 18.48 11.31 2473 782981 127295 45773313
Device deployment issue 18.43 11.31 19 785435 3484 45897124
Blister 18.39 11.31 923 784531 43708 45856900
Coagulation factor VII level decreased 18.33 11.31 9 785445 18 45900590
Type 2 diabetes mellitus 18.32 11.31 230 785224 19645 45880963
Neoplasm progression 18.31 11.31 327 785127 26356 45874252
Cystic fibrosis 18.30 11.31 21 785433 3667 45896941
Drug diversion 18.27 11.31 43 785411 818 45899790
Cardiovascular disorder 18.18 11.31 125 785329 12062 45888546
Agitation 18.13 11.31 1122 784332 54293 45846315
Angina pectoris 18.10 11.31 329 785125 26446 45874162
Self-medication 18.07 11.31 78 785376 2074 45898534
Transverse sinus thrombosis 17.87 11.31 37 785417 643 45899965
Electric shock 17.86 11.31 44 785410 863 45899745
Seizure 17.82 11.31 1805 783649 121249 45779359
Ductus arteriosus stenosis foetal 17.77 11.31 15 785439 99 45900509
Lymphocyte percentage decreased 17.67 11.31 91 785363 2608 45898000
Abnormal clotting factor 17.66 11.31 15 785439 100 45900508
Lupus-like syndrome 17.59 11.31 70 785384 7774 45892834
Bradycardia 17.57 11.31 1319 784135 64979 45835629
Intentional product use issue 17.52 11.31 1070 784384 51710 45848898
Brain oedema 17.40 11.31 301 785153 12177 45888431
Haemorrhage 17.38 11.31 750 784704 54119 45846489
Hyperglycaemia 17.33 11.31 453 785001 34618 45865990
Oedema 17.26 11.31 937 784517 66134 45834474
Jaundice 17.18 11.31 620 784834 28225 45872383
Poor quality device used 17.16 11.31 7 785447 2105 45898503
Electrocardiogram U-wave abnormality 17.16 11.31 11 785443 44 45900564
Musculoskeletal disorder 17.04 11.31 173 785281 15372 45885236
Graft versus host disease in gastrointestinal tract 16.93 11.31 11 785443 2539 45898069
Opiates positive 16.93 11.31 22 785432 253 45900355
Hallucination, visual 16.91 11.31 407 785047 17466 45883142
Rash maculo-papular 16.82 11.31 600 784854 27274 45873334
Drug screen negative 16.71 11.31 26 785428 357 45900251
Blood prolactin increased 16.40 11.31 16 785438 3011 45897597
Drug eruption 16.40 11.31 256 785198 21073 45879535
Immune reconstitution inflammatory syndrome 16.33 11.31 46 785408 5679 45894929
Haematoma muscle 16.30 11.31 34 785420 594 45900014
Glutathione decreased 16.23 11.31 6 785448 3 45900605
JC virus infection 16.18 11.31 4 785450 1658 45898950
Bursitis 16.18 11.31 443 785011 19399 45881209
Bladder dilatation 16.08 11.31 38 785416 725 45899883
Tonsillar inflammation 16.07 11.31 14 785440 97 45900511
Respiratory acidosis 15.96 11.31 166 785288 5982 45894626
Liver function test abnormal 15.91 11.31 945 784509 45542 45855066
Hypotension 15.80 11.31 4269 781185 228320 45672288
Haematemesis 15.68 11.31 613 784841 28193 45872415
Autonomic dysreflexia 15.64 11.31 19 785435 203 45900405
Vitamin K deficiency 15.57 11.31 28 785426 436 45900172
Ear pain 15.49 11.31 484 784970 21608 45879000
Loss of personal independence in daily activities 15.44 11.31 795 784659 56388 45844220
Basal cell carcinoma 15.38 11.31 247 785207 20240 45880368
Diabetic ketoacidosis 15.23 11.31 215 785239 17995 45882613
Hepatic infiltration eosinophilic 15.22 11.31 9 785445 30 45900578
Biliary dyskinesia 15.14 11.31 89 785365 2684 45897924
Specific gravity urine decreased 15.12 11.31 27 785427 418 45900190
Night sweats 15.10 11.31 581 784873 26669 45873939
Unintended pregnancy 15.04 11.31 47 785407 5613 45894995
Serotonin syndrome 15.02 11.31 523 784931 23697 45876911
Metastases to lymph nodes 14.98 11.31 59 785395 6572 45894036
Infusion site bruising 14.94 11.31 58 785396 1468 45899140
Toxicologic test abnormal 14.93 11.31 35 785419 664 45899944
Intestinal pseudo-obstruction 14.91 11.31 34 785420 633 45899975
Endophthalmitis 14.86 11.31 20 785434 3258 45897350
Anticholinergic syndrome 14.82 11.31 65 785389 1741 45898867
Peptic ulcer haemorrhage 14.78 11.31 44 785410 969 45899639
Epilepsy 14.72 11.31 296 785158 23442 45877166
Gallbladder adenocarcinoma 14.71 11.31 12 785442 75 45900533
Injection site haematoma 14.70 11.31 53 785401 6059 45894549
Tardive dyskinesia 14.67 11.31 71 785383 7472 45893136
Ventricular tachycardia 14.67 11.31 199 785255 16768 45883840
Lip pruritus 14.66 11.31 29 785425 487 45900121
Duplicate therapy error 14.61 11.31 8 785446 22 45900586
Type I hypersensitivity 14.60 11.31 78 785376 2268 45898340
Administration site pain 14.57 11.31 34 785420 643 45899965
Intramedullary rod insertion 14.56 11.31 9 785445 2134 45898474
Truncus coeliacus thrombosis 14.55 11.31 6 785448 6 45900602
Bone disorder 14.55 11.31 243 785211 19790 45880818
Rash 14.52 11.31 5587 779867 350925 45549683
Therapy cessation 14.50 11.31 339 785115 26290 45874318
Bacterial test 14.50 11.31 50 785404 1193 45899415
Cholangitis acute 14.48 11.31 27 785427 433 45900175
Hypothyroidism 14.39 11.31 409 785045 30929 45869679
Hepatitis B 14.37 11.31 25 785429 3668 45896940
Hypoprothrombinaemia 14.35 11.31 22 785432 298 45900310
Toxic skin eruption 14.23 11.31 290 785164 12097 45888511
Complication of device removal 14.16 11.31 23 785431 3467 45897141
Mydriasis 14.15 11.31 253 785201 10300 45890308
Osmolar gap 14.09 11.31 13 785441 98 45900510
Deafness transitory 13.94 11.31 5 785449 1627 45898981
Hyponatraemia 13.92 11.31 1927 783527 99405 45801203
Muscle injury 13.90 11.31 134 785320 4732 45895876
Vascular purpura 13.87 11.31 52 785402 1294 45899314
Polyneuropathy 13.86 11.31 127 785327 11517 45889091
Cholesterosis 13.86 11.31 26 785428 419 45900189
Normal newborn 13.81 11.31 53 785401 5948 45894660
Delirium 13.75 11.31 762 784692 36466 45864142
Culture urine positive 13.74 11.31 101 785353 3290 45897318
Blood urea increased 13.73 11.31 323 785131 25029 45875579
Deep vein thrombosis 13.67 11.31 1538 783916 78235 45822373
Bone density decreased 13.59 11.31 102 785352 9650 45890958
Drug tolerance decreased 13.53 11.31 19 785435 3040 45897568
White blood cell count decreased 13.53 11.31 1667 783787 110564 45790044
Cytomegalovirus viraemia 13.51 11.31 35 785419 4443 45896165
Pancreatic fibrosis 13.47 11.31 12 785442 86 45900522
Infectious thyroiditis 13.46 11.31 8 785446 27 45900581
Costovertebral angle tenderness 13.46 11.31 11 785443 69 45900539
Graft versus host disease in skin 13.43 11.31 12 785442 2355 45898253
Libido disorder 13.36 11.31 10 785444 54 45900554
Coronary arterial stent insertion 13.35 11.31 17 785437 2836 45897772
Post-traumatic stress disorder 13.35 11.31 115 785339 3933 45896675
Specific gravity urine increased 13.31 11.31 17 785437 192 45900416
Mediastinal abscess 13.26 11.31 6 785448 9 45900599
Hernial eventration 13.26 11.31 6 785448 9 45900599
Irritable bowel syndrome 13.26 11.31 368 785086 16147 45884461
Rheumatoid nodule 13.22 11.31 93 785361 8927 45891681
Malignant gastrointestinal obstruction 13.21 11.31 5 785449 3 45900605
Coagulation factor V level increased 13.21 11.31 5 785449 3 45900605
Red blood cell spherocytes present 13.21 11.31 5 785449 3 45900605
Capillary nail refill test abnormal 13.21 11.31 5 785449 3 45900605
Bronchopulmonary aspergillosis 13.21 11.31 73 785381 7423 45893185
Mycobacterium tuberculosis complex test positive 13.20 11.31 5 785449 1573 45899035
Nephrogenic systemic fibrosis 13.13 11.31 39 785415 4733 45895875
Human herpesvirus 6 infection 13.09 11.31 13 785441 2426 45898182
Product container issue 13.02 11.31 7 785447 1792 45898816
Product administration error 12.97 11.31 428 785026 19253 45881355
Blood pressure increased 12.96 11.31 2370 783084 124296 45776312
Neuroleptic malignant syndrome 12.94 11.31 122 785332 11000 45889608
Small for dates baby 12.94 11.31 26 785428 3611 45896997
Poor venous access 12.91 11.31 204 785250 8104 45892504
Periorbital cellulitis 12.90 11.31 27 785427 473 45900135
Alpha 1 microglobulin increased 12.89 11.31 6 785448 10 45900598
Injection site discolouration 12.89 11.31 66 785388 6844 45893764
Gestational diabetes 12.88 11.31 70 785384 7149 45893459
Gingival hypertrophy 12.87 11.31 4 785450 1425 45899183
Unevaluable event 12.84 11.31 640 784814 45535 45855073
Granuloma 12.80 11.31 28 785426 3770 45896838
Product substitution issue 12.74 11.31 177 785277 14854 45885754
Fracture nonunion 12.69 11.31 13 785441 2391 45898217
Toxic shock syndrome streptococcal 12.66 11.31 12 785442 94 45900514
Acute lymphocytic leukaemia recurrent 12.65 11.31 10 785444 2085 45898523
Upper gastrointestinal perforation 12.64 11.31 5 785449 4 45900604
Mania 12.61 11.31 119 785335 10727 45889881
Acute haemorrhagic oedema of infancy 12.60 11.31 7 785447 20 45900588
Meningorrhagia 12.59 11.31 14 785440 135 45900473
Pruritus 12.58 11.31 4401 781053 237951 45662657
Cardiac disorder 12.57 11.31 606 784848 43252 45857356
External ear cellulitis 12.48 11.31 8 785446 32 45900576
Sphincter of Oddi dysfunction 12.43 11.31 22 785432 338 45900270
Gallbladder cholesterolosis 12.43 11.31 35 785419 746 45899862
Melaena 12.42 11.31 579 784875 27193 45873415
Hip arthroplasty 12.41 11.31 222 785232 17890 45882718
Amenorrhoea 12.41 11.31 93 785361 8802 45891806
Neurone-specific enolase increased 12.41 11.31 4 785450 0 45900608
Fibrin D dimer decreased 12.41 11.31 4 785450 0 45900608
Analgesic drug level therapeutic 12.41 11.31 4 785450 0 45900608
Lip oedema 12.40 11.31 98 785356 3266 45897342
Withdrawal syndrome 12.38 11.31 396 785058 17738 45882870
Pulmonary fibrosis 12.32 11.31 251 785203 19841 45880767
Blood count abnormal 12.30 11.31 219 785235 17659 45882949
Red blood cell sedimentation rate increased 12.29 11.31 292 785162 22597 45878011
Intervertebral discitis 12.29 11.31 79 785375 2460 45898148
Anxiety 12.28 11.31 3339 782115 178618 45721990
Breast cancer recurrent 12.24 11.31 30 785424 3881 45896727
Jaundice cholestatic 12.22 11.31 134 785320 4895 45895713
Product tampering 12.22 11.31 11 785443 80 45900528
Concomitant disease aggravated 12.18 11.31 80 785374 7802 45892806
Nocardiosis 12.14 11.31 6 785448 1611 45898997
Brain compression 12.13 11.31 22 785432 345 45900263
Open globe injury 12.11 11.31 9 785445 48 45900560
Accidental exposure to product by child 12.09 11.31 44 785410 1079 45899529
Status epilepticus 12.07 11.31 164 785290 13815 45886793
Product counterfeit 12.03 11.31 13 785441 121 45900487
Cholestatic liver injury 12.01 11.31 68 785386 2022 45898586
Administration site swelling 12.00 11.31 45 785409 1120 45899488
Tuberculin test positive 12 11.31 20 785434 2984 45897624
Fluid overload 11.93 11.31 357 785097 26828 45873780
Muscle spasticity 11.90 11.31 264 785190 11176 45889432
Fracture 11.90 11.31 200 785254 16271 45884337
Infusion site pruritus 11.89 11.31 92 785362 3046 45897562
Pericardial effusion 11.82 11.31 333 785121 25210 45875398
Gastric ulcer perforation 11.78 11.31 44 785410 1093 45899515
Cytomegalovirus infection reactivation 11.77 11.31 5 785449 1467 45899141
Blood triglycerides increased 11.76 11.31 134 785320 11649 45888959
Murphy's sign positive 11.67 11.31 5 785449 6 45900602
Calculus urethral 11.67 11.31 5 785449 6 45900602
Macular oedema 11.66 11.31 33 785421 4068 45896540
Photophobia 11.66 11.31 324 785130 14220 45886388
Dyspnoea at rest 11.64 11.31 27 785427 3561 45897047
Respiratory rate increased 11.63 11.31 263 785191 11170 45889438
Dose calculation error 11.62 11.31 8 785446 37 45900571
Incorrect dose administered by device 11.56 11.31 20 785434 2940 45897668
Folliculitis 11.48 11.31 157 785297 6046 45894562
Neutrophil percentage increased 11.45 11.31 81 785373 2606 45898002
Metastases to central nervous system 11.44 11.31 127 785327 11094 45889514
Pleural effusion 11.43 11.31 1221 784233 81731 45818877
Pulmonary function test decreased 11.41 11.31 30 785424 3790 45896818
Hepatectomy 11.40 11.31 10 785444 70 45900538
Hypoglycaemic coma 11.38 11.31 16 785438 2558 45898050
Visual acuity reduced 11.36 11.31 284 785170 21829 45878779
BK virus infection 11.35 11.31 19 785435 2830 45897778
Stent placement 11.35 11.31 27 785427 3529 45897079
Mucosal hypertrophy 11.35 11.31 6 785448 15 45900593
Dialysis 11.33 11.31 112 785342 10004 45890604

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 1065.49 11.99 5173 422462 172010 29352833
Completed suicide 865.17 11.99 3251 424384 96241 29428602
Overdose 547.97 11.99 2521 425114 81816 29443027
Intentional overdose 456.81 11.99 1467 426168 40014 29484829
Infusion related reaction 363.08 11.99 1339 426296 39225 29485618
Acute hepatic failure 362.04 11.99 625 427010 11202 29513641
Drug ineffective 354.90 11.99 3133 424502 337254 29187589
Analgesic drug level increased 305.12 11.99 155 427480 434 29524409
Hepatocellular injury 296.08 11.99 918 426717 24553 29500290
Poisoning deliberate 191.25 11.99 320 427315 5584 29519259
Myocardial infarction 183.64 11.99 1047 426588 124578 29400265
Intentional product misuse 179.22 11.99 972 426663 33695 29491148
Drug resistance 164.73 11.99 42 427593 20091 29504752
Drug dependence 140.54 11.99 640 426995 20655 29504188
Treatment failure 130.09 11.99 183 427452 34496 29490347
Drug abuse 122.89 11.99 1747 425888 80325 29444518
Suicide attempt 118.17 11.99 913 426722 35784 29489059
Cardiac failure 117.65 11.99 703 426932 82715 29442128
Liver injury 106.42 11.99 404 427231 11996 29512847
Prescription form tampering 104.18 11.99 77 427558 493 29524350
Cardiac failure congestive 103.99 11.99 741 426894 83666 29441177
Drug interaction 95.55 11.99 2146 425489 197422 29327421
Accidental overdose 90.80 11.99 507 427128 17768 29507075
Off label use 84.99 11.99 2813 424822 246477 29278366
Hepatitis 83.30 11.99 576 427059 21780 29503063
Cholestasis 81.56 11.99 623 427012 24327 29500516
Toxic epidermal necrolysis 78.31 11.99 481 427154 17459 29507384
Somnolence 76.75 11.99 1866 425769 94897 29429946
Hepatitis acute 76.52 11.99 249 427386 6834 29518009
Blood pressure fluctuation 75.59 11.99 468 427167 17035 29507808
Chills 74.30 11.99 1448 426187 70890 29453953
Respiratory arrest 72.11 11.99 686 426949 28572 29496271
Cytomegalovirus infection 69.48 11.99 146 427489 23528 29501315
Vomiting 67.96 11.99 3811 423824 216007 29308836
Immune reconstitution inflammatory syndrome 67.12 11.99 23 427612 9078 29515765
Exposure to toxic agent 66.13 11.99 81 427554 1044 29523799
Psoriasis 65.42 11.99 348 427287 42158 29482685
Coagulopathy 64.61 11.99 469 427166 18018 29506825
Product dose omission issue 62.76 11.99 925 426710 90706 29434137
Hepatotoxicity 62.65 11.99 459 427176 17686 29507157
Product use in unapproved indication 61.84 11.99 713 426922 72980 29451863
Back pain 61.39 11.99 1908 425727 100688 29424155
Haematotoxicity 58.57 11.99 9 427626 6161 29518682
Constipation 58.41 11.99 2064 425571 110842 29414001
Urticaria 57.74 11.99 1098 426537 53508 29471335
Coronary artery disease 57.09 11.99 445 427190 49267 29475576
Contraindicated product administered 56.92 11.99 99 427536 17132 29507711
Coma 56.92 11.99 852 426783 39597 29485246
Anion gap 56.04 11.99 57 427578 589 29524254
Blood glucose increased 55.73 11.99 585 427050 60945 29463898
Prothrombin time shortened 55.40 11.99 88 427547 1467 29523376
Renal impairment 54.85 11.99 858 426777 83326 29441517
Pathogen resistance 54.30 11.99 26 427609 8384 29516459
Hepatic necrosis 54.25 11.99 149 427486 3714 29521129
Asthma 53.55 11.99 300 427335 35874 29488969
Cardio-respiratory arrest 53.17 11.99 1130 426505 56176 29468667
Pain 53.07 11.99 2992 424643 169649 29355194
Graft versus host disease 52.16 11.99 41 427594 10109 29514734
Respiratory depression 51.20 11.99 310 427325 11193 29513650
Progressive multifocal leukoencephalopathy 50.78 11.99 33 427602 8980 29515863
Cerebral infarction 48.77 11.99 202 427433 26171 29498672
Metabolic acidosis 46.98 11.99 774 426861 36687 29488156
Transaminases increased 46.87 11.99 527 427108 22930 29501913
Inadequate analgesia 46.86 11.99 113 427522 2595 29522248
Dependence 45.93 11.99 71 427564 1155 29523688
Peritonitis bacterial 45.76 11.99 57 427578 11321 29513522
Bone marrow failure 45.74 11.99 244 427391 29541 29495302
Injection site pain 45.61 11.99 250 427385 30060 29494783
Diabetes mellitus 43.86 11.99 384 427251 41481 29483362
Therapeutic product effect incomplete 43.61 11.99 293 427342 33541 29491302
Cerebrovascular accident 43.21 11.99 886 426749 82591 29442252
Miosis 42.87 11.99 222 427413 7554 29517289
General physical health deterioration 42.66 11.99 1093 426542 98851 29425992
Interstitial lung disease 42.13 11.99 605 427030 59592 29465251
Fixed eruption 40.81 11.99 66 427569 1118 29523725
Psychotic disorder 40.28 11.99 164 427471 21351 29503492
Abdominal pain 39.53 11.99 2340 425295 133314 29391529
Confusional state 39.32 11.99 2326 425309 132508 29392335
Venoocclusive liver disease 38.94 11.99 23 427612 6590 29518253
Post transplant lymphoproliferative disorder 38.12 11.99 14 427621 5292 29519551
Hospitalisation 37.86 11.99 427 427208 43892 29480951
Hepatocellular carcinoma 37.76 11.99 49 427586 9561 29515282
No adverse event 37.72 11.99 125 427510 17294 29507549
Hepatitis cholestatic 36.87 11.99 215 427420 7657 29517186
Anaemia 35.79 11.99 2522 425113 205470 29319373
Anaphylactic reaction 35.40 11.99 579 427056 27403 29497440
Mixed liver injury 35.39 11.99 84 427551 1909 29522934
Mucosal inflammation 34.98 11.99 273 427362 30221 29494622
Substance abuse 34.75 11.99 195 427440 6845 29517998
Therapy non-responder 34.58 11.99 262 427373 29191 29495652
Glycosylated haemoglobin increased 33.71 11.99 52 427583 9439 29515404
Peritoneal dialysis complication 33.01 11.99 9 427626 4118 29520725
Chronic graft versus host disease 32.92 11.99 9 427626 4110 29520733
Diarrhoea 32.63 11.99 4226 423409 329877 29194966
Acute myocardial infarction 32.00 11.99 547 427088 52392 29472451
Blood pressure diastolic abnormal 31.78 11.99 62 427573 1225 29523618
Pyroglutamate increased 31.65 11.99 28 427607 239 29524604
Wrong technique in product usage process 31.21 11.99 289 427346 30866 29493977
Acute graft versus host disease 31.01 11.99 23 427612 5841 29519002
Renal papillary necrosis 31.00 11.99 22 427613 131 29524712
Acute graft versus host disease in skin 30.66 11.99 13 427622 4503 29520340
Multiple organ dysfunction syndrome 30.47 11.99 682 426953 62805 29462038
Throat tightness 30.23 11.99 191 427444 7001 29517842
Aspergillus infection 29.96 11.99 63 427572 10151 29514692
Prothrombin time ratio decreased 29.63 11.99 31 427604 332 29524511
Death 29.43 11.99 4566 423069 352717 29172126
Transplant rejection 29.41 11.99 54 427581 9152 29515691
Hepatitis B 29.38 11.99 26 427609 6046 29518797
Drug-induced liver injury 29.10 11.99 446 427189 20828 29504015
Treatment noncompliance 29.00 11.99 226 427409 25027 29499816
Oxygen saturation decreased 28.96 11.99 819 426816 42621 29482222
Nocardiosis 28.66 11.99 7 427628 3448 29521395
Atrial fibrillation 28.34 11.99 1258 426377 106866 29417977
C-reactive protein abnormal 28.23 11.99 23 427612 5570 29519273
Bronchopulmonary aspergillosis 28.11 11.99 86 427549 12198 29512645
Drug abuser 28.09 11.99 131 427504 4270 29520573
Apparent death 27.82 11.99 8 427627 3534 29521309
Liver function test abnormal 27.63 11.99 607 427028 30343 29494500
Cell death 27.49 11.99 84 427551 2227 29522616
Viral load increased 27.46 11.99 4 427631 2850 29521993
BK virus infection 27.41 11.99 14 427621 4350 29520493
Ascites 26.92 11.99 356 427279 35565 29489278
Therapeutic response decreased 26.54 11.99 221 427414 24128 29500715
Acute generalised exanthematous pustulosis 26.29 11.99 163 427472 5935 29518908
Angina pectoris 26.16 11.99 282 427353 29236 29495607
Blood triglycerides increased 26.14 11.99 107 427528 13910 29510933
Hepatitis fulminant 25.66 11.99 118 427517 3823 29521020
Fluid retention 25.43 11.99 231 427404 24767 29500076
Nasal necrosis 25.20 11.99 13 427622 38 29524805
Methaemoglobinaemia 25.12 11.99 86 427549 2424 29522419
Infective pulmonary exacerbation of cystic fibrosis 25.04 11.99 53 427582 8519 29516324
Blood creatinine increased 25.00 11.99 1058 426577 90317 29434526
Kidney transplant rejection 24.93 11.99 43 427592 7466 29517377
Low birth weight baby 24.90 11.99 30 427605 6046 29518797
International normalised ratio increased 24.71 11.99 873 426762 46866 29477977
Hepatitis C 24.50 11.99 101 427534 13104 29511739
Sphincter of Oddi dysfunction 24.38 11.99 18 427617 115 29524728
Leukopenia 24.25 11.99 613 427022 55546 29469297
Myelosuppression 24.24 11.99 42 427593 7280 29517563
Visual acuity reduced 24.22 11.99 130 427505 15716 29509127
Hepatorenal failure 24.07 11.99 36 427599 568 29524275
Posterior reversible encephalopathy syndrome 23.66 11.99 56 427579 8651 29516192
Drug withdrawal syndrome 23.63 11.99 406 427229 19403 29505440
Symmetrical drug-related intertriginous and flexural exanthema 23.61 11.99 20 427615 160 29524683
Myelodysplastic syndrome 23.51 11.99 164 427471 18614 29506229
Drug tolerance 23.35 11.99 76 427559 2086 29522757
Drug screen positive 23.05 11.99 124 427511 4283 29520560
Back injury 22.98 11.99 106 427529 3439 29521404
Coronary artery bypass 22.78 11.99 24 427611 5138 29519705
Platelet count decreased 22.52 11.99 1262 426373 104867 29419976
Ductus arteriosus premature closure 22.45 11.99 16 427619 96 29524747
Viral mutation identified 22.42 11.99 5 427630 2621 29522222
Peritonitis 22.41 11.99 196 427439 21179 29503664
Hyperhidrosis 22.39 11.99 1172 426463 65918 29458925
Gastric ulcer perforation 22.27 11.99 43 427592 843 29524000
Mouth swelling 21.78 11.99 61 427574 1538 29523305
Osteonecrosis 21.66 11.99 138 427497 15997 29508846
Myopathy 21.55 11.99 78 427557 10508 29514335
Duodenal ulcer perforation 21.55 11.99 63 427572 1629 29523214
Hepatic failure 21.36 11.99 637 426998 33406 29491437
Renal failure 20.97 11.99 1571 426064 127395 29397448
Blood ethanol increased 20.78 11.99 26 427609 343 29524500
Coagulation factor VII level decreased 20.77 11.99 16 427619 110 29524733
Unresponsive to stimuli 20.76 11.99 509 427126 25910 29498933
Disease recurrence 20.65 11.99 118 427517 14043 29510800
Stevens-Johnson syndrome 20.64 11.99 359 427276 17197 29507646
Endophthalmitis 20.64 11.99 12 427623 3468 29521375
Graft versus host disease in gastrointestinal tract 20.57 11.99 9 427626 3060 29521783
Medication error 20.56 11.99 417 427218 20555 29504288
Mydriasis 20.41 11.99 154 427481 5989 29518854
Tachycardia 20.32 11.99 1266 426369 72473 29452370
Infection 20.31 11.99 909 426726 77165 29447678
Coronary arterial stent insertion 20.25 11.99 18 427617 4176 29520667
Ventricular fibrillation 20.05 11.99 130 427505 15008 29509835
Blood creatine phosphokinase increased 19.92 11.99 475 427160 43373 29481470
Prothrombin time abnormal 19.91 11.99 32 427603 539 29524304
Condition aggravated 19.86 11.99 1696 425939 136170 29388673
Respiratory failure 19.69 11.99 1206 426429 99436 29425407
Heart rate decreased 19.46 11.99 414 427221 20580 29504263
Lip oedema 19.29 11.99 73 427562 2164 29522679
Paradoxical drug reaction 19.16 11.99 7 427628 2655 29522188
Exposure via ingestion 19.14 11.99 81 427554 2530 29522313
Neuroleptic malignant syndrome 19.10 11.99 145 427490 16150 29508693
Angular cheilitis 19.04 11.99 15 427620 107 29524736
Cytokine release syndrome 18.87 11.99 221 427414 9712 29515131
Cytomegalovirus viraemia 18.84 11.99 33 427602 5696 29519147
Eyelid ptosis 18.83 11.99 28 427607 5160 29519683
Lethargy 18.83 11.99 716 426919 38803 29486040
Use of accessory respiratory muscles 18.82 11.99 24 427611 323 29524520
Pyroglutamic acidosis 18.78 11.99 14 427621 91 29524752
C-reactive protein increased 18.64 11.99 475 427160 42998 29481845
Blood urea increased 18.39 11.99 326 427309 31055 29493788
Cytomegalovirus chorioretinitis 18.36 11.99 12 427623 3256 29521587
Hyperaesthesia 18.33 11.99 100 427535 3473 29521370
Unintentional medical device removal 18.31 11.99 4 427631 2127 29522716
COVID-19 treatment 18.28 11.99 22 427613 278 29524565
Arrhythmia 18.06 11.99 349 427286 32820 29492023
Suspected suicide 17.95 11.99 91 427544 3070 29521773
Thrombotic microangiopathy 17.82 11.99 63 427572 8547 29516296
Infusion site extravasation 17.68 11.99 77 427558 2436 29522407
Coma scale abnormal 17.66 11.99 95 427540 3281 29521562
Hypertriglyceridaemia 17.61 11.99 58 427577 8040 29516803
Neurotoxicity 17.56 11.99 113 427522 13069 29511774
Schizophrenia 17.55 11.99 68 427567 8980 29515863
Kussmaul respiration 17.43 11.99 14 427621 103 29524740
Candida infection 17.40 11.99 138 427497 15224 29509619
Intraocular pressure increased 17.29 11.99 29 427606 5091 29519752
Cystitis haemorrhagic 17.22 11.99 26 427609 4761 29520082
Vascular stent thrombosis 17.14 11.99 6 427629 2337 29522506
Spinal cord compression 17.08 11.99 100 427535 3566 29521277
Pneumonia 16.99 11.99 4378 423257 329928 29194915
Rash maculo-papular 16.88 11.99 479 427156 24939 29499904
Metastases to liver 16.75 11.99 101 427534 11864 29512979
Hypoglycaemia 16.64 11.99 578 427057 50403 29474440
Pulmonary alveolar haemorrhage 16.58 11.99 44 427591 6537 29518306
Disease progression 16.54 11.99 952 426683 78922 29445921
Musculoskeletal disorder 16.49 11.99 123 427512 4766 29520077
Immunosuppressant drug level increased 16.47 11.99 26 427609 4676 29520167
Cerebral haemorrhage 16.43 11.99 351 427284 32536 29492307
Cardiac disorder 16.28 11.99 439 427196 39454 29485389
Graft versus host disease in skin 16.20 11.99 14 427621 3293 29521550
JC virus infection 16.13 11.99 3 427632 1787 29523056
Feeling hot 16.11 11.99 311 427324 15193 29509650
Band neutrophil percentage decreased 16.03 11.99 7 427628 12 29524831
Torsade de pointes 15.98 11.99 51 427584 7139 29517704
Prothrombin time prolonged 15.94 11.99 203 427432 9100 29515743
Enthesopathy 15.89 11.99 11 427624 2895 29521948
Psoriatic arthropathy 15.87 11.99 146 427489 15615 29509228
Parkinsonism 15.85 11.99 52 427583 7217 29517626
Haematemesis 15.82 11.99 488 427147 25715 29499128
Product monitoring error 15.51 11.99 3 427632 1738 29523105
Therapeutic product effect decreased 15.51 11.99 307 427328 28769 29496074
Oral pruritus 15.50 11.99 19 427616 245 29524598
Factor VIII inhibition 15.47 11.99 30 427605 590 29524253
Seizure 15.46 11.99 1203 426432 97272 29427571
Disseminated intravascular coagulation 15.44 11.99 223 427412 21948 29502895
Forearm fracture 15.44 11.99 11 427624 66 29524777
Aplasia pure red cell 15.43 11.99 36 427599 5590 29519253
Hepatic cirrhosis 15.34 11.99 150 427485 15849 29508994
Acidosis 15.27 11.99 219 427416 10082 29514761
Chondrocalcinosis 15.22 11.99 19 427616 250 29524593
Body temperature increased 15.20 11.99 296 427339 14484 29510359
Product storage error 15.16 11.99 44 427591 6347 29518496
Dysmorphism 15.04 11.99 5 427630 2012 29522831
Mucormycosis 15.03 11.99 33 427602 5235 29519608
Rhabdomyolysis 14.99 11.99 748 426887 62832 29462011
Periportal oedema 14.99 11.99 10 427625 53 29524790
Overlap syndrome 14.99 11.99 10 427625 53 29524790
Sudden cardiac death 14.88 11.99 19 427616 3733 29521110
Septic shock 14.87 11.99 749 426886 62858 29461985
Oedema 14.83 11.99 484 427151 42509 29482334
Blood pressure increased 14.82 11.99 1206 426429 70722 29454121
Gynaecomastia 14.80 11.99 65 427570 8286 29516557
Polydipsia 14.63 11.99 18 427617 3595 29521248
Injection site haemorrhage 14.62 11.99 60 427575 7795 29517048
Pruritus allergic 14.58 11.99 11 427624 73 29524770
Blood pressure systolic abnormal 14.53 11.99 51 427584 1456 29523387
Incision site complication 14.52 11.99 21 427614 321 29524522
Mitochondrial toxicity 14.44 11.99 9 427626 2505 29522338
Abdominal pain upper 14.41 11.99 1058 426577 61493 29463350
Pulmonary arterial hypertension 14.38 11.99 76 427559 9225 29515618
Crystal urine present 14.35 11.99 19 427616 266 29524577
Hepatitis B reactivation 14.31 11.99 12 427623 2865 29521978
Intracranial pressure increased 14.25 11.99 92 427543 3398 29521445
Diffuse large B-cell lymphoma recurrent 14.24 11.99 6 427629 2086 29522757
Status epilepticus 14.20 11.99 96 427539 10976 29513867
Aggression 14.07 11.99 410 427225 36497 29488346
Complications of transplanted kidney 14.06 11.99 23 427612 4078 29520765
Neutropenic sepsis 14.03 11.99 235 427400 11174 29513669
Acute myeloid leukaemia 14.02 11.99 177 427458 17829 29507014
Product counterfeit 13.90 11.99 15 427620 167 29524676
Environmental exposure 13.84 11.99 19 427616 276 29524567
Opiates positive 13.81 11.99 18 427617 248 29524595
Oedematous pancreatitis 13.79 11.99 21 427614 337 29524506
Product quality issue 13.72 11.99 187 427448 18587 29506256
Peripheral circulatory failure 13.67 11.99 16 427619 196 29524647
Myocardial ischaemia 13.57 11.99 170 427465 17147 29507696
Sinusitis 13.55 11.99 594 427041 32751 29492092
Cancer pain 13.50 11.99 71 427564 2431 29522412
Second primary malignancy 13.50 11.99 46 427589 6310 29518533
Accidental exposure to product by child 13.47 11.99 51 427584 1512 29523331
Injection site swelling 13.44 11.99 72 427563 8708 29516135
Intervertebral disc disorder 13.37 11.99 55 427580 1696 29523147
Forced expiratory volume decreased 13.37 11.99 16 427619 3234 29521609
Device leakage 13.35 11.99 20 427615 3674 29521169
Dose calculation error 13.33 11.99 8 427627 34 29524809
Ventricular tachycardia 13.32 11.99 250 427385 23612 29501231
Dermo-hypodermitis 13.30 11.99 19 427616 287 29524556
Cardiomyopathy 13.28 11.99 145 427490 14998 29509845
Tongue disorder 13.24 11.99 26 427609 4296 29520547
Acute haemorrhagic oedema of infancy 13.15 11.99 8 427627 35 29524808
Coagulation factor V level decreased 13.13 11.99 18 427617 261 29524582
Malaise 13.08 11.99 2637 424998 164325 29360518
Tuberculosis 13.06 11.99 65 427570 8012 29516831
Maternal exposure during breast feeding 13.05 11.99 52 427583 1580 29523263
Chronic obstructive pulmonary disease 13.04 11.99 532 427103 45594 29479249
Glucose-6-phosphate dehydrogenase deficiency 13.03 11.99 13 427622 131 29524712
Injection site reaction 12.97 11.99 95 427540 10665 29514178
Acute lung injury 12.95 11.99 40 427595 1067 29523776
Obstructive airways disorder 12.93 11.99 76 427559 8983 29515860
Respiratory tract oedema 12.86 11.99 22 427613 391 29524452
Angina unstable 12.85 11.99 113 427522 12197 29512646
Heart rate increased 12.82 11.99 676 426959 38045 29486798
Hyperkinesia 12.78 11.99 7 427628 2091 29522752
Pulmonary contusion 12.76 11.99 9 427626 53 29524790
Beta haemolytic streptococcal infection 12.74 11.99 25 427610 496 29524347
Oropharyngeal blistering 12.74 11.99 15 427620 185 29524658
Syncope 12.73 11.99 1041 426594 83862 29440981
Tenosynovitis 12.73 11.99 19 427616 3496 29521347
Pneumocystis jirovecii pneumonia 12.70 11.99 170 427465 16950 29507893
Gastrointestinal haemorrhage 12.69 11.99 1022 426613 82424 29442419
Kidney fibrosis 12.64 11.99 7 427628 2078 29522765
Depressed level of consciousness 12.60 11.99 667 426968 37555 29487288
Blood count abnormal 12.59 11.99 106 427529 11546 29513297
Nipple disorder 12.56 11.99 15 427620 188 29524655
Nipple inflammation 12.51 11.99 10 427625 73 29524770
Infusion site pruritus 12.50 11.99 27 427608 575 29524268
Bezoar 12.46 11.99 35 427600 884 29523959
Burning sensation mucosal 12.46 11.99 5 427630 6 29524837
Alpha-1 anti-trypsin decreased 12.46 11.99 5 427630 6 29524837
Oesophageal obstruction 12.44 11.99 22 427613 402 29524441
Dyspnoea exertional 12.43 11.99 398 427237 35032 29489811
Jaundice 12.39 11.99 575 427060 31911 29492932
Pneumonia cytomegaloviral 12.34 11.99 13 427622 2783 29522060
Mast cell activation syndrome 12.33 11.99 11 427624 95 29524748
Anal fissure 12.32 11.99 67 427568 2324 29522519
Loss of personal independence in daily activities 12.21 11.99 225 427410 21310 29503533
Injection site pruritus 12.20 11.99 40 427595 5552 29519291
Infusion site bruising 12.19 11.99 16 427619 222 29524621
Allergic cough 12.17 11.99 7 427628 27 29524816
Bradypnoea 12.13 11.99 57 427578 1864 29522979
Brain death 12.10 11.99 69 427566 2437 29522406
Cardiac failure chronic 12.07 11.99 43 427592 5820 29519023
Vascular purpura 12.06 11.99 50 427585 1547 29523296
Cryopyrin associated periodic syndrome 12.05 11.99 8 427627 42 29524801
Hyperlipasaemia 12.01 11.99 24 427611 483 29524360

Pharmacologic Action:

SourceCodeDescription
ATC N02BE01 NERVOUS SYSTEM
ANALGESICS
OTHER ANALGESICS AND ANTIPYRETICS
Anilides
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 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 drugs
CHEBI has role CHEBI:35493 anti-pyretic
CHEBI has role CHEBI:35703 xenobiotic
CHEBI has role CHEBI:50629 cyclooxygenase-2 inhibitor
CHEBI has role CHEBI:50630 cyclooxygenase-1 inhibitor
CHEBI has role CHEBI:50908 agente hepatotoxico
CHEBI has role CHEBI:73263 cyclo-oxygenase 3 inhibitors
CHEBI has role CHEBI:78298 environmental contaminants
CHEBI has role CHEBI:85234 human blood serum metabolites

Drug Use (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

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)

None

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

External reference:

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

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Norco HUMAN PRESCRIPTION DRUG LABEL 2 0023-6002 TABLET 325 mg ORAL ANDA 32 sections
Norco HUMAN PRESCRIPTION DRUG LABEL 2 0023-6021 TABLET 325 mg ORAL ANDA 32 sections
Norco HUMAN PRESCRIPTION DRUG LABEL 2 0023-6022 TABLET 325 mg ORAL ANDA 32 sections
Childrens Dimetapp Multi-Symptom Cold and Flu HUMAN OTC DRUG LABEL 3 0031-2249 LIQUID 320 mg ORAL Unapproved drug other 17 sections
ROBITUSSIN PEAK COLD DAYTIME COLD PLUS FLU HUMAN OTC DRUG LABEL 3 0031-8721 CAPSULE, LIQUID FILLED 325 mg ORAL OTC MONOGRAPH FINULLL 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 FINULLL 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 Honey Severe Cough, Flu Plus Sore Throat Nighttime HUMAN OTC DRUG LABEL 2 0031-8770 SOLUTION 650 mg ORAL OTC MONOGRAPH FINULLL 17 sections
Robitussin Honey Severe Cough, Flu Plus Sore Throat HUMAN OTC DRUG LABEL 2 0031-8771 SOLUTION 650 mg ORAL OTC MONOGRAPH FINULLL 17 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
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
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
THERAFLUSINUS AND PAIN HUMAN OTC DRUG LABEL 3 0067-7920 POWDER, FOR SOLUTION 650 mg ORAL OTC monograph final 17 sections
TriaminicMulti-Symptom Fever and Cold HUMAN OTC DRUG LABEL 4 0067-8116 SUSPENSION 160 mg ORAL OTC monograph final 15 sections