diphenhydramine Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
916 58-73-1

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • benadryl
  • diphenhydramine salicylate
  • diphenhydramine laurylsulfate
  • diphenhydramine
  • benzhydramine
  • probedryl
  • diphenhydramine hydrochloride
  • diphenhydramine citrate
  • diphenhydramine HCl
A histamine H1 antagonist used as an antiemetic, antitussive, for dermatoses and pruritus, for hypersensitivity reactions, as a hypnotic, an antiparkinson, and as an ingredient in common cold preparations. It has some undesired antimuscarinic and sedative effects.
  • Molecular weight: 255.36
  • Formula: C17H21NO
  • CLOGP: 3.45
  • LIPINSKI: 0
  • HAC: 2
  • HDO: 0
  • TPSA: 12.47
  • ALOGS: -3.53
  • ROTB: 6

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.20 g O
0.30 g O
0.20 g R
0.30 g R

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 1000 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 2 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 3.26 ┬ÁM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 72 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 6.50 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 9.80 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.19 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 9.30 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
March 4, 1946 FDA MCNEIL CONS

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
Completed suicide 3301.51 9.95 4984 461520 133217 52749345
Toxicity to various agents 2619.48 9.95 5864 460640 213734 52668828
Infusion related reaction 1289.10 9.95 3626 462878 152331 52730231
Overdose 522.87 9.95 2095 464409 105641 52776921
Sinusitis 456.50 9.95 2775 463729 165789 52716773
Urticaria 434.76 9.95 2339 464165 133546 52749016
Drug abuse 409.32 9.95 1383 465121 64143 52818419
Intentional product misuse 401.83 9.95 1143 465361 48249 52834313
Acute hepatic failure 373.96 9.95 586 465918 16134 52866428
Blood pressure fluctuation 366.11 9.95 897 465607 34573 52847989
Flushing 329.70 9.95 1357 465147 69243 52813319
Pruritus 326.23 9.95 3964 462540 289868 52592694
Respiratory arrest 314.62 9.95 818 465686 32722 52849840
Product dose omission issue 280.55 9.95 806 465698 190814 52691748
Cardio-respiratory arrest 263.06 9.95 1115 465389 57643 52824919
Intentional overdose 255.59 9.95 1215 465289 65990 52816572
Muscle injury 254.00 9.95 701 465803 29065 52853497
Folliculitis 248.37 9.95 724 465780 30985 52851577
Exposure to toxic agent 204.77 9.95 153 466351 1727 52880835
Throat irritation 201.57 9.95 673 465831 31008 52851554
Irritable bowel syndrome 201.54 9.95 836 465668 42796 52839766
Metabolic acidosis 197.97 9.95 813 465691 41429 52841133
Anion gap 193.70 9.95 123 466381 1041 52881521
Psoriasis 187.96 9.95 294 466210 86795 52795767
Exposure via ingestion 184.17 9.95 182 466322 3073 52879489
Injection site pain 183.20 9.95 454 466050 112937 52769625
Diarrhoea 178.59 9.95 4140 462364 621406 52261156
Cardiac failure 175.72 9.95 300 466204 85544 52797018
Hypersensitivity 174.44 9.95 2698 463806 207967 52674595
Device expulsion 172.53 9.95 27 466477 29786 52852776
Drug interaction 168.77 9.95 1173 465331 218156 52664406
Blood pressure increased 166.41 9.95 1920 464584 138559 52744003
Drug ineffective 166.36 9.95 5671 460833 811574 52070988
Ill-defined disorder 165.34 9.95 862 465642 48582 52833980
Lower respiratory tract infection 162.44 9.95 1355 465149 89626 52792936
Body temperature increased 161.45 9.95 641 465863 32158 52850404
Oxygen saturation decreased 159.73 9.95 1184 465320 75541 52807021
Anaemia 159.44 9.95 1598 464906 275120 52607442
Impaired healing 159.14 9.95 1034 465470 63171 52819391
Nasopharyngitis 156.22 9.95 2455 464049 189840 52692722
Hepatotoxicity 152.11 9.95 563 465941 27317 52855245
Acute kidney injury 151.71 9.95 1453 465051 252415 52630147
Poisoning 151.18 9.95 358 466146 13492 52869070
Blood pressure diastolic abnormal 144.61 9.95 268 466236 8477 52874085
Sleep disorder due to general medical condition, insomnia type 144.16 9.95 505 465999 23844 52858718
Urine abnormality 143.87 9.95 226 466278 6234 52876328
Intentional product use issue 138.76 9.95 1097 465407 71397 52811165
Sopor 136.92 9.95 13 466491 21071 52861491
Heart rate increased 135.95 9.95 1205 465299 81110 52801452
Hereditary angioedema 134.08 9.95 215 466289 6038 52876524
Blister 130.65 9.95 1154 465350 77599 52804963
Infusion site pain 126.07 9.95 303 466201 11530 52871032
Cardiac failure congestive 124.31 9.95 406 466098 92351 52790211
Heart rate decreased 124.11 9.95 645 465859 36302 52846260
Blood pressure systolic increased 123.68 9.95 622 465882 34555 52848007
Wrong technique in product usage process 121.74 9.95 211 466293 59821 52822741
Neutropenia 121.07 9.95 854 465650 158331 52724231
Blood pressure systolic abnormal 112.10 9.95 214 466290 6925 52875637
Urine leukocyte esterase positive 111.46 9.95 133 466371 2803 52879759
Infusion site swelling 111.10 9.95 210 466294 6744 52875818
Osteonecrosis of jaw 105.73 9.95 96 466408 36050 52846512
Helicobacter infection 103.48 9.95 640 465864 38429 52844133
Hospitalisation 102.10 9.95 301 466203 70711 52811851
Hyperkalaemia 101.75 9.95 200 466304 54056 52828506
Duodenal ulcer perforation 100.62 9.95 588 465916 34595 52847967
Throat tightness 99.70 9.95 422 466082 21794 52860768
Hyponatraemia 97.27 9.95 554 465950 108053 52774509
Infusion site erythema 95.17 9.95 227 466277 8595 52873967
Therapeutic product effect incomplete 94.69 9.95 446 466058 91338 52791224
Pancytopenia 94.30 9.95 441 466063 90487 52792075
Drug resistance 91.75 9.95 30 466474 19932 52862630
Joint swelling 91.04 9.95 2691 463813 231947 52650615
Rash 90.37 9.95 4767 461737 441424 52441138
Medication error 90.29 9.95 586 465918 35779 52846783
Peripheral swelling 89.77 9.95 2399 464105 203709 52678853
Myocardial infarction 88.86 9.95 507 465997 98847 52783715
Synovitis 87.32 9.95 1377 465127 106516 52776046
Food allergy 87.08 9.95 210 466294 8008 52874554
Crystal urine present 87.03 9.95 84 466420 1376 52881186
Lymphocyte count decreased 86.25 9.95 478 466026 27574 52854988
Cardiac arrest 86.14 9.95 1222 465282 92445 52790117
Therapy cessation 86.14 9.95 71 466433 27954 52854608
Product prescribing error 86.03 9.95 47 466457 22984 52859578
Renal impairment 85.87 9.95 405 466099 82913 52799649
Malignant neoplasm progression 85.25 9.95 329 466175 71212 52811350
Hepatic enzyme increased 84.84 9.95 1563 464941 124632 52757930
Interstitial lung disease 84.62 9.95 248 466256 58374 52824188
Chest discomfort 84.36 9.95 1282 465222 98413 52784149
Anti-cyclic citrullinated peptide antibody positive 83.83 9.95 816 465688 56356 52826206
White blood cells urine positive 82.43 9.95 145 466359 4400 52878162
Suspected suicide 81.36 9.95 141 466363 4227 52878335
Analgesic drug level increased 80.93 9.95 89 466415 1711 52880851
Urinary sediment present 79.55 9.95 94 466410 1960 52880602
Injection site bruising 78.45 9.95 130 466374 37516 52845046
Stomatitis 77.26 9.95 1247 465257 96911 52785651
Abortion spontaneous 76.62 9.95 185 466319 46450 52836112
Gastrointestinal disorder 76.38 9.95 1158 465346 88846 52793716
Coagulopathy 76.20 9.95 358 466146 19340 52863222
Fall 75.27 9.95 2475 464029 355965 52526597
Blood pressure diastolic decreased 75.26 9.95 319 466185 16484 52866078
Cerebrovascular accident 75.23 9.95 574 465930 104600 52777962
Pharyngitis 74.93 9.95 347 466157 18633 52863929
Pericarditis 74.27 9.95 876 465628 63530 52819032
Ear infection 72.85 9.95 431 466073 25469 52857093
Acute lung injury 72.30 9.95 76 466428 1385 52881177
Injection site erythema 71.91 9.95 389 466115 76860 52805702
Thrombocytopenia 71.34 9.95 822 465682 137905 52744657
Anticholinergic syndrome 71.34 9.95 87 466417 1877 52880685
Tachycardia 71.24 9.95 1336 465168 106876 52775686
Infusion site extravasation 71.20 9.95 164 466340 6068 52876494
Ear pain 71.13 9.95 474 466030 29199 52853363
Deafness transitory 70.99 9.95 84 466420 1754 52880808
Infusion site pruritus 70.62 9.95 122 466382 3648 52878914
No adverse event 70.00 9.95 149 466355 39116 52843446
Hepatic necrosis 69.79 9.95 155 466349 5595 52876967
Weight increased 69.51 9.95 2309 464195 202258 52680304
Chills 69.20 9.95 1295 465209 103553 52779009
Depressed level of consciousness 68.48 9.95 753 465751 53675 52828887
Temperature regulation disorder 68.40 9.95 128 466376 4079 52878483
Erythema 68.29 9.95 1827 464677 155142 52727420
Product substitution issue 67.56 9.95 27 466477 15839 52866723
Red blood cells urine positive 67.49 9.95 104 466400 2820 52879742
Pneumonia 67.15 9.95 2894 463610 404275 52478287
Renal failure 65.62 9.95 690 465814 117762 52764800
Cholecystitis chronic 65.61 9.95 222 466282 10296 52872266
Sedation complication 64.35 9.95 172 466332 6994 52875568
Epilepsy 63.54 9.95 79 466425 25688 52856874
Posterior reversible encephalopathy syndrome 61.80 9.95 32 466472 16128 52866434
Therapeutic product effect decreased 60.34 9.95 1482 465022 124173 52758389
Pain 59.72 9.95 5944 460560 582454 52300108
Suicide attempt 59.66 9.95 774 465730 57394 52825168
Foetal exposure during pregnancy 58.39 9.95 136 466368 34579 52847983
Pulmonary arterial hypertension 58.07 9.95 92 466412 27030 52855532
Maternal exposure during pregnancy 57.66 9.95 985 465519 154654 52727908
Product quality issue 57.61 9.95 151 466353 36872 52845690
Poor venous access 57.42 9.95 205 466299 9770 52872792
Lactic acidosis 57.16 9.95 153 466351 37100 52845462
Alopecia 57.00 9.95 1588 464916 232995 52649567
Respiratory rate increased 56.95 9.95 237 466267 12146 52870416
Red cell distribution width increased 56.67 9.95 190 466314 8770 52873792
Plasma cell myeloma 56.49 9.95 221 466283 47653 52834909
Respiratory depression 54.95 9.95 240 466264 12566 52869996
Feeling hot 54.69 9.95 580 465924 40964 52841598
Ear pruritus 54.41 9.95 86 466418 2385 52880177
Psoriatic arthropathy 54.01 9.95 227 466277 47963 52834599
Hepatic failure 53.44 9.95 513 465991 35293 52847269
Heart rate irregular 53.39 9.95 333 466171 20051 52862511
Diabetes mellitus 53.20 9.95 266 466238 53633 52828929
Neoplasm progression 51.30 9.95 116 466388 29803 52852759
Sepsis 51.28 9.95 936 465568 145493 52737069
Accidental overdose 50.82 9.95 342 466162 21137 52861425
Injury 50.09 9.95 673 465831 50298 52832264
Hepatocellular injury 50.01 9.95 118 466386 29868 52852694
Bone marrow failure 49.84 9.95 119 466385 29996 52852566
Accidental death 49.80 9.95 69 466435 1695 52880867
Muscle spasticity 49.63 9.95 296 466208 17542 52865020
Disease progression 49.28 9.95 612 465892 101308 52781254
Product storage error 48.74 9.95 27 466477 13103 52869459
Pyroglutamate increased 48.70 9.95 37 466467 429 52882133
Dyspnoea exertional 48.44 9.95 282 466222 54718 52827844
Blood urine present 48.17 9.95 237 466267 13048 52869514
Discomfort 47.94 9.95 1133 465371 94339 52788223
Anaphylactic reaction 47.76 9.95 746 465758 57580 52824982
Oedema peripheral 47.07 9.95 1135 465369 169652 52712910
Blood pressure diastolic increased 46.78 9.95 153 466351 6971 52875591
Lymphocyte percentage decreased 46.41 9.95 87 466417 2776 52879786
Septic shock 46.21 9.95 336 466168 61893 52820669
Neuropathy peripheral 46.07 9.95 630 465874 102557 52780005
Syncope 46.06 9.95 695 465809 111298 52771264
Immunodeficiency 45.98 9.95 255 466249 14712 52867850
Osteoarthritis 45.66 9.95 395 466109 70091 52812471
Hypertensive crisis 45.51 9.95 36 466468 14470 52868092
Atrial fibrillation 44.85 9.95 696 465808 110956 52771606
Postmortem blood drug level increased 44.64 9.95 38 466466 524 52882038
Body temperature decreased 44.41 9.95 273 466231 16354 52866208
Myelodysplastic syndrome 44.40 9.95 48 466456 16612 52865950
Pneumonia viral 44.26 9.95 150 466354 6962 52875600
Infusion site bruising 44.26 9.95 72 466432 2047 52880515
Urine ketone body present 44.22 9.95 77 466427 2317 52880245
Infusion site nodule 43.50 9.95 52 466452 1098 52881464
Death 43.43 9.95 3657 462847 353575 52528987
Diabetic ketoacidosis 43.16 9.95 67 466437 19848 52862714
Pneumocystis jirovecii pneumonia 42.75 9.95 48 466456 16330 52866232
Therapy interrupted 42.49 9.95 65 466439 19371 52863191
Creatinine renal clearance decreased 42.24 9.95 195 466309 10456 52872106
Headache 42.19 9.95 5334 461170 531487 52351075
Pulmonary hypertension 41.49 9.95 176 466328 37094 52845468
Neutrophil percentage increased 41.46 9.95 83 466421 2783 52879779
Polyneuropathy 41.32 9.95 33 466471 13200 52869362
Device malfunction 41.12 9.95 47 466457 15861 52866701
Labelled drug-drug interaction medication error 41.06 9.95 22 466482 10877 52871685
Swelling 41.01 9.95 2054 464450 189051 52693511
Anion gap abnormal 41.01 9.95 30 466474 327 52882235
Osteonecrosis 40.88 9.95 109 466395 26466 52856096
General physical health deterioration 40.63 9.95 976 465528 145966 52736596
Administration site swelling 40.33 9.95 51 466453 1143 52881419
Rash erythematous 40.00 9.95 504 466000 37119 52845443
Product use in unapproved indication 39.54 9.95 717 465787 111572 52770990
Mucosal inflammation 39.50 9.95 216 466288 42568 52839994
Cytomegalovirus infection 39.30 9.95 69 466435 19470 52863092
Cerebral haemorrhage 38.99 9.95 133 466371 29863 52852699
Hepatic cytolysis 37.91 9.95 153 466351 7732 52874830
Electric shock 37.77 9.95 46 466458 991 52881571
Leukopenia 36.69 9.95 438 466066 73025 52809537
Gastrooesophageal reflux disease 36.42 9.95 506 465998 82157 52800405
Brain death 36.41 9.95 81 466423 2927 52879635
Body temperature fluctuation 36.41 9.95 65 466439 1996 52880566
Hypokalaemia 36.32 9.95 609 465895 95908 52786654
Hypocalcaemia 36.18 9.95 133 466371 29204 52853358
Mydriasis 36.16 9.95 195 466309 11131 52871431
Device dislocation 36.14 9.95 97 466407 23500 52859062
Ischaemic stroke 35.78 9.95 64 466440 17929 52864633
Pathogen resistance 35.64 9.95 7 466497 6553 52876009
Soft tissue disorder 35.57 9.95 100 466404 4190 52878372
Respiratory failure 35.32 9.95 642 465862 99870 52782692
Injection site reaction 35.28 9.95 282 466222 50884 52831678
Treatment failure 34.91 9.95 855 465649 127548 52755014
Arthralgia 34.78 9.95 4372 462132 435411 52447151
Febrile bone marrow aplasia 34.48 9.95 10 466494 7179 52875383
Haematotoxicity 34.35 9.95 13 466491 7884 52874678
Culture urine positive 34.34 9.95 88 466416 3487 52879075
Haemoglobin urine present 34.26 9.95 39 466465 780 52881782
Gait disturbance 34.14 9.95 1093 465411 157749 52724813
Visual acuity reduced 34.00 9.95 93 466411 22392 52860170
Bone erosion 33.35 9.95 29 466475 11123 52871439
Blood calcium decreased 33.29 9.95 291 466213 19503 52863059
Fracture 33.28 9.95 67 466437 17952 52864610
Surgery 33.13 9.95 155 466349 31809 52850753
Heart rate abnormal 32.93 9.95 93 466411 3907 52878655
Unresponsive to stimuli 32.70 9.95 441 466063 32985 52849577
Inappropriate antidiuretic hormone secretion 32.69 9.95 50 466454 14901 52867661
Urine analysis abnormal 32.62 9.95 100 466404 4400 52878162
Coronary artery disease 32.43 9.95 166 466338 33271 52849291
Premature delivery 32.42 9.95 118 466386 25986 52856576
Peritonitis bacterial 31.88 9.95 22 466482 9483 52873079
Specific gravity urine decreased 31.67 9.95 33 466471 595 52881967
Blood count abnormal 31.49 9.95 83 466421 20232 52862330
Administration site pain 31.46 9.95 35 466469 682 52881880
Malaise 30.94 9.95 2699 463805 354918 52527644
Second primary malignancy 30.59 9.95 12 466492 7120 52875442
Cognitive disorder 30.19 9.95 555 465949 44223 52838339
Drug reaction with eosinophilia and systemic symptoms 30.05 9.95 166 466338 32634 52849928
Haematocrit decreased 30 9.95 476 466028 36855 52845707
Pyrexia 29.80 9.95 3992 462512 399201 52483361
Injection site haemorrhage 29.19 9.95 97 466407 21954 52860608
Emotional distress 29.04 9.95 420 466084 31897 52850665
Night sweats 28.99 9.95 448 466056 34499 52848063
Arthropathy 28.63 9.95 1512 464992 139941 52742621
Prothrombin time prolonged 28.62 9.95 165 466339 9657 52872905
Infusion site discomfort 28.38 9.95 35 466469 764 52881798
Toxicologic test abnormal 28.35 9.95 32 466472 634 52881928
Opiates positive 28.19 9.95 24 466480 331 52882231
Infection 28.02 9.95 1805 464699 170400 52712162
Bacterial test positive 27.98 9.95 102 466402 4911 52877651
Bacterial test 27.97 9.95 44 466460 1215 52881347
Transient ischaemic attack 27.93 9.95 190 466314 35535 52847027
Injection site pruritus 27.85 9.95 231 466273 41358 52841204
Multiple organ dysfunction syndrome 27.78 9.95 332 466172 55345 52827217
Gastrointestinal pain 27.76 9.95 146 466358 8253 52874309
Alanine aminotransferase increased 27.70 9.95 1055 465449 94040 52788522
Depression 27.64 9.95 1313 465191 181739 52700823
Peritonitis 27.62 9.95 97 466407 21590 52860972
Transplant rejection 27.33 9.95 29 466475 10122 52872440
Electrocardiogram QRS complex prolonged 27.27 9.95 111 466393 5631 52876931
Acute myeloid leukaemia 27.16 9.95 68 466436 16864 52865698
Thrombotic microangiopathy 27.06 9.95 25 466479 9312 52873250
Myelosuppression 27 9.95 44 466460 12784 52869778
Renal disorder 26.96 9.95 147 466357 28992 52853570
Exposure during pregnancy 26.86 9.95 859 465645 124001 52758561
Suicidal ideation 26.80 9.95 370 466134 60141 52822421
Cardiac failure acute 26.76 9.95 24 466480 9068 52873494
Breast cancer 26.71 9.95 289 466215 49069 52833493
Gastrointestinal haemorrhage 26.70 9.95 518 465986 79812 52802750
Infective pulmonary exacerbation of cystic fibrosis 26.68 9.95 35 466469 11121 52871441
Memory impairment 26.54 9.95 552 465952 84205 52798357
Serum sickness 26.53 9.95 66 466438 2567 52879995
Agranulocytosis 26.53 9.95 112 466392 23637 52858925
Disease recurrence 26.46 9.95 94 466410 20852 52861710
Gestational diabetes 26.44 9.95 19 466485 8020 52874542
Substance abuse 26.42 9.95 93 466411 4401 52878161
Hyperglycaemia 26.23 9.95 224 466280 39860 52842702
Dehydration 26.22 9.95 1204 465300 167206 52715356
Right ventricular failure 25.97 9.95 69 466435 16774 52865788
Palmar-plantar erythrodysaesthesia syndrome 25.96 9.95 99 466405 21507 52861055
Chronic kidney disease 25.92 9.95 248 466256 43122 52839440
Decreased appetite 25.92 9.95 1577 464927 213397 52669165
Brain oedema 25.83 9.95 205 466299 13353 52869209
Meningitis aseptic 25.64 9.95 91 466413 4324 52878238
Respiratory disorder 25.63 9.95 430 466074 33667 52848895
Asthma 25.58 9.95 741 465763 108231 52774331
Transplant dysfunction 25.34 9.95 6 466498 4932 52877630
Upper respiratory tract infection 24.99 9.95 786 465718 68311 52814251
Injection site warmth 24.86 9.95 54 466450 14074 52868488
Altered state of consciousness 24.83 9.95 122 466382 24714 52857848
Infusion site urticaria 24.70 9.95 34 466470 830 52881732
Analgesic drug level above therapeutic 24.61 9.95 17 466487 168 52882394
Injection site swelling 24.54 9.95 246 466258 42382 52840180
Complication associated with device 24.34 9.95 67 466437 16098 52866464
Hypoglycaemia 24.32 9.95 366 466138 58647 52823915
Administration site erythema 24.25 9.95 28 466476 569 52881993
Breast cancer metastatic 24.24 9.95 62 466442 15266 52867296
Bronchopulmonary aspergillosis 24.18 9.95 24 466480 8641 52873921
Chronic obstructive pulmonary disease 24.08 9.95 382 466122 60691 52821871
Hypotension 23.95 9.95 2555 463949 251521 52631041
Hand deformity 23.92 9.95 938 465566 83911 52798651
Haemophagocytic lymphohistiocytosis 23.61 9.95 27 466477 9110 52873452
Metastases to bone 23.59 9.95 88 466416 19240 52863322
Lung neoplasm malignant 23.53 9.95 73 466431 16879 52865683
Tongue disorder 23.37 9.95 146 466358 8795 52873767
Lung disorder 23.32 9.95 287 466217 47592 52834970
Device difficult to use 23.27 9.95 34 466470 10325 52872237
Infusion site mass 23.25 9.95 37 466467 1032 52881530
Intentional self-injury 23.14 9.95 128 466376 25156 52857406
Post transplant lymphoproliferative disorder 23.05 9.95 5 466499 4366 52878196
Electrolyte imbalance 23.03 9.95 86 466418 18798 52863764
Bursitis 22.93 9.95 299 466205 22193 52860369
Infusion site rash 22.84 9.95 38 466466 1101 52881461
Specific gravity urine increased 22.74 9.95 17 466487 192 52882370
Vitamin K deficiency 22.72 9.95 24 466480 440 52882122
Hepatic cirrhosis 22.69 9.95 81 466423 17941 52864621
Ejection fraction decreased 22.54 9.95 93 466411 19755 52862807
Haemorrhage 22.43 9.95 364 466140 57623 52824939
Incorrect drug administration rate 22.41 9.95 59 466445 2377 52880185
Cerebral infarction 22.24 9.95 124 466380 24320 52858242
Intermenstrual bleeding 22.15 9.95 26 466478 8672 52873890
Abortion induced 21.99 9.95 38 466466 10788 52871774
Drug screen positive 21.79 9.95 79 466425 3793 52878769
Injection site mass 21.68 9.95 71 466433 16143 52866419
Therapeutic response shortened 21.67 9.95 120 466384 6919 52875643
Unintentional medical device removal 21.60 9.95 10 466494 5376 52877186
Blood pH decreased 21.50 9.95 61 466443 2569 52879993
Treatment noncompliance 21.44 9.95 185 466319 32850 52849712
Anion gap increased 21.41 9.95 44 466460 1504 52881058
Hypomania 21.33 9.95 92 466412 4790 52877772
Endophthalmitis 21.33 9.95 3 466501 3584 52878978
Coeliac disease 21.21 9.95 140 466364 8595 52873967
Iron deficiency anaemia 21.14 9.95 87 466417 18493 52864069
Pyroglutamic acidosis 21.13 9.95 21 466483 357 52882205
Atypical femur fracture 21.02 9.95 10 466494 5291 52877271
Subdural haematoma 20.99 9.95 57 466447 13756 52868806
Incorrect dose administered by device 20.95 9.95 3 466501 3536 52879026
Vertigo 20.72 9.95 355 466149 55726 52826836
Neurotoxicity 20.67 9.95 67 466437 15282 52867280
Serum sickness-like reaction 20.66 9.95 24 466480 491 52882071
Metastases to central nervous system 20.46 9.95 47 466457 12010 52870552
Acute myocardial infarction 20.31 9.95 189 466315 33046 52849516
Urticaria thermal 20.21 9.95 14 466490 139 52882423
Shoulder arthroplasty 20.03 9.95 72 466432 3443 52879119
Accidental exposure to product 19.99 9.95 123 466381 23551 52859011
Blood creatinine decreased 19.95 9.95 94 466410 5084 52877478
Pharyngeal paraesthesia 19.70 9.95 40 466464 1355 52881207
Macular oedema 19.60 9.95 6 466498 4159 52878403
Infusion site streaking 19.50 9.95 21 466483 394 52882168
Product adhesion issue 19.42 9.95 12 466492 5485 52877077
Spinal stenosis 19.29 9.95 62 466442 14179 52868383
Sexual dysfunction 19.27 9.95 3 466501 3323 52879239
Cardiovascular disorder 19.03 9.95 51 466453 12362 52870200
C-reactive protein abnormal 18.99 9.95 325 466179 25545 52857017
Acute graft versus host disease 18.96 9.95 7 466497 4310 52878252
Left ventricular dysfunction 18.91 9.95 44 466460 11193 52871369
Hip fracture 18.90 9.95 157 466347 28100 52854462
Diffuse large B-cell lymphoma 18.89 9.95 18 466486 6607 52875955
Spinal fracture 18.87 9.95 77 466427 16408 52866154
Lumbar vertebral fracture 18.78 9.95 10 466494 4962 52877600
Forced expiratory volume decreased 18.63 9.95 13 466491 5572 52876990
Coma 18.60 9.95 688 465816 61095 52821467
Liver injury 18.58 9.95 284 466220 21819 52860743
Metastases to liver 18.51 9.95 111 466393 21385 52861177
Immune reconstitution inflammatory syndrome 18.38 9.95 17 466487 6329 52876233
Muscle spasms 18.19 9.95 978 465526 133817 52748745
Hemiplegia 18.12 9.95 25 466479 7775 52874787
Arrhythmia 18.08 9.95 220 466284 36559 52846003
Compartment syndrome 18.03 9.95 49 466455 2012 52880550
Injection site rash 18.02 9.95 79 466425 16500 52866062
Adrenergic syndrome 17.99 9.95 8 466496 29 52882533
Product residue present 17.81 9.95 7 466497 4149 52878413
Hyperlipidaemia 17.75 9.95 99 466405 19416 52863146
Urinary casts 17.75 9.95 25 466479 624 52881938
Sedation 17.69 9.95 361 466143 29314 52853248
Monocyte percentage increased 17.58 9.95 33 466471 1054 52881508
Aspartate aminotransferase increased 17.55 9.95 901 465603 83128 52799434
Oral pruritus 17.49 9.95 43 466461 1660 52880902
Mitral valve incompetence 17.34 9.95 100 466404 19451 52863111
Infusion site warmth 17.33 9.95 40 466464 1482 52881080
Sinus tachycardia 17.25 9.95 296 466208 23276 52859286
Ascites 17.22 9.95 244 466260 39491 52843071
Parkinsonism 17.09 9.95 33 466471 8980 52873582
Drug specific antibody present 16.97 9.95 67 466437 3351 52879211
Angina pectoris 16.85 9.95 165 466339 28560 52854002
Hypertransaminasaemia 16.83 9.95 7 466497 4009 52878553
Oedema 16.83 9.95 508 465996 73838 52808724
Device use error 16.81 9.95 14 466490 5485 52877077
Jaundice cholestatic 16.81 9.95 94 466410 5440 52877122
Infusion site irritation 16.80 9.95 24 466480 607 52881955
Administration site reaction 16.76 9.95 15 466489 222 52882340
Aphasia 16.74 9.95 180 466324 30598 52851964
Galactorrhoea 16.68 9.95 7 466497 3988 52878574
Condition aggravated 16.59 9.95 2311 464193 294823 52587739
Multiple-drug resistance 16.46 9.95 4 466500 3231 52879331
Pancreatic carcinoma 16.44 9.95 22 466482 6932 52875630
Chronic graft versus host disease 16.41 9.95 4 466500 3224 52879338
Graft versus host disease 16.37 9.95 23 466481 7099 52875463
Ageusia 16.34 9.95 56 466448 12558 52870004
Therapeutic response decreased 16.34 9.95 305 466199 47264 52835298
Wound 16.23 9.95 967 465537 90590 52791972
Unevaluable event 16.20 9.95 320 466184 49178 52833384
Pancreatitis acute 16.16 9.95 148 466356 25961 52856601
Metastases to lymph nodes 16.15 9.95 25 466479 7415 52875147
Cystic fibrosis pancreatic 16.05 9.95 9 466495 59 52882503
Device issue 16.04 9.95 117 466387 21541 52861021
Low turnover osteopathy 16 9.95 9 466495 4331 52878231
Seizure 15.95 9.95 948 465556 128561 52754001
Large intestine polyp 15.92 9.95 29 466475 8068 52874494
Mean cell haemoglobin concentration decreased 15.91 9.95 60 466444 2937 52879625
Eosinophil percentage increased 15.90 9.95 30 466474 962 52881600
Full blood count decreased 15.85 9.95 134 466370 23895 52858667
Joint stiffness 15.72 9.95 179 466325 30104 52852458
Gallbladder injury 15.64 9.95 36 466468 1331 52881231
Femoral neck fracture 15.63 9.95 31 466473 8352 52874210
Contusion 15.60 9.95 1147 465357 109585 52772977
Red blood cells urine 15.56 9.95 20 466484 456 52882106
Peripheral sensory neuropathy 15.53 9.95 24 466480 7124 52875438
Rheumatoid factor positive 15.52 9.95 471 466033 40727 52841835
Administration site bruise 15.42 9.95 16 466488 287 52882275
Dermatitis bullous 15.38 9.95 30 466474 8133 52874429
Infusion site haemorrhage 15.34 9.95 57 466447 2770 52879792
Sleep disorder due to a general medical condition 15.30 9.95 26 466478 7431 52875131
Kidney infection 15.27 9.95 243 466261 18824 52863738
Intentional dose omission 15.23 9.95 13 466491 5032 52877530
Mean cell haemoglobin concentration increased 15.23 9.95 20 466484 466 52882096
Hypothyroidism 15.20 9.95 223 466281 35884 52846678
Joint laxity 15.19 9.95 50 466454 2286 52880276
Epistaxis 15.18 9.95 471 466033 68239 52814323
Ketoacidosis 15.17 9.95 10 466494 4416 52878146
Nitrite urine present 15.14 9.95 28 466476 884 52881678
Mucosal dryness 15.12 9.95 54 466450 2574 52879988
Ductus arteriosus premature closure 15.09 9.95 17 466487 336 52882226
Lung adenocarcinoma 15.08 9.95 11 466493 4607 52877955
Obstructive airways disorder 15.00 9.95 90 466414 17339 52865223
Enthesopathy 15.00 9.95 103 466401 6408 52876154
Liver transplant 15.00 9.95 52 466452 2442 52880120
Migraine 14.96 9.95 853 465651 79564 52802998
Organising pneumonia 14.96 9.95 14 466490 5182 52877380
Liver disorder 14.89 9.95 254 466250 39901 52842661
Circulatory collapse 14.83 9.95 127 466377 22587 52859975
Pupil fixed 14.83 9.95 41 466463 1701 52880861
Ventricular fibrillation 14.74 9.95 54 466450 11871 52870691
Pneumonia aspiration 14.74 9.95 211 466293 34090 52848472
Anoxia 14.73 9.95 15 466489 263 52882299
Blood thyroid stimulating hormone decreased 14.66 9.95 77 466427 4350 52878212
Rhabdomyolysis 14.66 9.95 283 466221 43640 52838922
Cardiac disorder 14.66 9.95 306 466198 46660 52835902
Toxic skin eruption 14.65 9.95 62 466442 13077 52869485
Intervertebral discitis 14.63 9.95 56 466448 2761 52879801
Corneal reflex decreased 14.61 9.95 12 466492 157 52882405
Vision blurred 14.55 9.95 606 465898 84998 52797564
Haemolysis 14.51 9.95 102 466402 6394 52876168
Cardiotoxicity 14.48 9.95 26 466478 7273 52875289
Melaena 14.41 9.95 174 466330 28955 52853607
Osmolar gap 14.30 9.95 10 466494 101 52882461
Glycosylated haemoglobin increased 14.26 9.95 53 466451 11602 52870960
Pericardial effusion 14.25 9.95 161 466343 27117 52855445
Myalgia 14.24 9.95 990 465514 132501 52750061
Administration site extravasation 14.22 9.95 24 466480 704 52881858
Product physical issue 14.20 9.95 15 466489 5247 52877315
Invasive ductal breast carcinoma 14.12 9.95 23 466481 6684 52875878
Product monitoring error 14.10 9.95 4 466500 2913 52879649
Blindness 14.07 9.95 101 466403 18662 52863900
Graft versus host disease in skin 14.06 9.95 3 466501 2650 52879912
Malignant melanoma 13.97 9.95 48 466456 10754 52871808
Dermatitis allergic 13.94 9.95 66 466438 13502 52869060
Congestive cardiomyopathy 13.93 9.95 20 466484 6118 52876444
Disturbance in attention 13.91 9.95 214 466290 34169 52848393
Pain in jaw 13.89 9.95 261 466243 40408 52842154
Anxiety 13.79 9.95 1942 464562 194762 52687800
Injection site extravasation 13.74 9.95 113 466391 7439 52875123
Mucormycosis 13.66 9.95 3 466501 2597 52879965
Drug withdrawal syndrome 13.63 9.95 168 466336 27854 52854708
Myelocyte count increased 13.62 9.95 17 466487 376 52882186
Dizziness 13.62 9.95 2963 463541 369296 52513266
Device leakage 13.61 9.95 20 466484 6060 52876502
Dysphoria 13.61 9.95 16 466488 5333 52877229
Vitamin D deficiency 13.53 9.95 58 466446 12190 52870372
Transfusion-related acute lung injury 13.52 9.95 10 466494 111 52882451
Haematuria 13.51 9.95 171 466333 28218 52854344
Blood glucose increased 13.50 9.95 546 465958 76815 52805747
Hypothermia 13.49 9.95 174 466330 12882 52869680
Unintended pregnancy 13.47 9.95 20 466484 6033 52876529
Oropharyngeal pain 13.42 9.95 853 465651 80415 52802147
Vascular rupture 13.42 9.95 34 466470 1338 52881224
Epstein-Barr virus infection 13.34 9.95 28 466476 7390 52875172
Spinal pain 13.31 9.95 54 466450 11526 52871036
Limb mass 13.30 9.95 55 466449 2810 52879752
Pregnancy 13.30 9.95 194 466310 31247 52851315
Dyskinesia 13.26 9.95 197 466307 31636 52850926
Metastases to lung 13.19 9.95 55 466449 11649 52870913
Hepatic function abnormal 13.17 9.95 235 466269 36664 52845898
Somnolence 13.13 9.95 1667 464837 166067 52716495
Cystitis 13.13 9.95 519 465985 46469 52836093
Human herpesvirus 6 infection 13.13 9.95 3 466501 2527 52880035
Renal failure neonatal 13.12 9.95 12 466492 183 52882379
Anuria 13.08 9.95 60 466444 12380 52870182
Pulmonary tuberculosis 13.08 9.95 14 466490 4867 52877695
Cells in urine 13.07 9.95 12 466492 184 52882378
Vein rupture 13.03 9.95 25 466479 812 52881750
Back pain 13.02 9.95 2283 464221 231964 52650598
Normal newborn 13.00 9.95 27 466477 7152 52875410
Band neutrophil count increased 12.95 9.95 16 466488 350 52882212
Accidental exposure to product by child 12.94 9.95 31 466473 1177 52881385
Therapeutic response unexpected 12.93 9.95 93 466411 17177 52865385
Biliary dyskinesia 12.86 9.95 53 466451 2704 52879858
Cardiomyopathy 12.81 9.95 92 466412 16996 52865566
Administration site pruritus 12.80 9.95 15 466489 310 52882252
Pulmonary alveolar haemorrhage 12.80 9.95 12 466492 4438 52878124
Platelet morphology abnormal 12.78 9.95 4 466500 3 52882559
International normalised ratio increased 12.76 9.95 525 465979 47236 52835326
Fluid overload 12.74 9.95 169 466335 27662 52854900
Kidney transplant rejection 12.74 9.95 11 466493 4233 52878329
Personality change 12.64 9.95 21 466483 6056 52876506
Concomitant disease aggravated 12.58 9.95 37 466467 8701 52873861
Smear cervix abnormal 12.56 9.95 53 466451 2733 52879829
Post procedural pulmonary embolism 12.54 9.95 14 466490 274 52882288
Aplasia pure red cell 12.52 9.95 13 466491 4583 52877979
Thyroxine free increased 12.47 9.95 25 466479 839 52881723
Pleural effusion 12.45 9.95 640 465864 87939 52794623
Shock haemorrhagic 12.43 9.95 40 466464 9143 52873419
Neutropenic sepsis 12.42 9.95 76 466428 14573 52867989
Toothache 12.41 9.95 223 466281 17691 52864871
Blood creatine increased 12.37 9.95 80 466424 4877 52877685
Complication of device insertion 12.33 9.95 21 466483 5996 52876566
Hallucination, auditory 12.25 9.95 57 466447 11716 52870846
Prothrombin level increased 12.23 9.95 13 466491 240 52882322
Tri-iodothyronine free increased 12.22 9.95 12 466492 201 52882361
Hyperhidrosis 12.21 9.95 994 465510 95799 52786763
Low density lipoprotein increased 12.20 9.95 22 466482 6144 52876418
Hepatitis C 12.15 9.95 24 466480 6477 52876085
Withdrawal syndrome 12.12 9.95 109 466395 19192 52863370
Blood iron abnormal 12.12 9.95 7 466497 3320 52879242
Agitation 12.12 9.95 628 465876 57998 52824564
Renal papillary necrosis 12.11 9.95 13 466491 243 52882319
Sexual abuse 12.10 9.95 10 466494 132 52882430
Rash maculo-papular 12.09 9.95 185 466319 29564 52852998
Infusion site induration 12.07 9.95 25 466479 859 52881703
Pulmonary infarction 12.04 9.95 53 466451 2784 52879778
Post-traumatic stress disorder 12.01 9.95 77 466427 4681 52877881
White blood cells urine 11.97 9.95 15 466489 333 52882229
Groin pain 11.96 9.95 43 466461 9505 52873057
Long QT syndrome 11.92 9.95 7 466497 3289 52879273
Cellulitis 11.87 9.95 543 465961 75446 52807116
Nephropathy toxic 11.84 9.95 37 466467 8535 52874027
Cholestasis 11.81 9.95 178 466326 28517 52854045
Platelet count decreased 11.80 9.95 800 465704 107299 52775263
Systemic lupus erythematosus rash 11.80 9.95 37 466467 1648 52880914
Peritoneal dialysis complication 11.77 9.95 5 466499 2828 52879734
Haemarthrosis 11.74 9.95 7 466497 3263 52879299
Drug level below therapeutic 11.73 9.95 64 466440 3669 52878893
Bradyphrenia 11.71 9.95 26 466478 6724 52875838
Device related thrombosis 11.69 9.95 32 466472 1320 52881242
Haematoma 11.62 9.95 217 466287 33627 52848935
Band neutrophil percentage increased 11.62 9.95 12 466492 214 52882348
Product dispensing error 11.62 9.95 48 466456 10192 52872370
Red blood cell sedimentation rate 11.60 9.95 54 466450 2905 52879657
Vaginal haemorrhage 11.57 9.95 165 466339 26676 52855886
Periorbital swelling 11.57 9.95 37 466467 1666 52880896
Injection site induration 11.52 9.95 38 466466 8620 52873942
Impaired work ability 11.49 9.95 74 466430 14016 52868546
Atrioventricular block first degree 11.48 9.95 25 466479 6510 52876052
Thinking abnormal 11.46 9.95 50 466454 10458 52872104
Cardiac failure chronic 11.43 9.95 11 466493 4019 52878543
Body height decreased 11.40 9.95 46 466458 9833 52872729
Ulcer 11.37 9.95 248 466256 20371 52862191
Insomnia 11.36 9.95 1832 464672 185240 52697322
Dysgeusia 11.35 9.95 287 466217 42644 52839918
Sensation of foreign body 11.34 9.95 70 466434 4199 52878363
Mood swings 11.31 9.95 98 466406 17388 52865174
Cardiogenic shock 11.30 9.95 98 466406 17384 52865178
Temperature intolerance 11.28 9.95 115 466389 8038 52874524
Myopathy 11.27 9.95 45 466459 9647 52872915
Meniscus injury 11.25 9.95 26 466478 6629 52875933
Sucrose intolerance 11.24 9.95 3 466501 0 52882562
Analgesic drug level below therapeutic 11.24 9.95 3 466501 0 52882562
Nasal polyps 11.22 9.95 6 466498 2970 52879592
Angina unstable 11.21 9.95 31 466473 7437 52875125
Gallbladder disorder 11.17 9.95 222 466282 17943 52864619
Infusion site scar 11.15 9.95 12 466492 225 52882337
Vasodilation procedure 11.13 9.95 6 466498 36 52882526
Rhinitis allergic 11.13 9.95 33 466471 7740 52874822
Pelvic fracture 11.09 9.95 63 466441 12301 52870261
Anaphylactoid reaction 11.08 9.95 63 466441 3668 52878894
Spinal operation 11.07 9.95 25 466479 6426 52876136
Creatinine urine decreased 11.02 9.95 11 466493 188 52882374
Ventricular arrhythmia 11.00 9.95 62 466442 3598 52878964
Sputum increased 11.00 9.95 3 466501 2243 52880319
Asthenia 10.99 9.95 2752 463752 340838 52541724
Drug ineffective for unapproved indication 10.94 9.95 122 466382 20598 52861964
Gastric infection 10.93 9.95 55 466449 3055 52879507
Coronary artery bypass 10.91 9.95 4 466500 2474 52880088
Feeling cold 10.91 9.95 248 466256 20513 52862049
Orthostatic hypotension 10.90 9.95 339 466165 29414 52853148
Blood loss anaemia 10.88 9.95 40 466464 8783 52873779
Pulmonary mass 10.87 9.95 117 466387 19887 52862675
Injection site discolouration 10.86 9.95 30 466474 7200 52875362
Alpha 1 microglobulin increased 10.86 9.95 7 466497 61 52882501
Infusion site oedema 10.83 9.95 18 466486 521 52882041
Focal dyscognitive seizures 10.82 9.95 6 466498 2911 52879651
Partial seizures 10.82 9.95 19 466485 5361 52877201
Pre-eclampsia 10.79 9.95 39 466465 8608 52873954
PCO2 decreased 10.74 9.95 31 466473 1319 52881243
Polychromasia 10.73 9.95 8 466496 90 52882472
Extrapyramidal disorder 10.70 9.95 64 466440 12338 52870224
Bradypnoea 10.68 9.95 57 466447 3240 52879322
Multiple fractures 10.68 9.95 96 466408 6485 52876077
Coma hepatic 10.65 9.95 20 466484 639 52881923
Swollen joint count increased 10.65 9.95 148 466356 11142 52871420
Spinal compression fracture 10.61 9.95 73 466431 13617 52868945
Aspergillus infection 10.60 9.95 32 466472 7464 52875098
Latent tuberculosis 10.60 9.95 3 466501 2188 52880374
Taste disorder 10.58 9.95 35 466469 7933 52874629
Ductus arteriosus stenosis foetal 10.55 9.95 10 466494 160 52882402
Red cell distribution width decreased 10.54 9.95 26 466478 1006 52881556
Procedural anxiety 10.52 9.95 20 466484 645 52881917
Low birth weight baby 10.52 9.95 25 466479 6312 52876250
Device breakage 10.51 9.95 52 466452 10515 52872047
Hepatocellular carcinoma 10.50 9.95 7 466497 3073 52879489
Device deployment issue 10.40 9.95 10 466494 3654 52878908
Knee arthroplasty 10.39 9.95 219 466285 33350 52849212
Oropharyngeal discomfort 10.37 9.95 66 466438 4002 52878560
Caesarean section 10.37 9.95 99 466405 17221 52865341
Leukoencephalopathy 10.36 9.95 13 466491 4211 52878351
Pharyngitis streptococcal 10.36 9.95 123 466381 8932 52873630
Eosinophilia 10.34 9.95 128 466376 21207 52861355
Delusion 10.34 9.95 62 466442 11947 52870615
Status epilepticus 10.32 9.95 84 466420 15100 52867462
Immunosuppressant drug level increased 10.31 9.95 9 466495 3446 52879116
Fatigue 10.28 9.95 6751 459753 723755 52158807
Intestinal obstruction 10.27 9.95 183 466321 28558 52854004
Administration site irritation 10.26 9.95 6 466498 43 52882519
Multiple drug therapy 10.26 9.95 32 466472 1421 52881141
Muscle twitching 10.18 9.95 201 466303 16225 52866337
Gout 10.17 9.95 65 466439 12334 52870228
Pupillary light reflex tests abnormal 10.11 9.95 10 466494 169 52882393
Sinus node dysfunction 10.11 9.95 14 466490 4347 52878215
Priapism 10.06 9.95 7 466497 70 52882492
On and off phenomenon 10.01 9.95 5 466499 2573 52879989
Contraindicated product administered 9.99 9.95 1343 465161 134286 52748276

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
Completed suicide 1879.03 10.50 2614 204517 89903 32216492
Toxicity to various agents 1752.70 10.50 3639 203492 174402 32131993
Infusion related reaction 1183.05 10.50 1455 205676 44144 32262251
Drug abuse 572.96 10.50 1448 205683 78795 32227600
Intentional product misuse 370.28 10.50 752 206379 35299 32271096
Blood pressure fluctuation 311.56 10.50 502 206629 19633 32286762
Overdose 294.15 10.50 1216 205915 85861 32220534
Urticaria 283.42 10.50 930 206201 58684 32247711
Respiratory arrest 252.88 10.50 565 206566 28343 32278052
Intentional overdose 223.36 10.50 677 206454 40924 32265471
Flushing 216.88 10.50 557 206574 30570 32275825
Chills 202.68 10.50 1009 206122 77075 32229320
Blood pressure increased 193.08 10.50 1007 206124 78347 32228048
Drug ineffective 191.11 10.50 1547 205584 381930 31924465
Acute hepatic failure 170.88 10.50 301 206830 12668 32293727
Cardio-respiratory arrest 151.28 10.50 732 206399 55257 32251138
Heart rate decreased 135.11 10.50 410 206721 24790 32281605
Oxygen saturation decreased 134.39 10.50 635 206496 47464 32258931
Exposure via ingestion 134.16 10.50 115 207016 2242 32304153
Drug interaction 133.81 10.50 828 206303 217357 32089038
Myocardial infarction 121.37 10.50 403 206728 125273 32181122
Accidental overdose 120.42 10.50 332 206799 19007 32287388
Cardiac failure 119.64 10.50 253 206878 91420 32214975
Heart rate increased 117.41 10.50 553 206578 41275 32265120
Exposure to toxic agent 108.18 10.50 74 207057 1014 32305381
Anion gap 98.85 10.50 61 207070 693 32305702
Poisoning 96.32 10.50 217 206914 10941 32295454
Drug resistance 94.93 10.50 16 207115 22949 32283446
Product dose omission issue 91.57 10.50 340 206791 102235 32204160
Cardiac arrest 91.50 10.50 981 206150 95795 32210600
Sinusitis 90.92 10.50 467 206664 36093 32270302
Pruritus 87.55 10.50 1226 205905 127476 32178919
Blood pressure diastolic abnormal 86.55 10.50 89 207042 2201 32304194
Unresponsive to stimuli 84.89 10.50 375 206756 27234 32279161
Respiratory depression 82.44 10.50 227 206904 12984 32293411
Anaemia 81.90 10.50 971 206160 222653 32083742
Anaphylactic reaction 80.39 10.50 393 206738 29779 32276616
Blood pressure systolic increased 79.54 10.50 268 206863 17128 32289267
Acute kidney injury 78.71 10.50 1356 205775 292112 32014283
Cardiac failure congestive 75.88 10.50 281 206850 84571 32221824
General physical health deterioration 72.81 10.50 433 206698 114826 32191569
Psoriasis 71.97 10.50 114 207017 46009 32260386
Interstitial lung disease 69.38 10.50 199 206932 64802 32241593
Throat tightness 68.11 10.50 152 206979 7614 32298781
Diarrhoea 66.85 10.50 1792 205339 363010 31943385
Environmental exposure 64.07 10.50 32 207099 231 32306164
Renal impairment 63.79 10.50 335 206796 91637 32214758
Blood pressure systolic abnormal 61.90 10.50 72 207059 2052 32304343
Heart rate irregular 60.10 10.50 212 206919 13866 32292529
Tachycardia 59.32 10.50 767 206364 78321 32228074
Throat irritation 57.08 10.50 164 206967 9614 32296781
Coagulopathy 55.77 10.50 260 206871 19317 32287078
Foetal exposure during pregnancy 54.66 10.50 113 207018 41188 32265207
Suspected suicide 54.52 10.50 81 207050 2947 32303448
Therapeutic product effect incomplete 53.13 10.50 115 207016 41226 32265169
Erythema 53.00 10.50 783 206348 82322 32224073
Substance abuse 52.41 10.50 130 207001 6977 32299418
Blood pressure diastolic increased 52.12 10.50 87 207044 3503 32302892
Hepatotoxicity 48.76 10.50 248 206883 19089 32287306
Metabolic acidosis 48.41 10.50 433 206698 40266 32266129
Infusion site extravasation 48.26 10.50 77 207054 2984 32303411
Hepatic necrosis 48.20 10.50 89 207042 3886 32302509
Intentional product use issue 48.13 10.50 445 206686 41766 32264629
Cerebral haemorrhage 47.75 10.50 93 207038 34654 32271741
Infusion site swelling 46.37 10.50 58 207073 1786 32304609
Product use in unapproved indication 44.87 10.50 348 206783 86856 32219539
Coronary artery disease 43.50 10.50 166 206965 49540 32256855
Lymphocyte percentage decreased 41.55 10.50 60 207071 2127 32304268
Infusion site pain 41.54 10.50 71 207060 2915 32303480
Infusion site erythema 41.00 10.50 54 207077 1752 32304643
Aspartate aminotransferase increased 40.83 10.50 622 206509 65807 32240588
Body temperature increased 40.14 10.50 203 206928 15588 32290807
Hypotension 40.13 10.50 1721 205410 214389 32092006
Bone marrow failure 39.54 10.50 84 207047 30320 32276075
Cerebrovascular accident 39.20 10.50 356 206775 85964 32220431
Neutrophil percentage increased 39.06 10.50 55 207076 1904 32304491
Diabetes mellitus 38.80 10.50 152 206979 45021 32261374
Plasma cell myeloma 38.73 10.50 212 206919 57402 32248993
Alanine aminotransferase increased 38.39 10.50 708 206423 77771 32228624
Wrong technique in product usage process 38.38 10.50 106 207025 34953 32271442
Sopor 37.39 10.50 14 207117 11735 32294660
Suicide attempt 36.23 10.50 388 206743 37856 32268539
Hypersensitivity 35.95 10.50 542 206589 57216 32249179
Respiratory rate increased 35.80 10.50 136 206995 9221 32297174
Body temperature decreased 35.68 10.50 152 206979 10862 32295533
Hepatocellular carcinoma 34.82 10.50 11 207120 10259 32296136
Hospitalisation 34.70 10.50 177 206954 48794 32257601
Cerebral infarction 33.70 10.50 79 207052 27535 32278860
Feeling hot 33.51 10.50 203 206928 16683 32289712
Renal cortical necrosis 33.38 10.50 18 207113 155 32306240
Tongue disorder 33.36 10.50 85 207046 4639 32301756
Malignant neoplasm progression 32.97 10.50 330 206801 78166 32228229
Body temperature fluctuation 32.89 10.50 44 207087 1450 32304945
Medication error 32.82 10.50 251 206880 22284 32284111
Leukopenia 32.79 10.50 236 206895 59886 32246509
Poor venous access 32.69 10.50 65 207066 3001 32303394
Infusion site pruritus 32.43 10.50 30 207101 649 32305746
Angina pectoris 32.22 10.50 98 207033 31328 32275067
Septic shock 31.99 10.50 283 206848 68706 32237689
Analgesic drug level increased 31.94 10.50 29 207102 612 32305783
Cytokine release syndrome 31.64 10.50 170 206961 13365 32293030
Osteonecrosis of jaw 31.21 10.50 46 207085 19120 32287275
Accident 31.03 10.50 76 207055 4046 32302349
Urine abnormality 30.90 10.50 48 207083 1817 32304578
Ear infection 30.86 10.50 121 207010 8327 32298068
Glycosylated haemoglobin increased 30.44 10.50 14 207117 10375 32296020
Chest discomfort 30.35 10.50 469 206662 49761 32256634
Infusion site reaction 30.03 10.50 31 207100 770 32305625
Pancytopenia 29.99 10.50 405 206726 90830 32215565
Fall 29.76 10.50 988 206143 195213 32111182
Fluid retention 29.26 10.50 80 207051 26470 32279925
Hyperkalaemia 28.97 10.50 294 206837 69456 32236939
Nasopharyngitis 28.97 10.50 569 206562 63218 32243177
Labelled drug-drug interaction medication error 28.94 10.50 22 207109 12391 32294004
Blood pressure diastolic decreased 28.69 10.50 106 207025 7091 32299304
Headache 28.46 10.50 1525 205606 194672 32111723
Liver injury 28.44 10.50 170 206961 13904 32292491
Mental status changes 28.38 10.50 371 206760 37966 32268429
Hereditary angioedema 27.62 10.50 31 207100 849 32305546
Drug hypersensitivity 27.60 10.50 637 206494 72763 32233632
Treatment failure 27.49 10.50 142 206989 39021 32267374
Tenosynovitis 27.45 10.50 69 207062 3734 32302661
Epilepsy 27.18 10.50 63 207068 22046 32284349
Rash 27.04 10.50 1610 205521 207723 32098672
Blood pH decreased 26.75 10.50 51 207080 2282 32304113
Hepatocellular injury 26.64 10.50 78 207053 25240 32281155
Immune reconstitution inflammatory syndrome 26.32 10.50 14 207117 9545 32296850
Visual acuity reduced 26.26 10.50 40 207091 16405 32289990
Enthesopathy 26.09 10.50 65 207066 3498 32302897
Pathogen resistance 26.08 10.50 14 207117 9496 32296899
Monocyte percentage increased 25.62 10.50 31 207100 922 32305473
Hepatitis C 25.56 10.50 29 207102 13489 32292906
Graft versus host disease 25.39 10.50 19 207112 10787 32295608
Myopathy 25.31 10.50 21 207110 11320 32295075
Victim of child abuse 25.29 10.50 28 207103 755 32305640
Acute lung injury 25.01 10.50 37 207094 1341 32305054
Renal failure 24.90 10.50 659 206472 133819 32172576
Serum sickness 24.84 10.50 44 207087 1859 32304536
Pneumonia 24.67 10.50 1939 205192 353313 31953082
Peritonitis bacterial 24.52 10.50 26 207105 12470 32293925
Depression 24.46 10.50 453 206678 96607 32209788
Depressed level of consciousness 24.14 10.50 380 206751 40467 32265928
Therapeutic response shortened 23.62 10.50 75 207056 4645 32301750
Haematotoxicity 23.44 10.50 7 207124 6769 32299626
Neuropathy peripheral 23.43 10.50 347 206784 76635 32229760
Progressive multifocal leukoencephalopathy 23.39 10.50 16 207115 9515 32296880
Polyneuropathy 23.24 10.50 30 207101 13185 32293210
Hepatic cytolysis 23.24 10.50 110 207021 8223 32298172
Infusion site rash 23.20 10.50 18 207113 303 32306092
Methaemoglobinaemia 22.69 10.50 54 207077 2822 32303573
Hyperhidrosis 22.69 10.50 604 206527 70564 32235831
Asthma 22.58 10.50 176 206955 43889 32262506
Cardiac failure chronic 22.42 10.50 9 207122 7231 32299164
Post transplant lymphoproliferative disorder 22.14 10.50 5 207126 5829 32300566
Pulse absent 22.05 10.50 83 207048 5603 32300792
Accidental death 21.84 10.50 45 207086 2132 32304263
Alanine aminotransferase abnormal 21.78 10.50 55 207076 2985 32303410
Cytomegalovirus infection 21.66 10.50 86 207045 25378 32281017
Injection site pain 21.47 10.50 123 207008 32935 32273460
Urine sodium decreased 21.35 10.50 14 207117 178 32306217
Chronic obstructive pulmonary disease 21.29 10.50 203 206928 48550 32257845
Back pain 21.14 10.50 887 206244 110166 32196229
Lactic acidosis 21.13 10.50 126 207005 33410 32272985
Acute myocardial infarction 21.06 10.50 237 206894 54912 32251483
Memory impairment 21.06 10.50 161 206970 40318 32266077
Febrile neutropenia 20.99 10.50 947 206184 118619 32187776
Hypertriglyceridaemia 20.91 10.50 15 207116 8704 32297691
Drug screen positive 20.87 10.50 67 207064 4174 32302221
Eosinophilia 20.78 10.50 85 207046 24873 32281522
Osteonecrosis 20.72 10.50 47 207084 16575 32289820
Agitation 20.68 10.50 494 206637 56742 32249653
Upper respiratory tract infection 20.48 10.50 282 206849 29191 32277204
Pulmonary oedema 20.43 10.50 411 206720 45856 32260539
Brain oedema 20.37 10.50 147 206984 12813 32293582
Neutropenia 20.35 10.50 721 206410 141454 32164941
Atrial fibrillation 20.02 10.50 578 206553 116126 32190269
Pyrexia 20.00 10.50 2329 204802 317639 31988756
Oedema peripheral 19.84 10.50 564 206567 113527 32192868
Coma 19.64 10.50 381 206750 42231 32264164
Anion gap abnormal 19.47 10.50 12 207119 136 32306259
Mydriasis 19.39 10.50 87 207044 6359 32300036
Pallor 19.33 10.50 227 206904 22654 32283741
Crystal urine present 18.99 10.50 18 207113 402 32305993
Chronic gastrointestinal bleeding 18.40 10.50 15 207116 272 32306123
Red cell distribution width increased 18.27 10.50 71 207060 4866 32301529
Granulomatosis with polyangiitis 18.26 10.50 27 207104 978 32305417
Oxygen saturation abnormal 18.18 10.50 30 207101 1196 32305199
Renal papillary necrosis 18.08 10.50 12 207119 156 32306239
Myelosuppression 18.07 10.50 29 207102 11647 32294748
Ischaemic stroke 17.88 10.50 55 207076 17521 32288874
Hepatic function abnormal 17.80 10.50 191 206940 44649 32261746
White blood cells urine positive 17.55 10.50 30 207101 1232 32305163
Infusion site bruising 17.53 10.50 16 207115 340 32306055
Pulmonary embolism 17.36 10.50 403 206728 83256 32223139
Tuberculosis 17.31 10.50 18 207113 8711 32297684
Product use issue 17.13 10.50 449 206682 52328 32254067
Therapy cessation 17.09 10.50 49 207082 15964 32290431
Pancreatitis acute 17.06 10.50 103 207028 27232 32279163
Specific gravity urine increased 17.04 10.50 11 207120 136 32306259
Visual impairment 17.01 10.50 131 207000 32757 32273638
Accidental exposure to product by child 16.99 10.50 34 207097 1577 32304818
Ductus arteriosus premature closure 16.84 10.50 13 207118 217 32306178
Prothrombin time prolonged 16.72 10.50 113 207018 9642 32296753
Lip swelling 16.64 10.50 147 206984 13618 32292777
Pulmonary arterial hypertension 16.55 10.50 23 207108 9798 32296597
Infusion site nodule 16.54 10.50 9 207122 79 32306316
Hypoxia 16.48 10.50 442 206689 51690 32254705
Specific gravity urine decreased 16.45 10.50 9 207122 80 32306315
Circulatory collapse 16.33 10.50 74 207057 21051 32285344
Erectile dysfunction 16.25 10.50 68 207063 19771 32286624
Acid-base balance disorder mixed 16.22 10.50 8 207123 56 32306339
Lung neoplasm malignant 16.20 10.50 50 207081 15913 32290482
Enterocolitis infectious 16.15 10.50 29 207102 1239 32305156
Melaena 16.15 10.50 142 206989 34523 32271872
Haematuria 16.13 10.50 214 206917 48147 32258248
Anticholinergic syndrome 16.10 10.50 24 207107 876 32305519
Administration site pruritus 15.93 10.50 6 207125 19 32306376
Myalgia 15.83 10.50 395 206736 80835 32225560
Diabetic ketoacidosis 15.61 10.50 60 207071 17872 32288523
Vomiting 15.56 10.50 1721 205410 233836 32072559
Thrombocytopenia 15.54 10.50 779 206352 147520 32158875
Aplastic anaemia 15.50 10.50 90 207041 7283 32299112
Child abuse 15.50 10.50 15 207116 344 32306051
Bladder cancer 15.38 10.50 26 207105 10230 32296165
Anti-erythrocyte antibody positive 15.36 10.50 7 207124 40 32306355
Acidosis 15.34 10.50 120 207011 10726 32295669
Thrombotic microangiopathy 15.20 10.50 23 207108 9459 32296936
Synovitis 15.19 10.50 120 207011 10758 32295637
Condition aggravated 15.12 10.50 824 206307 154837 32151558
Cardiac failure acute 15.11 10.50 26 207105 10158 32296237
Incorrect drug administration rate 15.06 10.50 28 207103 1229 32305166
Shock haemorrhagic 15.05 10.50 28 207103 10617 32295778
Haemorrhage 15 10.50 223 206908 49225 32257170
Blood pressure decreased 15.00 10.50 429 206702 50651 32255744
Febrile bone marrow aplasia 14.90 10.50 19 207112 8396 32297999
Tooth infection 14.83 10.50 75 207056 5759 32300636
Abdominal pain 14.81 10.50 1125 206006 148404 32157991
Multiple-drug resistance 14.81 10.50 3 207128 3772 32302623
Mean cell haemoglobin concentration decreased 14.79 10.50 26 207105 1092 32305303
Asthenia 14.78 10.50 1298 205833 234646 32071749
Pemphigus 14.67 10.50 29 207102 1333 32305062
Stevens-Johnson syndrome 14.67 10.50 183 206948 18526 32287869
Inappropriate schedule of product administration 14.62 10.50 389 206742 45436 32260959
Intraocular pressure increased 14.56 10.50 9 207122 5649 32300746
Syncope 14.55 10.50 450 206681 89674 32216721
Administration site swelling 14.49 10.50 11 207120 179 32306216
Therapeutic product effect decreased 14.47 10.50 127 207004 30890 32275505
Bacterial test positive 14.42 10.50 48 207083 3048 32303347
Prostate cancer 14.25 10.50 109 207022 27297 32279098
Blood count abnormal 14.20 10.50 39 207092 12887 32293508
Blood creatine phosphokinase increased 14.17 10.50 204 206927 45272 32261123
Urine analysis abnormal 14.03 10.50 36 207095 1973 32304422
Pharyngeal paraesthesia 14.01 10.50 16 207115 447 32305948
Exposure via inhalation 13.96 10.50 7 207124 51 32306344
Cytomegalovirus chorioretinitis 13.90 10.50 3 207128 3609 32302786
Administration site pain 13.89 10.50 11 207120 191 32306204
Bronchopulmonary aspergillosis 13.80 10.50 43 207088 13644 32292751
Pupil fixed 13.80 10.50 34 207097 1817 32304578
Acute myeloid leukaemia 13.75 10.50 69 207062 19105 32287290
Administration site erythema 13.74 10.50 8 207123 81 32306314
Posterior reversible encephalopathy syndrome 13.71 10.50 25 207106 9551 32296844
Parkinsonism 13.70 10.50 18 207113 7851 32298544
Decreased appetite 13.69 10.50 862 206269 159951 32146444
Coronary arterial stent insertion 13.59 10.50 5 207126 4237 32302158
Gynaecomastia 13.56 10.50 22 207109 8797 32297598
Palmar-plantar erythrodysaesthesia syndrome 13.51 10.50 53 207078 15696 32290699
Sinus tachycardia 13.49 10.50 162 206969 16252 32290143
Death 13.48 10.50 2696 204435 379821 31926574
Haemolysis 13.46 10.50 90 207041 7651 32298744
Vertigo 13.39 10.50 95 207036 24188 32282207
Malignant neoplasm of spinal cord 13.24 10.50 5 207126 16 32306379
Low birth weight baby 13.23 10.50 15 207116 6979 32299416
Haematocrit decreased 13.23 10.50 279 206852 31383 32275012
Pemphigoid 13.01 10.50 21 207110 8415 32297980
Bacterial test 13.00 10.50 10 207121 166 32306229
Chronic graft versus host disease 12.98 10.50 6 207125 4434 32301961
Cardiac disorder 12.98 10.50 188 206943 41678 32264717
Drug level below therapeutic 12.90 10.50 57 207074 4138 32302257
Prostatic specific antigen increased 12.90 10.50 42 207089 13145 32293250
Ultrasound liver abnormal 12.87 10.50 9 207122 128 32306267
Rhabdomyolysis 12.86 10.50 328 206803 66937 32239458
Brain death 12.86 10.50 41 207090 2545 32303850
Hyponatraemia 12.78 10.50 369 206762 74144 32232251
Apparent life threatening event 12.77 10.50 11 207120 216 32306179
Hypoglycaemia 12.71 10.50 257 206874 54125 32252270
Renal disorder 12.70 10.50 101 207030 25082 32281313
Ascites 12.63 10.50 180 206951 40011 32266384
Crohn's disease 12.59 10.50 58 207073 4287 32302108
Pulmonary congestion 12.57 10.50 134 206997 13057 32293338
Post embolisation syndrome 12.54 10.50 7 207124 65 32306330
Infusion site urticaria 12.45 10.50 8 207123 98 32306297
Febrile nonhaemolytic transfusion reaction 12.39 10.50 5 207126 20 32306375
Pyroglutamic acidosis 12.37 10.50 10 207121 179 32306216
Ear infection viral 12.19 10.50 3 207128 0 32306395
Perineal rash 12.19 10.50 3 207128 0 32306395
Heart rate 12.19 10.50 3 207128 0 32306395
Appendicolith 12.11 10.50 46 207085 3119 32303276
Liver disorder 12.10 10.50 136 206995 31518 32274877
Hypoxic-ischaemic encephalopathy 12.06 10.50 62 207069 4792 32301603
Swelling face 12.04 10.50 206 206925 22299 32284096
Apparent death 12.03 10.50 4 207127 3611 32302784
Peritonitis 12.00 10.50 88 207043 22242 32284153
Bilirubin urine present 11.98 10.50 9 207122 144 32306251
Antineutrophil cytoplasmic antibody positive 11.93 10.50 17 207114 595 32305800
Agranulocytosis 11.92 10.50 94 207037 23383 32283012
Acute coronary syndrome 11.91 10.50 47 207084 13894 32292501
Urine leukocyte esterase positive 11.87 10.50 14 207117 405 32305990
Anaphylactoid reaction 11.85 10.50 37 207094 2271 32304124
Ejection fraction decreased 11.85 10.50 65 207066 17593 32288802
Product substitution issue 11.84 10.50 31 207100 10405 32295990
pH urine increased 11.77 10.50 7 207124 74 32306321
Acute graft versus host disease 11.68 10.50 14 207117 6356 32300039
Eosinophil percentage increased 11.65 10.50 16 207115 541 32305854
Injection site bruising 11.57 10.50 20 207111 7800 32298595
Product prescribing error 11.43 10.50 76 207055 19641 32286754
Disease progression 11.41 10.50 445 206686 86417 32219978
Analgesic drug level above therapeutic 11.31 10.50 11 207120 254 32306141
Malaise 11.30 10.50 973 206158 176165 32130230
Oral pruritus 11.27 10.50 11 207120 255 32306140
Myelodysplastic syndrome 11.24 10.50 78 207053 19960 32286435
Hepatic cirrhosis 11.21 10.50 62 207069 16747 32289648
Self-medication 11.16 10.50 37 207094 2344 32304051
Therapy partial responder 11.16 10.50 9 207122 4921 32301474
Oropharyngeal pain 11.13 10.50 270 206861 31082 32275313
Graft versus host disease in gastrointestinal tract 11.12 10.50 4 207127 3437 32302958
Osteoporosis 11.10 10.50 40 207091 12142 32294253
Erysipelas 11.10 10.50 9 207122 4907 32301488
Electrocardiogram QRS complex prolonged 11.07 10.50 58 207073 4516 32301879
Administration site irritation 11.03 10.50 4 207127 11 32306384
Torsade de pointes 11.02 10.50 83 207048 7332 32299063
Nocardiosis 10.98 10.50 5 207126 3726 32302669
Second primary malignancy 10.97 10.50 17 207114 6924 32299471
Neurotoxicity 10.94 10.50 54 207077 15016 32291379
Premature baby 10.93 10.50 71 207060 18447 32287948
Abnormal dreams 10.85 10.50 24 207107 8540 32297855
Endocardial fibrosis 10.77 10.50 5 207126 30 32306365
Inappropriate antidiuretic hormone secretion 10.73 10.50 40 207091 12023 32294372
Hallucinations, mixed 10.73 10.50 40 207091 2687 32303708
Injection site haemorrhage 10.72 10.50 24 207107 8504 32297891
Cardiovascular disorder 10.72 10.50 34 207097 10728 32295667
Vital functions abnormal 10.70 10.50 8 207123 127 32306268
Peritoneal dialysis complication 10.69 10.50 7 207124 4261 32302134
Rash erythematous 10.68 10.50 213 206918 23726 32282669
Balance disorder 10.61 10.50 182 206949 39277 32267118
Aspergillus infection 10.55 10.50 38 207093 11536 32294859
Fasting 10.55 10.50 4 207127 13 32306382

Pharmacologic Action:

SourceCodeDescription
ATC D04AA32 DERMATOLOGICALS
ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
Antihistamines for topical use
ATC R06AA02 RESPIRATORY SYSTEM
ANTIHISTAMINES FOR SYSTEMIC USE
ANTIHISTAMINES FOR SYSTEMIC USE
Aminoalkyl ethers
ATC R06AA52 RESPIRATORY SYSTEM
ANTIHISTAMINES FOR SYSTEMIC USE
ANTIHISTAMINES FOR SYSTEMIC USE
Aminoalkyl ethers
FDA MoA N0000000190 Histamine H1 Receptor Antagonists
FDA EPC N0000175587 Histamine-1 Receptor Antagonist
CHEBI has role CHEBI:35717 sedatives
CHEBI has role CHEBI:36333 local anaesthetics
CHEBI has role CHEBI:37955 H1-receptor blockers
CHEBI has role CHEBI:48407 antiparkinson agent
CHEBI has role CHEBI:48876 Antimuskarinika
CHEBI has role CHEBI:50857 anti-allergic agents
CHEBI has role CHEBI:50919 antiemetico
CHEBI has role CHEBI:51177 cough suppressant
CHEBI has role CHEBI:59683 anti-itching drug
CHEBI has role CHEBI:66956 antidyskinetic drugs
CHEBI has role CHEBI:146270 oneirogens
MeSH PA D000777 Anesthetics
MeSH PA D000779 Anesthetics, Local
MeSH PA D018926 Anti-Allergic Agents
MeSH PA D000932 Antiemetics
MeSH PA D002491 Central Nervous System Agents
MeSH PA D002492 Central Nervous System Depressants
MeSH PA D005765 Gastrointestinal Agents
MeSH PA D018494 Histamine Agents
MeSH PA D006633 Histamine Antagonists
MeSH PA D006634 Histamine H1 Antagonists
MeSH PA D006993 Hypnotics and Sedatives
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D018689 Sensory System Agents
MeSH PA D000068776 Sleep Aids, Pharmaceutical

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Vasomotor rhinitis indication 8229003 DOID:4730
Insomnia indication 193462001
Seasonal allergic rhinitis indication 367498001
Allergic conjunctivitis indication 473460002 DOID:11204
Migraine off-label use 37796009 DOID:6364
Anxiety disorder off-label use 197480006 DOID:2030
Local anesthesia off-label use 386761002

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 8.52 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
25MG;EQ 200MG FREE ACID AND POTASSIUM SALT ADVIL PM GLAXOSMITHKLINE N021393 Dec. 21, 2005 OTC CAPSULE ORAL 8883849 Jan. 17, 2022 A METHOD OF TREATING A PATIENT SUFFERING FROM A PAIN ASSOCIATED SLEEP DISTURBANCE COMPRISING ADMINISTERING A LIQUID COMPOSITION FORMULATED INSIDE A SOFT GEL CAPSULE, AS CLAIMED, TO THE PATIENT

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Histamine H1 receptor GPCR ANTAGONIST Ki 7.81 WOMBAT-PK CHEMBL
Sodium-dependent noradrenaline transporter Transporter Kd 6.02 WOMBAT-PK
5-hydroxytryptamine receptor 2A GPCR Ki 6.43 DRUG MATRIX
5-hydroxytryptamine receptor 2B GPCR Ki 6.15 DRUG MATRIX
5-hydroxytryptamine receptor 2C GPCR Ki 6.29 DRUG MATRIX
Histamine H4 receptor GPCR Ki 4.37 CHEMBL
Muscarinic acetylcholine receptor M1 GPCR Ki 7 WOMBAT-PK
Muscarinic acetylcholine receptor M2 GPCR Ki 6.92 WOMBAT-PK
Muscarinic acetylcholine receptor M3 GPCR Ki 6.64 WOMBAT-PK
Muscarinic acetylcholine receptor M4 GPCR Ki 6.95 WOMBAT-PK
Muscarinic acetylcholine receptor M5 GPCR Ki 6.59 WOMBAT-PK
Cytochrome P450 2D6 Enzyme Ki 4.93 WOMBAT-PK
Solute carrier family 22 member 2 Transporter IC50 4.68 WOMBAT-PK
Sodium channel alpha subunits; brain (Types I, II, III) Ion channel IC50 5.22 CHEMBL
Sodium-dependent serotonin transporter Transporter Kd 5.42 SCIENTIFIC LITERATURE
Potassium voltage-gated channel subfamily H member 2 Ion channel IC50 5.59 CHEMBL
Sodium-dependent dopamine transporter Transporter Kd 5.66 SCIENTIFIC LITERATURE
Histamine H1 receptor GPCR IC50 9 CHEMBL

External reference:

IDSource
4019724 VUID
N0000147816 NUI
D00300 KEGG_DRUG
7491-10-3 SECONDARY_CAS_RN
4017866 VANDF
4019724 VANDF
4020653 VANDF
C0012522 UMLSCUI
CHEBI:4636 CHEBI
2PM PDB_CHEM_ID
CHEMBL657 ChEMBL_ID
CHEMBL1201089 ChEMBL_ID
CHEMBL1620 ChEMBL_ID
DB01075 DRUGBANK_ID
D004155 MESH_DESCRIPTOR_UI
1774 INN_ID
3100 PUBCHEM_CID
1224 IUPHAR_LIGAND_ID
8GTS82S83M UNII
1362 RXNORM
1676 MMSL
4611 MMSL
4612 MMSL
899 MMSL
d00212 MMSL
003369 NDDF
004787 NDDF
005115 NDDF
19510001 SNOMEDCT_US
26458009 SNOMEDCT_US
372682005 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Childrens Dimetapp Multi-Symptom Cold and Flu HUMAN OTC DRUG LABEL 3 0031-2249 LIQUID 12.50 mg ORAL Unapproved drug other 17 sections
Robitussin Severe Multi-Symptom Cough Cold Flu Nighttime HUMAN OTC DRUG LABEL 3 0031-8752 SOLUTION 25 mg ORAL OTC monograph final 17 sections
Robitussin Honey Severe Cough, Flu Plus Sore Throat Nighttime HUMAN OTC DRUG LABEL 2 0031-8770 SOLUTION 25 mg ORAL OTC MONOGRAPH FINAL 17 sections
Excedrin PM Triple Action Caplets HUMAN OTC DRUG LABEL 3 0067-2056 TABLET, COATED 38 mg ORAL OTC monograph not final 16 sections
THERAFLUPOWERPODS NIGHTTIME SEVERE COLD HUMAN OTC DRUG LABEL 3 0067-6095 POWDER, FOR SOLUTION 25 mg ORAL OTC monograph final 16 sections
THERAFLUNIGHTTIME SEVERE COLD AND COUGH HUMAN OTC DRUG LABEL 3 0067-7918 POWDER, FOR SOLUTION 25 mg ORAL OTC monograph final 17 sections
TRIAMINICNight Time Cold and Cough HUMAN OTC DRUG LABEL 2 0067-8106 SYRUP 6.25 mg ORAL OTC monograph final 15 sections
Theraflu Nighttime Multi-Symptom Severe Cold Powder HUMAN OTC DRUG LABEL 3 0067-8124 POWDER 25 mg ORAL OTC monograph final 16 sections
Theraflu ExpressMaxNighttime Severe Cold and Cough HUMAN OTC DRUG LABEL 3 0067-8129 SYRUP 25 mg ORAL OTC monograph final 16 sections
Theraflu ExpressMaxNighttime Severe Cold and Cough HUMAN OTC DRUG LABEL 3 0067-8137 TABLET, FILM COATED 12.50 mg ORAL OTC monograph final 16 sections
good sense ibuprofen pm HUMAN OTC DRUG LABEL 2 0113-0050 TABLET, FILM COATED 38 mg ORAL ANDA 16 sections
good sense sleep time HUMAN OTC DRUG LABEL 1 0113-0052 CAPSULE, LIQUID FILLED 25 mg ORAL OTC monograph final 16 sections
Good Sense Sleep Time HUMAN OTC DRUG LABEL 1 0113-0186 SOLUTION 50 mg ORAL OTC monograph final 16 sections
good sense allergy HUMAN OTC DRUG LABEL 1 0113-0379 SOLUTION 12.50 mg ORAL OTC monograph final 14 sections
good sense nighttime sleep aid HUMAN OTC DRUG LABEL 1 0113-0431 TABLET, FILM COATED 25 mg ORAL OTC monograph final 16 sections
good sense pain relief pmextra strength HUMAN OTC DRUG LABEL 2 0113-0437 TABLET, FILM COATED 25 mg ORAL OTC monograph not final 16 sections
Good Sense Allergy Relief HUMAN OTC DRUG LABEL 1 0113-0462 CAPSULE 25 mg ORAL OTC monograph final 15 sections
good sense allergy relief HUMAN OTC DRUG LABEL 1 0113-0479 TABLET 25 mg ORAL OTC monograph final 15 sections
good sense itch relief HUMAN OTC DRUG LABEL 2 0113-0622 CREAM 2 g TOPICAL OTC monograph not final 14 sections
Good Sense Pain Relief PMExtra Strength HUMAN OTC DRUG LABEL 2 0113-0837 TABLET, COATED 25 mg ORAL OTC monograph not final 15 sections
good sense flu and severe cold and coughnighttime HUMAN OTC DRUG LABEL 3 0113-0964 POWDER, FOR SOLUTION 25 mg ORAL OTC monograph final 16 sections
good sense sleep aid HUMAN OTC DRUG LABEL 1 0113-1909 CAPSULE, LIQUID FILLED 50 mg ORAL OTC monograph final 16 sections
basic care nighttime sleep aid HUMAN OTC DRUG LABEL 1 0113-7186 SOLUTION 50 mg ORAL OTC monograph final 16 sections
basic care naproxen sodium pm HUMAN OTC DRUG LABEL 2 0113-7264 TABLET, FILM COATED 25 mg ORAL ANDA 16 sections
basic care childrens allergy relief HUMAN OTC DRUG LABEL 1 0113-7379 SOLUTION 12.50 mg ORAL OTC monograph final 14 sections
basic care acetaminophen PM HUMAN OTC DRUG LABEL 2 0113-7437 TABLET, FILM COATED 25 mg ORAL OTC monograph not final 16 sections
basic care allergy relief HUMAN OTC DRUG LABEL 1 0113-7479 TABLET 25 mg ORAL OTC monograph final 15 sections
basic care nighttime sleep aid HUMAN OTC DRUG LABEL 1 0113-7506 CAPSULE, LIQUID FILLED 50 mg ORAL OTC monograph final 16 sections
good sense naproxen sodium HUMAN OTC DRUG LABEL 2 0113-8264 TABLET, FILM COATED 25 mg ORAL ANDA 16 sections
DIPHENHYDRAMINE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0121-0489 SOLUTION 12.50 mg ORAL ANDA 20 sections