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

Stem definitionDrug idCAS RN
diazepam derivatives 2015 604-75-1

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • oxazepam
  • droxacepam
  • durazepam
  • noctazepam
  • tazepam
  • zaxopam
A benzodiazepine used in the treatment of anxiety, alcohol withdrawal, and insomnia.
  • Molecular weight: 286.72
  • Formula: C15H11ClN2O2
  • CLOGP: 2.31
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 2
  • TPSA: 61.69
  • ALOGS: -3.51
  • ROTB: 1

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
50 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.05 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 0.50 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 6.98 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 97 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.59 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 1.10 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.04 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 6.70 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
June 4, 1965 FDA

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
Toxicity to various agents 1395.16 13.89 1179 38105 246071 63203667
Depressed level of consciousness 1033.96 13.89 579 38705 61499 63388239
Coma 945.06 13.89 553 38731 63811 63385927
Orthostatic hypotension 937.38 13.89 454 38830 35706 63414032
Intentional overdose 882.78 13.89 557 38727 73595 63376143
Sedation complication 856.13 13.89 322 38962 13500 63436238
Sedation 854.16 13.89 436 38848 38373 63411365
Poisoning deliberate 822.86 13.89 296 38988 10922 63438816
Creatinine renal clearance decreased 814.83 13.89 325 38959 15983 63433755
Cognitive disorder 731.71 13.89 446 38838 55369 63394369
Blood calcium decreased 663.87 13.89 325 38959 26126 63423612
Fall 610.66 13.89 961 38323 391373 63058365
Hypotension 548.13 13.89 754 38530 271850 63177888
Balance disorder 543.25 13.89 436 38848 83986 63365752
Intentional self-injury 534.32 13.89 278 39006 25409 63424329
Somnolence 413.49 13.89 530 38754 178155 63271583
Suicide attempt 362.95 13.89 301 38983 60617 63389121
Drug abuse 338.82 13.89 312 38972 72206 63377532
Mobility decreased 304.82 13.89 375 38909 120784 63328954
Constipation 286.72 13.89 505 38779 224438 63225300
Hyponatraemia 285.75 13.89 349 38935 111551 63338187
Drug ineffective 239.12 13.89 180 39104 1044585 62405153
Overdose 238.94 13.89 324 38960 114754 63334984
Electrocardiogram QT prolonged 214.04 13.89 222 39062 59308 63390430
Drug interaction 201.23 13.89 440 38844 228691 63221047
Drug dependence 193.38 13.89 143 39141 24340 63425398
Miosis 177.32 13.89 88 39196 7265 63442473
Asphyxia 161.09 13.89 78 39206 6103 63443635
Bradycardia 157.71 13.89 210 39074 73017 63376721
Rash 146.19 13.89 83 39201 560788 62888950
Hepatocellular injury 143.91 13.89 126 39158 27255 63422483
Abdominal discomfort 137.75 13.89 18 39266 320867 63128871
Pneumonia aspiration 131.69 13.89 133 39151 34407 63415331
Confusional state 129.78 13.89 380 38904 236000 63213738
Prescription form tampering 121.23 13.89 34 39250 544 63449194
Drug intolerance 119.66 13.89 23 39261 308638 63141100
Drug hypersensitivity 114.58 13.89 26 39258 310661 63139077
Rhabdomyolysis 113.50 13.89 138 39146 43813 63405925
Inappropriate antidiuretic hormone secretion 110.31 13.89 85 39199 15377 63434361
Joint swelling 108.40 13.89 34 39250 327632 63122106
Arthralgia 104.98 13.89 119 39165 569591 62880147
Arthropathy 103.58 13.89 12 39272 234780 63214958
Product dose omission issue 103.31 13.89 12 39272 234301 63215437
Cholestasis 102.56 13.89 108 39176 29326 63420412
Respiratory depression 99.16 13.89 76 39208 13639 63436099
Sinusitis 98.95 13.89 12 39272 226641 63223097
Swelling 95.78 13.89 26 39258 275352 63174386
Hypothermia 95.44 13.89 74 39210 13507 63436231
Glossodynia 93.54 13.89 4 39280 178872 63270866
Pemphigus 93.21 13.89 5 39279 183721 63266017
Rheumatoid arthritis 92.04 13.89 22 39262 253797 63195941
Peripheral swelling 90.82 13.89 26 39258 265916 63183822
Hypersensitivity 88.84 13.89 35 39249 292650 63157088
Altered state of consciousness 88.66 13.89 93 39191 25137 63424601
Wrong patient received product 86.46 13.89 37 39247 2170 63447568
Aggression 85.05 13.89 88 39196 23410 63426328
Hallucination, visual 82.27 13.89 79 39205 19219 63430519
Bradypnoea 81.21 13.89 41 39243 3509 63446229
Contraindicated product administered 78.63 13.89 19 39265 217629 63232109
Poisoning 77.97 13.89 66 39218 13634 63436104
Headache 76.37 13.89 175 39109 633066 62816672
Acute kidney injury 76.36 13.89 344 38940 263071 63186667
Therapeutic product effect decreased 75.65 13.89 14 39270 193173 63256565
Alopecia 75.56 13.89 59 39225 337477 63112261
Hypokalaemia 73.02 13.89 183 39101 103621 63346117
Infusion related reaction 71.83 13.89 31 39253 245490 63204248
Victim of sexual abuse 69.32 13.89 23 39261 661 63449077
Lactic acidosis 69.22 13.89 101 39183 38186 63411552
Fatigue 68.11 13.89 301 38983 887727 62562011
Hand deformity 65.87 13.89 10 39274 159447 63290291
Bladder dilatation 64.24 13.89 23 39261 834 63448904
Wrong patient 64.24 13.89 17 39267 216 63449522
Reduced facial expression 64.20 13.89 29 39255 1937 63447801
Extrapyramidal disorder 63.58 13.89 58 39226 13226 63436512
Lower respiratory tract infection 62.96 13.89 5 39279 132302 63317436
Infection 62.32 13.89 32 39252 229141 63220597
Disturbance in attention 60.88 13.89 95 39189 38094 63411644
Multiple drug therapy 60.50 13.89 34 39250 3612 63446126
Intentional product misuse 60.26 13.89 123 39161 60794 63388944
Loss of consciousness 57.29 13.89 182 39102 117939 63331799
Mixed liver injury 57.25 13.89 36 39248 4699 63445039
Substance abuse 56.75 13.89 36 39248 4771 63444967
Akathisia 56.07 13.89 46 39238 9100 63440638
Mydriasis 54.89 13.89 51 39233 11905 63437833
Hyperthermia 53.94 13.89 45 39239 9111 63440627
Oxygen saturation decreased 53.93 13.89 148 39136 88437 63361301
Nasopharyngitis 53.70 13.89 47 39237 254210 63195528
Pericarditis 52.66 13.89 9 39275 131570 63318168
Agitation 52.54 13.89 115 39169 59642 63390096
Respiratory acidosis 52.50 13.89 39 39245 6676 63443062
Blister 51.69 13.89 9 39275 129805 63319933
Injection site pain 51.68 13.89 9 39275 129791 63319947
Listless 51.10 13.89 28 39256 2832 63446906
Urinary retention 50.57 13.89 77 39207 30224 63419514
Wound 50.36 13.89 19 39265 163244 63286494
Stomatitis 50.30 13.89 12 39272 138713 63311025
Benzodiazepine drug level increased 48.16 13.89 13 39271 179 63449559
Restlessness 47.96 13.89 74 39210 29379 63420359
Apathy 47.26 13.89 41 39243 8753 63440985
Victim of chemical submission 46.47 13.89 16 39268 516 63449222
Drug use disorder 45.96 13.89 32 39252 4952 63444786
Wheezing 44.41 13.89 4 39280 95591 63354147
On and off phenomenon 44.35 13.89 22 39262 1813 63447925
Back pain 43.45 13.89 60 39224 264085 63185653
Hypotonia 43.38 13.89 40 39244 9245 63440493
Neuroleptic malignant syndrome 43.35 13.89 45 39239 12011 63437727
Hepatic enzyme increased 43.19 13.89 37 39247 202291 63247447
Pneumonia 43.14 13.89 142 39142 456625 62993113
Cough 42.86 13.89 72 39212 292671 63157067
Suicidal ideation 42.77 13.89 109 39175 62312 63387426
Potentiating drug interaction 42.60 13.89 29 39255 4327 63445411
Off label use 42.22 13.89 245 39039 674217 62775521
Toxic epidermal necrolysis 41.74 13.89 64 39220 25270 63424468
Epilepsy 41.29 13.89 66 39218 26999 63422739
Serotonin syndrome 41.12 13.89 68 39216 28614 63421124
Faecal vomiting 40.33 13.89 15 39269 607 63449131
Tachycardia 40.10 13.89 162 39122 117994 63331744
Muscle rigidity 39.70 13.89 42 39242 11458 63438280
Pain in extremity 39.51 13.89 92 39192 331394 63118344
Disorientation 39.41 13.89 80 39204 39372 63410366
Haemodynamic instability 37.99 13.89 37 39247 9153 63440585
Behaviour disorder 37.87 13.89 24 39260 3175 63446563
Patient uncooperative 37.85 13.89 11 39273 201 63449537
Cardiac failure congestive 37.70 13.89 6 39278 92427 63357311
Prescription drug used without a prescription 36.24 13.89 21 39263 2365 63447373
Encephalopathy 35.86 13.89 76 39208 38544 63411194
Abnormal behaviour 35.12 13.89 54 39230 21372 63428366
Cardiogenic shock 34.89 13.89 49 39235 17883 63431855
Eosinophilia 34.04 13.89 55 39229 22701 63427037
Hypocoagulable state 33.78 13.89 16 39268 1191 63448547
COVID-19 33.49 13.89 14 39270 113089 63336649
Hyperkalaemia 33.41 13.89 91 39193 54112 63395626
Drug level above therapeutic 33.36 13.89 26 39258 4779 63444959
Small fibre neuropathy 33.11 13.89 12 39272 451 63449287
Housebound 32.50 13.89 10 39274 224 63449514
Delirium 32.31 13.89 86 39198 50455 63399283
Hypertonia 32.00 13.89 25 39259 4612 63445126
Hallucination 31.79 13.89 90 39194 54727 63395011
White blood cell count decreased 31.47 13.89 24 39260 139080 63310658
Hypoventilation 31.45 13.89 25 39259 4729 63445009
Psychomotor skills impaired 31.16 13.89 19 39265 2349 63447389
Chemical submission 30.66 13.89 10 39274 272 63449466
Blood cholesterol increased 30.60 13.89 10 39274 94022 63355716
Accidental overdose 30.42 13.89 53 39231 23256 63426482
Pyrexia 30.40 13.89 169 39115 470309 62979429
Pruritus 30.34 13.89 118 39166 361335 63088403
Hypereosinophilic syndrome 30.19 13.89 10 39274 286 63449452
Irritable bowel syndrome 30.12 13.89 7 39277 82405 63367333
Hypoaesthesia 30.00 13.89 36 39248 168357 63281381
Hepatic infiltration eosinophilic 29.32 13.89 6 39278 21 63449717
Blood thyroid stimulating hormone normal 29.32 13.89 8 39276 115 63449623
Neuropathy peripheral 29.23 13.89 17 39267 113650 63336088
Respiratory alkalosis 28.86 13.89 19 39265 2682 63447056
Foreign body 28.83 13.89 18 39266 2320 63447418
Therapy non-responder 28.64 13.89 6 39278 75895 63373843
Diarrhoea 28.62 13.89 294 38990 715072 62734666
Hypoventilation neonatal 28.49 13.89 6 39278 25 63449713
Drug withdrawal convulsions 28.39 13.89 15 39269 1410 63448328
Withdrawal syndrome 28.12 13.89 47 39237 19950 63429788
Upper respiratory tract infection 28.01 13.89 8 39276 82039 63367699
Prothrombin time ratio decreased 27.81 13.89 11 39273 527 63449211
Therapeutic response decreased 27.46 13.89 3 39281 61522 63388216
Chest pain 27.29 13.89 58 39226 215901 63233837
Parkinsonism 27.29 13.89 33 39251 10406 63439332
Freezing phenomenon 27.09 13.89 14 39270 1258 63448480
Urticaria 26.90 13.89 38 39246 165764 63283974
Impaired healing 26.85 13.89 15 39269 102527 63347211
Injection site erythema 26.79 13.89 9 39275 83165 63366573
Blood testosterone increased 26.76 13.89 8 39276 162 63449576
Disease progression 26.73 13.89 22 39262 122736 63327002
Antipsychotic drug level above therapeutic 26.69 13.89 13 39271 1030 63448708
Neurological examination abnormal 26.42 13.89 9 39275 281 63449457
Gastrointestinal disorder 25.63 13.89 26 39258 131213 63318525
Hepatic cytolysis 25.49 13.89 39 39245 15368 63434370
Injury 25.27 13.89 7 39277 73240 63376498
Adverse drug reaction 25.03 13.89 9 39275 79705 63370033
Psychomotor retardation 24.85 13.89 20 39264 3850 63445888
Stoma site erythema 24.49 13.89 13 39271 1234 63448504
Wrong rate 24.45 13.89 6 39278 55 63449683
Neurosensory hypoacusis 24.38 13.89 8 39276 222 63449516
Hallucination, synaesthetic 24.35 13.89 6 39278 56 63449682
Vertigo 24.34 13.89 87 39197 59800 63389938
Stoma site discharge 24.10 13.89 14 39270 1584 63448154
Asthma 24.09 13.89 26 39258 127535 63322203
Hepatitis 23.73 13.89 66 39218 39722 63410016
Antisocial behaviour 23.40 13.89 9 39275 400 63449338
Herpes zoster 23.17 13.89 11 39273 82451 63367287
Fibroma 23.13 13.89 11 39273 826 63448912
Sepsis 23.00 13.89 37 39247 153086 63296652
Respiratory distress 22.95 13.89 59 39225 33892 63415846
Foetal alcohol syndrome 22.52 13.89 5 39279 28 63449710
Liver injury 22.39 13.89 5 39279 60515 63389223
Pelvic fracture 22.38 13.89 34 39250 13314 63436424
Musculoskeletal pain 22.07 13.89 15 39269 92262 63357476
Therapeutic product effect incomplete 21.98 13.89 27 39257 125029 63324709
Analgesic drug level above therapeutic 21.98 13.89 7 39277 176 63449562
Medulloblastoma 21.69 13.89 5 39279 34 63449704
Dyspnoea 21.67 13.89 284 39000 661029 62788709
Foetal growth restriction 21.60 13.89 25 39259 7528 63442210
Drug level increased 21.40 13.89 45 39239 22691 63427047
Musculoskeletal stiffness 21.36 13.89 52 39232 184566 63265172
Ill-defined disorder 21.34 13.89 12 39272 81743 63367995
Product use issue 21.15 13.89 68 39216 220452 63229286
Psoriasis 20.98 13.89 14 39270 86943 63362795
Head discomfort 20.85 13.89 33 39251 13382 63436356
Gamma-glutamyltransferase increased 20.84 13.89 57 39227 33974 63415764
Vasoplegia syndrome 20.75 13.89 13 39271 1686 63448052
Fibromyalgia 20.71 13.89 12 39272 80408 63369330
Delusion 20.70 13.89 31 39253 11986 63437752
Concussion 20.63 13.89 27 39257 9217 63440521
Nausea 20.59 13.89 389 38895 854082 62595656
Platelet count decreased 20.49 13.89 25 39259 116097 63333641
Major depression 20.40 13.89 25 39259 7993 63441745
Apnoea 20.39 13.89 25 39259 7997 63441741
Electrocardiogram QRS complex abnormal 20.04 13.89 7 39277 236 63449502
Galactorrhoea 19.60 13.89 18 39266 4137 63445601
Injection site swelling 19.59 13.89 3 39281 47569 63402169
Needle track marks 19.55 13.89 4 39280 14 63449724
Sudden death 19.51 13.89 28 39256 10421 63439317
Feeling abnormal 19.46 13.89 39 39245 148353 63301385
Bezoar 19.45 13.89 12 39272 1514 63448224
Antidepressant drug level above therapeutic 19.37 13.89 8 39276 429 63449309
Cardioactive drug level above therapeutic 19.15 13.89 6 39278 143 63449595
Hypercapnia 19.04 13.89 20 39264 5411 63444327
Adverse event 18.99 13.89 9 39275 67550 63382188
Osteoarthritis 18.49 13.89 19 39265 95324 63354414
Genital paraesthesia 18.40 13.89 4 39280 20 63449718
Anal paraesthesia 18.40 13.89 4 39280 20 63449718
Retrograde amnesia 18.33 13.89 8 39276 492 63449246
Condition aggravated 18.29 13.89 160 39124 402057 63047681
Hepatic failure 18.24 13.89 56 39228 35600 63414138
Flushing 18.23 13.89 12 39272 75075 63374663
Salivary hypersecretion 18.06 13.89 23 39261 7643 63442095
Cholinergic syndrome 18.06 13.89 8 39276 510 63449228
Distributive shock 17.95 13.89 11 39273 1372 63448366
Shock haemorrhagic 17.73 13.89 26 39258 9869 63439869
Hospitalisation 17.61 13.89 16 39268 85065 63364673
Immobile 17.55 13.89 20 39264 5923 63443815
Hypercapnic coma 17.44 13.89 6 39278 193 63449545
Rash maculo-papular 17.17 13.89 51 39233 31845 63417893
Influenza like illness 17.17 13.89 10 39274 66814 63382924
Palatal swelling 17.12 13.89 5 39279 93 63449645
Frontotemporal dementia 17.12 13.89 7 39277 366 63449372
Poor quality sleep 17.10 13.89 38 39246 19897 63429841
Oropharyngeal pain 17.03 13.89 20 39264 94467 63355271
Hypopnoea 17.01 13.89 16 39268 3790 63445948
Dehydration 17.01 13.89 173 39111 173181 63276557
Megacolon 16.97 13.89 12 39272 1903 63447835
Nightmare 16.93 13.89 37 39247 19157 63430581
Adenocarcinoma metastatic 16.64 13.89 5 39279 103 63449635
Nasal congestion 16.62 13.89 10 39274 65650 63384088
Rhinorrhoea 16.58 13.89 10 39274 65567 63384171
Brain death 16.53 13.89 15 39269 3395 63446343
Antipsychotic drug level increased 16.44 13.89 15 39269 3420 63446318
Haematoma 16.27 13.89 53 39231 34767 63414971
Sinus tachycardia 16.23 13.89 42 39242 24226 63425512
Enanthema 16.22 13.89 7 39277 419 63449319
Lipohypertrophy 16.15 13.89 8 39276 657 63449081
Injection site reaction 16.14 13.89 8 39276 58516 63391222
Hyperkinesia 15.85 13.89 11 39273 1693 63448045
Pleurothotonus 15.67 13.89 10 39274 1339 63448399
Influenza 15.64 13.89 27 39257 108695 63341043
Medication error 15.63 13.89 69 39215 52215 63397523
Victim of crime 15.62 13.89 5 39279 128 63449610
Subileus 15.44 13.89 14 39270 3165 63446573
Genital neoplasm malignant female 15.40 13.89 5 39279 134 63449604
Maternal exposure during pregnancy 15.31 13.89 77 39207 219985 63229753
Fluid retention 15.23 13.89 9 39275 59677 63390061
Muscle spasms 15.07 13.89 48 39236 156102 63293636
Dyspepsia 15.05 13.89 25 39259 102171 63347567
Chondropathy 15.01 13.89 12 39272 2288 63447450
Thrombosis 14.86 13.89 11 39273 64744 63384994
Diarrhoea infectious 14.84 13.89 9 39275 1102 63448636
Adenocarcinoma gastric 14.75 13.89 7 39277 523 63449215
Migraine 14.57 13.89 26 39258 103320 63346418
Bradykinesia 14.55 13.89 17 39267 5171 63444567
Anterograde amnesia 14.54 13.89 7 39277 540 63449198
Pneumothorax traumatic 14.53 13.89 5 39279 161 63449577
Nephrolithiasis 14.50 13.89 4 39280 41980 63407758
Hyperammonaemic encephalopathy 14.41 13.89 12 39272 2422 63447316
Action tremor 14.37 13.89 6 39278 331 63449407
Amyotrophy 14.36 13.89 5 39279 167 63449571
Psychotic symptom 14.34 13.89 10 39274 1551 63448187
Labelled drug-food interaction medication error 14.03 13.89 5 39279 179 63449559
Mutism 13.95 13.89 10 39274 1620 63448118

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
Toxicity to various agents 1061.80 15.19 998 25037 199364 34731532
Drug abuse 796.39 15.19 628 25407 98468 34832428
Coma 687.70 15.19 426 25609 45252 34885644
Poisoning deliberate 399.28 15.19 167 25868 7677 34923219
Miosis 308.95 15.19 148 25887 9387 34921509
Drug dependence 307.12 15.19 203 25832 24014 34906882
Asphyxia 306.38 15.19 133 25902 6702 34924194
Overdose 220.96 15.19 304 25731 90755 34840141
Somnolence 220.22 15.19 337 25698 110779 34820117
Depressed level of consciousness 216.33 15.19 209 25826 42632 34888264
Poisoning 203.96 15.19 122 25913 12104 34918792
Intentional overdose 203.65 15.19 204 25831 43470 34887426
Drug use disorder 185.99 15.19 81 25954 4110 34926786
Aggression 172.49 15.19 177 25858 38787 34892109
Substance abuse 147.93 15.19 84 25951 7557 34923339
Suicide attempt 145.42 15.19 162 25873 38954 34891942
Logorrhoea 145.06 15.19 58 25977 2368 34928528
Altered state of consciousness 123.66 15.19 116 25919 22777 34908119
Hepatocellular injury 113.22 15.19 109 25926 22102 34908794
Abnormal behaviour 102.51 15.19 109 25926 24860 34906036
Agitation 98.19 15.19 163 25872 57236 34873660
Respiratory depression 96.84 15.19 87 25948 16158 34914738
Dysarthria 94.69 15.19 123 25912 34659 34896237
Restlessness 92.03 15.19 104 25931 25378 34905518
Confusional state 82.27 15.19 265 25770 143895 34787001
Intentional self-injury 78.64 15.19 72 25963 13699 34917197
Intentional product misuse 77.27 15.19 129 25906 45482 34885414
Alcohol abuse 73.54 15.19 45 25990 4645 34926251
Bradykinesia 73.20 15.19 42 25993 3851 34927045
Bezoar 70.35 15.19 28 26007 1129 34929767
Bradyphrenia 70.07 15.19 44 25991 4754 34926142
Mydriasis 69.04 15.19 51 25984 7186 34923710
Bradypnoea 68.31 15.19 36 25999 2793 34928103
Hypothermia 66.91 15.19 59 25976 10689 34920207
Drug interaction 63.08 15.19 333 25702 225613 34705283
Pneumonia aspiration 62.45 15.19 112 25923 41791 34889105
Dystonic tremor 62.16 15.19 17 26018 202 34930694
Bladder dilatation 60.27 15.19 27 26008 1465 34929431
Respiratory distress 56.60 15.19 98 25937 35567 34895329
Housebound 56.23 15.19 16 26019 222 34930674
Brain oedema 56.11 15.19 60 25975 13761 34917135
Hamartoma 55.99 15.19 12 26023 44 34930852
Disturbance in attention 55.92 15.19 82 25953 25863 34905033
Withdrawal syndrome 55.81 15.19 57 25978 12398 34918498
Drug screen positive 54.69 15.19 35 26000 3908 34926988
Product dose omission issue 53.21 15.19 12 26023 119699 34811197
Wrong patient received product 50.88 15.19 29 26006 2625 34928271
Platelet count decreased 49.35 15.19 14 26021 119703 34811193
Pulmonary oedema 49.09 15.19 109 25926 47420 34883476
Mania 49.06 15.19 47 25988 9464 34921432
Cardiac failure congestive 47.12 15.19 4 26031 83266 34847630
Respiratory acidosis 46.85 15.19 35 26000 5015 34925881
Fatigue 46.33 15.19 133 25902 370520 34560376
Accidental death 44.85 15.19 26 26009 2430 34928466
Oesophageal obstruction 44.30 15.19 16 26019 492 34930404
Homicide 44.25 15.19 19 26016 930 34929966
Hepatitis acute 43.90 15.19 40 25995 7561 34923335
Disorientation 43.54 15.19 84 25951 33104 34897792
Toxic epidermal necrolysis 41.79 15.19 65 25970 21581 34909315
Accidental overdose 41.03 15.19 62 25973 20078 34910818
Tardive dyskinesia 40.54 15.19 34 26001 5756 34925140
Nausea 39.56 15.19 126 25909 339782 34591114
Eosinophilic myocarditis 39.37 15.19 15 26020 537 34930359
Electrocardiogram QT prolonged 39.05 15.19 91 25944 40861 34890035
Melanoderma 38.56 15.19 11 26024 154 34930742
Drug hypersensitivity 37.99 15.19 7 26028 80522 34850374
Sedation 37.69 15.19 61 25974 20945 34909951
Pain 36.66 15.19 60 25975 204615 34726281
Hallucination, visual 36.57 15.19 55 25980 17736 34913160
Drug ineffective 36.52 15.19 196 25839 456555 34474341
Arthralgia 36.26 15.19 44 25991 169997 34760899
Tachycardia 35.54 15.19 141 25894 84631 34846265
Back pain 34.88 15.19 24 26011 121765 34809131
Rhabdomyolysis 33.23 15.19 119 25916 68044 34862852
Victim of crime 33.16 15.19 12 26023 371 34930525
Hyper IgE syndrome 33.16 15.19 8 26027 55 34930841
Troponin T increased 32.77 15.19 21 26014 2350 34928546
Reduced facial expression 32.50 15.19 16 26019 1075 34929821
Peripheral swelling 31.44 15.19 9 26026 76532 34854364
Hyperthermia 31.28 15.19 39 25996 10538 34920358
Pain in extremity 31.13 15.19 29 26006 126484 34804412
Behaviour disorder 30.65 15.19 27 26008 4883 34926013
Sepsis 30.59 15.19 48 25987 166513 34764383
Suicidal ideation 30.37 15.19 82 25953 40306 34890590
White blood cell count decreased 29.82 15.19 17 26018 95428 34835468
Oesophageal haemorrhage 29.64 15.19 16 26019 1302 34929594
Vasoplegia syndrome 29.59 15.19 18 26017 1838 34929058
Off label use 29.25 15.19 188 25847 419336 34511560
Psychotic behaviour 29.18 15.19 13 26022 696 34930200
Mixed liver injury 29.11 15.19 21 26014 2852 34928044
Status epilepticus 28.83 15.19 41 25994 12573 34918323
Cough 28.79 15.19 42 25993 150098 34780798
Neuropathy peripheral 28.75 15.19 13 26022 83250 34847646
Rash 28.43 15.19 79 25956 222673 34708223
Cardio-respiratory arrest 28.23 15.19 98 25937 55175 34875721
Pneumonia 28.16 15.19 157 25878 362470 34568426
Neuroleptic malignant syndrome 28.07 15.19 49 25986 17885 34913011
Substance use disorder 28.01 15.19 13 26022 766 34930130
Drug level increased 27.85 15.19 55 25980 22041 34908855
Diarrhoea 27.54 15.19 174 25861 389738 34541158
Hepatic cytolysis 27.24 15.19 43 25992 14453 34916443
Cholestasis 26.91 15.19 61 25974 26887 34904009
Foetal growth restriction 26.42 15.19 23 26012 4094 34926802
Hepatic fibrosis 26.12 15.19 24 26011 4583 34926313
Tongue biting 25.80 15.19 13 26022 918 34929978
Atonic seizures 25.35 15.19 9 26026 263 34930633
Urticaria chronic 25.16 15.19 7 26028 89 34930807
Dyskinesia 24.95 15.19 53 25982 22360 34908536
Food aversion 24.76 15.19 10 26025 419 34930477
Chest pain 24.75 15.19 35 26000 126727 34804169
Pulmonary congestion 24.73 15.19 40 25995 13725 34917171
Fall 24.68 15.19 245 25790 202640 34728256
Thrombosis 24.64 15.19 4 26031 50454 34880442
Hyperdynamic left ventricle 24.26 15.19 8 26027 186 34930710
Disease progression 24.06 15.19 27 26008 108050 34822846
COVID-19 23.95 15.19 14 26021 77536 34853360
Extrapyramidal disorder 23.92 15.19 38 25997 12842 34918054
Thinking abnormal 23.78 15.19 26 26009 6111 34924785
Cholestatic liver injury 23.31 15.19 17 26018 2347 34928549
Psychomotor hyperactivity 23.06 15.19 32 26003 9590 34921306
Hypoosmolar state 22.96 15.19 7 26028 125 34930771
Headache 22.84 15.19 75 25960 200560 34730336
Consciousness fluctuating 22.83 15.19 13 26022 1174 34929722
Pleurothotonus 22.65 15.19 13 26022 1192 34929704
Muscle rigidity 22.30 15.19 33 26002 10485 34920411
Constipation 21.94 15.19 43 25992 136939 34793957
Psychotic disorder 21.85 15.19 53 25982 24399 34906497
Hyponatraemia 21.70 15.19 120 25915 82571 34848325
Stomatitis 21.61 15.19 3 26032 42511 34888385
Urticaria 21.12 15.19 10 26025 62367 34868529
Hospitalisation 21.06 15.19 8 26027 56894 34874002
Cellulitis 20.36 15.19 7 26028 52944 34877952
Myoclonus 20.20 15.19 38 25997 14687 34916209
Visceral oedema 20.06 15.19 6 26029 100 34930796
Antasthmatic drug level 20.06 15.19 5 26030 40 34930856
Disturbance in social behaviour 19.83 15.19 14 26021 1837 34929059
Fluid replacement 19.77 15.19 7 26028 203 34930693
Analgesic drug level 19.74 15.19 5 26030 43 34930853
Muscle contracture 19.66 15.19 12 26023 1232 34929664
Hepatorenal syndrome 19.38 15.19 16 26019 2650 34928246
Therapy non-responder 19.35 15.19 3 26032 39143 34891753
Cognitive disorder 19.34 15.19 56 25979 28637 34902259
Neutrophil count decreased 19.23 15.19 7 26028 51097 34879799
Coordination abnormal 19.19 15.19 26 26009 7618 34923278
Otospondylomegaepiphyseal dysplasia 19.14 15.19 6 26029 118 34930778
N-terminal prohormone brain natriuretic peptide increased 19.12 15.19 16 26019 2699 34928197
Coagulation factor VII level decreased 19.09 15.19 6 26029 119 34930777
Pyrexia 18.93 15.19 158 25877 332855 34598041
Accidental poisoning 18.92 15.19 10 26025 780 34930116
Cardiac pacemaker evaluation 18.86 15.19 6 26029 124 34930772
Metabolic acidosis 18.57 15.19 73 25962 43607 34887289
Loss of consciousness 18.47 15.19 115 25920 82552 34848344
Obstructive pancreatitis 18.42 15.19 9 26026 595 34930301
Emotional disorder 18.40 15.19 22 26013 5694 34925202
Generalised onset non-motor seizure 18.39 15.19 4 26031 16 34930880
Analgesic drug level increased 18.17 15.19 10 26025 846 34930050
Blood disorder 18.10 15.19 17 26018 3337 34927559
Visceral congestion 18.06 15.19 9 26026 621 34930275
Apathy 18.05 15.19 24 26011 6908 34923988
Lactic acidosis 18.05 15.19 62 25973 34710 34896186
Rheumatoid nodule 17.98 15.19 16 26019 2931 34927965
Wrong patient 17.82 15.19 6 26029 149 34930747
Eye haematoma 17.80 15.19 5 26030 66 34930830
Delirium 17.48 15.19 72 25963 43919 34886977
Prescription form tampering 17.45 15.19 8 26027 458 34930438
Congestive hepatopathy 17.37 15.19 13 26022 1868 34929028
Patient uncooperative 17.30 15.19 8 26027 467 34930429
Joint swelling 16.87 15.19 12 26023 59878 34871018
Colitis ischaemic 16.22 15.19 22 26013 6453 34924443
Acute myocardial infarction 16.16 15.19 10 26025 53709 34877187
Oxygen saturation decreased 16.10 15.19 81 25954 53737 34877159
Dyspnoea 15.91 15.19 192 25843 376590 34554306
Spinal cord injury thoracic 15.87 15.19 5 26030 100 34930796
Vestibular disorder 15.78 15.19 10 26025 1097 34929799
Persecutory delusion 15.73 15.19 14 26021 2566 34928330
Priapism 15.71 15.19 19 26016 4975 34925921
Urinary tract infection 15.63 15.19 24 26011 84057 34846839
Prothrombin time shortened 15.52 15.19 11 26024 1453 34929443
Plasma cell myeloma 15.41 15.19 6 26029 42031 34888865
Judgement impaired 15.38 15.19 8 26027 604 34930292
Drug diversion 15.24 15.19 9 26026 870 34930026

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
Toxicity to various agents 2250.33 12.80 2110 57320 419430 79265528
Coma 1571.55 12.80 961 58469 99688 79585270
Poisoning deliberate 1157.57 12.80 459 58971 18369 79666589
Depressed level of consciousness 1092.58 12.80 754 58676 95898 79589060
Drug abuse 988.37 12.80 879 58551 161812 79523146
Sedation complication 798.62 12.80 334 59096 15335 79669623
Sedation 776.83 12.80 483 58947 51412 79633546
Orthostatic hypotension 741.81 12.80 483 58947 55681 79629277
Creatinine renal clearance decreased 739.84 12.80 335 59095 18667 79666291
Intentional overdose 659.61 12.80 581 58849 105379 79579579
Cognitive disorder 659.57 12.80 489 58941 69437 79615521
Blood calcium decreased 571.34 12.80 333 59097 31486 79653472
Somnolence 554.67 12.80 781 58649 238200 79446758
Fall 531.85 12.80 1140 58290 486489 79198469
Miosis 471.87 12.80 232 59198 15557 79669401
Balance disorder 457.46 12.80 460 58970 98397 79586561
Drug dependence 445.73 12.80 312 59118 40457 79644501
Asphyxia 422.76 12.80 196 59234 11524 79673434
Overdose 415.17 12.80 594 58836 183612 79501346
Hypotension 412.96 12.80 970 58460 439347 79245611
Suicide attempt 394.86 12.80 392 59038 82540 79602418
Intentional self-injury 347.12 12.80 245 59185 32174 79652784
Mobility decreased 282.39 12.80 399 59031 121776 79563182
Poisoning 279.88 12.80 195 59235 25077 79659881
Aggression 240.80 12.80 240 59190 50718 79634240
Hepatocellular injury 228.30 12.80 226 59204 47367 79637591
Electrocardiogram QT prolonged 215.93 12.80 300 59130 90086 79594872
Drug use disorder 214.28 12.80 112 59318 8539 79676419
Hyponatraemia 212.91 12.80 433 58997 177415 79507543
Drug interaction 202.35 12.80 724 58706 414459 79270499
Altered state of consciousness 195.34 12.80 200 59230 43622 79641336
Respiratory depression 194.99 12.80 163 59267 27467 79657491
Drug ineffective 183.88 12.80 329 59101 1080584 78604374
Confusional state 183.44 12.80 587 58843 317410 79367548
Pneumonia aspiration 171.60 12.80 230 59200 66737 79618221
Substance abuse 170.14 12.80 103 59327 10423 79674535
Constipation 164.56 12.80 524 58906 282526 79402432
Hypothermia 147.83 12.80 128 59302 22618 79662340
Arthralgia 136.68 12.80 135 59295 571668 79113290
Drug hypersensitivity 134.96 12.80 29 59401 298887 79386071
Rash 132.06 12.80 142 59288 578216 79106742
Intentional product misuse 131.14 12.80 246 59184 94919 79590039
Rhabdomyolysis 127.95 12.80 255 59175 102876 79582082
Wrong patient received product 126.54 12.80 64 59366 4554 79680404
Bradypnoea 123.76 12.80 69 59361 5983 79678975
Abnormal behaviour 123.55 12.80 144 59286 36277 79648681
Logorrhoea 121.09 12.80 61 59369 4304 79680654
Product dose omission issue 118.07 12.80 21 59409 247516 79437442
Bladder dilatation 117.48 12.80 48 59382 2071 79682887
Agitation 115.91 12.80 240 59190 99475 79585483
Bradycardia 115.03 12.80 288 59142 135269 79549689
Disturbance in attention 110.04 12.80 161 59269 50640 79634318
Joint swelling 109.78 12.80 39 59391 288607 79396351
Restlessness 109 12.80 153 59277 46339 79638619
Cholestasis 108.35 12.80 162 59268 51947 79633011
Peripheral swelling 106.76 12.80 34 59396 269583 79415375
Headache 105.43 12.80 205 59225 653567 79031391
Drug intolerance 103.36 12.80 34 59396 264085 79420873
Fatigue 100.11 12.80 357 59073 929370 78755588
Treatment failure 97.05 12.80 8 59422 170478 79514480
Abdominal discomfort 96.84 12.80 33 59397 250694 79434264
Sinusitis 96.74 12.80 15 59415 195486 79489472
Mydriasis 96.31 12.80 90 59340 17553 79667405
Respiratory acidosis 93.69 12.80 73 59357 11127 79673831
Hallucination, visual 89.35 12.80 116 59314 32613 79652345
Arthropathy 86.70 12.80 14 59416 177097 79507861
Housebound 86.02 12.80 26 59404 450 79684508
Rheumatoid arthritis 84.84 12.80 25 59405 208445 79476513
Swelling 82.85 12.80 29 59401 216682 79468276
Infusion related reaction 81.10 12.80 35 59395 230202 79454756
Alcohol abuse 80.34 12.80 50 59380 5313 79679645
Wrong patient 79.15 12.80 23 59407 345 79684613
Bezoar 78.80 12.80 39 59391 2649 79682309
Reduced facial expression 77.75 12.80 39 59391 2726 79682232
Dysarthria 77.67 12.80 162 59268 67460 79617498
Hyperthermia 76.17 12.80 80 59350 17957 79667001
Pain in extremity 76.07 12.80 96 59334 364442 79320516
Hypersensitivity 74.76 12.80 52 59378 262187 79422771
Lower respiratory tract infection 73.72 12.80 6 59424 129214 79555744
Therapeutic product effect decreased 73.70 12.80 16 59414 163847 79521111
Mixed liver injury 73.59 12.80 54 59376 7524 79677434
Inappropriate antidiuretic hormone secretion 72.98 12.80 94 59336 26219 79658739
Cardiac failure congestive 72.58 12.80 10 59420 142392 79542566
Back pain 72.32 12.80 72 59358 304108 79380850
Cough 72.04 12.80 101 59329 366688 79318270
Respiratory distress 72.01 12.80 144 59286 58195 79626763
Lactic acidosis 71.03 12.80 160 59270 70199 79614759
Systemic lupus erythematosus 70.88 12.80 5 59425 121144 79563814
Extrapyramidal disorder 70.86 12.80 86 59344 22593 79662365
Platelet count decreased 69.50 12.80 29 59401 194635 79490323
Off label use 67.33 12.80 399 59031 906816 78778142
Stomatitis 66.67 12.80 14 59416 146743 79538215
Behaviour disorder 65.89 12.80 47 59383 6266 79678692
Disorientation 65.89 12.80 145 59285 62631 79622327
Suicidal ideation 65.56 12.80 163 59267 76177 79608781
Oxygen saturation decreased 65.13 12.80 228 59202 128819 79556139
Toxic epidermal necrolysis 64.84 12.80 118 59312 44463 79640495
Glossodynia 64.32 12.80 3 59427 103334 79581624
Akathisia 63.61 12.80 63 59367 13196 79671762
Pneumonia 63.49 12.80 265 59165 659981 79024977
Apathy 62.89 12.80 62 59368 12915 79672043
Nasopharyngitis 62.77 12.80 58 59372 253823 79431135
Victim of sexual abuse 62.76 12.80 21 59409 511 79684447
Dystonic tremor 62.15 12.80 17 59413 202 79684756
Acute kidney injury 61.52 12.80 624 58806 518780 79166178
Contraindicated product administered 60.34 12.80 21 59409 157517 79527441
Bradykinesia 57.87 12.80 48 59382 7995 79676963
Accidental overdose 57.86 12.80 105 59325 39476 79645482
Infection 57.68 12.80 57 59373 241655 79443303
Loss of consciousness 56.87 12.80 262 59168 167681 79517277
White blood cell count decreased 56.82 12.80 35 59395 188253 79496705
Pericarditis 56.36 12.80 6 59424 104230 79580728
Neuroleptic malignant syndrome 56.30 12.80 85 59345 27474 79657484
Nausea 56.15 12.80 451 58979 956745 78728213
Pemphigus 55.77 12.80 5 59425 99577 79585381
Diarrhoea 55.32 12.80 407 59023 880082 78804876
Alopecia 54.69 12.80 55 59375 231300 79453658
Wheezing 53.25 12.80 11 59419 116653 79568305
COVID-19 52.36 12.80 26 59404 157648 79527310
Chest pain 52.22 12.80 81 59349 282223 79402735
Sepsis 52.07 12.80 75 59355 269353 79415605
Hand deformity 51.33 12.80 8 59422 103911 79581047
Multiple drug therapy 51.15 12.80 34 59396 4044 79680914
Injection site pain 50.25 12.80 17 59413 129821 79555137
Bradyphrenia 50.02 12.80 50 59380 10590 79674368
Patient uncooperative 49.47 12.80 19 59411 695 79684263
Pyrexia 49.46 12.80 300 59130 678409 79006549
Disease progression 49.37 12.80 39 59391 184323 79500635
Victim of crime 48.73 12.80 17 59413 471 79684487
Prescription form tampering 48.34 12.80 16 59414 376 79684582
Therapy non-responder 48.19 12.80 6 59424 92299 79592659
Withdrawal syndrome 48.15 12.80 78 59352 26776 79658182
Drug screen positive 47.45 12.80 38 59392 6025 79678933
Vasoplegia syndrome 47.31 12.80 31 59399 3599 79681359
Tachycardia 46.58 12.80 258 59172 177510 79507448
Urinary retention 45.58 12.80 118 59312 56512 79628446
Upper respiratory tract infection 45.07 12.80 7 59423 91161 79593797
Urticaria 44.95 12.80 43 59387 185158 79499800
Hepatic cytolysis 44.84 12.80 76 59354 27075 79657883
Neuropathy peripheral 44.41 12.80 25 59405 141280 79543678
Benzodiazepine drug level increased 43.12 12.80 13 59417 223 79684735
Victim of chemical submission 42.93 12.80 16 59414 538 79684420
Drug level above therapeutic 42.87 12.80 42 59388 8681 79676277
Hypokalaemia 42.48 12.80 216 59214 143824 79541134
Brain oedema 42.09 12.80 71 59359 25192 79659766
Drug level increased 42.07 12.80 92 59338 39559 79645399
Dyspnoea 41.79 12.80 423 59007 856602 78828356
Serotonin syndrome 41.70 12.80 99 59331 44928 79640030
Hypoaesthesia 39.74 12.80 45 59385 179307 79505651
Pulmonary oedema 39.50 12.80 150 59280 88104 79596854
Pruritus 38.72 12.80 157 59273 394491 79290467
Prothrombin time ratio decreased 38.18 12.80 17 59413 908 79684050
Homicide 37.14 12.80 18 59412 1168 79683790
Pleurothotonus 36.54 12.80 23 59407 2493 79682465
Listless 36.33 12.80 27 59403 3834 79681124
Accidental death 35.96 12.80 28 59402 4263 79680695
Hepatic enzyme increased 35.10 12.80 51 59379 182559 79502399
Hepatitis acute 34.72 12.80 50 59380 15492 79669466
Haemodynamic instability 34.64 12.80 53 59377 17329 79667629
Delirium 33.96 12.80 139 59291 84488 79600470
Weight increased 33.48 12.80 101 59329 277285 79407673
Oesophageal obstruction 33.42 12.80 16 59414 1010 79683948
Asthma 33.20 12.80 31 59399 135064 79549894
Psychomotor skills impaired 33.07 12.80 29 59401 5208 79679750
Blister 32.32 12.80 25 59405 119451 79565507
Neutrophil count decreased 31.94 12.80 15 59415 93944 79591014
Wound 31.82 12.80 24 59406 116155 79568803
Eosinophilia 31.00 12.80 89 59341 45256 79639702
Thrombosis 30.86 12.80 12 59418 84088 79600870
Cardio-respiratory arrest 30.79 12.80 161 59269 108349 79576609
Cholestatic liver injury 30.48 12.80 27 59403 4914 79680044
Hypoventilation 30.43 12.80 32 59398 7192 79677766
Hypertonia 30.40 12.80 32 59398 7200 79677758
Urinary tract infection 30.30 12.80 104 59326 274408 79410550
Potentiating drug interaction 30.12 12.80 35 59395 8784 79676174
Mania 30.00 12.80 51 59379 18209 79666749
Status epilepticus 29.93 12.80 61 59369 24980 79659978
Impaired healing 29.78 12.80 14 59416 87641 79597317
Encephalopathy 29.70 12.80 114 59316 67283 79617675
Delusion 29.62 12.80 54 59376 20369 79664589
Troponin T increased 29.55 12.80 23 59407 3499 79681459
Muscle rigidity 29.38 12.80 53 59377 19829 79665129
Small fibre neuropathy 29.02 12.80 12 59418 534 79684424
Injection site erythema 28.96 12.80 11 59419 78186 79606772
Gastrointestinal disorder 28.92 12.80 29 59401 122176 79562782
Melanoderma 28.73 12.80 11 59419 399 79684559
Epilepsy 28.72 12.80 81 59349 40779 79644179
Oropharyngeal pain 28.18 12.80 24 59406 109329 79575629
Myoclonus 28.01 12.80 63 59367 27597 79657361
Nasal congestion 27.96 12.80 11 59419 76541 79608417
Eosinophilic myocarditis 27.94 12.80 15 59415 1207 79683751
Dry skin 27.92 12.80 8 59422 67987 79616971
Hospitalisation 27.75 12.80 18 59412 94218 79590740
Blood thyroid stimulating hormone normal 27.72 12.80 8 59422 117 79684841
Subileus 27.37 12.80 27 59403 5627 79679331
Feeling abnormal 27.25 12.80 48 59382 159151 79525807
Therapeutic response decreased 27.21 12.80 8 59422 66845 79618113
Flushing 27.18 12.80 16 59414 88252 79596706
Influenza 27.12 12.80 34 59396 129572 79555386
Chemical submission 27.10 12.80 10 59420 327 79684631
Persecutory delusion 26.71 12.80 25 59405 4884 79680074
Faecal vomiting 26.27 12.80 14 59416 1110 79683848
Irritable bowel syndrome 26.16 12.80 7 59423 62234 79622724
Substance use disorder 25.70 12.80 13 59417 925 79684033
Fluid retention 25.55 12.80 10 59420 69799 79615159
Victim of homicide 24.93 12.80 8 59422 170 79684788
Injection site swelling 24.75 12.80 3 59427 47129 79637829
Gamma-glutamyltransferase increased 24.51 12.80 93 59337 54587 79630371
Drug withdrawal convulsions 24.26 12.80 17 59413 2203 79682755
Therapeutic product effect incomplete 23.98 12.80 43 59387 141602 79543356
Red blood cell sedimentation rate increased 23.94 12.80 3 59427 45939 79639019
Dyspnoea exertional 23.83 12.80 18 59412 87055 79597903
Myocardial infarction 23.70 12.80 65 59365 184064 79500894
Hepatitis 23.53 12.80 93 59337 55634 79629324
Psychotic behaviour 23.43 12.80 13 59417 1116 79683842
Chills 23.40 12.80 53 59377 160181 79524777
Abdominal distension 23.39 12.80 33 59397 119617 79565341
Vascular purpura 23.36 12.80 19 59411 3079 79681879
Hypercapnia 23.34 12.80 31 59399 8904 79676054
Mutism 23.25 12.80 17 59413 2355 79682603
Hypoosmolar state 23.21 12.80 9 59421 338 79684620
Rhinorrhoea 23.13 12.80 14 59416 76060 79608898
Agranulocytosis 23.08 12.80 80 59350 44950 79640008
Antipsychotic drug level above therapeutic 22.90 12.80 16 59414 2064 79682894
Hypotonia 22.55 12.80 37 59393 12833 79672125
Dyskinesia 22.47 12.80 79 59351 44694 79640264
Cellulitis 22.41 12.80 29 59401 109031 79575927
Hypereosinophilic syndrome 22.39 12.80 10 59420 538 79684420
Hypocoagulable state 22.36 12.80 16 59414 2143 79682815
Hallucination, synaesthetic 22.36 12.80 6 59424 66 79684892
Mesenteric vein thrombosis 22.35 12.80 15 59415 1812 79683146
Fibromyalgia 22.29 12.80 10 59420 64330 79620628
Wrong rate 22.19 12.80 6 59424 68 79684890
Blood glucose increased 22.19 12.80 32 59398 114943 79570015
Cytomegalovirus infection 21.71 12.80 3 59427 42641 79642317
Major depression 21.70 12.80 30 59400 8950 79676008
Psychotic disorder 21.60 12.80 74 59356 41328 79643630
Injection site pruritus 21.46 12.80 3 59427 42280 79642678
Food aversion 21.41 12.80 12 59418 1051 79683907
Cerebrovascular accident 21.37 12.80 53 59377 155239 79529719
Psychomotor hyperactivity 21.28 12.80 42 59388 16807 79668151
Accidental poisoning 21.23 12.80 14 59416 1643 79683315
Hyperkalaemia 21.18 12.80 152 59278 114246 79570712
Asthenia 21.12 12.80 262 59168 511427 79173531
Pancreatitis acute 21.12 12.80 83 59347 49521 79635437
Cataract 20.98 12.80 10 59420 62110 79622848
Muscle spasms 20.79 12.80 64 59366 174666 79510292
Injection site bruising 20.60 12.80 3 59427 40999 79643959
Tachyphrenia 20.60 12.80 15 59415 2065 79682893
On and off phenomenon 20.58 12.80 18 59412 3222 79681736
Wrong technique in product usage process 20.57 12.80 15 59415 73860 79611098
Throat irritation 20.56 12.80 3 59427 40943 79644015
Adverse drug reaction 20.49 12.80 12 59418 66380 79618578
Metabolic acidosis 20.42 12.80 118 59312 82411 79602547
Oesophageal haemorrhage 20.41 12.80 14 59416 1753 79683205
Sudden death 20.31 12.80 49 59381 22462 79662496
Foreign body 20.26 12.80 17 59413 2877 79682081
Full blood count abnormal 20.25 12.80 3 59427 40471 79644487
Musculoskeletal stiffness 20.20 12.80 65 59365 174943 79510015
Myelosuppression 20.13 12.80 3 59427 40293 79644665
Single umbilical artery 20.10 12.80 4 59426 9 79684949
Antasthmatic drug level 20.06 12.80 5 59425 40 79684918
Erythema 19.93 12.80 92 59338 223198 79461760
Analgesic drug level 19.53 12.80 5 59425 45 79684913
Abdominal pain upper 19.52 12.80 93 59337 223726 79461232
Weight decreased 19.51 12.80 170 59260 355028 79329930
Visceral oedema 19.48 12.80 6 59424 111 79684847
Migraine 19.32 12.80 22 59408 87471 79597487
Psoriasis 19.27 12.80 23 59407 89564 79595394
Psychotic symptom 19.20 12.80 16 59414 2681 79682277
Neurosensory hypoacusis 19.14 12.80 7 59423 223 79684735
Chronic kidney disease 18.98 12.80 13 59417 66141 79618817
Drug withdrawal syndrome 18.95 12.80 63 59367 34655 79650303
Prescription drug used without a prescription 18.84 12.80 19 59411 4066 79680892
Contusion 18.78 12.80 53 59377 148723 79536235
Galactorrhoea 18.75 12.80 18 59412 3628 79681330
Hyperdynamic left ventricle 18.56 12.80 8 59422 395 79684563
Cardiac pacemaker evaluation 18.54 12.80 6 59424 131 79684827
Neurological examination abnormal 18.51 12.80 9 59421 588 79684370
Irritability 18.46 12.80 70 59360 41074 79643884
Arthritis 18.45 12.80 36 59394 114844 79570114
Retrograde amnesia 18.40 12.80 9 59421 596 79684362
Hallucination 18.30 12.80 118 59312 85627 79599331
Therapy cessation 18.30 12.80 3 59427 37559 79647399
Injection site reaction 18.23 12.80 9 59421 54776 79630182
Coordination abnormal 18.17 12.80 40 59390 17272 79667686
Tongue biting 18.12 12.80 14 59416 2107 79682851
Lung disorder 17.90 12.80 112 59318 80445 79604513
Decreased appetite 17.87 12.80 166 59264 342252 79342706
Haematocrit decreased 17.66 12.80 12 59418 61300 79623658
Antipsychotic drug level increased 17.65 12.80 22 59408 5935 79679023
Ill-defined disorder 17.54 12.80 14 59416 65861 79619097
Megacolon 17.50 12.80 17 59413 3478 79681480
Anal paraesthesia 17.50 12.80 4 59426 21 79684937
Disturbance in social behaviour 17.43 12.80 20 59410 4950 79680008
Acute myocardial infarction 17.41 12.80 19 59411 77017 79607941
Haematochezia 17.30 12.80 24 59406 87621 79597337
Drug resistance 17.27 12.80 5 59425 42208 79642750
Hypovolaemic shock 17.22 12.80 32 59398 12244 79672714
Distributive shock 17.21 12.80 15 59415 2672 79682286
Rash maculo-papular 17.15 12.80 85 59345 55993 79628965
Osteoarthritis 17.15 12.80 24 59406 87285 79597673
Acute generalised exanthematous pustulosis 17.14 12.80 39 59391 17215 79667743
Hepatic fibrosis 17.12 12.80 24 59406 7256 79677702
Influenza like illness 16.98 12.80 17 59413 71690 79613268
Herpes zoster 16.91 12.80 27 59403 93056 79591902
Poor feeding infant 16.91 12.80 6 59424 175 79684783
Opiates positive 16.68 12.80 10 59420 994 79683964
Loss of personal independence in daily activities 16.60 12.80 32 59398 102548 79582410
Medulloblastoma 16.46 12.80 5 59425 88 79684870
Atonic seizures 16.27 12.80 9 59421 768 79684190
Salivary hypersecretion 16.23 12.80 34 59396 14190 79670768
Hepatic failure 16.12 12.80 89 59341 61123 79623835
Pelvic fracture 16.11 12.80 31 59399 12173 79672785
Chest discomfort 16.11 12.80 51 59379 137993 79546965
Coronary artery disease 16.11 12.80 15 59415 65459 79619499
Plasma cell myeloma 15.91 12.80 10 59420 53249 79631709
Hyper IgE syndrome 15.90 12.80 8 59422 563 79684395
Atopic keratoconjunctivitis 15.83 12.80 4 59426 34 79684924
Phlebotomy 15.82 12.80 5 59425 101 79684857
Adverse event 15.78 12.80 13 59417 60201 79624757
Red blood cell count decreased 15.59 12.80 12 59418 57501 79627457
Priapism 15.59 12.80 18 59412 4487 79680471
Oedema peripheral 15.56 12.80 117 59313 252171 79432787
Stress 15.52 12.80 22 59408 79590 79605368
Psychomotor retardation 15.46 12.80 21 59409 6163 79678795
Coagulation factor VII level decreased 15.45 12.80 6 59424 226 79684732
Pleural effusion 15.37 12.80 56 59374 145206 79539752
Shock haemorrhagic 15.32 12.80 41 59389 20019 79664939
Fungal infection 15.24 12.80 6 59424 41742 79643216
Anuria 15.16 12.80 42 59388 20921 79664037
Inappropriate schedule of product administration 15.16 12.80 50 59380 133578 79551380
Obstructive pancreatitis 15.13 12.80 9 59421 881 79684077
Bursitis 15.12 12.80 4 59426 35840 79649118
Analgesic drug level increased 15.06 12.80 15 59415 3163 79681795
Hypercapnic coma 15.00 12.80 7 59423 417 79684541
Muscle contracture 14.97 12.80 13 59417 2304 79682654
Theft 14.95 12.80 6 59424 247 79684711
Spinal cord injury thoracic 14.89 12.80 5 59425 123 79684835
Cardioactive drug level above therapeutic 14.88 12.80 6 59424 250 79684708
Subcutaneous haematoma 14.84 12.80 14 59416 2763 79682195
Vertigo 14.70 12.80 95 59335 68987 79615971
Consciousness fluctuating 14.69 12.80 12 59418 1957 79683001
Drug diversion 14.67 12.80 10 59420 1240 79683718
Action tremor 14.64 12.80 7 59423 441 79684517
Pulmonary congestion 14.63 12.80 49 59381 27051 79657907
Antidepressant drug level above therapeutic 14.63 12.80 8 59422 668 79684290
Mental status changes 14.60 12.80 17 59413 66942 79618016
Blood cholesterol increased 14.54 12.80 25 59405 83695 79601263
Visceral congestion 14.54 12.80 9 59421 947 79684011
Respiratory alkalosis 14.54 12.80 17 59413 4294 79680664
Blood pressure increased 14.51 12.80 95 59335 211265 79473693
Haematoma 14.49 12.80 77 59353 52118 79632840
Colitis ischaemic 14.47 12.80 34 59396 15325 79669633
Anterograde amnesia 14.46 12.80 8 59422 683 79684275
Genital paraesthesia 14.44 12.80 4 59426 50 79684908
Foetal alcohol syndrome 14.22 12.80 4 59426 53 79684905
High-pitched crying 14.22 12.80 3 59427 10 79684948
Maternal exposure during pregnancy 14.21 12.80 53 59377 136485 79548473
Aspiration 14.20 12.80 40 59390 20118 79664840
White blood cell count increased 14.18 12.80 21 59409 74612 79610346
Antisocial behaviour 14.14 12.80 8 59422 713 79684245
Tardive dyskinesia 14.14 12.80 27 59403 10544 79674414
Analgesic drug level above therapeutic 14.05 12.80 7 59423 482 79684476
Musculoskeletal pain 14.03 12.80 35 59395 102319 79582639
Liver injury 13.89 12.80 13 59417 56601 79628357
Parkinsonism 13.80 12.80 35 59395 16549 79668409
Palatal swelling 13.71 12.80 5 59425 158 79684800
Eye haematoma 13.56 12.80 5 59425 163 79684795
Tongue neoplasm malignant stage unspecified 13.50 12.80 9 59421 1075 79683883
Drug ineffective for unapproved indication 13.50 12.80 11 59419 51227 79633731
Fluid replacement 13.43 12.80 7 59423 530 79684428
Product administration error 13.32 12.80 53 59377 31793 79653165
Wrong product administered 13.28 12.80 24 59406 8988 79675970
Hypopnoea 13.18 12.80 18 59412 5311 79679647
Liver disorder 13.16 12.80 21 59409 72396 79612562
Hepatorenal syndrome 13.09 12.80 16 59414 4233 79680725
Product use issue 13.08 12.80 97 59333 209725 79475233
Myalgia 12.97 12.80 83 59347 185558 79499400
Affect lability 12.95 12.80 27 59403 11232 79673726
Adenocarcinoma metastatic 12.94 12.80 5 59425 186 79684772
Post-injection delirium sedation syndrome 12.87 12.80 7 59423 578 79684380

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC N05BA04 NERVOUS SYSTEM
PSYCHOLEPTICS
ANXIOLYTICS
Benzodiazepine derivatives
FDA CS M0002356 Benzodiazepines
MeSH PA D014151 Anti-Anxiety Agents
MeSH PA D002491 Central Nervous System Agents
MeSH PA D002492 Central Nervous System Depressants
MeSH PA D018682 GABA Agents
MeSH PA D018757 GABA Modulators
MeSH PA D006993 Hypnotics and Sedatives
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D011619 Psychotropic Drugs
MeSH PA D014149 Tranquilizing Agents
CHEBI has role CHEBI:35474 anti-anxiety agents
CHEBI has role CHEBI:35703 Xenobiotic
CHEBI has role CHEBI:78298 environmental contaminants
FDA EPC N0000175694 Benzodiazepine

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

DiseaseRelationSNOMED_IDDOID
Alcohol withdrawal delirium indication 8635005
Anxiety indication 48694002
Suicidal thoughts contraindication 6471006
Disorder of lung contraindication 19829001 DOID:850
Borderline personality disorder contraindication 20010003 DOID:10930
Alcohol intoxication contraindication 25702006
Shock contraindication 27942005
Depressive disorder contraindication 35489007
Low blood pressure contraindication 45007003
Substance abuse contraindication 66214007
Psychotic disorder contraindication 69322001
Sleep apnea contraindication 73430006 DOID:0050847
Decreased respiratory function contraindication 80954004
Kidney disease contraindication 90708001 DOID:557
Hypoalbuminemia contraindication 119247004
Disease of liver contraindication 235856003 DOID:409
Sleep automatism contraindication 247962006
Syncope contraindication 271594007
Pregnancy, function contraindication 289908002
Coma contraindication 371632003
Porphyria contraindication 418470004
Behavioral Disorders contraindication




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 9.41 acidic
pKa2 11.87 acidic
pKa3 1.83 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-1/beta-3/gamma-2 Ion channel POSITIVE ALLOSTERIC MODULATOR IC50 7.75 WOMBAT-PK CHEMBL

External reference:

IDSource
4018020 VUID
N0000146364 NUI
D00464 KEGG_DRUG
4018020 VANDF
C0029997 UMLSCUI
CHEBI:7823 CHEBI
CHEMBL568 ChEMBL_ID
DB00842 DRUGBANK_ID
D010076 MESH_DESCRIPTOR_UI
4616 PUBCHEM_CID
7253 IUPHAR_LIGAND_ID
1507 INN_ID
6GOW6DWN2A UNII
7781 RXNORM
4493 MMSL
5211 MMSL
d00040 MMSL
001462 NDDF
387455006 SNOMEDCT_US
79225003 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Oxazepam HUMAN PRESCRIPTION DRUG LABEL 1 0228-2067 CAPSULE, GELATIN COATED 10 mg ORAL ANDA 21 sections
Oxazepam HUMAN PRESCRIPTION DRUG LABEL 1 0228-2067 CAPSULE, GELATIN COATED 10 mg ORAL ANDA 21 sections
Oxazepam HUMAN PRESCRIPTION DRUG LABEL 1 0228-2067 CAPSULE, GELATIN COATED 10 mg ORAL ANDA 21 sections
Oxazepam HUMAN PRESCRIPTION DRUG LABEL 1 0228-2069 CAPSULE, GELATIN COATED 15 mg ORAL ANDA 21 sections
Oxazepam HUMAN PRESCRIPTION DRUG LABEL 1 0228-2069 CAPSULE, GELATIN COATED 15 mg ORAL ANDA 21 sections
Oxazepam HUMAN PRESCRIPTION DRUG LABEL 1 0228-2069 CAPSULE, GELATIN COATED 15 mg ORAL ANDA 21 sections
Oxazepam HUMAN PRESCRIPTION DRUG LABEL 1 0228-2073 CAPSULE, GELATIN COATED 30 mg ORAL ANDA 21 sections
Oxazepam HUMAN PRESCRIPTION DRUG LABEL 1 0228-2073 CAPSULE, GELATIN COATED 30 mg ORAL ANDA 21 sections
Oxazepam HUMAN PRESCRIPTION DRUG LABEL 1 0228-2073 CAPSULE, GELATIN COATED 30 mg ORAL ANDA 21 sections
OXAZEPAM HUMAN PRESCRIPTION DRUG LABEL 1 16590-304 CAPSULE 15 mg ORAL ANDA 13 sections
Oxazepam HUMAN PRESCRIPTION DRUG LABEL 1 43353-074 CAPSULE, GELATIN COATED 30 mg ORAL ANDA 19 sections
Oxazepam HUMAN PRESCRIPTION DRUG LABEL 1 43353-965 CAPSULE 10 mg ORAL ANDA 20 sections
Oxazepam HUMAN PRESCRIPTION DRUG LABEL 1 43353-980 CAPSULE 30 mg ORAL ANDA 20 sections
Oxazepam HUMAN PRESCRIPTION DRUG LABEL 1 52817-290 CAPSULE 10 mg ORAL ANDA 21 sections
Oxazepam HUMAN PRESCRIPTION DRUG LABEL 1 52817-291 CAPSULE 15 mg ORAL ANDA 21 sections
Oxazepam HUMAN PRESCRIPTION DRUG LABEL 1 52817-292 CAPSULE 30 mg ORAL ANDA 21 sections
Oxazepam HUMAN PRESCRIPTION DRUG LABEL 1 62584-812 CAPSULE, GELATIN COATED 10 mg ORAL ANDA 25 sections
Oxazepam HUMAN PRESCRIPTION DRUG LABEL 1 62584-812 CAPSULE, GELATIN COATED 10 mg ORAL ANDA 25 sections
Oxazepam HUMAN PRESCRIPTION DRUG LABEL 1 62584-813 CAPSULE, GELATIN COATED 15 mg ORAL ANDA 25 sections
Oxazepam HUMAN PRESCRIPTION DRUG LABEL 1 62584-813 CAPSULE, GELATIN COATED 15 mg ORAL ANDA 25 sections
Oxazepam HUMAN PRESCRIPTION DRUG LABEL 1 62584-814 CAPSULE, GELATIN COATED 30 mg ORAL ANDA 25 sections
Oxazepam HUMAN PRESCRIPTION DRUG LABEL 1 62584-814 CAPSULE, GELATIN COATED 30 mg ORAL ANDA 25 sections
Oxazepam HUMAN PRESCRIPTION DRUG LABEL 1 67544-117 CAPSULE, GELATIN COATED 10 mg ORAL ANDA 19 sections
Oxazepam HUMAN PRESCRIPTION DRUG LABEL 1 67544-268 CAPSULE, GELATIN COATED 15 mg ORAL ANDA 19 sections
Oxazepam HUMAN PRESCRIPTION DRUG LABEL 1 71610-639 CAPSULE 15 mg ORAL ANDA 21 sections