oxazepam 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
diazepam derivatives	2015	604-75-1

Description:

Molecule	Description
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

Molecule

Description

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:

Dose	Unit	Route
50	mg	O

ADMET properties:

Property	Value	Reference
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 µM/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:

Date	Agency	Company	Orphan
June 4, 1965	FDA

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients 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
Cholinergic syndrome	18.06	13.89	8	39276	510	63449228
Salivary hypersecretion	18.06	13.89	23	39261	7643	63442095
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 term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients 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 term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients 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:

Source	Code	Description
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|

Disease	Relation	SNOMED_ID	DOID
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

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (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:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
GABA-A receptor alpha-1/beta-3/gamma-2	Ion channel	P14867 P18507 P28472	GBRA1_HUMAN GBRG2_HUMAN GBRB3_HUMAN	POSITIVE ALLOSTERIC MODULATOR	IC50	7.75		WOMBAT-PK	CHEMBL

External reference:

ID	Source
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:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
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