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

Stem definitionDrug idCAS RN
hypnotic tranquillizers 2873 43200-80-2

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • zopiclone
  • zimovane
  • imovane
S(+)-enantiomer of racemic zopiclone; azabicyclo(4.3.0)nonane; a nonbenzodiazepine; one of the so-called of Z drugs (zopiclone, eszopiclone, zolpidem, and zaleplon) for which there is some correlation with tumors; was term of zopiclone 2004-2007
  • Molecular weight: 388.81
  • Formula: C17H17ClN6O3
  • CLOGP: 1.25
  • LIPINSKI: 0
  • HAC: 9
  • HDO: 0
  • TPSA: 91.76
  • ALOGS: -2.64
  • ROTB: 3

Drug dosage:

DoseUnitRoute
7.50 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.12 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 4.50 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.28 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
Vd (Volume of distribution) 1.30 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 3.30 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.20 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 5.20 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Dec. 15, 2004 FDA SUNOVION PHARMS INC

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
Lower respiratory tract infection 697.39 11.26 828 84012 94373 50425911
Intentional overdose 650.15 11.26 654 84186 61850 50458434
Coma 572.95 11.26 585 84255 56294 50463990
Intentional self-injury 561.62 11.26 395 84445 22717 50497567
Muscle spasticity 458.18 11.26 311 84529 16873 50503411
Folliculitis 414.17 11.26 414 84426 38811 50481473
Muscle injury 412.83 11.26 403 84437 36708 50483576
Ear pain 379.69 11.26 341 84499 27942 50492342
Body temperature increased 378.22 11.26 356 84484 30985 50489299
Ill-defined disorder 353.79 11.26 447 84393 54207 50466077
Irritable bowel syndrome 346.18 11.26 429 84411 51012 50469272
Respiratory disorder 323.37 11.26 326 84514 30861 50489423
Sinusitis 310.57 11.26 800 84040 169758 50350526
Night sweats 284.15 11.26 315 84525 33259 50487025
Pneumonia aspiration 278.23 11.26 300 84540 30704 50489580
Poisoning deliberate 269.40 11.26 167 84673 7745 50512539
Impaired healing 245.98 11.26 429 84411 69357 50450927
Peripheral swelling 241.16 11.26 826 84014 205110 50315174
Gastrointestinal disorder 240.89 11.26 506 84334 93950 50426334
Blister 240.81 11.26 477 84363 84941 50435343
Confusional state 234.75 11.26 765 84075 185163 50335121
Somnolence 226.43 11.26 671 84169 154314 50365970
Stomatitis 185.86 11.26 477 84363 100867 50419417
Pruritus 183.03 11.26 948 83892 282620 50237664
Product dose omission issue 177.03 11.26 45 84795 183793 50336491
Sleep disorder due to general medical condition, insomnia type 160.24 11.26 229 84611 31218 50489066
Insomnia 158.29 11.26 646 84194 174219 50346065
Joint swelling 147.87 11.26 805 84035 244481 50275803
Nasopharyngitis 145.77 11.26 675 84165 192252 50328032
Schizoaffective disorder 139.57 11.26 70 84770 2136 50518148
Urticaria 130.39 11.26 495 84345 129066 50391218
Death 118.33 11.26 229 84611 325150 50195134
Electric shock 116.76 11.26 49 84791 979 50519305
Electrocardiogram QT prolonged 112.94 11.26 261 84579 51625 50468659
Toxicity to various agents 111.30 11.26 672 84168 211827 50308457
Sleep disorder 110.54 11.26 275 84565 57008 50463276
Weight increased 105.43 11.26 638 84202 201253 50319031
Akathisia 102.14 11.26 95 84745 8134 50512150
Cardiac failure congestive 99.96 11.26 12 84828 84370 50435914
Therapeutic product effect decreased 95.36 11.26 466 84374 135584 50384700
Drug hypersensitivity 78.47 11.26 192 84648 250818 50269466
Prescription form tampering 77.93 11.26 31 84809 537 50519747
Depressed level of consciousness 76.70 11.26 226 84614 51727 50468557
Suicide attempt 76.34 11.26 225 84615 51507 50468777
Infection 74.00 11.26 520 84320 172434 50347850
Intervertebral discitis 70.59 11.26 48 84792 2608 50517676
Drug dependence 68.92 11.26 121 84719 19638 50500646
Antipsychotic drug level increased 68.27 11.26 50 84790 3059 50517225
Post-traumatic stress disorder 68.05 11.26 57 84783 4246 50516038
Neovascularisation 66.61 11.26 33 84807 980 50519304
Injection site pain 62.97 11.26 56 84784 110968 50409316
Hepatocellular injury 60.31 11.26 134 84706 25813 50494471
Miosis 60.01 11.26 63 84777 6247 50514037
Drug level increased 55.90 11.26 109 84731 19159 50501125
Abdominal pain upper 55.22 11.26 456 84384 158853 50361431
Back pain 52.54 11.26 582 84258 219448 50300836
Drug ineffective 52.29 11.26 1015 83825 818318 49701966
Sepsis 51.35 11.26 90 84750 132835 50387449
Lupus vasculitis 51.28 11.26 22 84818 465 50519819
Somnambulism 50.14 11.26 51 84789 4873 50515411
Fluid retention 49.46 11.26 12 84828 50637 50469647
Mydriasis 49.21 11.26 74 84766 10553 50509731
Gastrooesophageal reflux disease 48.03 11.26 254 84586 76174 50444110
Skin candida 47.71 11.26 29 84811 1297 50518987
Respiratory failure 47.05 11.26 50 84790 91131 50429153
Bronchial wall thickening 46.57 11.26 25 84815 880 50519404
Broncholithiasis 45.45 11.26 15 84825 147 50520137
Demyelination 43.31 11.26 52 84788 5974 50514310
Maternal exposure during pregnancy 43.28 11.26 131 84709 159647 50360637
Exposure during pregnancy 43.15 11.26 86 84754 120929 50399355
Pneumonia 43.13 11.26 416 84424 377985 50142299
Sputum discoloured 42.85 11.26 79 84761 13316 50506968
Sinus rhythm 42.53 11.26 21 84819 619 50519665
Myocardial infarction 40.41 11.26 54 84786 88973 50431311
Obstructive airways disorder 40.00 11.26 84 84756 15568 50504716
Injection site erythema 39.90 11.26 40 84800 74896 50445388
Contusion 39.86 11.26 323 84517 111860 50408424
Lymph node calcification 39.80 11.26 15 84825 223 50520061
Cerebrovascular accident 39.45 11.26 61 84779 94619 50425665
Rash 39.29 11.26 985 83855 436486 50083798
Abortion spontaneous 38.69 11.26 11 84829 41761 50478523
Alopecia 38.32 11.26 247 84593 244800 50275484
Injection site reaction 38.20 11.26 18 84822 50014 50470270
Wrong technique in product usage process 37.94 11.26 23 84817 55487 50464797
Unevaluable event 37.67 11.26 15 84825 46051 50474233
White blood cell count decreased 37.43 11.26 88 84752 116634 50403650
Swelling 37.36 11.26 507 84333 200365 50319919
Temperature intolerance 37.07 11.26 54 84786 7485 50512799
Pain in extremity 35.44 11.26 290 84550 272575 50247709
Cholestasis 35.12 11.26 108 84732 25293 50494991
Excessive eye blinking 34.84 11.26 21 84819 925 50519359
Calcium deficiency 34.76 11.26 21 84819 929 50519355
Platelet count decreased 34.70 11.26 73 84767 100653 50419631
Asphyxia 34.45 11.26 44 84796 5383 50514901
Product quality issue 32.82 11.26 6 84834 30852 50489432
Hyponatraemia 32.64 11.26 274 84566 95865 50424419
Depressed mood 32.53 11.26 128 84712 33895 50486389
Injection site bruising 31.70 11.26 11 84829 36757 50483527
Post-traumatic neck syndrome 31.66 11.26 26 84814 1884 50518400
Hospitalisation 31.04 11.26 41 84799 67896 50452388
Rheumatoid factor positive 30.93 11.26 23 84817 49836 50470448
Pyrexia 30.89 11.26 845 83995 379358 50140926
Postmortem blood drug level abnormal 30.70 11.26 14 84826 344 50519940
Pulmonary hypertension 30.58 11.26 9 84831 33408 50486876
C-reactive protein abnormal 30.47 11.26 5 84835 27804 50492480
Paradoxical drug reaction 30.45 11.26 34 84806 3613 50516671
Helicobacter infection 30.41 11.26 164 84676 49538 50470746
Injection site pruritus 30.15 11.26 15 84825 40396 50479888
Therapy cessation 30.06 11.26 4 84836 26007 50494277
Condition aggravated 29.95 11.26 336 84504 296722 50223562
Progressive multifocal leukoencephalopathy 29.87 11.26 62 84778 11395 50508889
Blood glucose increased 29.66 11.26 46 84794 71278 50449006
Libido increased 29.60 11.26 21 84819 1222 50519062
Mobility decreased 29.20 11.26 56 84784 79892 50440392
Nausea 29.03 11.26 932 83908 704466 49815818
No adverse event 29.03 11.26 10 84830 33568 50486716
Atrial fibrillation 28.56 11.26 82 84758 101663 50418621
Soft tissue injury 28.44 11.26 22 84818 1462 50518822
COVID-19 28.34 11.26 22 84818 46640 50473644
Concussion 28.28 11.26 48 84792 7580 50512704
Treatment failure 27.98 11.26 127 84713 137510 50382774
Chronic kidney disease 27.86 11.26 16 84824 39755 50480529
Completed suicide 27.83 11.26 120 84720 131769 50388515
Vocal cord dysfunction 27.38 11.26 13 84827 351 50519933
Coronary artery disease 27.21 11.26 8 84832 29718 50490566
Disease progression 27.10 11.26 77 84763 95789 50424495
Hostility 26.93 11.26 23 84817 1759 50518525
Duodenal ulcer perforation 26.89 11.26 149 84691 45462 50474822
Liver function test abnormal 26.81 11.26 21 84819 44318 50475966
Gallbladder adenocarcinoma 26.76 11.26 9 84831 94 50520190
Altered state of consciousness 26.51 11.26 89 84751 21821 50498463
Thrombosis 26.22 11.26 33 84807 55800 50464484
Urine leukocyte esterase positive 26.02 11.26 28 84812 2855 50517429
Abdominal discomfort 25.77 11.26 256 84584 231385 50288899
Blood creatinine increased 25.56 11.26 56 84784 76104 50444180
Urine abnormality 25.48 11.26 41 84799 6197 50514087
Overdose 25.23 11.26 267 84573 99460 50420824
Diabetes mellitus 25.16 11.26 27 84813 49006 50471278
Lupus nephritis 25.09 11.26 25 84815 2330 50517954
Coordination abnormal 25.06 11.26 58 84782 11476 50508808
Diaphragmatic rupture 24.99 11.26 11 84829 248 50520036
Hypervolaemia 24.98 11.26 6 84834 25493 50494791
Oedema 24.90 11.26 50 84790 70131 50450153
Behaviour disorder 24.87 11.26 25 84815 2355 50517929
Neutropenia 24.73 11.26 146 84694 147819 50372465
Renal failure 24.39 11.26 94 84746 106539 50413745
Distal intestinal obstruction syndrome 24.33 11.26 12 84828 353 50519931
Postmortem blood drug level increased 24.27 11.26 14 84826 568 50519716
Drug intolerance 24.01 11.26 243 84597 218861 50301423
Adrenal insufficiency 23.98 11.26 65 84775 14178 50506106
Antidepressant drug level above therapeutic 23.78 11.26 12 84828 371 50519913
Injection site swelling 23.75 11.26 21 84819 41752 50478532
Feeling abnormal 23.63 11.26 119 84721 125373 50394911
Gait disturbance 23.52 11.26 151 84689 149854 50370430
Dyspnoea exertional 23.32 11.26 31 84809 51202 50469082
Extrapyramidal disorder 23.21 11.26 57 84783 11713 50508571
Red blood cells urine 23.17 11.26 13 84827 500 50519784
White blood cells urine positive 22.81 11.26 33 84807 4545 50515739
Suicidal ideation 22.75 11.26 165 84675 55220 50465064
Hypocoagulable state 22.72 11.26 16 84824 920 50519364
Blood creatine increased 22.58 11.26 34 84806 4853 50515431
Hypothermia 22.44 11.26 57 84783 11959 50508325
Hypertension 22.42 11.26 236 84604 210967 50309317
Neoplasm malignant 22.42 11.26 6 84834 23709 50496575
Full blood count decreased 22.40 11.26 5 84835 22341 50497943
Cellulitis 22.19 11.26 54 84786 70744 50449540
Deep vein thrombosis 22.13 11.26 57 84783 73247 50447037
Psoriatic arthropathy 21.88 11.26 28 84812 47004 50473280
Balance disorder 21.77 11.26 197 84643 70393 50449891
Malignant polyp 21.58 11.26 9 84831 177 50520107
Hypersensitivity 21.53 11.26 492 84348 214669 50305615
Negative thoughts 21.48 11.26 15 84825 851 50519433
Renal impairment 21.21 11.26 61 84779 75600 50444684
Monocyte percentage increased 21.20 11.26 16 84824 1025 50519259
Haematocrit increased 21.11 11.26 21 84819 1953 50518331
Burnout syndrome 21.08 11.26 9 84831 188 50520096
Nightmare 20.95 11.26 67 84773 16019 50504265
Sternal fracture 20.87 11.26 21 84819 1981 50518303
Sopor 20.85 11.26 4 84836 19875 50500409
Toxicologic test abnormal 20.82 11.26 13 84827 610 50519674
Drug level above therapeutic 20.63 11.26 29 84811 3891 50516393
Disturbance in attention 20.51 11.26 105 84735 31081 50489203
Adverse event 20.41 11.26 26 84814 43737 50476547
Knee arthroplasty 20.41 11.26 18 84822 35828 50484456
Chest pain 20.29 11.26 194 84646 176688 50343596
Hallucination, synaesthetic 20.20 11.26 6 84834 40 50520244
Staphylococcal infection 20.14 11.26 18 84822 35598 50484686
Antipsychotic drug level above therapeutic 20.11 11.26 15 84825 944 50519340
Hypersensitivity vasculitis 20.09 11.26 29 84811 3986 50516298
Urinary tract infection 20.03 11.26 260 84580 223760 50296524
Carcinoid tumour pulmonary 19.87 11.26 11 84829 412 50519872
Incorrect route of product administration 19.30 11.26 72 84768 18594 50501690
Loss of personal independence in daily activities 19.26 11.26 57 84783 69993 50450291
Poor feeding infant 19.23 11.26 9 84831 235 50520049
Wrong rate 19.04 11.26 6 84834 50 50520234
Lactic acidosis 19.02 11.26 108 84732 33247 50487037
Contraindicated product administered 18.96 11.26 353 84487 148605 50371679
Eye irritation 18.96 11.26 3 84837 17137 50503147
Seizure 18.81 11.26 118 84722 117756 50402528
Pain 18.71 11.26 1166 83674 577737 49942547
Neutropenic sepsis 18.49 11.26 59 84781 14088 50506196
Middle insomnia 18.46 11.26 47 84793 9874 50510410
Inappropriate antidiuretic hormone secretion 18.28 11.26 56 84784 13087 50507197
Ligament pain 18.11 11.26 8 84832 182 50520102
Haemoglobin urine 18.05 11.26 7 84833 113 50520171
Cytomegalovirus infection 18.04 11.26 4 84836 17958 50502326
Laryngeal stenosis 17.91 11.26 13 84827 784 50519500
Bronchiolitis 17.86 11.26 21 84819 2360 50517924
Gait deviation 17.81 11.26 6 84834 63 50520221
Procedural anxiety 17.71 11.26 12 84828 648 50519636
Tooth hypoplasia 17.64 11.26 6 84834 65 50520219
Bulimia nervosa 17.53 11.26 10 84830 397 50519887
Myocarditis septic 17.28 11.26 5 84835 30 50520254
Myelocyte percentage increased 17.20 11.26 8 84832 206 50520078
Peripheral circulatory failure 16.98 11.26 11 84829 551 50519733
Band neutrophil percentage increased 16.95 11.26 8 84832 213 50520071
Product monitoring error 16.90 11.26 22 84818 2742 50517542
Housebound 16.78 11.26 8 84832 218 50520066
Adverse drug reaction 16.62 11.26 43 84797 55179 50465105
Presyncope 16.57 11.26 10 84830 24188 50496096
Newborn persistent pulmonary hypertension 16.54 11.26 7 84833 143 50520141
Cardiac arrest 16.51 11.26 78 84762 83573 50436711
Drug detoxification 16.49 11.26 7 84833 144 50520140
Granulomatous liver disease 16.43 11.26 12 84828 731 50519553
Urine oxalate increased 16.42 11.26 8 84832 229 50520055
Crystal urine present 16.36 11.26 16 84824 1458 50518826
Plasma cell myeloma 16.35 11.26 17 84823 31305 50488979
Granulocyte count increased 16.30 11.26 10 84830 455 50519829
Gallbladder disorder 16.28 11.26 4 84836 16738 50503546
Proctitis 16.14 11.26 18 84822 1910 50518374
Antibody test abnormal 16.10 11.26 10 84830 465 50519819
Vaginal flatulence 15.95 11.26 8 84832 244 50520040
Mixed liver injury 15.93 11.26 24 84816 3427 50516857
Urinary tract obstruction 15.82 11.26 17 84823 1731 50518553
Accommodation disorder 15.81 11.26 9 84831 356 50519928
Diabetic hyperosmolar coma 15.72 11.26 9 84831 360 50519924
Dyspnoea 15.70 11.26 1092 83748 546516 49973768
Medication error 15.66 11.26 109 84731 35995 50484289
Victim of chemical submission 15.63 11.26 8 84832 255 50520029
Therapeutic response decreased 15.62 11.26 35 84805 47196 50473088
Agitation neonatal 15.57 11.26 10 84830 493 50519791
Cholelithiasis 15.30 11.26 25 84815 37948 50482336
Bronchopulmonary aspergillosis allergic 15.26 11.26 14 84826 1177 50519107
Accidental exposure to product 15.14 11.26 10 84830 23047 50497237
Occult blood 15.10 11.26 14 84826 1193 50519091
Retinal depigmentation 15.10 11.26 8 84832 274 50520010
Surgery 15.09 11.26 17 84823 30188 50490096
Neuroleptic malignant syndrome 15.08 11.26 47 84793 11083 50509201
Right ventricular failure 15.06 11.26 4 84836 15889 50504395
Psychotic symptom 15.05 11.26 14 84826 1198 50519086
Psoriasis 15.03 11.26 62 84778 68938 50451346
Drug abuse 15.02 11.26 160 84680 59686 50460598
Drug reaction with eosinophilia and systemic symptoms 14.89 11.26 90 84750 28334 50491950
Neutrophil count increased 14.88 11.26 55 84785 14140 50506144
Atelectasis 14.85 11.26 6 84834 18264 50502020
Aspartate aminotransferase increased 14.65 11.26 74 84766 77924 50442360
Sensory level abnormal 14.62 11.26 6 84834 113 50520171
Device dislocation 14.62 11.26 9 84831 21537 50498747
Osteonecrosis 14.47 11.26 10 84830 22507 50497777
Foetal death 14.45 11.26 38 84802 8142 50512142
Therapeutic product effect incomplete 14.40 11.26 92 84748 91423 50428861
Tri-iodothyronine free decreased 14.39 11.26 8 84832 302 50519982
Vaginal haemorrhage 14.37 11.26 12 84828 24539 50495745
Total lung capacity decreased 14.30 11.26 14 84826 1277 50519007
Failed induction of labour 14.27 11.26 8 84832 307 50519977
Osteomyelitis 14.27 11.26 10 84830 22343 50497941
Pulmonary function test abnormal 14.12 11.26 14 84826 1297 50518987
Chest wall mass 14.09 11.26 5 84835 62 50520222
Procedural pain 14.06 11.26 3 84837 13829 50506455
Glucocorticoids increased 14.02 11.26 6 84834 126 50520158
Urinary sediment present 14.01 11.26 17 84823 1974 50518310
Post procedural complication 13.94 11.26 4 84836 15100 50505184
Multiple organ dysfunction syndrome 13.80 11.26 41 84799 50296 50469988
Bezoar 13.79 11.26 14 84826 1334 50518950
Infusion site scar 13.79 11.26 8 84832 328 50519956
Anaemia 13.55 11.26 321 84519 252135 50268149
Band neutrophil count increased 13.47 11.26 8 84832 343 50519941
Menopause 13.43 11.26 18 84822 2309 50517975
Myelocyte count increased 13.42 11.26 8 84832 345 50519939
Poor venous access 13.40 11.26 43 84797 10297 50509987
Urine ketone body present 13.39 11.26 18 84822 2315 50517969
Ureteric obstruction 13.29 11.26 15 84825 1613 50518671
Hallucination 13.28 11.26 128 84712 46529 50473755
Electrocardiogram repolarisation abnormality 13.27 11.26 13 84827 1187 50519097
Blood urea increased 13.24 11.26 12 84828 23573 50496711
Transient ischaemic attack 13.17 11.26 21 84819 32189 50488095
Pancreatic carcinoma recurrent 13.05 11.26 5 84835 78 50520206
Distributive shock 13.02 11.26 11 84829 829 50519455
Anuria 13.01 11.26 45 84795 11199 50509085
Anticonvulsant drug level above therapeutic 12.99 11.26 9 84831 504 50519780
Haemorrhage 12.94 11.26 46 84794 53395 50466889
Macular degeneration 12.94 11.26 4 84836 14384 50505900
Cholinergic syndrome 12.84 11.26 8 84832 374 50519910
Pharyngeal paraesthesia 12.79 11.26 14 84826 1455 50518829
Drug resistance 12.79 11.26 8 84832 18981 50501303
Hypoaesthesia 12.77 11.26 144 84696 127113 50393171
Pulmonary embolism 12.76 11.26 109 84731 101595 50418689
Product prescribing error 12.70 11.26 69 84771 20892 50499392
Device issue 12.66 11.26 9 84831 19963 50500321
Lymphadenopathy 12.64 11.26 23 84817 33476 50486808
Eczema 12.61 11.26 73 84767 22629 50497655
Social anxiety disorder 12.49 11.26 8 84832 393 50519891
Dysarthria 12.37 11.26 106 84734 37297 50482987
Throat irritation 12.36 11.26 90 84750 30149 50490135
Liver injury 12.35 11.26 14 84826 24792 50495492
Alanine aminotransferase increased 12.33 11.26 92 84748 88267 50432017
Substance use disorder 12.24 11.26 5 84835 93 50520191
Red blood cell sedimentation rate increased 12.20 11.26 19 84821 29397 50490887
Multiple sclerosis 12.11 11.26 67 84773 20426 50499858
Fibromyalgia 12.07 11.26 37 84803 44941 50475343
Arthralgia 12.06 11.26 872 83968 437830 50082454
Decreased appetite 12.05 11.26 251 84589 200672 50319612
Blood pressure systolic increased 12.00 11.26 101 84739 35348 50484936
Electrocardiogram QRS complex shortened 11.91 11.26 8 84832 426 50519858
Swollen joint count increased 11.90 11.26 5 84835 14868 50505416
Musculoskeletal stiffness 11.89 11.26 148 84692 128333 50391951
Fungal infection 11.82 11.26 20 84820 29945 50490339
Drug diversion 11.82 11.26 10 84830 755 50519529
Arthritis 11.77 11.26 91 84749 86630 50433654
Angina pectoris 11.76 11.26 16 84824 26172 50494112
Ataxia 11.70 11.26 50 84790 13736 50506548
Respiratory acidosis 11.68 11.26 29 84811 5999 50514285
Nodule 11.68 11.26 7 84833 16996 50503288
Bladder dilatation 11.67 11.26 10 84830 768 50519516
Mass 11.64 11.26 3 84837 12154 50508130
Anaphylactic reaction 11.50 11.26 49 84791 54006 50466278
Coagulopathy 11.49 11.26 8 84832 17936 50502348
Intentional product use issue 11.47 11.26 187 84653 76731 50443553
Complement factor C4 decreased 11.45 11.26 6 84834 201 50520083
Meningitis herpes 11.42 11.26 6 84834 202 50520082
Hip arthroplasty 11.38 11.26 21 84819 30408 50489876
Cutaneous lupus erythematosus 11.36 11.26 17 84823 2414 50517870
Heart rate decreased 11.32 11.26 102 84738 36395 50483889

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
Depression 705.06 11.71 672 34540 84475 29454840
Drug interaction 508.19 11.71 869 34343 196516 29342799
Coma 324.84 11.71 311 34901 39139 29500176
Poisoning deliberate 272.04 11.71 134 35078 5597 29533718
Intentional overdose 177.54 11.71 224 34988 38304 29501011
Loss of personal independence in daily activities 140.18 11.71 162 35050 25278 29514037
Somnolence 133.07 11.71 324 34888 93631 29445684
Toxicity to various agents 132.09 11.71 480 34732 173181 29366134
Suicide attempt 117.13 11.71 172 35040 33938 29505377
Intentional self-injury 107.66 11.71 101 35111 12360 29526955
Hypothermia 99.88 11.71 85 35127 9154 29530161
Drug dependence 93.44 11.71 120 35092 20861 29518454
Miosis 89.28 11.71 75 35137 7934 29531381
Prescription form tampering 87.17 11.71 29 35183 423 29538892
Hepatocellular injury 83.05 11.71 114 35098 21129 29518186
Electrocardiogram QT prolonged 76.79 11.71 147 35065 35990 29503325
Neuroleptic malignant syndrome 66.68 11.71 89 35123 16059 29523256
Blood mercury abnormal 63.81 11.71 19 35193 188 29539127
Confusional state 63.75 11.71 311 34901 127566 29411749
Overdose 62.47 11.71 223 34989 79596 29459719
5-hydroxyindolacetic acid in urine increased 61.67 11.71 19 35193 213 29539102
Low density lipoprotein decreased 57.97 11.71 27 35185 993 29538322
Housebound 53.32 11.71 17 35195 215 29539100
Cerebral artery thrombosis 52.86 11.71 23 35189 719 29538596
Disease progression 52.70 11.71 16 35196 81900 29457415
Product dose omission issue 48.80 11.71 27 35185 96356 29442959
Dystonic tremor 47.61 11.71 15 35197 182 29539133
Myocardial infarction 47.58 11.71 37 35175 110259 29429056
Brain scan abnormal 46.76 11.71 22 35190 828 29538487
Suicidal ideation 46.15 11.71 117 35095 34599 29504716
Cardiac failure congestive 44.05 11.71 18 35194 76563 29462752
Altered state of consciousness 43.58 11.71 82 35130 19807 29519508
Fall 42.08 11.71 357 34855 176821 29362494
Withdrawal syndrome 38.52 11.71 56 35156 10936 29528379
Macrophages increased 36.85 11.71 12 35200 163 29539152
Bradypnoea 36.80 11.71 27 35185 2344 29536971
Drug abuse 36.72 11.71 190 35022 79693 29459622
Cholestasis 36.46 11.71 84 35128 23378 29515937
Agitation 35.64 11.71 138 35074 51166 29488149
Logorrhoea 35.39 11.71 26 35186 2262 29537053
Asphyxia 34.68 11.71 37 35175 5278 29534037
Thrombosis 34.64 11.71 5 35207 43040 29496275
Hyperthermia 34.45 11.71 49 35163 9381 29529934
Agranulocytosis 34.04 11.71 75 35137 20265 29519050
Serum ferritin abnormal 33.54 11.71 12 35200 220 29539095
Toxic skin eruption 31.74 11.71 48 35164 9709 29529606
Pneumonia aspiration 31.62 11.71 106 35106 36631 29502684
Implant site extravasation 30.72 11.71 13 35199 379 29538936
Mental status changes 30.72 11.71 3 35209 34924 29504391
Drug intolerance 30.29 11.71 126 35086 48253 29491062
Contraindicated product administered 30.16 11.71 67 35145 18199 29521116
Puncture site haematoma 30.05 11.71 10 35202 146 29539169
Restless legs syndrome 29.60 11.71 39 35173 6945 29532370
Hepatic neoplasm 28.70 11.71 21 35191 1815 29537500
General physical health deterioration 28.59 11.71 215 34997 102642 29436673
Tremor 28.48 11.71 167 35045 73371 29465944
Gastrointestinal haemorrhage 28.03 11.71 32 35180 79501 29459814
Rheumatoid arthritis 27.88 11.71 93 35119 32059 29507256
Bladder dilatation 27.61 11.71 18 35194 1290 29538025
Dystonia 27.60 11.71 45 35167 9704 29529611
Faecaloma 26.97 11.71 29 35183 4173 29535142
Overlap syndrome 26.61 11.71 8 35204 82 29539233
Alcohol poisoning 26.60 11.71 25 35187 3064 29536251
Burnout syndrome 26.58 11.71 9 35203 139 29539176
Accessory spleen 26.28 11.71 9 35203 144 29539171
Drug monitoring procedure incorrectly performed 26.04 11.71 10 35202 225 29539090
Areflexia 25.09 11.71 23 35189 2731 29536584
Blood ethanol increased 24.85 11.71 12 35200 479 29538836
Muscle rigidity 24.71 11.71 42 35170 9369 29529946
Substance abuse 24.40 11.71 35 35177 6752 29532563
Post concussion syndrome 24.15 11.71 8 35204 115 29539200
Death 24.14 11.71 276 34936 341808 29197507
Antiphospholipid antibodies positive 24.01 11.71 10 35202 280 29539035
Psychomotor skills impaired 23.81 11.71 22 35190 2639 29536676
Renal failure 23.59 11.71 68 35144 118531 29420784
Arteriovenous fistula 23.45 11.71 13 35199 693 29538622
Behaviour disorder 23.29 11.71 25 35187 3591 29535724
Dysarthria 22.99 11.71 85 35127 30826 29508489
Hypoglycaemia 22.90 11.71 116 35096 48230 29491085
Restlessness 22.82 11.71 68 35144 22077 29517238
Paraneoplastic rash 22.60 11.71 7 35205 80 29539235
Coma scale abnormal 22.37 11.71 24 35188 3445 29535870
Femoral artery aneurysm 21.62 11.71 8 35204 162 29539153
Injection site pain 21.47 11.71 6 35206 32440 29506875
Pemphigoid 21.47 11.71 35 35177 7546 29531769
Coronary artery disease 21.46 11.71 13 35199 44177 29495138
Eosinophil percentage increased 21.43 11.71 11 35201 501 29538814
Respiratory failure 21.35 11.71 53 35159 97078 29442237
Normochromic normocytic anaemia 21.32 11.71 24 35188 3634 29535681
Opiates positive 21.23 11.71 11 35201 511 29538804
Psychiatric decompensation 20.83 11.71 16 35196 1488 29537827
Pneumonia 20.78 11.71 263 34949 319909 29219406
Lymphocyte percentage decreased 20.66 11.71 18 35194 1999 29537316
Neuropathy peripheral 20.55 11.71 33 35179 70994 29468321
Neutrophil percentage increased 20.51 11.71 17 35195 1764 29537551
Ischaemic stroke 20.35 11.71 53 35159 15924 29523391
Device dislocation 20.31 11.71 26 35186 4501 29534814
Diarrhoea 20.24 11.71 277 34935 332421 29206894
Loss of consciousness 20.11 11.71 154 35058 73902 29465413
Toxic epidermal necrolysis 19.91 11.71 57 35155 18096 29521219
Spinal cord haemorrhage 19.90 11.71 9 35203 309 29539006
Electrocardiogram abnormal 19.65 11.71 33 35179 7289 29532026
Hemiplegia 19.43 11.71 31 35181 6563 29532752
Sedation 19.43 11.71 55 35157 17350 29521965
Expired product administered 19.11 11.71 20 35192 2791 29536524
Urogenital haemorrhage 19.00 11.71 10 35202 480 29538835
Tooth injury 18.95 11.71 12 35200 818 29538497
Delirium febrile 18.70 11.71 5 35207 32 29539283
Blepharospasm 18.64 11.71 13 35199 1042 29538273
Blood pressure systolic increased 18.58 11.71 53 35159 16792 29522523
Rash maculo-papular 18.23 11.71 67 35145 24222 29515093
Intentional device misuse 17.93 11.71 7 35205 165 29539150
Urine leukocyte esterase positive 17.82 11.71 9 35203 396 29538919
Conjunctival hyperaemia 17.78 11.71 17 35195 2128 29537187
Dermatitis psoriasiform 17.75 11.71 13 35199 1125 29538190
Bradycardia 17.55 11.71 136 35076 65493 29473822
Body temperature decreased 17.47 11.71 39 35173 10625 29528690
Implant site infection 17.07 11.71 12 35200 974 29538341
Depressed level of consciousness 17.04 11.71 88 35124 36854 29502461
Band neutrophil percentage increased 17.03 11.71 6 35206 105 29539210
Disorientation 17.02 11.71 75 35137 29440 29509875
Pancreatitis 16.97 11.71 10 35202 34504 29504811
Capillary fragility 16.93 11.71 5 35207 48 29539267
Obsessive thoughts 16.77 11.71 10 35202 612 29538703
Mean cell haemoglobin concentration increased 16.76 11.71 8 35204 311 29539004
Clumsiness 16.57 11.71 14 35198 1492 29537823
General symptom 16.52 11.71 11 35201 817 29538498
Drug resistance 16.22 11.71 3 35209 21537 29517778
Erythrosis 16.15 11.71 5 35207 57 29539258
Behavioural addiction 16.14 11.71 4 35208 18 29539297
Depression suicidal 16.08 11.71 13 35199 1302 29538013
Blood creatinine increased 16.05 11.71 50 35162 85052 29454263
Drug ineffective 15.95 11.71 321 34891 362849 29176466
Intra-abdominal fluid collection 15.75 11.71 12 35200 1103 29538212
Bacillus bacteraemia 15.70 11.71 5 35207 63 29539252
Epilepsy 15.69 11.71 53 35159 18379 29520936
Hospitalisation 15.66 11.71 19 35193 45969 29493346
Malaise 15.31 11.71 271 34941 159331 29379984
Hyperkalaemia 15.20 11.71 125 35087 61267 29478048
Double inlet left ventricle 15.18 11.71 4 35208 24 29539291
Feelings of worthlessness 14.96 11.71 7 35205 260 29539055
Sensorimotor disorder 14.88 11.71 8 35204 401 29538914
pH urine increased 14.84 11.71 5 35207 76 29539239
Congenital hand malformation 14.79 11.71 9 35203 572 29538743
Hypercapnia 14.56 11.71 20 35192 3706 29535609
Deep vein thrombosis 14.50 11.71 29 35183 57370 29481945
Immune-mediated hepatitis 14.39 11.71 13 35199 1514 29537801
COVID-19 14.38 11.71 13 35199 36001 29503314
Phonophobia 14.34 11.71 6 35206 170 29539145
Abdominal compartment syndrome 14.04 11.71 10 35202 829 29538486
Reading disorder 14.03 11.71 8 35204 450 29538865
Neutrophil count increased 14.00 11.71 44 35168 14698 29524617
Spleen congestion 13.99 11.71 7 35205 302 29539013
Gamma-glutamyltransferase increased 13.97 11.71 66 35146 26671 29512644
Adrenocortical insufficiency acute 13.97 11.71 12 35200 1308 29538007
Haemorrhage 13.94 11.71 20 35192 45052 29494263
Therapy non-responder 13.78 11.71 10 35202 30901 29508414
Univentricular heart 13.77 11.71 4 35208 36 29539279
Speech disorder 13.75 11.71 60 35152 23456 29515859
Hypertension 13.71 11.71 82 35130 116532 29422783
Dyspnoea 13.68 11.71 291 34921 326441 29212874
Tachycardia 13.65 11.71 139 35073 72271 29467044
Antipsychotic drug level increased 13.57 11.71 18 35194 3225 29536090
Periarthritis 13.46 11.71 10 35202 885 29538430
Respiratory arrest 13.40 11.71 7 35205 25826 29513489
Vascular purpura 13.33 11.71 12 35200 1391 29537924
Pyrexia 13.28 11.71 252 34960 287370 29251945
Microvascular coronary artery disease 13.22 11.71 4 35208 42 29539273
Purpura 13.19 11.71 32 35180 9200 29530115
Hypersensitivity 13.13 11.71 27 35185 52876 29486439
Depressive symptom 13.10 11.71 13 35199 1704 29537611
Choking 13.08 11.71 21 35191 4470 29534845
Stoma site haemorrhage 13.05 11.71 9 35203 708 29538607
Exhibitionism 13.05 11.71 4 35208 44 29539271
Optic nerve cupping 13.05 11.71 4 35208 44 29539271
Blood creatine phosphokinase increased 13.04 11.71 88 35124 40556 29498759
Sinusitis 13.01 11.71 13 35199 34337 29504978
Dizziness 12.95 11.71 154 35058 189530 29349785
Onychomycosis 12.83 11.71 14 35198 2048 29537267
Obsessive-compulsive disorder 12.79 11.71 21 35191 4555 29534760
Disturbance in attention 12.78 11.71 55 35157 21369 29517946
Hepatic steatosis 12.74 11.71 43 35169 14903 29524412
Psychotic disorder 12.72 11.71 53 35159 20301 29519014
Akathisia 12.59 11.71 26 35186 6716 29532599
Acute respiratory failure 12.50 11.71 8 35204 26394 29512921
Chronic kidney disease 12.45 11.71 15 35197 36401 29502914
Cough 12.45 11.71 94 35118 126633 29412682
Band neutrophil count increased 12.44 11.71 6 35206 239 29539076
Asthenia 12.41 11.71 181 35031 215069 29324246
Diabetic coma 12.37 11.71 9 35203 771 29538544
Parkinsonism 12.36 11.71 27 35185 7251 29532064
Perineal pain 12.35 11.71 9 35203 773 29538542
Blood glucose increased 12.33 11.71 33 35179 58951 29480364
Cyanosis central 12.24 11.71 5 35207 133 29539182
Noninfective gingivitis 12.10 11.71 6 35206 254 29539061
Bone marrow failure 12.08 11.71 9 35203 27440 29511875
Hepatic cytolysis 12 11.71 29 35183 8318 29530997
Hyponatraemic seizure 11.98 11.71 4 35208 59 29539256
Acute kidney injury 11.91 11.71 406 34806 264861 29274454
Incorrect dose administered 11.91 11.71 13 35199 32971 29506344
Asocial behaviour 11.86 11.71 4 35208 61 29539254

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
Coma 840.78 10.69 864 103654 86751 64307463
Poisoning deliberate 524.43 10.69 306 104212 13152 64381062
Intentional overdose 514.45 10.69 680 103838 89264 64304950
Somnolence 381.05 10.69 945 103573 202700 64191514
Intentional self-injury 333.14 10.69 316 104202 28728 64365486
Lower respiratory tract infection 287.63 10.69 535 103983 94079 64300135
Pneumonia aspiration 232.20 10.69 375 104143 58896 64335318
Depression 231.65 10.69 738 103780 182553 64211661
Muscle spasticity 227.57 10.69 200 104318 16469 64377745
Ear pain 197.03 10.69 223 104295 24913 64369301
Suicide attempt 194.19 10.69 384 104134 70623 64323591
Toxicity to various agents 169.82 10.69 1088 103430 362425 64031789
Body temperature increased 165.95 10.69 248 104270 36418 64357796
Product dose omission issue 149.77 10.69 64 104454 194683 64199531
Confusional state 139.79 10.69 810 103708 260334 64133880
Respiratory disorder 135.33 10.69 224 104294 35887 64358327
Miosis 132.77 10.69 134 104384 13132 64381082
Cardiac failure congestive 131.25 10.69 26 104492 130554 64263660
Hepatocellular injury 121.67 10.69 243 104275 44992 64349222
Night sweats 117.24 10.69 210 104308 35836 64358378
Drug interaction 117.00 10.69 993 103525 361090 64033124
Electric shock 110.66 10.69 48 104470 1081 64393133
Electrocardiogram QT prolonged 107.68 10.69 328 104190 79120 64315094
Muscle injury 107.23 10.69 170 104348 26267 64367947
Hypothermia 101.05 10.69 142 104376 19714 64374500
Folliculitis 97.52 10.69 175 104343 29902 64364312
Drug dependence 96.93 10.69 185 104333 33127 64361087
Akathisia 96.86 10.69 106 104412 11404 64382810
Sinusitis 96.58 10.69 480 104038 145448 64248766
Death 83.95 10.69 450 104068 482255 63911959
Ill-defined disorder 83.79 10.69 206 104312 43846 64350368
Mental status changes 82.31 10.69 4 104514 61158 64333056
Irritable bowel syndrome 82.24 10.69 185 104333 37184 64357030
Suicidal ideation 81.23 10.69 265 104253 66277 64327937
Myocardial infarction 80.42 10.69 90 104428 165731 64228483
Insomnia 77.76 10.69 568 103950 197268 64196946
Antipsychotic drug level increased 77.17 10.69 65 104453 5050 64389164
Sleep disorder due to general medical condition, insomnia type 76.56 10.69 146 104372 26124 64368090
Post-traumatic stress disorder 70.90 10.69 57 104461 4148 64390066
Overdose 70.24 10.69 471 104047 159095 64235119
Respiratory failure 65.31 10.69 100 104418 161083 64233131
Asphyxia 65.17 10.69 79 104439 9487 64384727
Neovascularisation 65.01 10.69 33 104485 1070 64393144
Somnambulism 64.84 10.69 59 104459 5082 64389132
Housebound 63.30 10.69 25 104493 440 64393774
Altered state of consciousness 61.52 10.69 167 104351 37735 64356479
Cholestasis 61.47 10.69 186 104332 44686 64349528
Drug ineffective 60.68 10.69 978 103540 839269 63554945
Intervertebral discitis 60.23 10.69 50 104468 3807 64390407
Depressed level of consciousness 59.72 10.69 276 104242 81160 64313054
Neuroleptic malignant syndrome 58.67 10.69 127 104391 24869 64369345
Blood mercury abnormal 58.04 10.69 19 104499 188 64394026
Injection site pain 56.75 10.69 58 104460 111350 64282864
5-hydroxyindolacetic acid in urine increased 55.75 10.69 19 104499 215 64393999
Disease progression 55.40 10.69 90 104428 141590 64252624
Urticaria 55.03 10.69 418 104100 146899 64247315
Drug hypersensitivity 55.02 10.69 199 104319 237616 64156598
Sepsis 54.45 10.69 191 104327 230150 64164064
Lupus vasculitis 51.79 10.69 22 104496 470 64393744
Duodenal ulcer perforation 51.70 10.69 148 104370 34477 64359737
Helicobacter infection 50.66 10.69 157 104361 38205 64356009
Prescription form tampering 50.54 10.69 20 104498 354 64393860
Behaviour disorder 50.10 10.69 48 104470 4414 64389800
Pneumonia 48.82 10.69 627 103891 558949 63835265
Low density lipoprotein decreased 48.40 10.69 27 104491 1063 64393151
Depressed mood 47.08 10.69 160 104358 40852 64353362
Urine leukocyte esterase positive 46.78 10.69 41 104477 3362 64390852
Coronary artery disease 46.19 10.69 20 104498 60413 64333801
Peripheral swelling 46.06 10.69 530 103988 208623 64185591
Fluid retention 45.12 10.69 20 104498 59586 64334628
Drug resistance 45.07 10.69 3 104515 35099 64359115
Skin candida 44.35 10.69 30 104488 1673 64392541
Impaired healing 43.62 10.69 204 104314 60269 64333945
Dystonic tremor 43.07 10.69 15 104503 182 64394032
Broncholithiasis 42.72 10.69 14 104504 139 64394075
Renal failure 42.69 10.69 151 104367 181537 64212677
Blister 41.80 10.69 249 104269 80718 64313496
Gastrointestinal disorder 40.16 10.69 266 104252 89443 64304771
Monocyte percentage increased 40.00 10.69 30 104488 1970 64392244
Burnout syndrome 39.98 10.69 16 104502 292 64393922
Contusion 39.58 10.69 318 104200 113647 64280567
Nasopharyngitis 39.28 10.69 488 104030 195585 64198629
White blood cells urine positive 39.11 10.69 46 104472 5352 64388862
Temperature intolerance 39.01 10.69 57 104461 8198 64386016
Blood creatinine increased 38.16 10.69 104 104414 135678 64258536
Gastrooesophageal reflux disease 38.11 10.69 248 104270 82895 64311319
Demyelination 37.97 10.69 51 104467 6783 64387431
COVID-19 37.84 10.69 30 104488 65110 64329104
Wrong technique in product usage process 37.65 10.69 30 104488 64944 64329270
Calcium deficiency 37.53 10.69 20 104498 718 64393496
Bladder dilatation 37.51 10.69 28 104490 1826 64392388
Pruritus 36.94 10.69 711 103807 311689 64082525
Disturbance in attention 36.86 10.69 148 104370 40926 64353288
Hyponatraemia 36.35 10.69 384 104134 147955 64246259
Completed suicide 36.29 10.69 214 104304 224200 64170014
General physical health deterioration 36.02 10.69 497 104021 203928 64190286
Balance disorder 35.86 10.69 246 104272 83680 64310534
Cerebral artery thrombosis 35.84 10.69 22 104496 1037 64393177
Neutrophil percentage increased 35.78 10.69 40 104478 4405 64389809
Thrombosis 34.60 10.69 38 104480 70604 64323610
Lymphocyte percentage decreased 34.32 10.69 40 104478 4609 64389605
Postmortem blood drug level abnormal 34.23 10.69 18 104500 629 64393585
Cardiac arrest 33.60 10.69 132 104386 153932 64240282
Extrapyramidal disorder 33.60 10.69 88 104430 19464 64374750
Rheumatoid arthritis 32.93 10.69 409 104109 163885 64230329
Lymph node calcification 32.70 10.69 14 104504 305 64393909
Hallucination 32.68 10.69 216 104302 72572 64321642
Injection site erythema 32.61 10.69 40 104478 70760 64323454
Post-traumatic neck syndrome 32.53 10.69 26 104492 1876 64392338
Deep vein thrombosis 32.30 10.69 77 104441 105105 64289109
Renal impairment 31.85 10.69 112 104406 134905 64259309
Injection site reaction 31.80 10.69 18 104500 46646 64347568
Gastrointestinal haemorrhage 31.72 10.69 109 104409 132203 64262011
Mydriasis 31.69 10.69 74 104444 15238 64378976
Brain scan abnormal 31.43 10.69 21 104497 1147 64393067
Macrophages increased 31.38 10.69 12 104506 193 64394021
C-reactive protein abnormal 30.87 10.69 5 104513 29042 64365172
Bronchial wall thickening 30.36 10.69 25 104493 1882 64392332
Hypervolaemia 30.34 10.69 12 104506 38273 64355941
Product quality issue 29.78 10.69 6 104512 29793 64364421
Chronic kidney disease 29.66 10.69 30 104488 57889 64336325
Band neutrophil percentage increased 29.60 10.69 14 104504 388 64393826
Joint swelling 29.60 10.69 502 104016 214880 64179334
Sputum discoloured 29.29 10.69 79 104439 17777 64376437
Blood glucose increased 29.17 10.69 73 104445 98000 64296214
Alcohol poisoning 28.76 10.69 35 104483 4220 64389994
Atrial fibrillation 28.27 10.69 162 104356 170927 64223287
Hospitalisation 28.25 10.69 49 104469 75158 64319056
Obstructive airways disorder 27.98 10.69 92 104426 23093 64371121
Soft tissue injury 27.89 10.69 22 104496 1557 64392657
Injection site bruising 27.85 10.69 12 104506 36361 64357853
Toxic skin eruption 27.41 10.69 81 104437 19203 64375011
Cytomegalovirus infection 27.35 10.69 13 104505 37186 64357028
Agitation 27.18 10.69 240 104278 88127 64306087
Pemphigoid 27.13 10.69 63 104455 12923 64381291
Fall 27.13 10.69 875 103643 415951 63978263
Neutrophil count increased 26.97 10.69 96 104422 25078 64369136
Agranulocytosis 26.86 10.69 128 104390 38101 64356113
Sleep disorder 26.69 10.69 177 104341 59532 64334682
Urine abnormality 26.68 10.69 45 104473 7317 64386897
Diaphragmatic rupture 26.56 10.69 11 104507 220 64393994
Bradypnoea 26.40 10.69 37 104481 5122 64389092
Puncture site haematoma 26.14 10.69 10 104508 161 64394053
Blood urea increased 26.07 10.69 20 104498 44133 64350081
Nightmare 25.96 10.69 84 104434 20909 64373305
Gallbladder adenocarcinoma 25.93 10.69 9 104509 108 64394106
Vocal cord dysfunction 25.88 10.69 13 104505 412 64393802
Red blood cells urine 25.75 10.69 15 104503 642 64393572
Libido increased 25.48 10.69 22 104496 1768 64392446
Excessive eye blinking 25.43 10.69 19 104499 1241 64392973
Oedema 25.39 10.69 71 104447 91864 64302350
Injection site swelling 25.36 10.69 18 104500 41335 64352879
Choking 25.25 10.69 54 104464 10484 64383730
Lupus nephritis 25.20 10.69 25 104493 2399 64391815
Pulmonary hypertension 24.89 10.69 20 104498 43119 64351095
Blood pressure systolic increased 24.83 10.69 151 104367 49302 64344912
Neurotoxicity 24.48 10.69 7 104511 27397 64366817
Obsessive-compulsive disorder 23.83 10.69 34 104484 4784 64389430
Blood calcium decreased 23.83 10.69 6 104512 25548 64368666
Injection site pruritus 23.82 10.69 16 104502 37810 64356404
Postmortem blood drug level increased 23.71 10.69 15 104503 746 64393468
Coagulopathy 23.71 10.69 11 104507 31909 64362305
Hostility 23.39 10.69 23 104495 2184 64392030
Band neutrophil count increased 23.18 10.69 14 104504 641 64393573
Loss of personal independence in daily activities 22.92 10.69 198 104320 72256 64321958
Hyperthermia 22.76 10.69 66 104452 15484 64378730
Carcinoid tumour pulmonary 22.70 10.69 11 104507 322 64393892
Specific gravity urine increased 22.44 10.69 12 104506 434 64393780
Respiratory arrest 22.29 10.69 32 104486 52953 64341261
Acute respiratory failure 22.17 10.69 29 104489 49905 64344309
Pericarditis 22.00 10.69 175 104343 62341 64331873
Accessory spleen 21.92 10.69 9 104509 176 64394038
Concussion 21.76 10.69 43 104475 7895 64386319
Implant site extravasation 21.50 10.69 14 104504 732 64393482
Toxicologic test abnormal 21.50 10.69 17 104501 1208 64393006
Therapy cessation 21.47 10.69 13 104505 32476 64361738
Haemorrhage 21.38 10.69 62 104456 79289 64314925
Infusion related reaction 21.38 10.69 380 104138 164087 64230127
Scratch 21.34 10.69 38 104480 6451 64387763
Cellulitis 21.21 10.69 79 104439 93578 64300636
Coma scale abnormal 21.18 10.69 42 104476 7732 64386482
Serum ferritin abnormal 21.00 10.69 11 104507 381 64393833
Distal intestinal obstruction syndrome 20.95 10.69 13 104505 625 64393589
White blood cell count decreased 20.76 10.69 160 104358 157677 64236537
Platelet count decreased 20.68 10.69 173 104345 167538 64226676
Lactic acidosis 20.57 10.69 170 104348 61240 64332974
Paraneoplastic rash 20.48 10.69 7 104511 80 64394134
Tachycardia 20.30 10.69 348 104170 149231 64244983
Liver function test abnormal 20.28 10.69 41 104477 59360 64334854
Hypertension 20.19 10.69 297 104221 258964 64135250
Multiple organ dysfunction syndrome 20.17 10.69 90 104428 101323 64292891
Ascites 20.16 10.69 44 104474 61957 64332257
Multiple sclerosis 20.09 10.69 72 104446 18869 64375345
Antidepressant drug level above therapeutic 20.05 10.69 12 104506 540 64393674
Bilirubin urine present 19.82 10.69 10 104508 320 64393894
Inappropriate antidiuretic hormone secretion 19.75 10.69 80 104438 22209 64372005
Pain in extremity 19.71 10.69 359 104159 302726 64091488
Myelosuppression 19.67 10.69 7 104511 23823 64370391
Sternal fracture 19.44 10.69 21 104497 2226 64391988
Sopor 19.42 10.69 12 104506 29649 64364565
Substance abuse 19.33 10.69 45 104473 9247 64384967
Myelocyte percentage increased 19.28 10.69 9 104509 242 64393972
Erythrosis 19.26 10.69 7 104511 97 64394117
Hallucination, synaesthetic 19.24 10.69 6 104512 50 64394164
Malignant polyp 19.23 10.69 8 104510 162 64394052
Poor quality sleep 19.22 10.69 71 104447 18880 64375334
Angina pectoris 19.19 10.69 27 104491 45054 64349160
Opiates positive 19.15 10.69 14 104504 884 64393330
Unevaluable event 18.86 10.69 33 104485 50456 64343758
Drug abuse 18.70 10.69 310 104208 132064 64262150
Hepatic neoplasm 18.70 10.69 24 104494 3053 64391161
Dysarthria 18.61 10.69 162 104356 59244 64334970
Contraindicated product administered 18.50 10.69 261 104257 107568 64286646
Posterior reversible encephalopathy syndrome 18.50 10.69 7 104511 22939 64371275
Menopause 18.47 10.69 18 104500 1690 64392524
Wrong rate 18.36 10.69 6 104512 59 64394155
Procedural anxiety 18.27 10.69 12 104506 637 64393577
Mania 18.22 10.69 63 104455 16223 64377991
Femoral artery aneurysm 18.21 10.69 8 104510 186 64394028
Laryngeal stenosis 18.17 10.69 13 104505 794 64393420
Abortion spontaneous 18.16 10.69 9 104509 25134 64369080
Anti-cyclic citrullinated peptide antibody positive 18.13 10.69 140 104378 49422 64344792
Blood ethanol increased 18.12 10.69 12 104506 646 64393568
Gait deviation 18.09 10.69 6 104512 62 64394152
Drug monitoring procedure incorrectly performed 17.96 10.69 10 104508 392 64393822
Psychiatric decompensation 17.86 10.69 21 104497 2442 64391772
Ligament pain 17.86 10.69 8 104510 195 64394019
Therapeutic response decreased 17.83 10.69 36 104482 52152 64342062
Paradoxical drug reaction 17.81 10.69 34 104484 6086 64388128
Hypersensitivity vasculitis 17.79 10.69 36 104482 6725 64387489
Coordination abnormal 17.72 10.69 59 104459 14905 64379309
Haemoglobin urine 17.58 10.69 7 104511 126 64394088
Dyspnoea exertional 17.49 10.69 61 104457 73669 64320545
Myocarditis septic 17.45 10.69 5 104513 30 64394184
Psychomotor skills impaired 17.38 10.69 26 104492 3819 64390395
Staphylococcal infection 17.28 10.69 35 104483 50643 64343571
Exposure during pregnancy 17.28 10.69 66 104452 77609 64316605
Drug level above therapeutic 17.28 10.69 36 104482 6865 64387349
Product prescribing error 17.27 10.69 107 104411 35162 64359052
Heart rate decreased 17.16 10.69 150 104368 54917 64339297
Presyncope 17.04 10.69 19 104499 35070 64359144
Abdominal pain upper 16.94 10.69 387 104131 174643 64219571
Urine oxalate increased 16.90 10.69 8 104510 222 64393992
Arteriovenous fistula 16.82 10.69 13 104505 893 64393321
Malaise 16.81 10.69 794 103724 395453 63998761
Accidental exposure to product 16.80 10.69 11 104507 26353 64367861
Urine analysis abnormal 16.78 10.69 32 104486 5724 64388490
Crystal urine present 16.64 10.69 18 104500 1911 64392303
Mixed liver injury 16.63 10.69 31 104487 5450 64388764
Ventricular extrasystoles 16.57 10.69 4 104514 17525 64376689
Atelectasis 16.55 10.69 12 104506 27254 64366960
Bone marrow failure 16.45 10.69 33 104485 47919 64346295
Post procedural complication 16.42 10.69 7 104511 21346 64372868
Bradycardia 16.39 10.69 276 104242 117943 64276271
Logorrhoea 16.32 10.69 26 104492 4033 64390181
Feelings of worthlessness 16.20 10.69 10 104508 476 64393738
Rash maculo-papular 16.19 10.69 131 104387 46895 64347319
Cerebral infarction 16.10 10.69 26 104492 41018 64353196
Substance use disorder 16.05 10.69 9 104509 358 64393856
Blood pressure diastolic abnormal 15.94 10.69 49 104469 11868 64382346
Back pain 15.94 10.69 524 103994 249647 64144567
Reading disorder 15.83 10.69 12 104506 801 64393413
Infusion site scar 15.83 10.69 8 104510 257 64393957
Rheumatoid factor positive 15.81 10.69 20 104498 34918 64359296
Nystagmus 15.77 10.69 41 104477 9027 64385187
Neutropenic sepsis 15.69 10.69 77 104441 23195 64371019
Accommodation disorder 15.65 10.69 10 104508 506 64393708
Osteomyelitis 15.65 10.69 13 104505 27574 64366640
Incorrect route of product administration 15.64 10.69 77 104441 23221 64370993
Poor venous access 15.64 10.69 50 104468 12367 64381847
Plasma cell myeloma 15.56 10.69 32 104486 46043 64348171
Parkinsonism 15.56 10.69 55 104463 14318 64379896
No adverse event 15.55 10.69 14 104504 28547 64365667
Product monitoring error 15.50 10.69 30 104488 5424 64388790
Epilepsy 15.34 10.69 100 104418 33431 64360783
Cardiac valve disease 15.29 10.69 29 104489 5166 64389048
Cardio-respiratory arrest 15.27 10.69 95 104423 98298 64295916
Peripheral circulatory failure 15.25 10.69 11 104507 680 64393534
Weight increased 15.20 10.69 453 104065 212895 64181319
Disseminated intravascular coagulation 15.18 10.69 18 104500 32330 64361884
Red blood cell sedimentation rate increased 15.07 10.69 17 104501 31218 64362996
Ataxia 14.83 10.69 73 104445 22011 64372203
Restless legs syndrome 14.82 10.69 61 104457 17055 64377159
Alanine aminotransferase increased 14.72 10.69 149 104369 138882 64255332
Nephropathy toxic 14.70 10.69 5 104513 17509 64376705
Respiratory depression 14.70 10.69 76 104442 23367 64370847
Dry mouth 14.60 10.69 156 104362 60262 64333952
Neutropenia 14.59 10.69 287 104231 239337 64154877
Epistaxis 14.59 10.69 96 104422 98035 64296179
Adverse event 14.58 10.69 26 104492 39463 64354751
Eczema 14.44 10.69 90 104428 29630 64364584
Red blood cells urine positive 14.44 10.69 26 104492 4452 64389762
Urine ketone body present 14.43 10.69 22 104496 3285 64390929
Amyotrophy 14.42 10.69 10 104508 581 64393633
Anaemia 14.38 10.69 486 104032 378194 64016020
Retinal depigmentation 14.36 10.69 8 104510 314 64393900
Pancreatitis 14.35 10.69 49 104469 59558 64334656
Analgesic drug level increased 14.26 10.69 18 104500 2252 64391962
Progressive multifocal leukoencephalopathy 14.26 10.69 63 104455 18169 64376045
Haematocrit increased 14.24 10.69 22 104496 3323 64390891
Glucocorticoids increased 14.22 10.69 6 104512 126 64394088
Polymicrogyria 14.21 10.69 3 104515 3 64394211
Bronchiolitis 14.19 10.69 23 104495 3618 64390596
Adrenal insufficiency 14.17 10.69 73 104445 22414 64371800
Red cell distribution width increased 14.10 10.69 48 104470 12261 64381953
Surgery 14.01 10.69 15 104503 28198 64366016
Faecaloma 13.96 10.69 41 104477 9687 64384527
Paternal exposure timing unspecified 13.91 10.69 5 104513 67 64394147
Delirium febrile 13.84 10.69 5 104513 68 64394146
Transient ischaemic attack 13.83 10.69 32 104486 44150 64350064
Diabetes mellitus 13.82 10.69 58 104460 66416 64327798
Acute myocardial infarction 13.79 10.69 62 104456 69656 64324558
Mobility decreased 13.78 10.69 82 104436 85758 64308456
Hypocoagulable state 13.77 10.69 16 104502 1837 64392377
Occult blood 13.73 10.69 14 104504 1388 64392826
Antipsychotic drug level above therapeutic 13.72 10.69 16 104502 1845 64392369
Middle insomnia 13.70 10.69 49 104469 12828 64381386
Haematuria 13.70 10.69 51 104467 60420 64333794
Urine bilirubin decreased 13.64 10.69 6 104512 140 64394074
Full blood count decreased 13.62 10.69 10 104508 22572 64371642
Hypoglycaemia 13.62 10.69 213 104305 89679 64304535
Failed induction of labour 13.57 10.69 7 104511 235 64393979
Eosinophil percentage increased 13.55 10.69 14 104504 1410 64392804
Bronchopulmonary aspergillosis 13.53 10.69 7 104511 19078 64375136
Cerebrovascular accident 13.53 10.69 150 104368 137433 64256781
Tri-iodothyronine free decreased 13.51 10.69 8 104510 353 64393861
Metastases to lung 13.45 10.69 4 104514 15260 64378954
Hepatotoxicity 13.29 10.69 28 104490 39934 64354280
Cognitive disorder 13.20 10.69 142 104376 54945 64339269
Blood creatine increased 13.19 10.69 36 104482 8156 64386058
Stomatitis 13.10 10.69 250 104268 109355 64284859
Psoriatic arthropathy 13.03 10.69 32 104486 43249 64350965
Spinal cord haemorrhage 12.93 10.69 9 104509 526 64393688
Glossodynia 12.92 10.69 161 104357 64535 64329679
Transplant rejection 12.92 10.69 6 104512 17395 64376819
Urinary sediment present 12.92 10.69 17 104501 2217 64391997
Ileus 12.81 10.69 11 104507 22955 64371259
Thirst decreased 12.75 10.69 7 104511 267 64393947
Post concussion syndrome 12.75 10.69 9 104509 538 64393676
Diabetic hyperosmolar coma 12.70 10.69 10 104508 706 64393508
Incorrect dose administered 12.65 10.69 53 104465 60712 64333502
Negative thoughts 12.62 10.69 13 104505 1305 64392909
Withdrawal syndrome 12.60 10.69 73 104445 23419 64370795
Vascular purpura 12.59 10.69 18 104500 2538 64391676
Communication disorder 12.57 10.69 22 104496 3684 64390530
Disorientation 12.50 10.69 142 104376 55686 64338528
Device issue 12.45 10.69 11 104507 22637 64371577
Aspartate aminotransferase increased 12.42 10.69 129 104389 119659 64274555
Diabetic coma 12.38 10.69 12 104506 1119 64393095
Personality disorder 12.29 10.69 25 104493 4686 64389528
Tuberculosis 12.27 10.69 3 104515 13035 64381179
Psychotic disorder 12.27 10.69 97 104421 34481 64359733
Fungal infection 12.25 10.69 23 104495 34228 64359986
Hepatic function abnormal 12.24 10.69 58 104460 64255 64329959
Drug reaction with eosinophilia and systemic symptoms 12.18 10.69 138 104380 54079 64340135
Victim of chemical submission 12.16 10.69 7 104511 293 64393921
pH urine increased 12.16 10.69 8 104510 426 64393788
Pemphigus 12.10 10.69 151 104367 60550 64333664
Sinus rhythm 12.10 10.69 9 104509 584 64393630
Bronchopulmonary aspergillosis allergic 12.05 10.69 14 104504 1608 64392606
Angina unstable 12.01 10.69 5 104513 15462 64378752
International normalised ratio increased 11.99 10.69 77 104441 79090 64315124
Oral herpes 11.99 10.69 69 104449 22083 64372131
Distributive shock 11.99 10.69 15 104503 1860 64392354
Persecutory delusion 11.98 10.69 23 104495 4135 64390079
Psychotic symptom 11.95 10.69 16 104502 2122 64392092
Cutaneous lupus erythematosus 11.93 10.69 18 104500 2664 64391550
Depressive symptom 11.90 10.69 24 104494 4472 64389742
Social anxiety disorder 11.89 10.69 8 104510 442 64393772
Serotonin syndrome 11.86 10.69 29 104489 39253 64354961
Subdural haematoma 11.84 10.69 82 104436 27972 64366242
Alcohol abuse 11.78 10.69 25 104493 4827 64389387
Tumour marker abnormal 11.75 10.69 6 104512 197 64394017
Pharyngeal paraesthesia 11.73 10.69 15 104503 1902 64392312
Bacterial test 11.73 10.69 12 104506 1195 64393019
Pancreatic carcinoma recurrent 11.72 10.69 5 104513 108 64394106
Haemophagocytic lymphohistiocytosis 11.70 10.69 7 104511 17602 64376612
Treatment noncompliance 11.69 10.69 34 104484 43448 64350766
Lower gastrointestinal haemorrhage 11.67 10.69 4 104514 13935 64380279
Body temperature decreased 11.67 10.69 77 104441 25851 64368363
Oxygen saturation decreased 11.65 10.69 241 104277 106935 64287279
Therapy non-responder 11.64 10.69 61 104457 65838 64328376
Encephalitis 11.63 10.69 3 104515 12568 64381646
Granulomatous liver disease 11.60 10.69 12 104506 1210 64393004
Exhibitionism 11.60 10.69 4 104514 47 64394167
Psychiatric symptom 11.57 10.69 29 104489 6244 64387970
Bacillus bacteraemia 11.55 10.69 5 104513 112 64394102
Epstein-Barr virus infection 11.51 10.69 3 104515 12485 64381729
Phonophobia 11.42 10.69 8 104510 472 64393742
Decreased appetite 11.39 10.69 358 104160 280931 64113283
Tooth hypoplasia 11.37 10.69 6 104512 211 64394003
Total lung capacity decreased 11.37 10.69 14 104504 1708 64392506
Seizure 11.37 10.69 196 104322 166696 64227518
Anhedonia 11.36 10.69 4 104514 13702 64380512
Meningitis herpes 11.32 10.69 6 104512 213 64394001
Optic nerve cupping 11.24 10.69 4 104514 52 64394162
Cardiac failure 11.23 10.69 149 104369 132224 64261990
Throat irritation 11.19 10.69 91 104427 32620 64361594
Incoherent 11.18 10.69 31 104487 7087 64387127
Right ventricular failure 11.13 10.69 11 104507 21460 64372754
Drug screen positive 11.11 10.69 27 104491 5702 64388512
Antiphospholipid antibodies positive 11.06 10.69 9 104509 666 64393548
Injection site warmth 11.03 10.69 4 104514 13458 64380756
Urogenital haemorrhage 11.00 10.69 9 104509 671 64393543
Osteonecrosis 10.96 10.69 18 104500 28211 64366003
Paranoia 10.95 10.69 54 104464 16298 64377916
Toxic epidermal necrolysis 10.94 10.69 100 104418 37066 64357148
Maternal exposure during pregnancy 10.89 10.69 101 104417 95783 64298431
Chest wall mass 10.87 10.69 5 104513 130 64394084
Oliguria 10.86 10.69 5 104513 14571 64379643
Complement factor C4 decreased 10.85 10.69 6 104512 232 64393982
Loss of consciousness 10.83 10.69 316 104202 148049 64246165
Prothrombin time prolonged 10.83 10.69 6 104512 15735 64378479
Chills 10.76 10.69 157 104361 137107 64257107
Sensory level abnormal 10.73 10.69 5 104513 134 64394080
Vasomotor rhinitis 10.71 10.69 4 104514 60 64394154
Eye paraesthesia 10.71 10.69 4 104514 60 64394154
Bone density decreased 10.70 10.69 38 104480 9914 64384300

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC N05CF01 NERVOUS SYSTEM
PSYCHOLEPTICS
HYPNOTICS AND SEDATIVES
Benzodiazepine related drugs
MeSH PA D002491 Central Nervous System Agents
MeSH PA D002492 Central Nervous System Depressants
MeSH PA D006993 Hypnotics and Sedatives
CHEBI has role CHEBI:35488 central nervous system depressants
CHEBI has role CHEBI:35717 hypnotics

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Insomnia indication 193462001
Suicidal thoughts contraindication 6471006
Asthenia contraindication 13791008
Alcohol intoxication contraindication 25702006
Depressive disorder contraindication 35489007
Hepatic failure contraindication 59927004
Sleep automatism contraindication 247962006
Severe chronic obstructive pulmonary disease contraindication 313299006




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 7.95 Basic
pKa2 2.26 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
GABA A receptor alpha-5/beta-2/gamma-3 Ion channel POSITIVE MODULATOR Ki 6.75 WOMBAT-PK DRUG LABEL
GABA-A receptor alpha-1/beta-2/gamma-2 Ion channel POSITIVE MODULATOR Ki 7.18 WOMBAT-PK DRUG LABEL
GABA-A receptor alpha-5/beta-3/gamma-2 Ion channel POSITIVE MODULATOR Ki 7.28 WOMBAT-PK DRUG LABEL
GABA-A receptor alpha-1/beta-2/gamma-3 Ion channel POSITIVE MODULATOR Ki 7.16 WOMBAT-PK DRUG LABEL
GABA A receptor alpha-3/beta-2/gamma-2 Ion channel POSITIVE MODULATOR Ki 6.58 WOMBAT-PK DRUG LABEL
GABA A receptor alpha-3/beta-2/gamma-3 Ion channel POSITIVE MODULATOR Ki 6.49 WOMBAT-PK DRUG LABEL
GABA A receptor alpha-5/beta-3/gamma-3 Ion channel POSITIVE MODULATOR Ki 6.75 WOMBAT-PK DRUG LABEL
GABA A receptor alpha-5/beta-2/gamma-2 Ion channel POSITIVE MODULATOR Ki 7.28 WOMBAT-PK DRUG LABEL
GABA-A receptor; anion channel Ion channel IC50 7.54 CHEMBL

External reference:

IDSource
D01372 KEGG_DRUG
C1436328 UMLSCUI
CHEBI:53762 CHEBI
ZPC PDB_CHEM_ID
CHEMBL135400 ChEMBL_ID
DB01198 DRUGBANK_ID
C515050 MESH_SUPPLEMENTAL_RECORD_UI
5735 PUBCHEM_CID
7430 IUPHAR_LIGAND_ID
4462 INN_ID
03A5ORL08Q UNII
152527 RXNORM
003775 NDDF
321174005 SNOMEDCT_US
395929002 SNOMEDCT_US

Pharmaceutical products:

None