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 1073.58 13.76 982 32674 211517 50359951
Depressed level of consciousness 788.96 13.76 468 33188 51485 50519983
Intentional overdose 778.34 13.76 496 33160 62008 50509460
Coma 714.62 13.76 454 33202 56425 50515043
Orthostatic hypotension 677.06 13.76 349 33307 29132 50542336
Sedation 619.44 13.76 333 33323 30277 50541191
Sedation complication 610.82 13.76 227 33429 8539 50562929
Creatinine renal clearance decreased 560.73 13.76 232 33424 11649 50559819
Poisoning deliberate 537.03 13.76 201 33455 7711 50563757
Cognitive disorder 526.19 13.76 341 33315 43782 50527686
Intentional self-injury 525.89 13.76 272 33384 22840 50548628
Fall 455.80 13.76 804 32852 334128 50237340
Blood calcium decreased 437.69 13.76 232 33424 20474 50550994
Hypotension 377.76 13.76 609 33047 234860 50336608
Somnolence 360.50 13.76 478 33178 154507 50416961
Balance disorder 357.75 13.76 328 33328 70262 50501206
Suicide attempt 313.25 13.76 266 33390 51466 50520002
Hyponatraemia 266.74 13.76 324 33332 95815 50475653
Mobility decreased 232.45 13.76 276 33380 79672 50491796
Drug abuse 217.33 13.76 232 33424 59614 50511854
Drug ineffective 203.76 13.76 150 33506 819183 49752285
Overdose 190.27 13.76 280 33376 99447 50472021
Constipation 180.70 13.76 388 33268 185320 50386148
Electrocardiogram QT prolonged 177.60 13.76 195 33461 51691 50519777
Drug dependence 160.94 13.76 121 33535 19638 50551830
Miosis 145.51 13.76 75 33581 6235 50565233
Drug interaction 134.67 13.76 362 33294 199259 50372209
Bradycardia 131.69 13.76 187 33469 64239 50507229
Hepatocellular injury 130.13 13.76 120 33536 25827 50545641
Asphyxia 126.57 13.76 65 33591 5362 50566106
Confusional state 122.19 13.76 334 33322 185594 50385874
Prescription form tampering 119.39 13.76 34 33622 534 50570934
Rash 108.33 13.76 80 33576 437391 50134077
Cholestasis 105.68 13.76 106 33550 25295 50546173
Rhabdomyolysis 102.35 13.76 128 33528 38899 50532569
Pneumonia aspiration 101.68 13.76 114 33542 30890 50540578
Drug hypersensitivity 100.67 13.76 22 33634 250988 50320480
Abdominal discomfort 97.69 13.76 18 33638 231623 50339845
Product dose omission issue 89.98 13.76 9 33647 183829 50387639
Hypothermia 87.79 13.76 69 33587 11947 50559521
Inappropriate antidiuretic hormone secretion 86.52 13.76 71 33585 13072 50558396
Drug intolerance 86.24 13.76 20 33636 219084 50352384
Respiratory depression 83.54 13.76 67 33589 11943 50559525
Arthralgia 82.05 13.76 103 33553 438599 50132869
Rheumatoid arthritis 78.70 13.76 19 33637 202531 50368937
Peripheral swelling 78.69 13.76 20 33636 205916 50365552
Joint swelling 77.65 13.76 33 33623 245253 50326215
Swelling 75.81 13.76 20 33636 200852 50370616
Sinusitis 74.63 13.76 12 33644 170546 50400922
Lactic acidosis 72.86 13.76 100 33556 33255 50538213
Hallucination, visual 72.30 13.76 71 33585 16511 50554957
Aggression 71.56 13.76 79 33577 21037 50550431
Arthropathy 69.33 13.76 11 33645 157895 50413573
Hypokalaemia 68.93 13.76 169 33487 87823 50483645
Hypersensitivity 68.00 13.76 29 33627 215132 50356336
Bladder dilatation 64.80 13.76 23 33633 755 50570713
Wrong patient received product 63.01 13.76 28 33628 1672 50569796
Glossodynia 61.12 13.76 4 33652 115565 50455903
Headache 58.97 13.76 159 33497 506376 50065092
Acute kidney injury 57.31 13.76 301 33355 227757 50343711
Altered state of consciousness 56.06 13.76 71 33585 21839 50549629
Contraindicated product administered 55.86 13.76 15 33641 148943 50422525
Bradypnoea 55.34 13.76 31 33625 3043 50568425
Loss of consciousness 53.66 13.76 172 33484 104181 50467287
Hyperthermia 53.66 13.76 43 33613 7653 50563815
Akathisia 53.21 13.76 44 33612 8185 50563283
Reduced facial expression 51.94 13.76 24 33632 1570 50569898
Alopecia 51.76 13.76 52 33604 244995 50326473
Intentional product misuse 51.57 13.76 103 33553 46631 50524837
Therapeutic product effect decreased 50.45 13.76 14 33642 136036 50435432
Injection site pain 50.41 13.76 7 33649 111017 50460451
Victim of sexual abuse 49.53 13.76 17 33639 504 50570964
Fatigue 49.53 13.76 273 33383 707328 49864140
Urinary retention 49.07 13.76 73 33583 26117 50545351
Infusion related reaction 48.73 13.76 26 33630 169531 50401937
Infection 47.58 13.76 28 33628 172926 50398542
Benzodiazepine drug level increased 47.57 13.76 13 33643 174 50571294
Wound 47.27 13.76 7 33649 105787 50465681
Back pain 47.25 13.76 46 33610 219984 50351484
Poisoning 46.49 13.76 49 33607 12380 50559088
Disturbance in attention 46.11 13.76 78 33578 31108 50540360
Lower respiratory tract infection 45.67 13.76 5 33651 95196 50476272
Restlessness 45.50 13.76 69 33587 25104 50546364
Drug use disorder 44.75 13.76 27 33629 3045 50568423
Agitation 43.35 13.76 104 33552 53280 50518188
Listless 42.75 13.76 24 33632 2366 50569102
Respiratory acidosis 42.71 13.76 34 33622 5994 50565474
Oxygen saturation decreased 42.54 13.76 126 33530 73122 50498346
Neuroleptic malignant syndrome 41.85 13.76 44 33612 11086 50560382
Hand deformity 41.73 13.76 8 33648 100191 50471277
Mydriasis 41.73 13.76 43 33613 10584 50560884
Faecal vomiting 40.37 13.76 15 33641 562 50570906
Haemodynamic instability 40.00 13.76 37 33619 7987 50563481
Apathy 39.96 13.76 36 33620 7512 50563956
Patient uncooperative 39.86 13.76 11 33645 153 50571315
Extrapyramidal disorder 39.81 13.76 44 33612 11726 50559742
Delirium 39.55 13.76 82 33574 38110 50533358
Nasopharyngitis 39.52 13.76 42 33614 192885 50378583
Tachycardia 37.99 13.76 149 33507 99614 50471854
Cough 37.77 13.76 64 33592 241200 50330268
Cardiac failure congestive 36.74 13.76 6 33650 84376 50487092
Hypocoagulable state 36.57 13.76 16 33640 920 50570548
Stomatitis 36.51 13.76 11 33645 101333 50470135
Pain in extremity 36.10 13.76 80 33576 272785 50298683
Epilepsy 36.02 13.76 57 33599 21510 50549958
Suicidal ideation 35.77 13.76 99 33557 55286 50516182
Prescription drug used without a prescription 35.75 13.76 19 33637 1681 50569787
Disorientation 35.36 13.76 75 33581 35409 50536059
Pneumonia 35.35 13.76 131 33525 378270 50193198
Blister 35.19 13.76 7 33649 85411 50486057
Encephalopathy 34.46 13.76 72 33584 33639 50537829
Hypoventilation 34.13 13.76 25 33631 3896 50567572
Muscle rigidity 33.69 13.76 37 33619 9792 50561676
Housebound 32.13 13.76 10 33646 216 50571252
Drug level above therapeutic 31.89 13.76 24 33632 3896 50567572
Serotonin syndrome 31.60 13.76 58 33598 24655 50546813
Wrong patient 31.22 13.76 8 33648 82 50571386
Eosinophilia 30.74 13.76 49 33607 18603 50552865
Off label use 30.42 13.76 188 33468 474238 50097230
Hypereosinophilic syndrome 30.42 13.76 10 33646 259 50571209
Accidental overdose 30.40 13.76 50 33606 19483 50551985
Hypotonia 30.30 13.76 32 33624 8102 50563366
Potentiating drug interaction 30.24 13.76 23 33633 3793 50567675
Parkinsonism 29.80 13.76 33 33623 8814 50562654
Prothrombin time ratio decreased 29.79 13.76 11 33645 405 50571063
Hepatitis 29.64 13.76 65 33591 31388 50540080
Pericarditis 29.34 13.76 8 33648 78681 50492787
Hepatic infiltration eosinophilic 28.89 13.76 6 33650 21 50571447
Abnormal behaviour 28.83 13.76 49 33607 19609 50551859
Respiratory alkalosis 28.82 13.76 19 33637 2500 50568968
Hallucination 28.75 13.76 82 33574 46575 50524893
Blood thyroid stimulating hormone normal 28.75 13.76 8 33648 115 50571353
Drug withdrawal convulsions 28.11 13.76 15 33641 1338 50570130
Hypoventilation neonatal 28.06 13.76 6 33650 25 50571443
Wheezing 27.95 13.76 4 33652 62043 50509425
Neurological examination abnormal 27.79 13.76 9 33647 222 50571246
On and off phenomenon 27.51 13.76 15 33641 1397 50570071
Injection site erythema 27.23 13.76 8 33648 74928 50496540
Psychomotor skills impaired 27.16 13.76 17 33639 2047 50569421
White blood cell count decreased 26.70 13.76 23 33633 116699 50454769
Substance abuse 26.55 13.76 22 33634 4102 50567366
Pyrexia 26.30 13.76 147 33509 380056 50191412
Hallucination, synaesthetic 25.70 13.76 6 33650 40 50571428
Hyperkalaemia 25.36 13.76 80 33576 48009 50523459
Foreign body 25.35 13.76 16 33640 1955 50569513
Antisocial behaviour 25.25 13.76 9 33647 299 50571169
Behaviour disorder 24.94 13.76 17 33639 2363 50569105
Dyspnoea 24.76 13.76 239 33417 547369 50024099
Neuropathy peripheral 24.75 13.76 17 33639 96740 50474728
Withdrawal syndrome 24.69 13.76 43 33613 17547 50553921
Wrong rate 24.53 13.76 6 33650 50 50571418
Disease progression 24.32 13.76 17 33639 95849 50475619
Neurosensory hypoacusis 23.91 13.76 8 33648 219 50571249
Antipsychotic drug level above therapeutic 23.86 13.76 12 33644 947 50570521
Psychomotor retardation 23.62 13.76 19 33637 3399 50568069
Diarrhoea 23.28 13.76 265 33391 588211 49983257
Freezing phenomenon 23.21 13.76 12 33644 1003 50570465
Sepsis 22.93 13.76 33 33623 132892 50438576
Blood testosterone increased 22.86 13.76 7 33649 143 50571325
Vertigo 22.70 13.76 81 33575 51751 50519717
Distributive shock 22.34 13.76 11 33645 829 50570639
Upper respiratory tract infection 22.24 13.76 8 33648 65890 50505578
Hepatic enzyme increased 21.88 13.76 36 33620 137344 50434124
Medulloblastoma 21.73 13.76 5 33651 31 50571437
Analgesic drug level above therapeutic 21.64 13.76 7 33649 172 50571296
Hypoaesthesia 21.55 13.76 32 33624 127225 50444243
Therapeutic response decreased 21.38 13.76 3 33653 47228 50524240
Mixed liver injury 21.37 13.76 18 33638 3433 50568035
Sudden death 21.21 13.76 28 33628 8963 50562505
Hypertonia 21.13 13.76 19 33637 3954 50567514
Foetal growth restriction 21.09 13.76 24 33632 6603 50564865
Pruritus 21.05 13.76 107 33549 283461 50288007
COVID-19 21.04 13.76 3 33653 46659 50524809
Chest pain 20.88 13.76 55 33601 176827 50394641
Medication error 20.85 13.76 62 33594 36042 50535426
Urticaria 20.59 13.76 34 33622 129527 50441941
Hypercapnia 20.52 13.76 20 33636 4607 50566861
Gamma-glutamyltransferase increased 20.17 13.76 54 33602 29569 50541899
Apnoea 20.12 13.76 24 33632 6942 50564526
Herpes zoster 20.10 13.76 11 33645 70775 50500693
Bezoar 20.03 13.76 12 33644 1336 50570132
Electrocardiogram QRS complex abnormal 19.98 13.76 7 33649 221 50571247
Feeling abnormal 19.88 13.76 33 33623 125459 50446009
Cholinergic syndrome 19.85 13.76 8 33648 374 50571094
Retrograde amnesia 19.29 13.76 8 33648 403 50571065
Needle track marks 19.26 13.76 4 33652 14 50571454
Delusion 19.14 13.76 29 33627 10540 50560928
Stoma site erythema 18.85 13.76 10 33646 881 50570587
Cardioactive drug level above therapeutic 18.72 13.76 6 33650 143 50571325
Pelvic fracture 18.62 13.76 30 33626 11490 50559978
Nightmare 18.39 13.76 36 33620 16050 50555418
Galactorrhoea 18.23 13.76 17 33639 3706 50567762
Flushing 18.20 13.76 11 33645 67004 50504464
Anal paraesthesia 18.11 13.76 4 33652 20 50571448
Genital paraesthesia 18.11 13.76 4 33652 20 50571448
Stoma site discharge 18.04 13.76 11 33645 1264 50570204
Musculoskeletal pain 18.04 13.76 13 33643 72164 50499304
Salivary hypersecretion 17.88 13.76 22 33634 6569 50564899
Psoriasis 17.81 13.76 12 33644 68988 50502480
Adenocarcinoma metastatic 17.77 13.76 5 33651 75 50571393
Fibroma 17.71 13.76 9 33647 726 50570742
Therapy non-responder 17.55 13.76 6 33650 51016 50520452
Megacolon 17.44 13.76 12 33644 1694 50569774
Platelet count decreased 17.38 13.76 25 33631 100701 50470767
Hospitalisation 17.29 13.76 12 33644 67925 50503543
Hepatic cytolysis 17.24 13.76 24 33632 8079 50563389
Major depression 17.12 13.76 22 33634 6862 50564606
Palatal swelling 17.08 13.76 5 33651 87 50571381
Impaired healing 16.89 13.76 13 33643 69773 50501695
Head discomfort 16.87 13.76 28 33628 10991 50560477
Antipsychotic drug level increased 16.79 13.76 15 33641 3094 50568374
Enanthema 16.52 13.76 7 33649 372 50571096
Injury 16.41 13.76 6 33650 48919 50522549
Hypopnoea 16.39 13.76 13 33643 2280 50569188
Subileus 16.29 13.76 14 33642 2745 50568723
Lipohypertrophy 16.22 13.76 8 33648 605 50570863
Influenza like illness 16.21 13.76 9 33647 57450 50514018
Drug level increased 16.13 13.76 38 33618 19230 50552238
Irritable bowel syndrome 16.12 13.76 7 33649 51434 50520034
Psychotic symptom 15.99 13.76 10 33646 1202 50570266
Nasal congestion 15.95 13.76 7 33649 51113 50520355
Nausea 15.94 13.76 353 33303 705045 49866423
Diarrhoea infectious 15.70 13.76 9 33647 923 50570545
Therapeutic product effect incomplete 15.50 13.76 23 33633 91492 50479976
Thrombosis 15.39 13.76 9 33647 55824 50515644
Concussion 15.35 13.76 22 33634 7606 50563862
Chondropathy 15.21 13.76 12 33644 2088 50569380
Adverse drug reaction 15.08 13.76 9 33647 55213 50516255
Blood cholesterol increased 15.08 13.76 9 33647 55206 50516262
Gastrointestinal disorder 14.81 13.76 25 33631 94431 50477037
Frontotemporal dementia 14.80 13.76 6 33650 285 50571183
Mutism 14.80 13.76 10 33646 1371 50570097
Influenza 14.69 13.76 23 33633 89515 50481953
Adenocarcinoma gastric 14.66 13.76 7 33649 493 50570975
Anterograde amnesia 14.64 13.76 7 33649 495 50570973
Action tremor 14.58 13.76 6 33650 296 50571172
Haematoma 14.50 13.76 49 33607 30461 50541007
Dehydration 14.43 13.76 160 33496 152289 50419179
Amyotrophy 14.39 13.76 5 33651 154 50571314
Hyperkinesia 14.34 13.76 10 33646 1442 50570026
Suspected counterfeit product 14.28 13.76 6 33650 312 50571156
Pneumothorax traumatic 14.27 13.76 5 33651 158 50571310
Therapeutic response increased 14.21 13.76 6 33650 316 50571152
Nephrolithiasis 13.96 13.76 3 33653 34690 50536778
Subcutaneous haematoma 13.96 13.76 10 33646 1505 50569963
Immobile 13.92 13.76 17 33639 5037 50566431
Injection site reaction 13.88 13.76 8 33648 50024 50521444
Hypercapnic coma 13.86 13.76 5 33651 172 50571296
Irregular sleep wake rhythm disorder 13.81 13.76 5 33651 174 50571294

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 970.16 15.11 896 21441 172765 29379425
Coma 536.93 15.11 347 21990 39103 29513087
Drug abuse 493.81 15.11 438 21899 79445 29472745
Poisoning deliberate 250.46 15.11 110 22227 5621 29546569
Drug dependence 237.94 15.11 165 22172 20816 29531374
Asphyxia 225.75 15.11 100 22237 5215 29546975
Miosis 212.46 15.11 109 22228 7900 29544290
Overdose 191.59 15.11 267 22070 79552 29472638
Depressed level of consciousness 191.52 15.11 184 22153 36758 29515432
Intentional overdose 173.97 15.11 178 22159 38350 29513840
Somnolence 165.35 15.11 272 22065 93683 29458507
Drug use disorder 157.04 15.11 68 22269 3354 29548836
Aggression 149.30 15.11 158 22179 35383 29516807
Logorrhoea 140.58 15.11 56 22281 2232 29549958
Suicide attempt 124.74 15.11 141 22196 33969 29518221
Substance abuse 118.21 15.11 70 22267 6717 29545473
Hepatocellular injury 114.17 15.11 108 22229 21135 29531055
Abnormal behaviour 108.24 15.11 109 22228 23018 29529172
Respiratory depression 99.14 15.11 82 22255 13441 29538749
Altered state of consciousness 95.38 15.11 95 22242 19794 29532396
Dysarthria 91.90 15.11 115 22222 30796 29521394
Restlessness 88.62 15.11 96 22241 22049 29530141
Bezoar 79.39 15.11 28 22309 791 29551399
Alcohol abuse 76.26 15.11 45 22292 4288 29547902
Intentional self-injury 73.99 15.11 67 22270 12394 29539796
Agitation 73.72 15.11 136 22201 51168 29501022
Confusional state 71.87 15.11 236 22101 127641 29424549
Bradykinesia 69.20 15.11 39 22298 3408 29548782
Poisoning 67.88 15.11 58 22279 9935 29542255
Bradypnoea 62.07 15.11 32 22305 2339 29549851
Intentional product misuse 61.67 15.11 101 22236 34560 29517630
Hypothermia 59.46 15.11 52 22285 9187 29543003
Dystonic tremor 59.00 15.11 16 22321 181 29552009
Hamartoma 55.82 15.11 12 22325 44 29552146
Drug screen positive 55.42 15.11 35 22302 3766 29548424
Bradyphrenia 54.54 15.11 36 22301 4178 29548012
Drug interaction 53.17 15.11 291 22046 197094 29355096
Mania 52.25 15.11 47 22290 8616 29543574
Housebound 51.93 15.11 15 22322 217 29551973
Disturbance in attention 51.73 15.11 72 22265 21352 29530838
Mydriasis 51.17 15.11 40 22297 6045 29546145
Oesophageal obstruction 47.02 15.11 16 22321 405 29551785
Cardiac failure congestive 46.03 15.11 3 22334 76578 29475612
Pneumonia aspiration 44.92 15.11 91 22246 36646 29515544
Homicide 44.41 15.11 19 22318 909 29551281
Bladder dilatation 44.19 15.11 21 22316 1287 29550903
Withdrawal syndrome 42.82 15.11 47 22290 10945 29541245
Respiratory acidosis 42.02 15.11 31 22306 4297 29547893
Eosinophilic myocarditis 41.99 15.11 15 22322 440 29551750
Platelet count decreased 40.92 15.11 14 22323 104658 29447532
Product dose omission issue 39.25 15.11 12 22325 96371 29455819
Respiratory distress 38.62 15.11 79 22258 32027 29520163
Hallucination, visual 38.57 15.11 52 22285 14963 29537227
Melanoderma 38.41 15.11 11 22326 154 29552036
Brain oedema 37.15 15.11 46 22291 12174 29540016
Tachycardia 35.66 15.11 128 22209 72282 29479908
Electrocardiogram QT prolonged 35.57 15.11 82 22255 36055 29516135
Accidental overdose 35.04 15.11 54 22283 17539 29534651
Disorientation 34.76 15.11 72 22265 29443 29522747
Fatigue 34.07 15.11 124 22213 316697 29235493
Victim of crime 33.31 15.11 12 22325 361 29551829
Nausea 33.26 15.11 110 22227 289145 29263045
Wrong patient received product 33.24 15.11 21 22316 2261 29549929
Hepatic fibrosis 33.17 15.11 24 22313 3228 29548962
Hyper IgE syndrome 33.05 15.11 8 22329 55 29552135
Vasoplegia syndrome 32.83 15.11 18 22319 1490 29550700
Hyperthermia 32.77 15.11 38 22299 9392 29542798
Pulmonary oedema 32.61 15.11 88 22249 42647 29509543
Rhabdomyolysis 32.10 15.11 110 22227 60698 29491492
Arthralgia 31.96 15.11 35 22302 139582 29412608
Oesophageal haemorrhage 31.45 15.11 16 22321 1137 29551053
Neuroleptic malignant syndrome 31.37 15.11 49 22288 16099 29536091
Drug hypersensitivity 30.72 15.11 7 22330 68399 29483791
Psychotic behaviour 30.40 15.11 13 22324 621 29551569
Back pain 30.30 15.11 20 22317 102264 29449926
Mixed liver injury 30.19 15.11 19 22318 2032 29550158
Pain 30.18 15.11 52 22285 171380 29380810
White blood cell count decreased 29.51 15.11 13 22324 83349 29468841
Hyponatraemia 29.50 15.11 115 22222 67518 29484672
Cholestatic liver injury 28.23 15.11 17 22320 1680 29550510
Psychotic disorder 28.00 15.11 53 22284 20301 29531889
Hyperdynamic left ventricle 27.74 15.11 8 22329 115 29552075
Dyskinesia 27.31 15.11 52 22285 20009 29532181
Accidental death 27.18 15.11 18 22319 2100 29550090
Extrapyramidal disorder 27.04 15.11 37 22300 10794 29541396
Hypoosmolar state 26.78 15.11 7 22330 68 29552122
Food aversion 26.65 15.11 10 22327 338 29551852
Behaviour disorder 26.64 15.11 22 22315 3594 29548596
Cough 26.61 15.11 34 22303 126693 29425497
Cholestasis 26.19 15.11 56 22281 23406 29528784
Pain in extremity 26.03 15.11 27 22310 110406 29441784
Urticaria 25.76 15.11 5 22332 54655 29497535
Diarrhoea 25.18 15.11 148 22189 332550 29219640
Urticaria chronic 25.06 15.11 7 22330 89 29552101
Fall 24.88 15.11 223 22114 176955 29375235
Consciousness fluctuating 24.85 15.11 13 22324 979 29551211
Pleurothotonus 24.30 15.11 13 22324 1025 29551165
Disease progression 24.28 15.11 16 22321 81900 29470290
Peripheral swelling 24.08 15.11 9 22328 63730 29488460
Acute myocardial infarction 23.76 15.11 4 22333 48434 29503756
Neuropathy peripheral 23.71 15.11 12 22325 71015 29481175
Muscle rigidity 23.27 15.11 32 22305 9379 29542811
Hepatic cytolysis 23.12 15.11 30 22307 8317 29543873
Rash 22.59 15.11 71 22266 189748 29362442
Chest pain 22.52 15.11 31 22306 111942 29440248
Rheumatoid nodule 22.42 15.11 16 22321 2106 29550084
Hepatitis acute 22.38 15.11 26 22311 6436 29545754
Sepsis 21.85 15.11 47 22290 142635 29409555
Dyspnoea 21.81 15.11 151 22186 326581 29225609
Pulmonary congestion 21.78 15.11 36 22301 12400 29539790
Analgesic drug level increased 21.52 15.11 10 22327 582 29551608
Myoclonus 21.29 15.11 37 22300 13272 29538918
Hepatorenal syndrome 21.23 15.11 16 22321 2290 29549900
Pruritus 20.95 15.11 35 22302 116814 29435376
Disturbance in social behaviour 20.72 15.11 14 22323 1688 29550502
Coordination abnormal 20.38 15.11 26 22311 7088 29545102
Thrombosis 20.15 15.11 4 22333 43041 29509149
Antasthmatic drug level 19.99 15.11 5 22332 40 29552150
Analgesic drug level 19.99 15.11 5 22332 40 29552150
Otospondylomegaepiphyseal dysplasia 19.55 15.11 6 22331 108 29552082
Pneumonia 19.43 15.11 152 22185 320020 29232170
Headache 19.38 15.11 67 22270 173940 29378250
Emotional disorder 19.05 15.11 21 22316 4910 29547280
Coagulation factor VII level decreased 19.01 15.11 6 22331 119 29552071
Patient uncooperative 18.99 15.11 8 22329 368 29551822
Metabolic acidosis 18.88 15.11 67 22270 37595 29514595
Toxic epidermal necrolysis 18.75 15.11 42 22295 18111 29534079
Loss of consciousness 18.40 15.11 107 22230 73949 29478241
Apathy 18.38 15.11 23 22314 6148 29546042
Stomatitis 18.34 15.11 3 22334 37110 29515080
Congestive hepatopathy 18.29 15.11 13 22324 1701 29550489
Eye haematoma 18.09 15.11 5 22332 61 29552129
Colitis ischaemic 17.82 15.11 22 22315 5801 29546389
Drug level increased 17.78 15.11 42 22295 18745 29533445
Muscle contracture 17.77 15.11 11 22326 1142 29551048
Sedation 17.67 15.11 40 22297 17365 29534825
Prescription form tampering 17.58 15.11 8 22329 444 29551746
Tonic convulsion 17.20 15.11 10 22327 926 29551264
Priapism 17.15 15.11 19 22318 4469 29547721
Constipation 17.14 15.11 38 22299 114122 29438068
Drug ineffective 17.01 15.11 184 22153 362986 29189204
Pyrexia 16.76 15.11 138 22199 287484 29264706
Neutrophil count decreased 16.71 15.11 6 22331 43561 29508629
Agranulocytosis 16.64 15.11 43 22294 20297 29531893
Hospitalisation 16.54 15.11 7 22330 45981 29506209
Cellulitis 16.45 15.11 7 22330 45833 29506357
Foetal growth restriction 16.24 15.11 17 22320 3749 29548441
Vestibular disorder 16.11 15.11 10 22327 1044 29551146
Blood disorder 15.98 15.11 15 22322 2902 29549288
Spinal cord injury thoracic 15.89 15.11 5 22332 98 29552092
Prothrombin time shortened 15.84 15.11 11 22326 1387 29550803
Drug diversion 15.76 15.11 9 22328 806 29551384
Cerebrovascular accident 15.75 15.11 21 22316 76890 29475300
Cognitive disorder 15.57 15.11 46 22291 23453 29528737
COVID-19 15.55 15.11 4 22333 36010 29516180
Judgement impaired 15.52 15.11 8 22329 584 29551606
Off label use 15.47 15.11 149 22188 300651 29251539
Serotonin syndrome 15.34 15.11 38 22299 17474 29534716
Tachyphrenia 15.16 15.11 10 22327 1159 29551031

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 1865.72 12.82 1824 48904 361689 64086315
Coma 1193.93 12.82 783 49945 86832 64361172
Depressed level of consciousness 863.69 12.82 624 50104 80812 64367192
Poisoning deliberate 738.26 12.82 307 50421 13151 64434853
Sedation complication 590.88 12.82 243 50485 10111 64437893
Drug abuse 589.40 12.82 618 50110 131756 64316248
Sedation 572.19 12.82 374 50354 41088 64406916
Intentional overdose 562.18 12.82 506 50222 89438 64358566
Orthostatic hypotension 538.51 12.82 377 50351 46361 64401643
Creatinine renal clearance decreased 522.78 12.82 246 50482 14175 64433829
Cognitive disorder 493.95 12.82 382 50346 54705 64393299
Somnolence 451.56 12.82 670 50058 202975 64245029
Fall 414.19 12.82 970 49758 415856 64032148
Blood calcium decreased 385.75 12.82 244 50484 25310 64422694
Miosis 346.20 12.82 181 50547 13085 64434919
Drug dependence 345.15 12.82 252 50476 33060 64414944
Suicide attempt 343.55 12.82 347 50381 70660 64377344
Overdose 340.54 12.82 516 50212 159050 64288954
Intentional self-injury 338.40 12.82 236 50492 28808 64419196
Balance disorder 314.14 12.82 358 50370 83568 64364436
Asphyxia 309.61 12.82 151 50577 9415 64438589
Hypotension 284.79 12.82 797 49931 380177 64067827
Mobility decreased 216.98 12.82 301 50427 85539 64362465
Hyponatraemia 216.54 12.82 405 50323 147934 64300070
Hepatocellular injury 214.91 12.82 219 50509 45016 64402988
Aggression 203.76 12.82 215 50513 46017 64401987
Drug use disorder 191.22 12.82 94 50634 5960 64442044
Respiratory depression 183.04 12.82 150 50578 23293 64424711
Electrocardiogram QT prolonged 180.76 12.82 265 50463 79183 64368821
Confusional state 163.84 12.82 514 50214 260630 64187374
Drug interaction 142.81 12.82 613 50115 361470 64086534
Altered state of consciousness 135.48 12.82 158 50570 37744 64410260
Hypothermia 134.34 12.82 117 50611 19739 64428265
Pneumonia aspiration 129.46 12.82 194 50534 59077 64388927
Drug ineffective 129.25 12.82 295 50433 839952 63608052
Poisoning 120.75 12.82 115 50613 21764 64426240
Abnormal behaviour 119.90 12.82 140 50588 33482 64414522
Logorrhoea 116.31 12.82 59 50669 4000 64444004
Rhabdomyolysis 116.11 12.82 236 50492 91490 64356514
Cholestasis 115.78 12.82 159 50569 44713 64403291
Substance abuse 114.04 12.82 78 50650 9214 64438790
Drug hypersensitivity 111.99 12.82 25 50703 237790 64210214
Arthralgia 110.61 12.82 111 50617 442149 64005855
Intentional product misuse 107.35 12.82 199 50529 72096 64375908
Constipation 106.74 12.82 409 50319 228928 64219076
Bladder dilatation 103.99 12.82 43 50685 1811 64446193
Bradycardia 102.69 12.82 262 50466 117957 64330047
Restlessness 102.68 12.82 141 50587 39644 64408360
Rash 97.51 12.82 131 50597 458418 63989586
Product dose omission issue 94.69 12.82 19 50709 194728 64253276
Bradypnoea 92.46 12.82 55 50673 5104 64442900
Disturbance in attention 91.90 12.82 136 50592 40938 64407066
Peripheral swelling 87.10 12.82 28 50700 209125 64238879
Hallucination, visual 86.34 12.82 108 50620 27726 64420278
Headache 86.00 12.82 180 50548 529287 63918717
Wrong patient received product 85.95 12.82 47 50681 3715 64444289
Agitation 84.27 12.82 203 50525 88164 64359840
Bezoar 84.19 12.82 39 50689 2164 64445840
Alcohol abuse 82.48 12.82 50 50678 4802 64443202
Housebound 80.99 12.82 25 50703 440 64447564
Respiratory acidosis 78.89 12.82 64 50664 9791 64438213
Hyperthermia 76.95 12.82 77 50651 15473 64432531
Joint swelling 76.28 12.82 37 50691 215345 64232659
Fatigue 74.43 12.82 320 50408 748410 63699594
Cardiac failure congestive 71.88 12.82 9 50719 130571 64317433
Dysarthria 71.79 12.82 150 50578 59256 64388748
Drug intolerance 71.76 12.82 29 50699 187963 64260041
Back pain 70.58 12.82 56 50672 250115 64197889
Rheumatoid arthritis 70.18 12.82 21 50707 164273 64283731
Sinusitis 69.35 12.82 15 50713 145913 64302091
Pain in extremity 68.05 12.82 83 50645 303002 64145002
Swelling 67.49 12.82 21 50707 160197 64287807
Mydriasis 67.05 12.82 71 50657 15241 64432763
Abdominal discomfort 66.59 12.82 30 50698 182292 64265712
Lactic acidosis 66.13 12.82 148 50580 61262 64386742
Cough 64.46 12.82 86 50642 302062 64145942
Treatment failure 64.42 12.82 8 50720 116808 64331196
Neuroleptic malignant syndrome 59.15 12.82 85 50643 24911 64423093
Platelet count decreased 59.08 12.82 29 50699 167682 64280322
Arthropathy 58.36 12.82 12 50716 120955 64327049
Dystonic tremor 58.35 12.82 16 50712 181 64447823
Apathy 58.13 12.82 57 50671 11175 64436829
Inappropriate antidiuretic hormone secretion 57.50 12.82 79 50649 22210 64425794
Infusion related reaction 57.09 12.82 29 50699 164438 64283566
Akathisia 56.96 12.82 57 50671 11453 64436551
Disorientation 56.18 12.82 131 50597 55697 64392307
Bradykinesia 55.48 12.82 44 50684 6516 64441488
Hypersensitivity 55.36 12.82 44 50684 196408 64251596
Loss of consciousness 55.08 12.82 247 50481 148118 64299886
Lower respiratory tract infection 53.35 12.82 6 50722 94608 64353396
Extrapyramidal disorder 53.02 12.82 71 50657 19481 64428523
Reduced facial expression 52.75 12.82 28 50700 2085 64445919
Patient uncooperative 52.74 12.82 19 50709 548 64447456
Dyspnoea 51.90 12.82 342 50386 718332 63729672
Accidental overdose 51.84 12.82 94 50634 33463 64414541
Injection site pain 51.82 12.82 12 50716 111396 64336608
White blood cell count decreased 51.62 12.82 30 50698 157807 64290197
Behaviour disorder 51.33 12.82 36 50692 4426 64443578
Disease progression 50.66 12.82 24 50704 141656 64306348
Stomatitis 48.66 12.82 13 50715 109592 64338412
Acute kidney injury 48.45 12.82 553 50175 448687 63999317
Prescription form tampering 48.24 12.82 16 50712 358 64447646
Drug screen positive 47.54 12.82 38 50690 5691 64442313
Therapeutic product effect decreased 47.02 12.82 16 50712 115335 64332669
Pneumonia 46.83 12.82 254 50474 559322 63888682
Diarrhoea 46.28 12.82 356 50372 722348 63725656
Sepsis 44.72 12.82 70 50658 230271 64217733
Nasopharyngitis 44.71 12.82 53 50675 196020 64251984
Nausea 44.47 12.82 400 50328 785400 63662604
Suicidal ideation 44.38 12.82 134 50594 66408 64381596
Respiratory distress 44.38 12.82 115 50613 52216 64395788
Tachycardia 44.00 12.82 233 50495 149346 64298658
Pyrexia 43.81 12.82 259 50469 558385 63889619
Hypokalaemia 43.78 12.82 201 50527 121702 64326302
Chest pain 43.68 12.82 74 50654 235906 64212098
Systemic lupus erythematosus 43.56 12.82 5 50723 77607 64370397
Oxygen saturation decreased 43.25 12.82 183 50545 106993 64341011
Benzodiazepine drug level increased 43.15 12.82 13 50715 210 64447794
Victim of sexual abuse 43.03 12.82 15 50713 392 64447612
Mixed liver injury 42.62 12.82 35 50693 5446 64442558
Urticaria 41.49 12.82 33 50695 147284 64300720
Drug level above therapeutic 41.39 12.82 38 50690 6863 64441141
Off label use 40.81 12.82 311 50417 632495 63815509
Contraindicated product administered 40.53 12.82 17 50711 107812 64340192
Prothrombin time ratio decreased 40.24 12.82 17 50711 756 64447248
Bradyphrenia 40.09 12.82 43 50685 9363 64438641
Glossodynia 39.41 12.82 3 50725 64693 64383311
Infection 39.00 12.82 53 50675 184827 64263177
Haemodynamic instability 38.69 12.82 53 50675 14859 64433145
Victim of crime 38.56 12.82 14 50714 413 64447591
Urinary retention 38.55 12.82 105 50623 49096 64398908
Withdrawal syndrome 37.81 12.82 67 50661 23425 64424579
Pruritus 37.74 12.82 123 50605 312277 64135727
Psychomotor skills impaired 37.35 12.82 28 50700 3817 64444187
Homicide 36.73 12.82 18 50710 1133 64446871
Cholestatic liver injury 36.20 12.82 27 50701 3652 64444352
Neuropathy peripheral 36.12 12.82 24 50704 117501 64330503
Oesophageal obstruction 36.05 12.82 16 50712 803 64447201
Upper respiratory tract infection 35.56 12.82 7 50721 72778 64375226
Alopecia 35.45 12.82 47 50681 165643 64282361
Therapy non-responder 35.16 12.82 5 50723 65894 64382110
Hepatic cytolysis 33.57 12.82 48 50680 14001 64434003
Blister 33.39 12.82 11 50717 80956 64367048
Wheezing 33.14 12.82 11 50717 80568 64367436
Serotonin syndrome 32.97 12.82 86 50642 39196 64408808
COVID-19 32.39 12.82 6 50722 65134 64382870
Eosinophilic myocarditis 32.30 12.82 15 50713 837 64447167
Pleurothotonus 32.28 12.82 21 50707 2281 64445723
Delirium 30.95 12.82 122 50606 69072 64378932
Hand deformity 30.74 12.82 6 50722 62765 64385239
Encephalopathy 30.72 12.82 109 50619 58710 64389294
Pericarditis 30.57 12.82 6 50722 62510 64385494
Wound 30.48 12.82 11 50717 76466 64371538
Drug level increased 29.87 12.82 76 50652 34120 64413884
Listless 29.84 12.82 23 50705 3267 64444737
Hepatitis 29.65 12.82 91 50637 45491 64402513
Mania 29.56 12.82 49 50679 16237 64431767
Melanoderma 29.42 12.82 11 50717 353 64447651
Neutrophil count decreased 29.28 12.82 12 50716 77184 64370820
Hypoaesthesia 29.21 12.82 40 50688 139068 64308936
Subileus 29.06 12.82 27 50701 4950 64443054
Injection site erythema 28.53 12.82 10 50718 70790 64377214
Thrombosis 28.43 12.82 10 50718 70632 64377372
Wrong patient 27.85 12.82 9 50719 185 64447819
Psychotic disorder 27.29 12.82 74 50654 34504 64413500
Blood thyroid stimulating hormone normal 27.29 12.82 8 50720 117 64447887
Muscle rigidity 27.05 12.82 49 50679 17424 64430580
Faecal vomiting 26.77 12.82 14 50714 1011 64446993
Hypoventilation 26.56 12.82 28 50700 5978 64442026
Pulmonary oedema 26.24 12.82 127 50601 78547 64369457
Urinary tract infection 26.04 12.82 94 50634 231502 64216502
Brain oedema 25.79 12.82 55 50673 22020 64425984
Epilepsy 25.71 12.82 71 50657 33460 64414544
Flushing 25.63 12.82 15 50713 78633 64369371
Cerebrovascular accident 25.57 12.82 43 50685 137540 64310464
Food aversion 25.57 12.82 12 50716 686 64447318
Gamma-glutamyltransferase increased 25.42 12.82 90 50638 48420 64399584
Hypoosmolar state 25.13 12.82 9 50719 255 64447749
Hospitalisation 25.00 12.82 14 50714 75193 64372811
Nasal congestion 24.78 12.82 8 50720 59650 64388354
Mutism 24.78 12.82 17 50711 2017 64445987
Agranulocytosis 24.56 12.82 76 50652 38153 64409851
Victim of homicide 24.55 12.82 8 50720 169 64447835
Vasoplegia syndrome 24.35 12.82 19 50709 2748 64445256
Hypercapnia 24.09 12.82 30 50698 7664 64440340
Drug withdrawal convulsions 24.09 12.82 17 50711 2111 64445893
Influenza 24.05 12.82 29 50699 106502 64341502
Toxic epidermal necrolysis 23.99 12.82 74 50654 37092 64410912
Psychotic behaviour 23.91 12.82 13 50715 1016 64446988
Myocardial infarction 23.88 12.82 60 50668 165761 64282243
Hypocoagulable state 23.80 12.82 16 50712 1837 64446167
Weight increased 23.72 12.82 87 50641 213261 64234743
Feeling abnormal 23.70 12.82 43 50685 133559 64314445
Potentiating drug interaction 23.60 12.82 30 50698 7822 64440182
Hallucination, synaesthetic 23.53 12.82 6 50722 50 64447954
Therapeutic response decreased 23.52 12.82 6 50722 52182 64395822
Vascular purpura 23.47 12.82 18 50710 2538 64445466
Hypereosinophilic syndrome 22.97 12.82 10 50718 479 64447525
Dry skin 22.83 12.82 6 50722 51155 64396849
Cellulitis 22.77 12.82 24 50704 93633 64354371
Dyspnoea exertional 22.72 12.82 15 50713 73715 64374289
Wrong rate 22.64 12.82 6 50722 59 64447945
Oropharyngeal pain 22.49 12.82 22 50706 88845 64359159
Lung disorder 22.45 12.82 101 50627 60599 64387405
Delusion 22.35 12.82 46 50682 17968 64430036
Malignant neoplasm progression 22.17 12.82 34 50694 112837 64335167
Hypertonia 21.98 12.82 26 50702 6299 64441705
Fluid retention 21.44 12.82 10 50718 59596 64388408
Antipsychotic drug level above therapeutic 21.37 12.82 15 50713 1846 64446158
Accidental death 21.35 12.82 20 50708 3705 64444299
Distributive shock 21.27 12.82 15 50713 1860 64446144
Hepatic fibrosis 21.27 12.82 24 50704 5528 64442476
Tachyphrenia 21.26 12.82 15 50713 1861 64446143
Metabolic acidosis 21.16 12.82 111 50617 70847 64377157
Oesophageal haemorrhage 21.12 12.82 14 50714 1570 64446434
Chills 21.09 12.82 48 50680 137216 64310788
Prescription drug used without a prescription 21.05 12.82 17 50711 2583 64445421
Blood glucose increased 20.78 12.82 28 50700 98045 64349959
Abdominal distension 20.76 12.82 27 50701 95967 64352037
Hyperdynamic left ventricle 20.66 12.82 8 50720 283 64447721
Disturbance in social behaviour 20.63 12.82 20 50708 3867 64444137
Muscle spasms 20.33 12.82 51 50677 140972 64307032
Sudden death 20.04 12.82 47 50681 20049 64427955
Antasthmatic drug level 19.79 12.82 5 50723 40 64447964
Dyskinesia 19.72 12.82 72 50656 39316 64408688
Retrograde amnesia 19.59 12.82 9 50719 490 64447514
Coordination abnormal 19.50 12.82 39 50689 14925 64433079
Cytomegalovirus infection 19.43 12.82 3 50725 37196 64410808
Cataract 19.39 12.82 8 50720 51254 64396750
Analgesic drug level 19.37 12.82 5 50723 44 64447960
Hyperkalaemia 19.30 12.82 141 50587 100988 64347016
Neurological examination abnormal 19.30 12.82 9 50719 507 64447497
Myoclonus 19.07 12.82 53 50675 25065 64422939
Impaired healing 19.05 12.82 12 50716 60461 64387543
Erythema 19.05 12.82 79 50649 186991 64261013
Neurosensory hypoacusis 18.95 12.82 7 50721 217 64447787
Injection site bruising 18.85 12.82 3 50725 36370 64411634
Rhinorrhoea 18.75 12.82 12 50716 59957 64388047
Analgesic drug level increased 18.71 12.82 15 50713 2255 64445749
Megacolon 18.54 12.82 17 50711 3065 64444939
Asthma 18.40 12.82 29 50699 95196 64352808
Decreased appetite 18.17 12.82 138 50590 281151 64166853
Hypotonia 18.07 12.82 32 50696 11180 64436824
Poor feeding infant 17.97 12.82 6 50722 137 64447867
Galactorrhoea 17.91 12.82 17 50711 3202 64444802
Wrong technique in product usage process 17.73 12.82 15 50713 64959 64383045
Major depression 17.65 12.82 26 50702 7790 64440214
Foreign body 17.56 12.82 15 50713 2464 64445540
Salivary hypersecretion 17.53 12.82 33 50695 12080 64435924
Gastrointestinal haemorrhage 17.44 12.82 50 50678 132262 64315742
Anal paraesthesia 17.28 12.82 4 50724 21 64447983
Asthenia 17.28 12.82 235 50493 427809 64020195
Opiates positive 17.21 12.82 10 50718 888 64447116
Hepatic enzyme increased 17.21 12.82 49 50679 129894 64318110
Acute myocardial infarction 16.80 12.82 18 50710 69700 64378304
Gastrointestinal disorder 16.70 12.82 28 50700 89681 64358323
Priapism 16.66 12.82 18 50710 3952 64444052
Medulloblastoma 16.58 12.82 5 50723 81 64447923
Hyper IgE syndrome 16.57 12.82 8 50720 487 64447517
Atopic keratoconjunctivitis 16.56 12.82 4 50724 26 64447978
Colitis ischaemic 16.34 12.82 34 50694 13380 64434624
Consciousness fluctuating 16.29 12.82 12 50716 1593 64446411
Throat irritation 16.29 12.82 3 50725 32708 64415296
Chronic kidney disease 16.26 12.82 13 50715 57906 64390098
Eosinophilia 16.12 12.82 66 50662 38010 64409994
Psychomotor retardation 16.01 12.82 20 50708 5123 64442881
Rash pruritic 15.97 12.82 13 50715 57391 64390613
Persecutory delusion 15.97 12.82 18 50710 4140 64443864
Influenza like illness 15.93 12.82 15 50713 61687 64386317
Coagulation factor VII level decreased 15.75 12.82 6 50722 203 64447801
Adenocarcinoma metastatic 15.74 12.82 5 50723 97 64447907
Haematocrit decreased 15.68 12.82 12 50716 54643 64393361
Antisocial behaviour 15.60 12.82 8 50720 555 64447449
Myalgia 15.52 12.82 68 50660 158549 64289455
On and off phenomenon 15.36 12.82 14 50714 2505 64445499
Fungal infection 15.31 12.82 4 50724 34247 64413757
Red blood cell sedimentation rate increased 15.26 12.82 3 50725 31232 64416772
Coronary artery disease 15.24 12.82 15 50713 60418 64387586
Therapeutic product effect incomplete 15.24 12.82 37 50691 103445 64344559
Hepatitis acute 15.23 12.82 33 50695 13356 64434648
Respiratory alkalosis 15.19 12.82 17 50711 3880 64444124
Blood pressure increased 15.11 12.82 77 50651 172475 64275529
Injection site reaction 15.06 12.82 9 50719 46655 64401349
Accidental poisoning 15.05 12.82 11 50717 1442 64446562
Drug diversion 15.05 12.82 10 50718 1126 64446878
Theft 14.99 12.82 6 50722 232 64447772
Action tremor 14.93 12.82 7 50721 399 64447605
Eye haematoma 14.86 12.82 5 50723 117 64447887
Parkinsonism 14.75 12.82 34 50694 14339 64433665
Cardioactive drug level above therapeutic 14.71 12.82 6 50722 244 64447760
Psoriasis 14.66 12.82 21 50707 71682 64376322
Anterograde amnesia 14.63 12.82 8 50720 632 64447372
Spinal cord injury thoracic 14.63 12.82 5 50723 123 64447881
Antipsychotic drug level increased 14.52 12.82 19 50709 5096 64442908
Mental status changes 14.50 12.82 16 50712 61146 64386858
Analgesic drug level above therapeutic 14.49 12.82 7 50721 427 64447577
Pleural effusion 14.46 12.82 51 50677 126508 64321496
Hypopnoea 14.32 12.82 15 50713 3179 64444825
Full blood count abnormal 14.25 12.82 3 50725 29754 64418250
Urticaria chronic 14.23 12.82 7 50721 444 64447560
Genital paraesthesia 14.22 12.82 4 50724 50 64447954
Drug resistance 14.07 12.82 5 50723 35097 64412907
High-pitched crying 14.06 12.82 3 50725 10 64447994
Hepatorenal syndrome 14.02 12.82 16 50712 3730 64444274
Haematochezia 14.01 12.82 19 50709 66354 64381650
Drug withdrawal syndrome 13.85 12.82 55 50673 31236 64416768
Weight decreased 13.74 12.82 151 50577 285588 64162416
Palatal swelling 13.63 12.82 5 50723 152 64447852
Subcutaneous haematoma 13.60 12.82 13 50715 2470 64445534
Herpes zoster 13.58 12.82 26 50702 79161 64368843
Red blood cell count decreased 13.41 12.82 11 50717 48375 64399629
Anuria 13.41 12.82 39 50689 18925 64429079
Plasma cell myeloma 13.37 12.82 10 50718 46065 64401939
Insomnia 13.27 12.82 96 50632 197740 64250264
Muscle contracture 13.23 12.82 12 50716 2133 64445871
Abdominal pain upper 13.21 12.82 82 50646 174948 64273056
Post-injection delirium sedation syndrome 13.19 12.82 7 50721 521 64447483
Pulmonary congestion 13.11 12.82 45 50683 23835 64424169
Acute generalised exanthematous pustulosis 13.07 12.82 32 50696 14026 64433978
Dermo-hypodermitis 13.03 12.82 7 50721 534 64447470
Electrocardiogram QRS complex abnormal 12.87 12.82 7 50721 547 64447457

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 (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 0228-2069 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 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 62584-813 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 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