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 3147.03 9.95 4797 370784 141123 46169358
Toxicity to various agents 2625.31 9.95 5463 370118 206303 46104178
Infusion related reaction 1301.92 9.95 2655 372926 98553 46211928
Overdose 483.50 9.95 1859 373722 100120 46210361
Intentional product misuse 432.46 9.95 1082 374499 46046 46264435
Drug abuse 431.79 9.95 1305 374276 62103 46248378
Urticaria 346.37 9.95 1866 373715 116026 46194455
Flushing 326.04 9.95 1202 374379 63412 46247069
Respiratory arrest 315.04 9.95 781 374800 33035 46277446
Blood pressure fluctuation 301.56 9.95 720 374861 29728 46280753
Sinusitis 287.55 9.95 1908 373673 127860 46182621
Cardio-respiratory arrest 283.20 9.95 1091 374490 58778 46251703
Acute hepatic failure 276.01 9.95 455 375126 14266 46296215
Product dose omission issue 268.20 9.95 599 374982 167921 46142560
Drug ineffective 220.49 9.95 3987 371594 673851 45636630
Exposure to toxic agent 204.51 9.95 152 375429 1862 46308619
Throat irritation 203.40 9.95 602 374979 28299 46282182
Metabolic acidosis 201.94 9.95 729 374852 38051 46272430
Pruritus 188.55 9.95 2865 372716 239487 46070994
Intentional overdose 186.52 9.95 1022 374559 63922 46246559
Anion gap 186.27 9.95 113 375468 960 46309521
Exposure via ingestion 185.43 9.95 181 375400 3286 46307195
Hepatotoxicity 168.50 9.95 513 375068 24496 46285985
Oxygen saturation decreased 164.09 9.95 1035 374546 68129 46242352
Poisoning 161.93 9.95 352 375229 13642 46296839
Blood pressure increased 160.42 9.95 1641 373940 125025 46185456
Device expulsion 148.81 9.95 22 375559 27520 46282961
Urine abnormality 146.35 9.95 202 375379 5392 46305089
Injection site pain 143.92 9.95 415 375166 106737 46203744
Diarrhoea 142.90 9.95 3422 372159 556180 45754301
Hereditary angioedema 139.55 9.95 196 375385 5320 46305161
Cardiac failure 135.55 9.95 274 375307 79674 46230807
Heart rate increased 134.38 9.95 1046 374535 73745 46236736
Psoriasis 132.75 9.95 270 375311 78334 46232147
Drug interaction 130.05 9.95 1028 374553 202066 46108415
Sopor 124.67 9.95 9 375572 19819 46290662
Infusion site pain 117.82 9.95 255 375326 9852 46300629
Acute kidney injury 114.07 9.95 1280 374301 234575 46075906
Maternal exposure during pregnancy 112.42 9.95 434 375147 102115 46208366
Urine leukocyte esterase positive 111.31 9.95 119 375462 2416 46308065
Chest discomfort 111.15 9.95 1163 374418 89106 46221375
Anaemia 106.01 9.95 1435 374146 254344 46056137
Cardiac arrest 104.94 9.95 1151 374430 89248 46221233
Alopecia 104.89 9.95 820 374761 161594 46148887
Cardiac failure congestive 100.76 9.95 388 375193 91362 46219119
Throat tightness 99.90 9.95 379 375202 20260 46290221
Infusion site swelling 98.65 9.95 170 375411 5529 46304952
Heart rate decreased 97.69 9.95 509 375072 31214 46279267
Blood pressure diastolic abnormal 97.69 9.95 179 375402 6115 46304366
Wrong technique in product usage process 91.82 9.95 187 375394 54235 46256246
Crystal urine present 91.36 9.95 78 375503 1181 46309300
Ear infection 89.52 9.95 395 375186 22618 46287863
Blood pressure systolic increased 89.41 9.95 463 375118 28324 46282157
Chills 89.21 9.95 1172 374409 94860 46215621
Hospitalisation 88.40 9.95 241 375340 63144 46247337
Blood pressure systolic abnormal 87.02 9.95 158 375423 5359 46305122
Infusion site erythema 87.02 9.95 191 375390 7451 46303030
Death 86.93 9.95 3410 372171 332138 45978343
Body temperature increased 86.54 9.95 413 375168 24448 46286033
Pharyngitis 86.02 9.95 324 375257 17259 46293222
Osteonecrosis of jaw 84.59 9.95 91 375490 34311 46276170
White blood cells urine positive 84.05 9.95 132 375449 3968 46306513
Tachycardia 83.64 9.95 1194 374387 98428 46212053
Lymphocyte count decreased 83.28 9.95 417 375164 25172 46285309
Deafness transitory 83.19 9.95 83 375498 1549 46308932
Urinary sediment present 82.69 9.95 87 375494 1733 46308748
Coagulopathy 82.46 9.95 331 375250 18168 46292313
Food allergy 80.90 9.95 175 375406 6758 46303723
Cholecystitis chronic 76.06 9.95 221 375360 10278 46300203
Suspected suicide 75.45 9.95 135 375446 4526 46305955
Hyperkalaemia 75.15 9.95 187 375394 50522 46259959
Erythema 74.15 9.95 1585 373996 141235 46169246
Intentional product use issue 73.16 9.95 697 374884 52083 46258398
Acute lung injury 72.97 9.95 69 375512 1202 46309279
Neutropenia 72.41 9.95 769 374812 142435 46168046
Hepatic necrosis 70.72 9.95 146 375435 5455 46305026
Foetal exposure during pregnancy 70.53 9.95 86 375495 30661 46279820
Medication error 70.45 9.95 458 375123 30453 46280028
Drug resistance 70.02 9.95 26 375555 17342 46293139
Infusion site extravasation 69.91 9.95 140 375441 5116 46305365
Product prescribing error 69.82 9.95 37 375544 20010 46290471
Fall 69.59 9.95 2066 373515 327031 45983450
Myocardial infarction 68.37 9.95 481 375100 97047 46213434
Therapy cessation 68.22 9.95 68 375513 26561 46283920
Red blood cells urine positive 67.99 9.95 94 375487 2513 46307968
Hyponatraemia 67.54 9.95 507 375074 100825 46209656
Therapeutic product effect incomplete 67.53 9.95 361 375220 77792 46232689
No adverse event 66.33 9.95 108 375473 34123 46276358
Anticholinergic syndrome 65.94 9.95 77 375504 1729 46308752
Temperature regulation disorder 65.89 9.95 106 375475 3254 46307227
Anaphylactic reaction 62.87 9.95 679 374902 52433 46258048
Pancytopenia 62.85 9.95 413 375168 84645 46225836
Malignant neoplasm progression 61.76 9.95 290 375291 64636 46245845
Infusion site pruritus 61.54 9.95 99 375482 3039 46307442
Injection site bruising 61.35 9.95 121 375460 35515 46274966
Respiratory depression 61.16 9.95 219 375362 11381 46299100
Nasopharyngitis 60.51 9.95 1645 373936 152353 46158128
Systemic lupus erythematosus 60.32 9.95 294 375287 64886 46245595
Interstitial lung disease 59.94 9.95 227 375354 53722 46256759
Feeling hot 58.72 9.95 513 375068 37415 46273066
Treatment failure 58.64 9.95 473 375108 92614 46217867
Blood pressure diastolic decreased 56.86 9.95 246 375335 13965 46296516
Renal impairment 56.01 9.95 359 375222 74013 46236468
Cerebrovascular accident 55.86 9.95 531 375050 100508 46209973
Product substitution issue 54.97 9.95 26 375555 15005 46295476
Hepatic failure 54.90 9.95 458 375123 32958 46277523
Ear pruritus 54.63 9.95 76 375505 2044 46308437
Pyroglutamate increased 54.22 9.95 37 375544 392 46310089
Red cell distribution width increased 53.74 9.95 160 375421 7544 46302937
Blood urine present 53.34 9.95 218 375363 12064 46298417
Injection site erythema 53.17 9.95 365 375216 74062 46236419
Abortion spontaneous 52.24 9.95 178 375403 43468 46267013
Accidental death 52.17 9.95 69 375512 1766 46308715
Respiratory rate increased 52.10 9.95 206 375375 11227 46299254
Heart rate irregular 51.62 9.95 290 375291 18301 46292180
Pneumonia viral 51.46 9.95 143 375438 6481 46304000
Posterior reversible encephalopathy syndrome 51.20 9.95 29 375552 15112 46295369
Analgesic drug level increased 50.11 9.95 61 375520 1433 46309048
Lactic acidosis 49.50 9.95 126 375455 33783 46276698
Depressed level of consciousness 47.73 9.95 589 374992 46980 46263501
Pneumonia 47.71 9.95 2508 373073 373812 45936669
Headache 47.64 9.95 4466 371115 473886 45836595
Lymphocyte percentage decreased 47.36 9.95 81 375500 2618 46307863
Renal failure 47.06 9.95 637 374944 112957 46197524
Epilepsy 46.83 9.95 74 375507 23664 46286817
Product quality issue 46.42 9.95 140 375441 35508 46274973
Hypersensitivity 45.94 9.95 1557 374024 148764 46161717
Injury 45.85 9.95 549 375032 43478 46267003
Immunodeficiency 45.81 9.95 218 375363 12888 46297593
Accidental overdose 44.92 9.95 296 375285 19770 46290711
Poor venous access 44.78 9.95 158 375423 8150 46302331
Psoriatic arthropathy 44.47 9.95 147 375434 36232 46274249
Infusion site nodule 44.24 9.95 47 375534 947 46309534
Anion gap abnormal 44.03 9.95 30 375551 317 46310164
Urine ketone body present 43.96 9.95 69 375512 2073 46308408
General physical health deterioration 43.80 9.95 661 374920 115108 46195373
Hepatocellular injury 43.63 9.95 109 375472 29413 46281068
Rash erythematous 43.40 9.95 445 375136 33905 46276576
Administration site swelling 43.09 9.95 50 375531 1115 46309366
Pulmonary arterial hypertension 42.96 9.95 90 375491 25838 46284643
Suicide attempt 42.77 9.95 651 374930 54385 46256096
Pemphigus 42.59 9.95 203 375378 45071 46265410
Postmortem blood drug level increased 41.67 9.95 32 375549 413 46310068
Gastrointestinal pain 41.24 9.95 143 375438 7312 46303169
Thrombocytopenia 41.22 9.95 743 374838 125838 46184643
Plasma cell myeloma 40.36 9.95 202 375379 44276 46266205
Neutrophil percentage increased 39.92 9.95 75 375506 2612 46307869
Bone marrow failure 39.73 9.95 115 375466 29554 46280927
Emotional distress 39.36 9.95 399 375182 30308 46280173
Soft tissue disorder 39.30 9.95 97 375484 4089 46306392
Polyneuropathy 38.38 9.95 23 375558 11621 46298860
Infusion site bruising 38.27 9.95 54 375527 1472 46309009
Diabetes mellitus 38.03 9.95 241 375340 49824 46260657
Product storage error 37.89 9.95 24 375557 11768 46298713
Blood pressure diastolic increased 37.87 9.95 120 375461 5854 46304627
Product use in unapproved indication 37.83 9.95 505 375076 89768 46220713
Pain 37.67 9.95 4384 371197 472564 45837917
Brain death 37.31 9.95 75 375506 2748 46307733
Hypertensive crisis 36.95 9.95 33 375548 13582 46296899
Syncope 36.42 9.95 608 374973 104195 46206286
Body temperature fluctuation 36.25 9.95 58 375523 1772 46308709
Neoplasm progression 36.04 9.95 103 375478 26580 46283901
Culture urine positive 35.53 9.95 82 375499 3309 46307172
Electric shock 35.36 9.95 40 375541 867 46309614
Ear pain 35.33 9.95 301 375280 21791 46288690
Atrial fibrillation 35.33 9.95 603 374978 102987 46207494
Unresponsive to stimuli 35.18 9.95 405 375176 31769 46278712
Bone erosion 35.05 9.95 16 375565 9427 46301054
Haematocrit decreased 34.70 9.95 433 375148 34624 46275857
Haemoglobin urine present 34.18 9.95 34 375547 632 46309849
Sepsis 33.82 9.95 834 374747 135180 46175301
Administration site pain 33.72 9.95 34 375547 643 46309838
Pneumocystis jirovecii pneumonia 33.56 9.95 44 375537 15204 46295277
Prothrombin time prolonged 33.09 9.95 159 375422 9437 46301044
Opiates positive 33.07 9.95 23 375558 252 46310229
Myelodysplastic syndrome 32.91 9.95 47 375534 15664 46294817
Alanine aminotransferase increased 32.79 9.95 938 374643 87513 46222968
Labelled drug-drug interaction medication error 32.64 9.95 16 375565 9045 46301436
Diabetic ketoacidosis 32.06 9.95 61 375520 18149 46292332
Body temperature decreased 31.98 9.95 201 375380 13208 46297273
Therapy interrupted 31.96 9.95 24 375557 10767 46299714
Osteonecrosis 31.48 9.95 104 375477 25640 46284841
Dyspnoea exertional 31.44 9.95 256 375325 50033 46260448
Heart rate abnormal 31.29 9.95 78 375503 3309 46307172
Urine analysis abnormal 31.12 9.95 89 375492 4101 46306380
Injection site reaction 31.11 9.95 241 375340 47608 46262873
Muscle injury 31.08 9.95 98 375483 4768 46305713
Hypotension 30.66 9.95 2219 373362 230370 46080111
Serum sickness 30.59 9.95 64 375517 2414 46308067
Ischaemic stroke 30.34 9.95 55 375526 16667 46293814
Upper respiratory tract infection 30.30 9.95 697 374884 62859 46247622
Pulmonary hypertension 30.12 9.95 168 375413 35825 46274656
Septic shock 29.99 9.95 309 375272 57584 46252897
Bacterial test 29.72 9.95 43 375538 1200 46309281
Substance abuse 29.50 9.95 87 375494 4080 46306401
Condition aggravated 29.34 9.95 1642 373939 243410 46067071
Toxicologic test abnormal 29.27 9.95 32 375549 667 46309814
Cerebral haemorrhage 29.21 9.95 123 375458 28248 46282233
Specific gravity urine decreased 29.13 9.95 26 375555 419 46310062
Glossodynia 28.61 9.95 224 375357 44149 46266332
Osteoarthritis 28.58 9.95 340 375241 61685 46248796
Neuropathy peripheral 28.49 9.95 537 375044 90356 46220125
Rash 28.22 9.95 3278 372303 353234 45957247
Pathogen resistance 28.17 9.95 7 375574 6053 46304428
Febrile bone marrow aplasia 28.12 9.95 10 375571 6852 46303629
Device dislocation 28.11 9.95 86 375495 21716 46288765
Hypocalcaemia 27.66 9.95 116 375465 26669 46283812
Cytomegalovirus infection 27.59 9.95 66 375515 18078 46292403
Knee arthroplasty 27.31 9.95 98 375483 23567 46286914
Disease progression 27.22 9.95 544 375037 90756 46219725
Liver injury 27.18 9.95 221 375360 15780 46294701
Infusion site discomfort 27.08 9.95 30 375551 635 46309846
Mucosal inflammation 26.91 9.95 193 375388 38783 46271698
Fracture 26.60 9.95 58 375523 16413 46294068
Electrocardiogram QRS complex prolonged 26.31 9.95 100 375481 5349 46305132
Second primary malignancy 26.30 9.95 10 375571 6574 46303907
Oedema peripheral 26.12 9.95 1035 374546 158671 46151810
Folliculitis 26.07 9.95 109 375472 6094 46304387
Gait disturbance 26.06 9.95 931 374650 144332 46166149
Intentional self-injury 25.99 9.95 103 375478 24063 46286418
Inappropriate antidiuretic hormone secretion 25.93 9.95 46 375535 14056 46296425
Aspartate aminotransferase increased 25.77 9.95 822 374759 77878 46232603
Bacterial test positive 25.56 9.95 86 375495 4330 46306151
Hypokalaemia 25.49 9.95 527 375054 87497 46222984
Haematotoxicity 25.34 9.95 12 375569 6921 46303560
Analgesic drug level above therapeutic 25.24 9.95 17 375564 176 46310305
Anion gap increased 25.18 9.95 44 375537 1447 46309034
Device malfunction 25.16 9.95 43 375538 13331 46297150
Peritonitis 25.11 9.95 84 375497 20630 46289851
Anxiety 25.01 9.95 1742 373839 180215 46130266
Exposure during pregnancy 24.90 9.95 671 374910 107541 46202940
Administration site erythema 24.84 9.95 27 375554 559 46309922
Pregnancy 24.75 9.95 123 375458 27014 46283467
Visual acuity reduced 24.59 9.95 93 375488 22020 46288461
Drug screen positive 24.52 9.95 78 375503 3813 46306668
Mydriasis 24.43 9.95 157 375424 10396 46300085
Premature delivery 24.42 9.95 93 375488 21976 46288505
Vitamin K deficiency 24.40 9.95 24 375557 440 46310041
Meningitis aseptic 24.34 9.95 80 375501 3979 46306502
Shoulder arthroplasty 24.05 9.95 67 375514 3041 46307440
Specific gravity urine increased 24.01 9.95 17 375564 192 46310289
Gastrooesophageal reflux disease 23.99 9.95 437 375144 73907 46236574
Ill-defined disorder 23.89 9.95 325 375256 26502 46283979
Coronary artery disease 23.86 9.95 166 375415 33586 46276895
Surgery 23.74 9.95 135 375446 28650 46281831
Infusion site rash 23.71 9.95 34 375547 941 46309540
Leukopenia 23.56 9.95 397 375184 67946 46242535
Peritonitis bacterial 23.45 9.95 21 375560 8632 46301849
Injection site pruritus 23.19 9.95 206 375375 39537 46270944
Tongue disorder 23.10 9.95 117 375464 7093 46303388
Injection site haemorrhage 23.09 9.95 87 375494 20622 46289859
Drug reaction with eosinophilia and systemic symptoms 23.08 9.95 141 375440 29407 46281074
Altered state of consciousness 22.96 9.95 103 375478 23245 46287236
Sedation complication 22.91 9.95 73 375508 3572 46306909
Transplant dysfunction 22.57 9.95 5 375576 4677 46305804
Hypomania 22.42 9.95 82 375499 4306 46306175
Infusion site mass 22.31 9.95 32 375549 886 46309595
Sinus tachycardia 22.12 9.95 269 375312 21380 46289101
Parkinsonism 21.89 9.95 19 375562 7929 46302552
Memory impairment 21.80 9.95 465 375116 76872 46233609
Blood pH decreased 21.69 9.95 58 375523 2569 46307912
Brain oedema 21.55 9.95 173 375408 12305 46298176
Urinary casts 21.32 9.95 23 375558 472 46310009
Atypical femur fracture 20.97 9.95 7 375574 4990 46305491
Somnolence 20.89 9.95 1495 374086 155026 46155455
Transplant rejection 20.81 9.95 28 375553 9568 46300913
Transient ischaemic attack 20.77 9.95 180 375401 34723 46275758
Compartment syndrome 20.57 9.95 48 375533 1951 46308530
Thrombotic microangiopathy 20.38 9.95 22 375559 8284 46302197
Right ventricular failure 20.38 9.95 64 375517 16029 46294452
Hypoglycaemia 20.30 9.95 311 375270 54038 46256443
Gestational diabetes 20.19 9.95 17 375564 7202 46303279
Treatment noncompliance 20.15 9.95 148 375433 29583 46280898
Coeliac disease 20.07 9.95 112 375469 7049 46303432
Infusion site streaking 19.95 9.95 19 375562 334 46310147
Haemolysis 19.89 9.95 99 375482 5960 46304521
Disease recurrence 19.69 9.95 79 375502 18392 46292089
Palmar-plantar erythrodysaesthesia syndrome 19.64 9.95 91 375490 20360 46290121
Infusion site urticaria 19.63 9.95 27 375554 718 46309763
Renal disorder 19.48 9.95 130 375451 26556 46283925
Injection site warmth 19.46 9.95 52 375529 13720 46296761
Electrolyte imbalance 19.44 9.95 72 375509 17154 46293327
Jaundice cholestatic 19.31 9.95 86 375495 4943 46305538
Respiratory failure 19.28 9.95 598 374983 94218 46216263
Infective pulmonary exacerbation of cystic fibrosis 19.20 9.95 36 375545 10771 46299710
Mean cell haemoglobin concentration decreased 18.91 9.95 54 375527 2486 46307995
Spinal stenosis 18.78 9.95 46 375535 12497 46297984
Gallbladder injury 18.76 9.95 37 375544 1337 46309144
Bursitis 18.75 9.95 243 375338 19599 46290882
Adrenergic syndrome 18.63 9.95 8 375573 29 46310452
Multiple organ dysfunction syndrome 18.61 9.95 298 375283 51412 46259069
Liver transplant 18.60 9.95 52 375529 2365 46308116
Hip fracture 18.58 9.95 131 375450 26425 46284056
Breast cancer 18.56 9.95 256 375325 45262 46265219
Pupil fixed 18.47 9.95 42 375539 1678 46308803
Acute myeloid leukaemia 18.44 9.95 65 375516 15713 46294768
Muscle spasticity 18.36 9.95 156 375425 11284 46299197
Bronchopulmonary aspergillosis 18.23 9.95 20 375561 7476 46303005
Abdominal discomfort 18.23 9.95 1012 374569 150153 46160328
Injection site mass 18.22 9.95 61 375520 14979 46295502
Administration site reaction 18.18 9.95 15 375566 216 46310265
International normalised ratio increased 18.15 9.95 500 375081 46383 46264098
Blood count abnormal 18.10 9.95 78 375503 17800 46292681
Malaise 18.01 9.95 2362 373219 328870 45981611
Monocyte percentage increased 17.90 9.95 31 375550 1012 46309469
Blood creatinine decreased 17.73 9.95 80 375501 4624 46305857
Gallbladder disorder 17.69 9.95 217 375364 17281 46293200
Infusion site warmth 17.61 9.95 34 375547 1209 46309272
Low birth weight baby 17.54 9.95 11 375570 5423 46305058
Lung disorder 17.50 9.95 244 375337 43060 46267421
Incorrect drug administration rate 17.47 9.95 45 375536 1948 46308533
Injection site swelling 17.47 9.95 224 375357 40103 46270378
Cystitis 17.35 9.95 454 375127 41787 46268694
Oropharyngeal pain 17.33 9.95 746 374835 73422 46237059
Coma 17.20 9.95 602 374979 57747 46252734
Migraine 17.19 9.95 708 374873 69318 46241163
Complication associated with device 17.13 9.95 65 375516 15376 46295105
Cardiac failure acute 17.08 9.95 24 375557 8054 46302427
Neurotoxicity 17.06 9.95 55 375526 13662 46296819
Joint laxity 17.03 9.95 46 375535 2050 46308431
Feeling cold 16.95 9.95 228 375353 18543 46291938
Subdural haematoma 16.95 9.95 51 375530 12946 46297535
Post transplant lymphoproliferative disorder 16.90 9.95 5 375576 3851 46306630
Endophthalmitis 16.85 9.95 3 375578 3275 46307206
Macular oedema 16.77 9.95 6 375575 4095 46306386
Cystic fibrosis pancreatic 16.75 9.95 9 375572 59 46310422
Agranulocytosis 16.74 9.95 107 375474 22078 46288403
Oral pruritus 16.67 9.95 37 375544 1454 46309027
Red blood cells urine 16.61 9.95 19 375562 417 46310064
Diffuse large B-cell lymphoma 16.59 9.95 14 375567 5924 46304557
Haemophagocytic lymphohistiocytosis 16.46 9.95 26 375555 8316 46302165
Unintentional medical device removal 16.46 9.95 8 375573 4545 46305936
Hepatic enzyme increased 16.38 9.95 810 374771 80977 46229504
Lung neoplasm malignant 16.04 9.95 67 375514 15422 46295059
Myelocyte count increased 16.02 9.95 17 375564 342 46310139
Hip arthroplasty 16.00 9.95 83 375498 18029 46292452
Ejection fraction decreased 15.96 9.95 82 375499 17855 46292626
Peripheral swelling 15.96 9.95 1478 374103 156593 46153888
Administration site bruise 15.92 9.95 15 375566 260 46310221
Abortion induced 15.86 9.95 37 375544 10223 46300258
Synovitis 15.80 9.95 621 374960 60454 46250027
Cholelithiasis 15.68 9.95 415 375166 38266 46272215
Neutropenic sepsis 15.62 9.95 49 375532 12275 46298206
Hypothermia 15.46 9.95 158 375423 12025 46298456
Haemorrhage 15.44 9.95 330 375251 54539 46255942
Serum sickness-like reaction 15.39 9.95 18 375563 405 46310076
Post-traumatic stress disorder 15.38 9.95 69 375512 3979 46306502
Administration site extravasation 15.37 9.95 22 375559 608 46309873
Pharyngeal paraesthesia 15.36 9.95 31 375550 1139 46309342
Product residue present 15.33 9.95 6 375575 3876 46306605
Chronic kidney disease 15.22 9.95 234 375347 40637 46269844
Hyperhidrosis 15.19 9.95 871 374710 88437 46222044
Biliary dyskinesia 15.17 9.95 53 375528 2720 46307761
Iron deficiency anaemia 15.12 9.95 79 375502 17127 46293354
Hyperglycaemia 15.12 9.95 195 375386 34876 46275605
Ventricular arrhythmia 15.07 9.95 61 375520 3360 46307121
Osmolar gap 15.05 9.95 10 375571 101 46310380
Accidental exposure to product by child 15.04 9.95 30 375551 1093 46309388
Cerebral infarction 15.04 9.95 118 375463 23248 46287233
Suicidal ideation 15.03 9.95 342 375239 56040 46254441
Pyroglutamic acidosis 14.85 9.95 14 375567 243 46310238
Low turnover osteopathy 14.81 9.95 8 375573 4281 46306200
Blood bilirubin increased 14.80 9.95 370 375211 33814 46276667
Galactorrhoea 14.78 9.95 6 375575 3791 46306690
Acute myocardial infarction 14.70 9.95 175 375406 31749 46278732
Acute graft versus host disease 14.69 9.95 7 375574 4023 46306458
Lower respiratory tract infection 14.69 9.95 562 375019 54527 46255954
Live birth 14.60 9.95 39 375542 10291 46300190
Incorrect dose administered by device 14.60 9.95 3 375578 2957 46307524
Hypertransaminasaemia 14.44 9.95 5 375576 3483 46306998
C-reactive protein abnormal 14.42 9.95 246 375335 21024 46289457
Blood thyroid stimulating hormone decreased 14.41 9.95 67 375514 3922 46306559
Mean cell haemoglobin concentration increased 14.39 9.95 18 375563 435 46310046
Oedema 14.37 9.95 420 375161 66651 46243830
Anoxia 14.30 9.95 14 375567 255 46310226
Breast cancer metastatic 14.27 9.95 59 375522 13619 46296862
Ageusia 14.26 9.95 46 375535 11426 46299055
Enthesopathy 14.26 9.95 75 375506 4615 46305866
Arrhythmia 14.19 9.95 196 375385 34645 46275836
Mitral valve incompetence 14.18 9.95 91 375490 18761 46291720
Nitrite urine present 14.18 9.95 23 375558 711 46309770
Drug specific antibody present 14.07 9.95 55 375526 2981 46307500
Metastases to central nervous system 13.95 9.95 45 375536 11176 46299305
Irritable bowel syndrome 13.86 9.95 198 375383 16317 46294164
Activated partial thromboplastin time prolonged 13.86 9.95 99 375482 6790 46303691
Metastases to bone 13.85 9.95 83 375498 17393 46293088
Gastrointestinal haemorrhage 13.84 9.95 496 375085 76877 46233604
Therapeutic response decreased 13.79 9.95 254 375327 42891 46267590
Acidosis 13.75 9.95 144 375437 11030 46299451
Cardiovascular disorder 13.71 9.95 51 375530 12136 46298345
Mucosal dryness 13.61 9.95 45 375536 2245 46308236
Peripheral sensory neuropathy 13.59 9.95 20 375561 6583 46303898
Prothrombin level increased 13.59 9.95 13 375568 230 46310251
Lumbar vertebral fracture 13.58 9.95 10 375571 4532 46305949
Product adhesion issue 13.46 9.95 12 375569 4943 46305538
Intervertebral discitis 13.44 9.95 48 375533 2491 46307990
Sexual abuse 13.35 9.95 10 375571 124 46310357
Back pain 13.35 9.95 1906 373675 208133 46102348
Chronic obstructive pulmonary disease 13.35 9.95 357 375224 57276 46253205
Rheumatoid arthritis 13.27 9.95 1711 373870 238504 46071977
Ductus arteriosus premature closure 13.26 9.95 15 375566 325 46310156
Vertigo 13.24 9.95 318 375263 51730 46258751
Device related thrombosis 13.22 9.95 30 375551 1197 46309284
Transfusion-related acute lung injury 13.22 9.95 9 375572 95 46310386
Band neutrophil count increased 13.19 9.95 15 375566 327 46310154
Pulmonary fibrosis 13.15 9.95 101 375480 19991 46290490
Immune reconstitution inflammatory syndrome 13.14 9.95 16 375565 5709 46304772
Injection site rash 13.12 9.95 74 375507 15739 46294742
Platelet morphology abnormal 13.11 9.95 4 375577 3 46310478
Therapeutic response shortened 13.07 9.95 79 375502 5120 46305361
Renal papillary necrosis 13.06 9.95 13 375568 242 46310239
Mental status changes 13.04 9.95 400 375181 37688 46272793
Blood creatine increased 13.01 9.95 72 375509 4518 46305963
Vasodilation procedure 12.97 9.95 6 375575 27 46310454
Decreased appetite 12.97 9.95 1363 374218 192473 46118008
Chronic graft versus host disease 12.96 9.95 3 375578 2722 46307759
Vitamin D deficiency 12.92 9.95 46 375535 11088 46299393
Gastric infection 12.92 9.95 51 375530 2777 46307704
Anaphylactoid reaction 12.88 9.95 59 375522 3432 46307049
Smear cervix abnormal 12.84 9.95 47 375534 2469 46308012
Left ventricular dysfunction 12.83 9.95 41 375540 10214 46300267
Pharyngitis streptococcal 12.82 9.95 114 375467 8354 46302127
Toothache 12.78 9.95 196 375385 16396 46294085
Monocyte count increased 12.76 9.95 77 375504 4987 46305494
Infusion site irritation 12.75 9.95 18 375563 491 46309990
Infusion site induration 12.69 9.95 23 375558 779 46309702
Autonomic dysreflexia 12.65 9.95 12 375569 210 46310271
Glycosylated haemoglobin increased 12.58 9.95 45 375536 10831 46299650
Ulcer 12.47 9.95 203 375378 17189 46293292
Vascular rupture 12.47 9.95 30 375551 1244 46309237
Pancreatic carcinoma 12.41 9.95 21 375560 6536 46303945
Administration site pruritus 12.39 9.95 14 375567 303 46310178
Depression 12.36 9.95 1189 374392 168915 46141566
Hepatic cirrhosis 12.32 9.95 75 375506 15657 46294824
Procedural anxiety 12.29 9.95 18 375563 508 46309973
Dermatitis bullous 12.27 9.95 27 375554 7616 46302865
Tracheal oedema 12.11 9.95 5 375576 16 46310465
Gastrointestinal sounds abnormal 12.02 9.95 58 375523 3448 46307033
Forced expiratory volume decreased 12.00 9.95 14 375567 5090 46305391
Spinal fracture 11.97 9.95 73 375508 15232 46295249
Tri-iodothyronine free increased 11.94 9.95 11 375570 185 46310296
Off label use 11.91 9.95 2791 372790 377050 45933431
Femoral neck fracture 11.91 9.95 30 375551 8073 46302408
Infusion site oedema 11.90 9.95 17 375564 469 46310012
Device use error 11.88 9.95 14 375567 5067 46305414
White blood cells urine 11.86 9.95 14 375567 318 46310163
Temperature intolerance 11.82 9.95 103 375478 7504 46302977
Hyperlipidaemia 11.76 9.95 94 375487 18445 46292036
Cells in urine 11.73 9.95 10 375571 151 46310330
Hyperaemia 11.71 9.95 39 375542 1953 46308528
Liver disorder 11.68 9.95 220 375361 37026 46273455
Graft versus host disease 11.66 9.95 22 375559 6566 46303915
Adverse event 11.64 9.95 199 375382 33985 46276496
Pulmonary mass 11.58 9.95 90 375491 17767 46292714
Pupillary light reflex tests abnormal 11.57 9.95 10 375571 154 46310327
Hemiplegia 11.56 9.95 24 375557 6914 46303567
Sensation of foreign body 11.52 9.95 62 375519 3849 46306632
Sucrose intolerance 11.49 9.95 3 375578 0 46310481
Angina pectoris 11.49 9.95 149 375432 26626 46283855
Cognitive disorder 11.49 9.95 383 375198 36500 46273981
Coma hepatic 11.49 9.95 19 375562 597 46309884
Creatinine renal clearance decreased 11.44 9.95 95 375486 6825 46303656
Infusion site haemorrhage 11.42 9.95 41 375540 2133 46308348
Creatinine urine decreased 11.42 9.95 10 375571 157 46310324
Cardiac disorder 11.42 9.95 267 375314 43591 46266890
Cardiotoxicity 11.42 9.95 23 375558 6699 46303782
Limb mass 11.41 9.95 45 375536 2449 46308032
Allergy to plants 11.39 9.95 18 375563 544 46309937
Infusion site scar 11.39 9.95 11 375570 197 46310284
Drug hypersensitivity 11.38 9.95 2176 373405 241649 46068832
Postoperative ileus 11.35 9.95 17 375564 490 46309991
Sleep disorder 11.33 9.95 288 375293 46507 46263974
Band neutrophil percentage increased 11.30 9.95 11 375570 199 46310282
Blood calcium decreased 11.26 9.95 183 375398 15490 46294991
Joint stiffness 11.22 9.95 152 375429 26956 46283525
Kidney transplant rejection 11.15 9.95 10 375571 4108 46306373
Periorbital swelling 11.06 9.95 29 375552 1269 46309212
Joint swelling 11.03 9.95 1511 374070 164562 46145919
Blood pressure decreased 11.01 9.95 564 375017 56595 46253886
Metastases to lymph nodes 11.00 9.95 23 375558 6608 46303873
Thyroxine free increased 10.99 9.95 21 375560 741 46309740
Disturbance in attention 10.98 9.95 183 375398 31377 46279104
Organising pneumonia 10.94 9.95 14 375567 4888 46305593
Peritoneal dialysis complication 10.91 9.95 4 375577 2690 46307791
Large intestine polyp 10.87 9.95 30 375551 7831 46302650
Antidepressant drug level above therapeutic 10.80 9.95 14 375567 351 46310130
Malignant melanoma 10.76 9.95 44 375537 10190 46300291
Sexual dysfunction 10.74 9.95 3 375578 2400 46308081
Device difficult to use 10.73 9.95 31 375550 7973 46302508
Administration site irritation 10.73 9.95 6 375575 43 46310438
Mean cell haemoglobin decreased 10.59 9.95 49 375532 2863 46307618
Aplasia pure red cell 10.55 9.95 12 375569 4413 46306068
Pulmonary infarction 10.50 9.95 46 375535 2625 46307856
Graft versus host disease in skin 10.50 9.95 3 375578 2364 46308117
Eye infection 10.50 9.95 116 375465 9007 46301474
Mood swings 10.49 9.95 82 375499 16170 46294311
Lung adenocarcinoma 10.47 9.95 11 375570 4193 46306288
Device leakage 10.32 9.95 17 375564 5348 46305133
Eosinophil percentage increased 10.32 9.95 22 375559 841 46309640
Agitation 10.31 9.95 545 375036 54870 46255611
Pericardial effusion 10.29 9.95 144 375437 25399 46285082
Long QT syndrome 10.27 9.95 6 375575 3074 46307407
Ketoacidosis 10.24 9.95 10 375571 3945 46306536
Vein collapse 10.24 9.95 17 375564 536 46309945
Bradypnoea 10.22 9.95 50 375531 2989 46307492
Administration site nodule 10.19 9.95 6 375575 48 46310433
Infusion site discolouration 10.17 9.95 17 375564 539 46309942
Circulatory collapse 10.16 9.95 118 375463 21506 46288975
Pain in jaw 10.16 9.95 233 375348 38139 46272342
Thrombophlebitis superficial 10.13 9.95 72 375509 4931 46305550
Corneal reflex decreased 10.09 9.95 9 375572 145 46310336
Sleep disorder due to a general medical condition 10.09 9.95 8 375573 3491 46306990
Uterine perforation 10.08 9.95 96 375485 7171 46303310
Product physical issue 10.06 9.95 15 375566 4912 46305569
Pulmonary tuberculosis 10.06 9.95 14 375567 4717 46305764
Epstein-Barr virus infection 10.06 9.95 25 375556 6759 46303722
Oropharyngeal discomfort 10.05 9.95 51 375530 3094 46307387
Mucormycosis 9.99 9.95 3 375578 2289 46308192
Dehydration 9.98 9.95 1127 374454 158413 46152068
Ventricular fibrillation 9.98 9.95 53 375528 11443 46299038

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 1678.93 10.24 2539 183297 96953 29669689
Toxicity to various agents 1642.57 10.24 3478 182358 173705 29592937
Infusion related reaction 1120.67 10.24 1319 184517 39245 29727397
Drug abuse 487.21 10.24 1360 184476 80712 29685930
Intentional product misuse 329.99 10.24 690 185146 33977 29732665
Overdose 272.80 10.24 1141 184695 83196 29683446
Respiratory arrest 237.15 10.24 546 185290 28712 29737930
Blood pressure fluctuation 232.98 10.24 402 185434 17101 29749541
Urticaria 222.45 10.24 795 185041 53811 29712831
Flushing 204.31 10.24 518 185318 28974 29737668
Chills 197.02 10.24 930 184906 71408 29695234
Drug ineffective 165.77 10.24 1336 184500 339051 29427591
Intentional overdose 161.32 10.24 595 185241 40886 29725756
Blood pressure increased 142.44 10.24 847 184989 71081 29695561
Cardio-respiratory arrest 134.85 10.24 707 185129 56599 29710043
Exposure via ingestion 126.62 10.24 115 185721 2496 29764146
Acute hepatic failure 126.26 10.24 247 185589 11580 29755062
Myocardial infarction 126.15 10.24 381 185455 125244 29641398
Cardiac failure 122.04 10.24 206 185630 83212 29683430
Drug interaction 118.46 10.24 739 185097 198829 29567813
Oxygen saturation decreased 115.63 10.24 555 185281 42885 29723757
Accidental overdose 115.28 10.24 310 185526 17965 29748677
Exposure to toxic agent 107.71 10.24 74 185762 1051 29765591
Heart rate increased 105.44 10.24 498 185338 38223 29728419
Product dose omission issue 93.30 10.24 276 185560 91355 29675287
Poisoning 92.83 10.24 213 185623 11169 29755473
Cardiac arrest 92.32 10.24 931 184905 91919 29674723
Acute kidney injury 84.89 10.24 1193 184643 272649 29493993
Sinusitis 84.41 10.24 420 185416 32925 29733717
Heart rate decreased 79.79 10.24 299 185537 20695 29745947
Unresponsive to stimuli 78.00 10.24 348 185488 26071 29740571
Anion gap 77.69 10.24 49 185787 597 29766045
Cardiac failure congestive 77.00 10.24 267 185569 84140 29682502
Anaemia 76.35 10.24 874 184962 207118 29559524
Drug resistance 76.06 10.24 16 185820 20117 29746525
Pruritus 71.33 10.24 1079 184757 117125 29649517
Anaphylactic reaction 69.79 10.24 351 185485 27631 29739011
General physical health deterioration 68.40 10.24 353 185483 99591 29667051
Interstitial lung disease 67.45 10.24 173 185663 60024 29706618
Psoriasis 63.02 10.24 104 185732 42402 29724240
Diarrhoea 61.84 10.24 1590 184246 332513 29434129
Environmental exposure 61.39 10.24 32 185804 263 29766379
Coagulopathy 60.32 10.24 251 185585 18236 29748406
Tachycardia 58.83 10.24 708 185128 73031 29693611
Throat tightness 57.99 10.24 134 185702 7058 29759584
Foetal exposure during pregnancy 57.71 10.24 87 185749 36784 29729858
Respiratory depression 57.00 10.24 179 185657 11324 29755318
Blood pressure diastolic abnormal 53.42 10.24 52 185784 1235 29765407
Blood pressure systolic increased 52.34 10.24 209 185627 14901 29751741
Renal impairment 51.76 10.24 308 185528 83876 29682766
Hepatotoxicity 50.56 10.24 235 185601 17910 29748732
Product use in unapproved indication 48.88 10.24 263 185573 73430 29693212
Hepatic necrosis 47.86 10.24 86 185750 3777 29762865
Heart rate irregular 46.91 10.24 175 185661 12084 29754558
Coronary artery disease 46.84 10.24 155 185681 49557 29717085
Substance abuse 43.96 10.24 119 185717 6921 29759721
Infusion site swelling 43.63 10.24 52 185784 1564 29765078
Cerebral haemorrhage 42.92 10.24 87 185749 32800 29733842
Suspected suicide 42.57 10.24 73 185763 3088 29763554
Erythema 41.75 10.24 694 185142 76757 29689885
Therapeutic product effect incomplete 41.24 10.24 93 185743 33741 29732901
Aspartate aminotransferase increased 40.97 10.24 586 185250 62836 29703806
Hypotension 40.54 10.24 1574 184262 198991 29567651
Cerebrovascular accident 39.73 10.24 329 185507 83148 29683494
Throat irritation 39.61 10.24 130 185706 8418 29758224
Infusion site extravasation 39.18 10.24 62 185774 2451 29764191
Blood pressure diastolic increased 38.87 10.24 65 185771 2693 29763949
Blood pressure systolic abnormal 38.25 10.24 47 185789 1460 29765182
Alanine aminotransferase increased 37.30 10.24 658 185178 73618 29693024
Bone marrow failure 37.02 10.24 81 185755 29704 29736938
Infusion site erythema 36.50 10.24 48 185788 1598 29765044
Respiratory rate increased 36.42 10.24 130 185706 8785 29757857
Metabolic acidosis 35.91 10.24 373 185463 37088 29729554
Hypersensitivity 35.61 10.24 501 185335 53527 29713115
Body temperature increased 35.17 10.24 183 185653 14597 29752045
Neutrophil percentage increased 34.77 10.24 50 185786 1814 29764828
Lymphocyte percentage decreased 34.67 10.24 53 185783 2033 29764609
Chest discomfort 33.80 10.24 431 185405 45049 29721593
Sopor 33.65 10.24 13 185823 10978 29755664
Medication error 32.31 10.24 232 185604 20740 29745902
Hepatocellular carcinoma 31.78 10.24 10 185826 9600 29757042
Infusion site pain 31.56 10.24 58 185778 2592 29764050
Diabetes mellitus 31.43 10.24 143 185693 41722 29724920
Infusion site reaction 31.32 10.24 30 185806 698 29765944
Plasma cell myeloma 31.07 10.24 199 185637 53263 29713379
Hepatocellular injury 31.05 10.24 70 185766 25401 29741241
Enthesopathy 30.17 10.24 60 185776 2846 29763796
Infusion site pruritus 30.15 10.24 27 185809 575 29766067
Ear infection 29.67 10.24 107 185729 7267 29759375
Hospitalisation 29.47 10.24 158 185678 44161 29722481
Wrong technique in product usage process 29.44 10.24 97 185739 31058 29735584
Leukopenia 29.20 10.24 216 185620 55943 29710699
Osteonecrosis of jaw 29.06 10.24 44 185792 18574 29748068
Acute lung injury 28.87 10.24 35 185801 1072 29765570
Septic shock 28.77 10.24 254 185582 63353 29703289
Cerebral infarction 28.61 10.24 77 185759 26296 29740346
Mental status changes 28.23 10.24 353 185483 36726 29729916
Body temperature fluctuation 28.13 10.24 37 185799 1232 29765410
Cytokine release syndrome 27.20 10.24 128 185708 9805 29756837
Blood pH decreased 27.04 10.24 50 185786 2245 29764397
Tongue disorder 26.93 10.24 73 185763 4249 29762393
Urine abnormality 26.85 10.24 40 185796 1499 29765143
Analgesic drug level increased 26.73 10.24 25 185811 564 29766078
Tenosynovitis 26.72 10.24 64 185772 3451 29763191
Accident 26.62 10.24 65 185771 3548 29763094
Angina pectoris 26.47 10.24 94 185742 29424 29737218
Fluid retention 26.36 10.24 74 185762 24924 29741718
Glycosylated haemoglobin increased 26.25 10.24 13 185823 9478 29757164
Rash 26.20 10.24 1448 184388 190441 29576201
Body temperature decreased 26.13 10.24 124 185712 9531 29757111
Pancytopenia 26.05 10.24 371 185465 84681 29681961
Nasopharyngitis 25.95 10.24 511 185325 58338 29708304
Malignant neoplasm progression 25.95 10.24 305 185531 71982 29694660
Hereditary angioedema 25.85 10.24 28 185808 757 29765885
Epilepsy 25.77 10.24 54 185782 20115 29746527
Drug hypersensitivity 25.37 10.24 580 185256 67939 29698703
Treatment failure 25.12 10.24 120 185716 34559 29732083
Hyperkalaemia 25.07 10.24 275 185561 65735 29700907
Myopathy 24.39 10.24 18 185818 10568 29756074
Infusion site rash 24.28 10.24 18 185818 290 29766352
Labelled drug-drug interaction medication error 24.17 10.24 18 185818 10520 29756122
Blood pressure diastolic decreased 23.88 10.24 89 185747 6142 29760500
Hepatitis C 23.87 10.24 28 185808 13177 29753465
Injection site pain 23.68 10.24 102 185734 30208 29736434
Feeling hot 23.59 10.24 171 185665 15333 29751309
Visual acuity reduced 23.26 10.24 39 185797 15807 29750835
Immune reconstitution inflammatory syndrome 22.95 10.24 14 185822 9087 29757555
Monocyte percentage increased 22.73 10.24 28 185808 872 29765770
Polyneuropathy 22.55 10.24 24 185812 11799 29754843
Progressive multifocal leukoencephalopathy 22.54 10.24 14 185822 8999 29757643
Pulse absent 22.52 10.24 80 185756 5393 29761249
Serum sickness 22.37 10.24 40 185796 1750 29764892
Depressed level of consciousness 22.27 10.24 347 185489 37875 29728767
Hyperhidrosis 22.13 10.24 559 185277 66531 29700111
Chronic obstructive pulmonary disease 21.83 10.24 182 185654 45944 29720698
Urine sodium decreased 21.69 10.24 14 185822 178 29766464
Alanine aminotransferase abnormal 21.34 10.24 49 185787 2570 29764072
Fall 21.29 10.24 917 184919 180955 29585687
Graft versus host disease 21.21 10.24 19 185817 10131 29756511
Product prescribing error 21.21 10.24 45 185791 16688 29749954
Haematotoxicity 21.17 10.24 6 185830 6164 29760478
Headache 21.15 10.24 1356 184480 180950 29585692
Peritonitis bacterial 20.71 10.24 24 185812 11354 29755288
Methaemoglobinaemia 20.49 10.24 47 185789 2463 29764179
Drug screen positive 20.40 10.24 67 185769 4340 29762302
Back pain 20.39 10.24 804 185032 101792 29664850
Pancreatitis acute 20.36 10.24 86 185750 25609 29741033
Renal failure 20.34 10.24 627 185209 128339 29638303
Anion gap abnormal 20.22 10.24 12 185824 130 29766512
Brain oedema 20.18 10.24 139 185697 12259 29754383
Liver injury 20.17 10.24 139 185697 12261 29754381
Lactic acidosis 19.80 10.24 113 185723 31100 29735542
Depression 19.80 10.24 419 185417 90018 29676624
Pathogen resistance 19.76 10.24 14 185822 8396 29758246
Febrile bone marrow aplasia 19.67 10.24 13 185823 8084 29758558
Neuropathy peripheral 19.66 10.24 313 185523 70162 29696480
Red cell distribution width increased 19.63 10.24 63 185773 4031 29762611
Ischaemic stroke 19.62 10.24 45 185791 16230 29750412
Acute myocardial infarction 19.52 10.24 222 185614 52717 29713925
Agitation 19.48 10.24 456 185380 53617 29713025
Condition aggravated 19.43 10.24 680 185156 137186 29629456
Prothrombin time prolonged 19.31 10.24 111 185725 9192 29757450
Ascites 19.22 10.24 137 185699 35784 29730858
Osteonecrosis 19.13 10.24 45 185791 16090 29750552
Pulmonary oedema 19.09 10.24 381 185455 43594 29723048
Neutropenia 19.05 10.24 630 185206 127910 29638732
Upper respiratory tract infection 18.99 10.24 257 185579 27219 29739423
Cytomegalovirus infection 18.90 10.24 79 185757 23595 29743047
Crystal urine present 18.84 10.24 15 185821 270 29766372
Memory impairment 18.83 10.24 144 185692 37030 29729612
Pneumonia 18.75 10.24 1803 184033 332503 29434139
Suicide attempt 18.73 10.24 326 185510 36371 29730271
Poor venous access 18.68 10.24 45 185791 2435 29764207
Post transplant lymphoproliferative disorder 18.50 10.24 5 185831 5301 29761341
Accidental exposure to product by child 18.35 10.24 34 185802 1529 29765113
Oxygen saturation abnormal 18.28 10.24 28 185808 1076 29765566
Coma 18.08 10.24 352 185484 40097 29726545
Hyponatraemia 17.90 10.24 301 185535 66901 29699741
Pyrexia 17.85 10.24 2087 183749 292402 29474240
Intentional product use issue 17.63 10.24 321 185515 36119 29730523
Pallor 17.60 10.24 204 185632 20845 29745797
Infusion site nodule 17.26 10.24 9 185827 74 29766568
Enterocolitis infectious 16.99 10.24 28 185808 1146 29765496
Blood pressure decreased 16.96 10.24 397 185439 46678 29719964
Infusion site bruising 16.75 10.24 13 185823 225 29766417
Synovitis 16.71 10.24 111 185725 9672 29756970
White blood cells urine positive 16.61 10.24 27 185809 1092 29765550
Granulomatosis with polyangiitis 16.56 10.24 24 185812 877 29765765
Death 16.52 10.24 2491 183345 354792 29411850
Eosinophilia 16.45 10.24 76 185760 22084 29744558
Cardiac failure chronic 16.26 10.24 8 185828 5855 29760787
Myalgia 16.25 10.24 357 185479 76310 29690332
Hypertriglyceridaemia 15.94 10.24 16 185820 8082 29758560
Therapy cessation 15.81 10.24 45 185791 15092 29751550
Chronic gastrointestinal bleeding 15.79 10.24 13 185823 246 29766396
Asthma 15.68 10.24 146 185690 36028 29730614
Pulmonary embolism 15.67 10.24 367 185469 77768 29688874
Pulmonary congestion 15.63 10.24 130 185706 12157 29754485
Oedema peripheral 15.60 10.24 519 185317 105313 29661329
Haemorrhage 15.55 10.24 197 185639 45882 29720760
Anti-erythrocyte antibody positive 15.54 10.24 7 185829 40 29766602
Bacterial test positive 15.38 10.24 47 185789 2929 29763713
Hypoxia 15.27 10.24 397 185439 47457 29719185
Mydriasis 15.27 10.24 77 185759 6066 29760576
Palmar-plantar erythrodysaesthesia syndrome 14.96 10.24 45 185791 14825 29751817
Melaena 14.89 10.24 129 185707 32308 29734334
Administration site pain 14.80 10.24 11 185825 178 29766464
Acidosis 14.75 10.24 112 185724 10189 29756453
Urine leukocyte esterase positive 14.75 10.24 14 185822 322 29766320
Shock haemorrhagic 14.74 10.24 24 185812 9841 29756801
Tuberculosis 14.74 10.24 17 185819 8060 29758582
Parkinsonism 14.73 10.24 14 185822 7255 29759387
Specific gravity urine increased 14.67 10.24 9 185827 104 29766538
Atrial fibrillation 14.61 10.24 536 185300 107588 29659054
Syncope 14.57 10.24 408 185428 84495 29682147
Coronary arterial stent insertion 14.53 10.24 4 185832 4190 29762452
Renal papillary necrosis 14.50 10.24 10 185826 143 29766499
Pulmonary arterial hypertension 14.50 10.24 22 185814 9279 29757363
Low birth weight baby 14.43 10.24 10 185826 6066 29760576
Vertigo 14.33 10.24 82 185754 22553 29744089
Mean cell haemoglobin concentration decreased 14.32 10.24 24 185812 996 29765646
Brain death 14.31 10.24 41 185795 2465 29764177
Agranulocytosis 14.15 10.24 79 185757 21863 29744779
Decreased appetite 14.15 10.24 773 185063 149137 29617505
Specific gravity urine decreased 14.14 10.24 7 185829 51 29766591
Visual impairment 14.00 10.24 121 185715 30317 29736325
Administration site erythema 13.94 10.24 8 185828 81 29766561
Febrile neutropenia 13.92 10.24 802 185034 105891 29660751
Hepatic function abnormal 13.90 10.24 180 185656 41765 29724877
Anticholinergic syndrome 13.78 10.24 21 185815 803 29765839
Incorrect drug administration rate 13.70 10.24 25 185811 1111 29765531
Anaphylactoid reaction 13.70 10.24 37 185799 2149 29764493
Tooth infection 13.56 10.24 66 185770 5125 29761517
Circulatory collapse 13.47 10.24 72 185764 20142 29746500
Malignant neoplasm of spinal cord 13.37 10.24 5 185831 16 29766626
Apparent life threatening event 13.36 10.24 11 185825 208 29766434
Crohn's disease 13.35 10.24 58 185778 4294 29762348
Haematocrit decreased 13.33 10.24 266 185570 30433 29736209
Child abuse 13.28 10.24 11 185825 210 29766432
Acute myeloid leukaemia 13.22 10.24 62 185774 17944 29748698
Therapeutic product effect decreased 13.19 10.24 116 185720 28960 29737682
Second primary malignancy 13.16 10.24 12 185824 6344 29760298
Ultrasound liver abnormal 13.15 10.24 9 185827 127 29766515
Administration site pruritus 13.14 10.24 5 185831 17 29766625
Venoocclusive liver disease 13.09 10.24 13 185823 6600 29760042
Lung neoplasm malignant 13.03 10.24 49 185787 15083 29751559
Apparent death 13.00 10.24 3 185833 3539 29763103
Post embolisation syndrome 12.99 10.24 7 185829 62 29766580
Diabetic ketoacidosis 12.98 10.24 53 185783 15933 29750709
Administration site swelling 12.94 10.24 10 185826 172 29766470
Exposure via inhalation 12.89 10.24 7 185829 63 29766579
Haematuria 12.87 10.24 198 185638 44636 29722006
Infusion site urticaria 12.86 10.24 8 185828 95 29766547
Accidental death 12.84 10.24 35 185801 2044 29764598
Bladder cancer 12.82 10.24 23 185813 9079 29757563
No adverse event 12.77 10.24 60 185776 17359 29749283
Malaise 12.76 10.24 878 184958 166084 29600558
Intraocular pressure increased 12.74 10.24 8 185828 5112 29761530
Febrile nonhaemolytic transfusion reaction 12.72 10.24 5 185831 19 29766623
Self-medication 12.58 10.24 37 185799 2257 29764385
Vital functions abnormal 12.58 10.24 8 185828 99 29766543
Victim of child abuse 12.57 10.24 12 185824 278 29766364
Cardiac disorder 12.56 10.24 173 185663 39720 29726922
Pupil fixed 12.49 10.24 32 185804 1800 29764842
Erectile dysfunction 12.33 10.24 64 185772 18038 29748604
Acute coronary syndrome 12.32 10.24 43 185793 13530 29753112
Analgesic drug level above therapeutic 12.29 10.24 11 185825 234 29766408
Heart rate 12.27 10.24 3 185833 0 29766642
Rhabdomyolysis 12.09 10.24 301 185535 63279 29703363
Urine analysis abnormal 12.09 10.24 32 185804 1836 29764806
Stevens-Johnson syndrome 12.04 10.24 164 185672 17392 29749250
pH urine increased 11.94 10.24 7 185829 74 29766568
Thrombotic microangiopathy 11.91 10.24 22 185814 8588 29758054
Blood ethanol increased 11.87 10.24 13 185823 356 29766286
Cardiovascular disorder 11.86 10.24 32 185804 10920 29755722
Gynaecomastia 11.85 10.24 21 185815 8330 29758312
Therapeutic response shortened 11.83 10.24 49 185787 3551 29763091
Myelosuppression 11.72 10.24 17 185819 7305 29759337
Administration site discomfort 11.70 10.24 4 185832 9 29766633
Thrombocytopenia 11.61 10.24 714 185122 136330 29630312
Oral pruritus 11.59 10.24 11 185825 253 29766389
Bacterial test 11.49 10.24 9 185827 158 29766484
Blood creatine phosphokinase increased 11.48 10.24 197 185639 43651 29722991
Cardiac failure acute 11.48 10.24 25 185811 9184 29757458
Eosinophil percentage increased 11.39 10.24 15 185821 500 29766142
Alcohol abuse 11.21 10.24 10 185826 5343 29761299
Hypoglycaemia 11.20 10.24 236 185600 50745 29715897
Staring 11.15 10.24 27 185809 1466 29765176
Haemolysis 11.14 10.24 80 185756 7151 29759491
Administration site irritation 11.14 10.24 4 185832 11 29766631
Oropharyngeal pain 11.10 10.24 243 185593 28253 29738389
Bronchopulmonary aspergillosis 11.09 10.24 39 185797 12245 29754397
Anion gap increased 11.09 10.24 29 185807 1652 29764990
Acute graft versus host disease 11.07 10.24 12 185824 5852 29760790
Vomiting 11.00 10.24 1540 184296 218278 29548364
Pharyngeal paraesthesia 10.98 10.24 13 185823 388 29766254
Eye swelling 10.95 10.24 94 185742 8870 29757772
Systemic mastocytosis 10.94 10.24 8 185828 126 29766516
Endocardial fibrosis 10.90 10.24 5 185831 30 29766612
Prescribed overdose 10.87 10.24 23 185813 8538 29758104
Chronic graft versus host disease 10.86 10.24 6 185830 4113 29762529
Pneumocystis jirovecii pneumonia 10.85 10.24 62 185774 17058 29749584
Pemphigus 10.73 10.24 24 185812 1237 29765405
Auricular swelling 10.68 10.24 8 185828 131 29766511
Cholestasis 10.68 10.24 101 185735 24849 29741793
Blood magnesium abnormal 10.68 10.24 10 185826 226 29766416
Transplant rejection 10.66 10.24 26 185810 9180 29757462
Fasting 10.65 10.24 4 185832 13 29766629
International normalised ratio increased 10.65 10.24 379 185457 47360 29719282
Posterior reversible encephalopathy syndrome 10.55 10.24 24 185812 8683 29757959
Asthenia 10.54 10.24 1207 184629 220083 29546559
Compartment syndrome 10.45 10.24 37 185799 2490 29764152
Postural tremor 10.40 10.24 11 185825 289 29766353
Administration site reaction 10.35 10.24 6 185830 62 29766580
Leukoencephalopathy 10.31 10.24 6 185830 3996 29762646
Sinus tachycardia 10.30 10.24 144 185692 15360 29751282
Premature baby 10.28 10.24 61 185775 16630 29750012
Bilirubin urine present 10.27 10.24 7 185829 98 29766544

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 anesthetics
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)

None

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 dopamine transporter Transporter Kd 5.66 SCIENTIFIC LITERATURE
Muscarinic acetylcholine receptor M4 GPCR Ki 6.95 WOMBAT-PK
Muscarinic acetylcholine receptor M2 GPCR Ki 6.92 WOMBAT-PK
Muscarinic acetylcholine receptor M1 GPCR Ki 7 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
Muscarinic acetylcholine receptor M3 GPCR Ki 6.64 WOMBAT-PK
Histamine H4 receptor GPCR Ki 4.37 CHEMBL
Potassium voltage-gated channel subfamily H member 2 Ion channel IC50 5.59 CHEMBL
Sodium channel alpha subunits; brain (Types I, II, III) Ion channel IC50 5.22 CHEMBL
Muscarinic acetylcholine receptor M5 GPCR Ki 6.59 WOMBAT-PK
Cytochrome P450 2D6 Enzyme Ki 4.93 WOMBAT-PK
Sodium-dependent noradrenaline transporter Transporter Kd 6.02 WOMBAT-PK
Sodium-dependent serotonin transporter Transporter Kd 5.42 SCIENTIFIC LITERATURE
Solute carrier family 22 member 2 Transporter IC50 4.68 WOMBAT-PK
Histamine H1 receptor GPCR IC50 9 CHEMBL

External reference:

IDSource
4019724 VUID
N0000147816 NUI
D00300 KEGG_DRUG
88637-37-0 SECONDARY_CAS_RN
4017866 VANDF
4019724 VANDF
4020653 VANDF
C0700899 UMLSCUI
CHEBI:4636 CHEBI
2PM PDB_CHEM_ID
CHEMBL657 ChEMBL_ID
CHEMBL1620 ChEMBL_ID
CHEMBL1201089 ChEMBL_ID
DB01075 DRUGBANK_ID
D004155 MESH_DESCRIPTOR_UI
3100 PUBCHEM_CID
1224 IUPHAR_LIGAND_ID
1774 INN_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 NIGHTTIME COLD AND CONGESTION HUMAN OTC DRUG LABEL 2 0031-2247 LIQUID 6.25 mg ORAL OTC monograph final 16 sections
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 FINULLL 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 headache pm HUMAN OTC DRUG LABEL 2 0113-0355 TABLET, FILM COATED 25 mg ORAL OTC monograph not 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 15 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