zolpidem 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | 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

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
kinase-safety-class ACVR2B,ALK,AXL,BRAF,CAMK2B,CAMK2D,CDK5,CDK9,DDR1,DYRK1B,EIF2AK3,EPHB4,ERBB2,FLT3,GRK2,ITK,JAK2,MAP3K1,MAP3K21,MAP3K7,MAPK10,MAPK7,MARK4,MET,NTRK2,PDK4,PIK3CB,PIM2,PRKCD,PRKDC,SIK2,SIK3,STK33,TEK,TTK 35
pfas-class PFAS structural alert (1 = True, 0 = False) 0

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 1494.07 9.92 1625 176402 143433 90306987
Drug abuse 1363.53 9.92 1197 176830 81150 90369270
Intentional overdose 1089.52 9.92 1121 176906 92713 90357707
Suicide attempt 1002.97 9.92 970 177057 74429 90375991
Drug dependence 787.89 9.92 567 177460 28760 90421660
Toxicity to various agents 642.16 9.92 1609 176418 286237 90164183
Somnambulism 631.01 9.92 287 177740 5941 90444479
Synovitis 562.81 9.92 19 178008 329733 90120687
Hand deformity 554.31 9.92 5 178022 296357 90154063
Drug use disorder 534.12 9.92 281 177746 8062 90442358
Systemic lupus erythematosus 521.51 9.92 53 177974 361843 90088577
Sopor 514.72 9.92 410 177617 24234 90426186
Contraindicated product administered 479.64 9.92 40 177987 320099 90130321
Glossodynia 477.19 9.92 42 177985 321737 90128683
Somnolence 472.43 9.92 1175 176852 207909 90242511
Infusion related reaction 469.65 9.92 120 177907 416660 90033760
Drug intolerance 456.69 9.92 155 177872 447436 90002984
Joint swelling 448.86 9.92 214 177813 503086 89947334
Intentional self-injury 429.10 9.92 398 177629 28936 90421484
Pericarditis 406.71 9.92 33 177994 270118 90180302
Arthropathy 405.79 9.92 109 177918 366133 90084287
Treatment failure 399.98 9.92 60 177967 303868 90146552
Wound 398.30 9.92 60 177967 302920 90147500
Helicobacter infection 387.19 9.92 13 178014 226837 90223583
Folliculitis 347.73 9.92 12 178015 204341 90246079
Lower respiratory tract infection 340.28 9.92 45 177982 250614 90199806
Intentional product misuse 334.72 9.92 618 177409 88986 90361434
Off label use 333.16 9.92 1086 176941 1101166 89349254
Anxiety 326.25 9.92 1338 176689 308434 90141986
Overdose 314.50 9.92 846 177181 156863 90293557
Fall 304.30 9.92 1798 176229 480012 89970408
Muscle injury 291.63 9.92 13 178014 176641 90273779
Swelling 290.81 9.92 238 177789 418820 90031600
Maternal exposure during pregnancy 285.89 9.92 177 177850 359886 90090534
Coma 283.99 9.92 511 177516 72121 90378299
Hypersensitivity 282.50 9.92 286 177741 454391 89996029
Hepatic enzyme increased 277.29 9.92 184 177843 360552 90089868
Affect lability 275.67 9.92 251 177776 17812 90432608
Alopecia 263.87 9.92 352 177675 494719 89955701
Suicidal ideation 259.16 9.92 496 177531 73359 90377061
Abnormal sleep-related event 248.71 9.92 85 177942 786 90449634
Poisoning deliberate 245.58 9.92 226 177801 16260 90434160
Blister 237.03 9.92 102 177925 254896 90195524
Peripheral swelling 235.41 9.92 279 177748 412827 90037593
C-reactive protein abnormal 234.22 9.92 3 178024 127426 90322994
Amnesia 233.51 9.92 599 177428 107906 90342514
Loss of consciousness 233.48 9.92 705 177322 139533 90310887
Drug ineffective 232.33 9.92 1682 176345 1382616 89067804
Abdominal discomfort 231.10 9.92 363 177664 476965 89973455
Drug withdrawal syndrome 229.93 9.92 283 177744 28440 90421980
Carotid artery thrombosis 226.48 9.92 168 177859 8924 90441496
Cardio-respiratory arrest 226.41 9.92 428 177599 62712 90387708
Sleep disorder due to general medical condition, insomnia type 224.53 9.92 6 178021 128688 90321732
Impaired healing 223.60 9.92 90 177937 234109 90216311
Type 2 diabetes mellitus 222.09 9.92 62 177965 203182 90247238
Neurologic neglect syndrome 217.08 9.92 162 177865 8685 90441735
Motor dysfunction 212.59 9.92 224 177803 19006 90431414
Psoriatic arthropathy 211.14 9.92 92 177935 228243 90222177
Personality disorder 209.91 9.92 183 177844 12261 90438159
Adjustment disorder 209.01 9.92 164 177863 9478 90440942
Dysarthria 208.74 9.92 380 177647 54102 90396318
Poisoning 206.33 9.92 198 177829 15019 90435401
Infection 205.77 9.92 245 177782 361849 90088571
Therapeutic product effect decreased 204.70 9.92 148 177879 277423 90172997
Liver injury 204.01 9.92 43 177984 170524 90279896
Ill-defined disorder 200.90 9.92 57 177970 184834 90265586
Joint range of motion decreased 197.45 9.92 19 178008 135624 90314796
Discomfort 192.42 9.92 154 177873 274181 90176239
Respiratory arrest 191.16 9.92 279 177748 33032 90417388
Musculoskeletal stiffness 190.39 9.92 181 177846 296351 90154069
Irritable bowel syndrome 189.57 9.92 85 177942 207363 90243057
Hemiplegia 174.67 9.92 186 177841 15974 90434446
Sensory loss 174.43 9.92 196 177831 17879 90432541
Wheezing 174.15 9.92 128 177899 237952 90212468
Abnormal behaviour 173.19 9.92 218 177809 22410 90428010
Arterial occlusive disease 166.96 9.92 161 177866 12285 90438135
Agitation 165.07 9.92 390 177637 66708 90383712
Coordination abnormal 163.85 9.92 206 177821 21150 90429270
Rash 160.15 9.92 914 177113 795186 89655234
Altered state of consciousness 159.47 9.92 249 177778 31283 90419137
Product use issue 159.44 9.92 251 177776 329668 90120752
Eating disorder 158.00 9.92 233 177794 27840 90422580
Drug hypersensitivity 157.91 9.92 431 177596 463178 89987242
Gangrene 156.81 9.92 158 177869 12718 90437702
Facet joint syndrome 153.75 9.92 10 178017 98379 90352041
Depression 153.06 9.92 1063 176964 299538 90150882
Withdrawal syndrome 149.06 9.92 202 177825 22322 90428098
Lip dry 147.30 9.92 14 178013 100941 90349479
Skin haemorrhage 143.40 9.92 193 177834 21187 90429233
Grip strength decreased 142.93 9.92 10 178017 92566 90357854
Stomatitis 141.43 9.92 200 177827 274498 90175922
Sleep-related eating disorder 136.72 9.92 57 177970 947 90449473
Dysphagia 136.63 9.92 508 177519 111770 90338650
Sinus congestion 136.52 9.92 215 177812 27209 90423211
Fibromyalgia 134.59 9.92 124 177903 206145 90244275
Intentional product use issue 133.85 9.92 137 177890 216755 90233665
Blood cholesterol increased 133.43 9.92 127 177900 207885 90242535
Bursitis 131.60 9.92 47 177980 131607 90318813
Hallucination 131.51 9.92 354 177673 65605 90384815
Arthralgia 130.85 9.92 944 177083 777578 89672842
Tremor 128.70 9.92 619 177408 152554 90297866
Disorientation 128.18 9.92 274 177753 43840 90406580
Mental status changes 126.94 9.92 275 177752 44404 90406016
Sinus disorder 121.60 9.92 232 177795 34215 90416205
Dependence 121.27 9.92 66 177961 2029 90448391
Live birth 120.82 9.92 9 178018 79098 90371322
Inflammation 119.33 9.92 105 177922 178487 90271933
Wound infection 118.94 9.92 31 177996 106371 90344049
Restlessness 118.08 9.92 234 177793 35486 90414934
Influenza like illness 117.33 9.92 387 177640 80224 90370196
Urticaria 116.22 9.92 278 177749 312456 90137964
Depressed level of consciousness 114.62 9.92 359 177668 72425 90377995
Rheumatoid arthritis 112.56 9.92 352 177675 362262 90088158
Respiratory tract congestion 112.44 9.92 197 177830 27213 90423207
Impaired driving ability 112.15 9.92 88 177939 5085 90445335
Therapeutic product effect incomplete 111.32 9.92 130 177897 193766 90256654
Hyponatraemia 110.26 9.92 537 177490 133001 90317419
Mobility decreased 109.84 9.92 203 177824 250531 90199889
Hypercholesterolaemia 109.76 9.92 31 177996 100861 90349559
C-reactive protein increased 109.18 9.92 117 177910 181272 90269148
Hemiparesis 108.27 9.92 211 177816 31608 90418812
Drug interaction 107.92 9.92 919 177108 275534 90174886
Sneezing 107.70 9.92 203 177824 29666 90420754
Peripheral venous disease 104.86 9.92 19 178008 83902 90366518
Miosis 103.98 9.92 110 177917 9374 90441046
Angina pectoris 102.21 9.92 233 177794 38927 90411493
General physical health deterioration 101.09 9.92 358 177669 354757 90095663
Palpitations 100.39 9.92 532 177495 136196 90314224
Disturbance in attention 100.18 9.92 259 177768 46850 90403570
Pulmonary fibrosis 99.82 9.92 43 177984 107460 90342960
Aphasia 97.95 9.92 242 177785 42570 90407850
Product use in unapproved indication 95.67 9.92 339 177688 335897 90114523
Bradyphrenia 95.62 9.92 95 177932 7517 90442903
Cardiac arrest 94.66 9.92 433 177594 104502 90345918
Drug abuser 93.51 9.92 61 177966 2629 90447791
Autoimmune disorder 92.45 9.92 19 178008 76725 90373695
Red blood cell sedimentation rate increased 92.44 9.92 24 178003 82571 90367849
Mydriasis 90.89 9.92 129 177898 14883 90435537
Product substitution issue 90.76 9.92 142 177885 17866 90432554
Exposure during pregnancy 89.28 9.92 211 177816 238199 90212221
Hypotension 88.46 9.92 1003 177024 324394 90126026
Adjustment disorder with depressed mood 87.98 9.92 6 178021 56747 90393673
Prescribed overdose 87.58 9.92 41 177986 97584 90352836
Mental disorder 87.36 9.92 195 177832 32123 90418297
Syncope 85.92 9.92 499 177528 132164 90318256
Urinary retention 83.87 9.92 211 177816 37533 90412887
Cerebrovascular accident 81.53 9.92 467 177560 123066 90327354
Nasopharyngitis 81.27 9.92 468 177559 406636 90043784
Parkinsonism 80.97 9.92 118 177909 13947 90436473
Hip arthroplasty 80 9.92 25 178002 76183 90374237
Prescription form tampering 78.40 9.92 35 177992 692 90449728
Gait inability 77.97 9.92 104 177923 146352 90304068
Sciatica 77.39 9.92 52 177975 101330 90349090
Drug detoxification 76.17 9.92 28 177999 326 90450094
Bone erosion 75.65 9.92 8 178019 53013 90397407
Osteoarthritis 75.06 9.92 171 177856 195559 90254861
Bradykinesia 74.90 9.92 79 177948 6709 90443711
Onychomadesis 73.91 9.92 4 178023 45994 90404426
Condition aggravated 72.91 9.92 783 177244 594762 89855658
Muscle spasticity 72.85 9.92 192 177835 35130 90415290
Rhabdomyolysis 72.72 9.92 244 177783 51012 90399408
Emotional distress 72.30 9.92 196 177831 36466 90413954
Dehydration 70.94 9.92 637 177390 193810 90256610
Drug withdrawal convulsions 69.90 9.92 41 177986 1459 90448961
Skin exfoliation 68.66 9.92 290 177737 67623 90382797
Lung disorder 68.62 9.92 118 177909 149765 90300655
Sedation 67.18 9.92 228 177799 47943 90402477
Hypokalaemia 66.81 9.92 464 177563 130652 90319768
Lupus-like syndrome 63.36 9.92 10 178017 48836 90401584
Psychomotor skills impaired 62.57 9.92 49 177978 2823 90447597
Taste disorder 61.44 9.92 22 178005 61524 90388896
Immobilisation prolonged 61.09 9.92 19 178008 126 90450294
Sleep talking 60.92 9.92 34 177993 1099 90449321
Cognitive disorder 60.81 9.92 284 177743 69123 90381297
Seizure 60.34 9.92 509 177518 152120 90298300
Dissociative disorder 60.32 9.92 28 177999 608 90449812
Listless 59.31 9.92 50 177977 3199 90447221
Lower limb fracture 57.95 9.92 49 177978 84964 90365456
Head injury 56.82 9.92 162 177865 31026 90419394
Initial insomnia 56.36 9.92 80 177947 9230 90441190
Victim of chemical submission 56.32 9.92 28 177999 711 90449709
Substance abuse 56.27 9.92 61 177966 5345 90445075
Cystitis 55.54 9.92 269 177758 66449 90383971
Insomnia 55.14 9.92 941 177086 332533 90117887
Psychomotor retardation 55.10 9.92 57 177970 4732 90445688
Obesity 55.06 9.92 76 177951 105431 90344989
Night sweats 54.81 9.92 106 177921 128660 90321760
Nightmare 54.20 9.92 127 177900 21598 90428822
Unresponsive to stimuli 53.66 9.92 181 177846 37940 90412480
Irritability 53.48 9.92 173 177854 35489 90414931
Confusional state 53.46 9.92 1060 176967 385145 90065275
Tardive dyskinesia 53.44 9.92 85 177942 10845 90439575
Bradypnoea 52.80 9.92 55 177972 4603 90445817
Musculoskeletal pain 52.53 9.92 167 177860 171084 90279336
Myelosuppression 52.08 9.92 20 178007 53571 90396849
Feeling abnormal 51.65 9.92 529 177498 166706 90283714
Nail disorder 51.16 9.92 26 178001 59041 90391379
Dysuria 51.05 9.92 182 177845 39219 90411201
Vertigo 50.78 9.92 271 177756 69540 90380880
Hallucination, visual 50.16 9.92 128 177899 22964 90427456
Panic attack 50.04 9.92 139 177888 26226 90424194
Asthma 49.56 9.92 276 177751 241884 90208536
Exposure via ingestion 48.60 9.92 41 177986 2626 90447794
Hyperhidrosis 47.89 9.92 443 177584 135862 90314558
Tachycardia 47.86 9.92 497 177530 157176 90293244
Knee arthroplasty 47.47 9.92 56 177971 83126 90367294
Blepharospasm 47.14 9.92 25 178002 55420 90395000
Finger deformity 46.84 9.92 5 178022 32892 90417528
Pneumonia aspiration 46.28 9.92 181 177846 40759 90409661
Chest discomfort 46.27 9.92 445 177582 137920 90312500
Coeliac disease 46.17 9.92 15 178012 44595 90405825
Victim of sexual abuse 46.17 9.92 24 178003 671 90449749
Deep vein thrombosis 45.93 9.92 323 177704 91297 90359123
Colitis ulcerative 45.87 9.92 31 177996 60235 90390185
Therapy non-responder 45.75 9.92 128 177899 136576 90313844
Drug screen positive 45.56 9.92 46 177981 3711 90446709
Muscle rigidity 45.21 9.92 92 177935 14217 90436203
Aggression 45.20 9.92 135 177892 26533 90423887
Hallucination, auditory 44.99 9.92 98 177929 15877 90434543
Serotonin syndrome 44.87 9.92 170 177857 37717 90412703
Apathy 44.82 9.92 79 177948 10961 90439459
Adverse event 44.66 9.92 103 177924 117315 90333105
Cataract 44.61 9.92 268 177759 71824 90378596
Respiratory depression 43.25 9.92 95 177932 15480 90434940
Peripheral circulatory failure 43.03 9.92 31 177996 1573 90448847
Pruritus 42.60 9.92 778 177249 540747 89909673
Abnormal dreams 42.45 9.92 78 177949 11179 90439241
Prescribed underdose 42.28 9.92 51 177976 74968 90375452
Blood cholesterol decreased 42.19 9.92 33 177994 1898 90448522
Aspartate aminotransferase increased 42.12 9.92 346 177681 102591 90347829
Hepatic cirrhosis 41.25 9.92 38 177989 63215 90387205
Constipation 40.94 9.92 776 177251 279619 90170801
Mania 40.18 9.92 87 177940 14037 90436383
Foot deformity 39.90 9.92 35 177992 59616 90390804
Logorrhoea 39.86 9.92 37 177990 2690 90447730
Blood urea increased 39.84 9.92 141 177886 30272 90420148
Hiatus hernia 39.83 9.92 125 177902 25236 90425184
Nausea 39.82 9.92 2608 175419 1107708 89342712
Homicide 39.74 9.92 17 178010 302 90450118
Akathisia 39.18 9.92 75 177952 11084 90439336
Psychomotor hyperactivity 38.85 9.92 81 177946 12732 90437688
Dementia 38.76 9.92 119 177908 23742 90426678
High risk sexual behaviour 38.64 9.92 8 178019 4 90450416
Liver disorder 38.07 9.92 117 177910 121152 90329268
Neuroglycopenia 38.06 9.92 25 178002 1090 90449330
Hypotonia 37.94 9.92 75 177952 11351 90439069
Hypoglycaemia 37.84 9.92 251 177776 69597 90380823
Vision blurred 37.51 9.92 356 177671 109937 90340483
Oedema 37.41 9.92 235 177792 200060 90250360
Multiple sclerosis relapse 37.33 9.92 202 177825 52103 90398317
Cholecystitis chronic 36.94 9.92 68 177959 9758 90440662
Weight increased 36.87 9.92 588 177439 417339 90033081
Rhinorrhoea 36.75 9.92 298 177729 88018 90362402
Multiple drug therapy 36.34 9.92 56 177971 6953 90443467
Sinus tachycardia 36.33 9.92 131 177896 28382 90422038
Frequent bowel movements 36.20 9.92 35 177992 56900 90393520
Stupor 36.02 9.92 49 177978 5433 90444987
Slow speech 35.81 9.92 30 177997 1903 90448517
Choroidal infarction 35.69 9.92 12 178015 105 90450315
Dry mouth 35.39 9.92 214 177813 183845 90266575
Dyspepsia 34.73 9.92 237 177790 197923 90252497
Reduced facial expression 34.19 9.92 33 177994 2520 90447900
Diplopia 34.14 9.92 129 177898 28585 90421835
Joint dislocation 33.84 9.92 23 178004 44559 90405861
Laryngitis 33.68 9.92 30 177997 50723 90399697
Premature delivery 33.66 9.92 17 178010 38745 90411675
Liver function test increased 33.44 9.92 73 177954 84782 90365638
Gastrointestinal disorder 33.15 9.92 333 177694 256354 90194066
Delirium 33.11 9.92 332 177695 104027 90346393
Foreign body 32.96 9.92 32 177995 2462 90447958
Gastric polyps 32.59 9.92 43 177984 4629 90445791
Dermatitis artefacta 32.59 9.92 10 178017 63 90450357
Alcohol abuse 32.49 9.92 29 177998 2004 90448416
Macular degeneration 32.46 9.92 17 178010 37953 90412467
Pain 32.35 9.92 1614 176413 994727 89455693
Atrioventricular block first degree 32.12 9.92 59 177968 8452 90441968
Alcohol poisoning 32.01 9.92 28 177999 1884 90448536
Dysphoria 31.67 9.92 49 177978 6105 90444315
Urinary hesitation 31.42 9.92 31 177996 2432 90447988
Self-medication 31.21 9.92 35 177992 3185 90447235
Prescription drug used without a prescription 30.90 9.92 35 177992 3220 90447200
Suspected suicide 30.80 9.92 62 177965 9506 90440914
Asthenia 30.62 9.92 1311 176716 532440 89917980
Alcohol use 30.48 9.92 26 178001 1691 90448729
Disorganised speech 30.35 9.92 27 178000 1858 90448562
Sleep disorder due to a general medical condition 30.23 9.92 26 178001 44712 90405708
Peptic ulcer 30.17 9.92 45 177982 5430 90444990
Onychomycosis 30.12 9.92 18 178009 37358 90413062
Injury 29.84 9.92 246 177781 197103 90253317
Multiple sclerosis 29.79 9.92 121 177906 27719 90422701
Immunodeficiency 29.36 9.92 25 178002 43209 90407211
Bulimia nervosa 29.22 9.92 16 178011 498 90449922
Tension 29.01 9.92 36 177991 3646 90446774
Incoherent 29.00 9.92 42 177985 4935 90445485
Hangover 28.76 9.92 28 177999 2161 90448259
Crying 28.68 9.92 113 177914 25532 90424888
Balance disorder 28.50 9.92 304 177723 96776 90353644
Illusion 28.48 9.92 22 178005 1242 90449178
Behaviour disorder 28.31 9.92 40 177987 4595 90445825
Maternal exposure timing unspecified 28.28 9.92 5 178022 22478 90427942
Laryngeal pain 28.26 9.92 39 177988 4383 90446037
Back injury 28.11 9.92 30 177997 46592 90403828
Exostosis 27.99 9.92 38 177989 53096 90397324
Lethargy 27.88 9.92 216 177811 62923 90387497
Anger 27.70 9.92 74 177953 13646 90436774
Restless legs syndrome 27.59 9.92 102 177925 22368 90428052
Feeling drunk 27.50 9.92 40 177987 4718 90445702
Crime 27.23 9.92 7 178020 20 90450400
Ulcer haemorrhage 26.97 9.92 9 178018 26312 90424108
Injection site reaction 26.71 9.92 92 177935 91988 90358432
Ear infection 26.70 9.92 61 177966 69714 90380706
Product complaint 26.44 9.92 72 177955 13428 90436992
Transient ischaemic attack 26.39 9.92 160 177867 43016 90407404
Blood potassium decreased 26.15 9.92 172 177855 47555 90402865
Speech disorder 26.02 9.92 166 177861 45419 90405001
Nervousness 26.00 9.92 134 177893 33922 90416498
Blood pressure systolic increased 25.73 9.92 47 177980 58298 90392122
Adverse drug reaction 25.53 9.92 130 177897 116571 90333849
Mood swings 25.44 9.92 94 177933 20608 90429812
Major depression 25.40 9.92 59 177968 9976 90440444
Drug diversion 25.30 9.92 19 178008 1028 90449392
Hepatitis B DNA increased 25.14 9.92 12 178015 278 90450142
Alanine aminotransferase increased 24.91 9.92 348 177679 117990 90332430
Joint stiffness 24.70 9.92 75 177952 77967 90372453
Electrocardiogram QT prolonged 24.69 9.92 234 177793 72222 90378198
Dyskinesia 24.67 9.92 139 177888 36395 90414025
Melaena 24.57 9.92 134 177893 34663 90415757
Loss of proprioception 24.47 9.92 14 178013 475 90449945
Visual acuity reduced 24.46 9.92 101 177926 23309 90427111
Rheumatoid nodule 24.27 9.92 5 178022 20161 90430259
Anterograde amnesia 24.13 9.92 15 178012 594 90449826
Blood pressure decreased 24.11 9.92 239 177788 74656 90375764
Milk-alkali syndrome 24.09 9.92 20 178007 1253 90449167
Decreased interest 23.97 9.92 36 177991 4371 90446049
Device expulsion 23.89 9.92 27 178000 40859 90409561
Hypertension 23.67 9.92 701 177326 456831 89993589
Euphoric mood 23.65 9.92 40 177987 5369 90445051
Inappropriate antidiuretic hormone secretion 23.49 9.92 88 177939 19417 90431003
Anhedonia 23.43 9.92 62 177965 11369 90439051
Dissociation 23.42 9.92 45 177982 6670 90443750
Blood creatine phosphokinase increased 23.34 9.92 130 177897 33893 90416527
Blood pressure increased 23.25 9.92 529 177498 196688 90253732
Hypoaesthesia 23.25 9.92 456 177571 313754 90136666
Blood pressure systolic abnormal 23.09 9.92 5 178022 19473 90430947
Incorrect route of product administration 23.03 9.92 40 177987 50586 90399834
Encephalopathy 22.84 9.92 163 177864 46281 90404139
Depressed mood 22.84 9.92 173 177854 50049 90400371
Psychotic disorder 22.55 9.92 121 177906 31109 90419311
Cerebral atrophy 22.40 9.92 40 177987 5606 90444814
Walking aid user 22.37 9.92 22 178005 35484 90414936
Sleep disorder 22.32 9.92 265 177762 197765 90252655
Normal newborn 22.23 9.92 9 178018 23353 90427067
Persistent genital arousal disorder 22.22 9.92 15 178012 685 90449735
Respiratory disorder 22.19 9.92 60 177967 64756 90385664
Platelet count decreased 22.05 9.92 385 177642 136584 90313836
Head discomfort 21.63 9.92 76 177951 16257 90434163
Pustular psoriasis 21.52 9.92 5 178022 18551 90431869
Femoral neck fracture 21.48 9.92 56 177971 10177 90440243
Autonomic nervous system imbalance 21.41 9.92 30 177997 3420 90447000
Cholecystectomy 21.35 9.92 61 177966 11694 90438726
Drug tolerance increased 21.18 9.92 10 178017 226 90450194
Attention deficit hyperactivity disorder 21.09 9.92 33 177994 4151 90446269
Amnestic disorder 21.06 9.92 12 178015 404 90450016
Prothrombin time prolonged 21.05 9.92 54 177973 9718 90440702
International normalised ratio increased 20.96 9.92 162 177865 47154 90403266
Influenza 20.85 9.92 387 177640 138877 90311543
Cardiomegaly 20.85 9.92 83 177944 18842 90431578
Abdominal pain upper 20.79 9.92 496 177531 332178 90118242
Panic disorder 20.70 9.92 28 177999 3087 90447333
Disinhibition 20.67 9.92 17 178010 1051 90449369
Imprisonment 20.43 9.92 11 178016 331 90450089
Infusion site reaction 20.42 9.92 6 178021 19033 90431387
Depressive symptom 20.41 9.92 37 177990 5248 90445172
Spinal osteoarthritis 20.31 9.92 83 177944 19065 90431355
Atrial fibrillation 20.25 9.92 372 177655 133239 90317181
Drug resistance 20.20 9.92 18 178009 30431 90419989
Social problem 20.20 9.92 18 178009 1241 90449179
Proctitis 20.07 9.92 3 178024 15256 90435164
Fear 20.03 9.92 75 177952 16547 90433873
Inadequate analgesia 19.95 9.92 28 177999 3196 90447224
Labelled drug-food interaction issue 19.95 9.92 6 178021 35 90450385
Anaemia 19.85 9.92 865 177162 351937 90098483
Epilepsy 19.47 9.92 89 177938 82117 90368303
Anaphylactic reaction 19.43 9.92 97 177930 87427 90362993
Dyspnoea 19.41 9.92 1479 176548 879476 89570944
Alopecia scarring 19.41 9.92 9 178018 195 90450225
Blood alkaline phosphatase increased 19.33 9.92 161 177866 47918 90402502
Facial nerve disorder 19.29 9.92 13 178014 592 90449828
Intervertebral disc degeneration 19.22 9.92 76 177951 17198 90433222
Blood pressure fluctuation 19.11 9.92 47 177980 52366 90398054
General symptom 19.03 9.92 3 178024 14665 90435755
Temperature regulation disorder 18.87 9.92 3 178024 14576 90435844
Left ventricular hypertrophy 18.82 9.92 39 177988 6105 90444315
Arrhythmia 18.79 9.92 145 177882 42187 90408233
Coma scale abnormal 18.76 9.92 37 177990 5589 90444831
Borderline personality disorder 18.76 9.92 16 178011 1040 90449380
Aortic valve calcification 18.74 9.92 13 178014 621 90449799
Pupil fixed 18.72 9.92 22 178005 2106 90448314
Bipolar disorder 18.69 9.92 49 177978 8936 90441484
Compulsive shopping 18.68 9.92 14 178013 755 90449665
Panniculitis 18.66 9.92 3 178024 14455 90435965
Generalised tonic-clonic seizure 18.64 9.92 125 177902 34778 90415642
Atelectasis 18.60 9.92 96 177931 24313 90426107
Malnutrition 18.56 9.92 79 177948 18479 90431941
Dysgeusia 18.54 9.92 171 177856 52389 90398031
Drug ineffective for unapproved indication 18.38 9.92 68 177959 66576 90383844
Thirst 18.38 9.92 72 177955 16223 90434197
Extrapyramidal disorder 18.36 9.92 72 177955 16231 90434189
Skin abrasion 18.22 9.92 56 177971 11179 90439241
Performance fear 18.17 9.92 4 178023 4 90450416
Hyperlipidaemia 18.07 9.92 91 177936 22825 90427595
Catatonia 18.03 9.92 38 177989 6018 90444402
Blood sodium decreased 17.95 9.92 104 177923 27509 90422911
Drug-induced liver injury 17.89 9.92 104 177923 90214 90360206
Tearfulness 17.87 9.92 33 177994 4747 90445673
Affective disorder 17.77 9.92 44 177983 7749 90442671
Genotype drug resistance test positive 17.64 9.92 11 178016 438 90449982
Urinary tract infection 17.55 9.92 751 177276 304881 90145539
Cerebellar syndrome 17.42 9.92 29 177998 3843 90446577
Pregnancy 17.32 9.92 63 177964 61984 90388436
Mood altered 17.16 9.92 73 177954 17071 90433349
Persecutory delusion 17.15 9.92 26 178001 3182 90447238
Coagulation factor V level decreased 17.15 9.92 10 178017 352 90450068
Galactorrhoea 17.15 9.92 32 177995 4640 90445780
Legal problem 17.10 9.92 5 178022 26 90450394
Protrusion tongue 17.07 9.92 10 178017 355 90450065
Tangentiality 16.79 9.92 6 178021 64 90450356
Accidental overdose 16.79 9.92 104 177923 28169 90422251
COVID-19 16.78 9.92 232 177795 168611 90281809
Suicidal behaviour 16.57 9.92 24 178003 2820 90447600
Coronary artery disease 16.53 9.92 118 177909 33505 90416915
Tracheal atresia 16.50 9.92 5 178022 30 90450390
Bedridden 16.50 9.92 57 177970 12091 90438329
Blood pressure diastolic decreased 16.47 9.92 17 178010 26809 90423611
Gastritis 16.36 9.92 139 177888 41614 90408806
Substance use disorder 16.32 9.92 20 178007 2000 90448420
Executive dysfunction 16.29 9.92 9 178018 285 90450135
Emotional poverty 16.13 9.92 10 178017 394 90450026
Hot flush 15.95 9.92 183 177844 59305 90391115
Therapeutic response unexpected 15.95 9.92 85 177942 21795 90428625
Prothrombin time shortened 15.94 9.92 21 178006 2257 90448163
Hepatitis 15.93 9.92 78 177949 70661 90379759
Disseminated intravascular coagulation 15.92 9.92 84 177943 21454 90428966
Brain contusion 15.92 9.92 12 178015 653 90449767
Feeling hot 15.89 9.92 89 177938 77919 90372501
Waxy flexibility 15.89 9.92 7 178020 134 90450286
Bezoar 15.83 9.92 23 178004 2711 90447709
Neurogenic bladder 15.82 9.92 27 178000 3651 90446769
Food allergy 15.81 9.92 16 178011 25462 90424958
Increased appetite 15.80 9.92 55 177972 11710 90438710
Ventricular fibrillation 15.80 9.92 62 177965 13982 90436438
Pulmonary embolism 15.76 9.92 352 177675 130468 90319952
Parasomnia 15.74 9.92 12 178015 664 90449756
Generalised anxiety disorder 15.74 9.92 23 178004 2724 90447696
Diverticulum 15.73 9.92 56 177971 12057 90438363
Dental fistula 15.73 9.92 12 178015 665 90449755
Gait apraxia 15.72 9.92 5 178022 36 90450384
Cholelithiasis 15.68 9.92 165 177862 52341 90398079
Neuroleptic malignant syndrome 15.67 9.92 65 177962 15031 90435389
Blood creatine increased 15.53 9.92 39 177988 6928 90443492
Intervertebral disc protrusion 15.50 9.92 99 177928 27097 90423323
Delusion 15.49 9.92 61 177966 13779 90436641
Pelvic fracture 15.38 9.92 65 177962 15154 90435266
Posturing 15.32 9.92 11 178016 555 90449865
Ventricular extrasystoles 15.32 9.92 59 177968 13191 90437229
Hyperkalaemia 15.31 9.92 195 177832 64769 90385651
Haematoma 15.30 9.92 130 177897 38918 90411502
Neutropenia 15.26 9.92 331 177696 224573 90225847
Chills 15.23 9.92 353 177674 131628 90318792
Ecchymosis 15.18 9.92 56 177971 12267 90438153
Asphyxia 15.04 9.92 39 177988 7064 90443356
Hepatic function abnormal 15.04 9.92 148 177879 46140 90404280
Axonal neuropathy 15.02 9.92 15 178012 1194 90449226
Homicidal ideation 14.99 9.92 18 178009 1762 90448658
Fibrocystic breast disease 14.97 9.92 15 178012 1199 90449221
Papilloedema 14.97 9.92 30 177997 4585 90445835
Dizziness 14.82 9.92 1347 176680 587937 89862483
Clonus 14.76 9.92 34 177993 5716 90444704
Brachial artery entrapment syndrome 14.75 9.92 5 178022 45 90450375
Contusion 14.75 9.92 378 177649 250838 90199582
Urinary incontinence 14.68 9.92 125 177902 37441 90412979
Muscular weakness 14.49 9.92 519 177508 206147 90244273
Self-injurious ideation 14.42 9.92 24 178003 3179 90447241
Decreased activity 14.39 9.92 42 177985 8150 90442270
Multiple injuries 14.32 9.92 18 178009 1847 90448573
Obsessive-compulsive disorder 14.28 9.92 29 177998 4475 90445945
Erythema 14.25 9.92 342 177685 228904 90221516
Dental caries 14.21 9.92 52 177975 11345 90439075
Spleen congestion 14.16 9.92 6 178021 104 90450316
Poor quality sleep 14.14 9.92 90 177937 24603 90425817
Creatinine renal clearance decreased 14.01 9.92 10 178017 18889 90431531
Accidental poisoning 13.98 9.92 13 178014 947 90449473
Flat affect 13.92 9.92 17 178010 1694 90448726
Hypoacusis 13.84 9.92 98 177929 27752 90422668
Spondylolisthesis 13.83 9.92 27 178000 4048 90446372
Paranoia 13.73 9.92 56 177971 12852 90437568
Leukocytosis 13.67 9.92 106 177921 30884 90419536
Hypertransaminasaemia 13.65 9.92 7 178020 15818 90434602
Benzodiazepine drug level 13.63 9.92 3 178024 3 90450417
Anorexia nervosa 13.48 9.92 8 178019 291 90450129
Spinal rod insertion 13.35 9.92 4 178023 23 90450397
Bone pain 13.33 9.92 183 177844 61800 90388620
Drop attacks 13.33 9.92 11 178016 683 90449737
Blood glucose increased 13.33 9.92 262 177765 94984 90355436
Hepatocellular injury 13.31 9.92 100 177927 28858 90421562
Sinusitis 13.26 9.92 545 177482 342543 90107877
Haemangioma congenital 13.24 9.92 10 178017 546 90449874
Polyarthritis 13.23 9.92 10 178017 18340 90432080
Haematocrit decreased 13.22 9.92 133 177894 41699 90408721
Angioedema 13.22 9.92 74 177953 64802 90385618
Physical abuse 13.20 9.92 4 178023 24 90450396
Terminal insomnia 13.16 9.92 14 178013 1201 90449219
Gallbladder disorder 13.14 9.92 75 177952 19728 90430692
Obstructive airways disorder 13.13 9.92 19 178008 25850 90424570
Barrett's oesophagus 13.13 9.92 10 178017 553 90449867
Incorrect dose administered 13.11 9.92 223 177804 78707 90371713
Carotid artery stenosis 13.11 9.92 31 177996 5303 90445117
Liver function test abnormal 13.01 9.92 155 177872 50690 90399730
Intravascular haemolysis 12.95 9.92 9 178018 431 90449989
Chromaturia 12.95 9.92 73 177954 19114 90431306
Sluggishness 12.91 9.92 33 177994 5926 90444494
Respiratory distress 12.88 9.92 125 177902 38821 90411599
Hyperglycaemia 12.87 9.92 155 177872 50815 90399605
Toxic epidermal necrolysis 12.80 9.92 28 177999 32500 90417920
Scar 12.76 9.92 62 177965 15333 90435087
Pupillary reflex impaired 12.73 9.92 20 178007 2525 90447895
Drug withdrawal syndrome neonatal 12.69 9.92 19 178008 2300 90448120
Vertigo CNS origin 12.68 9.92 4 178023 28 90450392
Malocclusion 12.65 9.92 6 178021 137 90450283
Thinking abnormal 12.56 9.92 51 177976 11681 90438739
Dreamy state 12.55 9.92 4 178023 29 90450391
Duodenitis 12.55 9.92 27 178000 4336 90446084
Nervous system disorder 12.55 9.92 79 177948 21514 90428906
Hepatotoxicity 12.50 9.92 47 177980 45795 90404625
Ischaemic cardiomyopathy 12.34 9.92 20 178007 2593 90447827
Electrocardiogram QRS complex prolonged 12.26 9.92 37 177990 7311 90443109
Drug-disease interaction 12.20 9.92 12 178015 938 90449482
Housebound 12.20 9.92 7 178020 239 90450181
Middle insomnia 12.16 9.92 65 177962 16686 90433734
Hypokinesia 12.14 9.92 62 177965 15635 90434785
Sudden death 12.14 9.92 48 177979 10861 90439559
Arteriosclerosis coronary artery 12.13 9.92 44 177983 9559 90440861
Social anxiety disorder 12.09 9.92 10 178017 623 90449797
Eyelid ptosis 12.01 9.92 42 177985 8964 90441456
Myoglobin blood increased 11.95 9.92 15 178012 1537 90448883
Automatism 11.78 9.92 5 178022 87 90450333
Haemangioma of liver 11.78 9.92 14 178013 1356 90449064
Bronchiectasis 11.73 9.92 16 178011 22314 90428106
Crohn's disease 11.71 9.92 28 177999 4823 90445597
Faecaloma 11.69 9.92 46 177981 10385 90440035
Cancer pain 11.69 9.92 25 178002 4000 90446420
Ear pain 11.66 9.92 66 177961 57636 90392784
Hyporeflexia 11.60 9.92 18 178009 2248 90448172
Pre-existing condition improved 11.57 9.92 42 177985 9127 90441293
Hepatosplenomegaly 11.53 9.92 21 178006 2988 90447432
Depression suicidal 11.52 9.92 17 178010 2032 90448388
Concomitant disease aggravated 11.49 9.92 49 177978 11469 90438951
Micturition disorder 11.48 9.92 21 178006 2999 90447421
Breakthrough pain 11.48 9.92 14 178013 1393 90449027
Economic problem 11.46 9.92 22 178005 3259 90447161
Chemical submission 11.45 9.92 9 178018 521 90449899
Diverticular fistula 11.43 9.92 5 178022 94 90450326
Immobile 11.43 9.92 33 177994 6365 90444055
Cardiac failure congestive 11.40 9.92 264 177763 98430 90351990
Feelings of worthlessness 11.39 9.92 8 178019 390 90450030
Myalgia 11.35 9.92 436 177591 174689 90275731
Adverse reaction 11.34 9.92 26 178001 29686 90420734
Female genital tract fistula 11.34 9.92 11 178016 17857 90432563
Drug tolerance 11.33 9.92 67 177960 17849 90432571
Therapeutic response decreased 11.33 9.92 117 177910 89612 90360808
Aplastic anaemia 11.25 9.92 6 178021 13263 90437157
Maternal exposure before pregnancy 11.20 9.92 4 178023 11209 90439211
Cyanosis 11.20 9.92 71 177956 19384 90431036
Bradycardia 11.19 9.92 229 177798 83618 90366802
Spondylitis 11.19 9.92 7 178020 14171 90436249
Victim of crime 11.17 9.92 11 178016 861 90449559
Fracture 11.16 9.92 78 177949 21998 90428422
Neonatal behavioural syndrome 11.15 9.92 5 178022 100 90450320
Gastric ulcer haemorrhage 11.08 9.92 29 177998 5282 90445138
Withdrawal catatonia 11.01 9.92 6 178021 185 90450235
Renal failure 10.97 9.92 336 177691 130671 90319749
Cholecystitis 10.96 9.92 64 177963 16976 90433444
Respiratory acidosis 10.94 9.92 38 177989 8081 90442339
Ligament sprain 10.84 9.92 57 177970 14542 90435878
Hydroureter 10.82 9.92 9 178018 565 90449855
Verbal abuse 10.71 9.92 5 178022 110 90450310
Snoring 10.71 9.92 28 177999 5098 90445322
Intentional product misuse to child 10.70 9.92 4 178023 49 90450371
Sudden onset of sleep 10.67 9.92 9 178018 576 90449844
Inappropriate schedule of product administration 10.65 9.92 219 177808 149714 90300706
Rash vesicular 10.65 9.92 12 178015 18185 90432235
Ventricular tachycardia 10.62 9.92 84 177943 24624 90425796
Micturition urgency 10.61 9.92 47 177980 11186 90439234
Bone scan abnormal 10.59 9.92 8 178019 437 90449983
Weight fluctuation 10.53 9.92 14 178013 19735 90430685
Dilatation atrial 10.51 9.92 16 178011 1965 90448455
Long QT syndrome 10.51 9.92 24 178003 4013 90446407
Bradyarrhythmia 10.50 9.92 18 178009 2443 90447977
Transplant rejection 10.49 9.92 6 178021 12752 90437668
Ataxia 10.48 9.92 66 177961 17976 90432444
Sinus bradycardia 10.47 9.92 63 177964 16889 90433531
Neurological examination normal 10.42 9.92 4 178023 53 90450367
Blood triglycerides increased 10.40 9.92 54 177973 13707 90436713
Compulsions 10.40 9.92 6 178021 207 90450213
Eustachian tube disorder 10.39 9.92 5 178022 118 90450302
Nephropathy toxic 10.38 9.92 6 178021 12682 90437738
Hepatic necrosis 10.36 9.92 32 177995 6406 90444014
Facial spasm 10.25 9.92 10 178017 774 90449646
Muscle twitching 10.24 9.92 82 177945 24120 90426300
Gun shot wound 10.24 9.92 5 178022 122 90450298
Eye movement disorder 10.15 9.92 31 177996 6167 90444253
Cerebral infarction 10.13 9.92 88 177939 26508 90423912
Accidental death 10.11 9.92 16 178011 2032 90448388
Blood albumin decreased 10.10 9.92 62 177965 16741 90433679
Electrocardiogram ST segment abnormal 10 9.92 12 178015 1174 90449246
Pulmonary vasculitis 9.97 9.92 6 178021 224 90450196
Complication of device insertion 9.96 9.92 4 178023 10432 90439988
Sleep terror 9.96 9.92 25 178002 4439 90445981
Periventricular leukomalacia 9.95 9.92 6 178021 225 90450195

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Completed suicide 712.71 10.37 981 95694 95484 42429176
Somnambulism 592.06 10.37 240 96435 3175 42521485
Drug dependence 513.65 10.37 467 96208 28627 42496033
Drug abuse 489.63 10.37 863 95812 103908 42420752
Intentional overdose 426.53 10.37 554 96121 50902 42473758
Suicide attempt 362.93 10.37 484 96191 45616 42479044
Off label use 297.14 10.37 630 96045 637705 41886955
Amnesia 278.48 10.37 333 96342 28104 42496556
Drug use disorder 218.72 10.37 184 96491 10149 42514511
Intentional self-injury 186.20 10.37 200 96475 15002 42509658
Sopor 181.95 10.37 185 96490 13017 42511643
Poisoning 181.12 10.37 194 96481 14505 42510155
Somnolence 175.75 10.37 709 95966 140396 42384264
Overdose 167.96 10.37 573 96102 104691 42419969
Road traffic accident 166.58 10.37 211 96464 18882 42505778
Toxicity to various agents 160.48 10.37 977 95698 228159 42296501
Delirium 154.25 10.37 357 96318 52162 42472498
Confusional state 137.09 10.37 745 95930 166852 42357808
Drug withdrawal syndrome 130.79 10.37 200 96475 21349 42503311
Insomnia 127.61 10.37 569 96106 117684 42406976
Suicidal ideation 124.88 10.37 312 96363 47849 42476811
Disorientation 121.03 10.37 260 96415 36129 42488531
Respiratory arrest 114.62 10.37 220 96455 28204 42496456
Drug ineffective 109.90 10.37 910 95765 629287 41895373
Intentional product misuse 107.59 10.37 347 96328 61553 42463107
Anxiety 106.47 10.37 541 96134 118019 42406641
Impaired driving ability 98.60 10.37 69 96606 2886 42521774
Abnormal sleep-related event 97.33 10.37 38 96637 452 42524208
Abnormal behaviour 93.76 10.37 194 96481 26257 42498403
Coma 92.87 10.37 300 96375 53254 42471406
Product use in unapproved indication 91.16 10.37 175 96500 184281 42340379
Prescription form tampering 89.16 10.37 38 96637 574 42524086
Depression 87.57 10.37 490 96185 110873 42413787
Homicide 86.40 10.37 42 96633 873 42523787
Loss of consciousness 79.79 10.37 417 96258 91937 42432723
Agitation 78.20 10.37 321 96354 63993 42460667
Sleep-related eating disorder 74.43 10.37 29 96646 343 42524317
Withdrawal syndrome 71.79 10.37 124 96551 14651 42510009
Restlessness 70.11 10.37 184 96491 29065 42495595
Victim of chemical submission 67.36 10.37 22 96653 148 42524512
Bradyphrenia 65.78 10.37 70 96605 5192 42519468
Drug abuser 64.85 10.37 58 96617 3473 42521187
Parasomnia 64.64 10.37 28 96647 441 42524219
Gun shot wound 64.57 10.37 36 96639 1001 42523659
Myelosuppression 64.29 10.37 8 96667 40453 42484207
Automatism 63.75 10.37 20 96655 116 42524544
Poisoning deliberate 62.82 10.37 95 96580 10039 42514621
Hallucination 62.16 10.37 277 96398 57230 42467430
Aggression 60.60 10.37 229 96446 43934 42480726
Cardio-respiratory arrest 60.07 10.37 278 96397 58358 42466302
Dissociative disorder 57.96 10.37 29 96646 643 42524017
Altered state of consciousness 56.33 10.37 170 96505 29089 42495571
Fall 55.93 10.37 793 95882 233727 42290933
Anterograde amnesia 55.16 10.37 22 96653 278 42524382
Dependence 52.77 10.37 36 96639 1444 42523216
Drug diversion 52.71 10.37 31 96644 956 42523704
Condition aggravated 52.50 10.37 361 96314 260393 42264267
Thinking abnormal 49.99 10.37 71 96604 7090 42517570
Substance use disorder 49.70 10.37 61 96614 5284 42519376
Therapeutic product effect incomplete 48.01 10.37 54 96621 70885 42453775
Multiple organ dysfunction syndrome 47.07 10.37 93 96582 96942 42427718
Lower respiratory tract infection 44.22 10.37 19 96656 41187 42483473
Logorrhoea 43.61 10.37 42 96633 2765 42521895
Incoherent 42.80 10.37 53 96622 4632 42520028
Drug intolerance 42.63 10.37 73 96602 80351 42444309
Febrile neutropenia 41.47 10.37 249 96426 185454 42339206
Non-cardiogenic pulmonary oedema 41.29 10.37 26 96649 909 42523751
Antidepressant drug level above therapeutic 39.87 10.37 17 96658 257 42524403
Memory impairment 39.43 10.37 221 96454 50001 42474659
Disturbance in attention 38.62 10.37 152 96523 29714 42494946
Bradypnoea 37.44 10.37 48 96627 4345 42520315
Panic attack 36.80 10.37 79 96596 10966 42513694
Analgesic drug level above therapeutic 36.79 10.37 17 96658 314 42524346
Dysphoria 36.56 10.37 38 96637 2742 42521918
Legal problem 35.31 10.37 13 96662 130 42524530
Miosis 33.67 10.37 86 96589 13360 42511300
Disorganised speech 33.50 10.37 27 96648 1401 42523259
COVID-19 32.94 10.37 143 96532 115805 42408855
Neutropenia 32.68 10.37 292 96383 199139 42325521
Dysarthria 32.47 10.37 177 96498 39630 42485030
Hypokinesia 32.19 10.37 70 96605 9801 42514859
Angioedema 31.37 10.37 30 96645 42447 42482213
Drug detoxification 31.09 10.37 16 96659 377 42524283
Hallucination, visual 30.50 10.37 111 96564 20909 42503751
Mania 30.17 10.37 71 96604 10476 42514184
Cytomegalovirus infection 30.02 10.37 18 96657 32288 42492372
Nervousness 29.29 10.37 82 96593 13450 42511210
Rectal haemorrhage 29.16 10.37 42 96633 49564 42475096
Rheumatoid arthritis 29.04 10.37 32 96643 42408 42482252
Treatment failure 28.68 10.37 62 96613 62562 42462098
Drug withdrawal convulsions 28.67 10.37 24 96651 1314 42523346
Septic shock 28.58 10.37 109 96566 91563 42433097
Loss of personal independence in daily activities 28.48 10.37 43 96632 49773 42474887
Infection 28.43 10.37 144 96531 111924 42412736
Initial insomnia 28.19 10.37 40 96635 3990 42520670
Sleep apnoea syndrome 27.96 10.37 110 96565 21498 42503162
Pulmonary fibrosis 27.54 10.37 13 96662 26668 42497992
Persistent depressive disorder 27.51 10.37 16 96659 483 42524177
Asthma 27.47 10.37 63 96612 62251 42462409
Joint swelling 27.45 10.37 72 96603 67950 42456710
Mental impairment 27.01 10.37 75 96600 12242 42512418
Death 26.96 10.37 839 95836 470346 42054314
Mental disorder 26.83 10.37 96 96579 17933 42506727
Confabulation 26.76 10.37 11 96664 151 42524509
Depressed level of consciousness 26.46 10.37 193 96482 47777 42476883
Irritability 26.35 10.37 130 96545 27998 42496662
General physical health deterioration 26.30 10.37 218 96457 151028 42373632
Abnormal dreams 26.23 10.37 58 96617 8213 42516447
Alcohol interaction 25.98 10.37 28 96647 2107 42522553
Oedematous pancreatitis 25.93 10.37 18 96657 743 42523917
Unresponsive to stimuli 25.86 10.37 140 96535 31263 42493397
Gastrointestinal injury 25.75 10.37 21 96654 1108 42523552
Dissociation 25.54 10.37 37 96638 3761 42520899
Bronchiectasis 25.37 10.37 5 96670 18014 42506646
Product dose omission issue 24.41 10.37 228 96447 154137 42370523
Obstructive airways disorder 24.15 10.37 13 96662 24746 42499914
Alcohol use 24.08 10.37 31 96644 2817 42521843
Reduced facial expression 23.93 10.37 23 96652 1510 42523150
Sepsis 23.75 10.37 314 96361 199020 42325640
Erythema 23.67 10.37 147 96528 108646 42416014
Anger 23.52 10.37 74 96601 12944 42511716
Drug tolerance 23.52 10.37 33 96642 3257 42521403
Depressed mood 22.57 10.37 109 96566 23275 42501385
Leukopenia 21.95 10.37 91 96584 74655 42450005
Acute kidney injury 21.73 10.37 651 96024 366686 42157974
Psychomotor hyperactivity 21.40 10.37 64 96611 10894 42513766
Tachyphrenia 21.36 10.37 21 96654 1418 42523242
Feeling abnormal 21.24 10.37 247 96428 69539 42455121
Circadian rhythm sleep disorder 21.19 10.37 14 96661 532 42524128
Disease progression 21.10 10.37 216 96459 143440 42381220
Self-medication 20.79 10.37 31 96644 3235 42521425
Synovitis 20.54 10.37 5 96670 15562 42509098
Drug screen positive 20.50 10.37 35 96640 4096 42520564
Sleep disorder due to a general medical condition 20.47 10.37 7 96668 17446 42507214
Poor quality sleep 20.23 10.37 57 96618 9383 42515277
Inappropriate schedule of product administration 20.13 10.37 131 96544 95771 42428889
Procalcitonin abnormal 20.03 10.37 12 96663 383 42524277
Full blood count abnormal 19.92 10.37 23 96652 29853 42494807
Anaphylactic reaction 19.83 10.37 42 96633 42701 42481959
Infusion related reaction 19.80 10.37 71 96604 60735 42463925
Major depression 19.60 10.37 40 96635 5358 42519302
Intentional product use issue 19.54 10.37 90 96585 71743 42452917
Victim of crime 18.83 10.37 13 96662 532 42524128
Encephalomalacia 18.64 10.37 17 96658 1044 42523616
Drug ineffective for unapproved indication 18.52 10.37 49 96626 46114 42478546
Toxic epidermal necrolysis 18.49 10.37 20 96655 26730 42497930
Dyspnoea 18.37 10.37 819 95856 441802 42082858
Cardiomegaly 18.28 10.37 81 96594 16685 42507975
Respiratory tract infection bacterial 18.09 10.37 22 96653 1887 42522773
Myasthenia gravis 18.03 10.37 7 96668 16130 42508530
Personality change 18.02 10.37 40 96635 5679 42518981
Mucosal inflammation 17.90 10.37 55 96620 49319 42475341
Victim of homicide 17.85 10.37 9 96666 203 42524457
Sexual abuse 17.76 10.37 8 96667 139 42524521
Brain contusion 17.72 10.37 16 96659 970 42523690
Fear 17.72 10.37 60 96615 10905 42513755
Hangover 17.63 10.37 17 96658 1121 42523539
Product use issue 17.59 10.37 102 96573 76649 42448011
Product substitution issue 17.56 10.37 61 96614 11229 42513431
Pruritus 17.49 10.37 312 96363 188459 42336201
Galactorrhoea 17.34 10.37 12 96663 493 42524167
Tubulointerstitial nephritis 17.30 10.37 28 96647 31520 42493140
Thrombotic microangiopathy 17.21 10.37 6 96669 14776 42509884
Sleep talking 17.01 10.37 13 96662 624 42524036
Hospitalisation 16.92 10.37 99 96576 74231 42450429
Pyrexia 16.78 10.37 727 95948 393315 42131345
Substance-induced mood disorder 16.76 10.37 6 96669 55 42524605
Asphyxia 16.61 10.37 49 96626 8277 42516383
Vascular dementia 16.49 10.37 12 96663 534 42524126
Exposure via ingestion 16.25 10.37 22 96653 2100 42522560
Amimia 15.99 10.37 4 96671 8 42524652
Cardiac arrest 15.97 10.37 342 96333 108978 42415682
Cytomegalovirus infection reactivation 15.95 10.37 3 96672 11175 42513485
Frequent bowel movements 15.94 10.37 15 96660 21392 42503268
Pre-existing condition improved 15.90 10.37 26 96649 2937 42521723
Wheezing 15.89 10.37 67 96608 54714 42469946
Inappropriate antidiuretic hormone secretion 15.89 10.37 77 96598 16464 42508196
Appendicitis 15.88 10.37 14 96661 20599 42504061
End stage renal disease 15.70 10.37 9 96666 16549 42508111
Emotional distress 15.52 10.37 75 96600 16018 42508642
Coagulation factor VII level decreased 15.41 10.37 7 96668 124 42524536
Lactic acidosis 15.31 10.37 52 96623 45209 42479451
Stress at work 15.29 10.37 9 96666 278 42524382
Heart rate decreased 15.25 10.37 38 96637 36494 42488166
Pneumonitis chemical 15.20 10.37 9 96666 281 42524379
Electrocardiogram QT prolonged 15.17 10.37 171 96504 47774 42476886
Blood pressure systolic increased 15.17 10.37 25 96650 27943 42496717
Cytokine release syndrome 15.16 10.37 51 96624 44476 42480184
Drug reaction with eosinophilia and systemic symptoms 15.16 10.37 47 96628 42028 42482632
Mental status changes 15.09 10.37 154 96521 41961 42482699
Therapy partial responder 14.94 10.37 14 96661 20007 42504653
Neurotoxicity 14.93 10.37 19 96656 23632 42501028
Euphoric mood 14.85 10.37 40 96635 6413 42518247
Suspected suicide 14.85 10.37 39 96636 6160 42518500
Feeling jittery 14.78 10.37 32 96643 4466 42520194
Vasculitis 14.77 10.37 12 96663 18382 42506278
Decreased interest 14.61 10.37 24 96651 2721 42521939
Staring 14.61 10.37 18 96657 1565 42523095
Colitis ulcerative 14.57 10.37 23 96652 26152 42498508
Aspergillus infection 14.47 10.37 9 96666 15828 42508832
Delusion 14.45 10.37 69 96606 14665 42509995
Hepatitis C virus test positive 14.39 10.37 9 96666 311 42524349
Labelled drug-food interaction medication error 14.35 10.37 5 96670 42 42524618
Libido decreased 14.24 10.37 34 96641 5064 42519596
Apallic syndrome 14.21 10.37 9 96666 318 42524342
Psychomotor retardation 14.12 10.37 31 96644 4368 42520292
Urticaria 14.12 10.37 104 96571 73932 42450728
Bronchopulmonary aspergillosis 14.02 10.37 14 96661 19415 42505245
Haematotoxicity 13.60 10.37 4 96671 10981 42513679
Peripheral swelling 13.55 10.37 135 96540 90135 42434525
Hallucination, auditory 13.43 10.37 68 96607 14796 42509864
Blood alcohol increased 13.35 10.37 11 96664 589 42524071
Implant site inflammation 13.33 10.37 6 96669 104 42524556
Crime 13.32 10.37 5 96670 53 42524607
Cough 13.31 10.37 305 96370 177798 42346862
Paranoia 13.26 10.37 65 96610 13961 42510699
Sleep disorder 13.22 10.37 167 96508 47928 42476732
Hepatotoxicity 13.18 10.37 23 96652 25144 42499516
Haematocrit decreased 13.16 10.37 129 96546 34779 42489881
Exposure during pregnancy 13.13 10.37 46 96629 8502 42516158
Bipolar disorder 13.00 10.37 28 96647 3894 42520766
Cardiogenic shock 12.71 10.37 40 96635 35600 42489060
Speech disorder 12.68 10.37 111 96564 29010 42495650
Product administration error 12.63 10.37 78 96597 18265 42506395
PO2 decreased 12.55 10.37 17 96658 1624 42523036
Pilonidal cyst congenital 12.50 10.37 4 96671 25 42524635
Skin laceration 12.48 10.37 64 96611 13994 42510666
Cholestasis 12.37 10.37 36 96639 32843 42491817
Lethargy 12.12 10.37 161 96514 46729 42477931
Amnestic disorder 12.09 10.37 8 96667 305 42524355
Enuresis 11.98 10.37 22 96653 2726 42521934
Extra dose administered 11.92 10.37 34 96641 5635 42519025
Akathisia 11.78 10.37 51 96624 10400 42514260
Nightmare 11.77 10.37 97 96578 24915 42499745
Low birth weight baby 11.66 10.37 4 96671 9951 42514709
Nasopharyngitis 11.63 10.37 128 96547 83868 42440792
Drug tolerance increased 11.58 10.37 9 96666 443 42524217
Labile hypertension 11.41 10.37 5 96670 81 42524579
PCO2 decreased 11.38 10.37 17 96658 1777 42522883
Parkinsonism 11.34 10.37 51 96624 10572 42514088
C-reactive protein increased 11.31 10.37 91 96584 63469 42461191
Hyperhidrosis 11.30 10.37 277 96398 90235 42434425
No adverse event 11.15 10.37 48 96627 38973 42485687
Needle issue 11.14 10.37 3 96672 8724 42515936
Drug half-life reduced 11.14 10.37 3 96672 9 42524651
Tension 11.09 10.37 20 96655 2444 42522216
Tremor 11.03 10.37 293 96382 96636 42428024
Feeling drunk 11.03 10.37 19 96656 2239 42522421
Nystagmus 11.00 10.37 32 96643 5364 42519296
Drug hypersensitivity 10.95 10.37 159 96516 99230 42425430
Pulmonary congestion 10.90 10.37 67 96608 15663 42508997
Distributive shock 10.90 10.37 20 96655 2476 42522184
Blood pressure increased 10.90 10.37 164 96511 101764 42422896
Renal impairment 10.90 10.37 180 96495 110048 42414612
Patient elopement 10.89 10.37 6 96669 163 42524497
Acetonaemia 10.88 10.37 7 96668 254 42524406
Head injury 10.88 10.37 82 96593 20500 42504160
Sexual dysfunction 10.88 10.37 37 96638 6738 42517922
Haematochezia 10.71 10.37 83 96592 58353 42466307
Imprisonment 10.70 10.37 10 96665 634 42524026
Ulcer 10.60 10.37 13 96662 16428 42508232
Congenital hydrocephalus 10.57 10.37 6 96669 173 42524487
Rash 10.54 10.37 517 96158 276437 42248223
Dyssomnia 10.52 10.37 4 96671 44 42524616
Hostility 10.49 10.37 11 96664 802 42523858
Systemic lupus erythematosus 10.49 10.37 4 96671 9320 42515340
Prostate cancer 10.40 10.37 59 96616 44584 42480076

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 2276.31 9.92 2602 217437 239779 110129481
Drug abuse 1531.20 9.92 1825 218214 175586 110193674
Suicide attempt 1168.70 9.92 1225 218814 102169 110267091
Intentional overdose 1157.49 9.92 1372 218667 131129 110238131
Drug dependence 1152.01 9.92 886 219153 49134 110320126
Somnambulism 825.82 9.92 351 219688 6054 110363206
Toxicity to various agents 797.64 9.92 2430 217609 478125 109891135
Drug use disorder 693.23 9.92 438 219601 17636 110351624
Sopor 650.31 9.92 557 219482 35989 110333271
Off label use 527.70 9.92 1404 218635 1498781 108870479
Somnolence 524.69 9.92 1538 218501 295911 110073349
Intentional self-injury 489.26 9.92 480 219559 36949 110332311
Synovitis 477.10 9.92 15 220024 274077 110095183
Overdose 428.60 9.92 1226 218813 232568 110136692
Hand deformity 399.27 9.92 7 220032 218499 110150761
Poisoning 391.15 9.92 379 219660 28726 110340534
Drug intolerance 385.69 9.92 163 219876 406349 109962911
Joint swelling 379.70 9.92 204 219835 442641 109926619
Systemic lupus erythematosus 367.59 9.92 39 220000 254299 110114961
Intentional product misuse 362.97 9.92 811 219228 132093 110237167
Infusion related reaction 350.25 9.92 160 219879 381002 109988258
Coma 350.05 9.92 744 219295 117125 110252135
Anxiety 341.66 9.92 1476 218563 343602 110025658
Lower respiratory tract infection 334.67 9.92 44 219995 243062 110126198
Duodenal ulcer perforation 331.92 9.92 4 220035 177696 110191564
Drug withdrawal syndrome 331.80 9.92 394 219645 37660 110331600
Amnesia 323.06 9.92 674 219365 104734 110264526
Respiratory arrest 319.43 9.92 481 219558 57818 110311442
Suicidal ideation 319.23 9.92 627 219412 93310 110275950
Drug ineffective 314.00 9.92 1763 218276 1518777 108850483
Helicobacter infection 309.28 9.92 12 220027 181865 110187395
Contraindicated product administered 307.92 9.92 60 219979 248207 110121053
Glossodynia 306.02 9.92 40 219999 221964 110147296
Poisoning deliberate 300.82 9.92 314 219725 26017 110343243
Treatment failure 291.75 9.92 94 219945 277140 110092120
Abnormal sleep-related event 291.41 9.92 97 219942 809 110368451
Fall 291.29 9.92 2126 217913 601356 109767904
Pericarditis 289.13 9.92 45 219994 219069 110150191
Cardio-respiratory arrest 286.66 9.92 680 219359 115156 110254104
Affect lability 281.61 9.92 259 219780 18378 110350882
Folliculitis 278.63 9.92 13 220026 167640 110201620
Loss of consciousness 278.57 9.92 942 219097 195364 110173896
Arthropathy 266.70 9.92 119 219920 287403 110081857
Wound 265.95 9.92 69 219970 234368 110134892
C-reactive protein abnormal 237.53 9.92 4 220035 129691 110239569
Hypersensitivity 231.29 9.92 278 219761 403720 109965540
Maternal exposure during pregnancy 230.92 9.92 109 219930 254774 110114486
Carotid artery thrombosis 226.76 9.92 173 219866 9465 110359795
Disorientation 224.86 9.92 459 219580 70212 110299048
Dysarthria 221.42 9.92 506 219533 83615 110285645
Muscle injury 221.41 9.92 15 220024 140792 110228468
Neurologic neglect syndrome 221.19 9.92 168 219871 9130 110360130
Personality disorder 218.89 9.92 191 219848 12646 110356614
Adjustment disorder 213.63 9.92 175 219864 10620 110358640
Hepatic enzyme increased 209.10 9.92 198 219841 320694 110048566
Swelling 206.88 9.92 236 219803 350805 110018455
Agitation 203.21 9.92 589 219450 112462 110256798
Abnormal behaviour 198.23 9.92 311 219728 38728 110330532
Withdrawal syndrome 196.75 9.92 276 219763 31104 110338156
Peripheral swelling 195.26 9.92 314 219725 403720 109965540
Altered state of consciousness 192.54 9.92 382 219657 57244 110312016
Psoriatic arthropathy 191.14 9.92 76 219963 196685 110172575
Motor dysfunction 188.93 9.92 238 219801 24168 110345092
Blister 180.16 9.92 115 219924 227261 110141999
Delirium 179.32 9.92 634 219405 134391 110234869
Wheezing 176.42 9.92 149 219890 255081 110114179
Impaired healing 175.30 9.92 86 219953 196631 110172629
Infection 174.51 9.92 282 219757 361918 110007342
Facet joint syndrome 173.24 9.92 4 220035 96824 110272436
Sleep disorder due to general medical condition, insomnia type 172.93 9.92 9 220030 105634 110263626
Musculoskeletal stiffness 171.58 9.92 182 219857 279640 110089620
Alopecia 169.24 9.92 291 219748 364462 110004798
Sleep-related eating disorder 168.53 9.92 65 219974 860 110368400
Depression 167.34 9.92 1143 218896 316192 110053068
Confusional state 165.89 9.92 1540 218499 467140 109902120
Bradyphrenia 165.66 9.92 157 219882 11571 110357689
Restlessness 163.35 9.92 352 219687 55907 110313353
Hallucination 162.05 9.92 507 219532 100925 110268335
Drug hypersensitivity 159.25 9.92 424 219615 453666 109915594
Joint range of motion decreased 158.47 9.92 26 220013 121806 110247454
Ill-defined disorder 156.63 9.92 58 219981 156795 110212465
Sensory loss 154.71 9.92 202 219837 21255 110348005
Dependence 154.26 9.92 85 219954 2644 110366616
Coordination abnormal 153.88 9.92 219 219820 25009 110344251
Product use in unapproved indication 151.44 9.92 425 219614 446952 109922308
Lip dry 148.04 9.92 14 220025 100069 110269191
Arterial occlusive disease 144.28 9.92 165 219874 15143 110354117
Type 2 diabetes mellitus 144.04 9.92 87 219952 177145 110192115
Gangrene 142.11 9.92 169 219870 16172 110353088
Drug abuser 140.43 9.92 103 219936 5306 110363954
Hemiplegia 139.30 9.92 198 219841 22584 110346676
Abdominal discomfort 137.88 9.92 368 219671 393490 109975770
Intentional product use issue 137.15 9.92 175 219864 247731 110121529
Eating disorder 135.22 9.92 230 219809 30628 110338632
Irritable bowel syndrome 134.31 9.92 80 219959 164135 110205125
Therapeutic product effect decreased 132.55 9.92 175 219864 244141 110125119
Fibromyalgia 131.90 9.92 89 219950 170820 110198440
Miosis 131.39 9.92 189 219850 21794 110347466
Disturbance in attention 131.25 9.92 343 219696 61652 110307608
Bursitis 129.78 9.92 48 219991 129870 110239390
Arthralgia 129.43 9.92 964 219075 778668 109590592
Skin haemorrhage 126.34 9.92 198 219841 24629 110344631
Sinus congestion 125.59 9.92 221 219818 30238 110339022
Sinus disorder 124.15 9.92 229 219810 32499 110336761
Therapeutic product effect incomplete 123.78 9.92 158 219881 223647 110145613
Inflammation 123.75 9.92 121 219918 193117 110176143
Liver injury 123.40 9.92 73 219966 150340 110218920
Depressed level of consciousness 121.59 9.92 494 219545 111784 110257476
Rash 121.57 9.92 1047 218992 819917 109549343
Urticaria 120.04 9.92 287 219752 318570 110050690
Grip strength decreased 119.16 9.92 11 220028 80163 110289097
Live birth 113.47 9.92 6 220033 69478 110299782
Victim of chemical submission 112.74 9.92 48 219991 831 110368429
Myelosuppression 112.37 9.92 25 220014 94315 110274945
Dissociative disorder 111.59 9.92 53 219986 1198 110368062
Homicide 111.50 9.92 51 219988 1055 110368205
Stomatitis 107.57 9.92 236 219803 270006 110099254
Dysphagia 106.55 9.92 594 219445 153006 110216254
Discomfort 106.35 9.92 164 219875 214543 110154717
C-reactive protein increased 105.52 9.92 169 219870 217750 110151510
Wound infection 104.48 9.92 31 220008 96434 110272826
Cardiac arrest 104.40 9.92 710 219329 196043 110173217
Sneezing 103.21 9.92 209 219830 31775 110337485
Pulmonary fibrosis 101.42 9.92 38 220001 102004 110267256
Product use issue 99.66 9.92 304 219735 311391 110057869
Condition aggravated 99.66 9.92 958 219081 733878 109635382
Peripheral venous disease 98.77 9.92 23 220016 84094 110285166
Tremor 98.65 9.92 715 219324 201517 110167743
Mental disorder 98.38 9.92 230 219809 38561 110330699
Respiratory tract congestion 97.63 9.92 200 219839 30657 110338603
Drug detoxification 95.44 9.92 38 220001 550 110368710
General physical health deterioration 94.93 9.92 479 219560 424816 109944444
Asthma 92.83 9.92 227 219812 250064 110119196
Bradypnoea 91.44 9.92 99 219940 8550 110360710
Aggression 90.92 9.92 292 219747 58918 110310342
Mental status changes 90.56 9.92 345 219694 75777 110293483
Muscle spasticity 90.04 9.92 212 219827 35703 110333557
Blood cholesterol increased 89.74 9.92 143 219896 184642 110184618
Autoimmune disorder 89.71 9.92 12 220027 65471 110303789
Red blood cell sedimentation rate increased 88.84 9.92 23 220016 78279 110290981
Mobility decreased 87.52 9.92 216 219823 237206 110132054
Drug withdrawal convulsions 85.61 9.92 56 219983 2393 110366867
Influenza like illness 83.34 9.92 373 219666 88039 110281221
Angina pectoris 83.08 9.92 293 219746 62002 110307258
Mydriasis 82.74 9.92 154 219885 22003 110347257
Osteoarthritis 82.54 9.92 148 219891 182475 110186785
Palpitations 82.35 9.92 571 219468 158641 110210619
Rheumatoid arthritis 82.31 9.92 312 219727 299301 110069959
Impaired driving ability 81.93 9.92 81 219958 6289 110362971
Initial insomnia 79.91 9.92 101 219938 10288 110358972
Insomnia 79.07 9.92 1079 218960 359511 110009749
Hallucination, visual 78.64 9.92 214 219825 39391 110329869
Incoherent 78.62 9.92 90 219949 8268 110360992
Exposure during pregnancy 76.28 9.92 135 219904 167289 110201971
Aphasia 75.70 9.92 274 219765 58723 110310537
Sciatica 75.56 9.92 45 219994 92354 110276906
Parkinsonism 75.21 9.92 148 219891 22039 110347221
Onychomadesis 74.38 9.92 4 220035 45659 110323601
Hemiparesis 73.39 9.92 223 219816 43680 110325580
Parasomnia 72.88 9.92 34 220005 737 110368523
Substance use disorder 72.83 9.92 81 219958 7209 110362051
Bone erosion 72.71 9.92 5 220034 46366 110322894
Lung disorder 72.64 9.92 156 219883 179891 110189369
Automatism 71.80 9.92 24 220015 203 110369057
Unresponsive to stimuli 71.71 9.92 284 219755 63506 110305754
Emotional distress 71.45 9.92 224 219815 44623 110324637
Anterograde amnesia 71.29 9.92 35 220004 853 110368407
Disorganised speech 70.56 9.92 56 219983 3247 110366013
Hypercholesterolaemia 70.47 9.92 47 219992 90790 110278470
Logorrhoea 69.33 9.92 66 219973 4891 110364369
Dysphoria 68.70 9.92 74 219965 6354 110362906
Cerebrovascular accident 67.18 9.92 602 219437 180682 110188578
Nasopharyngitis 67.01 9.92 484 219555 393877 109975383
Psychomotor retardation 66.79 9.92 80 219959 7712 110361548
Drug interaction 66.32 9.92 1379 218660 498804 109870456
Bradykinesia 66.30 9.92 94 219945 10694 110358566
Exposure via ingestion 64.31 9.92 63 219976 4837 110364423
X-ray abnormal 63.16 9.92 3 220036 38114 110331146
Sedation 61.97 9.92 289 219750 69394 110299866
Panic attack 61.12 9.92 160 219879 28780 110340480
Obesity 60.62 9.92 82 219957 113269 110255991
Adjustment disorder with depressed mood 60.21 9.92 8 220031 43875 110325385
Irritability 59.62 9.92 220 219819 47589 110321671
Hyponatraemia 59.12 9.92 678 219361 216975 110152285
Taste disorder 59.11 9.92 28 220011 65359 110303901
Psychomotor hyperactivity 59.00 9.92 127 219912 20150 110349110
Colitis ulcerative 58.72 9.92 41 219998 77322 110291938
Rhabdomyolysis 58.28 9.92 425 219614 119976 110249284
Head injury 57.08 9.92 202 219837 42815 110326445
Night sweats 56.65 9.92 113 219926 133870 110235390
Reduced facial expression 55.66 9.92 51 219988 3600 110365660
Cognitive disorder 55.16 9.92 330 219709 87181 110282079
Gait inability 55.14 9.92 118 219921 136258 110233002
Immobilisation prolonged 53.98 9.92 18 220021 151 110369109
Frequent bowel movements 53.96 9.92 38 220001 71352 110297908
Euphoric mood 52.91 9.92 76 219963 8751 110360509
Syncope 52.82 9.92 626 219413 201910 110167350
Nail disorder 52.08 9.92 25 220014 57910 110311350
Urinary retention 52.02 9.92 275 219764 69408 110299852
Listless 51.84 9.92 54 219985 4461 110364799
Hypotension 51.57 9.92 1386 218653 522463 109846797
Mania 51.31 9.92 122 219917 20674 110348586
Pruritus 50.92 9.92 832 219207 580728 109788532
Lower limb fracture 50.79 9.92 45 219994 75303 110293957
Finger deformity 50.65 9.92 4 220035 33088 110336172
Gun shot wound 50.43 9.92 30 220009 1082 110368178
Coeliac disease 50.32 9.92 12 220027 43175 110326085
Hip arthroplasty 50.30 9.92 24 220015 55789 110313471
Lupus-like syndrome 50.24 9.92 10 220029 40782 110328478
Psychomotor skills impaired 50.19 9.92 66 219973 6992 110362268
Muscle rigidity 49.87 9.92 132 219907 23899 110345361
Weight increased 49.46 9.92 565 219474 419079 109950181
Sleep talking 49.29 9.92 31 220008 1237 110368023
Alcohol use 48.59 9.92 50 219989 4072 110365188
Self-medication 48.59 9.92 61 219978 6171 110363089
Hypokinesia 48.50 9.92 123 219916 21703 110347557
Neutropenia 48.31 9.92 494 219545 374126 109995134
Dehydration 48.25 9.92 803 219236 278708 110090552
Cystitis 48.20 9.92 259 219780 65777 110303483
Dissociation 48.02 9.92 77 219962 9765 110359495
Pneumonia aspiration 47.84 9.92 301 219738 80932 110288328
Hallucination, auditory 46.89 9.92 137 219902 26260 110343000
Musculoskeletal pain 46.81 9.92 196 219843 182827 110186433
Major depression 46.31 9.92 79 219960 10542 110358718
Prescription form tampering 46.25 9.92 22 220017 499 110368761
Serotonin syndrome 45.92 9.92 236 219803 58917 110310343
Blepharospasm 45.86 9.92 26 220013 54825 110314435
Skin exfoliation 45.68 9.92 315 219724 87336 110281924
Apathy 45.30 9.92 100 219939 16139 110353121
Depressed mood 44.72 9.92 239 219800 60570 110308690
Seizure 44.47 9.92 652 219387 220533 110148727
Suspected suicide 43.99 9.92 95 219944 15104 110354156
Akathisia 43.97 9.92 102 219937 17011 110352249
Therapy non-responder 43.70 9.92 163 219876 157144 110212116
Peripheral circulatory failure 43.56 9.92 33 220006 1786 110367474
Blood pressure systolic increased 43.41 9.92 61 219978 82930 110286330
Substance abuse 42.08 9.92 83 219956 12380 110356880
Sleep disorder due to a general medical condition 41.74 9.92 26 220013 52086 110317174
Tachycardia 41.67 9.92 658 219381 225987 110143273
Drug ineffective for unapproved indication 41.55 9.92 89 219950 102749 110266511
Feeling abnormal 41.31 9.92 545 219494 180166 110189094
Dyspnoea 41.24 9.92 1792 218247 1105080 109264180
Fear 40.84 9.92 120 219919 23073 110346187
Prescribed overdose 40.44 9.92 70 219969 87511 110281749
Hyperhidrosis 40.40 9.92 559 219480 186739 110182521
Legal problem 40.08 9.92 14 220025 137 110369123
Tension 40.06 9.92 50 219989 5028 110364232
Angioedema 40.01 9.92 85 219954 98415 110270845
Cytomegalovirus infection 39.82 9.92 30 220009 54414 110314846
Drug screen positive 39.61 9.92 56 219983 6354 110362906
Dry mouth 39.18 9.92 235 219804 199713 110169547
Electrocardiogram QT prolonged 38.91 9.92 359 219680 108601 110260659
Anaphylactic reaction 38.29 9.92 109 219930 114191 110255069
Blood pressure fluctuation 38.14 9.92 56 219983 74768 110294492
Speech disorder 38.05 9.92 231 219808 61338 110307922
Anger 38.03 9.92 103 219936 18904 110350356
Analgesic drug level above therapeutic 37.72 9.92 19 220020 490 110368770
Thinking abnormal 37.55 9.92 89 219950 15051 110354209
Neuroglycopenia 37.55 9.92 25 220014 1101 110368159
Abnormal dreams 37.13 9.92 80 219959 12700 110356560
Nervousness 36.64 9.92 158 219881 36693 110332567
Erythema 36.47 9.92 387 219652 291060 110078200
Foot deformity 36.39 9.92 26 220013 48454 110320806
Behaviour disorder 35.95 9.92 67 219972 9580 110359680
COVID-19 35.92 9.92 313 219726 244747 110124513
Inappropriate antidiuretic hormone secretion 35.88 9.92 148 219891 33703 110335557
Slow speech 35.64 9.92 39 220000 3409 110365851
Stupor 35.41 9.92 61 219978 8204 110361056
Blood pressure systolic abnormal 35.39 9.92 4 220035 24846 110344414
Dysuria 35.35 9.92 223 219816 60008 110309252
Multiple sclerosis relapse 35.28 9.92 195 219844 50045 110319215
Drug diversion 35.20 9.92 26 220013 1354 110367906
Product substitution issue 34.74 9.92 113 219926 22948 110346312
Cardiomegaly 34.62 9.92 132 219907 28998 110340262
Aspartate aminotransferase increased 34.35 9.92 477 219562 159459 110209801
Onychomycosis 34.07 9.92 17 220022 38514 110330746
Blood cholesterol decreased 33.94 9.92 34 220005 2682 110366578
Cataract 33.13 9.92 271 219768 79214 110290046
Nightmare 32.96 9.92 159 219880 38704 110330556
Hiatus hernia 32.73 9.92 125 219914 27481 110341779
Adverse event 32.72 9.92 109 219930 108700 110260560
Deep vein thrombosis 32.01 9.92 422 219617 139465 110229795
Delusion 31.90 9.92 112 219927 23643 110345617
Dermatitis artefacta 31.44 9.92 10 220029 71 110369189
Brain contusion 31.39 9.92 26 220013 1602 110367658
Vision blurred 31.11 9.92 393 219646 128629 110240631
Victim of sexual abuse 31.05 9.92 17 220022 522 110368738
Bronchiectasis 30.94 9.92 17 220022 36476 110332784
Laryngeal pain 30.88 9.92 48 219991 5927 110363333
Obstructive airways disorder 30.58 9.92 28 220011 46121 110323139
Dementia 30.12 9.92 134 219905 31539 110337721
Lethargy 29.81 9.92 301 219738 93275 110275985
Galactorrhoea 29.77 9.92 39 220000 4116 110365144
Hypokalaemia 29.59 9.92 519 219520 181929 110187331
Premature delivery 29.45 9.92 12 220027 30620 110338640
Chest discomfort 29.45 9.92 498 219541 173350 110195910
Drug tolerance increased 29.43 9.92 17 220022 580 110368680
Femoral neck fracture 29.16 9.92 72 219967 12495 110356765
Inappropriate schedule of product administration 29.00 9.92 262 219777 203375 110165885
Respiratory disorder 28.65 9.92 62 219977 71320 110297940
Liver function test increased 28.53 9.92 86 219953 88462 110280798
Toxic epidermal necrolysis 28.38 9.92 43 219996 56684 110312576
Gastrointestinal disorder 28.38 9.92 326 219713 241626 110127634
Choroidal infarction 28.22 9.92 12 220027 207 110369053
Cholecystitis chronic 28.21 9.92 60 219979 9440 110359820
Antidepressant drug level above therapeutic 28.16 9.92 18 220021 739 110368521
Multiple drug therapy 27.82 9.92 54 219985 7960 110361300
Laryngitis 27.78 9.92 26 220013 42385 110326875
Febrile neutropenia 27.74 9.92 453 219586 316314 110052946
Drug tolerance 27.49 9.92 84 219955 16501 110352759
Loss of personal independence in daily activities 27.48 9.92 180 219859 149840 110219420
Hangover 27.08 9.92 29 220010 2473 110366787
Feeling drunk 26.79 9.92 43 219996 5457 110363803
Blood urea increased 26.59 9.92 194 219845 54763 110314497
Mental impairment 26.42 9.92 102 219937 22537 110346723
Urinary hesitation 26.31 9.92 39 220000 4619 110364641
Blood creatine phosphokinase increased 26.20 9.92 241 219798 72836 110296424
Victim of homicide 26.11 9.92 12 220027 251 110369009
Foreign body 26.08 9.92 31 220008 2964 110366296
Blood pressure diastolic decreased 25.96 9.92 20 220019 35865 110333395
Psychotic disorder 25.91 9.92 182 219857 50755 110318505
Prescribed underdose 25.84 9.92 57 219982 65117 110304143
Haematocrit decreased 25.74 9.92 222 219817 65895 110303365
Normal newborn 25.67 9.92 6 220033 21890 110347370
Imprisonment 25.67 9.92 17 220022 742 110368518
Septic shock 25.45 9.92 196 219843 157332 110211928
Gastric polyps 25.30 9.92 42 219997 5481 110363779
Immunodeficiency 25.22 9.92 24 220015 38814 110330446
Rectal haemorrhage 24.99 9.92 138 219901 119695 110249565
Disinhibition 24.95 9.92 31 220008 3103 110366157
Injection site reaction 24.92 9.92 92 219947 88978 110280282
Exostosis 24.81 9.92 33 220006 45923 110323337
Decreased interest 24.77 9.92 39 220000 4869 110364391
Generalised tonic-clonic seizure 24.75 9.92 190 219849 54490 110314770
Multiple sclerosis 24.65 9.92 109 219930 25589 110343671
Atrial fibrillation 24.41 9.92 614 219425 229028 110140232
Aplastic anaemia 24.24 9.92 9 220030 24299 110344961
Gastrointestinal injury 24.11 9.92 24 220015 1879 110367381
Panic disorder 24.05 9.92 32 220007 3429 110365831
Alcohol interaction 23.91 9.92 33 220006 3661 110365599
Inadequate analgesia 23.79 9.92 39 220000 5038 110364222
Bronchopulmonary aspergillosis 23.77 9.92 15 220024 29848 110339412
Disease progression 23.74 9.92 342 219697 243692 110125568
Rhinorrhoea 23.60 9.92 310 219729 102356 110266904
Confabulation 23.48 9.92 14 220025 507 110368753
Constipation 23.47 9.92 902 219137 356884 110012376
Liver disorder 23.44 9.92 176 219863 142067 110227193
Adverse reaction 23.38 9.92 15 220024 29579 110339681
Cerebral atrophy 23.18 9.92 54 219985 9031 110360229
Ear infection 23.15 9.92 57 219982 62675 110306585
Illusion 23.04 9.92 24 220015 1983 110367277
Hepatic cirrhosis 23.01 9.92 64 219975 67562 110301698
Respiratory depression 23.00 9.92 125 219914 31876 110337384
Encephalomalacia 22.93 9.92 21 220018 1481 110367779
Tardive dyskinesia 22.72 9.92 69 219970 13510 110355750
Anhedonia 22.70 9.92 75 219964 15353 110353907
Sinus tachycardia 22.65 9.92 159 219880 44334 110324926
Persistent genital arousal disorder 22.52 9.92 15 220024 661 110368599
Knee arthroplasty 22.45 9.92 61 219978 64887 110304373
Victim of crime 22.42 9.92 20 220019 1363 110367897
Bipolar disorder 22.39 9.92 53 219986 8954 110360306
Feeling hot 21.81 9.92 100 219939 91006 110278254
Dyspepsia 21.74 9.92 259 219780 190706 110178554
Mucosal inflammation 21.57 9.92 108 219931 96033 110273227
Sudden death 21.55 9.92 101 219938 24294 110344966
Vertigo 21.54 9.92 266 219773 86604 110282656
Alanine aminotransferase increased 21.53 9.92 498 219541 183275 110185985
Incorrect route of product administration 21.52 9.92 61 219978 64000 110305260
Alcohol poisoning 21.27 9.92 52 219987 8968 110360292
Multiple organ dysfunction syndrome 21.24 9.92 196 219843 151514 110217746
Oedema 21.22 9.92 292 219747 209684 110159576
Proctitis 21.16 9.92 4 220035 16923 110352337
Amnestic disorder 21.11 9.92 15 220024 735 110368525
Procalcitonin abnormal 21.11 9.92 12 220027 397 110368863
Poor quality sleep 21.08 9.92 111 219928 27966 110341294
Post transplant lymphoproliferative disorder 21.05 9.92 3 220036 15610 110353650
Bulimia nervosa 20.98 9.92 11 220028 309 110368951
Therapy partial responder 20.64 9.92 26 220013 37035 110332225
Hyperlipidaemia 20.59 9.92 132 219907 35716 110333544
Staring 20.50 9.92 27 220012 2865 110366395
Pathogen resistance 20.41 9.92 5 220034 17667 110351593
Catatonia 20.41 9.92 59 219980 11241 110358019
Restless legs syndrome 20.34 9.92 100 219939 24526 110344734
Prescription drug used without a prescription 20.27 9.92 38 220001 5458 110363802
Abdominal pain upper 20.25 9.92 534 219505 348577 110020683
Accidental overdose 20.15 9.92 174 219865 51660 110317600
Thrombotic microangiopathy 20.14 9.92 17 220022 29132 110340128
Hepatotoxicity 20.12 9.92 62 219977 63338 110305922
PCO2 decreased 20.10 9.92 28 220011 3133 110366127
Cholecystectomy 20.07 9.92 57 219982 10752 110358508
Ulcer haemorrhage 19.89 9.92 10 220029 22561 110346699
Prothrombin time shortened 19.84 9.92 30 220009 3616 110365644
Joint stiffness 19.78 9.92 68 219971 67175 110302085
Generalised anxiety disorder 19.78 9.92 26 220013 2753 110366507
Labelled drug-food interaction issue 19.77 9.92 8 220031 121 110369139
Heart rate decreased 19.71 9.92 91 219948 82665 110286595
Alopecia scarring 19.60 9.92 9 220030 188 110369072
Suicidal behaviour 19.35 9.92 29 220010 3468 110365792
Peptic ulcer 19.12 9.92 45 219994 7574 110361686
Atrioventricular block first degree 19.04 9.92 67 219972 14158 110355102
Dyskinesia 18.61 9.92 170 219869 51276 110317984
Homicidal ideation 18.55 9.92 29 220010 3598 110365662
Self-injurious ideation 18.52 9.92 32 220007 4314 110364946
Asthenia 18.43 9.92 1601 218438 687398 109681862
Back injury 18.34 9.92 42 219997 47357 110321903
Facial nerve disorder 18.31 9.92 14 220025 768 110368492
Libido decreased 18.22 9.92 38 220001 5897 110363363
Asphyxia 18.21 9.92 66 219973 14149 110355111
Blood potassium decreased 18.17 9.92 176 219863 53938 110315322
Performance fear 18.12 9.92 4 220035 4 110369256
Nausea 18.08 9.92 2761 217278 1232929 109136331
Balance disorder 17.98 9.92 329 219710 116231 110253029
Attention deficit hyperactivity disorder 17.76 9.92 32 220007 4459 110364801
Productive cough 17.63 9.92 144 219895 114161 110255099
Hypotonia 17.61 9.92 70 219969 15675 110353585
Oedematous pancreatitis 17.60 9.92 19 220020 1635 110367625
Diplopia 17.54 9.92 143 219896 41751 110327509
High risk sexual behaviour 17.35 9.92 7 220032 105 110369155
Diverticulum 17.34 9.92 69 219970 15457 110353803
Social problem 17.32 9.92 20 220019 1854 110367406
Sudden onset of sleep 17.30 9.92 13 220026 695 110368565
Hypertensive heart disease 17.23 9.92 32 220007 4564 110364696
Diarrhoea 17.22 9.92 1995 218044 1137510 109231750
Hepatitis B DNA increased 17.21 9.92 14 220025 841 110368419
Crime 17.15 9.92 6 220033 59 110369201
Hospitalisation 17.09 9.92 191 219848 142302 110226958
Migraine 16.88 9.92 240 219799 171412 110197848
Pregnancy 16.88 9.92 49 219990 51018 110318242
Device expulsion 16.86 9.92 22 220017 30869 110338391
Myasthenia gravis 16.86 9.92 11 220028 21500 110347760
Decreased activity 16.73 9.92 54 219985 10920 110358340
Haematochezia 16.72 9.92 148 219891 115376 110253884
Tachyphrenia 16.70 9.92 22 220017 2334 110366926
Nephropathy toxic 16.68 9.92 18 220021 27460 110341800
Hypoaesthesia 16.59 9.92 487 219552 313736 110055524
Loss of proprioception 16.39 9.92 14 220025 900 110368360
Mood altered 16.39 9.92 85 219954 21290 110347970
Carotid artery stenosis 16.38 9.92 48 219991 9215 110360045
Encephalopathy 16.30 9.92 239 219800 80816 110288444
Adverse drug reaction 16.28 9.92 133 219906 105426 110263834
Depressive symptom 16.24 9.92 45 219994 8369 110360891
Milk-alkali syndrome 16.23 9.92 20 220019 1985 110367275
Road traffic accident 16.17 9.92 302 219737 107096 110262164
Neurogenic bladder 16.16 9.92 33 220006 5046 110364214
Temperature regulation disorder 16.10 9.92 3 220036 12823 110356437
Labelled drug-food interaction medication error 16.04 9.92 8 220031 202 110369058
International normalised ratio increased 15.96 9.92 252 219787 86520 110282740
PO2 decreased 15.87 9.92 25 220014 3123 110366137
Neurotoxicity 15.85 9.92 38 220001 42169 110327091
Accidental poisoning 15.77 9.92 22 220017 2465 110366795
Bipolar I disorder 15.70 9.92 21 220018 2262 110366998
Mood swings 15.66 9.92 88 219951 22724 110346536
Coagulation factor VII level decreased 15.65 9.92 8 220031 213 110369047
Hepatitis C virus test positive 15.64 9.92 10 220029 411 110368849
Drug-induced liver injury 15.59 9.92 158 219881 119909 110249351
Pain 15.58 9.92 1663 218376 953292 109415968
Skin necrosis 15.54 9.92 12 220027 21500 110347760
Perseveration 15.51 9.92 10 220029 417 110368843
Pulmonary congestion 15.38 9.92 110 219929 30856 110338404
Platelet count decreased 15.35 9.92 582 219457 229861 110139399
Sleep apnoea syndrome 15.32 9.92 135 219904 40312 110328948
Substance-induced mood disorder 15.32 9.92 6 220033 83 110369177
Gait apraxia 15.20 9.92 5 220034 40 110369220
Joint dislocation 15.18 9.92 28 220011 34162 110335098
Skin abrasion 15.11 9.92 68 219971 16083 110353177
Pyrexia 15.09 9.92 1561 218478 896704 109472556
Blood alcohol increased 15.00 9.92 14 220025 1012 110368248
Hypoglycaemia 14.98 9.92 319 219720 115785 110253475
Full blood count abnormal 14.97 9.92 59 219980 55993 110313267
Blood test abnormal 14.92 9.92 21 220018 28533 110340727
Blood testosterone decreased 14.89 9.92 23 220016 2825 110366435
Head discomfort 14.88 9.92 76 219963 18924 110350336
Respiratory tract infection bacterial 14.77 9.92 21 220018 2395 110366865
Product complaint 14.74 9.92 61 219978 13911 110355349
Pupil fixed 14.74 9.92 27 220012 3811 110365449
Enuresis 14.71 9.92 28 220011 4068 110365192
Intervertebral disc degeneration 14.63 9.92 73 219966 18012 110351248
Chronic sinusitis 14.60 9.92 17 220022 25067 110344193
Swollen tongue 14.60 9.92 66 219973 60296 110308964
Blood parathyroid hormone decreased 14.55 9.92 4 220035 13085 110356175
Ulcer 14.52 9.92 41 219998 43075 110326185
Cerebellar syndrome 14.51 9.92 36 220003 6266 110362994
Paranoia 14.50 9.92 85 219954 22289 110346971
Affective disorder 14.24 9.92 52 219987 11189 110358071
Nodule 14.24 9.92 27 220012 32604 110336656
Vascular dementia 14.21 9.92 13 220026 916 110368344
SARS-CoV-2 test positive 14.19 9.92 8 220031 16927 110352333
Respiratory symptom 14.13 9.92 6 220033 14939 110354321
Physical abuse 14.13 9.92 5 220034 51 110369209
Epstein-Barr virus infection 14.13 9.92 10 220029 18728 110350532
Apallic syndrome 14.11 9.92 14 220025 1092 110368168
Dizziness 14.09 9.92 1591 218448 696602 109672658
Product administration error 13.98 9.92 124 219915 37093 110332167
Increased appetite 13.97 9.92 63 219976 14914 110354346
Cytopenia 13.97 9.92 24 220015 30092 110339168
Mouth ulceration 13.94 9.92 49 219990 48089 110321171
Infusion site reaction 13.91 9.92 9 220030 17673 110351587
Haemophagocytic lymphohistiocytosis 13.87 9.92 26 220013 31533 110337727
Posturing 13.83 9.92 14 220025 1118 110368142
Drug reaction with eosinophilia and systemic symptoms 13.80 9.92 101 219938 81994 110287266
Injection site pain 13.78 9.92 260 219779 177662 110191598
Injury 13.74 9.92 259 219780 177006 110192254
Immobile 13.70 9.92 40 219999 7662 110361598
Nervous system disorder 13.68 9.92 109 219930 31612 110337648
Stress cardiomyopathy 13.64 9.92 65 219974 15741 110353519
Hepatitis 13.64 9.92 114 219925 89940 110279320
Haematoma 13.62 9.92 177 219862 58299 110310961
Female genital tract fistula 13.57 9.92 8 220031 16511 110352749
Colitis 13.55 9.92 134 219905 102189 110267071
Brachial artery entrapment syndrome 13.48 9.92 5 220034 59 110369201
Hyporesponsive to stimuli 13.44 9.92 22 220017 2838 110366422
Transient ischaemic attack 13.40 9.92 190 219849 63792 110305468
Pain in extremity 13.38 9.92 813 219226 486305 109882955
Hypertension 13.38 9.92 855 219184 509229 109860031
Product commingling 13.35 9.92 6 220033 119 110369141
Food allergy 13.34 9.92 12 220027 19936 110349324
Therapeutic response shortened 13.33 9.92 24 220015 29559 110339701
Atelectasis 13.12 9.92 121 219918 36591 110332669
Anorexia nervosa 13.09 9.92 8 220031 303 110368957
Cytokine release syndrome 13.05 9.92 84 219955 70222 110299038
Blood sodium decreased 13.05 9.92 125 219914 38194 110331066
Leukopenia 12.94 9.92 213 219826 148578 110220682
Ventricular hypertrophy 12.93 9.92 37 220002 7008 110362252
Drug effective for unapproved indication 12.91 9.92 6 220033 14161 110355099
Crohn's disease 12.88 9.92 18 220021 2020 110367240
Drug resistance 12.83 9.92 63 219976 56311 110312949
Tangentiality 12.81 9.92 7 220032 214 110369046
Sudden cardiac death 12.77 9.92 32 220007 5605 110363655
Tubulointerstitial nephritis 12.74 9.92 60 219979 54224 110315036
Diabetic ketoacidosis 12.73 9.92 42 219997 42016 110327244
Blood creatine increased 12.71 9.92 51 219988 11470 110357790
Circadian rhythm sleep disorder 12.63 9.92 13 220026 1059 110368201
Walking aid user 12.55 9.92 19 220020 25056 110344204
Dental fistula 12.54 9.92 10 220029 584 110368676
Vertigo CNS origin 12.50 9.92 4 220035 29 110369231
Bezoar 12.50 9.92 26 220013 4028 110365232
Concomitant disease aggravated 12.50 9.92 65 219974 16299 110352961
Clonus 12.49 9.92 42 219997 8674 110360586
Creatinine renal clearance decreased 12.47 9.92 15 220024 21800 110347460
Acute graft versus host disease 12.46 9.92 5 220034 12876 110356384
Sleep paralysis 12.42 9.92 12 220027 906 110368354
Persistent depressive disorder 12.39 9.92 15 220024 1462 110367798
Skin ulcer 12.35 9.92 75 219964 63570 110305690
Joint effusion 12.35 9.92 14 220025 20891 110348369
Cytomegalovirus infection reactivation 12.29 9.92 11 220028 18322 110350938
Product confusion 12.27 9.92 7 220032 233 110369027
Alcohol abuse 12.25 9.92 29 220010 4900 110364360
Peripheral ischaemia 12.24 9.92 49 219990 11009 110358251
Swelling face 12.19 9.92 121 219918 92200 110277060
Patient elopement 12.19 9.92 8 220031 344 110368916
Urinary incontinence 12.14 9.92 149 219890 48438 110320822
Refusal of treatment by relative 12.07 9.92 11 220028 771 110368489
Diverticular fistula 12.07 9.92 3 220036 7 110369253
Micturition disorder 12.07 9.92 28 220011 4670 110364590
Spinal osteoarthritis 12.01 9.92 75 219964 20108 110349152
Coronary artery disease 12.00 9.92 205 219834 71485 110297775
Polyarthritis 11.99 9.92 12 220027 18951 110350309
Coagulation factor VIII level increased 11.85 9.92 4 220035 35 110369225
Snoring 11.85 9.92 35 220004 6749 110362511
Nystagmus 11.79 9.92 50 219989 11527 110357733
Hyperkinesia 11.72 9.92 22 220017 3162 110366098
Therapeutic response decreased 11.71 9.92 129 219910 96370 110272890
Ventricular extrasystoles 11.58 9.92 81 219958 22560 110346700
Rectocele repair 11.52 9.92 3 220036 9 110369251
Haematotoxicity 11.52 9.92 15 220024 21067 110348193
Bedridden 11.44 9.92 55 219984 13370 110355890
Coagulation factor V level decreased 11.32 9.92 10 220029 673 110368587
Neurological examination normal 11.29 9.92 4 220035 41 110369219
Refusal of treatment by patient 11.26 9.92 43 219996 9451 110359809
Macular degeneration 11.24 9.92 16 220023 21643 110347617
Weight decreased 11.19 9.92 791 219248 467266 109901994
Gastritis 11.06 9.92 159 219880 53540 110315720
Pancreatic haemorrhage 11.04 9.92 5 220034 101 110369159
Eustachian tube disorder 11.00 9.92 5 220034 102 110369158
Withdrawal catatonia 10.96 9.92 8 220031 409 110368851
Poor venous access 10.96 9.92 20 220019 24502 110344758
No adverse event 10.95 9.92 94 219945 73745 110295515
Hypoosmolar state 10.93 9.92 8 220031 411 110368849
Tearfulness 10.93 9.92 36 220003 7359 110361901
Tobacco abuse 10.92 9.92 12 220027 1054 110368206
Hyporeflexia 10.91 9.92 25 220014 4135 110365125
Waxy flexibility 10.83 9.92 7 220032 293 110368967
Executive dysfunction 10.82 9.92 8 220031 417 110368843
Posterior reversible encephalopathy syndrome 10.82 9.92 33 220006 33828 110335432
Prothrombin time prolonged 10.81 9.92 65 219974 17196 110352064
Anxiety disorder 10.78 9.92 28 220011 5012 110364248
Aortic valve calcification 10.78 9.92 11 220028 887 110368373
Thirst 10.71 9.92 77 219962 21630 110347630
Grandiosity 10.65 9.92 9 220030 570 110368690
Tenosynovitis 10.64 9.92 10 220029 16273 110352987
Ataxia 10.64 9.92 99 219940 30009 110339251
Drug-disease interaction 10.64 9.92 16 220023 1920 110367340
Sputum discoloured 10.62 9.92 25 220014 27920 110341340
Hepatic cytolysis 10.62 9.92 65 219974 54988 110314272
Duplicate therapy error 10.59 9.92 8 220031 431 110368829
Paraesthesia 10.58 9.92 446 219593 276075 110093185
Feelings of worthlessness 10.51 9.92 9 220030 581 110368679
Dyssomnia 10.50 9.92 4 220035 51 110369209
Crying 10.47 9.92 87 219952 25541 110343719
Abulia 10.47 9.92 13 220026 1300 110367960
Pupillary reflex impaired 10.39 9.92 24 220015 3991 110365269
Dermatitis allergic 10.36 9.92 17 220022 21707 110347553
Toxic optic neuropathy 10.36 9.92 13 220026 1315 110367945
Rales 10.34 9.92 21 220018 24718 110344542
Coeliac artery compression syndrome 10.33 9.92 5 220034 118 110369142
Marital problem 10.33 9.92 6 220033 207 110369053
Contusion 10.32 9.92 370 219669 232991 110136269
Foetal death 10.32 9.92 10 220029 16035 110353225
Tic 10.30 9.92 22 220017 3471 110365789
Epilepsy 10.25 9.92 139 219900 100070 110269190
Extrapyramidal disorder 10.24 9.92 95 219944 28772 110340488
Hypoacusis 10.17 9.92 111 219928 35080 110334180
Bacterial infection 10.16 9.92 52 219987 45984 110323276
Feeling of despair 10.16 9.92 23 220016 3775 110365485
Transplant rejection 10.14 9.92 21 220018 24546 110344714
Memory impairment 10.09 9.92 484 219555 196460 110172800
Malocclusion 10.07 9.92 6 220033 217 110369043
Basal cell carcinoma 10.07 9.92 51 219988 45219 110324041
End stage renal disease 10.06 9.92 17 220022 21456 110347804
Personality change 10.05 9.92 46 219993 10956 110358304
Dopamine dysregulation syndrome 10.03 9.92 9 220030 618 110368642
Rectocele 10.00 9.92 10 220029 787 110368473
Paraesthesia oral 9.94 9.92 34 220005 33637 110335623
Product dose omission issue 9.93 9.92 531 219508 321251 110048009

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC N05CF02 NERVOUS SYSTEM
PSYCHOLEPTICS
HYPNOTICS AND SEDATIVES
Benzodiazepine related drugs
FDA MoA N0000000196 GABA A Agonists
FDA Chemical/Ingredient N0000007570 Pyridines
MeSH PA D000068776 Sleep Aids, Pharmaceutical
MeSH PA D002492 Central Nervous System Depressants
MeSH PA D006993 Hypnotics and Sedatives
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D018682 GABA Agents
MeSH PA D058785 GABA-A Receptor Agonists
FDA PE N0000175728 Central Nervous System Depression
FDA EPC N0000175759 gamma-Aminobutyric Acid-ergic Agonist
CHEBI has role CHEBI:35469 antidepressant
CHEBI has role CHEBI:35474 anxiolytic drug
CHEBI has role CHEBI:35476 antipsychotic agent
CHEBI has role CHEBI:35480 analgesic
CHEBI has role CHEBI:35488 central nervous system depressant
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:35717 sedative
CHEBI has role CHEBI:48407 antiparkinson drug
CHEBI has role CHEBI:51373 GABA agonist
CHEBI has role CHEBI:74518 anti-obesity agent
FDA MoA N0000193997 GABA A Receptor Positive Modulators
FDA EPC N0000194083 gamma-Aminobutyric Acid A Receptor Positive Modulator

Related Drugs by ATC class:

N05CF Benzodiazepine related drugs 3 drugs
eszopiclonezaleplonzopiclone

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
10MG EDLUAR VIATRIS N021997 March 13, 2009 RX TABLET SUBLINGUAL 9597281 April 6, 2027 METHOD OF TREATING INSOMNIA CHARACTERIZED BY DIFFICULTY WITH SLEEP ONSET
5MG EDLUAR VIATRIS 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 VIATRIS N021997 March 13, 2009 RX TABLET SUBLINGUAL 9265720 Feb. 25, 2031 METHOD OF TREATING INSOMNIA CHARACTERIZED BY DIFFICULTY WITH SLEEP ONSET
5MG EDLUAR VIATRIS 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
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
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 0024-5421 TABLET, FILM COATED 10 mg ORAL NDA 34 sections
AmbienCR HUMAN PRESCRIPTION DRUG LABEL 1 0024-5501 TABLET, COATED 6.25 mg ORAL NDA 34 sections
AmbienCR 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
Ambien HUMAN PRESCRIPTION DRUG LABEL 1 0713-5401 TABLET, FILM COATED 5 mg ORAL NDA 34 sections
Ambien HUMAN PRESCRIPTION DRUG LABEL 1 0713-5421 TABLET, FILM COATED 10 mg ORAL NDA 34 sections
Ambien CR HUMAN PRESCRIPTION DRUG LABEL 1 0713-5501 TABLET, COATED 6.25 mg ORAL NDA 34 sections
Ambien CR HUMAN PRESCRIPTION DRUG LABEL 1 0713-5521 TABLET, COATED 12.50 mg ORAL NDA 34 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 0781-5317 TABLET, COATED 5 mg ORAL ANDA 30 sections
Zolpidem Tartrate HUMAN PRESCRIPTION DRUG LABEL 1 0781-5318 TABLET, COATED 10 mg ORAL ANDA 30 sections
ZOLPIDEM TARTRATE HUMAN PRESCRIPTION DRUG LABEL 1 0904-6082 TABLET 5 mg ORAL ANDA 31 sections
ZOLPIDEM TARTRATE HUMAN PRESCRIPTION DRUG LABEL 1 0904-6083 TABLET 10 mg ORAL ANDA 31 sections
ZOLPIDEM TARTRATE HUMAN PRESCRIPTION DRUG LABEL 1 10544-040 TABLET 10 mg ORAL ANDA 31 sections
Zolpidem Tartrate HUMAN PRESCRIPTION DRUG LABEL 1 10544-539 TABLET, FILM COATED 10 mg ORAL ANDA 31 sections
Zolpidem Tartrate HUMAN PRESCRIPTION DRUG LABEL 1 10544-540 TABLET, FILM COATED 5 mg ORAL ANDA 31 sections
Zolpidem Tartrate HUMAN PRESCRIPTION DRUG LABEL 1 10544-548 TABLET, FILM COATED 10 mg ORAL ANDA 31 sections
ZOLPIDEM TARTRATE HUMAN PRESCRIPTION DRUG LABEL 1 12634-943 TABLET 5 mg ORAL ANDA 14 sections
ZOLPIDEM TARTRATE HUMAN PRESCRIPTION DRUG LABEL 1 12634-944 TABLET 10 mg ORAL ANDA 14 sections
ZOLPIDEM TARTRATE HUMAN PRESCRIPTION DRUG LABEL 1 13668-007 TABLET 5 mg ORAL ANDA 31 sections
ZOLPIDEM TARTRATE HUMAN PRESCRIPTION DRUG LABEL 1 13668-008 TABLET 10 mg ORAL ANDA 31 sections
Zolpidem Tartrate HUMAN PRESCRIPTION DRUG LABEL 1 13668-775 CAPSULE 7.50 mg ORAL ANDA 20 sections
AMBIEN HUMAN PRESCRIPTION DRUG LABEL 1 16590-009 TABLET, FILM COATED 5 mg ORAL NDA 34 sections
AMBIEN HUMAN PRESCRIPTION DRUG LABEL 1 16590-010 TABLET, FILM COATED 10 mg ORAL NDA 34 sections
AMBIEN CR HUMAN PRESCRIPTION DRUG LABEL 1 16590-436 TABLET, COATED 12.50 mg ORAL NDA 34 sections