zolpidem 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
hypnotics/sedatives, zolpidem derivatives 2870 82626-48-0

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • ambien
  • zolpidem
  • zolpidem tartrate
An imidazopyridine derivative and short-acting GABA-A receptor agonist that is used for the treatment of INSOMNIA.
  • Molecular weight: 307.40
  • Formula: C19H21N3O
  • CLOGP: 3.03
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 0
  • TPSA: 37.61
  • ALOGS: -3.99
  • ROTB: 3
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
10 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.08 mg/mL Bocci G, Oprea TI, Benet LZ
EoM (Fraction excreted unchanged in urine) 0.50 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.47 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 72 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.54 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 4.30 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.08 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 1.70 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Dec. 16, 1992 FDA SANOFI AVENTIS US

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 947.66 9.95 1432 149956 144241 63193393
Drug abuse 764.26 9.95 903 150485 71615 63266019
Intentional overdose 726.85 9.95 890 150498 73262 63264372
Suicide attempt 537.65 9.95 694 150694 60224 63277410
Somnambulism 513.15 9.95 255 151133 5288 63332346
Drug dependence 507.58 9.95 440 150948 24043 63313591
Contraindicated product administered 448.15 9.95 16 151372 217632 63120002
Drug intolerance 390.62 9.95 125 151263 308536 63029098
Synovitis 380.44 9.95 15 151373 186903 63150731
Hand deformity 354.03 9.95 5 151383 159452 63178182
Sopor 334.90 9.95 334 151054 21830 63315804
Amnesia 334.86 9.95 528 150860 55057 63282577
Systemic lupus erythematosus 333.88 9.95 50 151338 208868 63128766
Treatment failure 333.83 9.95 41 151347 199002 63138632
Joint swelling 321.00 9.95 192 151196 327474 63010160
Drug ineffective 293.08 9.95 1392 149996 1043373 62294261
Arthropathy 291.78 9.95 98 151290 234694 63102940
Infusion related reaction 290.61 9.95 111 151277 245410 63092224
Glossodynia 289.99 9.95 41 151347 178835 63158799
Intentional self-injury 287.25 9.95 330 151058 25357 63312277
Anxiety 270.57 9.95 1131 150257 216410 63121224
Off label use 267.58 9.95 778 150610 673684 62663950
Overdose 242.88 9.95 713 150675 114365 63223269
Pericarditis 236.25 9.95 21 151367 131558 63206076
Toxicity to various agents 226.03 9.95 1175 150213 246075 63091559
Wound 225.08 9.95 56 151332 163207 63174427
Somnolence 221.29 9.95 928 150460 177757 63159877
Abnormal sleep-related event 217.77 9.95 79 151309 714 63336920
Intentional product misuse 214.69 9.95 459 150929 60458 63277176
Alopecia 211.62 9.95 298 151090 337238 63000396
Depression 204.50 9.95 969 150419 195523 63142111
Maternal exposure during pregnancy 198.93 9.95 141 151247 219921 63117713
Rheumatoid arthritis 194.51 9.95 191 151197 253628 63084006
Swelling 189.13 9.95 227 151161 275151 63062483
Abdominal discomfort 188.76 9.95 296 151092 320589 63017045
Poisoning deliberate 188.08 9.95 179 151209 11039 63326595
Peripheral swelling 185.01 9.95 217 151171 265725 63071909
Lower respiratory tract infection 179.24 9.95 47 151341 132260 63205374
Hypersensitivity 176.91 9.95 265 151123 292420 63045214
Helicobacter infection 171.54 9.95 13 151375 92772 63244862
Poisoning 170.27 9.95 186 151202 13514 63324120
Coma 160.59 9.95 424 150964 63940 63273694
Drug withdrawal syndrome 160.50 9.95 256 151132 26938 63310696
Therapeutic product effect decreased 155.45 9.95 139 151249 193048 63144586
Fall 154.90 9.95 1521 149867 390813 62946821
Product use issue 145.87 9.95 187 151201 220333 63117301
Hepatic enzyme increased 141.83 9.95 164 151224 202164 63135470
Respiratory arrest 140.06 9.95 267 151121 32378 63305256
Suicidal ideation 136.64 9.95 392 150996 62029 63275605
Drug use disorder 133.51 9.95 104 151284 4880 63332754
Cardio-respiratory arrest 131.69 9.95 377 151011 59582 63278052
Discomfort 131.58 9.95 123 151265 167251 63170383
Rash 128.82 9.95 797 150591 560074 62777560
Abnormal behaviour 126.85 9.95 202 151186 21224 63316410
Folliculitis 121.51 9.95 13 151375 70304 63267330
Infection 121.26 9.95 226 151162 228947 63108687
Musculoskeletal stiffness 118.54 9.95 160 151228 184458 63153176
Loss of consciousness 116.59 9.95 574 150814 117547 63220087
Arthralgia 116.53 9.95 838 150550 568872 62768762
Muscle injury 113.12 9.95 12 151376 65333 63272301
Blister 112.28 9.95 87 151301 129727 63207907
Impaired driving ability 107.74 9.95 88 151300 4423 63333211
Sleep disorder due to general medical condition, insomnia type 103.48 9.95 5 151383 52212 63285422
Sleep-related eating disorder 102.73 9.95 47 151341 804 63336830
Affect lability 99.78 9.95 128 151260 11023 63326611
Agitation 91.44 9.95 332 151056 59425 63278209
Withdrawal syndrome 88.80 9.95 166 151222 19831 63317803
Hallucination 88.53 9.95 310 151078 54507 63283127
Therapeutic product effect incomplete 87.98 9.95 101 151287 124955 63212679
Insomnia 87.91 9.95 841 150547 214411 63123223
Mental status changes 86.95 9.95 249 151139 39350 63298284
Disorientation 84.62 9.95 246 151142 39206 63298428
Road traffic accident 84.01 9.95 234 151154 36398 63301236
Drug hypersensitivity 83.96 9.95 418 150970 310269 63027365
Restlessness 83.82 9.95 204 151184 29249 63308385
Intentional product use issue 82.92 9.95 110 151278 127782 63209852
Bradyphrenia 80.26 9.95 91 151297 6889 63330745
Mydriasis 79.58 9.95 119 151269 11837 63325797
Nasopharyngitis 75.20 9.95 331 151057 253926 63083708
Ill-defined disorder 71.69 9.95 54 151334 81701 63255933
Product substitution issue 71.29 9.95 133 151255 15863 63321771
Product use in unapproved indication 71.01 9.95 206 151182 178874 63158760
Delirium 70.83 9.95 273 151115 50268 63287366
Tremor 70.37 9.95 548 150840 131691 63205943
Carotid artery thrombosis 69.89 9.95 56 151332 2738 63334896
Condition aggravated 68.98 9.95 620 150768 401597 62936037
Drug abuser 67.67 9.95 56 151332 2867 63334767
Liver injury 65.67 9.95 31 151357 60489 63277145
Impaired healing 65.64 9.95 89 151299 102453 63235181
Cardiac arrest 64.78 9.95 410 150978 92135 63245499
Psoriatic arthropathy 63.19 9.95 75 151313 91445 63246189
Neurologic neglect syndrome 62.72 9.95 52 151336 2669 63334965
Dysarthria 62.56 9.95 234 151154 42477 63295157
Personality disorder 62.17 9.95 73 151315 5738 63331896
Dependence 61.48 9.95 46 151342 2031 63335603
Hyponatraemia 60.80 9.95 466 150922 111434 63226200
Drug detoxification 58.67 9.95 24 151364 308 63337326
Immobilisation prolonged 58.22 9.95 18 151370 93 63337541
Exposure during pregnancy 57.33 9.95 185 151203 155362 63182272
Confusional state 56.26 9.95 833 150555 235547 63102087
Psychomotor skills impaired 56.14 9.95 46 151342 2322 63335312
Parkinsonism 55.81 9.95 94 151294 10345 63327289
Altered state of consciousness 53.79 9.95 157 151231 25073 63312561
Pain 53.68 9.95 1351 150037 739277 62598357
Sleep talking 53.60 9.95 32 151356 964 63336670
Mental disorder 53.08 9.95 159 151229 25760 63311874
Miosis 53.01 9.95 76 151312 7277 63330357
Substance abuse 52.45 9.95 61 151327 4746 63332888
Drug withdrawal convulsions 52.38 9.95 36 151352 1389 63336245
Urinary retention 52.10 9.95 175 151213 30126 63307508
Adjustment disorder 51.92 9.95 50 151338 3128 63334506
Hip arthroplasty 49.29 9.95 26 151362 47620 63290014
Red blood cell sedimentation rate increased 48.54 9.95 22 151366 43960 63293674
Depressed level of consciousness 48.49 9.95 283 151105 61795 63275839
Gastrointestinal disorder 47.73 9.95 157 151231 131082 63206552
Disturbance in attention 47.67 9.95 199 151189 37990 63299644
Irritable bowel syndrome 47.42 9.95 77 151311 82335 63255299
Motor dysfunction 47.36 9.95 89 151299 10672 63326962
Listless 46.73 9.95 45 151343 2815 63334819
Rhabdomyolysis 46.51 9.95 218 151170 43733 63293901
Bradykinesia 45.55 9.95 59 151329 5129 63332505
Dissociative disorder 45.55 9.95 21 151367 366 63337268
Adverse drug reaction 43.54 9.95 77 151311 79637 63257997
Tardive dyskinesia 43.40 9.95 75 151313 8427 63329207
Type 2 diabetes mellitus 43.38 9.95 53 151335 63815 63273819
Emotional distress 43.31 9.95 173 151215 32376 63305258
Wheezing 43.18 9.95 103 151285 95492 63242142
Syncope 42.71 9.95 448 150940 116937 63220697
High risk sexual behaviour 40.33 9.95 8 151380 0 63337634
Hemiplegia 39.67 9.95 76 151312 9247 63328387
Stomatitis 39.53 9.95 183 151205 138542 63199092
Exposure via ingestion 38.79 9.95 41 151347 2868 63334766
Hypokalaemia 38.16 9.95 397 150991 103407 63234227
Drug screen positive 37.85 9.95 45 151343 3584 63334050
Initial insomnia 37.76 9.95 59 151329 6098 63331536
Dehydration 37.42 9.95 601 150787 172753 63164881
Sensory loss 37.03 9.95 78 151310 10160 63327474
Akathisia 37.01 9.95 73 151315 9073 63328561
Bradypnoea 36.99 9.95 44 151344 3506 63334128
Live birth 36.86 9.95 8 151380 25622 63312012
Coordination abnormal 36.66 9.95 93 151295 13680 63323954
Panic attack 36.66 9.95 127 151261 22204 63315430
Logorrhoea 36.39 9.95 37 151351 2473 63335161
Tachycardia 36.20 9.95 436 150952 117720 63219914
Mobility decreased 35.61 9.95 158 151230 121001 63216633
Eating disorder 35.54 9.95 113 151275 18903 63318731
Hallucination, visual 35.45 9.95 114 151274 19184 63318450
Premature delivery 35.25 9.95 14 151374 30267 63307367
Dysphagia 35.06 9.95 344 151044 88241 63249393
C-reactive protein increased 34.63 9.95 113 151275 94594 63243040
Skin haemorrhage 34.32 9.95 75 151313 10019 63327615
Blood pressure fluctuation 34.11 9.95 36 151352 46281 63291353
Urticaria 33.67 9.95 244 151144 165558 63172076
Inflammation 33.05 9.95 94 151294 82179 63255455
General physical health deterioration 32.49 9.95 315 151073 201087 63136547
Hallucination, auditory 32.49 9.95 85 151303 12739 63324895
Vertigo 32.28 9.95 249 151139 59638 63277996
Head injury 32.06 9.95 140 151248 27256 63310378
Knee arthroplasty 31.79 9.95 50 151338 54156 63283478
Victim of sexual abuse 31.76 9.95 20 151368 664 63336970
Joint range of motion decreased 31.67 9.95 19 151369 32409 63305225
Homicide 30.65 9.95 16 151372 369 63337265
Irritability 30.51 9.95 153 151235 31541 63306093
Abnormal dreams 30.09 9.95 73 151315 10443 63327191
Grip strength decreased 30.00 9.95 8 151380 22279 63315355
Hypotension 29.24 9.95 854 150534 271750 63065884
Blood cholesterol increased 29.24 9.95 120 151268 93912 63243722
Drug interaction 29.18 9.95 734 150654 228397 63109237
Persistent genital arousal disorder 28.99 9.95 14 151374 272 63337362
Pruritus 28.92 9.95 649 150739 360804 62976830
Nightmare 28.81 9.95 106 151282 19088 63318546
Influenza like illness 28.67 9.95 264 151124 66560 63271074
Blood pressure systolic increased 28.48 9.95 43 151345 47354 63290280
Multiple drug therapy 28.23 9.95 39 151349 3607 63334027
Illusion 27.95 9.95 22 151366 1048 63336586
COVID-19 27.79 9.95 157 151231 112946 63224688
Bulimia nervosa 27.53 9.95 16 151372 458 63337176
Prescription drug used without a prescription 27.25 9.95 31 151357 2355 63335279
Device expulsion 27.02 9.95 26 151362 34896 63302738
Sinus tachycardia 26.88 9.95 122 151266 24146 63313488
Alcohol abuse 26.43 9.95 29 151359 2117 63335517
Mania 26.40 9.95 77 151311 12290 63325344
Anaphylactic reaction 26.20 9.95 76 151312 66024 63271610
Apathy 26.19 9.95 62 151326 8732 63328902
Cholecystitis chronic 25.56 9.95 68 151320 10293 63327341
Peptic ulcer 25.45 9.95 42 151346 4545 63333089
Rheumatoid nodule 25.40 9.95 5 151383 17150 63320484
Self-medication 25.17 9.95 32 151356 2731 63334903
Deep vein thrombosis 25.13 9.95 308 151080 83492 63254142
Obstructive airways disorder 25.05 9.95 9 151379 20690 63316944
Unresponsive to stimuli 25.01 9.95 152 151236 33664 63303970
Memory impairment 24.99 9.95 368 151020 103890 63233744
Urinary hesitation 24.78 9.95 29 151359 2271 63335363
Multiple sclerosis relapse 24.72 9.95 199 151189 48279 63289355
Sinus congestion 24.65 9.95 97 151291 18026 63319608
Incoherent 24.49 9.95 41 151347 4489 63333145
Foreign body 24.40 9.95 29 151359 2309 63335325
Therapy non-responder 24.14 9.95 96 151292 75805 63261829
Hyperhidrosis 24.06 9.95 376 151012 107460 63230174
Hepatitis B DNA increased 23.62 9.95 12 151376 261 63337373
Fatigue 23.49 9.95 1812 149576 886216 62451418
Respiratory depression 23.39 9.95 79 151309 13636 63323998
Reduced facial expression 23.23 9.95 26 151362 1940 63335694
Drug resistance 23.01 9.95 13 151375 22920 63314714
Asthenia 22.45 9.95 1124 150264 382480 62955154
Imprisonment 22.44 9.95 11 151377 221 63337413
Aggression 22.31 9.95 113 151275 23385 63314249
Multiple sclerosis 22.30 9.95 116 151272 24256 63313378
Labelled drug-food interaction issue 22.23 9.95 6 151382 17 63337617
Aspartate aminotransferase increased 22.17 9.95 320 151068 89957 63247677
Dysuria 22.08 9.95 147 151241 33591 63304043
Laryngeal pain 22.08 9.95 39 151349 4459 63333175
Hiatus hernia 22.04 9.95 106 151282 21488 63316146
Drug tolerance 21.80 9.95 50 151338 6899 63330735
Hangover 21.71 9.95 23 151365 1613 63336021
Feeling abnormal 21.51 9.95 484 150904 147908 63189726
Psychomotor hyperactivity 21.44 9.95 65 151323 10598 63327036
Peripheral circulatory failure 21.28 9.95 18 151370 950 63336684
Product complaint 21.16 9.95 73 151315 12736 63324898
Seizure 20.95 9.95 438 150950 132196 63205438
Bone erosion 20.94 9.95 8 151380 17709 63319925
Anger 20.58 9.95 71 151317 12385 63325249
Feeling drunk 20.44 9.95 36 151352 4106 63333528
Alcohol use 20.41 9.95 25 151363 2054 63335580
Pulmonary fibrosis 20.37 9.95 40 151348 39769 63297865
Myelosuppression 20.33 9.95 16 151372 23687 63313947
Vision blurred 20.31 9.95 320 151068 91604 63246030
Macular degeneration 20.23 9.95 17 151371 24359 63313275
Major depression 20.16 9.95 53 151335 7965 63329669
Behaviour disorder 20.10 9.95 31 151357 3168 63334466
Neutropenia 20.03 9.95 295 151093 174710 63162924
Respiratory tract congestion 20.01 9.95 90 151298 17742 63319892
Cognitive disorder 19.81 9.95 212 151176 55603 63282031
Blood pressure systolic abnormal 19.61 9.95 4 151384 13382 63324252
Dyspnoea 19.61 9.95 1336 150052 659977 62677657
Serotonin syndrome 19.39 9.95 126 151262 28556 63309078
Crying 19.26 9.95 108 151280 23235 63314399
Sinus disorder 19.21 9.95 112 151276 24441 63313193
Tension 18.88 9.95 30 151358 3145 63334489
Panic disorder 18.67 9.95 27 151361 2606 63335028
Disinhibition 18.56 9.95 16 151372 867 63336767
Muscle rigidity 18.53 9.95 65 151323 11435 63326199
Diplopia 18.41 9.95 108 151280 23620 63314014
Aortic valve calcification 18.37 9.95 13 151375 526 63337108
Sneezing 18.28 9.95 89 151299 18129 63319505
Dementia 18.28 9.95 91 151297 18703 63318931
Anterograde amnesia 18.20 9.95 13 151375 534 63337100
Affective disorder 17.94 9.95 43 151345 6103 63331531
Inadequate analgesia 17.77 9.95 28 151360 2915 63334719
Facial nerve disorder 17.74 9.95 13 151375 556 63337078
Anhedonia 17.65 9.95 62 151326 10912 63326722
Panniculitis 17.54 9.95 3 151385 11382 63326252
Left ventricular hypertrophy 17.51 9.95 39 151349 5276 63332358
Blood potassium decreased 17.51 9.95 165 151223 41861 63295773
Blood pressure diastolic decreased 17.45 9.95 17 151371 22689 63314945
Psychotic disorder 17.41 9.95 113 151275 25599 63312035
Performance fear 17.40 9.95 4 151384 4 63337630
Cough 17.26 9.95 549 150839 292194 63045440
Hypoglycaemia 17.24 9.95 219 151169 59846 63277788
Catatonia 17.24 9.95 35 151353 4442 63333192
Femoral neck fracture 17.18 9.95 52 151336 8471 63329163
Legal problem 17.01 9.95 5 151383 21 63337613
Decreased interest 17.00 9.95 29 151359 3225 63334409
Depressive symptom 16.91 9.95 33 151355 4069 63333565
Prescribed overdose 16.89 9.95 35 151353 34118 63303516
Creatinine renal clearance decreased 16.72 9.95 9 151379 16299 63321335
Sinusitis 16.70 9.95 412 150976 226241 63111393
Arterial occlusive disease 16.66 9.95 41 151347 5917 63331717
Accidental poisoning 16.59 9.95 13 151375 615 63337019
Fibromyalgia 16.48 9.95 118 151270 80302 63257332
Compulsive shopping 16.45 9.95 14 151374 745 63336889
Palpitations 16.39 9.95 368 151020 112402 63225232
Coagulation factor V level decreased 16.27 9.95 10 151378 318 63337316
Euphoric mood 16.26 9.95 36 151352 4851 63332783
Drug tolerance increased 16.06 9.95 9 151379 240 63337394
Genotype drug resistance test positive 16.06 9.95 11 151377 422 63337212
Lethargy 15.99 9.95 204 151184 55803 63281831
Tracheal atresia 15.99 9.95 5 151383 27 63337607
Loss of proprioception 15.99 9.95 11 151377 425 63337209
Inappropriate antidiuretic hormone secretion 15.85 9.95 76 151312 15386 63322248
Immunodeficiency 15.76 9.95 15 151373 20239 63317395
Inappropriate schedule of product administration 15.76 9.95 165 151223 103800 63233834
Angioedema 15.68 9.95 60 151328 47905 63289729
Visual acuity reduced 15.45 9.95 97 151291 21729 63315905
Emotional poverty 15.44 9.95 10 151378 349 63337285
Prothrombin time prolonged 15.36 9.95 54 151334 9510 63328124
Pulmonary vasculitis 15.23 9.95 7 151381 121 63337513
Brain contusion 15.22 9.95 12 151376 573 63337061
Cholecystectomy 15.22 9.95 58 151330 10619 63327015
Protrusion tongue 15.16 9.95 10 151378 360 63337274
Neuroglycopenia 15.08 9.95 11 151377 467 63337167
Prothrombin time shortened 14.94 9.95 21 151367 1974 63335660
Arthritis 14.84 9.95 191 151197 115730 63221904
Electrocardiogram QT prolonged 14.60 9.95 211 151177 59319 63278315
Psychomotor retardation 14.60 9.95 30 151358 3840 63333794
Constipation 14.59 9.95 666 150722 224277 63113357
Adverse event 14.40 9.95 98 151290 67461 63270173
Blood urea increased 14.39 9.95 110 151278 26269 63311365
Bursitis 14.38 9.95 43 151345 36998 63300636
Therapeutic response unexpected 14.31 9.95 85 151303 18674 63318960
Self-injurious ideation 14.29 9.95 24 151364 2635 63334999
Neurogenic bladder 14.25 9.95 27 151361 3258 63334376
Erythema 14.19 9.95 315 151073 175436 63162198
Spinal rod insertion 14.18 9.95 4 151384 14 63337620
Pyrexia 14.16 9.95 949 150439 469529 62868105
Terminal insomnia 14.01 9.95 13 151375 776 63336858
Intervertebral disc degeneration 13.79 9.95 74 151314 15658 63321976
Drug diversion 13.79 9.95 14 151374 934 63336700
Hemiparesis 13.79 9.95 99 151289 23183 63314451
Social anxiety disorder 13.78 9.95 10 151378 421 63337213
Fear 13.71 9.95 74 151314 15692 63321942
Bipolar disorder 13.70 9.95 46 151342 7914 63329720
Hepatotoxicity 13.67 9.95 44 151344 36997 63300637
Skin abrasion 13.56 9.95 51 151337 9278 63328356
Cardiomegaly 13.55 9.95 80 151308 17534 63320100
Lupus-like syndrome 13.53 9.95 10 151378 15285 63322349
Mood swings 13.48 9.95 82 151306 18166 63319468
Persecutory delusion 13.45 9.95 24 151364 2766 63334868
Blood creatine phosphokinase increased 13.45 9.95 121 151267 30309 63307325
Spinal osteoarthritis 13.43 9.95 75 151313 16111 63321523
Cerebral atrophy 13.27 9.95 34 151354 5032 63332602
Intravascular haemolysis 13.21 9.95 9 151379 342 63337292
Atelectasis 13.10 9.95 92 151296 21391 63316243
Nervousness 13.09 9.95 122 151266 30857 63306777
Benzodiazepine drug level 13.05 9.95 3 151385 3 63337631
Aphasia 12.97 9.95 128 151260 32872 63304762
Cholelithiasis 12.97 9.95 161 151227 43764 63293870
Neonatal behavioural syndrome 12.91 9.95 5 151383 55 63337579
Anorexia nervosa 12.80 9.95 8 151380 262 63337372
Fibrocystic breast disease 12.79 9.95 15 151373 1177 63336457
Sedation 12.67 9.95 145 151243 38664 63298970
Dysphoria 12.67 9.95 33 151355 4933 63332701
Accidental overdose 12.60 9.95 97 151291 23212 63314422
Homicidal ideation 12.47 9.95 18 151370 1734 63335900
Automatism 12.45 9.95 5 151383 61 63337573
Gastric polyps 12.38 9.95 26 151362 3379 63334255
Head discomfort 12.38 9.95 64 151324 13351 63324283
Spleen congestion 12.31 9.95 6 151382 119 63337515
Drug dependence, antepartum 12.30 9.95 4 151384 25 63337609
Restless legs syndrome 12.28 9.95 81 151307 18450 63319184
Diarrhoea 12.19 9.95 1507 149881 713859 62623775
Secretion discharge 12.18 9.95 7 151381 12224 63325410
Mucosal inflammation 12.15 9.95 64 151324 46864 63290770
Generalised tonic-clonic seizure 12.12 9.95 114 151274 28902 63308732
Multiple injuries 12.11 9.95 18 151370 1780 63335854
Hypotonia 12.07 9.95 49 151339 9236 63328398
Periventricular leukomalacia 12.05 9.95 6 151382 125 63337509
Autonomic nervous system imbalance 12.02 9.95 23 151365 2795 63334839
Extrapyramidal disorder 12.00 9.95 63 151325 13221 63324413
Vertigo CNS origin 11.91 9.95 4 151384 28 63337606
Osteoarthritis 11.87 9.95 158 151230 95185 63242449
Transient ischaemic attack 11.85 9.95 140 151248 37613 63300021
Suicidal behaviour 11.83 9.95 22 151366 2617 63335017
Dreamy state 11.79 9.95 4 151384 29 63337605
Ecchymosis 11.71 9.95 55 151333 11039 63326595
Spondylolisthesis 11.71 9.95 26 151362 3510 63334124
Toxic epidermal necrolysis 11.67 9.95 27 151361 25307 63312327
Drop attacks 11.66 9.95 11 151377 671 63336963
Thirst 11.61 9.95 65 151323 13976 63323658
Speech disorder 11.60 9.95 148 151240 40481 63297153
Waxy flexibility 11.59 9.95 6 151382 136 63337498
Labelled drug-drug interaction medication error 11.55 9.95 9 151379 13390 63324244
Stupor 11.52 9.95 29 151359 4246 63333388
Amnestic disorder 11.36 9.95 8 151380 321 63337313
Alanine aminotransferase increased 11.35 9.95 326 151062 103444 63234190
Housebound 11.26 9.95 7 151381 227 63337407
Blood alkaline phosphatase increased 11.22 9.95 154 151234 42813 63294821
Ventricular fibrillation 11.22 9.95 57 151331 11810 63325824
Prescription form tampering 11.20 9.95 10 151378 568 63337066
Haemangioma congenital 11.18 9.95 9 151379 443 63337191
Dyskinesia 11.10 9.95 121 151267 31881 63305753
Colitis ulcerative 11.08 9.95 29 151359 26062 63311572
Foot deformity 11.05 9.95 32 151356 27821 63309813
Injection site reaction 10.98 9.95 88 151300 58436 63279198
Transplant rejection 10.98 9.95 6 151382 10774 63326860
Neurological examination normal 10.94 9.95 4 151384 37 63337597
Diverticulum 10.92 9.95 57 151331 11934 63325700
Coma scale abnormal 10.92 9.95 32 151356 5121 63332513
Hyperlipidaemia 10.89 9.95 82 151306 19489 63318145
Asphyxia 10.89 9.95 36 151352 6145 63331489
Leukocytosis 10.89 9.95 102 151286 25833 63311801
Atrioventricular block first degree 10.77 9.95 40 151348 7233 63330401
Cytomegalovirus infection 10.76 9.95 21 151367 20931 63316703
Hepatosplenomegaly 10.74 9.95 21 151367 2593 63335041
Mood altered 10.73 9.95 66 151322 14677 63322957
Dizziness 10.67 9.95 1176 150212 428749 62908885
Skin exfoliation 10.66 9.95 153 151235 42949 63294685
Injury 10.63 9.95 239 151149 73008 63264626
Neurotoxicity 10.61 9.95 15 151373 16975 63320659
Trance 10.58 9.95 4 151384 41 63337593
Sciatica 10.54 9.95 44 151344 34280 63303354
Hypokinesia 10.53 9.95 63 151325 13873 63323761
Depression suicidal 10.53 9.95 17 151371 1806 63335828
Pelvic fracture 10.51 9.95 61 151327 13287 63324347
Accidental exposure to product 10.50 9.95 32 151356 27373 63310261
Flat affect 10.47 9.95 15 151373 1435 63336199
Dysgeusia 10.46 9.95 163 151225 46547 63291087
Renal impairment 10.43 9.95 148 151240 88207 63249427
Barrett's oesophagus 10.39 9.95 10 151378 625 63337009
Pneumonia aspiration 10.37 9.95 127 151261 34413 63303221
Dental caries 10.35 9.95 52 151336 10727 63326907
Intervertebral disc protrusion 10.33 9.95 94 151294 23615 63314019
Lip dry 10.33 9.95 13 151375 15457 63322177
Verbal abuse 10.31 9.95 5 151383 98 63337536
Lymphatic disorder 10.31 9.95 8 151380 373 63337261
Ischaemic cardiomyopathy 10.30 9.95 20 151368 2457 63335177
Eustachian tube disorder 10.27 9.95 5 151383 99 63337535
Heart rate decreased 10.26 9.95 65 151323 45495 63292139
Malnutrition 10.22 9.95 67 151321 15231 63322403
Gangrene 10.20 9.95 35 151353 6088 63331546
Drug withdrawal syndrome neonatal 10.16 9.95 18 151370 2063 63335571
Herpes zoster 10.14 9.95 137 151251 82325 63255309
Cerebrovascular accident 10.12 9.95 333 151055 107691 63229943
Blastocystis infection 10.10 9.95 4 151384 47 63337587
Stress cardiomyopathy 10.09 9.95 47 151341 9403 63328231
Enthesopathy 10.00 9.95 4 151384 8610 63329024
Galactorrhoea 9.98 9.95 27 151361 4128 63333506
Optic disc haemorrhage 9.96 9.95 5 151383 106 63337528

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
Somnambulism 564.21 10.23 230 85463 2842 34868396
Completed suicide 526.38 10.23 897 84796 97271 34773967
Drug dependence 337.97 10.23 354 85339 23863 34847375
Intentional overdose 319.85 10.23 461 85232 43213 34828025
Amnesia 248.63 10.23 316 85377 26247 34844991
Drug abuse 244.62 10.23 661 85032 98435 34772803
Off label use 201.04 10.23 459 85234 419065 34452173
Suicide attempt 177.79 10.23 333 85360 38783 34832455
Road traffic accident 157.60 10.23 204 85489 17246 34853992
Intentional self-injury 137.07 10.23 169 85524 13602 34857636
Poisoning 120.01 10.23 149 85544 12077 34859161
Delirium 117.06 10.23 302 85391 43689 34827549
Confusional state 111.30 10.23 668 85025 143492 34727746
Drug withdrawal syndrome 109.61 10.23 184 85509 19650 34851588
Insomnia 109.12 10.23 524 85169 103383 34767855
Suicidal ideation 108.21 10.23 278 85415 40110 34831128
Overdose 105.78 10.23 473 85220 90586 34780652
Respiratory arrest 103.63 10.23 219 85474 27824 34843414
Sopor 103.57 10.23 138 85555 11998 34859240
Impaired driving ability 98.60 10.23 68 85625 2565 34868673
Somnolence 92.25 10.23 525 85168 110591 34760647
Abnormal sleep-related event 87.83 10.23 36 85657 451 34870787
Disorientation 87.41 10.23 227 85466 32961 34838277
Anxiety 84.65 10.23 473 85220 98955 34772283
Depression 81.39 10.23 460 85233 96638 34774600
Homicide 76.12 10.23 40 85653 909 34870329
Sleep-related eating disorder 75.29 10.23 28 85665 265 34870973
Abnormal behaviour 73.30 10.23 178 85515 24791 34846447
Product use in unapproved indication 70.42 10.23 112 85581 117387 34753851
Automatism 68.08 10.23 21 85672 104 34871134
Drug ineffective 65.18 10.23 762 84931 455989 34415249
Parasomnia 59.96 10.23 26 85667 378 34870860
Gun shot wound 59.16 10.23 36 85657 1092 34870146
Drug use disorder 57.95 10.23 61 85632 4130 34867108
Bradyphrenia 54.51 10.23 63 85630 4735 34866503
Restlessness 53.95 10.23 161 85532 25321 34845917
Drug abuser 53.69 10.23 57 85636 3897 34867341
Coma 52.77 10.23 237 85456 45441 34825797
Intentional product misuse 52.20 10.23 236 85457 45375 34825863
Agitation 47.43 10.23 271 85422 57128 34814110
Cardio-respiratory arrest 47.02 10.23 263 85430 55010 34816228
Poisoning deliberate 46.33 10.23 75 85618 7769 34863469
Fall 44.38 10.23 721 84972 202164 34669074
Thinking abnormal 43.72 10.23 64 85629 6073 34865165
Aggression 43.39 10.23 200 85493 38764 34832474
Toxicity to various agents 42.70 10.23 709 84984 199653 34671585
Withdrawal syndrome 42.26 10.23 94 85599 12361 34858877
Therapeutic product effect incomplete 38.71 10.23 40 85653 50501 34820737
Dissociative disorder 38.28 10.23 20 85673 449 34870789
Memory impairment 38.09 10.23 208 85485 43110 34828128
Loss of consciousness 37.16 10.23 337 85356 82330 34788908
Antidepressant drug level above therapeutic 37.06 10.23 16 85677 230 34871008
Hallucination 36.72 10.23 234 85459 51264 34819974
Dependence 34.59 10.23 26 85667 1124 34870114
Analgesic drug level above therapeutic 33.37 10.23 16 85677 297 34870941
Myelosuppression 33.36 10.23 4 85689 19261 34851977
Lower respiratory tract infection 33.28 10.23 18 85675 31619 34839619
Persistent depressive disorder 32.07 10.23 16 85677 325 34870913
Oedematous pancreatitis 31.69 10.23 18 85675 479 34870759
Legal problem 31.28 10.23 13 85680 169 34871069
Multiple organ dysfunction syndrome 30.87 10.23 91 85602 76475 34794763
Panic attack 30.68 10.23 70 85623 9362 34861876
Nightmare 29.59 10.23 90 85603 14301 34856937
Rheumatoid arthritis 29.58 10.23 30 85663 38208 34833030
Hypokinesia 28.99 10.23 66 85627 8814 34862424
Initial insomnia 28.94 10.23 37 85656 3087 34868151
Cytomegalovirus infection 28.79 10.23 14 85679 26121 34845117
Acute kidney injury 28.71 10.23 551 85142 304437 34566801
Death 28.71 10.23 750 84943 397299 34473939
Anterograde amnesia 28.27 10.23 12 85681 165 34871073
Angioedema 28.15 10.23 30 85663 37344 34833894
Joint swelling 28.08 10.23 66 85627 59824 34811414
Drug intolerance 27.65 10.23 66 85627 59504 34811734
Prescription form tampering 27.38 10.23 16 85677 450 34870788
Intentional product use issue 27.19 10.23 67 85626 59749 34811489
Febrile neutropenia 27.19 10.23 210 85483 136639 34734599
Drug tolerance 26.49 10.23 34 85659 2848 34868390
Drug detoxification 26.15 10.23 13 85680 262 34870976
Logorrhoea 26.13 10.23 31 85662 2395 34868843
Condition aggravated 25.96 10.23 324 85369 191872 34679366
General physical health deterioration 25.40 10.23 197 85496 128072 34743166
Drug diversion 24.52 10.23 19 85674 860 34870378
Incoherent 24.19 10.23 41 85652 4411 34866827
Altered state of consciousness 23.65 10.23 115 85578 22778 34848460
Anger 23.20 10.23 73 85620 11811 34859427
Circadian rhythm sleep disorder 22.42 10.23 14 85679 445 34870793
Nervousness 22.41 10.23 75 85618 12531 34858707
Tachyphrenia 22.22 10.23 21 85672 1248 34869990
Abnormal dreams 22.21 10.23 54 85639 7524 34863714
Hallucination, visual 21.82 10.23 94 85599 17697 34853541
Sleep apnoea syndrome 21.65 10.23 103 85590 20218 34851020
Septic shock 21.29 10.23 97 85596 71737 34799501
Neutropenia 21.27 10.23 264 85429 156514 34714724
Poor quality sleep 21.24 10.23 56 85637 8200 34863038
Drug screen positive 21.01 10.23 36 85657 3907 34867331
Reduced facial expression 20.93 10.23 19 85674 1072 34870166
Bradypnoea 20.88 10.23 30 85663 2799 34868439
Infection 20.74 10.23 134 85559 90781 34780457
Irritability 20.01 10.23 116 85577 24574 34846664
Rectal haemorrhage 19.97 10.23 43 85650 40206 34831032
Victim of chemical submission 19.96 10.23 7 85686 55 34871183
Substance use disorder 19.92 10.23 16 85677 763 34870475
Synovitis 19.83 10.23 5 85688 14061 34857177
Sepsis 19.51 10.23 289 85404 166272 34704966
Dyspnoea 19.36 10.23 742 84951 376040 34495198
Product dose omission issue 19.22 10.23 194 85499 119517 34751721
Self-medication 18.98 10.23 28 85665 2675 34868563
Product use issue 18.95 10.23 85 85608 63131 34808107
Distributive shock 18.68 10.23 19 85674 1235 34870003
Encephalomalacia 18.57 10.23 16 85677 842 34870396
Cardiac arrest 18.52 10.23 335 85358 95824 34775414
Patient elopement 18.49 10.23 6 85687 36 34871202
Major depression 18.40 10.23 37 85656 4535 34866703
Mental disorder 18.37 10.23 80 85613 15129 34856109
Infusion related reaction 17.99 10.23 68 85625 52989 34818249
Disturbance in attention 17.93 10.23 117 85576 25828 34845410
Drug withdrawal convulsions 17.84 10.23 18 85675 1159 34870079
Dysarthria 17.81 10.23 146 85547 34636 34836602
Treatment failure 17.75 10.23 57 85636 46640 34824598
Inappropriate antidiuretic hormone secretion 17.70 10.23 70 85623 12683 34858555
Asthma 17.69 10.23 50 85643 42606 34828632
Alcohol use 17.49 10.23 30 85663 3258 34867980
Heart rate decreased 17.40 10.23 32 85661 31713 34839525
Hyperlipidaemia 17.23 10.23 76 85617 14453 34856785
Procalcitonin abnormal 17.04 10.23 11 85682 371 34870867
Erythema 16.80 10.23 138 85555 88642 34782596
Sexual abuse 16.56 10.23 8 85685 151 34871087
Neurotoxicity 16.52 10.23 12 85681 17998 34853240
Respiratory tract infection bacterial 16.34 10.23 21 85672 1761 34869477
Leukopenia 16.26 10.23 89 85604 62767 34808471
Sleep disorder 16.22 10.23 133 85560 31555 34839683
Feeling abnormal 16.19 10.23 231 85462 63004 34808234
Vascular dementia 15.96 10.23 12 85681 519 34870719
Sleep talking 15.74 10.23 12 85681 530 34870708
Amimia 15.68 10.23 4 85689 8 34871230
Pre-existing condition improved 15.60 10.23 25 85668 2567 34868671
Mania 15.52 10.23 55 85638 9456 34861782
Apallic syndrome 15.47 10.23 9 85684 251 34870987
Personality change 15.47 10.23 37 85656 5102 34866136
Peripheral swelling 15.40 10.23 117 85576 76424 34794814
Galactorrhoea 15.40 10.23 11 85682 439 34870799
Product administration error 15.40 10.23 80 85613 16264 34854974
Product substitution issue 15.31 10.23 57 85636 10038 34861200
Accidental overdose 15.27 10.23 93 85600 20047 34851191
Coagulation factor VII level decreased 15.21 10.23 7 85686 118 34871120
Pneumonitis chemical 15.06 10.23 8 85685 186 34871052
Bronchiectasis 14.79 10.23 3 85690 9798 34861440
Pulmonary fibrosis 14.73 10.23 14 85679 18382 34852856
Tubulointerstitial nephritis 14.61 10.23 18 85675 21006 34850232
Cardiac failure 14.59 10.23 148 85545 91100 34780138
Toxic epidermal necrolysis 14.56 10.23 19 85674 21627 34849611
Exposure via ingestion 14.47 10.23 22 85671 2159 34869079
COVID-19 14.47 10.23 121 85572 77429 34793809
Loss of personal independence in daily activities 14.43 10.23 38 85655 33141 34838097
Libido decreased 14.34 10.23 34 85659 4662 34866576
Labelled drug-food interaction medication error 14.07 10.23 5 85688 41 34871197
Mental status changes 14.04 10.23 149 85544 37934 34833304
Transplant rejection 13.91 10.23 4 85689 10307 34860931
Skin laceration 13.76 10.23 64 85629 12445 34858793
Substance-induced mood disorder 13.61 10.23 6 85687 91 34871147
Dysphoria 13.58 10.23 22 85671 2280 34868958
Congenital hydrocephalus 13.55 10.23 6 85687 92 34871146
Prostate cancer 13.32 10.23 51 85642 39598 34831640
Stress at work 13.32 10.23 8 85685 237 34871001
Depressed level of consciousness 13.26 10.23 162 85531 42679 34828559
Urticaria 13.19 10.23 94 85599 62283 34808955
Emotional distress 13.10 10.23 72 85621 14954 34856284
Mental impairment 13.01 10.23 55 85638 10267 34860971
Pruritus 12.86 10.23 258 85435 141723 34729515
Aspergillus infection 12.85 10.23 7 85686 12247 34858991
Thrombotic microangiopathy 12.81 10.23 5 85688 10625 34860613
Hepatitis C virus test positive 12.81 10.23 9 85684 350 34870888
Bipolar disorder 12.79 10.23 28 85665 3641 34867597
Mucosal inflammation 12.77 10.23 50 85643 38572 34832666
Paranoia 12.73 10.23 61 85632 12007 34859231
Implant site inflammation 12.73 10.23 6 85687 107 34871131
Delusion 12.71 10.23 63 85630 12572 34858666
Stress cardiomyopathy 12.59 10.23 20 85673 2039 34869199
Blood pressure fluctuation 12.50 10.23 27 85666 25222 34846016
Therapy partial responder 12.48 10.23 4 85689 9612 34861626
Hospitalisation 12.40 10.23 85 85608 56817 34814421
Pyrexia 12.37 10.23 679 85014 332334 34538904
Slow speech 12.36 10.23 15 85678 1187 34870051
Respiratory tract infection viral 12.14 10.23 22 85671 2495 34868743
Victim of homicide 11.93 10.23 6 85687 124 34871114
Pilonidal cyst congenital 11.93 10.23 4 85689 27 34871211
Psychomotor hyperactivity 11.92 10.23 51 85642 9571 34861667
Enuresis 11.91 10.23 21 85672 2332 34868906
Electrocardiogram QT prolonged 11.88 10.23 153 85540 40799 34830439
Crime 11.83 10.23 5 85688 68 34871170
Blood pressure systolic increased 11.82 10.23 24 85669 22928 34848310
Hallucination, auditory 11.69 10.23 59 85634 11858 34859380
Akathisia 11.65 10.23 45 85648 8064 34863174
Depressed mood 11.51 10.23 84 85609 19233 34852005
Staring 11.46 10.23 16 85677 1454 34869784
Miosis 11.40 10.23 50 85643 9485 34861753
Renal impairment 11.40 10.23 163 85530 94350 34776888
Scar pain 11.39 10.23 5 85688 75 34871163
Euphoric mood 11.33 10.23 35 85658 5606 34865632
Labile hypertension 11.16 10.23 5 85688 79 34871159
Psychotic disorder 11.13 10.23 100 85593 24352 34846886
Obstructive airways disorder 11.05 10.23 13 85680 15481 34855757
Alcohol interaction 11.04 10.23 23 85670 2890 34868348
Blood pressure increased 10.96 10.23 151 85542 87951 34783287
Alcohol poisoning 10.95 10.23 26 85667 3567 34867671
Haematocrit decreased 10.93 10.23 124 85569 32092 34839146
Drug half-life reduced 10.90 10.23 3 85690 9 34871229
Amnestic disorder 10.64 10.23 7 85686 244 34870994
Hangover 10.62 10.23 13 85680 1038 34870200
Hepatotoxicity 10.62 10.23 23 85670 21462 34849776
Decreased interest 10.60 10.23 20 85673 2340 34868898
PO2 decreased 10.56 10.23 16 85677 1565 34869673
Anaphylactic reaction 10.56 10.23 42 85651 32259 34838979
Drug tolerance increased 10.55 10.23 9 85684 467 34870771
Pneumothorax traumatic 10.47 10.23 5 85688 92 34871146
Leukoplakia 10.45 10.23 3 85690 11 34871227

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 1530.46 9.59 2333 182911 243434 79315710
Drug abuse 814.10 9.59 1400 183844 161291 79397853
Drug dependence 807.96 9.59 706 184538 40063 79519081
Intentional overdose 745.93 9.59 1067 184177 104893 79454251
Somnambulism 702.04 9.59 317 184927 5404 79553740
Suicide attempt 545.54 9.59 809 184435 82123 79477021
Sopor 425.15 9.59 451 184793 32559 79526585
Off label use 390.66 9.59 967 184277 906248 78652896
Amnesia 386.02 9.59 595 184649 62462 79496682
Intentional self-injury 313.87 9.59 382 184862 32037 79527107
Overdose 295.76 9.59 1021 184223 183185 79375959
Synovitis 294.64 9.59 13 185231 150721 79408423
Drug ineffective 287.10 9.59 1416 183828 1079497 78479647
Drug intolerance 285.58 9.59 128 185116 263991 79295153
Poisoning 284.94 9.59 322 184922 24950 79534194
Anxiety 266.05 9.59 1213 184031 247299 79311845
Toxicity to various agents 262.30 9.59 1776 183468 419764 79139380
Abnormal sleep-related event 255.58 9.59 91 185153 798 79558346
Drug withdrawal syndrome 253.45 9.59 356 184888 34362 79524782
Respiratory arrest 252.38 9.59 468 184776 57082 79502062
Contraindicated product administered 251.47 9.59 34 185210 157504 79401640
Intentional product misuse 251.29 9.59 630 184614 94535 79464609
Joint swelling 250.52 9.59 183 185061 288463 79270681
Somnolence 239.99 9.59 1145 184099 237836 79321308
Poisoning deliberate 224.45 9.59 247 184997 18581 79540563
Depression 218.58 9.59 1040 184204 215750 79343394
Hand deformity 209.77 9.59 7 185237 103912 79455232
Infusion related reaction 200.99 9.59 145 185099 230092 79329052
Delirium 193.52 9.59 531 184713 84096 79475048
Treatment failure 193.21 9.59 77 185167 170409 79388735
Coma 192.13 9.59 592 184652 100057 79459087
Cardio-respiratory arrest 185.96 9.59 615 184629 107895 79451249
Suicidal ideation 185.62 9.59 490 184754 75850 79483294
Drug use disorder 181.80 9.59 155 185089 8496 79550648
Lower respiratory tract infection 171.86 9.59 44 185200 129176 79429968
Systemic lupus erythematosus 167.50 9.59 38 185206 121111 79438033
Fall 159.76 9.59 1783 183461 485846 79073298
Arthropathy 156.56 9.59 110 185134 177001 79382143
Rheumatoid arthritis 150.72 9.59 157 185087 208313 79350831
Disorientation 149.62 9.59 400 184844 62376 79496768
Peripheral swelling 148.95 9.59 248 184996 269369 79289775
Pericarditis 143.49 9.59 33 185211 104203 79454941
Confusional state 141.15 9.59 1239 184005 316758 79242386
Abnormal behaviour 141.01 9.59 281 184963 36140 79523004
Sleep-related eating disorder 139.24 9.59 55 185189 659 79558485
Bradyphrenia 138.07 9.59 146 185098 10494 79548650
Maternal exposure during pregnancy 135.64 9.59 74 185170 136464 79422680
Duodenal ulcer perforation 135.27 9.59 4 185240 66207 79492937
Hypersensitivity 133.32 9.59 254 184990 261985 79297159
Glossodynia 130.28 9.59 39 185205 103298 79455846
Helicobacter infection 124.14 9.59 10 185234 69694 79489450
Loss of consciousness 119.73 9.59 733 184511 167210 79391934
Road traffic accident 116.17 9.59 290 184954 43374 79515770
Insomnia 114.88 9.59 967 184277 244203 79314941
Withdrawal syndrome 113.48 9.59 215 185029 26639 79532505
Wound 111.04 9.59 66 185178 116113 79443031
Restlessness 110.53 9.59 296 184948 46196 79512948
Affect lability 106.25 9.59 131 185113 11128 79548016
Product use in unapproved indication 106.21 9.59 268 184976 250091 79309053
Infection 105.47 9.59 255 184989 241457 79317687
Agitation 105.22 9.59 485 184759 99230 79459914
Drug abuser 104.97 9.59 97 185147 5916 79553228
Arthralgia 102.63 9.59 843 184401 570960 78988184
Hepatic enzyme increased 99.84 9.59 169 185075 182441 79376703
Alopecia 98.64 9.59 247 184997 231108 79328036
Swelling 96.62 9.59 226 185018 216485 79342659
Hallucination 94.90 9.59 423 184821 85322 79473822
Musculoskeletal stiffness 93.82 9.59 164 185080 174844 79384300
Intentional product use issue 92.50 9.59 131 185113 151981 79407163
Homicide 91.93 9.59 48 185196 1138 79558006
Therapeutic product effect incomplete 90.15 9.59 118 185126 141527 79417617
Folliculitis 85.89 9.59 13 185231 55367 79503777
Abdominal discomfort 84.96 9.59 298 184946 250429 79308715
Rash 82.66 9.59 902 184342 577456 78981688
Product use issue 82.62 9.59 233 185011 209589 79349555
Cardiac arrest 80.67 9.59 679 184565 171417 79387727
Impaired driving ability 80.59 9.59 80 185164 5335 79553809
Therapeutic product effect decreased 78.69 9.59 164 185080 163699 79395445
Drug detoxification 78.44 9.59 31 185213 372 79558772
Dependence 78.32 9.59 56 185188 2366 79556778
Sleep disorder due to general medical condition, insomnia type 78.25 9.59 6 185238 43550 79515594
Automatism 76.23 9.59 25 185219 166 79558978
Dissociative disorder 74.63 9.59 37 185207 784 79558360
Blister 74.53 9.59 101 185143 119375 79439769
Condition aggravated 73.80 9.59 776 184468 500348 79058796
Drug hypersensitivity 71.26 9.59 405 184839 298511 79260633
Dysarthria 69.18 9.59 326 184918 67296 79491848
Muscle injury 67.57 9.59 15 185229 48546 79510598
Carotid artery thrombosis 66.82 9.59 56 185188 2997 79556147
Mental status changes 66.46 9.59 320 184924 66639 79492505
Personality disorder 65.37 9.59 76 185168 6070 79553074
Altered state of consciousness 65.13 9.59 237 185007 43585 79515559
Nasopharyngitis 64.34 9.59 337 184907 253544 79305600
Neurologic neglect syndrome 62.96 9.59 53 185191 2854 79556290
Parasomnia 62.28 9.59 29 185215 532 79558612
Drug withdrawal convulsions 62.02 9.59 47 185197 2173 79556971
Blood pressure fluctuation 61.58 9.59 40 185204 67105 79492039
Initial insomnia 61.12 9.59 78 185166 6860 79552284
Mental disorder 59.57 9.59 184 185060 31118 79528026
Miosis 58.94 9.59 120 185124 15669 79543475
Disturbance in attention 58.77 9.59 254 184990 50547 79508597
Discomfort 57.58 9.59 129 185115 125488 79433656
Bradypnoea 56.44 9.59 70 185174 5982 79553162
Tremor 55.96 9.59 623 184621 169460 79389684
Adjustment disorder 53.89 9.59 56 185188 3944 79555200
Hallucination, visual 53.80 9.59 183 185061 32546 79526598
Exposure via ingestion 53.39 9.59 63 185181 5111 79554033
Incoherent 53.36 9.59 77 185167 7615 79551529
Immobilisation prolonged 53.30 9.59 17 185227 102 79559042
Psoriatic arthropathy 52.74 9.59 62 185182 77937 79481207
Red blood cell sedimentation rate increased 51.60 9.59 21 185223 45921 79513223
Psychomotor skills impaired 51.14 9.59 62 185182 5175 79553969
Mydriasis 51.00 9.59 121 185123 17522 79541622
Aggression 50.91 9.59 244 185000 50714 79508430
Wheezing 50.90 9.59 123 185121 116541 79442603
Parkinsonism 48.22 9.59 114 185130 16470 79542674
Logorrhoea 48.14 9.59 55 185189 4310 79554834
Neutropenia 47.98 9.59 432 184812 287278 79271866
Depressed level of consciousness 46.67 9.59 384 184860 96268 79462876
Akathisia 46.24 9.59 98 185146 13161 79545983
Myelosuppression 45.95 9.59 18 185226 40278 79518866
Panic attack 44.84 9.59 141 185103 24075 79535069
Gun shot wound 44.76 9.59 30 185214 1140 79558004
Impaired healing 44.40 9.59 85 185159 87570 79471574
Sleep talking 44.10 9.59 29 185215 1067 79558077
Emotional distress 44.07 9.59 197 185047 39772 79519372
Hypokinesia 43.94 9.59 120 185124 18940 79540204
Urticaria 43.52 9.59 252 184992 184949 79374195
Gastrointestinal disorder 42.88 9.59 143 185101 122062 79437082
Ill-defined disorder 42.81 9.59 54 185190 65821 79493323
Blood pressure systolic increased 42.40 9.59 56 185188 66930 79492214
General physical health deterioration 41.75 9.59 423 184821 274815 79284329
Cytomegalovirus infection 41.05 9.59 24 185220 42620 79516524
Self-medication 41.02 9.59 55 185189 5077 79554067
Angioedema 40.95 9.59 71 185173 75964 79483180
Exposure during pregnancy 40.00 9.59 112 185132 101020 79458124
Anterograde amnesia 39.84 9.59 23 185221 668 79558476
Reduced facial expression 39.59 9.59 40 185204 2725 79556419
Substance abuse 39.29 9.59 80 185164 10446 79548698
Euphoric mood 39.21 9.59 67 185177 7659 79551485
Dyspnoea 38.97 9.59 1612 183632 855413 78703731
Rhabdomyolysis 38.23 9.59 387 184857 102744 79456400
Memory impairment 37.52 9.59 411 184833 111323 79447821
C-reactive protein increased 37.49 9.59 163 185081 128864 79430280
Bradykinesia 37.25 9.59 67 185177 7976 79551168
Motor dysfunction 37.25 9.59 96 185148 14637 79544507
Major depression 36.83 9.59 71 185173 8909 79550235
Nightmare 36.03 9.59 137 185107 25724 79533420
Legal problem 35.73 9.59 14 185230 164 79558980
High risk sexual behaviour 35.47 9.59 7 185237 0 79559144
Irritability 35.46 9.59 189 185055 40955 79518189
Drug screen positive 35.39 9.59 56 185188 6007 79553137
Listless 34.95 9.59 44 185200 3817 79555327
Psychomotor hyperactivity 34.85 9.59 102 185142 16747 79542397
Hallucination, auditory 34.27 9.59 116 185128 20577 79538567
Head injury 33.82 9.59 174 185070 37195 79521949
COVID-19 33.68 9.59 221 185023 157453 79401691
Inflammation 33.37 9.59 109 185135 93644 79465500
Alcohol use 32.98 9.59 48 185196 4783 79554361
Analgesic drug level above therapeutic 32.87 9.59 18 185226 471 79558673
Anger 32.76 9.59 101 185143 17061 79542083
Drug tolerance 32.46 9.59 66 185178 8609 79550535
Behaviour disorder 32.37 9.59 55 185189 6258 79552886
Anaphylactic reaction 32.19 9.59 94 185150 83649 79475495
Coordination abnormal 31.32 9.59 100 185144 17212 79541932
Liver injury 31.28 9.59 52 185192 56562 79502582
Pruritus 31.12 9.59 689 184555 393959 79165185
Hyponatraemia 31.01 9.59 583 184661 177265 79381879
Inappropriate antidiuretic hormone secretion 30.76 9.59 132 185112 26181 79532963
Pulmonary fibrosis 29.89 9.59 35 185209 44077 79515067
Obstructive airways disorder 29.87 9.59 18 185226 31441 79527703
Dysphagia 29.71 9.59 423 184821 121713 79437431
Multiple organ dysfunction syndrome 29.66 9.59 161 185083 120085 79439059
Persistent genital arousal disorder 29.57 9.59 14 185230 267 79558877
Asthma 29.54 9.59 188 185056 134907 79424237
Septic shock 29.43 9.59 166 185078 122635 79436509
Blood pressure systolic abnormal 29.29 9.59 3 185241 17244 79541900
Hip arthroplasty 29.27 9.59 24 185220 35732 79523412
Apathy 29.21 9.59 81 185163 12896 79546248
Acute kidney injury 29.15 9.59 952 184292 518452 79040692
Urinary retention 28.97 9.59 228 185016 56402 79502742
Mobility decreased 28.82 9.59 166 185078 122009 79437135
Product substitution issue 28.79 9.59 108 185136 20148 79538996
Abnormal dreams 28.48 9.59 74 185170 11338 79547806
Heart rate decreased 28.46 9.59 77 185167 70239 79488905
Erythema 27.66 9.59 359 184885 222931 79336213
Premature delivery 27.56 9.59 10 185234 23457 79535687
Mania 27.34 9.59 99 185145 18161 79540983
Sensory loss 27.21 9.59 79 185165 12912 79546232
Skin haemorrhage 27.19 9.59 75 185169 11906 79547238
Unresponsive to stimuli 27.11 9.59 222 185022 55566 79503578
Multiple sclerosis relapse 26.99 9.59 193 185051 46340 79512804
Hyperlipidaemia 26.83 9.59 126 185118 25967 79533177
Eating disorder 26.69 9.59 107 185137 20590 79538554
Labelled drug-food interaction issue 26.63 9.59 8 185236 38 79559106
Substance use disorder 26.52 9.59 20 185224 918 79558226
Stomatitis 25.93 9.59 217 185027 146540 79412604
Bone erosion 25.89 9.59 5 185239 17842 79541302
Muscle rigidity 25.81 9.59 103 185141 19779 79539365
Live birth 25.65 9.59 6 185238 18738 79540406
Imprisonment 25.38 9.59 16 185228 547 79558597
Dysphoria 25.28 9.59 42 185202 4692 79554452
Electrocardiogram QT prolonged 25.26 9.59 321 184923 90065 79469079
Cough 25.15 9.59 654 184590 366135 79193009
Blood pressure diastolic decreased 25.09 9.59 20 185224 30196 79528948
Antidepressant drug level above therapeutic 25.06 9.59 17 185227 659 79558485
Tension 24.77 9.59 40 185204 4364 79554780
Thinking abnormal 24.70 9.59 77 185167 13084 79546060
Laryngeal pain 24.66 9.59 48 185196 6066 79553078
Toxic epidermal necrolysis 24.58 9.59 41 185203 44540 79514604
Grip strength decreased 24.55 9.59 10 185234 21859 79537285
Adverse drug reaction 24.46 9.59 76 185168 66316 79492828
Mucosal inflammation 24.13 9.59 92 185152 75488 79483656
Neurotoxicity 24.03 9.59 24 185220 32494 79526650
Irritable bowel syndrome 23.82 9.59 70 185174 62171 79496973
Drug tolerance increased 23.57 9.59 16 185228 621 79558523
Pyrexia 23.39 9.59 1314 183930 677395 78881749
Hemiplegia 23.22 9.59 82 185162 14857 79544287
Deep vein thrombosis 23.04 9.59 402 184842 120517 79438627
Peripheral circulatory failure 23.00 9.59 20 185224 1126 79558018
Joint range of motion decreased 22.99 9.59 26 185218 33256 79525888
Inappropriate schedule of product administration 22.97 9.59 199 185045 133429 79425715
Accidental overdose 22.86 9.59 164 185080 39417 79519727
Illusion 22.78 9.59 24 185220 1717 79557427
Nervousness 22.62 9.59 144 185100 33271 79525873
Therapy non-responder 22.53 9.59 124 185120 92181 79466963
Productive cough 22.49 9.59 117 185127 88214 79470930
Fear 22.48 9.59 106 185138 21880 79537264
Psychotic disorder 22.46 9.59 169 185075 41233 79517911
Panic disorder 22.30 9.59 31 185213 2961 79556183
Inadequate analgesia 22.00 9.59 39 185205 4590 79554554
Brain contusion 21.77 9.59 21 185223 1352 79557792
Urinary hesitation 21.66 9.59 37 185207 4229 79554915
Syncope 21.63 9.59 558 184686 178891 79380253
Encephalomalacia 21.62 9.59 20 185224 1221 79557923
Multiple drug therapy 21.54 9.59 36 185208 4042 79555102
Drug diversion 21.50 9.59 20 185224 1230 79557914
Bipolar disorder 21.35 9.59 52 185192 7655 79551489
Pain 21.17 9.59 1380 183864 702422 78856722
Pathogen resistance 20.84 9.59 4 185240 14338 79544806
Diarrhoea 20.82 9.59 1762 183482 878727 78680417
Oedematous pancreatitis 20.69 9.59 19 185225 1149 79557995
Cholecystitis chronic 20.52 9.59 60 185184 9846 79549298
Aplastic anaemia 20.41 9.59 8 185236 17897 79541247
Sinus congestion 20.40 9.59 96 185148 19800 79539344
Galactorrhoea 20.35 9.59 33 185211 3613 79555531
Multiple sclerosis 20.34 9.59 104 185140 22178 79536966
Femoral neck fracture 20.23 9.59 60 185184 9924 79549220
Feeling drunk 20.20 9.59 38 185206 4681 79554463
Accidental poisoning 20.20 9.59 22 185222 1635 79557509
Vision blurred 20.15 9.59 352 184892 105546 79453598
Transplant rejection 20.08 9.59 10 185234 19427 79539717
Tachycardia 20.06 9.59 548 184696 177220 79381924
Catatonia 20.05 9.59 55 185189 8701 79550443
Labelled drug-drug interaction medication error 19.76 9.59 21 185223 27629 79531515
Stress cardiomyopathy 19.75 9.59 64 185180 11102 79548042
Bronchiectasis 19.64 9.59 14 185230 22372 79536772
Disinhibition 19.49 9.59 27 185217 2571 79556573
Fibromyalgia 19.47 9.59 80 185164 64260 79494884
Feeling abnormal 19.18 9.59 495 184749 158704 79400440
Victim of homicide 19.14 9.59 9 185235 169 79558975
Febrile neutropenia 19.14 9.59 400 184844 230599 79328545
Delusion 19.11 9.59 96 185148 20327 79538817
Prothrombin time shortened 19.10 9.59 30 185214 3198 79555946
Self-injurious ideation 19.06 9.59 32 185212 3606 79555538
Hangover 19.01 9.59 24 185220 2088 79557056
Victim of sexual abuse 18.83 9.59 13 185231 519 79558625
Drug resistance 18.81 9.59 44 185200 42169 79516975
Aspartate aminotransferase increased 18.77 9.59 438 184806 138203 79420941
Hepatotoxicity 18.76 9.59 59 185185 51293 79507851
Foreign body 18.67 9.59 28 185216 2866 79556278
Weight increased 18.63 9.59 496 184748 276890 79282254
Bulimia nervosa 18.60 9.59 10 185234 252 79558892
Immunodeficiency 18.59 9.59 14 185230 21754 79537390
Sinus disorder 18.55 9.59 102 185142 22362 79536782
Sinus tachycardia 18.55 9.59 148 185096 36760 79522384
Hyperhidrosis 18.53 9.59 472 184772 151020 79408124
Depressed mood 18.48 9.59 183 185061 48297 79510847
Peptic ulcer 18.33 9.59 43 185201 6180 79552964
Tardive dyskinesia 18.16 9.59 60 185184 10511 79548633
Disease progression 18.12 9.59 310 184934 184052 79375092
Poor quality sleep 17.99 9.59 102 185142 22620 79536524
Performance fear 17.51 9.59 4 185240 4 79559140
Muscle spasticity 17.39 9.59 97 185147 21378 79537766
Facial nerve disorder 17.39 9.59 14 185230 708 79558436
Decreased interest 17.38 9.59 31 185213 3666 79555478
Enthesopathy 17.38 9.59 3 185241 11605 79547539
Procalcitonin abnormal 17.37 9.59 11 185233 379 79558765
Sneezing 17.36 9.59 91 185153 19592 79539552
Haematocrit decreased 17.24 9.59 218 185026 61094 79498050
Speech disorder 17.24 9.59 198 185046 54247 79504897
Skin ulcer 17.23 9.59 66 185178 54084 79505060
Thrombotic microangiopathy 17.19 9.59 13 185231 20156 79538988
Post transplant lymphoproliferative disorder 17.08 9.59 3 185241 11461 79547683
Libido decreased 17.04 9.59 38 185206 5283 79553861
Device expulsion 17.01 9.59 21 185223 25840 79533304
Bronchopulmonary aspergillosis 17.00 9.59 16 185228 22278 79536866
Cardiomegaly 16.88 9.59 112 185132 26240 79532904
Therapeutic response decreased 16.76 9.59 89 185155 66764 79492380
Hiatus hernia 16.74 9.59 102 185142 23210 79535934
Type 2 diabetes mellitus 16.68 9.59 72 185172 57050 79502094
Sudden onset of sleep 16.60 9.59 13 185231 631 79558513
Renal impairment 16.60 9.59 262 184982 157521 79401623
Lethargy 16.48 9.59 273 184971 81019 79478125
Prescription drug used without a prescription 16.39 9.59 32 185212 4053 79555091
Poor venous access 16.38 9.59 11 185233 18138 79541006
Skin necrosis 16.28 9.59 11 185233 18076 79541068
Palpitations 16.23 9.59 397 184847 126213 79432931
Tachyphrenia 16.18 9.59 22 185222 2058 79557086
Anhedonia 16.10 9.59 73 185171 14825 79544319
Alcohol poisoning 16.08 9.59 35 185209 4786 79554358
Victim of chemical submission 16.08 9.59 12 185232 542 79558602
Hypokalaemia 15.95 9.59 443 184801 143597 79415547
Dehydration 15.92 9.59 717 184527 247470 79311674
Hepatitis B DNA increased 15.90 9.59 14 185230 801 79558343
Cerebral atrophy 15.86 9.59 48 185196 8027 79551117
Loss of personal independence in daily activities 15.80 9.59 157 185087 102423 79456721
Hypertensive heart disease 15.74 9.59 32 185212 4174 79554970
Influenza like illness 15.73 9.59 244 185000 71463 79487681
Cholecystectomy 15.73 9.59 53 185191 9379 79549765
Neurogenic bladder 15.70 9.59 32 185212 4180 79554964
Circadian rhythm sleep disorder 15.62 9.59 13 185231 689 79558455
PCO2 decreased 15.54 9.59 27 185217 3127 79556017
Enuresis 15.41 9.59 27 185217 3149 79555995
Prostate cancer 15.37 9.59 34 185210 33234 79525910
Depressive symptom 15.37 9.59 41 185203 6382 79552762
Neuroglycopenia 15.21 9.59 11 185233 473 79558671
Blood parathyroid hormone decreased 15.18 9.59 3 185241 10533 79548611
Dysuria 15.12 9.59 183 185061 50768 79508376
Homicidal ideation 15.00 9.59 28 185216 3429 79555715
Cognitive disorder 14.98 9.59 237 185007 69689 79489455
Suicidal behaviour 14.98 9.59 27 185217 3220 79555924
Knee arthroplasty 14.89 9.59 51 185193 43197 79515947
Prescription form tampering 14.87 9.59 10 185234 382 79558762
Staring 14.85 9.59 24 185220 2621 79556523
Perseveration 14.76 9.59 10 185234 387 79558757
Vertigo 14.75 9.59 234 185010 68848 79490296
Facet joint syndrome 14.73 9.59 4 185240 11298 79547846
Dementia 14.72 9.59 103 185141 24556 79534588
Drug ineffective for unapproved indication 14.71 9.59 65 185179 51173 79507971
Suspected suicide 14.71 9.59 56 185188 10520 79548624
Posterior reversible encephalopathy syndrome 14.65 9.59 24 185220 26257 79532887
Tenosynovitis 14.62 9.59 9 185235 15545 79543599
Stupor 14.60 9.59 42 185202 6830 79552314
Herpes zoster 14.53 9.59 142 185102 92941 79466203
Generalised tonic-clonic seizure 14.49 9.59 161 185083 43749 79515395
Hepatitis C virus test positive 14.31 9.59 10 185234 407 79558737
Bipolar I disorder 14.31 9.59 21 185223 2108 79557036
Eye pruritus 14.28 9.59 16 185228 20554 79538590
Coagulation factor VII level decreased 14.12 9.59 8 185236 224 79558920
Arthritis 14.10 9.59 185 185059 114695 79444449
Affective disorder 14.10 9.59 47 185197 8272 79550872
Creatinine renal clearance decreased 14.07 9.59 14 185230 18988 79540156
Nephropathy toxic 14.05 9.59 16 185228 20403 79538741
Apallic syndrome 13.85 9.59 14 185230 954 79558190
Therapy partial responder 13.84 9.59 12 185232 17385 79541759
Generalised anxiety disorder 13.81 9.59 21 185223 2176 79556968
Blood creatine phosphokinase increased 13.79 9.59 223 185021 65867 79493277
Joint effusion 13.65 9.59 13 185231 18001 79541143
Product dose omission issue 13.54 9.59 455 184789 247082 79312062
Sudden death 13.42 9.59 94 185150 22417 79536727
Mouth ulceration 13.41 9.59 45 185199 38349 79520795
Anorexia nervosa 13.39 9.59 8 185236 248 79558896
Colitis ulcerative 13.35 9.59 39 185205 34703 79524441
Blood potassium decreased 13.34 9.59 166 185078 46346 79512798
Diabetic ketoacidosis 13.33 9.59 38 185206 34084 79525060
Seizure 13.33 9.59 551 184693 188283 79370861
Respiratory tract infection bacterial 13.27 9.59 20 185224 2057 79557087
Intervertebral disc degeneration 13.25 9.59 72 185172 15713 79543431
Slow speech 13.25 9.59 22 185222 2456 79556688
Vascular dementia 13.11 9.59 13 185231 866 79558278
Persistent depressive disorder 12.98 9.59 15 185229 1190 79557954
Sciatica 12.98 9.59 37 185207 33185 79525959
PO2 decreased 12.86 9.59 24 185220 2939 79556205
Sinusitis 12.75 9.59 351 184893 195150 79363994
Oropharyngeal pain 12.74 9.59 178 185066 109175 79449969
Carotid artery stenosis 12.70 9.59 47 185197 8711 79550433
Epstein-Barr virus infection 12.66 9.59 9 185235 14407 79544737
Oesophageal carcinoma 12.55 9.59 5 185239 11079 79548065
Therapeutic response shortened 12.55 9.59 11 185233 15852 79543292
Injection site pain 12.54 9.59 219 185025 129619 79429525
Osteoarthritis 12.48 9.59 136 185108 87173 79471971
Injury 12.46 9.59 251 184993 77245 79481899
Substance-induced mood disorder 12.46 9.59 6 185238 119 79559025
Feeling of despair 12.43 9.59 23 185221 2798 79556346
Drug dependence, antepartum 12.40 9.59 4 185240 25 79559119
Secretion discharge 12.40 9.59 10 185234 15012 79544132
Respiratory tract congestion 12.30 9.59 84 185160 19870 79539274
Attention deficit hyperactivity disorder 12.17 9.59 25 185219 3284 79555860
Pneumonia aspiration 12.17 9.59 221 185023 66746 79492398
Product complaint 11.97 9.59 62 185182 13287 79545857
Distributive shock 11.96 9.59 22 185222 2665 79556479
Sedation 11.93 9.59 178 185066 51717 79507427
Asthenia 11.88 9.59 1360 183884 510329 79048815
Alanine aminotransferase abnormal 11.82 9.59 3 185241 8864 79550280
Eustachian tube disorder 11.77 9.59 5 185239 73 79559071
Bone marrow failure 11.75 9.59 70 185174 51037 79508107
Death 11.70 9.59 1145 184099 565369 78993775
Respiratory disorder 11.65 9.59 59 185185 44797 79514347
Foot deformity 11.62 9.59 24 185220 24050 79535094
Cardiotoxicity 11.62 9.59 7 185237 12232 79546912
Haematochezia 11.56 9.59 139 185105 87506 79471638
Social anxiety disorder 11.53 9.59 10 185234 561 79558583
Abulia 11.50 9.59 13 185231 1007 79558137
Peripheral ischaemia 11.49 9.59 48 185196 9409 79549735
Immobile 11.47 9.59 39 185205 6934 79552210
Atelectasis 11.45 9.59 120 185124 32137 79527007
Cerebrovascular accident 11.39 9.59 455 184789 154837 79404307
Blood cholesterol increased 11.34 9.59 132 185112 83588 79475556
Fatigue 11.28 9.59 1944 183300 927783 78631361
Blood testosterone decreased 11.26 9.59 20 185224 2357 79556787
Vertigo CNS origin 11.24 9.59 4 185240 35 79559109
Diverticulum 11.22 9.59 66 185178 14830 79544314
Hypoosmolar state 11.17 9.59 8 185236 339 79558805
Sudden cardiac death 11.16 9.59 32 185212 5193 79553951
Feeling hot 11.15 9.59 87 185157 59647 79499497
Neurological examination normal 11.14 9.59 4 185240 36 79559108
Coagulation factor VIII level increased 11.14 9.59 4 185240 36 79559108
Sputum discoloured 11.08 9.59 21 185223 21722 79537422
Rectocele repair 11.06 9.59 3 185241 9 79559135
Cytopenia 11.00 9.59 19 185225 20364 79538780
Respiratory depression 10.87 9.59 105 185139 27525 79531619
Acute graft versus host disease 10.86 9.59 5 185239 10162 79548982
Refusal of treatment by relative 10.85 9.59 11 185233 752 79558392
Leukopenia 10.78 9.59 198 185046 116315 79442829
Aortic valve calcification 10.77 9.59 11 185233 759 79558385
Amnestic disorder 10.76 9.59 10 185234 614 79558530
Head discomfort 10.76 9.59 64 185180 14438 79544706
Lip dry 10.70 9.59 12 185232 15406 79543738
Tubulointerstitial nephritis 10.68 9.59 49 185195 38186 79520958
Coagulation factor V level decreased 10.67 9.59 10 185234 621 79558523
Labelled drug-food interaction medication error 10.66 9.59 6 185238 166 79558978
COVID-19 pneumonia 10.64 9.59 33 185211 28816 79530328
Crohn's disease 10.63 9.59 18 185226 2042 79557102
Dermatitis allergic 10.63 9.59 16 185228 18114 79541030
Dyssomnia 10.60 9.59 4 185240 42 79559102
Loss of proprioception 10.58 9.59 11 185233 775 79558369
Pancreatic haemorrhage 10.58 9.59 5 185239 95 79559049
Bursitis 10.58 9.59 45 185199 35799 79523345
Psychomotor retardation 10.54 9.59 35 185209 6149 79552995
Lupus-like syndrome 10.50 9.59 10 185234 13847 79545297
Left ventricular dysfunction 10.49 9.59 18 185226 19343 79539801
Sepsis 10.49 9.59 515 184729 268913 79290231
Mental impairment 10.49 9.59 78 185166 18958 79540186
Rales 10.47 9.59 19 185225 19982 79539162
Autoimmune disorder 10.40 9.59 14 185230 16598 79542546
Mood altered 10.34 9.59 74 185170 17773 79541371
Diplopia 10.28 9.59 121 185123 33345 79525799
Aspergillus infection 10.22 9.59 18 185226 19143 79540001
Serotonin syndrome 10.18 9.59 154 185090 44873 79514271
Activation syndrome 10.17 9.59 7 185237 278 79558866
Product administration error 10.16 9.59 116 185128 31730 79527414
Mood swings 10.14 9.59 80 185164 19800 79539344
Blastocystis infection 10.12 9.59 4 185240 48 79559096
Gastric polyps 10.08 9.59 25 185219 3722 79555422
Ulcer 9.88 9.59 36 185208 29936 79529208
Coeliac artery compression syndrome 9.87 9.59 5 185239 111 79559033
Therapeutic product effect increased 9.85 9.59 15 185229 1556 79557588
Product commingling 9.79 9.59 5 185239 113 79559031
Vasculitis 9.77 9.59 28 185216 25074 79534070
Skin abrasion 9.74 9.59 59 185185 13397 79545747
Dental pulp disorder 9.70 9.59 3 185241 16 79559128
Pleurodesis 9.70 9.59 4 185240 54 79559090

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC N05CF02 NERVOUS SYSTEM
PSYCHOLEPTICS
HYPNOTICS AND SEDATIVES
Benzodiazepine related drugs
FDA CS M0018233 Pyridines
FDA MoA N0000000196 GABA A Agonists
FDA Chemical/Ingredient N0000007570 Pyridines
MeSH PA D002491 Central Nervous System Agents
MeSH PA D002492 Central Nervous System Depressants
MeSH PA D018682 GABA Agents
MeSH PA D018755 GABA Agonists
MeSH PA D058785 GABA-A Receptor Agonists
MeSH PA D006993 Hypnotics and Sedatives
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D000068776 Sleep Aids, Pharmaceutical
CHEBI has role CHEBI:35488 central nervous system depressants
CHEBI has role CHEBI:35717 hypnotics
CHEBI has role CHEBI:51373 gamma-aminobutyric acid receptor agonist
FDA PE N0000175728 Central Nervous System Depression
FDA EPC N0000175759 gamma-Aminobutyric Acid-ergic Agonist

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

DiseaseRelationSNOMED_IDDOID
Initial insomnia indication 59050008
Insomnia indication 193462001
Cognitive impairment following traumatic brain injury off-label use 127295002
Arousal post traumatic brain injury off-label use 127295002
Suicidal thoughts contraindication 6471006
Hallucinations contraindication 7011001
Asthenia contraindication 13791008
Alcohol intoxication contraindication 25702006
Depressive disorder contraindication 35489007
Aggressive behavior contraindication 61372001
Substance abuse contraindication 66214007
Sleep apnea contraindication 73430006 DOID:0050847
Disease of liver contraindication 235856003 DOID:409
Sleep automatism contraindication 247962006
Severe chronic obstructive pulmonary disease contraindication 313299006
Impaired cognition contraindication 386806002
Memory impairment contraindication 386807006
Attention deficit hyperactivity disorder contraindication 406506008




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 5.73 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
1.75MG INTERMEZZO PURDUE PHARMA N022328 Nov. 23, 2011 DISCN TABLET SUBLINGUAL 7682628 Feb. 16, 2025 METHOD FOR TREATING INSOMNIA
3.5MG INTERMEZZO PURDUE PHARMA N022328 Nov. 23, 2011 DISCN TABLET SUBLINGUAL 7682628 Feb. 16, 2025 METHOD FOR TREATING INSOMNIA
10MG EDLUAR MYLAN SPECIALITY LP N021997 March 13, 2009 RX TABLET SUBLINGUAL 9597281 April 6, 2027 METHOD OF TREATING INSOMNIA CHARACTERIZED BY DIFFICULTY WITH SLEEP ONSET
5MG EDLUAR MYLAN SPECIALITY LP N021997 March 13, 2009 RX TABLET SUBLINGUAL 9597281 April 6, 2027 METHOD OF TREATING INSOMNIA CHARACTERIZED BY DIFFICULTY WITH SLEEP ONSET
1.75MG INTERMEZZO PURDUE PHARMA N022328 Nov. 23, 2011 DISCN TABLET SUBLINGUAL 7658945 April 15, 2027 METHOD FOR TREATING INSOMNIA
3.5MG INTERMEZZO PURDUE PHARMA N022328 Nov. 23, 2011 DISCN TABLET SUBLINGUAL 7658945 April 15, 2027 METHOD FOR TREATING INSOMNIA
1.75MG INTERMEZZO PURDUE PHARMA N022328 Nov. 23, 2011 DISCN TABLET SUBLINGUAL 8242131 Aug. 20, 2029 METHOD OF TREATING MIDDLE-OF-THE-NIGHT INSOMNIA
3.5MG INTERMEZZO PURDUE PHARMA N022328 Nov. 23, 2011 DISCN TABLET SUBLINGUAL 8242131 Aug. 20, 2029 METHOD OF TREATING MIDDLE-OF-THE-NIGHT INSOMNIA
10MG EDLUAR MYLAN SPECIALITY LP N021997 March 13, 2009 RX TABLET SUBLINGUAL 9265720 Feb. 25, 2031 METHOD OF TREATING INSOMNIA CHARACTERIZED BY DIFFICULTY WITH SLEEP ONSET
5MG EDLUAR MYLAN SPECIALITY LP N021997 March 13, 2009 RX TABLET SUBLINGUAL 9265720 Feb. 25, 2031 METHOD OF TREATING INSOMNIA CHARACTERIZED BY DIFFICULTY WITH SLEEP ONSET
5MG/SPRAY ZOLPIMIST AYTU N022196 Dec. 19, 2008 DISCN SPRAY, METERED ORAL 8236285 Aug. 7, 2032 TREATMENT OF TRANSIENT INSOMNIA

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
GABA A receptor alpha-3/beta-2/gamma-2 Ion channel POSITIVE ALLOSTERIC MODULATOR Ki 6.16 WOMBAT-PK CHEMBL
Gamma-aminobutyric acid receptor subunit alpha-1 Ion channel ALLOSTERIC MODULATOR Ki 7.68 IUPHAR IUPHAR
GABA-A receptor alpha-1/beta-2/gamma-2 Ion channel POSITIVE ALLOSTERIC MODULATOR EC50 6.70 WOMBAT-PK CHEMBL
GABA-A receptor alpha-2/beta-3/gamma-2 Ion channel POSITIVE ALLOSTERIC MODULATOR Ki 6.81 WOMBAT-PK CHEMBL
GABA-A receptor alpha-3/beta-3/gamma-2 Ion channel POSITIVE ALLOSTERIC MODULATOR Ki 6.42 WOMBAT-PK CHEMBL
GABA-A receptor alpha-1/beta-3/gamma-2 Ion channel POSITIVE ALLOSTERIC MODULATOR Ki 7.57 WOMBAT-PK CHEMBL
Gamma-aminobutyric acid receptor subunit alpha-2 Ion channel Ki 6.39 CHEMBL
Gamma-aminobutyric acid receptor subunit alpha-3 Ion channel Ki 6.01 CHEMBL
Multidrug resistance protein 1 Transporter Km 3.70 WOMBAT-PK
Gamma-aminobutyric acid receptor subunit alpha-1 Ion channel Ki 7.30 CHEMBL
Gamma-aminobutyric acid receptor subunit alpha-2 Ion channel Ki 6.12 CHEMBL
Gamma-aminobutyric acid receptor subunit alpha-5 Ion channel Ki 7.46 CHEMBL
GABA A receptor alpha-6/beta-2/gamma-2 Ion channel Ki 6.01 CHEMBL
GABA-A receptor; alpha-1/beta-2/gamma-2 Ion channel Ki 7.72 CHEMBL
GABA A receptor alpha-2/beta-2/gamma-2 Ion channel Ki 6.81 CHEMBL
CAAX prenyl protease 2 Enzyme AC50 4.77 CHEMBL
GABA-A receptor; anion channel Ion channel Ki 7.60 CHEMBL
GABA A receptor alpha-3/beta-2/gamma-2 Ion channel Ki 6.42 CHEMBL
Translocator protein Membrane receptor IC50 5.33 CHEMBL

External reference:

IDSource
D00706 KEGG_DRUG
99294-93-6 SECONDARY_CAS_RN
4020811 VANDF
4023596 VANDF
C0078839 UMLSCUI
CHEBI:10125 CHEBI
R5R PDB_CHEM_ID
CHEMBL911 ChEMBL_ID
CHEMBL3989820 ChEMBL_ID
DB00425 DRUGBANK_ID
CHEMBL1723343 ChEMBL_ID
D000077334 MESH_DESCRIPTOR_UI
5732 PUBCHEM_CID
4348 IUPHAR_LIGAND_ID
5741 INN_ID
7K383OQI23 UNII
131725 RXNORM
109404 MMSL
343 MMSL
5713 MMSL
d00910 MMSL
004146 NDDF
004147 NDDF
387569009 SNOMEDCT_US
395928005 SNOMEDCT_US
96231005 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Ambien HUMAN PRESCRIPTION DRUG LABEL 1 0024-5401 TABLET, FILM COATED 5 mg ORAL NDA 34 sections
Ambien HUMAN PRESCRIPTION DRUG LABEL 1 0024-5401 TABLET, FILM COATED 5 mg ORAL NDA 34 sections
Ambien HUMAN PRESCRIPTION DRUG LABEL 1 0024-5421 TABLET, FILM COATED 10 mg ORAL NDA 34 sections
Ambien HUMAN PRESCRIPTION DRUG LABEL 1 0024-5421 TABLET, FILM COATED 10 mg ORAL NDA 34 sections
Ambien CR HUMAN PRESCRIPTION DRUG LABEL 1 0024-5501 TABLET, COATED 6.25 mg ORAL NDA 34 sections
Ambien CR HUMAN PRESCRIPTION DRUG LABEL 1 0024-5501 TABLET, COATED 6.25 mg ORAL NDA 34 sections
Ambien CR HUMAN PRESCRIPTION DRUG LABEL 1 0024-5521 TABLET, COATED 12.50 mg ORAL NDA 34 sections
Ambien CR HUMAN PRESCRIPTION DRUG LABEL 1 0024-5521 TABLET, COATED 12.50 mg ORAL NDA 34 sections
Edluar HUMAN PRESCRIPTION DRUG LABEL 1 0037-6010 TABLET 10 mg ORAL NDA 33 sections
Edluar HUMAN PRESCRIPTION DRUG LABEL 1 0037-6010 TABLET 10 mg ORAL NDA 33 sections
Edluar HUMAN PRESCRIPTION DRUG LABEL 1 0037-6050 TABLET 5 mg ORAL NDA 33 sections
Edluar HUMAN PRESCRIPTION DRUG LABEL 1 0037-6050 TABLET 5 mg ORAL NDA 33 sections
Zolpidem Tartrate HUMAN PRESCRIPTION DRUG LABEL 1 0054-0086 TABLET, FILM COATED 5 mg ORAL ANDA 31 sections
Zolpidem Tartrate HUMAN PRESCRIPTION DRUG LABEL 1 0054-0087 TABLET, FILM COATED 10 mg ORAL ANDA 31 sections
Zolpidem Tartrate HUMAN PRESCRIPTION DRUG LABEL 1 0093-0073 TABLET, FILM COATED 5 mg ORAL ANDA 31 sections
Zolpidem Tartrate HUMAN PRESCRIPTION DRUG LABEL 1 0093-0073 TABLET, FILM COATED 5 mg ORAL ANDA 31 sections
Zolpidem Tartrate HUMAN PRESCRIPTION DRUG LABEL 1 0093-0074 TABLET, FILM COATED 10 mg ORAL ANDA 31 sections
Zolpidem Tartrate HUMAN PRESCRIPTION DRUG LABEL 1 0093-0074 TABLET, FILM COATED 10 mg ORAL ANDA 31 sections
Zolpidem Tartrate HUMAN PRESCRIPTION DRUG LABEL 1 0615-8225 TABLET, FILM COATED 5 mg ORAL ANDA 32 sections
Zolpidem Tartrate HUMAN PRESCRIPTION DRUG LABEL 1 0615-8226 TABLET, FILM COATED 10 mg ORAL ANDA 32 sections
Zolpidem tartrate HUMAN PRESCRIPTION DRUG LABEL 1 0781-5315 TABLET, EXTENDED RELEASE 6.25 mg ORAL ANDA 32 sections
Zolpidem tartrate HUMAN PRESCRIPTION DRUG LABEL 1 0781-5315 TABLET, EXTENDED RELEASE 6.25 mg ORAL ANDA 32 sections
Zolpidem tartrate HUMAN PRESCRIPTION DRUG LABEL 1 0781-5316 TABLET, EXTENDED RELEASE 12.50 mg ORAL ANDA 32 sections
Zolpidem tartrate HUMAN PRESCRIPTION DRUG LABEL 1 0781-5316 TABLET, EXTENDED RELEASE 12.50 mg ORAL ANDA 32 sections
Zolpidem Tartrate HUMAN PRESCRIPTION DRUG LABEL 1 0781-5317 TABLET, COATED 5 mg ORAL ANDA 31 sections
Zolpidem Tartrate HUMAN PRESCRIPTION DRUG LABEL 1 0781-5317 TABLET, COATED 5 mg ORAL ANDA 31 sections
Zolpidem Tartrate HUMAN PRESCRIPTION DRUG LABEL 1 0781-5318 TABLET, COATED 10 mg ORAL ANDA 31 sections
Zolpidem Tartrate HUMAN PRESCRIPTION DRUG LABEL 1 0781-5318 TABLET, COATED 10 mg ORAL ANDA 31 sections
ZOLPIDEM TARTRATE HUMAN PRESCRIPTION DRUG LABEL 1 0904-6082 TABLET 5 mg ORAL ANDA 31 sections
ZOLPIDEM TARTRATE HUMAN PRESCRIPTION DRUG LABEL 1 0904-6082 TABLET 5 mg ORAL ANDA 31 sections