hydroxyzine 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | 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 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 80 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 2.928 High 1
caco2-efflux Caco-2 efflux ratio (BA/AB) 0.419 High 1
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 38.019 10^-6 cm/s High 1
dh-clint Dog hepatocyte intrinsic clearance 20.464 uL/min/10^6 cells High 1
dppb Dog plasma protein binding (% unbound) 8.850 % High 1
fcs-ppb Fetal calf serum protein binding (% unbound) 16.600 % High 1
herg hERG pIC50 5.591 pIC50 High 1
hh-clint Human hepatocyte intrinsic clearance 20.989 uL/min/10^6 cells High 1
hlm-clint Human liver microsomal intrinsic clearance 28.314 uL/min/mg protein High 1
hppb Human plasma protein binding (% unbound) 8.270 % High 1
kinase-safety-class ACVR2B,AKT2,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK5,CDK9,EIF2AK3,EPHB4,ERBB2,GRK2,ITK,MAPK10,MET,NTRK2,PDK2,PDK4,PIK3CB,PRKDC,TEK 22
kinase-selectivity-class AXL,SIK2 2
mdck-mdr1-bcrp-efflux MDCK-MDR1-BCRP efflux ratio 0.318 High 1
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 0.351 High 1
mh-clint Mouse hepatocyte intrinsic clearance 61.802 High 1
mppb Mouse plasma protein binding (% unbound) 10.670 High 1
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 0.959 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pld-class Phospholipidosis risk class (1 = positive, 0 = negative) 1 High 1
pppb Pig plasma protein binding (% unbound) 21.910 % High 1
rat-kpuu-brain Rat brain Kpuu 1.042 % High 1
rh-clint Rat hepatocyte intrinsic clearance 106.905 uL/min/10^6 cells High 1
rh-fuinc Rat hepatocyte fraction unbound in incubation 46.950 % High 1
rppb Rat plasma protein binding (% unbound) 10.110 % High 1
solubility-dd Solubility at pH 7.4 in DMSO 774.462 uM High 1

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 1939.62 10.31 1440 94929 143618 90388460
Toxicity to various agents 855.23 10.31 1275 95094 286571 90245507
Dermatitis atopic 685.79 10.31 382 95987 23090 90508988
Intentional overdose 639.60 10.31 634 95735 93200 90438878
Pruritus 527.10 10.31 1511 94858 540014 89992064
Drug abuse 437.04 10.31 487 95882 81860 90450218
Intentional self-injury 417.47 10.31 303 96066 29031 90503047
Synovitis 309.28 10.31 9 96360 329743 90202335
Pemphigus 306.28 10.31 9 96360 326855 90205223
Glossodynia 277.71 10.31 16 96353 321763 90210315
Cardio-respiratory arrest 270.98 10.31 335 96034 62805 90469273
Systemic lupus erythematosus 268.96 10.31 34 96335 361862 90170216
Suicide attempt 262.77 10.31 361 96008 75038 90457040
Hand deformity 261.16 10.31 13 96356 296349 90235729
Joint swelling 239.68 10.31 118 96251 503182 90028896
Poisoning deliberate 238.43 10.31 172 96197 16314 90515764
Arthropathy 229.34 10.31 54 96315 366188 90165890
Contraindicated product administered 228.58 10.31 34 96335 320105 90211973
Respiratory arrest 226.59 10.31 225 96144 33086 90498992
Pericarditis 225.44 10.31 16 96353 270135 90261943
Wound 209.91 10.31 35 96334 302945 90229133
Helicobacter infection 209.73 10.31 7 96362 226843 90305235
Eczema 205.44 10.31 267 96102 52603 90479475
Infusion related reaction 202.50 10.31 95 96274 416685 90115393
Urticaria 196.71 10.31 754 95615 311980 90220098
Suspected suicide 183.89 10.31 119 96250 9449 90522629
Dry skin 182.11 10.31 332 96037 87741 90444337
Hepatic enzyme increased 181.83 10.31 78 96291 360658 90171420
Folliculitis 179.87 10.31 9 96360 204344 90327734
Rheumatoid arthritis 171.02 10.31 86 96283 362528 90169550
Somnolence 169.24 10.31 548 95821 208536 90323542
Cardiac arrest 168.91 10.31 356 96013 104579 90427499
Drug intolerance 161.57 10.31 143 96226 447448 90084630
Muscle injury 161.35 10.31 6 96363 176648 90355430
Impaired healing 160.10 10.31 28 96341 234171 90297907
Lower respiratory tract infection 152.85 10.31 39 96330 250620 90281458
Scratch 145.10 10.31 104 96265 9762 90522316
Skin plaque 144.07 10.31 104 96265 9871 90522207
Treatment failure 143.40 10.31 72 96297 303856 90228222
Abdominal discomfort 135.38 10.31 186 96183 477142 90054936
Product dose omission issue 127.84 10.31 631 95738 291056 90241022
Drug dependence 126.42 10.31 156 96213 29171 90502907
Skin exfoliation 125.44 10.31 244 96125 67669 90464409
Irritable bowel syndrome 125.08 10.31 33 96336 207415 90324663
Suicidal ideation 122.84 10.31 254 96115 73601 90458477
Poisoning 118.98 10.31 111 96258 15106 90516972
Sleep disorder due to general medical condition, insomnia type 118.81 10.31 4 96365 128690 90403388
Therapeutic product effect decreased 114.94 10.31 77 96292 277494 90254584
Type 2 diabetes mellitus 113.98 10.31 37 96332 203207 90328871
Distributive shock 106.21 10.31 58 96311 3366 90528712
Coma 106.10 10.31 237 96132 72395 90459683
Anxiety 103.88 10.31 623 95746 309149 90222929
Blood cholesterol increased 98.49 10.31 49 96320 207963 90324115
Sleep disorder due to a general medical condition 98.01 10.31 173 96196 44565 90487513
Injection site pain 97.15 10.31 404 95965 173295 90358783
Illness 93.44 10.31 243 96126 81726 90450352
General physical health deterioration 92.20 10.31 147 96222 354968 90177110
Alopecia 92.17 10.31 248 96121 494823 90037255
Stomatitis 91.73 10.31 94 96275 274604 90257474
Facet joint syndrome 91.02 10.31 3 96366 98386 90433692
Musculoskeletal stiffness 90.75 10.31 109 96260 296423 90235655
Lip dry 90.25 10.31 4 96365 100951 90431127
Bursitis 89.37 10.31 16 96353 131638 90400440
Dissociation 87.94 10.31 66 96303 6649 90525429
Bradypnoea 84.79 10.31 56 96313 4602 90527476
Drug reaction with eosinophilia and systemic symptoms 83.10 10.31 157 96212 42601 90489477
Osteoarthritis 82.76 10.31 53 96316 195677 90336401
Urticaria thermal 81.77 10.31 28 96341 505 90531573
Product use in unapproved indication 81.42 10.31 624 95745 335612 90196466
Hypercholesterolaemia 81.23 10.31 7 96362 100885 90431193
Anticholinergic syndrome 81.06 10.31 45 96324 2698 90529380
Maternal exposure during pregnancy 80.93 10.31 163 96206 359900 90172178
Psoriatic arthropathy 79.84 10.31 75 96294 228260 90303818
Liver injury 79.51 10.31 41 96328 170526 90361552
Injury 78.68 10.31 57 96312 197292 90334786
Chemical submission 78.04 10.31 27 96342 503 90531575
Angioedema 77.74 10.31 196 96173 64680 90467398
Pulmonary fibrosis 77.62 10.31 11 96358 107492 90424586
Therapeutic response shortened 74.37 10.31 106 96263 22773 90509305
Serotonin syndrome 73.48 10.31 139 96230 37748 90494330
Victim of chemical submission 72.84 10.31 28 96341 711 90531367
Musculoskeletal pain 71.54 10.31 47 96322 171204 90360874
Urinary retention 71.38 10.31 137 96232 37607 90494471
Peripheral venous disease 69.86 10.31 5 96364 83916 90448162
Inappropriate schedule of product administration 69.65 10.31 330 96039 149603 90382475
Swelling 69.18 10.31 222 96147 418836 90113242
Drug interaction 68.55 10.31 516 95853 275937 90256141
Skin fissures 68.51 10.31 97 96272 20712 90511366
Joint range of motion decreased 67.20 10.31 30 96339 135613 90396465
Electrocardiogram QT prolonged 65.07 10.31 197 96172 72259 90459819
Wound infection 63.97 10.31 17 96352 106385 90425693
Fibromyalgia 63.96 10.31 75 96294 206194 90325884
Agitation 63.64 10.31 186 96183 66912 90465166
Burning mouth syndrome 63.58 10.31 24 96345 579 90531499
Blood cholesterol decreased 63.49 10.31 34 96335 1897 90530181
Irritability 63.26 10.31 126 96243 35536 90496542
Ill-defined disorder 63.15 10.31 62 96307 184829 90347249
C-reactive protein increased 62.91 10.31 60 96309 181329 90350749
Decompression sickness 61.17 10.31 16 96353 106 90531972
Overdose 59.87 10.31 328 96041 157381 90374697
Initial insomnia 59.83 10.31 61 96308 9249 90522829
Prescribed overdose 59.83 10.31 15 96354 97610 90434468
Exposure during pregnancy 59.68 10.31 101 96268 238309 90293769
Red blood cell sedimentation rate increased 58.36 10.31 9 96360 82586 90449492
Depression 56.37 10.31 527 95842 300074 90232004
Sciatica 55.86 10.31 19 96350 101363 90430715
Grip strength decreased 55.26 10.31 15 96354 92561 90439517
Blister 55.10 10.31 118 96251 254880 90277198
Peripheral circulatory failure 54.88 10.31 29 96340 1575 90530503
Neuroblastoma recurrent 54.58 10.31 16 96353 169 90531909
Parkinsonism 54.56 10.31 71 96298 13994 90518084
Product dose omission in error 53.85 10.31 86 96283 20417 90511661
Live birth 52.85 10.31 10 96359 79097 90452981
Areflexia 52.55 10.31 38 96331 3615 90528463
Neuroglycopenia 52.40 10.31 25 96344 1090 90530988
Alcoholism 51.74 10.31 29 96340 1771 90530307
Hypersensitivity 50.75 10.31 280 96089 454397 90077681
Product administration interrupted 49.93 10.31 64 96305 12428 90519650
Mydriasis 49.45 10.31 70 96299 14942 90517136
Seizure 49.19 10.31 304 96065 152325 90379753
Wheezing 49.11 10.31 113 96256 237967 90294111
Perfume sensitivity 48.88 10.31 23 96346 972 90531106
Multiple drug therapy 48.87 10.31 48 96321 6961 90525117
Intentional product use issue 48.85 10.31 98 96271 216794 90315284
Gait inability 47.86 10.31 51 96318 146405 90385673
Eye pruritus 47.27 10.31 99 96270 28928 90503150
Neurodermatitis 46.92 10.31 33 96336 3005 90529073
Miosis 46.71 10.31 54 96315 9430 90522648
Gastrointestinal disorder 46.63 10.31 130 96239 256557 90275521
Disturbance in attention 46.03 10.31 132 96237 46977 90485101
Corneal reflex decreased 45.90 10.31 16 96353 305 90531773
Prescription form tampering 45.84 10.31 20 96349 707 90531371
Hypoaesthesia 45.43 10.31 176 96193 314034 90218044
Rash maculo-papular 45.25 10.31 120 96249 40813 90491265
Sedation 45.16 10.31 133 96236 48038 90484040
Erythema 44.51 10.31 405 95964 228841 90303237
Intentional product misuse 44.38 10.31 201 96168 89403 90442675
Infection 44.32 10.31 216 96153 361878 90170200
Gastric polyps 44.29 10.31 38 96331 4634 90527444
Hip arthroplasty 44.27 10.31 13 96356 76195 90455883
Blepharospasm 44.21 10.31 4 96365 55441 90476637
Lung disorder 43.82 10.31 57 96312 149826 90382252
Mastocytosis 43.61 10.31 21 96348 935 90531143
Chronic spontaneous urticaria 43.48 10.31 26 96343 1794 90530284
Night sweats 43.02 10.31 44 96325 128722 90403356
Respiratory acidosis 42.99 10.31 48 96321 8071 90524007
Adjustment disorder with depressed mood 42.91 10.31 5 96364 56748 90475330
Product use issue 42.02 10.31 194 96175 329725 90202353
Skin swelling 41.90 10.31 43 96326 6571 90525507
Stress 41.37 10.31 184 96185 81211 90450867
Incorrect dose administered 41.31 10.31 180 96189 78750 90453328
Bezoar 40.61 10.31 29 96340 2705 90529373
Cardiogenic shock 40.49 10.31 84 96285 24384 90507694
Vasoplegia syndrome 39.86 10.31 29 96340 2785 90529293
Metabolic acidosis 39.73 10.31 140 96229 55536 90476542
Skin haemorrhage 39.68 10.31 77 96292 21303 90510775
Adverse event 39.36 10.31 40 96329 117378 90414700
Dermatitis 38.80 10.31 78 96291 22142 90509936
Hypotonia 38.71 10.31 54 96315 11372 90520706
Dementia 38.41 10.31 81 96288 23780 90508298
Exposure via skin contact 38.39 10.31 52 96317 10653 90521425
Feeling abnormal 38.00 10.31 306 96063 166929 90365149
Impaired quality of life 37.76 10.31 79 96290 23065 90509013
Pain of skin 37.58 10.31 64 96305 16018 90516060
Bradykinesia 37.44 10.31 41 96328 6747 90525331
Psoriasis 37.26 10.31 277 96092 147477 90384601
Hyperglycaemia 37.09 10.31 129 96240 50841 90481237
Mixed liver injury 36.86 10.31 43 96326 7580 90524498
Papule 36.81 10.31 44 96325 7958 90524120
Inflammation 36.63 10.31 85 96284 178507 90353571
Liver disorder 36.61 10.31 45 96324 121224 90410854
Drug screen positive 36.52 10.31 31 96338 3726 90528352
Mobility decreased 36.52 10.31 140 96229 250594 90281484
Prescribed underdose 36.51 10.31 17 96352 75002 90457076
Victim of crime 36.32 10.31 18 96351 854 90531224
Dyspepsia 35.50 10.31 101 96268 198059 90334019
Myelosuppression 35.32 10.31 7 96362 53584 90478494
Foot deformity 34.97 10.31 10 96359 59641 90472437
Skin discolouration 34.75 10.31 115 96254 44200 90487878
Atrioventricular block first degree 34.64 10.31 44 96325 8467 90523611
Nail disorder 34.45 10.31 10 96359 59057 90473021
Hallucination, gustatory 33.86 10.31 9 96360 64 90532014
COVID-19 33.63 10.31 300 96069 168543 90363535
Mental disorder 32.98 10.31 92 96277 32226 90499852
Bacterial disease carrier 32.92 10.31 22 96347 1844 90530234
Hypotension 32.84 10.31 507 95862 324890 90207188
Dysuria 32.47 10.31 104 96265 39297 90492781
Aggression 32.39 10.31 81 96288 26587 90505491
Rash pruritic 31.86 10.31 172 96197 82042 90450036
Hereditary angioedema 31.34 10.31 44 96325 9321 90522757
Blood pressure decreased 31.30 10.31 160 96209 74735 90457343
Skin weeping 31.18 10.31 25 96344 2775 90529303
Hallucination, visual 31.11 10.31 73 96296 23019 90509059
Pupillary reflex impaired 31.09 10.31 24 96345 2521 90529557
Asphyxia 30.95 10.31 38 96331 7065 90525013
Panic attack 30.89 10.31 79 96290 26286 90505792
Knee arthroplasty 30.64 10.31 26 96343 83156 90448922
Hallucination 30.48 10.31 145 96224 65814 90466264
Tremor 30.42 10.31 272 96097 152901 90379177
Stupor 30.04 10.31 33 96336 5449 90526629
Allergy test positive 29.97 10.31 15 96354 727 90531351
Administration site erythema 29.87 10.31 16 96353 893 90531185
Pneumonia 29.85 10.31 488 95881 637571 89894507
Macular degeneration 29.58 10.31 3 96366 37967 90494111
Autoimmune disorder 29.50 10.31 23 96346 76721 90455357
Exostosis 29.19 10.31 10 96359 53124 90478954
Dry eye 28.72 10.31 130 96239 57801 90474277
Faecal vomiting 28.65 10.31 15 96354 799 90531279
Skin lesion 28.44 10.31 96 96273 37269 90494809
Onychomadesis 28.31 10.31 7 96362 45991 90486087
Encephalopathy 28.30 10.31 111 96258 46333 90485745
Blood lactic acid abnormal 28.10 10.31 7 96362 37 90532041
Bronchial wall thickening 28.03 10.31 21 96348 2110 90529968
Withdrawal syndrome 27.97 10.31 69 96300 22455 90509623
Psychiatric symptom 27.71 10.31 36 96333 7082 90524996
Cerebral disorder 27.34 10.31 32 96337 5662 90526416
Linear IgA disease 26.81 10.31 21 96348 2253 90529825
Cognitive disorder 26.75 10.31 145 96224 69262 90462816
Injection site mass 26.73 10.31 67 96302 22023 90510055
Obesity 26.11 10.31 45 96324 105462 90426616
Mental status changes 25.80 10.31 105 96264 44574 90487504
Hepatic cirrhosis 25.55 10.31 18 96351 63235 90468843
Sinusitis 25.25 10.31 238 96131 342850 90189228
Long QT syndrome 25.13 10.31 26 96343 4011 90528067
Wrong technique in device usage process 25.08 10.31 31 96338 5804 90526274
Nasal congestion 24.92 10.31 163 96206 83251 90448827
Hallucinations, mixed 24.85 10.31 31 96338 5858 90526220
Pregnancy 24.61 10.31 18 96351 62029 90470049
Spinal cord compression 24.25 10.31 28 96341 4883 90527195
Postoperative delirium 24.25 10.31 9 96360 207 90531871
Generalised tonic-clonic seizure 24.24 10.31 87 96282 34816 90497262
Lower limb fracture 24.16 10.31 33 96336 84980 90447098
Liver function test increased 24.05 10.31 33 96336 84822 90447256
Altered state of consciousness 23.99 10.31 81 96288 31451 90500627
Cholestasis 23.97 10.31 89 96280 36210 90495868
Lupus-like syndrome 23.88 10.31 11 96358 48835 90483243
Lip oedema 23.83 10.31 27 96342 4612 90527466
Blood creatine increased 23.71 10.31 33 96336 6934 90525144
Total cholesterol/HDL ratio abnormal 23.62 10.31 7 96362 77 90532001
Bruxism 23.45 10.31 26 96343 4337 90527741
Hypertension 23.38 10.31 344 96025 457188 90074890
Apallic syndrome 23.36 10.31 13 96356 783 90531295
Diet failure 23.17 10.31 6 96363 38 90532040
Post-traumatic stress disorder 22.73 10.31 32 96337 6796 90525282
Psychotic symptom 22.72 10.31 19 96350 2237 90529841
Neutropenia 22.66 10.31 143 96226 224761 90307317
Oropharyngeal pain 22.59 10.31 204 96165 114983 90417095
Labile hypertension 22.55 10.31 11 96358 504 90531574
Mouth breathing 22.50 10.31 8 96361 162 90531916
Interstitial lung disease 22.38 10.31 29 96340 76376 90455702
Finger deformity 22.31 10.31 4 96365 32893 90499185
Tachycardia 22.22 10.31 261 96108 157412 90374666
Persistent genital arousal disorder 22.11 10.31 12 96357 688 90531390
Thymoma 22.04 10.31 9 96360 269 90531809
Bronchial secretion retention 21.99 10.31 23 96346 3592 90528486
Frequent bowel movements 21.96 10.31 17 96352 56918 90475160
Nasopharyngitis 21.88 10.31 303 96066 406801 90125277
Malignant neoplasm progression 21.80 10.31 51 96318 106819 90425259
Rectal haemorrhage 21.67 10.31 34 96335 82710 90449368
Mast cell activation syndrome 21.62 10.31 16 96353 1578 90530500
Disturbance in sexual arousal 21.61 10.31 9 96360 283 90531795
Intentional dose omission 21.58 10.31 54 96315 17729 90514349
Blood immunoglobulin E increased 21.46 10.31 25 96344 4400 90527678
Toxic skin eruption 21.39 10.31 50 96319 15724 90516354
Peripheral swelling 21.31 10.31 310 96059 412796 90119282
Enuresis 21.27 10.31 22 96347 3392 90528686
Contusion 21.27 10.31 168 96201 251048 90281030
Insomnia 21.26 10.31 484 95885 332990 90199088
Fall 21.16 10.31 666 95703 481144 90050934
No adverse event 21.01 10.31 134 96235 67848 90464230
Depressed level of consciousness 20.99 10.31 141 96228 72643 90459435
Surgery 20.97 10.31 99 96270 44788 90487290
Electrocardiogram QRS complex prolonged 20.93 10.31 32 96337 7316 90524762
Lip swelling 20.93 10.31 89 96280 38521 90493557
Nodular rash 20.93 10.31 8 96361 200 90531878
Oedema 20.88 10.31 126 96243 200169 90331909
Diabetes mellitus inadequate control 20.88 10.31 55 96314 18629 90513449
Temperature intolerance 20.73 10.31 42 96327 11988 90520090
Labelled drug-drug interaction issue 20.66 10.31 18 96351 2240 90529838
Disease progression 20.57 10.31 91 96278 156524 90375554
Substance abuse 20.52 10.31 27 96342 5379 90526699
Photosensitivity reaction 20.49 10.31 53 96316 17754 90514324
Akathisia 20.48 10.31 40 96329 11119 90520959
Nightmare 20.38 10.31 60 96309 21665 90510413
Plasma cell myeloma 20.26 10.31 9 96360 40819 90491259
Pigmentation disorder 19.98 10.31 28 96341 5921 90526157
Anaemia 19.89 10.31 260 96109 352542 90179536
Psychomotor retardation 19.87 10.31 25 96344 4764 90527314
Dermatitis exfoliative generalised 19.80 10.31 27 96342 5566 90526512
Colitis ulcerative 19.66 10.31 21 96348 60245 90471833
Injection site reaction 19.57 10.31 166 96203 91914 90440164
Asthma 19.55 10.31 364 96005 241796 90290282
Lymphomatoid papulosis 19.50 10.31 7 96362 146 90531932
Burnout syndrome 19.44 10.31 8 96361 244 90531834
Skin burning sensation 19.20 10.31 55 96314 19556 90512522
Road traffic accident 19.16 10.31 55 96314 107571 90424507
Ear swelling 19.15 10.31 16 96353 1881 90530197
Skin discomfort 18.98 10.31 16 96353 1905 90530173
Vision blurred 18.98 10.31 190 96179 110103 90421975
Term birth 18.66 10.31 7 96362 166 90531912
Snoring 18.53 10.31 25 96344 5101 90526977
Cold agglutinins positive 18.52 10.31 5 96364 38 90532040
Perineal pain 18.43 10.31 10 96359 573 90531505
Rash macular 18.15 10.31 72 96297 30208 90501870
Drug tolerance decreased 17.73 10.31 6 96363 32124 90499954
Foetal growth restriction 17.67 10.31 34 96335 9346 90522732
Sensitivity to weather change 17.65 10.31 33 96336 8881 90523197
Female reproductive tract disorder 17.61 10.31 10 96359 626 90531452
Joint dislocation 17.59 10.31 13 96356 44569 90487509
Skin infection 17.39 10.31 50 96319 17814 90514264
Osteonecrosis of jaw 17.34 10.31 10 96359 39093 90492985
Heart rate increased 17.31 10.31 190 96179 112712 90419366
Rebound atopic dermatitis 17.18 10.31 14 96355 1590 90530488
Muscle rigidity 16.89 10.31 43 96326 14266 90517812
Eye irritation 16.65 10.31 76 96293 33902 90498176
Tonsillar hypertrophy 16.42 10.31 12 96357 1160 90530918
Blood urea increased 16.40 10.31 70 96299 30343 90501735
Decreased eye contact 16.35 10.31 8 96361 369 90531709
Obsessive-compulsive disorder 16.33 10.31 22 96347 4482 90527596
Derailment 16.25 10.31 5 96364 63 90532015
Crying 16.20 10.31 62 96307 25583 90506495
Skin irritation 16.19 10.31 41 96328 13562 90518516
Somnambulism 16.18 10.31 26 96343 6202 90525876
Accidental death 16.13 10.31 15 96354 2033 90530045
Pneumonitis 16.03 10.31 14 96355 44156 90487922
Muscular weakness 15.78 10.31 142 96227 206524 90325554
Muscle spasticity 15.71 10.31 9 96360 35313 90496765
Therapy interrupted 15.63 10.31 99 96270 50009 90482069
Unresponsive to stimuli 15.62 10.31 81 96288 38040 90494038
Confusional state 15.60 10.31 303 96066 385902 90146176
Loss of personal independence in daily activities 15.60 10.31 83 96286 136022 90396056
Needle issue 15.55 10.31 41 96328 13893 90518185
Panic reaction 15.54 10.31 22 96347 4695 90527383
Binge eating 15.39 10.31 9 96360 596 90531482
Epilepsy 15.38 10.31 41 96328 82165 90449913
Antidepressant discontinuation syndrome 15.30 10.31 6 96363 161 90531917
Joint ankylosis 15.29 10.31 12 96357 1291 90530787
Psychomotor skills impaired 15.24 10.31 17 96352 2855 90529223
Drug effect less than expected 15.10 10.31 25 96344 6113 90525965
Bipolar disorder 15.04 10.31 31 96338 8954 90523124
Negative thoughts 14.85 10.31 11 96358 1086 90530992
Menopause 14.85 10.31 18 96351 3303 90528775
Thrombocytopenia 14.83 10.31 146 96223 208579 90323499
Vascular stent thrombosis 14.68 10.31 11 96358 1105 90530973
Hyperleukocytosis 14.55 10.31 10 96359 877 90531201
Micturition disorder 14.54 10.31 17 96352 3003 90529075
Exposure via ingestion 14.52 10.31 16 96353 2651 90529427
Decreased appetite 14.43 10.31 298 96071 376242 90155836
Hallucination, olfactory 14.43 10.31 7 96362 317 90531761
Self-destructive behaviour 14.36 10.31 8 96361 483 90531595
Victim of sexual abuse 14.24 10.31 9 96360 686 90531392
Myositis 14.23 10.31 4 96365 24124 90507954
Cough 14.13 10.31 502 95867 368460 90163618
Restlessness 14.02 10.31 75 96294 35645 90496433
Exposure to toxic agent 13.95 10.31 28 96341 7939 90524139
Granulomatous liver disease 13.95 10.31 10 96359 939 90531139
Hallucination, auditory 13.93 10.31 43 96326 15932 90516146
Body mass index increased 13.83 10.31 12 96357 1485 90530593
Discomfort 13.74 10.31 207 96162 274128 90257950
Dysarthria 13.64 10.31 102 96267 54380 90477698
Psychomotor hyperactivity 13.59 10.31 37 96332 12776 90519302
Eosinophilia 13.38 10.31 63 96306 28470 90503608
Ventricular fibrillation 13.38 10.31 39 96330 14005 90518073
Injection site swelling 13.31 10.31 109 96260 59730 90472348
Anaphylactic reaction 13.28 10.31 147 96222 87377 90444701
Therapeutic product effect incomplete 13.20 10.31 137 96232 193759 90338319
Wound secretion 13.20 10.31 21 96348 4969 90527109
Arthritis 13.19 10.31 114 96255 167201 90364877
Alpha 1 globulin increased 13.19 10.31 5 96364 122 90531956
Gastrointestinal hypomotility 13.16 10.31 11 96358 1294 90530784
Eyelid haemangioma 13.15 10.31 3 96366 10 90532068
White blood cell count decreased 13.12 10.31 114 96255 166995 90365083
Superior mesenteric artery syndrome 13.08 10.31 5 96364 125 90531953
Postural orthostatic tachycardia syndrome 13.01 10.31 14 96355 2258 90529820
Insurance issue 13.01 10.31 33 96336 10925 90521153
Pleural effusion 13.00 10.31 68 96301 111923 90420155
Complication of device insertion 12.99 10.31 32 96337 10404 90521674
Hepatocellular injury 12.90 10.31 63 96306 28895 90503183
Taste disorder 12.85 10.31 29 96340 61517 90470561
Burning sensation 12.76 10.31 113 96256 63339 90468739
Breast adenoma 12.68 10.31 4 96365 55 90532023
Transverse sinus thrombosis 12.66 10.31 8 96361 609 90531469
Alpha 2 globulin increased 12.65 10.31 5 96364 137 90531941
Talipes 12.64 10.31 12 96357 1668 90530410
Hiatus hernia 12.63 10.31 57 96312 25304 90506774
Immature respiratory system 12.62 10.31 4 96365 56 90532022
Acarodermatitis 12.59 10.31 11 96358 1375 90530703
Depressed mood 12.56 10.31 94 96275 50128 90481950
Eosinophilic oesophagitis 12.49 10.31 9 96360 852 90531226
Social anxiety disorder 12.48 10.31 8 96361 625 90531453
Human herpesvirus 6 infection reactivation 12.46 10.31 8 96361 626 90531452
Formication 12.45 10.31 20 96349 4771 90527307
Drug withdrawal syndrome 12.45 10.31 62 96307 28661 90503417
Joint stiffness 12.39 10.31 42 96327 78000 90454078
Product quality issue 12.39 10.31 43 96326 79282 90452796
Adverse drug reaction 12.38 10.31 73 96296 116628 90415450
Viral uveitis 12.29 10.31 5 96364 148 90531930
Resting tremor 12.28 10.31 9 96360 874 90531204
Laryngitis 12.23 10.31 22 96347 50731 90481347
Syringe issue 12.22 10.31 18 96351 3984 90528094
Brain death 12.15 10.31 18 96351 4003 90528075
Inability to afford medication 12.09 10.31 17 96352 3605 90528473
Congenital uterine anomaly 12.07 10.31 5 96364 155 90531923
Coeliac disease 12.00 10.31 18 96351 44592 90487486
Restless arm syndrome 11.90 10.31 4 96365 68 90532010
Therapy non-responder 11.76 10.31 91 96278 136613 90395465
Micrognathia 11.72 10.31 6 96363 305 90531773
Intercepted product storage error 11.69 10.31 7 96362 484 90531594
Underdose 11.65 10.31 25 96344 53992 90478086
Attention deficit hyperactivity disorder 11.61 10.31 18 96351 4166 90527912
Blood pressure increased 11.56 10.31 283 96086 196934 90335144
Infusion site reaction 11.52 10.31 3 96366 19036 90513042
Cytomegalovirus infection 11.51 10.31 7 96362 26595 90505483
Libido decreased 11.48 10.31 15 96354 2967 90529111
Gastritis fungal 11.48 10.31 5 96364 176 90531902
Neuroblastoma 11.39 10.31 4 96365 78 90532000
Myofascial pain syndrome 11.38 10.31 15 96354 2992 90529086
Haematochezia 11.37 10.31 38 96331 70875 90461203
Tic 11.34 10.31 12 96357 1899 90530179
Adverse reaction 11.30 10.31 9 96360 29703 90502375
Ulcer haemorrhage 11.29 10.31 7 96362 26314 90505764
Fat necrosis 11.22 10.31 8 96361 744 90531334
Foetal death 11.21 10.31 4 96365 20719 90511359
Blood pressure abnormal 11.21 10.31 46 96323 19599 90512479
Gastrointestinal ischaemia 11.17 10.31 5 96364 188 90531890
Genital pain 11.17 10.31 8 96361 750 90531328
Emotional distress 11.16 10.31 72 96297 36590 90495488
Rash papular 11.09 10.31 47 96322 20308 90511770
Hypertonic bladder 11.09 10.31 18 96351 4330 90527748
Schizoaffective disorder bipolar type 11.07 10.31 5 96364 192 90531886
Eyelids pruritus 11.07 10.31 12 96357 1952 90530126
Compulsive shopping 11.06 10.31 8 96361 761 90531317
Clonus 11.03 10.31 21 96348 5729 90526349
Orbital oedema 10.99 10.31 6 96363 348 90531730
Pancreatitis 10.92 10.31 118 96251 69708 90462370
Retrograde amnesia 10.92 10.31 7 96362 547 90531531
Wrist fracture 10.90 10.31 39 96330 15585 90516493
Drug use disorder 10.83 10.31 26 96343 8317 90523761
Idiopathic urticaria 10.82 10.31 6 96363 359 90531719
Substance use disorder 10.79 10.31 12 96357 2008 90530070
Urticaria chronic 10.77 10.31 8 96361 793 90531285
Superior sagittal sinus thrombosis 10.73 10.31 8 96361 798 90531280
Injection site nodule 10.71 10.31 18 96351 4455 90527623
Sleep apnoea syndrome 10.70 10.31 64 96305 31683 90500395
Skin tightness 10.67 10.31 18 96351 4470 90527608
Dyskinesia 10.67 10.31 71 96298 36463 90495615
Postoperative wound infection 10.67 10.31 35 96334 13391 90518687
Dry mouth 10.60 10.31 135 96234 183924 90348154
Foetal exposure during delivery 10.59 10.31 6 96363 374 90531704
Eyelid skin dryness 10.58 10.31 7 96362 577 90531501
Back injury 10.54 10.31 21 96348 46601 90485477
Fatigue 10.51 10.31 1071 95298 1152952 89379126
Mood altered 10.46 10.31 41 96328 17103 90514975
Dependence 10.44 10.31 12 96357 2083 90529995
Haemoglobin decreased 10.39 10.31 116 96253 161840 90370238
Melaena 10.39 10.31 68 96301 34729 90497349
Mechanical urticaria 10.36 10.31 7 96362 597 90531481

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 1047.49 11.30 841 43854 95624 42481016
Toxicity to various agents 631.33 11.30 971 43724 228165 42348475
Drug abuse 475.71 11.30 567 44128 104204 42472436
Dermatitis atopic 415.67 11.30 220 44475 12184 42564456
Pruritus 304.08 11.30 634 44061 188137 42388503
Intentional overdose 140.65 11.30 218 44477 51238 42525402
Dry skin 121.35 11.30 197 44498 48141 42528499
Priapism 117.57 11.30 77 44618 6330 42570310
Respiratory arrest 114.35 11.30 145 44550 28279 42548361
Coma 112.97 11.30 202 44493 53352 42523288
Poisoning 111.97 11.30 105 44590 14594 42562046
Cardio-respiratory arrest 108.44 11.30 209 44486 58427 42518213
Suspected suicide 98.18 11.30 68 44627 6131 42570509
Sleep disorder due to a general medical condition 88.19 11.30 100 44595 17353 42559287
Eczema 80.25 11.30 135 44560 33951 42542689
Urticaria 79.81 11.30 213 44482 73823 42502817
Rash 76.27 11.30 524 44171 276430 42300210
Dissociation 70.55 11.30 46 44649 3752 42572888
Intentional self-injury 68.29 11.30 82 44613 15120 42561520
Skin fissures 67.77 11.30 66 44629 9610 42567030
Overdose 67.46 11.30 253 44442 105011 42471629
Cardiac arrest 64.53 11.30 256 44439 109064 42467576
Discomfort 62.20 11.30 102 44593 25117 42551523
Sleep disorder 60.79 11.30 147 44548 47948 42528692
Suicide attempt 60.53 11.30 143 44552 45957 42530683
Skin exfoliation 60.20 11.30 134 44561 41419 42535221
Suicidal behaviour 56.27 11.30 29 44666 1517 42575123
Drug reaction with eosinophilia and systemic symptoms 53.60 11.30 129 44566 41946 42534694
Neuroblastoma recurrent 53.33 11.30 19 44676 393 42576247
Adulterated product 51.63 11.30 22 44673 744 42575896
Disease progression 49.02 11.30 47 44648 143609 42433031
General physical health deterioration 46.55 11.30 54 44641 151192 42425448
Ventricular tachyarrhythmia 45.75 11.30 17 44678 398 42576242
Suicidal ideation 44.44 11.30 131 44564 48030 42528610
Parasomnia 43.72 11.30 17 44678 452 42576188
Somnolence 42.97 11.30 274 44421 140831 42435809
Psoriasis 41.83 11.30 129 44566 48475 42528165
Hyperthermia 41.12 11.30 58 44637 12516 42564124
Injection site pain 37.05 11.30 139 44556 57659 42518981
Anticholinergic syndrome 36.44 11.30 22 44673 1567 42575073
Drug dependence 35.77 11.30 88 44607 29006 42547634
Ureteric compression 35.24 11.30 13 44682 298 42576342
Serotonin syndrome 34.82 11.30 81 44614 25764 42550876
Pyelocaliectasis 33.59 11.30 20 44675 1389 42575251
Therapeutic response shortened 32.31 11.30 54 44641 13500 42563140
Fixed eruption 32.17 11.30 24 44671 2430 42574210
Ocular hyperaemia 32.09 11.30 59 44636 15904 42560736
Diarrhoea 32.07 11.30 319 44376 460530 42116110
Pneumonia 31.58 11.30 287 44408 421862 42154778
Personal relationship issue 31.48 11.30 12 44683 302 42576338
Anaemia 31.01 11.30 170 44525 280108 42296532
Alcoholism 30.49 11.30 25 44670 2905 42573735
Panic attack 30.43 11.30 47 44648 10998 42565642
Andropause 29.93 11.30 9 44686 106 42576534
Toxic epidermal necrolysis 29.85 11.30 78 44617 26672 42549968
Thymus disorder 29.82 11.30 11 44684 252 42576388
Mental disorder 29.38 11.30 61 44634 17968 42558672
Poisoning deliberate 29.15 11.30 44 44651 10090 42566550
Myelosuppression 29 11.30 4 44691 40457 42536183
Cerebrovascular accident 28.48 11.30 36 44659 97124 42479516
Exposure via ingestion 28.37 11.30 21 44674 2101 42574539
Delusion of parasitosis 28.32 11.30 9 44686 129 42576511
Porphyria acute 28.21 11.30 12 44683 404 42576236
Chemical submission 28.07 11.30 8 44687 77 42576563
Neuroblastoma 27.63 11.30 11 44684 312 42576328
Bradypnoea 27.14 11.30 28 44667 4365 42572275
Face oedema 26.83 11.30 50 44645 13616 42563024
Emotional disorder of childhood 26.53 11.30 7 44688 49 42576591
Altered state of consciousness 26.42 11.30 79 44616 29180 42547460
Abnormal sleep-related event 26.32 11.30 12 44683 478 42576162
Hypothermia 26.10 11.30 47 44648 12468 42564172
Administration related reaction 25.92 11.30 9 44686 172 42576468
Disturbance in attention 25.44 11.30 79 44616 29787 42546853
Asphyxia 25.17 11.30 37 44658 8289 42568351
Miosis 24.91 11.30 48 44647 13398 42563242
Electrocardiogram QT prolonged 24.89 11.30 108 44587 47837 42528803
Substance use disorder 24.28 11.30 29 44666 5316 42571324
Agitation 24.13 11.30 132 44563 64182 42512458
Atrial fibrillation 24.08 11.30 71 44624 139522 42437118
Myocardial infarction 23.69 11.30 60 44635 123949 42452691
Sensory integrative dysfunction 23.53 11.30 6 44689 36 42576604
Pulmonary embolism 23.53 11.30 57 44638 119555 42457085
Troponin T increased 23.39 11.30 21 44674 2759 42573881
Clonus 22.78 11.30 23 44672 3497 42573143
Dissociative disorder 22.73 11.30 12 44683 660 42575980
Postmortem blood drug level 22.56 11.30 8 44687 163 42576477
Dermatitis exfoliative generalised 22.29 11.30 29 44666 5795 42570845
Victim of crime 22.10 11.30 11 44684 534 42576106
Autism spectrum disorder 22.09 11.30 21 44674 2967 42573673
Eye irritation 21.71 11.30 41 44654 11277 42565363
Scaphocephaly 21.61 11.30 6 44689 52 42576588
Non-cardiogenic pulmonary oedema 21.58 11.30 13 44682 922 42575718
Eye pruritus 21.46 11.30 41 44654 11371 42565269
Thrombocytopenia 21.24 11.30 115 44580 190164 42386476
Product dose omission in error 20.88 11.30 34 44661 8320 42568320
Electrocardiogram QRS complex prolonged 20.75 11.30 28 44667 5795 42570845
Aplastic anaemia 20.29 11.30 42 44653 12342 42564298
Antidepressant drug level increased 20.19 11.30 8 44687 224 42576416
Product dose omission issue 20.19 11.30 249 44446 154116 42422524
Respiratory depression 20.02 11.30 54 44641 18814 42557826
Scratch 19.83 11.30 26 44669 5235 42571405
Impaired quality of life 19.72 11.30 45 44650 14132 42562508
Accidental death 19.68 11.30 20 44675 3063 42573577
Phlebotomy 19.63 11.30 6 44689 75 42576565
Injection 19.41 11.30 4 44691 7 42576633
Cardiac failure congestive 19.13 11.30 38 44657 85564 42491076
Rash maculo-papular 19.10 11.30 84 44611 37419 42539221
Tachyphrenia 18.70 11.30 14 44681 1425 42575215
Cardiogenic shock 18.66 11.30 7 44688 35633 42541007
Eosinophilia 18.54 11.30 76 44619 32823 42543817
Multiple organ dysfunction syndrome 18.49 11.30 47 44648 96988 42479652
Drug withdrawal syndrome 18.35 11.30 57 44638 21492 42555148
Skin haemorrhage 18.24 11.30 31 44664 7854 42568786
C-reactive protein increased 18.16 11.30 24 44671 63536 42513104
Mumps 18.16 11.30 6 44689 98 42576542
Pityriasis rubra pilaris 18.15 11.30 8 44687 294 42576346
Rheumatoid arthritis 18.14 11.30 11 44684 42429 42534211
Near death experience 18.10 11.30 8 44687 296 42576344
Drug use disorder 18.07 11.30 36 44659 10297 42566343
Cardiac failure 17.95 11.30 55 44640 106801 42469839
Conjunctivitis 17.92 11.30 41 44654 12898 42563742
Coronary artery disease 17.81 11.30 18 44677 53702 42522938
Stereotypy 17.63 11.30 11 44684 831 42575809
Acute myocardial infarction 17.62 11.30 21 44674 58144 42518496
Injection site mass 17.62 11.30 32 44663 8543 42568097
Anxiety 17.60 11.30 196 44499 118364 42458276
Haematoma 17.42 11.30 4 44691 28019 42548621
Victim of homicide 17.37 11.30 7 44688 205 42576435
False positive investigation result 17.36 11.30 10 44685 653 42575987
Febrile bone marrow aplasia 17.24 11.30 35 44660 10146 42566494
Diarrhoea infectious 16.96 11.30 10 44685 682 42575958
Non-compaction cardiomyopathy 16.94 11.30 5 44690 55 42576585
Dermatitis 16.86 11.30 38 44657 11837 42564803
Cardiac pacemaker evaluation 16.75 11.30 6 44689 126 42576514
Injection site reaction 16.68 11.30 45 44650 15676 42560964
Skin irritation 16.50 11.30 29 44666 7545 42569095
Skin discomfort 16.39 11.30 10 44685 726 42575914
Depressed level of consciousness 16.37 11.30 96 44599 47874 42528766
Tachycardia 16.34 11.30 170 44525 100917 42475723
Echolalia 16.22 11.30 8 44687 381 42576259
Neonatal hypoxia 16.15 11.30 9 44686 551 42576089
Dry eye 16.07 11.30 44 44651 15462 42561178
Lower respiratory tract infection 15.85 11.30 12 44683 41194 42535446
Agoraphobia 15.79 11.30 7 44688 261 42576379
Reduced facial expression 15.78 11.30 13 44682 1520 42575120
Depressed mood 15.61 11.30 57 44638 23327 42553313
Distributive shock 15.59 11.30 16 44679 2480 42574160
Leukopenia 15.19 11.30 35 44660 74711 42501929
Acute generalised exanthematous pustulosis 15.09 11.30 30 44665 8565 42568075
Renal impairment 15.00 11.30 62 44633 110166 42466474
Product administration interrupted 14.91 11.30 22 44673 4944 42571696
Post-traumatic stress disorder 14.91 11.30 15 44680 2270 42574370
Deep vein thrombosis 14.87 11.30 37 44658 76920 42499720
Neurosis 14.85 11.30 6 44689 177 42576463
Haematochezia 14.80 11.30 24 44671 58412 42518228
Prostate cancer 14.75 11.30 15 44680 44628 42532012
Hypercapnic coma 14.75 11.30 6 44689 180 42576460
Rash pruritic 14.70 11.30 72 44623 33531 42543109
Neuropathy peripheral 14.68 11.30 56 44639 101797 42474843
Bladder dilatation 14.68 11.30 13 44682 1677 42574963
Cerebral disorder 14.60 11.30 17 44678 3033 42573607
Joint swelling 14.52 11.30 31 44664 67991 42508649
Pulmonary fibrosis 14.38 11.30 5 44690 26676 42549964
Dyspnoea exertional 14.26 11.30 19 44676 50129 42526511
Upper gastrointestinal haemorrhage 14.19 11.30 7 44688 30292 42546348
Thrombosis 13.98 11.30 32 44663 68479 42508161
Insomnia 13.87 11.30 187 44508 118066 42458574
Hyponatraemia 13.85 11.30 57 44638 101405 42475235
Haematoma muscle 13.82 11.30 14 44681 2136 42574504
Thyroiditis acute 13.79 11.30 5 44690 109 42576531
Benzodiazepine drug level increased 13.72 11.30 4 44691 42 42576598
Drug diversion 13.72 11.30 10 44685 977 42575663
Amputation stump pain 13.70 11.30 3 44692 8 42576632
Periorbital swelling 13.60 11.30 12 44683 1541 42575099
Acute respiratory distress syndrome 13.52 11.30 65 44630 30043 42546597
Rash erythematous 13.50 11.30 68 44627 32023 42544617
Syncope 13.47 11.30 56 44639 99350 42477290
Drug screen positive 13.42 11.30 19 44676 4112 42572528
Metabolic acidosis 13.41 11.30 21 44674 51837 42524803
Transaminases increased 13.40 11.30 9 44686 32876 42543764
Pemphigoid 13.37 11.30 34 44661 11433 42565207
Allergy to chemicals 13.30 11.30 5 44690 121 42576519
Neurodermatitis 13.22 11.30 9 44686 789 42575851
Maternal exposure during pregnancy 13.04 11.30 25 44670 6953 42569687
Intentional product misuse 12.95 11.30 110 44585 61790 42514850
N-terminal prohormone brain natriuretic peptide increased 12.91 11.30 17 44678 3436 42573204
Product use in unapproved indication 12.88 11.30 268 44427 184188 42392452
Rash macular 12.86 11.30 43 44652 16848 42559792
Throat tightness 12.83 11.30 30 44665 9569 42567071
Allergy to metals 12.75 11.30 5 44690 136 42576504
Pupillary reflex impaired 12.73 11.30 12 44683 1677 42574963
Hyperbilirubinaemia 12.70 11.30 49 44646 20586 42556054
Haemoglobin decreased 12.69 11.30 84 44611 132387 42444253
Analgesic drug level increased 12.69 11.30 10 44685 1098 42575542
Blood creatinine increased 12.53 11.30 66 44629 109937 42466703
Mixed dementia 12.52 11.30 6 44689 268 42576372
Full blood count abnormal 12.42 11.30 8 44687 29868 42546772
Alcohol withdrawal syndrome 12.28 11.30 11 44684 1440 42575200
Neurodevelopmental disorder 12.24 11.30 7 44688 451 42576189
Asthenia 12.23 11.30 214 44481 280579 42296061
Arthritis allergic 12.22 11.30 3 44692 15 42576625
Infective pulmonary exacerbation of cystic fibrosis 12.21 11.30 26 44669 7792 42568848
Angina pectoris 12.12 11.30 10 44685 32886 42543754
Cerebral infarction 12.08 11.30 9 44686 31160 42545480
Tremor 12.08 11.30 155 44540 96774 42479866
Neuralgia 11.90 11.30 6 44689 25641 42550999
Sinus tachycardia 11.87 11.30 48 44647 20605 42556035
Tremor neonatal 11.69 11.30 7 44688 491 42576149
Lymphopenia 11.69 11.30 4 44691 21559 42555081
White blood cell count decreased 11.61 11.30 68 44627 110328 42466312
Erythema 11.53 11.30 169 44526 108624 42468016
Hepatotoxicity 11.51 11.30 6 44689 25161 42551479
Skin weeping 11.49 11.30 11 44684 1568 42575072
Cardiomyopathy 11.44 11.30 3 44692 19207 42557433

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 2912.97 10.12 2270 117117 240111 110229801
Toxicity to various agents 1542.80 10.12 2223 117164 478332 109991580
Drug abuse 840.38 10.12 996 118391 176415 110293497
Dermatitis atopic 752.06 10.12 420 118967 25121 110444791
Intentional overdose 691.15 10.12 782 118605 131719 110338193
Pruritus 592.26 10.12 1666 117721 579894 109890018
Cardio-respiratory arrest 356.81 10.12 527 118860 115309 110354603
Intentional self-injury 344.14 10.12 301 119086 37128 110432784
Respiratory arrest 332.89 10.12 361 119026 57938 110411974
Suicide attempt 307.82 10.12 463 118924 102931 110366981
Suspected suicide 272.46 10.12 182 119205 15017 110454895
Synovitis 259.36 10.12 8 119379 274084 110195828
Urticaria 249.28 10.12 834 118553 318023 110151889
Poisoning deliberate 246.57 10.12 214 119173 26117 110443795
Poisoning 239.73 10.12 220 119167 28885 110441027
Cardiac arrest 221.68 10.12 586 118801 196167 110273745
Coma 213.95 10.12 424 118963 117445 110352467
Dry skin 209.72 10.12 399 118988 107254 110362658
Joint swelling 201.21 10.12 114 119273 442731 110027181
Somnolence 195.47 10.12 735 118652 296714 110173198
Eczema 193.10 10.12 308 119079 71985 110397927
Pemphigus 190.42 10.12 10 119377 214560 110255352
Hand deformity 188.36 10.12 12 119375 218494 110251418
Glossodynia 183.31 10.12 15 119372 221989 110247923
Arthropathy 174.96 10.12 47 119340 287475 110182437
Systemic lupus erythematosus 174.04 10.12 32 119355 254306 110215606
Pericarditis 169.83 10.12 19 119368 219095 110250817
Helicobacter infection 162.89 10.12 8 119379 181869 110288043
Rheumatoid arthritis 151.24 10.12 67 119320 299546 110170366
Dissociation 150.79 10.12 107 119280 9735 110460177
Contraindicated product administered 150.26 10.12 41 119346 248226 110221686
Lower respiratory tract infection 147.41 10.12 40 119347 243066 110226846
Wound 137.65 10.12 41 119346 234396 110235516
Infusion related reaction 135.53 10.12 127 119260 381035 110088877
Muscle injury 130.03 10.12 5 119382 140802 110329110
Drug reaction with eosinophilia and systemic symptoms 129.73 10.12 279 119108 81816 110388096
Drug dependence 129.31 10.12 210 119177 49810 110420102
Skin plaque 127.00 10.12 107 119280 12538 110457374
Drug intolerance 123.92 10.12 154 119233 406358 110063554
Folliculitis 123.89 10.12 17 119370 167636 110302276
Scratch 122.54 10.12 106 119281 12873 110457039
Serotonin syndrome 122.34 10.12 225 119162 58928 110410984
Impaired healing 121.85 10.12 31 119356 196686 110273226
Anticholinergic syndrome 116.81 10.12 67 119320 4213 110465699
Priapism 116.79 10.12 75 119312 5786 110464126
Sleep disorder due to a general medical condition 116.43 10.12 205 119182 51907 110418005
Hepatic enzyme increased 113.95 10.12 107 119280 320785 110149127
Distributive shock 113.83 10.12 74 119313 5830 110464082
General physical health deterioration 112.80 10.12 178 119209 425117 110044795
Skin exfoliation 109.96 10.12 272 119115 87379 110382533
Chemical submission 106.46 10.12 35 119352 545 110469367
Bradypnoea 105.52 10.12 82 119305 8567 110461345
Overdose 104.97 10.12 515 118872 233279 110236633
Suicidal ideation 101.88 10.12 276 119111 93661 110376251
Neuroblastoma recurrent 100.78 10.12 33 119354 507 110469405
Treatment failure 94.30 10.12 96 119291 277138 110192774
Lip dry 87.72 10.12 5 119382 100078 110369834
Sleep disorder due to general medical condition, insomnia type 87.56 10.12 7 119380 105636 110364276
Bursitis 87.44 10.12 17 119370 129901 110340011
Irritable bowel syndrome 87.22 10.12 34 119353 164181 110305731
Therapeutic product effect decreased 86.09 10.12 82 119305 244234 110225678
Injection site pain 85.69 10.12 400 118987 177522 110292390
Skin fissures 85.11 10.12 118 119269 24340 110445572
Blood cholesterol increased 84.64 10.12 47 119340 184738 110285174
Product dose omission issue 83.97 10.12 615 118772 321167 110148745
Musculoskeletal stiffness 83.16 10.12 108 119279 279714 110190198
Abdominal discomfort 82.38 10.12 190 119197 393668 110076244
Urticaria thermal 81.46 10.12 28 119359 503 110469409
Osteoarthritis 78.65 10.12 50 119337 182573 110287339
Anxiety 77.54 10.12 637 118750 344441 110125471
Maternal exposure during pregnancy 77.16 10.12 97 119290 254786 110215126
Type 2 diabetes mellitus 77.04 10.12 48 119339 177184 110292728
Hypercholesterolaemia 75.34 10.12 6 119381 90831 110379081
Agitation 73.83 10.12 279 119108 112772 110357140
C-reactive protein increased 72.36 10.12 77 119310 217842 110252070
Psoriatic arthropathy 71.73 10.12 64 119323 196697 110273215
Myelosuppression 71.05 10.12 9 119378 94331 110375581
Fibromyalgia 70.62 10.12 49 119338 170860 110299052
Electrocardiogram QT prolonged 69.59 10.12 267 119120 108693 110361219
Pulmonary fibrosis 69.42 10.12 13 119374 102029 110367883
Disturbance in attention 68.06 10.12 183 119204 61812 110408100
Victim of chemical submission 67.72 10.12 28 119359 851 110469061
Peripheral venous disease 65.90 10.12 7 119380 84110 110385802
Therapeutic response shortened 64.30 10.12 115 119272 29468 110440444
Musculoskeletal pain 63.80 10.12 62 119325 182961 110286951
Intentional product misuse 63.39 10.12 298 119089 132606 110337306
Illness 63.23 10.12 214 119173 81957 110387955
Eye pruritus 63.19 10.12 121 119266 32654 110437258
Injury 63.02 10.12 59 119328 177206 110292706
Miosis 61.92 10.12 96 119291 21887 110448025
Victim of crime 61.51 10.12 30 119357 1353 110468559
Rash maculo-papular 61.31 10.12 198 119189 74024 110395888
Initial insomnia 60.44 10.12 65 119322 10324 110459588
Burning mouth syndrome 60.39 10.12 24 119363 657 110469255
Joint range of motion decreased 60.25 10.12 28 119359 121804 110348108
Intentional product use issue 59.93 10.12 110 119277 247796 110222116
Alcoholism 58.41 10.12 41 119346 3666 110466246
Angioedema 57.76 10.12 235 119152 98265 110371647
Exposure during pregnancy 56.88 10.12 58 119329 167366 110302546
Peripheral circulatory failure 56.50 10.12 31 119356 1788 110468124
Wound infection 56.36 10.12 17 119370 96448 110373464
Stomatitis 55.96 10.12 131 119256 270111 110199801
Decompression sickness 55.92 10.12 15 119372 109 110469803
Red blood cell sedimentation rate increased 55.40 10.12 9 119378 78293 110391619
Alopecia 55.11 10.12 205 119182 364548 110105364
Asphyxia 54.66 10.12 72 119315 14143 110455769
Drug interaction 54.34 10.12 799 118588 499384 109970528
Adulterated product 54.22 10.12 26 119361 1129 110468783
Urinary retention 54.07 10.12 182 119205 69501 110400411
Inflammation 53.95 10.12 78 119309 193160 110276752
Live birth 53.88 10.12 6 119381 69478 110400434
Electrocardiogram QRS complex prolonged 53.26 10.12 68 119319 12953 110456959
Wheezing 52.63 10.12 124 119263 255106 110214806
Anaemia 52.61 10.12 360 119027 546726 109923186
Neuroglycopenia 51.81 10.12 25 119362 1101 110468811
Liver injury 51.22 10.12 52 119335 150361 110319551
Disease progression 50.76 10.12 118 119269 243916 110225996
Mydriasis 50.57 10.12 88 119299 22069 110447843
Neurodermatitis 49.89 10.12 34 119353 2898 110467014
Blood cholesterol decreased 49.82 10.12 33 119354 2683 110467229
Sciatica 49.27 10.12 19 119368 92380 110377532
Suicidal behaviour 48.96 10.12 36 119351 3461 110466451
Gait inability 48.93 10.12 45 119342 136331 110333581
Pneumonia 48.88 10.12 660 118727 876054 109593858
Prescribed overdose 48.40 10.12 17 119370 87564 110382348
Panic attack 47.60 10.12 100 119287 28840 110441072
Sedation 47.18 10.12 174 119213 69509 110400403
Grip strength decreased 47.07 10.12 14 119373 80160 110389752
Perfume sensitivity 46.53 10.12 23 119364 1068 110468844
Multiple drug therapy 46.37 10.12 50 119337 7964 110461948
Incorrect dose administered 46.25 10.12 228 119159 103413 110366499
Altered state of consciousness 46.04 10.12 152 119235 57474 110412438
Inappropriate schedule of product administration 45.20 10.12 375 119012 203262 110266650
Pupillary reflex impaired 44.55 10.12 36 119351 3979 110465933
Blepharospasm 44.45 10.12 4 119383 54847 110415065
Lung disorder 44.30 10.12 79 119308 179968 110289944
Chronic spontaneous urticaria 43.46 10.12 27 119360 1966 110467946
Mental disorder 43.07 10.12 115 119272 38676 110431236
Mastocytosis 42.96 10.12 20 119367 812 110469100
Impaired quality of life 41.77 10.12 97 119290 29920 110439992
Gastrointestinal disorder 41.27 10.12 129 119258 241823 110228089
Administration site erythema 40.78 10.12 16 119371 423 110469489
Corneal reflex decreased 40.53 10.12 17 119370 536 110469376
Areflexia 40.52 10.12 43 119344 6726 110463186
Exposure via ingestion 40.26 10.12 37 119350 4863 110465049
Gastric polyps 40.21 10.12 39 119348 5484 110464428
Seizure 40.21 10.12 390 118997 220795 110249117
Rash 40.17 10.12 1165 118222 819799 109650113
Swelling 39.98 10.12 219 119168 350822 110119090
Depression 39.30 10.12 519 118868 316816 110153096
Product use in unapproved indication 39.30 10.12 690 118697 446687 110023225
Hyperthermia 39.14 10.12 77 119310 21195 110448717
Vasoplegia syndrome 38.84 10.12 38 119349 5401 110464511
Cerebral disorder 38.47 10.12 42 119345 6784 110463128
Erythema 38.34 10.12 482 118905 290965 110178947
Parasomnia 38.16 10.12 18 119369 753 110469159
Irritability 38.09 10.12 126 119261 47683 110422229
Night sweats 36.49 10.12 55 119332 133928 110335984
Injection site mass 35.87 10.12 81 119306 24532 110445380
Accidental death 35.78 10.12 35 119352 4974 110464938
Dermatitis exfoliative generalised 35.31 10.12 51 119336 10921 110458991
Tachycardia 35.20 10.12 387 119000 226258 110243654
Ureteric compression 34.75 10.12 13 119374 301 110469611
Parkinsonism 34.57 10.12 75 119312 22112 110447800
Dermatitis 34.49 10.12 86 119301 27751 110442161
Product administration interrupted 34.19 10.12 51 119336 11241 110458671
Hypoaesthesia 34.17 10.12 199 119188 314024 110155888
Ill-defined disorder 34.11 10.12 74 119313 156779 110313133
Feeling abnormal 34.01 10.12 321 119066 180390 110289522
Papule 33.93 10.12 48 119339 10085 110459827
Psoriasis 33.89 10.12 263 119124 139730 110330182
Drug screen positive 33.65 10.12 38 119349 6372 110463540
Faecal vomiting 33.60 10.12 21 119366 1545 110468367
Hallucination, gustatory 33.60 10.12 9 119378 65 110469847
Substance use disorder 32.91 10.12 40 119347 7250 110462662
Blister 32.89 10.12 130 119257 227246 110242666
Neuroblastoma 32.81 10.12 13 119374 353 110469559
Nail disorder 32.44 10.12 11 119376 57924 110411988
Hypotension 32.43 10.12 767 118620 523082 109946830
Eye irritation 32.05 10.12 94 119293 33358 110436554
Diarrhoea 31.92 10.12 962 118425 1138543 109331369
Rash pruritic 31.86 10.12 198 119189 97871 110372041
Eosinophilia 31.43 10.12 135 119252 57801 110412111
Obesity 31.39 10.12 46 119341 113305 110356607
Psychotic symptom 31.39 10.12 29 119358 3838 110466074
Infection 31.10 10.12 246 119141 361954 110107958
Fixed eruption 31.03 10.12 30 119357 4202 110465710
Exposure via skin contact 31.03 10.12 53 119334 13094 110456818
Liver disorder 31.02 10.12 67 119320 142176 110327736
Hyperglycaemia 30.98 10.12 177 119210 84913 110384999
Bacterial disease carrier 30.96 10.12 23 119364 2246 110467666
Withdrawal syndrome 30.86 10.12 89 119298 31291 110438621
Ocular hyperaemia 30.82 10.12 103 119284 39183 110430729
Product dose omission in error 30.57 10.12 74 119313 23438 110446474
Respiratory acidosis 30.37 10.12 54 119333 13772 110456140
Bezoar 30.22 10.12 29 119358 4025 110465887
Drug withdrawal syndrome 30.06 10.12 100 119287 37954 110431958
Tremor 29.89 10.12 342 119045 201890 110268022
Aggression 29.87 10.12 135 119252 59075 110410837
Andropause 29.68 10.12 9 119378 106 110469806
Neutropenia 29.65 10.12 260 119127 374360 110095552
Depressed level of consciousness 29.47 10.12 215 119172 112063 110357849
Post-traumatic stress disorder 29.46 10.12 36 119351 6560 110463352
Thrombocytopenia 29.02 10.12 239 119148 348646 110121266
Respiratory depression 28.84 10.12 88 119299 31913 110437999
Vision blurred 28.83 10.12 238 119149 128784 110341128
Frequent bowel movements 28.78 10.12 21 119366 71369 110398543
Mobility decreased 28.76 10.12 145 119242 237277 110232635
No adverse event 28.48 10.12 156 119231 73683 110396229
Pain of skin 28.17 10.12 65 119322 19964 110449948
Insomnia 28.11 10.12 546 118841 360044 110109868
Drug use disorder 28.05 10.12 61 119326 18013 110451899
Personal relationship issue 27.82 10.12 10 119377 206 110469706
Injection site reaction 27.80 10.12 178 119209 88892 110381020
Dementia 27.53 10.12 86 119301 31587 110438325
Stupor 27.45 10.12 39 119348 8226 110461686
Dysuria 27.22 10.12 133 119254 60098 110409814
Allergy test positive 26.67 10.12 15 119372 908 110469004
Depressed mood 26.57 10.12 133 119254 60676 110409236
Haematochezia 26.38 10.12 53 119334 115471 110354441
Psychomotor retardation 26.22 10.12 37 119350 7755 110462157
Mental status changes 26.19 10.12 156 119231 75966 110393946
Blood lactic acid abnormal 25.87 10.12 8 119379 101 110469811
Hip arthroplasty 25.83 10.12 14 119373 55799 110414113
Dry eye 25.79 10.12 124 119263 55669 110414243
Rectal haemorrhage 25.67 10.12 57 119330 119776 110350136
Autoimmune disorder 25.45 10.12 20 119367 65463 110404449
Skin swelling 25.19 10.12 37 119350 8043 110461869
Onychomadesis 25.00 10.12 9 119378 45654 110424258
Skin discolouration 24.87 10.12 112 119275 48934 110420978
Toxic epidermal necrolysis 24.74 10.12 124 119263 56603 110413309
Malignant neoplasm progression 24.49 10.12 101 119286 174466 110295446
Clonus 24.46 10.12 38 119349 8678 110461234
Sinus tachycardia 24.39 10.12 104 119283 44389 110425523
Atrioventricular block first degree 24.39 10.12 50 119337 14175 110455737
Haemoglobin decreased 24.20 10.12 163 119224 248564 110221348
Dyspepsia 24.07 10.12 115 119272 190850 110279062
Pyelocaliectasis 24.00 10.12 15 119372 1104 110468808
Prescribed underdose 23.98 10.12 21 119366 65153 110404759
Thymus disorder 23.95 10.12 12 119375 574 110469338
Knee arthroplasty 23.81 10.12 21 119366 64927 110404985
Neuropathy peripheral 23.76 10.12 106 119281 179171 110290741
Skin discomfort 23.58 10.12 19 119368 2091 110467821
Encephalopathy 23.48 10.12 159 119228 80896 110389016
Arthritis 23.48 10.12 97 119290 167489 110302423
Renal impairment 23.45 10.12 114 119273 188331 110281581
Total cholesterol/HDL ratio abnormal 23.43 10.12 7 119380 78 110469834
Toxic skin eruption 23.26 10.12 74 119313 27441 110442471
Hypersensitivity 23.22 10.12 302 119085 403696 110066216
Diet failure 23.08 10.12 6 119381 38 110469874
Skin haemorrhage 23.06 10.12 69 119318 24758 110445154
Needle issue 23.04 10.12 56 119331 17784 110452128
Skin irritation 23.00 10.12 53 119334 16266 110453646
Finger deformity 22.97 10.12 4 119383 33088 110436824
Nasal congestion 22.88 10.12 183 119204 98099 110371813
Skin weeping 22.84 10.12 24 119363 3711 110466201
Hallucination, visual 22.82 10.12 94 119293 39511 110430401
Colitis ulcerative 22.81 10.12 30 119357 77333 110392579
Foot deformity 22.67 10.12 12 119375 48468 110421444
Skin lesion 22.61 10.12 113 119274 51518 110418394
Hallucination 22.60 10.12 187 119200 101245 110368667
Mixed liver injury 22.56 10.12 44 119343 12035 110457877
Skin burning sensation 22.53 10.12 63 119324 21762 110448150
Dissociative disorder 22.47 10.12 15 119372 1236 110468676
Plasma cell myeloma 22.30 10.12 21 119366 62915 110406997
Delusion of parasitosis 22.26 10.12 9 119378 258 110469654
Bronchial wall thickening 22.15 10.12 22 119365 3185 110466727
Onychomycosis 22.13 10.12 7 119380 38524 110431388
Therapeutic product effect incomplete 22.11 10.12 146 119241 223659 110246253
Generalised tonic-clonic seizure 22.09 10.12 117 119270 54563 110415349
Pregnancy 21.95 10.12 14 119373 51053 110418859
Sensitivity to weather change 21.81 10.12 39 119348 9989 110459923
Hallucinations, mixed 21.79 10.12 36 119351 8657 110461255
Tachyphrenia 21.75 10.12 19 119368 2337 110467575
Adverse event 21.52 10.12 54 119333 108755 110361157
Aplastic anaemia 21.12 10.12 66 119321 24242 110445670
Bradykinesia 21.01 10.12 40 119347 10748 110459164
Labile hypertension 20.82 10.12 11 119376 588 110469324
Febrile neutropenia 20.79 10.12 230 119157 316537 110153375
Cardiac failure congestive 20.79 10.12 88 119299 150912 110319000
Wrong technique in device usage process 20.65 10.12 31 119356 6870 110463042
Autism spectrum disorder 20.63 10.12 17 119370 1931 110467981
White blood cell count decreased 20.52 10.12 154 119233 229236 110240676
Binge eating 20.30 10.12 11 119376 619 110469293
Pleural effusion 20.14 10.12 111 119276 177598 110292314
Long QT syndrome 19.93 10.12 31 119356 7087 110462825
Mast cell activation syndrome 19.76 10.12 15 119372 1513 110468399
Face oedema 19.73 10.12 80 119307 33389 110436523
Leukopenia 19.70 10.12 88 119299 148703 110321209
Unresponsive to stimuli 19.61 10.12 127 119260 63663 110406249
Exposure to toxic agent 19.50 10.12 43 119344 12815 110457097
Lower limb fracture 19.50 10.12 32 119355 75316 110394596
Apallic syndrome 19.23 10.12 13 119374 1093 110468819
Exostosis 19.21 10.12 13 119374 45943 110423969
Hyperleukocytosis 19.10 10.12 21 119366 3418 110466494
Asthenia 18.90 10.12 583 118804 688416 109781496
Drug diversion 18.86 10.12 14 119373 1366 110468546
Hypotonia 18.83 10.12 48 119339 15697 110454215
Blood immunoglobulin E increased 18.77 10.12 31 119356 7451 110462461
Phlebotomy 18.71 10.12 6 119381 86 110469826
Bronchiectasis 18.65 10.12 8 119379 36485 110433427
Pityriasis rubra pilaris 18.59 10.12 8 119379 269 110469643
False positive investigation result 18.55 10.12 14 119373 1400 110468512
Lip oedema 18.42 10.12 31 119356 7569 110462343
Cytomegalovirus infection 18.33 10.12 19 119368 54425 110415487
Rash erythematous 18.30 10.12 151 119236 81681 110388231
Urticaria chronic 18.27 10.12 11 119376 757 110469155
Thymoma 18.27 10.12 9 119378 415 110469497
Prostate cancer 18.07 10.12 9 119378 37632 110432280
Cerebrovascular accident 18.03 10.12 118 119269 181166 110288746
Blood creatine increased 18.01 10.12 39 119348 11482 110458430
Pigmentation disorder 17.95 10.12 30 119357 7281 110462631
Road traffic accident 17.78 10.12 58 119329 107340 110362572
Acute respiratory distress syndrome 17.65 10.12 108 119279 53090 110416822
Administration related reaction 17.61 10.12 8 119379 307 110469605
Pneumonitis 17.57 10.12 35 119352 76496 110393416
Injection 17.56 10.12 4 119383 13 110469899
Cerebral infarction 17.55 10.12 18 119369 51820 110418092
Postmortem blood drug level 17.48 10.12 8 119379 312 110469600
Liver function test increased 17.46 10.12 44 119343 88504 110381408
Eosinophilic oesophagitis 17.24 10.12 13 119374 1299 110468613
Contusion 17.13 10.12 165 119222 233196 110236716
Bronchial secretion retention 17.12 10.12 24 119363 5000 110464912
Arthritis allergic 17.11 10.12 4 119383 15 110469897
Nodular rash 17.11 10.12 8 119379 328 110469584
Cold agglutinins positive 17.05 10.12 5 119382 52 110469860
Acute myocardial infarction 17.02 10.12 41 119346 83736 110386176
Persistent genital arousal disorder 16.91 10.12 10 119377 666 110469246
Gastrointestinal haemorrhage 16.84 10.12 107 119280 165411 110304501
Menopause 16.77 10.12 17 119370 2521 110467391
Negative thoughts 16.68 10.12 14 119373 1632 110468280
Pemphigoid 16.66 10.12 53 119334 19654 110450258
Abnormal sleep-related event 16.60 10.12 11 119376 895 110469017
Complication of device insertion 16.27 10.12 32 119355 8806 110461106
Wrist fracture 16.27 10.12 43 119344 14374 110455538
Victim of sexual abuse 16.23 10.12 9 119378 530 110469382
Inability to afford medication 16.22 10.12 21 119366 4055 110465857
Cardiac pacemaker evaluation 16.16 10.12 6 119381 136 110469776
Temperature intolerance 16.14 10.12 42 119345 13908 110456004
Rebound atopic dermatitis 15.98 10.12 15 119372 2026 110467886
Substance abuse 15.96 10.12 39 119348 12424 110457488
Oedema peripheral 15.95 10.12 254 119133 328406 110141506
Near death experience 15.95 10.12 11 119376 956 110468956
Emotional disorder of childhood 15.87 10.12 4 119383 22 110469890
Drug tolerance decreased 15.82 10.12 5 119382 27535 110442377
Fear 15.77 10.12 58 119329 23135 110446777
Atrial fibrillation 15.76 10.12 165 119222 229477 110240435
Photosensitivity reaction 15.75 10.12 62 119325 25527 110444385
Cognitive disorder 15.74 10.12 154 119233 87357 110382555
Victim of homicide 15.72 10.12 7 119380 256 110469656
Febrile bone marrow aplasia 15.71 10.12 48 119339 17417 110452495
Disturbance in sexual arousal 15.67 10.12 8 119379 398 110469514
Myositis 15.62 10.12 7 119380 31109 110438803
Sinusitis 15.52 10.12 226 119161 296462 110173450
Rash papular 15.45 10.12 65 119322 27574 110442338
Ascites 15.45 10.12 50 119337 92758 110377154
Periorbital swelling 15.45 10.12 24 119363 5481 110464431
Acute generalised exanthematous pustulosis 15.42 10.12 55 119332 21609 110448303
Polymicrogyria 15.42 10.12 3 119384 3 110469909
Oropharyngeal pain 15.40 10.12 218 119169 135058 110334854
Hypertension 15.38 10.12 426 118961 509658 109960254
Nasopharyngitis 15.30 10.12 317 119070 394044 110075868
Blood pressure systolic abnormal 15.22 10.12 4 119383 24846 110445066
Joint dislocation 15.21 10.12 9 119378 34181 110435731
Analgesic drug level increased 15.19 10.12 20 119367 3926 110465986
Lupus-like syndrome 15.18 10.12 13 119374 40779 110429133
Derailment 15.14 10.12 5 119382 79 110469833
Antidepressant drug level increased 15.11 10.12 9 119378 607 110469305
Rash macular 15.10 10.12 82 119305 38604 110431308
Linear IgA disease 15.01 10.12 21 119366 4368 110465544
International normalised ratio increased 14.97 10.12 46 119341 86726 110383186
Transplant rejection 14.96 10.12 4 119383 24563 110445349
Hypocalcaemia 14.91 10.12 30 119357 65336 110404576
Injection site swelling 14.90 10.12 116 119271 61674 110408238
Osteonecrosis of jaw 14.80 10.12 18 119369 47999 110421913
Metastases to liver 14.80 10.12 10 119377 35376 110434536
Product quality issue 14.79 10.12 39 119348 77260 110392652
Interstitial lung disease 14.73 10.12 89 119298 139245 110330667
Tonsillar hypertrophy 14.71 10.12 14 119373 1924 110467988
Hallucination, auditory 14.70 10.12 62 119325 26335 110443577
Cardiomyopathy 14.67 10.12 9 119378 33516 110436396
Coeliac disease 14.62 10.12 15 119372 43172 110426740
Labelled drug-drug interaction issue 14.59 10.12 20 119367 4081 110465831
Non-cardiogenic pulmonary oedema 14.43 10.12 14 119373 1970 110467942
Anion gap 14.42 10.12 14 119373 1971 110467941
Methaemoglobinaemia 14.29 10.12 31 119356 9137 110460775
Macular degeneration 14.22 10.12 3 119384 21656 110448256
Loss of consciousness 14.19 10.12 294 119093 196012 110273900
Poor feeding infant 14.08 10.12 6 119381 197 110469715
Mental impairment 14.06 10.12 55 119332 22584 110447328
Hypercapnic coma 13.89 10.12 8 119379 507 110469405
Product preparation error 13.89 10.12 34 119353 10845 110459067
Troponin T increased 13.83 10.12 20 119367 4286 110465626
Off label use 13.81 10.12 1414 117973 1498771 108971141
Transaminases increased 13.70 10.12 30 119357 63360 110406552
Condition aggravated 13.69 10.12 651 118736 734185 109735727
Dyspnoea 13.61 10.12 1020 118367 1105852 109364060
Haemorrhage 13.58 10.12 64 119323 106628 110363284
Ear swelling 13.56 10.12 14 119373 2122 110467790
Progressive multifocal leukoencephalopathy 13.52 10.12 5 119382 24951 110444961
Spinal cord compression 13.49 10.12 27 119360 7525 110462387
Therapy non-responder 13.41 10.12 107 119280 157200 110312712
Crying 13.35 10.12 59 119328 25569 110444343
Peptic ulcer 13.32 10.12 27 119360 7592 110462320
Taste disorder 13.28 10.12 32 119355 65355 110404557
Upper limb fracture 13.17 10.12 51 119336 20837 110449075
Dystonia 13.14 10.12 59 119328 25746 110444166
Breast adenoma 13.05 10.12 4 119383 49 110469863
Adverse drug reaction 13.04 10.12 64 119323 105495 110364417
Prothrombin time ratio decreased 13.04 10.12 12 119375 1580 110468332
Cerebral haemorrhage 13.03 10.12 32 119355 64936 110404976
Burnout syndrome 13.00 10.12 7 119380 389 110469523
Asthma 12.96 10.12 358 119029 249933 110219979
Injection site induration 12.89 10.12 34 119353 11349 110458563
Tardive dyskinesia 12.86 10.12 38 119349 13541 110456371
Neoplasm progression 12.81 10.12 32 119355 64563 110405349
Diabetic ketoacidosis 12.72 10.12 16 119371 42042 110427870
Alpha 1 globulin increased 12.72 10.12 5 119382 133 110469779
Lymphomatoid papulosis 12.69 10.12 7 119380 408 110469504
Pancytopenia 12.66 10.12 155 119232 209458 110260454
Dyskinesia 12.64 10.12 97 119290 51349 110418563
Acarodermatitis 12.60 10.12 13 119374 1968 110467944
Product use issue 12.55 10.12 249 119138 311446 110158466
Loss of personal independence in daily activities 12.35 10.12 103 119284 149917 110319995
Diabetes mellitus inadequate control 12.22 10.12 64 119323 29711 110440201
Decreased appetite 12.22 10.12 406 118981 475440 109994472
Blood pressure decreased 12.12 10.12 183 119204 114908 110355004
Antidepressant discontinuation syndrome 12.09 10.12 5 119382 152 110469760
Middle insomnia 12.08 10.12 49 119338 20453 110449459
Pulmonary embolism 12.06 10.12 161 119226 214313 110255599
Burning sensation 12.06 10.12 121 119266 69091 110400821
Blood test abnormal 12.04 10.12 8 119379 28546 110441366
Oedema 12.04 10.12 157 119230 209819 110260093
Peripheral swelling 12.03 10.12 338 119049 403696 110066216
Mixed dementia 11.97 10.12 6 119381 287 110469625
Alpha 2 globulin increased 11.97 10.12 5 119382 156 110469756
Surgery 11.97 10.12 81 119306 41202 110428710
Autonomic nervous system imbalance 11.96 10.12 22 119365 5758 110464154
Hypercalcaemia 11.90 10.12 20 119367 46637 110423275
Skin infection 11.86 10.12 52 119335 22457 110447455
Restless arm syndrome 11.84 10.12 4 119383 68 110469844
Clostridium difficile infection 11.83 10.12 24 119363 52105 110417807
Hypothermia 11.83 10.12 58 119329 26244 110443668
Eyelids pruritus 11.81 10.12 12 119375 1785 110468127
Haematotoxicity 11.81 10.12 4 119383 21078 110448834
Akathisia 11.80 10.12 43 119344 17070 110452842
Substance abuser 11.78 10.12 7 119380 470 110469442
Maternal exposure timing unspecified 11.75 10.12 4 119383 21009 110448903
Polyarthritis 11.71 10.12 3 119384 18960 110450952
Mouth breathing 11.71 10.12 6 119381 301 110469611
Enuresis 11.69 10.12 18 119369 4078 110465834
Sensory integrative dysfunction 11.68 10.12 3 119384 18 110469894
Lacrimation increased 11.67 10.12 65 119322 30885 110439027
Accidental exposure to product 11.57 10.12 93 119294 49915 110419997
Muscle rigidity 11.53 10.12 54 119333 23977 110445935
Rebound eczema 11.51 10.12 12 119375 1840 110468072
Conjunctivitis 11.46 10.12 69 119318 33723 110436189
Female reproductive tract disorder 11.45 10.12 7 119380 495 110469417
Nodule 11.43 10.12 11 119376 32620 110437292
Drug level decreased 11.33 10.12 3 119384 18545 110451367
Rash pustular 11.30 10.12 35 119352 12794 110457118
Myocardial infarction 11.24 10.12 143 119244 191940 110277972
Pelvic inflammatory disease 11.21 10.12 11 119376 1569 110468343
Lip erythema 11.18 10.12 7 119380 517 110469395
Metabolic acidosis 11.05 10.12 160 119227 99584 110370328
Intentional dose omission 11.05 10.12 47 119340 20033 110449879
Hereditary angioedema 11.03 10.12 24 119363 7090 110462822
Electric shock sensation 11.02 10.12 12 119375 1932 110467980
Mood altered 10.98 10.12 49 119338 21326 110448586
Psychiatric symptom 10.93 10.12 28 119359 9185 110460727
Fatigue 10.91 10.12 1148 118239 1214810 109255102
Normal newborn 10.87 10.12 5 119382 21891 110448021
Transverse sinus thrombosis 10.87 10.12 8 119379 770 110469142
Panic reaction 10.69 10.12 20 119367 5302 110464610
Appendicitis 10.68 10.12 9 119378 28455 110441457
Abdominal pain upper 10.66 10.12 291 119096 348820 110121092
Generalised bullous fixed drug eruption 10.64 10.12 8 119379 796 110469116
Tuberculosis 10.62 10.12 3 119384 17771 110452141
Injection site bruising 10.62 10.12 93 119294 51170 110418742
Drug screen false positive 10.60 10.12 10 119377 1359 110468553
Epilepsy 10.59 10.12 64 119323 100145 110369767
Thyroiditis acute 10.58 10.12 5 119382 210 110469702
Drug-induced liver injury 10.55 10.12 81 119306 119986 110349926
Lip swelling 10.54 10.12 92 119295 50575 110419337
Product administered at inappropriate site 10.51 10.12 20 119367 5373 110464539
Superior mesenteric artery syndrome 10.41 10.12 5 119382 218 110469694
Hyperreflexia 10.41 10.12 28 119359 9457 110460455
Bladder dilatation 10.39 10.12 13 119374 2426 110467486
Cholestasis 10.39 10.12 111 119276 64407 110405505
Hallucination, olfactory 10.37 10.12 7 119380 587 110469325
Proteinuria 10.35 10.12 17 119370 40001 110429911
Libido decreased 10.34 10.12 21 119366 5914 110463998
Bruxism 10.33 10.12 19 119368 4975 110464937
Bipolar disorder 10.30 10.12 27 119360 8980 110460932
Self-destructive behaviour 10.20 10.12 8 119379 847 110469065
Metastases to central nervous system 10.16 10.12 6 119381 22811 110447101
Secondary hypogonadism 10.13 10.12 8 119379 855 110469057
Alcohol withdrawal syndrome 10.13 10.12 12 119375 2118 110467794

FDA Adverse Event Reporting System (Pediatric)

None

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 D006633 Histamine Antagonists
MeSH PA D006634 Histamine H1 Antagonists
MeSH PA D018377 Neurotransmitter Agents
CHEBI has role CHEBI:35469 antidepressant
CHEBI has role CHEBI:35474 anxiolytic drug
CHEBI has role CHEBI:35476 antipsychotic agent
CHEBI has role CHEBI:37955 H<small><sub>1</sub></small>-receptor antagonist
CHEBI has role CHEBI:50177 dermatologic drug
CHEBI has role CHEBI:59683 antipruritic drug
CHEBI has role CHEBI:149553 anticoronaviral agent
FDA EPC N0000175750 Antihistamine

Related Drugs by ATC class:

N05BB Diphenylmethane derivatives 1 drug
captodiame

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




🐶 Veterinary Drug Use

None

🐶 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 Viral envelope protein IC50 5.20 CHEMBL

External reference:

IDSource
4019782 VUID
N0000147873 NUI
D00672 KEGG_DRUG
10246-75-0 SECONDARY_CAS_RN
2192-20-3 SECONDARY_CAS_RN
4017874 VANDF
4017875 VANDF
4019782 VANDF
C0020404 UMLSCUI
CHEBI:5818 CHEBI
CHEMBL896 ChEMBL_ID
CHEMBL1200467 ChEMBL_ID
CHEMBL3186993 ChEMBL_ID
DB00557 DRUGBANK_ID
D006919 MESH_DESCRIPTOR_UI
3658 PUBCHEM_CID
7199 IUPHAR_LIGAND_ID
599 INN_ID
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
30S50YM8OG INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
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 0093-5062 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 0121-1034 SOLUTION 10 mg ORAL ANDA 11 sections
Hydroxyzine Pamoate HUMAN PRESCRIPTION DRUG LABEL 1 0185-0613 CAPSULE 25 mg ORAL ANDA 13 sections
hydroxyzine pamoate HUMAN PRESCRIPTION DRUG LABEL 1 0185-0615 CAPSULE 50 mg ORAL ANDA 13 sections
hydroxyzine pamoate HUMAN PRESCRIPTION DRUG LABEL 1 0185-0674 CAPSULE 25 mg ORAL ANDA 13 sections
Hydroxyzine pamoate HUMAN PRESCRIPTION DRUG LABEL 1 0185-0676 CAPSULE 50 mg ORAL ANDA 13 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
Hydroxyzine HUMAN PRESCRIPTION DRUG LABEL 1 0404-9878 INJECTION, SOLUTION 50 mg INTRAMUSCULAR ANDA 10 sections
Hydroxyzine HUMAN PRESCRIPTION DRUG LABEL 1 0404-9878 INJECTION, SOLUTION 50 mg INTRAMUSCULAR ANDA 10 sections
Hydroxyzine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0440-1617 TABLET, FILM COATED 25 mg ORAL ANDA 11 sections
Hydroxyzine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0517-4201 INJECTION, SOLUTION 25 mg INTRAMUSCULAR ANDA 11 sections
Hydroxyzine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0517-5601 INJECTION, SOLUTION 50 mg INTRAMUSCULAR ANDA 11 sections
Hydroxyzine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0517-5602 INJECTION, SOLUTION 50 mg INTRAMUSCULAR ANDA 11 sections
Hydroxyzine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0517-5610 INJECTION, SOLUTION 50 mg INTRAMUSCULAR ANDA 11 sections
Hydroxyzine Pamoate HUMAN PRESCRIPTION DRUG LABEL 1 0555-0302 CAPSULE 50 mg ORAL ANDA 13 sections
Hydroxyzine Pamoate HUMAN PRESCRIPTION DRUG LABEL 1 0555-0302 CAPSULE 50 mg ORAL ANDA 13 sections
Hydroxyzine Pamoate HUMAN PRESCRIPTION DRUG LABEL 1 0555-0323 CAPSULE 25 mg ORAL ANDA 13 sections
Hydroxyzine Pamoate HUMAN PRESCRIPTION DRUG LABEL 1 0555-0323 CAPSULE 25 mg ORAL ANDA 13 sections
Hydroxyzine Pamoate HUMAN PRESCRIPTION DRUG LABEL 1 0555-0324 CAPSULE 100 mg ORAL ANDA 13 sections
Hydroxyzine Pamoate HUMAN PRESCRIPTION DRUG LABEL 1 0555-0324 CAPSULE 100 mg ORAL ANDA 13 sections
Hydroxyzine hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-8082 TABLET 25 mg ORAL ANDA 12 sections
Hydroxyzine Pamoate HUMAN PRESCRIPTION DRUG LABEL 1 0615-8419 CAPSULE 25 mg ORAL ANDA 13 sections
Hydroxyzine Pamoate HUMAN PRESCRIPTION DRUG LABEL 1 0615-8420 CAPSULE 50 mg ORAL ANDA 13 sections