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

Stem definitionDrug idCAS RN
diphenylmethyl piperazine derivatives 1400 68-88-2

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • hydroxyzine pamoate
  • hydroxizine
  • hydroxyzin
  • hydroxyzyne
  • tranquizine
  • hydroxyzine
  • hydroxyzine hydrochloride
  • hydroxyzine dihydrochloride
  • hydroxyzine HCl
A histamine H1 receptor antagonist that is effective in the treatment of chronic urticaria, dermatitis, and histamine-mediated pruritus. Unlike its major metabolite CETIRIZINE, it does cause drowsiness. It is also effective as an antiemetic, for relief of anxiety and tension, and as a sedative.
  • Molecular weight: 374.91
  • Formula: C21H27ClN2O2
  • CLOGP: 4
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 1
  • TPSA: 35.94
  • ALOGS: -3.61
  • ROTB: 8

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
75 mg O
75 mg P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 700 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 0.10 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 15.24 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 80 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

DateAgencyCompanyOrphan
April 12, 1956 FDA PFIZER

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 1037.68 10.03 1041 71625 144632 63271724
Intentional overdose 423.79 10.03 472 72194 73680 63342676
Toxicity to various agents 400.41 10.03 877 71789 246373 63169983
Intentional self-injury 343.05 10.03 263 72403 25424 63390932
Pruritus 300.48 10.03 1002 71664 360451 63055905
Dermatitis atopic 280.44 10.03 161 72505 9563 63406793
Drug abuse 274.12 10.03 375 72291 72143 63344213
Urticaria 261.06 10.03 582 72084 165220 63251136
Synovitis 179.94 10.03 8 72658 186910 63229446
Contraindicated product administered 179.03 10.03 20 72646 217628 63198728
Pemphigus 176.41 10.03 8 72658 183718 63232638
Systemic lupus erythematosus 164.95 10.03 22 72644 208896 63207460
Cardio-respiratory arrest 160.57 10.03 264 72402 59695 63356661
Hand deformity 156.23 10.03 6 72660 159451 63256905
Joint swelling 155.72 10.03 91 72575 327575 63088781
Glossodynia 150.78 10.03 15 72651 178861 63237495
Poisoning deliberate 143.50 10.03 112 72554 11106 63405250
Rheumatoid arthritis 136.24 10.03 60 72606 253759 63162597
Pericarditis 136 10.03 3 72663 131576 63284780
Respiratory arrest 131.17 10.03 174 72492 32471 63383885
Arthropathy 128.39 10.03 54 72612 234738 63181618
Treatment failure 122.01 10.03 38 72628 199005 63217351
Poisoning 121.98 10.03 111 72555 13589 63402767
Suicide attempt 118.02 10.03 233 72433 60685 63355671
Drug dependence 111.71 10.03 139 72527 24344 63392012
Drug intolerance 110.73 10.03 114 72552 308547 63107809
Skin plaque 108.44 10.03 84 72582 8236 63408120
Anxiety 107.31 10.03 513 72153 217028 63199328
Cardiac arrest 107.23 10.03 289 72377 92256 63324100
Wound 104.00 10.03 29 72637 163234 63253122
Abdominal discomfort 98.54 10.03 134 72532 320751 63095605
Infusion related reaction 95.84 10.03 84 72582 245437 63170919
Scratch 91.54 10.03 69 72597 6496 63409860
Hepatic enzyme increased 88.07 10.03 62 72604 202266 63214090
Therapeutic product effect decreased 85.68 10.03 58 72608 193129 63223227
Suicidal ideation 83.72 10.03 206 72460 62215 63354141
Helicobacter infection 83.03 10.03 6 72660 92779 63323577
Eczema 80.84 10.03 138 72528 32153 63384203
Suspected suicide 80.61 10.03 64 72602 6504 63409852
Anticholinergic syndrome 78.34 10.03 43 72623 2339 63414017
Urticaria thermal 77.11 10.03 26 72640 413 63415943
Somnolence 74.46 10.03 402 72264 178283 63238073
Drug reaction with eosinophilia and systemic symptoms 71.13 10.03 134 72532 33702 63382654
Distributive shock 68.82 10.03 33 72633 1350 63415006
Coma 68.59 10.03 195 72471 64169 63352187
Maternal exposure during pregnancy 67.39 10.03 92 72574 219970 63196386
Overdose 66.86 10.03 285 72381 114793 63301563
Alopecia 66.13 10.03 184 72482 337352 63079004
Psoriasis 63.99 10.03 232 72434 86725 63329631
Bradypnoea 62.52 10.03 43 72623 3507 63412849
Lower respiratory tract infection 62.38 10.03 37 72629 132270 63284086
Burning mouth syndrome 62.04 10.03 23 72643 488 63415868
Irritability 59.89 10.03 120 72546 31574 63384782
Chemical submission 58.76 10.03 19 72647 263 63416093
Folliculitis 54.05 10.03 8 72658 70309 63346047
Electrocardiogram QT prolonged 53.64 10.03 170 72496 59360 63356996
Angioedema 52.75 10.03 147 72519 47818 63368538
Muscle injury 51.24 10.03 7 72659 65338 63351018
Impaired healing 50.75 10.03 27 72639 102515 63313841
Depression 49.23 10.03 389 72277 196103 63220253
Prescription form tampering 48.84 10.03 20 72646 558 63415798
General physical health deterioration 47.96 10.03 99 72567 201303 63215053
Musculoskeletal stiffness 46.32 10.03 88 72578 184530 63231826
Vasoplegia syndrome 45.98 10.03 27 72639 1672 63414684
Product dose omission issue 45.24 10.03 438 72228 233875 63182481
Decompression sickness 45.20 10.03 12 72654 78 63416278
Urinary retention 41.67 10.03 101 72565 30200 63386156
Rash maculo-papular 41.42 10.03 104 72562 31792 63384564
Chronic spontaneous urticaria 41.15 10.03 22 72644 1135 63415221
Sleep disorder 39.87 10.03 192 72474 81374 63334982
Alcoholism 39.24 10.03 25 72641 1793 63414563
Product use in unapproved indication 38.70 10.03 343 72323 178737 63237619
Multiple drug therapy 37.37 10.03 32 72634 3614 63412742
Agitation 36.24 10.03 150 72516 59607 63356749
Intentional product misuse 36.23 10.03 152 72514 60765 63355591
Drug screen positive 35.47 10.03 31 72635 3598 63412758
Irritable bowel syndrome 34.85 10.03 26 72640 82386 63333970
Insomnia 34.28 10.03 387 72279 214865 63201491
Victim of chemical submission 33.67 10.03 15 72651 517 63415839
Parkinsonism 33.53 10.03 50 72616 10389 63405967
Hallucination, gustatory 33.20 10.03 9 72657 64 63416292
Dry skin 33.10 10.03 141 72525 56746 63359610
Asphyxia 32.96 10.03 38 72628 6143 63410213
Mastocytosis 32.28 10.03 15 72651 571 63415785
Drug ineffective 32.25 10.03 931 71735 1043834 62372522
Infection 32.04 10.03 144 72522 229029 63187327
Allergy test positive 31.48 10.03 15 72651 605 63415751
Illness 31.22 10.03 125 72541 48934 63367422
Skin exfoliation 30.85 10.03 114 72552 42988 63373368
Serotonin syndrome 30.64 10.03 87 72579 28595 63387761
Swelling 30.15 10.03 188 72478 275190 63141166
Long QT syndrome 30.04 10.03 27 72639 3252 63413104
Cerebral disorder 29.65 10.03 31 72635 4495 63411861
Stomatitis 29.10 10.03 73 72593 138652 63277704
Papule 28.70 10.03 34 72632 5657 63410699
Mixed liver injury 28.49 10.03 31 72635 4704 63411652
Faecal vomiting 28.42 10.03 14 72652 608 63415748
Hereditary angioedema 28.37 10.03 39 72627 7523 63408833
Drug hypersensitivity 28.24 10.03 506 72160 310181 63106175
Peripheral circulatory failure 27.83 10.03 16 72650 952 63415404
Red blood cell sedimentation rate increased 27.64 10.03 8 72658 43974 63372382
Hip arthroplasty 27.58 10.03 10 72656 47636 63368720
Metabolic acidosis 27.22 10.03 113 72553 44956 63371400
Withdrawal syndrome 26.80 10.03 66 72600 19931 63396425
Linear IgA disease 26.56 10.03 18 72648 1433 63414923
Migraine 26.07 10.03 205 72461 103141 63313215
Administration site erythema 25.68 10.03 14 72652 751 63415605
Seizure 25.11 10.03 247 72419 132387 63283969
Initial insomnia 25.00 10.03 33 72633 6124 63410232
Off label use 24.97 10.03 585 72081 673877 62742479
Erythema 24.45 10.03 308 72358 175443 63240913
Blood cholesterol increased 24.30 10.03 44 72622 93988 63322368
Respiratory acidosis 24.25 10.03 34 72632 6681 63409675
Mental disorder 24.24 10.03 75 72591 25844 63390512
Panic attack 24.11 10.03 68 72598 22263 63394093
Hallucination, visual 24.09 10.03 62 72604 19236 63397120
Exposure during pregnancy 24.05 10.03 94 72572 155453 63260903
Pulmonary fibrosis 23.66 10.03 8 72658 39801 63376555
Interstitial lung disease 23.14 10.03 22 72644 61886 63354470
Total cholesterol/HDL ratio abnormal 23.11 10.03 7 72659 77 63416279
Diet failure 22.60 10.03 6 72660 39 63416317
Hypersensitivity 22.58 10.03 220 72446 292465 63123891
Neuroglycopenia 22.56 10.03 11 72655 467 63415889
Labile hypertension 22.39 10.03 11 72655 475 63415881
Perfume sensitivity 22.33 10.03 13 72653 792 63415564
Dementia 22.05 10.03 59 72607 18735 63397621
Miosis 21.89 10.03 34 72632 7319 63409037
Knee arthroplasty 21.78 10.03 18 72648 54188 63362168
Product use issue 21.40 10.03 156 72510 220364 63195992
Skin fissures 21.37 10.03 43 72623 11345 63405011
Osteoarthritis 20.92 10.03 49 72617 95294 63321062
Psychotic symptom 20.86 10.03 16 72650 1545 63414811
Inappropriate schedule of product administration 20.85 10.03 196 72470 103769 63312587
Asthma 20.58 10.03 230 72436 127331 63289025
Nodular rash 20.47 10.03 8 72658 197 63416159
Neutropenia 20.44 10.03 117 72549 174888 63241468
Stress 20.23 10.03 139 72527 67028 63349328
Depressed level of consciousness 20.22 10.03 131 72535 61947 63354409
Akathisia 20.19 10.03 37 72629 9109 63407247
Feeling abnormal 20.19 10.03 259 72407 148133 63268223
Pancreatitis 20.14 10.03 110 72556 48945 63367411
Plasma cell myeloma 20.01 10.03 8 72658 35897 63380459
Injection site reaction 19.99 10.03 125 72541 58399 63357957
Lymphomatoid papulosis 19.85 10.03 7 72659 128 63416228
C-reactive protein increased 19.73 10.03 50 72616 94657 63321699
Binge eating 19.53 10.03 10 72656 472 63415884
Mast cell activation syndrome 19.45 10.03 12 72654 813 63415543
Injection site mass 19.36 10.03 56 72610 18600 63397756
Skin lesion 19.32 10.03 78 72588 30643 63385713
Toxic skin eruption 18.85 10.03 44 72622 12841 63403515
Dermatitis 18.66 10.03 52 72614 16906 63399450
Gastrointestinal disorder 18.61 10.03 82 72584 131157 63285199
Tremor 18.49 10.03 232 72434 132007 63284349
Substance abuse 18.35 10.03 25 72641 4782 63411574
Altered state of consciousness 18.28 10.03 67 72599 25163 63391193
Temperature intolerance 18.21 10.03 35 72631 8929 63407427
Sensitivity to weather change 18.20 10.03 31 72635 7206 63409150
Cold agglutinins positive 18.15 10.03 5 72661 38 63416318
Atrioventricular block first degree 18.09 10.03 31 72635 7242 63409114
Dermatitis exfoliative generalised 17.98 10.03 22 72644 3785 63412571
Blood cholesterol decreased 17.97 10.03 12 72654 932 63415424
Enuresis 17.53 10.03 18 72648 2555 63413801
Photosensitivity reaction 17.52 10.03 47 72619 14947 63401409
Anaemia 17.37 10.03 234 72432 293196 63123160
Pleural effusion 17.34 10.03 52 72614 93158 63323198
Disturbance in attention 17.30 10.03 88 72578 38101 63378255
Emotional distress 16.90 10.03 78 72588 32471 63383885
Intentional product use issue 16.89 10.03 82 72584 127810 63288546
Loss of personal independence in daily activities 16.88 10.03 56 72610 97234 63319122
Joint ankylosis 16.86 10.03 12 72654 1034 63415322
Liver injury 16.84 10.03 27 72639 60493 63355863
Talipes 16.78 10.03 14 72652 1526 63414830
Postural orthostatic tachycardia syndrome 16.77 10.03 13 72653 1276 63415080
Antidepressant discontinuation syndrome 16.76 10.03 5 72661 52 63416304
Therapeutic response shortened 16.75 10.03 40 72626 11848 63404508
Burnout syndrome 16.71 10.03 7 72659 207 63416149
Aggression 16.69 10.03 62 72604 23436 63392920
Drug interaction 16.69 10.03 361 72305 228770 63187586
Post-traumatic stress disorder 16.65 10.03 25 72641 5226 63411130
Pneumonia 16.63 10.03 397 72269 456370 62959986
Disease progression 16.63 10.03 78 72588 122680 63293676
Therapeutic product effect incomplete 16.62 10.03 80 72586 124976 63291380
Bursitis 16.56 10.03 11 72655 37030 63379326
Skin haemorrhage 16.47 10.03 36 72630 10058 63406298
Pneumonitis 16.38 10.03 10 72656 35212 63381144
Areflexia 16.34 10.03 19 72647 3099 63413257
Skin discolouration 16.33 10.03 86 72580 37742 63378614
Decreased eye contact 16.31 10.03 8 72658 344 63416012
Hyperleukocytosis 16.23 10.03 10 72656 676 63415680
Blood immunoglobulin E increased 16.20 10.03 21 72645 3828 63412528
Derailment 16.11 10.03 5 72661 60 63416296
Discomfort 15.95 10.03 119 72547 167255 63249101
Malignant neoplasm progression 15.86 10.03 45 72621 82076 63334280
Psoriatic arthropathy 15.66 10.03 53 72613 91467 63324889
Cholestasis 15.63 10.03 71 72595 29363 63386993
Myelosuppression 15.48 10.03 4 72662 23699 63392657
Encephalopathy 15.45 10.03 86 72580 38534 63377822
Fatigue 15.17 10.03 847 71819 887181 62529175
Thrombocytopenia 15.11 10.03 106 72560 151051 63265305
Dependence 15.01 10.03 15 72651 2062 63414294
Bipolar disorder 14.87 10.03 30 72636 7930 63408426
Neuroblastoma recurrent 14.80 10.03 5 72661 80 63416276
Drug withdrawal syndrome 14.74 10.03 66 72600 27128 63389228
Wound secretion 14.68 10.03 22 72644 4592 63411764
Tardive dyskinesia 14.65 10.03 31 72635 8471 63407885
Arthralgia 14.50 10.03 520 72146 569190 62847166
Bruxism 14.48 10.03 19 72647 3506 63412850
Macular degeneration 14.31 10.03 5 72661 24371 63391985
Blood pressure decreased 14.26 10.03 125 72541 64897 63351459
Ill-defined disorder 14.22 10.03 47 72619 81708 63334648
Wrong technique in device usage process 14.17 10.03 19 72647 3579 63412777
Musculoskeletal pain 14.10 10.03 56 72610 92221 63324135
Labelled drug-drug interaction issue 14.09 10.03 11 72655 1090 63415266
Bradykinesia 14.09 10.03 23 72643 5165 63411191
Ehlers-Danlos syndrome 14.06 10.03 6 72660 186 63416170
Superior mesenteric artery syndrome 14.05 10.03 5 72661 94 63416262
Urticaria chronic 13.99 10.03 9 72657 656 63415700
Sedation 13.95 10.03 84 72582 38725 63377631
Eye pruritus 13.88 10.03 50 72616 18621 63397735
Obsessive-compulsive disorder 13.84 10.03 20 72646 4040 63412316
Accidental overdose 13.73 10.03 58 72608 23251 63393105
Rash pruritic 13.66 10.03 116 72550 59683 63356673
Lip erythema 13.55 10.03 6 72660 204 63416152
Mydriasis 13.49 10.03 37 72629 11919 63404437
Blister 13.49 10.03 90 72576 129724 63286632
Thymoma 13.46 10.03 6 72660 207 63416149
Gastric polyps 13.44 10.03 18 72648 3387 63412969
Anaphylactic reaction 13.44 10.03 125 72541 65975 63350381
Panic reaction 13.42 10.03 20 72646 4154 63412202
Product dose omission in error 13.40 10.03 28 72638 7584 63408772
Apallic syndrome 13.33 10.03 9 72657 712 63415644
Alpha 1 globulin increased 13.32 10.03 5 72661 110 63416246
Pigmentation disorder 13.19 10.03 21 72645 4618 63411738
Atrial fibrillation 13.07 10.03 79 72587 116557 63299799
Human herpesvirus 6 infection reactivation 12.99 10.03 7 72659 367 63415989
Restless arm syndrome 12.97 10.03 4 72662 47 63416309
Eyelid haemangioma 12.93 10.03 3 72663 10 63416346
Transverse sinus thrombosis 12.86 10.03 8 72658 550 63415806
Tonsillar hypertrophy 12.81 10.03 10 72656 991 63415365
Dysuria 12.76 10.03 74 72592 33664 63382692
Skin infection 12.74 10.03 42 72624 14960 63401396
Granulomatous liver disease 12.71 10.03 9 72657 769 63415587
Psychiatric symptom 12.65 10.03 22 72644 5201 63411155
Superior sagittal sinus thrombosis 12.58 10.03 9 72657 782 63415574
Gastrointestinal haemorrhage 12.57 10.03 49 72617 81127 63335229
Osteonecrosis of jaw 12.53 10.03 13 72653 35110 63381246
Exposure via ingestion 12.45 10.03 16 72650 2893 63413463
Breast adenoma 12.39 10.03 4 72662 55 63416301
Adverse event 12.34 10.03 38 72628 67521 63348835
Live birth 12.31 10.03 7 72659 25623 63390733
Alpha 2 globulin increased 12.29 10.03 5 72661 137 63416219
Resting tremor 12.26 10.03 9 72657 814 63415542
Haemoglobin decreased 12.22 10.03 107 72559 145378 63270978
Hallucination, olfactory 12.21 10.03 6 72660 259 63416097
Crying 12.17 10.03 56 72610 23287 63393069
Therapy interrupted 12.15 10.03 71 72595 32384 63383972
Mucosal inflammation 12.08 10.03 22 72644 46906 63369450
Social anxiety disorder 12.06 10.03 7 72659 424 63415932
Incorrect dose administered 11.99 10.03 113 72553 59855 63356501
Skin swelling 11.73 10.03 17 72649 3442 63412914
Ventricular fibrillation 11.72 10.03 35 72631 11832 63404524
Micrognathia 11.66 10.03 6 72660 286 63416070
Hyperglycaemia 11.65 10.03 85 72581 41782 63374574
Fat necrosis 11.64 10.03 8 72658 652 63415704
COVID-19 11.63 10.03 188 72478 112915 63303441
Foot deformity 11.50 10.03 9 72657 27844 63388512
Nightmare 11.49 10.03 48 72618 19146 63397210
Lip oedema 11.48 10.03 18 72648 3906 63412450
Herpes zoster meningoencephalitis 11.43 10.03 6 72660 298 63416058
Eosinophilia 11.43 10.03 54 72612 22702 63393654
Mechanical urticaria 11.42 10.03 7 72659 469 63415887
Mood altered 11.40 10.03 40 72626 14703 63401653
Tension 11.35 10.03 16 72650 3159 63413197
Orbital oedema 11.34 10.03 6 72660 303 63416053
Negative thoughts 11.30 10.03 9 72657 918 63415438
Neuroblastoma 11.30 10.03 4 72662 74 63416282
Bronchial wall thickening 11.16 10.03 11 72655 1488 63414868
Ear swelling 11.14 10.03 11 72655 1490 63414866
Affect lability 11.12 10.03 33 72633 11118 63405238
Retrograde amnesia 11.10 10.03 7 72659 493 63415863
Micturition disorder 10.92 10.03 14 72652 2524 63413832
Type 2 diabetes mellitus 10.92 10.03 37 72629 63831 63352525
Staphylococcal skin infection 10.90 10.03 9 72657 966 63415390
Vascular stent thrombosis 10.89 10.03 9 72657 968 63415388
Caesarean section 10.88 10.03 3 72663 17029 63399327
Nasal congestion 10.86 10.03 119 72547 65541 63350815
Gastrointestinal ischaemia 10.84 10.03 5 72661 187 63416169
Hypotonia 10.74 10.03 29 72637 9256 63407100
Compulsive shopping 10.63 10.03 8 72658 751 63415605
Injection site pain 10.59 10.03 208 72458 129592 63286764
Tachycardia 10.55 10.03 192 72474 117964 63298392
White blood cell count decreased 10.52 10.03 105 72561 138999 63277357
Somnambulism 10.48 10.03 21 72645 5522 63410834
Oropharyngeal pain 10.45 10.03 159 72507 94328 63322028
Dysmorphism 10.41 10.03 13 72653 2283 63414073
Breath odour 10.41 10.03 10 72656 1310 63415046
Muscle spasticity 10.40 10.03 6 72660 21788 63394568
Lip swelling 10.39 10.03 66 72600 30997 63385359
Renal impairment 10.35 10.03 59 72607 88296 63328060
Bacterial disease carrier 10.34 10.03 10 72656 1321 63415035
Peripheral swelling 10.26 10.03 229 72437 265713 63150643
Hypercreatininaemia 10.25 10.03 7 72659 564 63415792
Vasculitis 10.24 10.03 4 72662 18205 63398151
Neurodermatitis 10.18 10.03 10 72656 1346 63415010
Activation syndrome 10.15 10.03 5 72661 217 63416139
Dyspnoea 10.14 10.03 637 72029 660676 62755680
Hair colour changes 10.07 10.03 15 72651 3112 63413244
Acidosis 10.04 10.03 32 72634 11201 63405155
Osteonecrosis 10.04 10.03 8 72658 24522 63391834

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 648.14 10.99 631 34143 97537 34824620
Toxicity to various agents 398.94 10.99 713 34061 199649 34722508
Drug abuse 260.14 10.99 400 34374 98696 34823461
Dermatitis atopic 201.78 10.99 101 34673 5246 34916911
Pruritus 126.39 10.99 368 34406 141613 34780544
Intentional overdose 105.61 10.99 170 34604 43504 34878653
Respiratory arrest 92.02 10.99 126 34648 27917 34894240
Coma 88.30 10.99 161 34613 45517 34876640
Poisoning 86.72 10.99 82 34692 12144 34910013
Cardio-respiratory arrest 86.31 10.99 178 34596 55095 34867062
Urticaria 64.57 10.99 171 34603 62206 34859951
Drug reaction with eosinophilia and systemic symptoms 62.07 10.99 115 34659 32897 34889260
Suicidal behaviour 58.60 10.99 29 34745 1468 34920689
Cardiac arrest 58.28 10.99 219 34555 95940 34826217
Intentional self-injury 57.93 10.99 70 34704 13701 34908456
Overdose 55.69 10.99 208 34566 90851 34831306
Priapism 52.64 10.99 42 34732 4952 34917205
Suspected suicide 52.35 10.99 41 34733 4707 34917450
Ventricular tachyarrhythmia 48.35 10.99 17 34757 357 34921800
Parasomnia 47.07 10.99 17 34757 387 34921770
General physical health deterioration 43.68 10.99 38 34736 128231 34793926
Toxic epidermal necrolysis 41.42 10.99 76 34698 21570 34900587
Sleep disorder 40.28 10.99 94 34680 31594 34890563
Hyperthermia 40.04 10.99 51 34723 10526 34911631
Bradypnoea 39.15 10.99 28 34746 2801 34919356
Dry skin 37.81 10.99 91 34683 31196 34890961
Ureteric compression 37.24 10.99 13 34761 267 34921890
Anticholinergic syndrome 36.52 10.99 20 34754 1249 34920908
Psoriasis 34.79 10.99 101 34673 38711 34883446
Chemical submission 33.89 10.99 8 34766 35 34922122
Alcoholism 33.55 10.99 26 34748 2939 34919218
Electrocardiogram QT prolonged 32.41 10.99 102 34672 40850 34881307
Somnolence 30.45 10.99 202 34572 110914 34811243
Rash 29.55 10.99 345 34429 222407 34699750
Personal relationship issue 28.91 10.99 11 34763 291 34921866
Exposure via ingestion 28.84 10.99 21 34753 2160 34919997
Suicidal ideation 28.72 10.99 97 34677 40291 34881866
Fixed eruption 28.66 10.99 19 34755 1681 34920476
Autism spectrum disorder 27.88 10.99 21 34753 2275 34919882
Drug dependence 27.73 10.99 69 34705 24148 34898009
Serotonin syndrome 27.40 10.99 61 34713 19872 34902285
Troponin T increased 27.28 10.99 21 34753 2350 34919807
Eczema 27.14 10.99 58 34716 18378 34903779
Disease progression 27.05 10.99 41 34733 108036 34814121
Abnormal sleep-related event 27.00 10.99 12 34762 475 34921682
Hypothermia 26.17 10.99 42 34732 10706 34911451
Skin exfoliation 26.15 10.99 73 34701 27359 34894798
Diarrhoea 25.76 10.99 256 34518 389656 34532501
Agitation 25.54 10.99 119 34655 57280 34864877
Face oedema 25.35 10.99 43 34731 11473 34910684
Mental disorder 24.92 10.99 50 34724 15159 34906998
Sensory integrative dysfunction 23.85 10.99 6 34768 36 34922121
Non-cardiogenic pulmonary oedema 23.51 10.99 12 34762 649 34921508
Emotional disorder of childhood 23.43 10.99 6 34768 39 34922118
Miosis 22.86 10.99 37 34737 9498 34912659
Clonus 22.53 10.99 20 34754 2730 34919427
Pyelocaliectasis 22.44 10.99 14 34760 1116 34921041
Electrocardiogram QRS complex prolonged 22.43 10.99 26 34748 4868 34917289
Disturbance in attention 21.80 10.99 66 34708 25879 34896278
Postmortem blood drug level 21.71 10.99 8 34766 193 34921964
Myocardial infarction 21.62 10.99 56 34718 121029 34801128
Acute generalised exanthematous pustulosis 21.54 10.99 30 34744 6746 34915411
Injection site reaction 21.53 10.99 43 34731 12990 34909167
Dermatitis exfoliative generalised 20.99 10.99 22 34752 3685 34918472
Tachyphrenia 20.95 10.99 14 34760 1255 34920902
Pneumonia 20.75 10.99 246 34528 362381 34559776
Haematoma muscle 20.00 10.99 14 34760 1354 34920803
Injection 19.62 10.99 4 34770 7 34922150
Poisoning deliberate 19.58 10.99 31 34743 7813 34914344
Mumps 19.52 10.99 6 34768 81 34922076
Skin fissures 19.34 10.99 25 34749 5234 34916923
Stereotypy 19.24 10.99 11 34763 747 34921410
Anaemia 19.00 10.99 145 34629 233190 34688967
Phlebotomy 18.76 10.99 6 34768 93 34922064
Distributive shock 18.72 10.99 13 34761 1241 34920916
Febrile bone marrow aplasia 18.53 10.99 31 34743 8178 34913979
Depressed level of consciousness 18.45 10.99 88 34686 42753 34879404
Echolalia 18.41 10.99 8 34766 300 34921857
False positive investigation result 18.36 10.99 9 34765 446 34921711
Drug withdrawal syndrome 18.14 10.99 52 34722 19782 34902375
Altered state of consciousness 18.09 10.99 57 34717 22836 34899321
Panic attack 17.89 10.99 33 34741 9399 34912758
Injection site mass 17.67 10.99 27 34747 6599 34915558
Conjunctivitis 17.22 10.99 33 34741 9672 34912485
Cardiac pacemaker evaluation 17.15 10.99 6 34768 124 34922033
Eosinophilia 16.92 10.99 61 34713 26161 34895996
Anxiety 16.90 10.99 162 34612 99266 34822891
Bladder dilatation 16.70 10.99 13 34761 1479 34920678
Discomfort 16.69 10.99 49 34725 18889 34903268
Agoraphobia 16.56 10.99 7 34767 245 34921912
Drug screen positive 16.51 10.99 20 34754 3923 34918234
Tachycardia 16.37 10.99 142 34632 84630 34837527
Respiratory depression 16.24 10.99 44 34730 16201 34905956
Cerebrovascular accident 16.09 10.99 38 34736 84773 34837384
Rheumatoid arthritis 16.08 10.99 9 34765 38229 34883928
Diarrhoea infectious 16.06 10.99 9 34765 588 34921569
Rash erythematous 16.03 10.99 58 34716 24919 34897238
Dissociation 15.49 10.99 13 34761 1645 34920512
Analgesic drug level increased 15.49 10.99 10 34764 846 34921311
Hypercapnic coma 15.35 10.99 6 34768 171 34921986
Dissociative disorder 15.20 10.99 8 34766 461 34921696
N-terminal prohormone brain natriuretic peptide increased 15.17 10.99 16 34758 2699 34919458
Intentional product misuse 15.04 10.99 87 34687 45524 34876633
Benzodiazepine drug level increased 14.79 10.99 4 34770 33 34922124
Atrial fibrillation 14.78 10.99 67 34707 122326 34799831
Acute respiratory distress syndrome 14.76 10.99 58 34716 25911 34896246
Administration related reaction 14.54 10.99 5 34769 98 34922059
Cardiac failure congestive 14.48 10.99 39 34735 83231 34838926
Infective pulmonary exacerbation of cystic fibrosis 14.45 10.99 25 34749 6776 34915381
Tremor 14.25 10.99 135 34639 82452 34839705
Cardiac failure 14.23 10.99 45 34729 91203 34830954
Thyroiditis acute 14.09 10.99 5 34769 108 34922049
C-reactive protein increased 14.04 10.99 20 34754 54078 34868079
Victim of crime 13.76 10.99 7 34767 376 34921781
Prothrombin time ratio decreased 13.66 10.99 7 34767 382 34921775
Aplastic anaemia 13.65 10.99 30 34744 9686 34912471
Victim of homicide 13.40 10.99 5 34769 125 34922032
Rash maculo-papular 13.40 10.99 60 34714 28391 34893766
Thrombocytopenia 13.22 10.99 96 34678 156151 34766006
Throat tightness 13.12 10.99 27 34747 8331 34913826
Neonatal respiratory distress 13.12 10.99 8 34766 612 34921545
Renal impairment 13.12 10.99 49 34725 94464 34827693
Neurodevelopmental disorder 12.89 10.99 7 34767 430 34921727
Meningioma 12.88 10.99 11 34763 1425 34920732
Faecal vomiting 12.81 10.99 7 34767 435 34921722
Generalised oedema 12.80 10.99 34 34740 12374 34909783
Mixed dementia 12.74 10.99 6 34768 272 34921885
Psychotic disorder 12.61 10.99 53 34721 24399 34897758
Neuroblastoma recurrent 12.46 10.99 5 34769 153 34922004
Arthritis allergic 12.38 10.99 3 34771 15 34922142
Speech disorder developmental 12.35 10.99 13 34761 2187 34919970
Pupillary reflex impaired 12.35 10.99 11 34763 1508 34920649
Haematoma 12.34 10.99 5 34769 25600 34896557
Neuropathy peripheral 12.33 10.99 42 34732 83221 34838936
Neurosis 12.31 10.99 5 34769 158 34921999
Hyponatraemia 12.05 10.99 42 34732 82649 34839508
Insomnia 12.03 10.99 157 34617 103750 34818407
Engraftment syndrome 11.84 10.99 9 34765 988 34921169
Drug screen false positive 11.83 10.99 8 34766 731 34921426
Cell death 11.61 10.99 13 34761 2344 34919813
Cardiogenic shock 11.58 10.99 6 34768 26612 34895545
Pharyngeal dyskinesia 11.40 10.99 3 34771 22 34922135
Allergy to chemicals 11.29 10.99 4 34770 86 34922071
Dyspnoea exertional 11.23 10.99 16 34758 43263 34878894
Neuroblastoma 11.23 10.99 5 34769 199 34921958
Lower respiratory tract infection 11.21 10.99 9 34765 31628 34890529
Skin plaque 11.19 10.99 18 34756 4596 34917561
Reduced facial expression 11.13 10.99 9 34765 1082 34921075
Acute myocardial infarction 11.06 10.99 23 34751 53696 34868461

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Completed suicide 1624.90 9.99 1673 88122 244094 79410499
Toxicity to various agents 783.43 9.99 1565 88230 419975 79234618
Drug abuse 459.93 9.99 727 89068 161964 79492629
Intentional overdose 430.92 9.99 563 89232 105397 79549196
Pruritus 311.51 9.99 1064 88731 393584 79261009
Urticaria 307.75 9.99 658 89137 184543 79470050
Dermatitis atopic 304.70 9.99 171 89624 9885 79644708
Intentional self-injury 269.69 9.99 251 89544 32168 79622425
Cardio-respiratory arrest 231.24 9.99 428 89367 108082 79546511
Respiratory arrest 215.69 9.99 294 89501 57256 79597337
Poisoning 212.77 9.99 197 89598 25075 79629518
Cardiac arrest 151.44 9.99 482 89313 171614 79482979
Poisoning deliberate 149.34 9.99 142 89653 18686 79635907
Coma 144.95 9.99 338 89457 100311 79554282
Synovitis 140.56 9.99 7 89788 150727 79503866
Suspected suicide 124.74 9.99 100 89695 10476 79644117
Drug reaction with eosinophilia and systemic symptoms 121.52 9.99 241 89554 64003 79590590
Joint swelling 118.48 9.99 91 89704 288555 79366038
Anticholinergic syndrome 113.73 9.99 63 89732 3548 79651045
Suicide attempt 113.42 9.99 273 89522 82659 79571934
Skin plaque 104.75 9.99 91 89704 10654 79643939
Rheumatoid arthritis 104.55 9.99 52 89743 208418 79446175
Contraindicated product administered 99.69 9.99 27 89768 157511 79497082
Overdose 98.61 9.99 440 89355 183766 79470827
Bradypnoea 97.57 9.99 69 89726 5983 79648610
Somnolence 97.35 9.99 528 89267 238453 79416140
Drug dependence 95.94 9.99 168 89627 40601 79613992
Pericarditis 93.60 9.99 6 89789 104230 79550363
Hand deformity 93.26 9.99 6 89789 103913 79550680
Chemical submission 88.53 9.99 27 89768 310 79654283
Arthropathy 86.09 9.99 46 89749 177065 79477528
Distributive shock 82.23 9.99 46 89749 2641 79651952
Pemphigus 80.49 9.99 9 89786 99573 79555020
Urticaria thermal 77.18 9.99 26 89769 419 79654174
Eczema 77.03 9.99 153 89642 40665 79613928
Anxiety 76.84 9.99 511 89284 248001 79406592
General physical health deterioration 76.27 9.99 120 89675 275118 79379475
Systemic lupus erythematosus 76.20 9.99 21 89774 121128 79533465
Glossodynia 74.93 9.99 13 89782 103324 79551269
Scratch 71.95 9.99 66 89729 8297 79646296
Treatment failure 70.87 9.99 53 89742 170433 79484160
Drug intolerance 70.51 9.99 118 89677 264001 79390592
Serotonin syndrome 63.46 9.99 150 89645 44877 79609716
Lower respiratory tract infection 60.70 9.99 35 89760 129185 79525408
Burning mouth syndrome 60.64 9.99 23 89772 530 79654063
Electrocardiogram QT prolonged 58.57 9.99 229 89566 90157 79564436
Therapeutic product effect decreased 57.20 9.99 60 89735 163803 79490790
Helicobacter infection 57.09 9.99 6 89789 69698 79584895
Infusion related reaction 55.94 9.99 109 89686 230128 79424465
Hepatic enzyme increased 55.08 9.99 75 89720 182535 79472058
Suicidal ideation 54.92 9.99 200 89595 76140 79578453
Wound 52.42 9.99 33 89762 116146 79538447
Alcoholism 52.18 9.99 39 89756 3684 79650909
Agitation 50.19 9.99 234 89561 99481 79555112
Rash maculo-papular 50.11 9.99 158 89637 55920 79598673
Suicidal behaviour 50.00 9.99 36 89759 3211 79651382
Intentional product misuse 49.14 9.99 225 89570 94940 79559653
Abdominal discomfort 48.59 9.99 134 89661 250593 79404000
Priapism 47.68 9.99 40 89755 4465 79650128
Dry skin 46.28 9.99 175 89620 67820 79586773
Decompression sickness 44.88 9.99 12 89783 82 79654511
Vasoplegia syndrome 44.25 9.99 35 89760 3595 79650998
Chronic spontaneous urticaria 43.12 9.99 23 89772 1201 79653392
Psoriasis 42.73 9.99 207 89588 89380 79565213
Anaemia 41 9.99 313 89482 444702 79209891
Drug hypersensitivity 40.37 9.99 514 89281 298402 79356191
Parasomnia 39.61 9.99 17 89778 544 79654049
Faecal vomiting 39.26 9.99 21 89774 1103 79653490
Cerebral disorder 38.74 9.99 39 89756 5499 79649094
Multiple drug therapy 38.67 9.99 34 89761 4044 79650549
Miosis 38.36 9.99 66 89729 15723 79638870
Musculoskeletal stiffness 38.19 9.99 88 89707 174920 79479673
Disturbance in attention 38.16 9.99 135 89660 50666 79603927
Exposure via ingestion 37.23 9.99 37 89758 5137 79649456
Insomnia 36.75 9.99 430 89365 244740 79409853
Impaired healing 36.73 9.99 27 89768 87628 79566965
Urinary retention 36.29 9.99 143 89652 56487 79598106
Irritability 35.91 9.99 115 89680 41029 79613564
Injection site reaction 35.64 9.99 139 89656 54646 79599947
Administration site erythema 35.59 9.99 14 89781 357 79654236
Ureteric compression 35.53 9.99 13 89782 270 79654323
Muscle injury 35.44 9.99 6 89789 48555 79606038
Dermatitis exfoliative generalised 35.01 9.99 42 89753 7199 79647394
Product dose omission issue 34.84 9.99 429 89366 247108 79407485
Maternal exposure during pregnancy 34.59 9.99 63 89732 136475 79518118
Skin exfoliation 34.39 9.99 138 89657 54962 79599631
Angioedema 34.35 9.99 173 89622 75862 79578731
Disease progression 33.89 9.99 101 89694 184261 79470332
Asphyxia 33.89 9.99 53 89742 11667 79642926
Pneumonia 33.67 9.99 532 89263 659714 78994879
Panic attack 33.39 9.99 80 89715 24136 79630457
Altered state of consciousness 33.38 9.99 117 89678 43705 79610888
Hallucination, gustatory 33.22 9.99 9 89786 65 79654528
Hyperthermia 32.11 9.99 66 89729 17971 79636622
Drug withdrawal syndrome 32.10 9.99 99 89696 34619 79619974
Depression 31.50 9.99 378 89417 216412 79438181
Electrocardiogram QRS complex prolonged 31.34 9.99 49 89746 10784 79643809
Peripheral circulatory failure 30.73 9.99 18 89777 1128 79653465
Drug screen positive 30.69 9.99 36 89759 6027 79648566
Mastocytosis 30.47 9.99 14 89781 528 79654065
Diarrhoea 29.98 9.99 759 89036 879730 78774863
Allergy test positive 29.42 9.99 15 89780 713 79653880
Exposure during pregnancy 29.03 9.99 43 89752 101089 79553504
C-reactive protein increased 28.86 9.99 64 89731 128963 79525630
Depressed level of consciousness 28.77 9.99 197 89598 96455 79558138
Fixed eruption 28.75 9.99 25 89770 2929 79651664
Pyelocaliectasis 28.62 9.99 16 89779 917 79653676
Injection site mass 28.17 9.99 67 89728 20117 79634476
Alopecia 27.78 9.99 150 89645 231205 79423388
Neuroblastoma recurrent 27.45 9.99 10 89785 205 79654388
Myelosuppression 27.24 9.99 6 89789 40290 79614303
Renal impairment 27.19 9.99 89 89706 157694 79496899
Victim of chemical submission 27.10 9.99 13 89782 541 79654052
Pulmonary fibrosis 27.07 9.99 8 89787 44104 79610489
Red blood cell sedimentation rate increased 27.00 9.99 9 89786 45933 79608660
Sleep disorder 26.93 9.99 177 89618 85500 79569093
Mental disorder 26.87 9.99 87 89708 31215 79623378
Infection 26.71 9.99 161 89634 241551 79413042
Irritable bowel syndrome 26.30 9.99 19 89776 62222 79592371
Eosinophilia 26.28 9.99 111 89684 45234 79609359
Skin fissures 25.87 9.99 50 89745 13023 79641570
Thrombocytopenia 25.62 9.99 184 89611 265075 79389518
Neutropenia 24.78 9.99 206 89589 287504 79367089
Folliculitis 24.61 9.99 16 89779 55364 79599229
Atrial fibrillation 24.48 9.99 127 89668 197759 79456834
Personal relationship issue 24.42 9.99 9 89786 191 79654402
Long QT syndrome 23.17 9.99 31 89764 5924 79648669
Off label use 23.15 9.99 813 88982 906402 78748191
Total cholesterol/HDL ratio abnormal 23.14 9.99 7 89788 78 79654515
Tachyphrenia 23.12 9.99 19 89776 2061 79652532
Respiratory depression 23.00 9.99 76 89719 27554 79627039
Tremor 22.73 9.99 292 89503 169791 79484802
Diet failure 22.70 9.99 6 89789 39 79654554
Psychotic symptom 22.65 9.99 21 89774 2676 79651917
Neuroglycopenia 22.60 9.99 11 89784 473 79654120
Neuroblastoma 22.47 9.99 9 89786 241 79654352
Initial insomnia 22.36 9.99 33 89762 6905 79647688
Therapeutic product effect incomplete 22.32 9.99 83 89712 141562 79513031
Erythema 22.18 9.99 364 89431 222926 79431667
Intentional product use issue 22.14 9.99 92 89703 152020 79502573
Arthritis allergic 22.04 9.99 5 89790 15 79654578
Haemoglobin decreased 21.97 9.99 153 89642 221966 79432627
Product use in unapproved indication 21.94 9.99 400 89395 249959 79404634
Pleural effusion 21.68 9.99 87 89708 145175 79509418
Perfume sensitivity 21.47 9.99 13 89782 866 79653727
Labile hypertension 21.29 9.99 11 89784 538 79654055
Toxic epidermal necrolysis 21.24 9.99 103 89692 44478 79610115
Feeling abnormal 21.14 9.99 273 89522 158926 79495667
Neuropathy peripheral 20.85 9.99 85 89710 141220 79513373
Papule 20.73 9.99 33 89762 7374 79647219
Withdrawal syndrome 20.71 9.99 72 89723 26782 79627811
Osteoarthritis 20.61 9.99 42 89753 87267 79567326
Drug resistance 20.44 9.99 11 89784 42202 79612391
Acute respiratory distress syndrome 20.42 9.99 101 89694 43966 79610627
Plasma cell myeloma 20.32 9.99 18 89777 53241 79601352
Urticaria chronic 20.26 9.99 11 89784 595 79653998
Sensitivity to weather change 20.03 9.99 34 89761 8013 79646580
Post-traumatic stress disorder 19.90 9.99 26 89769 4855 79649738
Gastrointestinal haemorrhage 19.88 9.99 92 89703 147627 79506966
Face oedema 19.63 9.99 73 89722 28063 79626530
Victim of crime 19.56 9.99 10 89785 478 79654115
Drug ineffective 19.34 9.99 1008 88787 1079905 78574688
Tachycardia 19.24 9.99 294 89501 177474 79477119
Cerebral infarction 19.22 9.99 14 89781 45662 79608931
Binge eating 19.17 9.99 10 89785 499 79654094
Blood cholesterol increased 19.15 9.99 41 89754 83679 79570914
Hallucination, visual 18.87 9.99 80 89715 32649 79621944
Mixed liver injury 18.83 9.99 32 89763 7546 79647047
Accidental overdose 18.54 9.99 91 89704 39490 79615103
Knee arthroplasty 18.54 9.99 13 89782 43235 79611358
Seizure 18.44 9.99 307 89488 188527 79466066
Cardiac failure congestive 18.40 9.99 90 89705 142312 79512281
Prothrombin time ratio decreased 18.37 9.99 12 89783 913 79653680
Toxic skin eruption 18.27 9.99 61 89734 22232 79632361
Injection 18.16 9.99 4 89791 10 79654583
Tardive dyskinesia 18.02 9.99 38 89757 10533 79644060
Febrile bone marrow aplasia 17.93 9.99 43 89752 12977 79641616
Hip arthroplasty 17.78 9.99 9 89786 35747 79618846
Illness 17.72 9.99 101 89694 46410 79608183
Respiratory acidosis 17.64 9.99 39 89756 11161 79643432
Myocardial infarction 17.64 9.99 128 89667 184001 79470592
Phlebotomy 17.62 9.99 6 89789 100 79654493
Hyperleukocytosis 17.56 9.99 18 89777 2592 79652001
Sedation 17.40 9.99 109 89686 51786 79602807
Skin lesion 17.37 9.99 93 89702 41751 79612842
Dementia 17.22 9.99 64 89731 24595 79629998
Nodular rash 17.14 9.99 8 89787 313 79654280
Cold agglutinins positive 17.11 9.99 5 89790 49 79654544
Parkinsonism 16.95 9.99 49 89746 16535 79638058
Blood creatinine increased 16.75 9.99 104 89691 154953 79499640
Temperature intolerance 16.67 9.99 35 89760 9670 79644923
Postmortem blood drug level 16.52 9.99 8 89787 340 79654253
False positive investigation result 16.37 9.99 12 89783 1100 79653493
Abnormal sleep-related event 16.37 9.99 11 89784 878 79653715
Troponin T increased 16.33 9.99 20 89775 3502 79651091
Injection site pain 16.13 9.99 220 89575 129618 79524975
Cardiac pacemaker evaluation 16.12 9.99 6 89789 131 79654462
Haematochezia 16.11 9.99 48 89747 87597 79566996
Mydriasis 16.02 9.99 50 89745 17593 79637000
Autism spectrum disorder 15.99 9.99 12 89783 1140 79653453
Haemorrhage 15.97 9.99 51 89744 91067 79563526
Dyspnoea 15.92 9.99 796 88999 856229 78798364
International normalised ratio increased 15.86 9.99 46 89749 84675 79569918
Malignant neoplasm progression 15.86 9.99 89 89706 135901 79518692
Photosensitivity reaction 15.74 9.99 56 89739 21071 79633522
Migraine 15.65 9.99 159 89636 87334 79567259
Prostate cancer 15.63 9.99 9 89786 33259 79621334
Inappropriate schedule of product administration 15.63 9.99 224 89571 133404 79521189
Pancytopenia 15.50 9.99 116 89679 165629 79488964
Polymicrogyria 15.30 9.99 3 89792 3 79654590
Aggression 15.24 9.99 104 89691 50854 79603739
Non-cardiogenic pulmonary oedema 15.23 9.99 13 89782 1486 79653107
Interstitial lung disease 15.23 9.99 70 89725 112530 79542063
White blood cell count decreased 15.22 9.99 137 89658 188151 79466442
Lip erythema 15.07 9.99 7 89788 271 79654322
Acute myocardial infarction 15.03 9.99 41 89754 76995 79577598
Hypercapnic coma 15.03 9.99 8 89787 416 79654177
Derailment 14.93 9.99 5 89790 79 79654514
Eye pruritus 14.88 9.99 54 89741 20516 79634077
Linear IgA disease 14.87 9.99 18 89777 3114 79651479
Blood immunoglobulin E increased 14.83 9.99 25 89770 5857 79648736
Substance abuse 14.75 9.99 35 89760 10491 79644102
Dissociative disorder 14.74 9.99 10 89785 811 79653782
Analgesic drug level increased 14.66 9.99 18 89777 3160 79651433
Cardiac failure 14.65 9.99 108 89687 154734 79499859
Dermatitis 14.61 9.99 55 89740 21266 79633327
Areflexia 14.60 9.99 24 89771 5510 79649083
Clonus 14.57 9.99 27 89768 6813 79647780
Poor feeding infant 14.50 9.99 6 89789 175 79654418
Dystonia 14.49 9.99 55 89740 21344 79633249
Alpha 1 globulin increased 14.33 9.99 5 89790 90 79654503
Pigmentation disorder 14.33 9.99 24 89771 5594 79648999
Cerebral haemorrhage 14.25 9.99 27 89768 57646 79596947
Affect lability 14.25 9.99 36 89759 11223 79643370
Wrong technique in device usage process 14.21 9.99 20 89775 4008 79650585
Ascites 14.16 9.99 41 89754 75521 79579072
Psoriatic arthropathy 14.13 9.99 43 89752 77956 79576637
Arthritis 14.05 9.99 74 89721 114806 79539787
Haematoma muscle 14.03 9.99 16 89779 2599 79651994
Pancreatitis 13.92 9.99 128 89667 68447 79586146
Gastric polyps 13.81 9.99 19 89776 3728 79650865
Bursitis 13.81 9.99 12 89783 35832 79618761
Aplastic anaemia 13.80 9.99 48 89747 17857 79636736
Osteonecrosis of jaw 13.80 9.99 17 89778 43209 79611384
Pneumonitis 13.76 9.99 30 89765 60830 79593763
Condition aggravated 13.68 9.99 445 89350 500679 79153914
Incorrect dose administered 13.58 9.99 139 89656 76491 79578102
Therapeutic response shortened 13.53 9.99 44 89751 15819 79638774
Postural orthostatic tachycardia syndrome 13.52 9.99 10 89785 930 79653663
Dysuria 13.50 9.99 101 89694 50850 79603743
Lymphomatoid papulosis 13.48 9.99 7 89788 346 79654247
Antidepressant discontinuation syndrome 13.44 9.99 4 89791 42 79654551
Rash erythematous 13.38 9.99 111 89684 57658 79596935
Encephalopathy 13.28 9.99 125 89670 67272 79587321
Rash pruritic 13.21 9.99 131 89664 71498 79583095
Leukopenia 13.18 9.99 77 89718 116436 79538157
Rash 13.17 9.99 786 89009 577572 79077021
Stomatitis 13.11 9.99 104 89691 146653 79507940
Mental status changes 13.10 9.99 124 89671 66835 79587758
Acute generalised exanthematous pustulosis 13.08 9.99 46 89749 17208 79637385
Injection site induration 13.07 9.99 32 89763 9787 79644806
Vasculitis 12.97 9.99 6 89789 25096 79629497
Restless arm syndrome 12.96 9.99 4 89791 48 79654545
Breast adenoma 12.46 9.99 4 89791 55 79654538
Clostridium difficile infection 12.39 9.99 18 89777 42667 79611926
Proteinuria 12.38 9.99 11 89784 32491 79622102
Pupillary reflex impaired 12.36 9.99 17 89778 3336 79651257
Bronchiectasis 12.12 9.99 5 89790 22381 79632212
Drug screen false positive 12.05 9.99 10 89785 1099 79653494
Loss of personal independence in daily activities 12.03 9.99 67 89728 102513 79552080
Thymoma 11.91 9.99 6 89789 278 79654315
Atrioventricular block first degree 11.90 9.99 36 89759 12455 79642138
Vaginal lesion 11.89 9.99 5 89790 152 79654441
Labelled drug-drug interaction issue 11.86 9.99 11 89784 1402 79653191
Arthralgia 11.80 9.99 525 89270 571278 79083315
Alpha 2 globulin increased 11.80 9.99 5 89790 155 79654438
Mixed dementia 11.77 9.99 6 89789 285 79654308
Transverse sinus thrombosis 11.70 9.99 8 89787 657 79653936
Steal syndrome 11.70 9.99 3 89792 17 79654576
Inflammation 11.68 9.99 60 89735 93693 79560900
Gastrointestinal disorder 11.67 9.99 85 89710 122120 79532473
Skin infection 11.63 9.99 46 89749 18199 79636394
Sensory integrative dysfunction 11.55 9.99 3 89792 18 79654575
Metastases to liver 11.50 9.99 9 89786 28305 79626288
Dyskinesia 11.44 9.99 88 89707 44685 79609908
Bladder dilatation 11.43 9.99 13 89782 2106 79652487
Mood altered 11.38 9.99 45 89750 17802 79636791
Neurodermatitis 11.37 9.99 10 89785 1190 79653403
Hallucination, olfactory 11.36 9.99 7 89788 481 79654112
Diabetic ketoacidosis 11.34 9.99 13 89782 34109 79620484
Victim of homicide 11.28 9.99 5 89790 173 79654420
Infective pulmonary exacerbation of cystic fibrosis 11.28 9.99 36 89759 12815 79641778
Cerebrovascular accident 11.28 9.99 116 89679 155176 79499417
Neoplasm progression 11.25 9.99 26 89769 51656 79602937
Antithrombin III decreased 11.21 9.99 7 89788 493 79654100
Rash pustular 11.16 9.99 33 89762 11278 79643315
Mast cell activation syndrome 11.13 9.99 8 89787 712 79653881
Anion gap 11.12 9.99 13 89782 2168 79652425
Transplant rejection 11.09 9.99 4 89791 19433 79635160
Apallic syndrome 11.09 9.99 9 89786 959 79653634
Emotional disorder of childhood 11.04 9.99 3 89792 22 79654571
Therapy non-responder 10.98 9.99 60 89735 92245 79562348
Burnout syndrome 10.96 9.99 6 89789 330 79654263
Tonsillar hypertrophy 10.93 9.99 11 89784 1551 79653042
Superior mesenteric artery syndrome 10.92 9.99 5 89790 187 79654406
Hypotension 10.90 9.99 603 89192 439714 79214879
Autonomic nervous system imbalance 10.79 9.99 19 89776 4611 79649982
Thyroiditis acute 10.70 9.99 5 89790 196 79654397
Panic reaction 10.68 9.99 19 89776 4646 79649947
Hypertensive crisis 10.68 9.99 5 89790 20765 79633828
Deep vein thrombosis 10.66 9.99 86 89709 120833 79533760
Akathisia 10.62 9.99 36 89759 13223 79641370
Rectal haemorrhage 10.57 9.99 47 89748 76253 79578340
Mental impairment 10.56 9.99 46 89749 18990 79635603
Fatigue 10.49 9.99 903 88892 928824 78725769
Febrile neutropenia 10.46 9.99 190 89605 230809 79423784
Live birth 10.46 9.99 4 89791 18740 79635853
Adenoidectomy 10.39 9.99 4 89791 96 79654497
Accidental poisoning 10.38 9.99 11 89784 1646 79652947
Human herpesvirus 6 infection reactivation 10.31 9.99 7 89788 568 79654025
Agoraphobia 10.28 9.99 7 89788 571 79654022
Wheezing 10.27 9.99 83 89712 116581 79538012
Unresponsive to stimuli 10.27 9.99 102 89693 55686 79598907
Wound secretion 10.26 9.99 22 89773 6166 79648427
Compulsive shopping 10.23 9.99 8 89787 808 79653785
Asthma 10.18 9.99 211 89584 134884 79519709
Hypocalcaemia 10.17 9.99 26 89769 49898 79604695
Food allergy 10.13 9.99 31 89764 10793 79643800
Inability to afford medication 10.13 9.99 14 89781 2759 79651834
Sensation of blood flow 10.10 9.99 4 89791 104 79654489
Cataract 10.04 9.99 36 89759 62084 79592509
Skin swelling 10.04 9.99 17 89778 3997 79650596
Dissociation 10.02 9.99 17 89778 4004 79650589
Blood cholesterol decreased 10.02 9.99 11 89784 1714 79652879

FDA Adverse Event Reporting System (Pediatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Eyelid haemangioma 20.65 17.21 3 7 9 89773

Pharmacologic Action:

SourceCodeDescription
ATC N05BB01 NERVOUS SYSTEM
PSYCHOLEPTICS
ANXIOLYTICS
Diphenylmethane derivatives
ATC N05BB51 NERVOUS SYSTEM
PSYCHOLEPTICS
ANXIOLYTICS
Diphenylmethane derivatives
FDA MoA N0000000207 Histamine Receptor Antagonists
MeSH PA D000982 Antipruritics
MeSH PA D003879 Dermatologic Agents
MeSH PA D018494 Histamine Agents
MeSH PA D006633 Histamine Antagonists
MeSH PA D006634 Histamine H1 Antagonists
MeSH PA D018377 Neurotransmitter Agents
CHEBI has role CHEBI:35474 anti-anxiety agents
CHEBI has role CHEBI:37955 H1 receptor antagonists
CHEBI has role CHEBI:50177 dermatologic agent
CHEBI has role CHEBI:59683 antipruritic drugs
CHEBI has role CHEBI:149553 anticoronaviral drug
FDA EPC N0000175750 Antihistamine

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

DiseaseRelationSNOMED_IDDOID
Dermatographic urticaria indication 7632005 DOID:743
Atopic dermatitis indication 24079001 DOID:3310
Allergic rhinitis indication 61582004
Nasal discharge indication 64531003
Urticaria indication 126485001
Itching of skin indication 418363000
Allergic conjunctivitis indication 473460002 DOID:11204
Severe Pruritus off-label use
Tachyarrhythmia contraindication 6285003
Alcoholism contraindication 7200002
Peptic ulcer contraindication 13200003 DOID:750
Pulmonary edema contraindication 19242006 DOID:11396
Myocardial infarction contraindication 22298006 DOID:5844
Shock contraindication 27942005
Hyperthyroidism contraindication 34486009 DOID:7998
Acute hepatitis contraindication 37871000
Hypertensive disorder contraindication 38341003 DOID:10763
Hypothyroidism contraindication 40930008 DOID:1459
Third trimester pregnancy contraindication 41587001
Conduction disorder of the heart contraindication 44808001
Chronic heart failure contraindication 48447003
Disorder of cardiovascular system contraindication 49601007 DOID:1287
Multiple organ failure contraindication 57653000
Psychotic disorder contraindication 69322001
Diabetes mellitus contraindication 73211009 DOID:9351
Chronic idiopathic constipation contraindication 82934008
Cor pulmonale contraindication 83291003 DOID:8515
Open-angle glaucoma contraindication 84494001 DOID:1067
Seizure disorder contraindication 128613002
Cystic fibrosis contraindication 190905008 DOID:1485
Angina pectoris contraindication 194828000
Disease of liver contraindication 235856003 DOID:409
Bladder outflow obstruction contraindication 236645006
Sepsis syndrome contraindication 238150007
Benign prostatic hyperplasia contraindication 266569009
Retention of urine contraindication 267064002
Continuous fever contraindication 271751000
Smoking cessation assistance contraindication 384742004
Angle-closure glaucoma contraindication 392291006 DOID:13550
Chronic myocardial ischemia contraindication 413844008 DOID:3393
Disorder of coronary artery contraindication 414024009
Myocardial ischemia contraindication 414795007 DOID:3393
Smokes tobacco daily contraindication 449868002
Severe Hypoxemia contraindication
Theophylline Toxicity contraindication




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 7.53 Basic
pKa2 3.53 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 8.70 WOMBAT-PK CHEMBL
D(2) dopamine receptor GPCR Ki 6.42 CHEMBL
5-hydroxytryptamine receptor 2A GPCR Ki 7.30 CHEMBL
Cytochrome P450 2D6 Enzyme Ki 5.41 WOMBAT-PK
Envelope glycoprotein gp160 Viral envelope protein IC50 5.20 CHEMBL
Envelope glycoprotein gp160 [Cleaved into: Surface protein gp120 Unclassified IC50 5.20 CHEMBL

External reference:

IDSource
4019782 VUID
N0000147873 NUI
D00672 KEGG_DRUG
10246-75-0 SECONDARY_CAS_RN
4017874 VANDF
4017875 VANDF
4019782 VANDF
C0020404 UMLSCUI
CHEBI:5818 CHEBI
CHEMBL1201007 ChEMBL_ID
CHEMBL896 ChEMBL_ID
CHEMBL3186993 ChEMBL_ID
CHEMBL1200467 ChEMBL_ID
DB00557 DRUGBANK_ID
D006919 MESH_DESCRIPTOR_UI
3658 PUBCHEM_CID
7199 IUPHAR_LIGAND_ID
599 INN_ID
2192-20-3 SECONDARY_CAS_RN
30S50YM8OG UNII
154987 RXNORM
4857 MMSL
4858 MMSL
4859 MMSL
6478 MMSL
7094 MMSL
d00907 MMSL
001451 NDDF
001452 NDDF
001453 NDDF
372856003 SNOMEDCT_US
80165005 SNOMEDCT_US
83933007 SNOMEDCT_US
83945003 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Vistaril HUMAN PRESCRIPTION DRUG LABEL 1 0069-5410 CAPSULE 25 mg ORAL NDA 15 sections
Vistaril HUMAN PRESCRIPTION DRUG LABEL 1 0069-5410 CAPSULE 25 mg ORAL NDA 15 sections
Vistaril HUMAN PRESCRIPTION DRUG LABEL 1 0069-5420 CAPSULE 50 mg ORAL NDA 15 sections
Vistaril HUMAN PRESCRIPTION DRUG LABEL 1 0069-5420 CAPSULE 50 mg ORAL NDA 15 sections
Vistaril HUMAN PRESCRIPTION DRUG LABEL 1 0069-5440 SUSPENSION 25 mg ORAL NDA 15 sections
Hydroxyzine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0093-5060 TABLET, FILM COATED 10 mg ORAL ANDA 13 sections
Hydroxyzine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0093-5060 TABLET, FILM COATED 10 mg ORAL ANDA 13 sections
Hydroxyzine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0093-5061 TABLET, FILM COATED 25 mg ORAL ANDA 13 sections
Hydroxyzine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0093-5061 TABLET, FILM COATED 25 mg ORAL ANDA 13 sections
Hydroxyzine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0093-5062 TABLET, FILM COATED 50 mg ORAL ANDA 13 sections
Hydroxyzine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0093-5062 TABLET, FILM COATED 50 mg ORAL ANDA 13 sections
Hydroxyzine Pamoate HUMAN PRESCRIPTION DRUG LABEL 1 0115-1670 CAPSULE 25 mg ORAL ANDA 13 sections
Hydroxyzine Pamoate HUMAN PRESCRIPTION DRUG LABEL 1 0115-1671 CAPSULE 50 mg ORAL ANDA 13 sections
Hydroxyzine Pamoate HUMAN PRESCRIPTION DRUG LABEL 1 0115-1803 CAPSULE 25 mg ORAL ANDA 13 sections
Hydroxyzine Pamoate HUMAN PRESCRIPTION DRUG LABEL 1 0115-1804 CAPSULE 50 mg ORAL ANDA 13 sections
Hydroxyzine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0121-4822 SYRUP 10 mg ORAL ANDA 14 sections
Hydroxyzine Pamoate HUMAN PRESCRIPTION DRUG LABEL 1 0185-0613 CAPSULE 25 mg ORAL ANDA 14 sections
Hydroxyzine Pamoate HUMAN PRESCRIPTION DRUG LABEL 1 0185-0613 CAPSULE 25 mg ORAL ANDA 14 sections
Hydroxyzine Pamoate HUMAN PRESCRIPTION DRUG LABEL 1 0185-0613 CAPSULE 25 mg ORAL ANDA 14 sections
hydroxyzine pamoate HUMAN PRESCRIPTION DRUG LABEL 1 0185-0615 CAPSULE 50 mg ORAL ANDA 14 sections
hydroxyzine pamoate HUMAN PRESCRIPTION DRUG LABEL 1 0185-0615 CAPSULE 50 mg ORAL ANDA 14 sections
hydroxyzine pamoate HUMAN PRESCRIPTION DRUG LABEL 1 0185-0615 CAPSULE 50 mg ORAL ANDA 14 sections
hydroxyzine pamoate HUMAN PRESCRIPTION DRUG LABEL 1 0185-0674 CAPSULE 25 mg ORAL ANDA 14 sections
hydroxyzine pamoate HUMAN PRESCRIPTION DRUG LABEL 1 0185-0674 CAPSULE 25 mg ORAL ANDA 14 sections
hydroxyzine pamoate HUMAN PRESCRIPTION DRUG LABEL 1 0185-0674 CAPSULE 25 mg ORAL ANDA 14 sections
Hydroxyzine pamoate HUMAN PRESCRIPTION DRUG LABEL 1 0185-0676 CAPSULE 50 mg ORAL ANDA 14 sections
Hydroxyzine pamoate HUMAN PRESCRIPTION DRUG LABEL 1 0185-0676 CAPSULE 50 mg ORAL ANDA 14 sections
Hydroxyzine pamoate HUMAN PRESCRIPTION DRUG LABEL 1 0185-0676 CAPSULE 50 mg ORAL ANDA 14 sections
Hydroxyzine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0404-9877 INJECTION, SOLUTION 50 mg INTRAMUSCULAR ANDA 9 sections
Hydroxyzine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0404-9877 INJECTION, SOLUTION 50 mg INTRAMUSCULAR ANDA 9 sections