zolpidem ๐Ÿถ 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) 23 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 0.50 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.47 ยตM/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 893.81 9.63 1391 144185 132442 56014049
Drug abuse 730.03 9.63 887 144689 66723 56079768
Intentional overdose 627.97 9.63 826 144750 67291 56079200
Somnambulism 514.05 9.63 255 145321 4837 56141654
Rheumatoid arthritis 511.84 9.63 176 145400 382428 55764063
Suicide attempt 443.69 9.63 642 144934 57194 56089297
Drug dependence 442.77 9.63 407 145169 22126 56124365
Contraindicated product administered 415.46 9.63 15 145561 186271 55960220
Amnesia 372.60 9.63 526 145050 45796 56100695
Drug intolerance 358.69 9.63 119 145457 264699 55881792
Synovitis 356.19 9.63 14 145562 161291 55985200
Hand deformity 322.00 9.63 5 145571 134487 56012004
Treatment failure 317.56 9.63 35 145541 170357 55976134
Systemic lupus erythematosus 306.96 9.63 49 145527 180029 55966462
Joint swelling 302.55 9.63 188 145388 289612 55856879
Anxiety 292.47 9.63 1129 144447 192043 55954448
Infusion related reaction 289.70 9.63 90 145486 208841 55937650
Sopor 280.25 9.63 307 145269 20615 56125876
Drug ineffective 274.26 9.63 1337 144239 917652 55228839
Arthropathy 267.57 9.63 92 145484 200183 55946308
Intentional self-injury 266.40 9.63 326 145250 24666 56121825
Glossodynia 265.48 9.63 39 145537 152419 55994072
Insomnia 239.64 9.63 1057 144519 190803 55955688
Overdose 222.33 9.63 690 144886 105140 56041351
Off label use 219.11 9.63 724 144852 555456 55591035
Abnormal sleep-related event 216.22 9.63 79 145497 667 56145824
Depression 211.17 9.63 974 144602 179143 55967348
Pericarditis 209.02 9.63 20 145556 108903 56037588
Intentional product misuse 207.45 9.63 430 145146 51074 56095417
Wound 199.24 9.63 56 145520 138748 56007743
Alopecia 194.57 9.63 286 145290 293172 55853319
Somnolence 188.80 9.63 880 144696 162533 55983958
Poisoning deliberate 182.43 9.63 173 145403 9780 56136711
Maternal exposure during pregnancy 181.55 9.63 135 145441 189418 55957073
Peripheral swelling 176.80 9.63 208 145368 234518 55911973
Toxicity to various agents 174.15 9.63 1084 144492 223480 55923011
Swelling 172.66 9.63 220 145356 239551 55906940
Hypersensitivity 169.82 9.63 250 145326 256158 55890333
Lower respiratory tract infection 169.09 9.63 44 145532 114750 56031741
Abdominal discomfort 168.82 9.63 286 145290 276988 55869503
Poisoning 151.10 9.63 176 145400 12637 56133854
Drug withdrawal syndrome 150.65 9.63 253 145323 25604 56120887
Therapeutic product effect decreased 143.40 9.63 136 145440 169316 55977175
Helicobacter infection 141.75 9.63 13 145563 73255 56073236
Fall 136.30 9.63 1468 144108 356042 55790449
Coma 134.62 9.63 399 145177 59256 56087235
Suicidal ideation 131.06 9.63 387 145189 57355 56089136
Respiratory arrest 129.57 9.63 261 145315 30364 56116127
Product use issue 127.44 9.63 177 145399 185864 55960627
Cardio-respiratory arrest 123.87 9.63 369 145207 54952 56091539
Hepatic enzyme increased 121.49 9.63 159 145417 171225 55975266
Rash 120.66 9.63 764 144812 492283 55654208
Drug use disorder 117.21 9.63 97 145479 4572 56141919
Infection 115.00 9.63 214 145362 199992 55946499
Discomfort 113.92 9.63 119 145457 141642 56004849
Abnormal behaviour 111.03 9.63 193 145383 20079 56126412
Arthralgia 110.95 9.63 801 144775 500868 55645623
Impaired driving ability 106.81 9.63 87 145489 4009 56142482
Road traffic accident 104.12 9.63 226 145350 27701 56118790
Loss of consciousness 103.62 9.63 557 145019 108792 56037699
Musculoskeletal stiffness 102.31 9.63 153 145423 155854 55990637
Sleep-related eating disorder 101.64 9.63 47 145529 757 56145734
Folliculitis 98.14 9.63 13 145563 54966 56091525
Muscle injury 94.71 9.63 12 145564 52488 56094003
Blister 93.72 9.63 86 145490 108801 56037690
Sleep disorder due to general medical condition, insomnia type 91.57 9.63 5 145571 43333 56103158
Withdrawal syndrome 84.94 9.63 163 145413 18299 56128192
Affect lability 82.87 9.63 116 145460 10009 56136482
Disorientation 80.79 9.63 243 145333 36370 56110121
Therapeutic product effect incomplete 80.76 9.63 93 145483 105938 56040553
Hallucination 80.58 9.63 295 145281 48854 56097637
Restlessness 80.24 9.63 198 145378 26388 56120103
Mental status changes 80.04 9.63 246 145330 37255 56109236
Agitation 79.31 9.63 321 145255 55715 56090776
Mydriasis 77.77 9.63 118 145458 10953 56135538
Nasopharyngitis 77.73 9.63 301 145275 220658 55925833
Drug hypersensitivity 77.57 9.63 407 145169 274798 55871693
Product substitution issue 71.01 9.63 132 145444 14467 56132024
Bradyphrenia 69.95 9.63 86 145490 6534 56139957
Drug abuser 64.79 9.63 56 145520 2803 56143688
Tremor 62.73 9.63 531 145045 120558 56025933
Intentional product use issue 62.31 9.63 101 145475 99632 56046859
Ill-defined disorder 60.32 9.63 53 145523 68490 56078001
Dependence 59.77 9.63 46 145530 1951 56144540
Immobilisation prolonged 57.77 9.63 18 145558 87 56146404
Delirium 57.35 9.63 240 145336 42277 56104214
Carotid artery thrombosis 57.12 9.63 47 145529 2197 56144294
Hyponatraemia 56.70 9.63 455 145121 101684 56044807
Condition aggravated 55.96 9.63 596 144980 344302 55802189
Confusional state 55.49 9.63 800 144776 207355 55939136
Product use in unapproved indication 55.36 9.63 183 145393 140639 56005852
Impaired healing 55.14 9.63 87 145489 86754 56059737
Dysarthria 54.72 9.63 225 145351 39325 56107166
Cardiac arrest 53.76 9.63 395 145181 85919 56060572
Miosis 53.17 9.63 75 145501 6517 56139974
Pain 52.96 9.63 1309 144267 661875 55484616
Sleep talking 52.69 9.63 32 145544 915 56145576
Exposure during pregnancy 51.67 9.63 180 145396 136162 56010329
Mental disorder 51.45 9.63 156 145420 23448 56123043
Psoriatic arthropathy 50.03 9.63 71 145505 73937 56072554
Substance abuse 49.79 9.63 60 145516 4465 56142026
Neurologic neglect syndrome 49.70 9.63 43 145533 2155 56144336
Urinary retention 48.99 9.63 172 145404 27902 56118589
Parkinsonism 48.56 9.63 88 145488 9458 56137033
Personality disorder 48.01 9.63 63 145513 5110 56141381
Dissociative disorder 47.51 9.63 20 145556 254 56146237
Drug withdrawal convulsions 46.61 9.63 34 145542 1328 56145163
Drug detoxification 45.48 9.63 17 145559 154 56146337
Altered state of consciousness 44.53 9.63 146 145430 22875 56123616
Disturbance in attention 44.13 9.63 184 145392 32356 56114135
Listless 43.07 9.63 43 145533 2589 56143902
Gastrointestinal disorder 42.56 9.63 149 145427 112553 56033938
Red blood cell sedimentation rate increased 42.10 9.63 21 145555 36602 56109889
Emotional distress 41.71 9.63 170 145406 29593 56116898
Liver injury 41.05 9.63 29 145547 41819 56104672
Psychomotor skills impaired 40.75 9.63 38 145538 2102 56144389
Hip arthroplasty 40.27 9.63 25 145551 38598 56107893
Initial insomnia 38.53 9.63 59 145517 5520 56140971
Irritable bowel syndrome 38.52 9.63 74 145502 68384 56078107
Tardive dyskinesia 38.29 9.63 72 145504 7959 56138532
Persistent genital arousal disorder 37.94 9.63 18 145558 308 56146183
Bradypnoea 37.77 9.63 44 145532 3159 56143332
Exposure via ingestion 37.24 9.63 41 145535 2767 56143724
Motor dysfunction 36.93 9.63 78 145498 9379 56137112
Syncope 35.95 9.63 433 145143 107766 56038725
Logorrhoea 35.89 9.63 37 145539 2315 56144176
Memory impairment 35.44 9.63 361 145215 86196 56060295
Dehydration 35.26 9.63 592 144984 158233 55988258
Premature delivery 35.11 9.63 13 145563 27047 56119444
Drug screen positive 34.99 9.63 44 145532 3420 56143071
Depressed level of consciousness 34.98 9.63 258 145318 56175 56090316
Stomatitis 34.91 9.63 177 145399 120633 56025858
Hallucination, visual 34.88 9.63 112 145464 17356 56129135
High risk sexual behaviour 34.72 9.63 7 145569 0 56146491
Multiple drug therapy 34.00 9.63 39 145537 2753 56143738
Tachycardia 34.00 9.63 421 145155 105455 56041036
Panic attack 33.73 9.63 123 145453 20324 56126167
Akathisia 33.37 9.63 71 145505 8581 56137910
Bradykinesia 33.05 9.63 51 145525 4803 56141688
Adverse drug reaction 32.79 9.63 75 145501 65057 56081434
Adjustment disorder 32.69 9.63 35 145541 2288 56144203
Eating disorder 32.65 9.63 108 145468 16997 56129494
Victim of sexual abuse 32.35 9.63 20 145556 591 56145900
Blood pressure fluctuation 31.15 9.63 35 145541 40325 56106166
Hypokalaemia 30.96 9.63 377 145199 94060 56052431
Hallucination, auditory 30.81 9.63 82 145494 11442 56135049
Urticaria 30.39 9.63 234 145342 144442 56002049
Head injury 30.36 9.63 137 145439 24929 56121562
Wheezing 29.81 9.63 97 145479 74929 56071562
Sensory loss 29.60 9.63 69 145507 8866 56137625
Homicide 29.47 9.63 16 145560 368 56146123
Rhabdomyolysis 29.39 9.63 193 145383 40465 56106026
Skin haemorrhage 29.01 9.63 66 145510 8347 56138144
Hyperhidrosis 28.87 9.63 371 145205 93717 56052774
Nightmare 28.42 9.63 102 145474 16724 56129767
Coordination abnormal 28.05 9.63 84 145492 12537 56133954
Bulimia nervosa 27.99 9.63 16 145560 408 56146083
Live birth 27.94 9.63 8 145568 19597 56126894
Pruritus 27.92 9.63 615 144961 316008 55830483
Illusion 27.80 9.63 22 145554 972 56145519
Dysphagia 27.68 9.63 329 145247 81618 56064873
Inflammation 27.65 9.63 89 145487 68982 56077509
Anaphylactic reaction 27.28 9.63 71 145505 58924 56087567
C-reactive protein increased 27.10 9.63 108 145468 78576 56067915
Irritability 26.83 9.63 149 145427 29439 56117052
Sinus tachycardia 26.68 9.63 122 145454 22322 56124169
Prescription drug used without a prescription 26.41 9.63 29 145547 1951 56144540
Alcohol abuse 26.36 9.63 29 145547 1955 56144536
Blood pressure systolic increased 25.83 9.63 41 145535 40795 56105696
Abnormal dreams 25.13 9.63 68 145508 9581 56136910
Device expulsion 25.07 9.63 25 145551 30424 56116067
Vertigo 24.98 9.63 233 145343 54339 56092152
Knee arthroplasty 24.76 9.63 48 145528 44211 56102280
Peptic ulcer 24.73 9.63 41 145535 4103 56142388
General physical health deterioration 24.68 9.63 301 145275 169709 55976782
Type 2 diabetes mellitus 24.37 9.63 53 145523 46809 56099682
Deep vein thrombosis 24.24 9.63 305 145271 76672 56069819
Mania 24.04 9.63 75 145501 11445 56135046
Incoherent 23.84 9.63 41 145535 4228 56142263
Mobility decreased 23.77 9.63 154 145422 98837 56047654
Apathy 23.74 9.63 59 145517 7895 56138596
Cholecystitis chronic 23.71 9.63 67 145509 9681 56136810
Hemiplegia 23.69 9.63 61 145515 8343 56138148
Fatigue 23.43 9.63 1740 143836 786812 55359679
Rheumatoid nodule 23.23 9.63 5 145571 14852 56131639
Joint range of motion decreased 23.06 9.63 19 145557 25346 56121145
Foreign body 22.97 9.63 28 145548 2108 56144383
Drug tolerance 22.90 9.63 49 145527 5945 56140546
Hangover 22.70 9.63 23 145553 1410 56145081
Asthenia 22.63 9.63 1094 144482 341879 55804612
Grip strength decreased 22.50 9.63 7 145569 16249 56130242
Multiple sclerosis relapse 22.22 9.63 195 145381 44708 56101783
Hypotension 22.14 9.63 824 144752 249684 55896807
Behaviour disorder 22.08 9.63 31 145545 2682 56143809
Hiatus hernia 22.02 9.63 105 145471 19547 56126944
Therapy non-responder 21.91 9.63 83 145493 61272 56085219
Drug resistance 21.83 9.63 13 145563 20529 56125962
Labelled drug-food interaction issue 21.74 9.63 6 145570 17 56146474
Imprisonment 21.73 9.63 11 145565 218 56146273
Dysuria 21.68 9.63 145 145431 30584 56115907
Laryngeal pain 21.59 9.63 39 145537 4181 56142310
Diplopia 21.51 9.63 107 145469 20262 56126229
Psychomotor hyperactivity 21.49 9.63 65 145511 9755 56136736
Neutropenia 21.48 9.63 284 145292 157883 55988608
Product complaint 21.34 9.63 73 145503 11687 56134804
Obstructive airways disorder 21.27 9.63 9 145567 17273 56129218
COVID-19 21.10 9.63 111 145465 74947 56071544
Influenza like illness 20.65 9.63 245 145331 60743 56085748
Feeling drunk 20.63 9.63 36 145540 3756 56142735
Sinus congestion 20.61 9.63 88 145488 15636 56130855
Major depression 20.31 9.63 54 145522 7530 56138961
Vision blurred 20.20 9.63 314 145262 82629 56063862
Feeling abnormal 20.19 9.63 470 145106 133132 56013359
Dyspnoea 20.14 9.63 1292 144284 591285 55555206
Cough 20.11 9.63 515 145061 259446 55887045
Reduced facial expression 20.06 9.63 24 145552 1772 56144719
Drug interaction 20.01 9.63 696 144880 209059 55937432
Anger 19.92 9.63 71 145505 11601 56134890
Bone erosion 19.75 9.63 7 145569 14967 56131524
Unresponsive to stimuli 19.63 9.63 145 145431 31580 56114911
Self-medication 19.62 9.63 28 145548 2459 56144032
Crying 19.46 9.63 108 145468 21332 56125159
Aortic valve calcification 19.05 9.63 13 145563 456 56146035
Peripheral circulatory failure 18.92 9.63 17 145559 896 56145595
Tension 18.91 9.63 30 145546 2894 56143597
Aggression 18.76 9.63 109 145467 21897 56124594
Depressive symptom 18.46 9.63 33 145543 3508 56142983
Injury 18.35 9.63 236 145340 59615 56086876
Cognitive disorder 18.27 9.63 201 145375 48932 56097559
Panic disorder 18.14 9.63 27 145549 2464 56144027
Inadequate analgesia 18.10 9.63 28 145548 2643 56143848
Arthritis 18.04 9.63 168 145408 99684 56046807
Dementia 18.03 9.63 90 145486 17068 56129423
Alcohol use 17.77 9.63 24 145552 2001 56144490
Psychotic disorder 17.74 9.63 113 145463 23445 56123046
Femoral neck fracture 17.54 9.63 52 145524 7719 56138772
Anterograde amnesia 17.31 9.63 13 145563 531 56145960
Blood potassium decreased 17.14 9.63 164 145412 38508 56107983
Facial nerve disorder 17.08 9.63 13 145563 542 56145949
Euphoric mood 17.08 9.63 36 145540 4322 56142169
Performance fear 17.08 9.63 4 145572 4 56146487
Sinusitis 17.04 9.63 385 145191 197196 55949295
Serotonin syndrome 16.92 9.63 122 145454 26368 56120123
Seizure 16.75 9.63 433 145143 124686 56021805
Decreased interest 16.68 9.63 29 145547 3017 56143474
Legal problem 16.61 9.63 5 145571 21 56146470
Sinus disorder 16.58 9.63 101 145475 20633 56125858
Hepatotoxicity 16.39 9.63 35 145541 31118 56115373
Coagulation factor V level decreased 16.34 9.63 10 145566 290 56146201
Affective disorder 16.14 9.63 41 145535 5562 56140929
Urinary hesitation 16.13 9.63 23 145553 2019 56144472
Thirst 16.06 9.63 64 145512 11026 56135465
Panniculitis 16.04 9.63 3 145573 9839 56136652
Compulsive shopping 15.99 9.63 14 145562 713 56145778
Left ventricular hypertrophy 15.98 9.63 38 145538 4946 56141545
Loss of proprioception 15.94 9.63 11 145565 393 56146098
Blood pressure systolic abnormal 15.89 9.63 3 145573 9774 56136717
Blood cholesterol increased 15.89 9.63 116 145460 72463 56074028
Mucosal inflammation 15.88 9.63 57 145519 42753 56103738
Anhedonia 15.82 9.63 59 145517 9855 56136636
Palpitations 15.79 9.63 353 145223 99319 56047172
Muscle rigidity 15.79 9.63 62 145514 10609 56135882
Inappropriate antidiuretic hormone secretion 15.78 9.63 74 145502 13682 56132809
Creatinine renal clearance decreased 15.77 9.63 9 145567 14550 56131941
Drug tolerance increased 15.62 9.63 9 145567 233 56146258
Tracheal atresia 15.59 9.63 5 145571 27 56146464
Protrusion tongue 15.58 9.63 10 145566 316 56146175
Prothrombin time shortened 15.54 9.63 21 145555 1752 56144739
Aspartate aminotransferase increased 15.52 9.63 300 145276 82302 56064189
Sleep terror 15.52 9.63 14 145562 742 56145749
Lethargy 15.42 9.63 202 145374 51239 56095252
Accidental poisoning 15.40 9.63 13 145563 630 56145861
Respiratory tract congestion 15.14 9.63 80 145496 15511 56130980
Self-injurious ideation 15.04 9.63 24 145552 2326 56144165
Macular degeneration 15.03 9.63 16 145560 18892 56127599
Emotional poverty 14.93 9.63 10 145566 340 56146151
Cholecystectomy 14.93 9.63 57 145519 9627 56136864
Brain contusion 14.88 9.63 12 145564 545 56145946
Myelosuppression 14.75 9.63 14 145562 17441 56129050
Blood pressure diastolic decreased 14.65 9.63 17 145559 19306 56127185
Sneezing 14.54 9.63 79 145497 15481 56131010
Dizziness 14.53 9.63 1145 144431 374995 55771496
Prothrombin time prolonged 14.52 9.63 54 145522 9006 56137485
Constipation 14.33 9.63 649 144927 201294 55945197
Intravascular haemolysis 14.32 9.63 9 145567 274 56146217
Terminal insomnia 14.27 9.63 13 145563 698 56145793
Atelectasis 14.16 9.63 92 145484 19216 56127275
Accidental overdose 14.11 9.63 96 145480 20365 56126126
Neurological examination normal 14.09 9.63 4 145572 13 56146478
Erythema 13.97 9.63 302 145274 155637 55990854
Spinal rod insertion 13.86 9.63 4 145572 14 56146477
Intervertebral disc degeneration 13.75 9.63 73 145503 14181 56132310
Social anxiety disorder 13.50 9.63 10 145566 400 56146091
Blastocystis infection 13.25 9.63 4 145572 17 56146474
Neuroglycopenia 13.18 9.63 10 145566 415 56146076
Colitis ulcerative 13.17 9.63 27 145549 24364 56122127
Sedation 13.14 9.63 143 145433 34711 56111780
Neurogenic bladder 13.03 9.63 26 145550 3003 56143488
Mood swings 13.03 9.63 81 145495 16666 56129825
Blood urea increased 13.01 9.63 108 145468 24365 56122126
Therapeutic response unexpected 12.99 9.63 82 145494 16962 56129529
Pulmonary vasculitis 12.90 9.63 6 145570 98 56146393
Pulmonary fibrosis 12.87 9.63 37 145539 29721 56116770
Cerebral atrophy 12.85 9.63 34 145542 4726 56141765
Benzodiazepine drug level 12.81 9.63 3 145573 3 56146488
Transient ischaemic attack 12.77 9.63 138 145438 33439 56113052
Anorexia nervosa 12.74 9.63 8 145568 243 56146248
Injection site reaction 12.69 9.63 83 145493 53164 56093327
Cholelithiasis 12.69 9.63 157 145419 39307 56107184
Disinhibition 12.68 9.63 13 145563 808 56145683
Periventricular leukomalacia 12.58 9.63 6 145570 104 56146387
Pyrexia 12.53 9.63 923 144653 417850 55728641
Neonatal behavioural syndrome 12.52 9.63 5 145571 55 56146436
Renal impairment 12.43 9.63 141 145435 80572 56065919
Diarrhoea 12.41 9.63 1454 144122 637053 55509438
Angioedema 12.39 9.63 60 145516 41393 56105098
Herpes zoster 12.32 9.63 131 145445 75758 56070733
Respiratory depression 12.21 9.63 64 145512 12371 56134120
Persecutory delusion 12.20 9.63 23 145553 2547 56143944
Automatism 12.06 9.63 5 145571 61 56146430
Autonomic nervous system imbalance 12.06 9.63 23 145553 2570 56143921
Enthesopathy 12.04 9.63 3 145573 8060 56138431
Bipolar disorder 12 9.63 45 145531 7535 56138956
Drug dependence, antepartum 11.98 9.63 4 145572 25 56146466
Inappropriate schedule of product administration 11.95 9.63 148 145428 83239 56063252
Accidental exposure to product 11.91 9.63 29 145547 24618 56121873
Spleen congestion 11.90 9.63 6 145570 118 56146373
Nervousness 11.86 9.63 121 145455 28894 56117597
Visual acuity reduced 11.85 9.63 93 145483 20633 56125858
Cardiomegaly 11.80 9.63 78 145498 16389 56130102
Psychomotor retardation 11.79 9.63 28 145548 3641 56142850
Death 11.62 9.63 744 144832 340682 55805809
Vertigo CNS origin 11.60 9.63 4 145572 28 56146463
Dysgeusia 11.57 9.63 159 145417 40756 56105735
Fear 11.53 9.63 72 145504 14836 56131655
Dreamy state 11.48 9.63 4 145572 29 56146462
Immunodeficiency 11.42 9.63 15 145561 16142 56130349
Restless legs syndrome 11.38 9.63 79 145497 16868 56129623
Ecchymosis 11.36 9.63 55 145521 10301 56136190
Spondylolisthesis 11.30 9.63 26 145550 3313 56143178
Multiple injuries 11.26 9.63 18 145558 1748 56144743
Head discomfort 11.23 9.63 61 145515 11953 56134538
Middle insomnia 11.20 9.63 57 145519 10893 56135598
Stress cardiomyopathy 11.19 9.63 47 145529 8289 56138202
Fibrocystic breast disease 11.14 9.63 14 145562 1088 56145403
Waxy flexibility 11.13 9.63 6 145570 136 56146355
Extrapyramidal disorder 11.05 9.63 62 145514 12294 56134197
Drop attacks 11.05 9.63 11 145565 660 56145831
Transplant rejection 10.97 9.63 6 145570 9928 56136563
Hypotonia 10.94 9.63 48 145528 8629 56137862
Gastric polyps 10.93 9.63 25 145551 3173 56143318
Housebound 10.91 9.63 7 145569 221 56146270
Amnestic disorder 10.82 9.63 8 145568 319 56146172
Neurotoxicity 10.82 9.63 15 145561 15780 56130711
Poor sucking reflex 10.77 9.63 7 145569 226 56146265
Hyperlipidaemia 10.77 9.63 82 145494 18027 56128464
Secretion discharge 10.75 9.63 7 145569 10539 56135952
Parasomnia 10.75 9.63 9 145567 431 56146060
Cytomegalovirus infection 10.73 9.63 21 145555 19275 56127216
Haemangioma congenital 10.64 9.63 9 145567 437 56146054
Hepatosplenomegaly 10.60 9.63 21 145555 2412 56144079
Hypoglycaemia 10.58 9.63 203 145373 55612 56090879
Asphyxia 10.56 9.63 36 145540 5753 56140738
Dysphoria 10.55 9.63 32 145544 4810 56141681
Trance 10.53 9.63 4 145572 38 56146453
Uveitis 10.48 9.63 8 145568 11087 56135404
Lupus-like syndrome 10.47 9.63 10 145566 12417 56134074
Spinal osteoarthritis 10.46 9.63 70 145506 14766 56131725
Malnutrition 10.43 9.63 67 145509 13941 56132550
Eustachian tube disorder 10.36 9.63 5 145571 89 56146402
Homicidal ideation 10.33 9.63 17 145559 1691 56144800
Speech disorder 10.32 9.63 145 145431 37348 56109143
Flat affect 10.26 9.63 15 145561 1347 56145144
Arterial occlusive disease 10.18 9.63 34 145542 5376 56141115
Labelled drug-drug interaction medication error 10.14 9.63 9 145567 11577 56134914
Intervertebral disc protrusion 10.11 9.63 93 145483 21601 56124890
Leukocytosis 10.10 9.63 100 145476 23691 56122800
Pelvic fracture 10.09 9.63 60 145516 12153 56134338
Haemangioma of liver 10.08 9.63 13 145563 1036 56145455
Blood alkaline phosphatase increased 10.08 9.63 149 145427 38796 56107695
Muscular weakness 10.05 9.63 347 145229 104105 56042386
Hypokinesia 10.01 9.63 62 145514 12741 56133750
Mouth ulceration 10.00 9.63 41 145535 29599 56116892
Multiple sclerosis 10.00 9.63 113 145463 27689 56118802
Productive cough 9.98 9.63 95 145481 56137 56090354
Barrett's oesophagus 9.98 9.63 10 145566 605 56145886
Verbal abuse 9.93 9.63 5 145571 98 56146393
Bone scan abnormal 9.93 9.63 8 145568 363 56146128
Therapeutic response shortened 9.89 9.63 6 145570 9380 56137111
Ischaemic cardiomyopathy 9.88 9.63 20 145556 2334 56144157
Toxic epidermal necrolysis 9.83 9.63 27 145549 22015 56124476
Ventricular fibrillation 9.83 9.63 55 145521 10897 56135594
Skin ulcer 9.81 9.63 59 145517 38549 56107942
Optic disc haemorrhage 9.79 9.63 5 145571 101 56146390
Poor quality sleep 9.79 9.63 79 145497 17676 56128815
Lymphatic disorder 9.78 9.63 8 145568 371 56146120
Atrioventricular block first degree 9.76 9.63 39 145537 6726 56139765
Galactorrhoea 9.70 9.63 27 145549 3868 56142623
Heart rate decreased 9.64 9.63 63 145513 40364 56106127
Adverse event 9.64 9.63 94 145482 55282 56091209

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 554.90 10.13 226 81830 2626 31612662
Completed suicide 489.36 10.13 861 81195 90653 31524635
Drug dependence 301.84 10.13 331 81725 22248 31593040
Intentional overdose 279.50 10.13 433 81623 40956 31574332
Amnesia 260.34 10.13 312 81744 23090 31592198
Drug abuse 253.17 10.13 642 81414 87116 31528172
Insomnia 239.25 10.13 660 81396 94176 31521112
Suicide attempt 186.51 10.13 341 81715 36907 31578381
Off label use 179.06 10.13 397 81659 346877 31268411
Road traffic accident 157.44 10.13 203 81853 16178 31599110
Intentional self-injury 150.47 10.13 179 81877 13136 31602152
Poisoning 119.57 10.13 141 81915 10250 31605038
Respiratory arrest 105.34 10.13 219 81837 26038 31589250
Drug withdrawal syndrome 103.24 10.13 179 81877 18571 31596717
Impaired driving ability 98.04 10.13 67 81989 2354 31612934
Delirium 96.16 10.13 280 81776 41141 31574147
Suicidal ideation 90.25 10.13 252 81804 36154 31579134
Sopor 88.08 10.13 128 81928 11424 31603864
Abnormal sleep-related event 86.95 10.13 36 82020 437 31614851
Confusional state 86.42 10.13 616 81440 132718 31482570
Overdose 86.11 10.13 440 81616 84224 31531064
Anxiety 81.63 10.13 457 81599 90576 31524712
Depression 78.85 10.13 452 81604 90363 31524925
Somnolence 76.79 10.13 480 81576 98965 31516323
Homicide 74.75 10.13 40 82016 892 31614396
Sleep-related eating disorder 72.89 10.13 28 82028 275 31615013
Product use in unapproved indication 72.56 10.13 90 81966 99081 31516207
Abnormal behaviour 71.35 10.13 177 81879 23651 31591637
Drug use disorder 70.60 10.13 68 81988 3915 31611373
Disorientation 67.70 10.13 204 81852 30540 31584748
Automatism 63.94 10.13 20 82036 98 31615190
Parasomnia 60.66 10.13 26 82030 346 31614942
Drug ineffective 59.93 10.13 696 81360 394877 31220411
Gun shot wound 58.37 10.13 36 82020 1058 31614230
Rheumatoid arthritis 54.21 10.13 28 82028 47781 31567507
Intentional product misuse 53.29 10.13 217 81839 37734 31577554
Drug abuser 52.01 10.13 57 81999 3823 31611465
Bradyphrenia 46.15 10.13 57 81999 4347 31610941
Restlessness 44.98 10.13 148 81908 23213 31592075
Fall 44.74 10.13 703 81353 185386 31429902
Cardio-respiratory arrest 42.61 10.13 254 81802 51472 31563816
Poisoning deliberate 41.58 10.13 71 81985 7273 31608015
Aggression 40.83 10.13 198 81858 37093 31578195
Coma 40.49 10.13 212 81844 40938 31574350
Agitation 39.00 10.13 257 81799 53912 31561376
Thinking abnormal 38.54 10.13 59 81997 5514 31609774
Nightmare 36.16 10.13 90 81966 12047 31603241
Hallucination 35.75 10.13 224 81832 46186 31569102
Memory impairment 35.17 10.13 193 81863 37937 31577351
Withdrawal syndrome 35.02 10.13 87 81969 11630 31603658
Antidepressant drug level above therapeutic 34.18 10.13 15 82041 212 31615076
Therapeutic product effect incomplete 33.70 10.13 38 82018 43658 31571630
Persistent depressive disorder 32.64 10.13 16 82040 295 31614993
Death 32.31 10.13 700 81356 359869 31255419
Oedematous pancreatitis 31.79 10.13 18 82038 450 31614838
Toxicity to various agents 31.02 10.13 650 81406 180837 31434451
Legal problem 30.74 10.13 13 82043 167 31615121
Analgesic drug level above therapeutic 30.29 10.13 15 82041 283 31615005
Dependence 30.12 10.13 24 82032 1070 31614218
Dissociative disorder 30.01 10.13 14 82042 230 31615058
Lower respiratory tract infection 29.89 10.13 18 82038 28219 31587069
Loss of consciousness 28.94 10.13 317 81739 77038 31538250
Cytomegalovirus infection 28.71 10.13 14 82042 24693 31590595
Initial insomnia 27.86 10.13 36 82020 2873 31612415
Multiple organ dysfunction syndrome 27.33 10.13 88 81968 68115 31547173
Febrile neutropenia 27.22 10.13 194 81862 121655 31493633
Drug tolerance 26.95 10.13 33 82023 2494 31612794
Sleep disorder 26.78 10.13 137 81919 26211 31589077
Intentional product use issue 26.43 10.13 55 82001 49292 31565996
Acute kidney injury 26.19 10.13 539 81517 279175 31336113
Asthma 25.90 10.13 44 82012 42567 31572721
Joint swelling 25.81 10.13 63 81993 53368 31561920
Myelosuppression 25.56 10.13 4 82052 14916 31600372
Angioedema 25.10 10.13 30 82026 33588 31581700
Septic shock 24.71 10.13 88 81968 66070 31549218
Drug intolerance 24.63 10.13 62 81994 51971 31563317
Logorrhoea 24.27 10.13 30 82026 2289 31612999
Incoherent 23.99 10.13 41 82015 4203 31611085
Anger 23.60 10.13 73 81983 11080 31604208
Panic attack 23.30 10.13 62 81994 8641 31606647
Substance use disorder 22.54 10.13 15 82041 504 31614784
Altered state of consciousness 22.48 10.13 111 81945 20940 31594348
General physical health deterioration 22.33 10.13 187 81869 113248 31502040
Treatment failure 22.24 10.13 45 82011 40747 31574541
Circadian rhythm sleep disorder 22.15 10.13 14 82042 430 31614858
Bradypnoea 22.05 10.13 30 82026 2517 31612771
Hypokinesia 22.02 10.13 58 81998 8034 31607254
Hallucination, visual 21.91 10.13 90 81966 15704 31599584
Anterograde amnesia 21.51 10.13 10 82046 163 31615125
Abnormal dreams 21.48 10.13 53 82003 7055 31608233
Major depression 21.34 10.13 39 82017 4214 31611074
Neutropenia 20.72 10.13 248 81808 140116 31475172
Psoriasis 20.34 10.13 58 81998 46661 31568627
Drug screen positive 20.19 10.13 36 82020 3816 31611472
Victim of chemical submission 20.16 10.13 7 82049 50 31615238
Tachyphrenia 20.12 10.13 20 82036 1197 31614091
Infection 20.01 10.13 127 81929 81804 31533484
Poor quality sleep 19.85 10.13 54 82002 7624 31607664
Distributive shock 19.84 10.13 19 82037 1086 31614202
Condition aggravated 19.45 10.13 303 81753 163706 31451582
Infusion related reaction 19.25 10.13 62 81994 47993 31567295
Irritability 19.22 10.13 113 81943 22776 31592512
Cardiac arrest 18.60 10.13 329 81727 88733 31526555
Product use issue 18.33 10.13 80 81976 56679 31558609
Sepsis 18.24 10.13 280 81776 151649 31463639
Rectal haemorrhage 18.17 10.13 42 82014 36262 31579026
Encephalomalacia 17.96 10.13 16 82040 833 31614455
Dyspnoea 17.83 10.13 718 81338 342761 31272527
Synovitis 17.55 10.13 5 82051 12278 31603010
Inappropriate antidiuretic hormone secretion 17.50 10.13 67 81989 11320 31603968
Hyperlipidaemia 17.48 10.13 74 81982 13086 31602202
Loss of personal independence in daily activities 17.38 10.13 29 82027 28259 31587029
Drug withdrawal convulsions 17.14 10.13 18 82038 1150 31614138
Nervousness 16.97 10.13 68 81988 11732 31603556
Feeling abnormal 16.68 10.13 223 81833 56779 31558509
Product dose omission issue 16.56 10.13 184 81872 105402 31509886
Erythema 16.52 10.13 131 81925 80274 31535014
Procalcitonin abnormal 16.49 10.13 11 82045 371 31614917
Sleep talking 16.48 10.13 12 82044 467 31614821
Sleep apnoea syndrome 16.32 10.13 93 81963 18532 31596756
Sexual abuse 16.29 10.13 8 82048 148 31615140
Neurotoxicity 16.27 10.13 11 82045 16215 31599073
Prostate cancer 16.14 10.13 47 82009 37554 31577734
Cardiac failure 15.89 10.13 144 81912 85809 31529479
Dysarthria 15.77 10.13 139 81917 31878 31583410
Galactorrhoea 15.52 10.13 11 82045 410 31614878
Leukopenia 15.51 10.13 87 81969 57741 31557547
Amimia 15.46 10.13 4 82052 8 31615280
Paranoia 15.32 10.13 61 81995 10494 31604794
Apallic syndrome 15.21 10.13 9 82047 245 31615043
Product substitution issue 14.91 10.13 56 82000 9376 31605912
Coagulation factor VII level decreased 14.84 10.13 7 82049 118 31615170
Exposure via ingestion 14.80 10.13 22 82034 2003 31613285
Heart rate decreased 14.72 10.13 32 82024 28234 31587054
Alcohol use 14.59 10.13 28 82028 3139 31612149
Psoriatic arthropathy 14.57 10.13 18 82038 19865 31595423
Skin laceration 14.32 10.13 63 81993 11328 31603960
Peripheral swelling 14.21 10.13 110 81946 67755 31547533
Drug diversion 14.21 10.13 14 82042 829 31614459
Reduced facial expression 14.19 10.13 14 82042 830 31614458
Mental disorder 14.10 10.13 72 81984 13762 31601526
Vascular dementia 13.81 10.13 11 82045 490 31614798
Stress at work 13.81 10.13 8 82048 209 31615079
Labelled drug-food interaction medication error 13.81 10.13 5 82051 41 31615247
Transplant rejection 13.78 10.13 4 82052 9704 31605584
Renal impairment 13.73 10.13 150 81906 86199 31529089
Personality change 13.70 10.13 35 82021 4760 31610528
Drug detoxification 13.68 10.13 8 82048 213 31615075
Substance-induced mood disorder 13.60 10.13 6 82050 86 31615202
Hallucination, auditory 13.56 10.13 58 81998 10302 31604986
Pre-existing condition improved 13.48 10.13 23 82033 2354 31612934
Depressed level of consciousness 13.43 10.13 156 81900 38445 31576843
Congenital hydrocephalus 13.41 10.13 6 82050 89 31615199
Pulmonary fibrosis 13.38 10.13 14 82042 16646 31598642
Blood pressure fluctuation 13.34 10.13 24 82032 22712 31592576
Libido decreased 13.32 10.13 33 82023 4403 31610885
Slow speech 13.29 10.13 15 82041 1039 31614249
Mania 13.29 10.13 53 82003 9124 31606164
Tubulointerstitial nephritis 13.28 10.13 17 82039 18479 31596809
Toxic epidermal necrolysis 12.96 10.13 19 82037 19505 31595783
Mental status changes 12.80 10.13 146 81910 35822 31579466
Aspergillus infection 12.70 10.13 7 82049 11521 31603767
Drug resistance 12.67 10.13 26 82030 23427 31591861
Prescription form tampering 12.63 10.13 10 82046 442 31614846
Urticaria 12.62 10.13 92 81964 57425 31557863
Implant site inflammation 12.47 10.13 6 82050 106 31615182
Stress cardiomyopathy 12.45 10.13 19 82037 1771 31613517
Respiratory tract infection bacterial 12.29 10.13 17 82039 1449 31613839
Hospitalisation 12.26 10.13 77 81979 49730 31565558
Akathisia 12.25 10.13 44 82012 7209 31608079
Emotional distress 12.13 10.13 71 81985 14285 31601003
Psychomotor hyperactivity 12.13 10.13 50 82006 8737 31606551
Euphoric mood 12.12 10.13 34 82022 4886 31610402
Pilonidal cyst congenital 12.12 10.13 4 82052 24 31615264
Pruritus 12.02 10.13 240 81816 124927 31490361
Disturbance in attention 11.86 10.13 99 81957 22351 31592937
Labelled drug-drug interaction medication error 11.82 10.13 10 82046 13153 31602135
Pyrexia 11.78 10.13 655 81401 303185 31312103
Victim of homicide 11.75 10.13 6 82050 121 31615167
Crime 11.63 10.13 5 82051 67 31615221
Self-medication 11.62 10.13 21 82035 2250 31613038
Leukoplakia 11.60 10.13 3 82053 6 31615282
Labile hypertension 11.44 10.13 5 82051 70 31615218
Mucosal inflammation 11.43 10.13 48 82008 34379 31580909
Thrombotic microangiopathy 11.32 10.13 5 82051 9346 31605942
Delusion 11.24 10.13 61 81995 11936 31603352
Miosis 11.23 10.13 48 82008 8522 31606766
Atelectasis 11.15 10.13 76 81980 16113 31599175
Psychotic disorder 11.09 10.13 97 81959 22196 31593092
Dysphoria 11.00 10.13 20 82036 2152 31613136
Bronchiectasis 10.99 10.13 3 82053 7577 31607711
Decreased interest 10.92 10.13 20 82036 2165 31613123
Alcohol interaction 10.87 10.13 23 82033 2766 31612522
Scar pain 10.84 10.13 5 82051 80 31615208
Bradycardia 10.79 10.13 121 81935 69206 31546082
Drug half-life reduced 10.74 10.13 3 82053 9 31615279
Hangover 10.73 10.13 13 82043 972 31614316
Hyperhidrosis 10.71 10.13 239 81817 67154 31548134
Amnestic disorder 10.68 10.13 7 82049 229 31615059
Gastrooesophageal reflux disease 10.53 10.13 134 81922 33737 31581551
Blood pressure increased 10.51 10.13 144 81912 79489 31535799
Bipolar disorder 10.45 10.13 27 82029 3697 31611591
PO2 decreased 10.31 10.13 16 82040 1513 31613775
Hypovolaemia 10.30 10.13 46 82010 8326 31606962
Drug tolerance increased 10.29 10.13 9 82047 457 31614831
Pneumothorax traumatic 10.21 10.13 5 82051 92 31615196

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 1436.66 9.58 2258 174879 224877 70526430
Drug abuse 857.11 9.58 1411 175726 145845 70605462
Drug dependence 714.28 9.58 654 176483 36667 70714640
Somnambulism 692.86 9.58 313 176824 4947 70746360
Intentional overdose 647.74 9.58 998 176139 97437 70653870
Suicide attempt 494.94 9.58 786 176351 78724 70672583
Amnesia 432.13 9.58 590 176547 51565 70699742
Sopor 361.68 9.58 418 176719 30849 70720458
Rheumatoid arthritis 353.85 9.58 143 176994 291662 70459645
Off label use 331.73 9.58 867 176270 742193 70009114
Intentional self-injury 316.62 9.58 393 176744 31257 70720050
Insomnia 308.27 9.58 1217 175920 216589 70534718
Anxiety 285.52 9.58 1198 175939 219132 70532175
Drug ineffective 269.74 9.58 1321 175816 938431 69812876
Synovitis 268.25 9.58 13 177124 129215 70622092
Poisoning 264.26 9.58 304 176833 22318 70728989
Drug intolerance 260.11 9.58 119 177018 225568 70525739
Overdose 259.35 9.58 972 176165 168773 70582534
Abnormal sleep-related event 251.27 9.58 91 177046 777 70750530
Intentional product misuse 250.00 9.58 589 176548 79006 70672301
Drug withdrawal syndrome 242.56 9.58 351 176786 32364 70718943
Respiratory arrest 242.44 9.58 462 176675 53471 70697836
Joint swelling 231.86 9.58 176 176961 253035 70498272
Depression 227.33 9.58 1042 176095 197932 70553375
Contraindicated product administered 226.84 9.58 33 177104 134579 70616728
Poisoning deliberate 214.14 9.58 238 176899 16822 70734485
Toxicity to various agents 198.67 9.58 1631 175506 380541 70370766
Somnolence 198.55 9.58 1062 176075 214544 70536763
Infusion related reaction 197.10 9.58 125 177012 197409 70553898
Treatment failure 187.43 9.58 63 177074 144079 70607228
Hand deformity 185.10 9.58 7 177130 86475 70664832
Drug use disorder 180.06 9.58 155 176982 7996 70743311
Cardio-respiratory arrest 171.89 9.58 598 176539 100079 70651228
Suicidal ideation 160.77 9.58 459 176678 69137 70682170
Lower respiratory tract infection 159.96 9.58 41 177096 111872 70639435
Delirium 159.82 9.58 479 176658 74135 70677172
Coma 154.59 9.58 543 176594 91301 70660006
Systemic lupus erythematosus 148.22 9.58 36 177101 101866 70649441
Fall 144.42 9.58 1719 175418 442377 70308930
Peripheral swelling 141.37 9.58 233 176904 236330 70514977
Road traffic accident 138.79 9.58 283 176854 34399 70716908
Sleep-related eating disorder 135.76 9.58 55 177082 654 70750653
Arthropathy 135.10 9.58 106 177031 149951 70601356
Disorientation 127.02 9.58 375 176762 57548 70693759
Hypersensitivity 126.76 9.58 238 176899 229574 70521733
Abnormal behaviour 124.68 9.58 271 176866 34438 70716869
Maternal exposure during pregnancy 120.59 9.58 69 177068 115276 70636031
Confusional state 119.37 9.58 1159 175978 283239 70468068
Pericarditis 119.20 9.58 32 177105 84673 70666634
Bradyphrenia 118.41 9.58 135 177002 9811 70741496
Glossodynia 113.80 9.58 37 177100 86450 70664857
Duodenal ulcer perforation 109.84 9.58 4 177133 51108 70700199
Withdrawal syndrome 102.96 9.58 206 176931 24698 70726609
Helicobacter infection 102.72 9.58 10 177127 55646 70695661
Loss of consciousness 101.21 9.58 701 176436 155015 70596292
Drug abuser 101.06 9.58 97 177040 5767 70745540
Wound 99.08 9.58 62 177075 98670 70652637
Infection 98.93 9.58 239 176898 210546 70540761
Restlessness 98.39 9.58 279 176858 41849 70709458
Product use in unapproved indication 96.00 9.58 237 176900 207241 70544066
Arthralgia 93.90 9.58 805 176332 502585 70248722
Affect lability 90.43 9.58 119 177018 10027 70741280
Homicide 89.28 9.58 48 177089 1122 70750185
Agitation 85.84 9.58 460 176677 92915 70658392
Hallucination 85.18 9.58 397 176740 75863 70675444
Hepatic enzyme increased 83.54 9.58 166 176971 156824 70594483
Alopecia 83.27 9.58 238 176899 198252 70553055
Swelling 80.62 9.58 224 176913 188315 70562992
Therapeutic product effect incomplete 80.36 9.58 109 177028 119773 70631534
Impaired driving ability 79.30 9.58 78 177059 4779 70746528
Musculoskeletal stiffness 77.12 9.58 158 176979 147602 70603705
Intentional product use issue 75.82 9.58 114 177023 120028 70631279
Product use issue 73.11 9.58 219 176918 179718 70571589
Dependence 72.76 9.58 54 177083 2246 70749061
Rash 72.59 9.58 871 176266 509691 70241616
Abdominal discomfort 72.47 9.58 283 176854 214375 70536932
Automatism 72.31 9.58 24 177113 153 70751154
Cardiac arrest 71.25 9.58 660 176477 159174 70592133
Therapeutic product effect decreased 69.60 9.58 159 176978 142859 70608448
Sleep disorder due to general medical condition, insomnia type 67.06 9.58 6 177131 35726 70715581
Dissociative disorder 66.74 9.58 30 177107 468 70750839
Folliculitis 66.02 9.58 13 177124 42557 70708750
Nasopharyngitis 63.44 9.58 312 176825 221894 70529413
Parasomnia 61.90 9.58 29 177108 500 70750807
Drug hypersensitivity 61.63 9.58 393 176744 262066 70489241
Initial insomnia 60.93 9.58 77 177060 6232 70745075
Mental status changes 60.82 9.58 315 176822 62786 70688521
Dysarthria 60.02 9.58 311 176826 62002 70689305
Blister 60.00 9.58 99 177038 100427 70650880
Condition aggravated 59.41 9.58 733 176404 426902 70324405
Blood pressure fluctuation 59.27 9.58 37 177100 58975 70692332
Miosis 58.71 9.58 117 177020 13984 70737323
Bradypnoea 58.16 9.58 70 177067 5389 70745918
Drug withdrawal convulsions 56.08 9.58 45 177092 2103 70749204
Altered state of consciousness 55.95 9.58 223 176914 39799 70711508
Carotid artery thrombosis 55.39 9.58 48 177089 2498 70748809
Immobilisation prolonged 53.41 9.58 17 177120 93 70751214
Muscle injury 53.29 9.58 15 177122 38479 70712828
Personality disorder 52.46 9.58 67 177070 5481 70745826
Hallucination, visual 52.42 9.58 177 176960 29160 70722147
Exposure via ingestion 52.32 9.58 63 177074 4852 70746455
Incoherent 52.13 9.58 77 177060 7229 70744078
Neurologic neglect syndrome 52.03 9.58 45 177092 2336 70748971
Mental disorder 51.01 9.58 171 176966 28069 70723238
Neutropenia 50.66 9.58 405 176732 256751 70494556
Tremor 50.64 9.58 603 176534 155021 70596286
Mydriasis 50.09 9.58 119 177018 16034 70735273
Disturbance in attention 47.66 9.58 223 176914 42671 70708636
Logorrhoea 45.88 9.58 54 177083 4060 70747247
Memory impairment 45.60 9.58 391 176746 92250 70659057
Psoriatic arthropathy 45.34 9.58 57 177080 64714 70686593
Discomfort 45.24 9.58 125 177012 105311 70645996
Red blood cell sedimentation rate increased 45.04 9.58 20 177117 38622 70712685
Aggression 44.73 9.58 239 176898 48207 70703100
Akathisia 44.16 9.58 96 177041 12197 70739110
Psychomotor skills impaired 44.12 9.58 54 177083 4230 70747077
Sleep talking 43.55 9.58 29 177108 1012 70750295
Gun shot wound 43.43 9.58 30 177107 1113 70750194
Drug detoxification 42.70 9.58 19 177118 289 70751018
Emotional distress 41.81 9.58 194 176943 36994 70714313
Parkinsonism 41.29 9.58 107 177030 15218 70736089
Cytomegalovirus infection 41.23 9.58 24 177113 39734 70711573
Euphoric mood 39.95 9.58 66 177071 6823 70744484
Urticaria 39.87 9.58 241 176896 162808 70588499
Gastrointestinal disorder 39.51 9.58 133 177004 105294 70646013
Major depression 39.19 9.58 74 177063 8500 70742807
Nightmare 38.99 9.58 133 177004 22023 70729284
Persistent genital arousal disorder 38.81 9.58 18 177119 303 70751004
Dyspnoea 37.69 9.58 1557 175580 768503 69982804
Wheezing 37.24 9.58 116 177021 94054 70657253
Substance abuse 36.69 9.58 78 177059 9759 70741548
Panic attack 36.52 9.58 130 177007 21989 70729318
Impaired healing 35.91 9.58 83 177054 74291 70677016
Acute kidney injury 35.81 9.58 907 176230 473717 70277590
Hypokinesia 35.51 9.58 110 177027 17322 70733985
Septic shock 35.35 9.58 152 176985 112106 70639201
Drug tolerance 35.06 9.58 65 177072 7363 70743944
Legal problem 35.05 9.58 14 177123 160 70751147
Depressed level of consciousness 34.97 9.58 353 176784 87078 70664229
High risk sexual behaviour 34.97 9.58 7 177130 0 70751307
Angioedema 34.93 9.58 71 177066 66539 70684768
General physical health deterioration 34.86 9.58 399 176738 235632 70515675
Psychomotor hyperactivity 34.85 9.58 101 177036 15332 70735975
Exposure during pregnancy 34.72 9.58 108 177029 87609 70663698
Blood pressure systolic increased 34.52 9.58 56 177081 57203 70694104
Myelosuppression 34.52 9.58 16 177121 30129 70721178
Hallucination, auditory 34.00 9.58 112 177025 18216 70733091
Asthma 33.65 9.58 171 176966 120622 70630685
Ill-defined disorder 33.51 9.58 53 177084 54688 70696619
Anterograde amnesia 33.46 9.58 21 177116 661 70750646
Adjustment disorder 32.98 9.58 40 177097 3104 70748203
Drug screen positive 32.59 9.58 55 177082 5785 70745522
Behaviour disorder 32.56 9.58 53 177084 5411 70745896
Inflammation 32.46 9.58 95 177042 78570 70672737
Irritability 32.23 9.58 184 176953 38041 70713266
Anger 32.12 9.58 101 177036 16031 70735276
Listless 32.08 9.58 42 177095 3521 70747786
Anaphylactic reaction 32.07 9.58 89 177048 74885 70676422
Head injury 31.91 9.58 169 176968 33972 70717335
Hyponatraemia 31.69 9.58 569 176568 159518 70591789
C-reactive protein increased 31.61 9.58 155 176982 110362 70640945
Inappropriate antidiuretic hormone secretion 30.40 9.58 127 177010 23149 70728158
Motor dysfunction 29.96 9.58 86 177051 12984 70738323
Pruritus 29.75 9.58 647 176490 344913 70406394
Analgesic drug level above therapeutic 29.48 9.58 17 177120 457 70750850
Alcohol use 29.11 9.58 46 177091 4581 70746726
Erythema 28.43 9.58 340 176797 199223 70552084
Premature delivery 28.22 9.58 9 177128 21295 70730012
Product substitution issue 28.19 9.58 106 177031 18407 70732900
Reduced facial expression 28.12 9.58 32 177105 2320 70748987
Multiple organ dysfunction syndrome 27.79 9.58 158 176979 108357 70642950
Self-medication 27.71 9.58 44 177093 4399 70746908
Bradykinesia 27.42 9.58 59 177078 7443 70743864
Mucosal inflammation 27.23 9.58 83 177054 67767 70683540
Substance use disorder 26.53 9.58 18 177119 648 70750659
Hyperlipidaemia 26.46 9.58 124 177013 23739 70727568
Drug resistance 26.32 9.58 34 177103 38156 70713151
Multiple drug therapy 26.25 9.58 36 177101 3156 70748151
Apathy 26.00 9.58 77 177060 11831 70739476
Heart rate decreased 25.51 9.58 75 177062 61940 70689367
Tension 25.31 9.58 40 177097 3984 70747323
Cough 25.26 9.58 619 176518 324758 70426549
Urinary retention 24.97 9.58 220 176917 52300 70699007
Imprisonment 24.63 9.58 16 177121 535 70750772
Coordination abnormal 24.48 9.58 92 177045 15974 70735333
Neurotoxicity 24.47 9.58 23 177114 29803 70721504
Laryngeal pain 24.42 9.58 48 177089 5680 70745627
Mania 24.25 9.58 96 177041 17078 70734229
Dysphagia 24.10 9.58 406 176731 112428 70638879
Multiple sclerosis relapse 24.10 9.58 187 176950 42830 70708477
Stomatitis 24.09 9.58 205 176932 128306 70623001
Obstructive airways disorder 24.05 9.58 18 177119 26095 70725212
Psychotic disorder 23.45 9.58 168 176969 37533 70713774
Inadequate analgesia 23.24 9.58 39 177098 4083 70747224
Eating disorder 23.24 9.58 100 177037 18465 70732842
Labelled drug-drug interaction medication error 23.04 9.58 16 177121 24111 70727196
Hyperhidrosis 23.04 9.58 459 176678 131127 70620180
Pathogen resistance 22.96 9.58 3 177134 13276 70738031
Productive cough 22.90 9.58 109 177028 78228 70673079
Drug tolerance increased 22.80 9.58 16 177121 609 70750698
Bone erosion 22.77 9.58 5 177132 15168 70736139
Antidepressant drug level above therapeutic 22.75 9.58 16 177121 611 70750696
Skin haemorrhage 22.39 9.58 66 177071 10114 70741193
Illusion 22.30 9.58 24 177113 1635 70749672
Sensory loss 22.29 9.58 71 177066 11348 70739959
Pulmonary fibrosis 22.18 9.58 32 177105 34278 70717029
Blood pressure systolic abnormal 22.12 9.58 3 177134 12906 70738401
Labelled drug-food interaction issue 22.04 9.58 7 177130 38 70751269
COVID-19 22.00 9.58 164 176973 105593 70645714
Oedematous pancreatitis 21.84 9.58 19 177118 994 70750313
Pyrexia 21.82 9.58 1267 175870 605685 70145622
Renal impairment 21.75 9.58 242 176895 143695 70607612
Toxic epidermal necrolysis 21.74 9.58 41 177096 39516 70711791
Deep vein thrombosis 21.72 9.58 394 176743 110648 70640659
Abnormal dreams 21.68 9.58 67 177070 10536 70740771
Brain contusion 21.54 9.58 21 177116 1273 70750034
Hip arthroplasty 21.43 9.58 23 177114 28017 70723290
Unresponsive to stimuli 21.40 9.58 211 176926 51720 70699587
Rhabdomyolysis 21.35 9.58 347 176790 95413 70655894
Hepatotoxicity 21.30 9.58 49 177088 43937 70707370
Encephalomalacia 21.16 9.58 20 177117 1166 70750141
Peripheral circulatory failure 21.05 9.58 19 177118 1044 70750263
Blood pressure diastolic decreased 21.01 9.58 20 177117 25760 70725547
Stress cardiomyopathy 20.80 9.58 63 177074 9799 70741508
Dysphoria 20.78 9.58 39 177098 4459 70746848
Muscle rigidity 20.74 9.58 97 177040 18553 70732754
Vision blurred 20.73 9.58 343 176794 94641 70656666
Aplastic anaemia 20.53 9.58 8 177129 16708 70734599
Galactorrhoea 20.45 9.58 33 177104 3345 70747962
Feeling drunk 20.34 9.58 38 177099 4329 70746978
Transplant rejection 20.26 9.58 10 177127 18161 70733146
Therapy non-responder 20.23 9.58 111 177026 76804 70674503
Panic disorder 20.17 9.58 30 177107 2834 70748473
Febrile neutropenia 20.13 9.58 374 176763 203944 70547363
Femoral neck fracture 20.13 9.58 59 177078 9014 70742293
Thinking abnormal 20.04 9.58 71 177066 11980 70739327
Injury 19.98 9.58 250 176887 64995 70686312
Inappropriate schedule of product administration 19.96 9.58 172 176965 107383 70643924
Bronchopulmonary aspergillosis 19.96 9.58 14 177123 20988 70730319
Death 19.92 9.58 1056 176081 509005 70242302
Mobility decreased 19.89 9.58 163 176974 102836 70648471
Prothrombin time shortened 19.55 9.58 30 177107 2912 70748395
Accidental poisoning 19.41 9.58 22 177115 1588 70749719
Self-injurious ideation 19.38 9.58 32 177105 3306 70748001
Victim of sexual abuse 19.36 9.58 13 177124 460 70750847
Hangover 19.32 9.58 24 177113 1909 70749398
Prescription drug used without a prescription 19.14 9.58 30 177107 2967 70748340
Drug diversion 19.01 9.58 19 177118 1187 70750120
Cholecystitis chronic 18.94 9.58 59 177078 9317 70741990
Foreign body 18.86 9.58 28 177109 2640 70748667
Feeling abnormal 18.80 9.58 477 176660 141842 70609465
Pain 18.76 9.58 1335 175802 627481 70123826
Diarrhoea 18.63 9.58 1694 175443 781647 69969660
Victim of homicide 18.56 9.58 9 177128 168 70751139
Bipolar disorder 18.36 9.58 51 177086 7557 70743750
Sinus tachycardia 18.21 9.58 146 176991 33767 70717540
Victim of chemical submission 18.09 9.58 12 177125 416 70750891
Live birth 17.93 9.58 6 177131 13773 70737534
Bulimia nervosa 17.85 9.58 10 177127 254 70751053
Poor quality sleep 17.84 9.58 99 177038 20250 70731057
Arthritis 17.61 9.58 158 176979 97822 70653485
Syncope 17.57 9.58 540 176597 165169 70586138
Enthesopathy 17.54 9.58 3 177134 10866 70740441
Prostate cancer 17.39 9.58 32 177105 31131 70720176
Decreased interest 17.37 9.58 31 177106 3410 70747897
Hiatus hernia 17.33 9.58 101 177036 21033 70730274
Delusion 17.32 9.58 94 177043 19071 70732236
Nervousness 17.27 9.58 135 177002 30985 70720322
Performance fear 17.22 9.58 4 177133 4 70751303
Irritable bowel syndrome 17.16 9.58 67 177070 50783 70700524
Sinus disorder 17.14 9.58 93 177044 18866 70732441
Colitis ulcerative 17.07 9.58 37 177100 33886 70717421
Urinary hesitation 17.00 9.58 32 177105 3667 70747640
Depressive symptom 16.97 9.58 39 177098 5142 70746165
Grip strength decreased 16.94 9.58 9 177128 15676 70735631
Sinus congestion 16.92 9.58 87 177050 17286 70734021
Thrombotic microangiopathy 16.83 9.58 12 177125 17836 70733471
Post transplant lymphoproliferative disorder 16.82 9.58 3 177134 10542 70740765
Procalcitonin abnormal 16.80 9.58 11 177126 373 70750934
Epstein-Barr virus infection 16.74 9.58 6 177131 13192 70738115
Facial nerve disorder 16.70 9.58 14 177123 696 70750611
Therapeutic response decreased 16.70 9.58 82 177055 58371 70692936
Palpitations 16.69 9.58 378 176759 110375 70640932
Tachycardia 16.64 9.58 516 176621 158030 70593277
Accidental overdose 16.63 9.58 147 176990 34974 70716333
Liver injury 16.61 9.58 50 177087 40985 70710322
Peptic ulcer 16.55 9.58 41 177096 5672 70745635
Posterior reversible encephalopathy syndrome 16.53 9.58 22 177115 24380 70726927
Adverse drug reaction 16.32 9.58 73 177064 53271 70698036
Libido decreased 16.10 9.58 37 177100 4879 70746428
Tardive dyskinesia 16.08 9.58 58 177079 9871 70741436
Sudden onset of sleep 16.08 9.58 13 177124 614 70750693
Disinhibition 16.05 9.58 24 177113 2277 70749030
Dysuria 16.02 9.58 180 176957 45614 70705693
Speech disorder 16.00 9.58 195 176942 50385 70700922
Herpes zoster 15.95 9.58 136 177001 85099 70666208
Skin ulcer 15.89 9.58 64 177073 48081 70703226
Cholecystectomy 15.83 9.58 52 177085 8445 70742862
Lethargy 15.78 9.58 270 176867 74980 70676327
Cerebral atrophy 15.72 9.58 48 177089 7499 70743808
Hypertensive heart disease 15.71 9.58 32 177105 3884 70747423
Cardiomegaly 15.63 9.58 110 177027 24435 70726872
Cognitive disorder 15.55 9.58 226 176911 60730 70690577
Circadian rhythm sleep disorder 15.45 9.58 13 177124 650 70750657
Dehydration 15.30 9.58 701 176436 225441 70525866
Skin necrosis 15.30 9.58 11 177126 16280 70735027
Dementia 15.29 9.58 102 177035 22263 70729044
Joint range of motion decreased 15.18 9.58 26 177111 26000 70725307
Device expulsion 15.13 9.58 20 177117 22226 70729081
Neurogenic bladder 15.11 9.58 31 177106 3782 70747525
Injection site pain 15.03 9.58 205 176932 117414 70633893
Fear 14.89 9.58 96 177041 20715 70730592
Bipolar I disorder 14.84 9.58 21 177116 1896 70749411
Depressed mood 14.77 9.58 171 176966 43649 70707658
Tachyphrenia 14.55 9.58 21 177116 1930 70749377
Sneezing 14.55 9.58 82 177055 16869 70734438
Intervertebral disc degeneration 14.52 9.58 71 177066 13829 70737478
Neurological examination normal 14.47 9.58 4 177133 12 70751295
Perseveration 14.45 9.58 10 177127 372 70750935
Loss of personal independence in daily activities 14.36 9.58 139 176998 84771 70666536
Nephropathy toxic 14.35 9.58 15 177122 18499 70732808
Poor venous access 14.20 9.58 10 177127 14961 70736346
Generalised anxiety disorder 14.11 9.58 21 177116 1984 70749323
Haematocrit decreased 14.10 9.58 211 176926 57047 70694260
Apallic syndrome 14.08 9.58 14 177123 869 70750438
Sleep disorder 14.04 9.58 249 176888 69623 70681684
Diplopia 13.95 9.58 119 177018 28028 70723279
Persistent depressive disorder 13.89 9.58 15 177122 1026 70750281
Immunodeficiency 13.86 9.58 14 177123 17541 70733766
Coagulation factor VII level decreased 13.84 9.58 8 177129 216 70751091
Mouth ulceration 13.79 9.58 42 177095 34307 70717000
Blastocystis infection 13.79 9.58 4 177133 15 70751292
Aspartate aminotransferase increased 13.78 9.58 415 176722 126563 70624744
Distributive shock 13.74 9.58 22 177115 2215 70749092
Oropharyngeal pain 13.74 9.58 164 176973 96146 70655161
Tenosynovitis 13.71 9.58 9 177128 13967 70737340
Therapy partial responder 13.70 9.58 7 177130 12467 70738840
Bronchiectasis 13.70 9.58 12 177125 16085 70735222
Staring 13.53 9.58 23 177114 2433 70748874
Product dose omission issue 13.44 9.58 427 176710 217041 70534266
Neuroglycopenia 13.37 9.58 10 177127 421 70750886
Sinusitis 13.35 9.58 321 176816 168874 70582433
Anorexia nervosa 13.30 9.58 8 177129 233 70751074
Bone marrow failure 13.29 9.58 70 177067 48940 70702367
Creatinine renal clearance decreased 13.26 9.58 14 177123 17186 70734121
Homicidal ideation 13.15 9.58 27 177110 3296 70748011
Atelectasis 13.09 9.58 120 177017 28842 70722465
Diabetic ketoacidosis 13.04 9.58 38 177099 31474 70719833
Anhedonia 13.04 9.58 70 177067 14143 70737164
Suspected suicide 12.97 9.58 50 177087 8784 70742523
Blood potassium decreased 12.75 9.58 162 176975 42259 70709048
Neutropenic sepsis 12.56 9.58 27 177110 24803 70726504
Hemiplegia 12.45 9.58 68 177069 13827 70737480
Product complaint 12.44 9.58 62 177075 12169 70739138
Affective disorder 12.38 9.58 44 177093 7435 70743872
Feeling of despair 12.26 9.58 23 177114 2628 70748679
Eustachian tube disorder 12.23 9.58 5 177132 61 70751246
Hypokalaemia 12.22 9.58 421 176716 130767 70620540
Weight increased 12.20 9.58 488 176649 241843 70509464
Disease progression 12.15 9.58 298 176839 156374 70594933
Social anxiety disorder 12.14 9.58 10 177127 485 70750822
Coagulation factor VIII level increased 12.12 9.58 4 177133 25 70751282
Drug dependence, antepartum 12.12 9.58 4 177133 25 70751282
Substance-induced mood disorder 12.05 9.58 6 177131 119 70751188
Sudden death 12.04 9.58 92 177045 20972 70730335
Catatonia 11.92 9.58 46 177091 8087 70743220
Asthenia 11.87 9.58 1311 175826 456355 70294952
Influenza like illness 11.80 9.58 229 176908 65102 70686205
Abulia 11.66 9.58 13 177124 922 70750385
Dysgeusia 11.64 9.58 181 176956 49321 70701986
Therapeutic response shortened 11.63 9.58 9 177128 12829 70738478
Carotid artery stenosis 11.60 9.58 46 177091 8190 70743117
Transient ischaemic attack 11.58 9.58 170 176967 45774 70705533
Attention deficit hyperactivity disorder 11.51 9.58 24 177113 2963 70748344
Joint effusion 11.49 9.58 13 177124 15464 70735843
Alanine aminotransferase abnormal 11.42 9.58 3 177134 8056 70743251
PCO2 decreased 11.41 9.58 24 177113 2980 70748327
Slow speech 11.39 9.58 20 177117 2172 70749135
Sepsis 11.35 9.58 497 176640 244048 70507259
Muscle spasticity 11.25 9.58 86 177051 19603 70731704
Suicidal behaviour 11.13 9.58 24 177113 3032 70748275
Acute graft versus host disease 11.06 9.58 5 177132 9557 70741750
Drug ineffective for unapproved indication 11.04 9.58 54 177083 38484 70712823
Cardiotoxicity 11.03 9.58 7 177130 11063 70740244
Fatigue 10.97 9.58 1851 175286 822468 69928839
SARS-CoV-2 test positive 10.96 9.58 4 177133 8697 70742610
Vertigo CNS origin 10.96 9.58 4 177133 35 70751272
Diverticulum 10.95 9.58 65 177072 13628 70737679
Labelled drug-food interaction medication error 10.94 9.58 6 177131 146 70751161
Pancreatic haemorrhage 10.90 9.58 5 177132 82 70751225
Inappropriate schedule of product discontinuation 10.85 9.58 3 177134 9 70751298
Vascular dementia 10.83 9.58 12 177125 845 70750462
Peripheral ischaemia 10.83 9.58 47 177090 8711 70742596
Refusal of treatment by relative 10.75 9.58 11 177126 707 70750600
Paranoia 10.73 9.58 77 177060 17211 70734096
Oesophageal carcinoma 10.68 9.58 5 177132 9361 70741946
Sedation 10.66 9.58 170 176967 46561 70704746
Aortic valve calcification 10.65 9.58 11 177126 715 70750592
Blood testosterone decreased 10.62 9.58 20 177117 2293 70749014
Secretion discharge 10.58 9.58 10 177127 12923 70738384
Loss of proprioception 10.53 9.58 11 177126 724 70750583
Leukopenia 10.50 9.58 195 176942 106365 70644942
Electrocardiogram QT prolonged 10.46 9.58 278 176859 83239 70668068
Medication error 10.45 9.58 200 176937 56712 70694595
Coagulation factor V level decreased 10.45 9.58 10 177127 592 70750715
Left ventricular dysfunction 10.42 9.58 18 177119 17939 70733368
Amnestic disorder 10.41 9.58 10 177127 595 70750712
Therapeutic product effect increased 10.41 9.58 15 177122 1377 70749930
Dyssomnia 10.32 9.58 4 177133 42 70751265
Muscle spasms 10.30 9.58 477 176660 153569 70597738
Aspergillus infection 10.28 9.58 18 177119 17850 70733457
Seizure 10.23 9.58 543 176594 177419 70573888
Cholestatic liver injury 10.12 9.58 28 177109 4140 70747167
Sudden cardiac death 10.11 9.58 31 177106 4854 70746453
Fibromyalgia 10.06 9.58 74 177063 47800 70703507
Respiratory disorder 9.99 9.58 57 177080 39066 70712241
Mood swings 9.97 9.58 79 177058 18207 70733100
Dermatitis allergic 9.97 9.58 16 177121 16415 70734892
Neutrophil count increased 9.90 9.58 34 177103 26761 70724546
Activation syndrome 9.87 9.58 7 177130 271 70751036
Product commingling 9.87 9.58 5 177132 103 70751204
Hypoosmolar state 9.76 9.58 7 177130 276 70751031
Coeliac artery compression syndrome 9.70 9.58 5 177132 107 70751200
Tendonitis 9.65 9.58 26 177111 22096 70729211
Enuresis 9.60 9.58 22 177115 2895 70748412

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




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 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 RX 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
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
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-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-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
Gamma-aminobutyric acid receptor subunit alpha-1 Ion channel Ki 7.30 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