All FDA-approved EMA-approved PMDA-approved
Target Card Uniprot Example: P23975

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

Stem definition	Drug id	CAS RN
hypnotics, barbituric acid derivatives	2134	50-06-6

Description:

Molecule

Description

Molfile Inchi Smiles Synonyms: phenobarbitone phenobarbital adonal dormiral versomnal neurobarb phenaemal sedophen phenobarbital sodium

A barbituric acid derivative that acts as a nonselective central nervous system depressant. It potentiates GAMMA-AMINOBUTYRIC ACID action on GABA-A RECEPTORS, and modulates chloride currents through receptor channels. It also inhibits glutamate induced depolarizations. Molecular weight: 232.24 Formula: C12H12N2O3 CLOGP: 1.36 LIPINSKI: 0 HAC: 5 HDO: 2 TPSA: 75.27 ALOGS: -2.93 ROTB: 2 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Drug dosage:

Dose	Unit	Route
0.10	g	O
0.10	g	P

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	1 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	24 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	9.30 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	99 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	0.54 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	0.06 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.49 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	99 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
Jan. 1, 1912	YEAR INTRODUCED

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
Multiple-drug resistance	537.14	16.06	145	16199	5025	63467653
Seizure	520.66	16.06	358	15986	132276	63340402
Status epilepticus	430.64	16.06	158	16186	15075	63457603
Drug reaction with eosinophilia and systemic symptoms	329.80	16.06	165	16179	33671	63439007
Drug ineffective	202.55	16.06	656	15688	1044109	62428569
Epilepsy	189.82	16.06	106	16238	26959	63445719
Toxicity to various agents	176.44	16.06	264	16080	246986	63225692
Drug resistance	164.04	16.06	91	16253	22842	63449836
Drug interaction	163.92	16.06	245	16099	228886	63243792
Anticonvulsant drug level increased	109.41	16.06	32	16312	1485	63471193
Intra-abdominal pressure increased	106.52	16.06	22	16322	227	63472451
Generalised tonic-clonic seizure	94.23	16.06	70	16274	28946	63443732
Hyperammonaemia	93.66	16.06	39	16305	5193	63467485
Myoclonic epilepsy	92.86	16.06	27	16317	1227	63471451
Coma	91.18	16.06	97	16247	64267	63408411
Ataxia	86.52	16.06	52	16292	15143	63457535
Drug withdrawal convulsions	85.17	16.06	26	16318	1399	63471279
Abortion spontaneous	84.97	16.06	81	16263	47114	63425564
Pneumatosis	83.83	16.06	20	16324	415	63472263
Kounis syndrome	80.21	16.06	26	16318	1704	63470974
Anticonvulsant drug level decreased	79.79	16.06	24	16320	1228	63471450
Necrosis ischaemic	79.41	16.06	22	16322	838	63471840
Overdose	77.74	16.06	120	16224	114958	63357720
Angiofibroma	77.69	16.06	15	16329	106	63472572
Drug ineffective for unapproved indication	74.07	16.06	65	16279	33998	63438680
Infantile spasms	69.10	16.06	15	16329	200	63472478
Multiple organ dysfunction syndrome	69.07	16.06	79	16265	56673	63416005
Haemophagocytic lymphohistiocytosis	67.41	16.06	39	16305	10588	63462090
Cognitive disorder	66.75	16.06	77	16267	55738	63416940
Nystagmus	65.47	16.06	32	16312	6188	63466490
Partial seizures	64.33	16.06	31	16313	5811	63466867
Fatigue	62.17	16.06	83	16261	887945	62584733
Developmental glaucoma	60.74	16.06	11	16333	52	63472626
Abdominal discomfort	58.50	16.06	7	16337	320878	63151800
Breast hyperplasia	58.34	16.06	14	16330	298	63472380
Arthralgia	57.70	16.06	38	16306	569672	62903006
Intestinal ischaemia	57.14	16.06	31	16313	7437	63465241
Hyperammonaemic encephalopathy	56.93	16.06	22	16322	2412	63470266
Tachycardia	55.68	16.06	105	16239	118051	63354627
Systemic inflammatory response syndrome	53.48	16.06	27	16317	5594	63467084
Angiomyolipoma	52.23	16.06	12	16332	210	63472468
Oropharyngeal oedema	51.77	16.06	13	16331	336	63472342
Cytomegalovirus hepatitis	51.15	16.06	13	16331	353	63472325
Joint swelling	51.11	16.06	11	16333	327655	63145023
Foetal exposure during pregnancy	50.32	16.06	51	16293	31911	63440767
Alopecia	49.36	16.06	13	16331	337523	63135155
Petit mal epilepsy	47.51	16.06	22	16322	3772	63468906
Hypotension	47.38	16.06	166	16178	272438	63200240
Focal dyscognitive seizures	46.38	16.06	20	16324	2901	63469777
Cerebellar atrophy	46.21	16.06	14	16330	734	63471944
Hypotonia	45.79	16.06	29	16315	9256	63463422
Infusion related reaction	45.62	16.06	5	16339	245516	63227162
Rheumatoid arthritis	45.12	16.06	6	16338	253813	63218865
Off label use	45.08	16.06	312	16032	674150	62798528
Foetal anticonvulsant syndrome	44.68	16.06	13	16331	592	63472086
Contraindicated product administered	44.33	16.06	3	16341	217645	63255033
Ultrasound ovary abnormal	44.01	16.06	9	16335	88	63472590
Lymphangioleiomyomatosis	43.15	16.06	10	16334	182	63472496
Mitral valve disease	42.75	16.06	18	16326	2462	63470216
Unmasking of previously unidentified disease	42.54	16.06	14	16330	962	63471716
Metabolic acidosis	42.25	16.06	55	16289	45014	63427664
Anticonvulsant drug level above therapeutic	41.82	16.06	12	16332	520	63472158
Stillbirth	40.77	16.06	24	16320	6726	63465952
Necrotising colitis	40.33	16.06	12	16332	591	63472087
Systolic dysfunction	39.35	16.06	15	16329	1584	63471094
Macroglossia	38.48	16.06	12	16332	693	63471985
Arthropathy	38.44	16.06	7	16337	234785	63237893
Depressed level of consciousness	38.10	16.06	62	16282	62016	63410662
Product administered to patient of inappropriate age	37.99	16.06	18	16326	3250	63469428
Laryngeal stenosis	37.29	16.06	13	16331	1065	63471613
Malabsorption	37.11	16.06	19	16325	4053	63468625
Systemic lupus erythematosus	36.98	16.06	5	16339	208913	63263765
Irritability	36.67	16.06	43	16301	31651	63441027
Perforation	36.11	16.06	13	16331	1170	63471508
Seizure cluster	35.60	16.06	9	16335	239	63472439
Atonic seizures	35.40	16.06	11	16333	628	63472050
Electrocardiogram ST segment elevation	34.85	16.06	18	16326	3909	63468769
Ventricular hypokinesia	34.76	16.06	19	16325	4625	63468053
Stevens-Johnson syndrome	34.24	16.06	37	16307	24913	63447765
Altered state of consciousness	33.90	16.06	37	16307	25193	63447485
Exposure during pregnancy	33.53	16.06	102	16242	155445	63317233
Urine delta aminolevulinate increased	32.86	16.06	5	16339	5	63472673
Swelling	32.69	16.06	15	16329	275363	63197315
Sinusitis	32.60	16.06	9	16335	226644	63246034
Sopor	32.42	16.06	34	16310	22130	63450548
Hypertonia	32.04	16.06	18	16326	4619	63468059
Electrocardiogram repolarisation abnormality	31.14	16.06	12	16332	1305	63471373
Electrocardiogram QRS complex prolonged	30.42	16.06	19	16325	5919	63466759
Electroencephalogram abnormal	30.21	16.06	16	16328	3656	63469022
Eosinophilia	29.93	16.06	33	16311	22723	63449955
Hypothermia	29.68	16.06	26	16318	13555	63459123
Cardio-respiratory arrest	29.11	16.06	54	16290	59905	63412773
Coma blister	28.99	16.06	7	16337	153	63472525
Choreoathetosis	28.86	16.06	9	16335	520	63472158
Intensive care unit acquired weakness	28.78	16.06	10	16334	811	63471867
Cardiac arrest	28.26	16.06	69	16275	92476	63380202
Peripheral swelling	27.86	16.06	17	16327	265925	63206753
Enterocolitis	27.86	16.06	20	16324	7838	63464840
Euthyroid sick syndrome	27.71	16.06	6	16338	79	63472599
Nausea	27.56	16.06	120	16224	854351	62618327
Hepatitis	27.54	16.06	42	16302	39746	63432932
Left ventricular hypertrophy	27.21	16.06	17	16327	5298	63467380
Diarrhoea	27.19	16.06	94	16250	715272	62757406
Anticonvulsant drug level below therapeutic	27.19	16.06	9	16335	630	63472048
Pain	27.04	16.06	99	16245	740529	62732149
Necrotising enterocolitis neonatal	26.94	16.06	7	16337	208	63472470
Rhesus incompatibility	26.74	16.06	6	16338	94	63472584
Intentional overdose	26.72	16.06	59	16285	74093	63398585
Porphyrins stool increased	26.60	16.06	5	16339	30	63472648
Labelled drug-drug interaction medication error	26.02	16.06	24	16320	13375	63459303
Respiratory failure	26.01	16.06	71	16273	101787	63370891
Urine copper increased	25.82	16.06	4	16340	5	63472673
Calcinosis	25.36	16.06	12	16332	2160	63470518
Maternal exposure during pregnancy	25.35	16.06	118	16226	219944	63252734
Bradyphrenia	25.28	16.06	18	16326	6962	63465716
Haemodynamic instability	25.07	16.06	20	16324	9170	63463508
Eye movement disorder	24.96	16.06	16	16328	5212	63467466
Acute hepatic failure	24.83	16.06	27	16317	18300	63454378
Neonatal seizure	24.83	16.06	8	16336	514	63472164
Pneumonia aspiration	24.67	16.06	37	16307	34503	63438175
Atrioventricular block first degree	24.62	16.06	18	16326	7255	63465423
Myoclonus	24.39	16.06	25	16319	15843	63456835
Cardiotoxicity	24.39	16.06	19	16325	8419	63464259
Intensive care unit delirium	24.26	16.06	5	16339	51	63472627
Sedation complication	23.49	16.06	23	16321	13799	63458879
Developmental delay	23.04	16.06	10	16334	1473	63471205
Nasopharyngitis	23.02	16.06	19	16325	254238	63218440
Severe myoclonic epilepsy of infancy	22.67	16.06	5	16339	72	63472606
Wound	22.52	16.06	7	16337	163256	63309422
Cardiomegaly	22.23	16.06	25	16319	17589	63455089
Somnolence	22.20	16.06	98	16246	178587	63294091
Drug abuse	22.06	16.06	54	16290	72464	63400214
Gingival hypertrophy	21.90	16.06	10	16334	1661	63471017
Respiratory depression	21.79	16.06	22	16322	13693	63458985
Sedation	21.46	16.06	37	16307	38772	63433906
Suicide attempt	21.41	16.06	48	16296	60870	63411808
Pain in extremity	21.07	16.06	33	16311	331453	63141225
Aggression	20.97	16.06	28	16316	23470	63449208
Apnoea	20.91	16.06	17	16327	8005	63464673
Cerebral atrophy	20.54	16.06	14	16330	5052	63467626
Lactic acidosis	20.51	16.06	36	16308	38251	63434427
Asthma	20.44	16.06	4	16340	127557	63345121
Creatinine renal clearance decreased	20.33	16.06	23	16321	16285	63456393
Drug intolerance	20.31	16.06	30	16314	308631	63164047
Peritoneal perforation	20.22	16.06	5	16339	121	63472557
Ovarian cancer stage III	20.14	16.06	6	16338	297	63472381
Magnetic resonance imaging head abnormal	20.12	16.06	10	16334	2003	63470675
Febrile infection-related epilepsy syndrome	19.72	16.06	3	16341	3	63472675
Headache	19.72	16.06	90	16254	633151	62839527
Cross sensitivity reaction	19.45	16.06	10	16334	2152	63470526
Rhabdomyolysis	19.37	16.06	38	16306	43913	63428765
Impulsive behaviour	19.26	16.06	9	16335	1574	63471104
Ammonia increased	19.19	16.06	13	16331	4643	63468035
Respiratory acidosis	19.15	16.06	15	16329	6700	63465978
Intellectual disability	19.11	16.06	8	16336	1078	63471600
Back pain	19.06	16.06	24	16320	264121	63208557
Cachexia	18.99	16.06	14	16330	5712	63466966
Cardiac dysfunction	18.80	16.06	10	16334	2305	63470373
Resuscitation	18.71	16.06	8	16336	1136	63471542
Drug level increased	18.64	16.06	26	16318	22710	63449968
Immobile	18.53	16.06	14	16330	5929	63466749
Urine amphetamine positive	18.24	16.06	4	16340	56	63472622
Acquired macroglossia	18.24	16.06	5	16339	183	63472495
Crystalluria	18.17	16.06	6	16338	417	63472261
Circulatory collapse	17.85	16.06	25	16319	21913	63450765
Hypoxic-ischaemic encephalopathy	17.74	16.06	12	16332	4275	63468403
Stomatitis	17.33	16.06	7	16337	138718	63333960
Sinus bradycardia	17.26	16.06	20	16324	14531	63458147
Congenital megaureter	17.10	16.06	4	16340	76	63472602
Blood calcium decreased	17.02	16.06	27	16317	26424	63446254
Pulmonary venous thrombosis	16.97	16.06	3	16341	12	63472666
Ventricular dysfunction	16.93	16.06	10	16334	2818	63469860
Impaired healing	16.89	16.06	3	16341	102539	63370139
Hypersensitivity	16.88	16.06	31	16313	292654	63180024
Congenital eyelid malformation	16.78	16.06	3	16341	13	63472665
Primitive reflex test positive	16.78	16.06	3	16341	13	63472665
Encephalitis autoimmune	16.71	16.06	8	16336	1478	63471200
Completed suicide	16.67	16.06	78	16266	145595	63327083
Abscess	16.65	16.06	21	16323	16647	63456031
Propofol infusion syndrome	16.50	16.06	7	16337	976	63471702
Lip erosion	16.43	16.06	7	16337	986	63471692
Hypertrophic cardiomyopathy	16.21	16.06	8	16336	1579	63471099
Cholestasis	16.19	16.06	28	16316	29406	63443272

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
Drug ineffective	467.93	17.64	722	13151	456029	34487029
Seizure	457.72	17.64	358	13515	104499	34838559
Status epilepticus	379.46	17.64	154	13719	12460	34930598
Multiple-drug resistance	369.25	17.64	120	13753	5119	34937939
Epilepsy	198.32	17.64	117	13756	21378	34921680
Respiratory depression	143.48	17.64	86	13787	16159	34926899
Hyperammonaemia	139.07	17.64	62	13811	6305	34936753
Drug reaction with eosinophilia and systemic symptoms	129.03	17.64	106	13767	32906	34910152
Victim of child abuse	111.31	17.64	32	13841	895	34942163
Infantile spasms	106.37	17.64	23	13850	187	34942871
Partial seizures	106.02	17.64	47	13826	4713	34938345
Drug resistance	104.97	17.64	85	13788	25842	34917216
Anticonvulsant drug level above therapeutic	97.57	17.64	27	13846	655	34942403
Epidural lipomatosis	90.15	17.64	28	13845	1026	34942032
Toxicity to various agents	86.19	17.64	222	13651	200140	34742918
Drug dependence	82.74	17.64	72	13801	24145	34918913
Coma	82.37	17.64	96	13777	45582	34897476
Off label use	77.77	17.64	350	13523	419174	34523884
Intellectual disability	75.72	17.64	26	13847	1312	34941746
Generalised tonic-clonic seizure	74.45	17.64	64	13809	21110	34921948
Juvenile idiopathic arthritis	74.03	17.64	28	13845	1869	34941189
Product prescribing error	72.02	17.64	65	13808	22862	34920196
Sedation	70.84	17.64	62	13811	20944	34922114
Product use issue	69.20	17.64	104	13769	63112	34879946
Necrosis ischaemic	67.93	17.64	17	13856	275	34942783
Electroencephalogram abnormal	66.78	17.64	28	13845	2450	34940608
Autism spectrum disorder	65.43	17.64	27	13846	2269	34940789
Dyspnoea	62.74	17.64	36	13837	376746	34566312
Nausea	61.72	17.64	29	13844	339879	34603179
Excessive eye blinking	61.36	17.64	18	13855	541	34942517
Petit mal epilepsy	57.83	17.64	27	13846	3051	34940007
Dysmorphism	57.19	17.64	27	13846	3129	34939929
Drug ineffective for unapproved indication	56.97	17.64	58	13815	23657	34919401
Urine copper increased	55.26	17.64	9	13864	9	34943049
Gaze palsy	55.20	17.64	22	13851	1690	34941368
Anticonvulsant drug level increased	52.92	17.64	21	13852	1595	34941463
Drug withdrawal convulsions	51.89	17.64	19	13854	1158	34941900
Developmental delay	51.08	17.64	24	13849	2751	34940307
Sudden unexplained death in epilepsy	50.75	17.64	15	13858	463	34942595
Intensive care unit acquired weakness	50.60	17.64	18	13855	1009	34942049
Nystagmus	49.65	17.64	28	13845	4687	34938371
Intestinal ischaemia	48.25	17.64	33	13840	7761	34935297
Foetal anticonvulsant syndrome	48.06	17.64	18	13855	1169	34941889
Tonic convulsion	47.85	17.64	18	13855	1183	34941875
Mucosal ulceration	47.37	17.64	17	13856	978	34942080
Superinfection	47.03	17.64	22	13851	2497	34940561
Hypotonia	45.68	17.64	32	13841	7821	34935237
Hyperammonaemic encephalopathy	45.57	17.64	21	13852	2303	34940755
Pneumonia aspiration	44.49	17.64	68	13805	41835	34901223
Drug abuse	43.69	17.64	111	13762	98985	34844073
Child abuse	43.60	17.64	13	13860	414	34942644
Language disorder	43.04	17.64	20	13853	2236	34940822
Porphyrins stool increased	42.98	17.64	7	13866	7	34943051
Ataxia	42.95	17.64	39	13834	13814	34929244
Somnolence	42.44	17.64	118	13755	110998	34832060
Anticonvulsant drug level decreased	42.18	17.64	16	13857	1076	34941982
Porphyria acute	41.75	17.64	12	13861	335	34942723
Behaviour disorder	40.76	17.64	25	13848	4885	34938173
Fatigue	40.32	17.64	53	13820	370600	34572458
Posture abnormal	40.09	17.64	19	13854	2220	34940838
Psychomotor retardation	39.31	17.64	22	13851	3628	34939430
Partial seizures with secondary generalisation	37.68	17.64	11	13862	325	34942733
Hypertelorism	35.64	17.64	12	13861	570	34942488
Cognitive disorder	35.42	17.64	50	13823	28643	34914415
Benzodiazepine drug level decreased	35.30	17.64	7	13866	35	34943023
Ehlers-Danlos syndrome	35.30	17.64	7	13866	35	34943023
Myoclonic epilepsy	34.31	17.64	14	13859	1143	34941915
Foetal exposure during pregnancy	33.82	17.64	57	13816	38044	34905014
Systemic inflammatory response syndrome	33.67	17.64	25	13848	6684	34936374
Arthralgia	33.18	17.64	13	13860	170028	34773030
Misleading laboratory test result	32.69	17.64	6	13867	18	34943040
Cerebellar atrophy	32.26	17.64	11	13862	543	34942515
Necrotising enterocolitis neonatal	31.71	17.64	9	13864	240	34942818
Coma neonatal	31.55	17.64	6	13867	23	34943035
Testicular atrophy	31.55	17.64	11	13862	581	34942477
Hepatitis fulminant	31.42	17.64	20	13853	4170	34938888
Muscle mass	31.19	17.64	9	13864	255	34942803
Obesity	30.02	17.64	31	13842	12847	34930211
Diarrhoea	29.47	17.64	70	13803	389842	34553216
Pain	29.33	17.64	23	13850	204652	34738406
Blood lactic acid increased	29.21	17.64	23	13850	6705	34936353
Laryngomalacia	29.15	17.64	9	13864	323	34942735
Malaise	29.09	17.64	19	13854	185806	34757252
Poor feeding infant	28.70	17.64	10	13863	527	34942531
Hepatic adenoma	27.72	17.64	6	13867	49	34943009
Posthaemorrhagic hydrocephalus	27.64	17.64	7	13866	119	34942939
Cerebral atrophy	27.53	17.64	19	13854	4533	34938525
Atonic seizures	26.56	17.64	8	13865	264	34942794
Sopor	26.12	17.64	28	13845	12108	34930950
Irritability	26.10	17.64	40	13833	24650	34918408
Fanconi syndrome	26.00	17.64	13	13860	1707	34941351
Mental disability	25.95	17.64	6	13867	68	34942990
Strabismus	25.92	17.64	13	13860	1718	34941340
Respiratory acidosis	25.75	17.64	19	13854	5031	34938027
Hyperchloraemia	25.43	17.64	9	13864	497	34942561
Hyperlipasaemia	25.41	17.64	9	13864	498	34942560
Drug monitoring procedure not performed	25.10	17.64	8	13865	319	34942739
Dizziness	24.99	17.64	30	13843	218491	34724567
Overdose	24.79	17.64	86	13787	90973	34852085
Therapeutic product effect incomplete	24.77	17.64	59	13814	50482	34892576
Urine delta aminolevulinate increased	24.56	17.64	4	13869	4	34943054
Abdominal pain	23.92	17.64	18	13855	163600	34779458
Asterixis	23.73	17.64	11	13862	1222	34941836
Anticonvulsant drug level below therapeutic	23.27	17.64	9	13864	638	34942420
Propofol infusion syndrome	23	17.64	10	13863	956	34942102
Completed suicide	22.75	17.64	88	13785	98080	34844978
Acute hepatic failure	22.74	17.64	28	13845	14046	34929012
Chest pain	22.64	17.64	11	13862	126751	34816307
Idiopathic generalised epilepsy	22.57	17.64	5	13868	46	34943012
Drug interaction	22.50	17.64	160	13713	225786	34717272
Malignant neoplasm progression	22.31	17.64	4	13869	88042	34855016
Condition aggravated	22.06	17.64	141	13732	192055	34751003
Drug withdrawal syndrome neonatal	21.63	17.64	15	13858	3604	34939454
Purple glove syndrome	21.29	17.64	5	13868	61	34942997
Change in seizure presentation	21.21	17.64	6	13867	158	34942900
Autonomic nervous system imbalance	21.20	17.64	13	13860	2538	34940520
Pain in extremity	21.09	17.64	12	13861	126501	34816557
Myocardial fibrosis	20.95	17.64	10	13863	1187	34941871
Psychomotor skills impaired	20.60	17.64	15	13858	3891	34939167
Product administered to patient of inappropriate age	20.52	17.64	14	13859	3277	34939781
Abnormal labour affecting foetus	20.52	17.64	4	13869	18	34943040
Drug level decreased	20.32	17.64	20	13853	7826	34935232
Haematuria traumatic	20.06	17.64	6	13867	193	34942865
Cerebral ataxia	19.70	17.64	4	13869	23	34943035
Clonic convulsion	19.69	17.64	8	13865	646	34942412
Back pain	19.66	17.64	12	13861	121777	34821281
Focal dyscognitive seizures	19.59	17.64	10	13863	1371	34941687
Abdominal wall haematoma	19.59	17.64	11	13862	1826	34941232
Growth retardation	19.53	17.64	11	13862	1837	34941221
Cross sensitivity reaction	19.48	17.64	10	13863	1387	34941671
Talipes	19.12	17.64	11	13862	1912	34941146
Pancytopenia	19	17.64	7	13866	95150	34847908
Social avoidant behaviour	18.83	17.64	13	13860	3101	34939957
Necrotising colitis	18.77	17.64	9	13864	1079	34941979
Myoclonus	18.67	17.64	26	13847	14699	34928359
Psychomotor hyperactivity	18.63	17.64	21	13852	9601	34933457
Blood pressure increased	18.42	17.64	6	13867	88096	34854962
Prognathism	18.08	17.64	5	13868	121	34942937
Camptodactyly congenital	17.88	17.64	5	13868	126	34942932
Chills	17.88	17.64	5	13868	81038	34862020
Scoliosis	17.70	17.64	12	13861	2781	34940277

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
Status epilepticus	687.62	15.13	268	24707	24773	79694640
Seizure	669.48	15.13	518	24457	188316	79531097
Multiple-drug resistance	630.35	15.13	193	24782	8615	79710798
Drug ineffective	465.55	15.13	1031	23944	1079882	78639531
Drug reaction with eosinophilia and systemic symptoms	436.91	15.13	264	24711	63980	79655433
Epilepsy	311.89	15.13	181	24794	40679	79678734
Hyperammonaemia	226.27	15.13	96	24879	10997	79708416
Toxicity to various agents	223.62	15.13	440	24535	421100	79298313
Drug resistance	167.04	15.13	124	24851	42089	79677324
Drug interaction	159.89	15.13	381	24594	414802	79304611
Coma	155.19	15.13	174	24801	100475	79618938
Partial seizures	154.72	15.13	69	24906	8909	79710504
Generalised tonic-clonic seizure	147.46	15.13	117	24858	43793	79675620
Respiratory depression	146.24	15.13	97	24878	27533	79691880
Necrosis ischaemic	146.17	15.13	39	24936	1051	79718362
Anticonvulsant drug level above therapeutic	138.74	15.13	38	24937	1133	79718280
Anticonvulsant drug level increased	127.56	15.13	43	24932	2610	79716803
Ataxia	125.53	15.13	85	24890	24954	79694459
Intestinal ischaemia	123.50	15.13	67	24908	13203	79706210
Drug withdrawal convulsions	122.82	15.13	40	24935	2180	79717233
Victim of child abuse	117.91	15.13	32	24943	921	79718492
Anticonvulsant drug level decreased	115.79	15.13	37	24938	1897	79717516
Nystagmus	109.19	15.13	56	24919	9848	79709565
Drug ineffective for unapproved indication	104.70	15.13	103	24872	51135	79668278
Intra-abdominal pressure increased	99.65	15.13	22	24953	258	79719155
Infantile spasms	99.03	15.13	22	24953	266	79719147
Drug dependence	98.64	15.13	90	24885	40679	79678734
Hyperammonaemic encephalopathy	92.93	15.13	40	24935	4742	79714671
Epidural lipomatosis	92.46	15.13	28	24947	1200	79718213
Systemic inflammatory response syndrome	90.63	15.13	52	24923	11413	79708000
Overdose	89.76	15.13	186	24789	184020	79535393
Off label use	85.15	15.13	529	24446	906686	78812727
Urine copper increased	82.40	15.13	13	24962	14	79719399
Intensive care unit acquired weakness	79.98	15.13	28	24947	1905	79717508
Drug abuse	78.92	15.13	164	24811	162527	79556886
Arthralgia	78.02	15.13	41	24934	571762	79147651
Pneumonia aspiration	77.29	15.13	100	24875	66867	79652546
Cerebellar atrophy	76.93	15.13	24	24951	1137	79718276
Petit mal epilepsy	76.81	15.13	37	24938	5690	79713723
Fatigue	76.74	15.13	108	24867	929619	78789794
Nausea	75.29	15.13	115	24860	957081	78762332
Product prescribing error	75.11	15.13	81	24894	44732	79674681
Pneumatosis	74.42	15.13	22	24953	867	79718546
Angiofibroma	73.01	15.13	15	24960	121	79719292
Porphyrins stool increased	67.96	15.13	12	24963	37	79719376
Cognitive disorder	67.89	15.13	96	24879	69830	79649583
Breast hyperplasia	65.44	15.13	14	24961	140	79719273
Myoclonic epilepsy	64.49	15.13	24	24951	1946	79717467
Electroencephalogram abnormal	63.61	15.13	32	24943	5402	79714011
Atonic seizures	59.72	15.13	18	24957	759	79718654
Anticonvulsant drug level below therapeutic	57.87	15.13	19	24956	1062	79718351
Urine delta aminolevulinate increased	57.39	15.13	9	24966	9	79719404
Dyspnoea	56.41	15.13	115	24860	856910	78862503
Sopor	55.90	15.13	60	24915	32950	79686463
Juvenile idiopathic arthritis	55.61	15.13	28	24947	4735	79714678
Joint swelling	54.29	15.13	12	24963	288634	79430779
Malabsorption	54.16	15.13	28	24947	5004	79714409
Sudden unexplained death in epilepsy	53.61	15.13	16	24959	652	79718761
Kounis syndrome	52.43	15.13	26	24949	4256	79715157
Multiple organ dysfunction syndrome	52.28	15.13	116	24859	120130	79599283
Gaze palsy	51.46	15.13	23	24952	2982	79716431
Acute hepatic failure	51.46	15.13	55	24920	30058	79689355
Angiomyolipoma	51.01	15.13	12	24963	190	79719223
Partial seizures with secondary generalisation	49.91	15.13	15	24960	626	79718787
Cerebral atrophy	49.24	15.13	31	24944	8044	79711369
Stevens-Johnson syndrome	49.16	15.13	61	24914	39105	79680308
Somnolence	48.68	15.13	175	24800	238806	79480607
Rheumatoid arthritis	47.52	15.13	5	24970	208465	79510948
Intellectual disability	46.60	15.13	17	24958	1303	79718110
Infusion related reaction	46.60	15.13	8	24967	230229	79489184
Child abuse	46.58	15.13	13	24962	416	79718997
Oropharyngeal oedema	46.08	15.13	13	24962	433	79718980
Abdominal discomfort	46.00	15.13	11	24964	250716	79468697
Excessive eye blinking	45.90	15.13	18	24957	1683	79717730
Cardiotoxicity	44.06	15.13	34	24941	12205	79707208
Irritability	43.69	15.13	59	24916	41085	79678328
Electrocardiogram QRS complex prolonged	43.22	15.13	32	24943	10801	79708612
Hypotonia	42.55	15.13	34	24941	12836	79706577
Ultrasound ovary abnormal	42.25	15.13	9	24966	88	79719325
Lymphangioleiomyomatosis	42.24	15.13	10	24965	163	79719250
Metabolic acidosis	42.11	15.13	85	24890	82444	79636969
Focal dyscognitive seizures	42.04	15.13	21	24954	3491	79715922
Peripheral swelling	41.92	15.13	16	24959	269601	79449812
Mucosal ulceration	40.83	15.13	17	24958	1856	79717557
Alopecia	40.80	15.13	11	24964	231344	79488069
Blood lactic acid increased	40.72	15.13	33	24942	12711	79706702
Pain	40.11	15.13	102	24873	703700	79015713
Respiratory acidosis	40.07	15.13	31	24944	11169	79708244
Propofol infusion syndrome	39.89	15.13	17	24958	1966	79717447
Completed suicide	39.49	15.13	167	24808	245600	79473813
Haemophagocytic lymphohistiocytosis	39.29	15.13	41	24934	21796	79697617
Malaise	39.19	15.13	58	24917	489811	79229602
Cytomegalovirus hepatitis	38.85	15.13	13	24962	771	79718642
Diarrhoea	38.55	15.13	144	24831	880345	78839068
Superinfection	38.12	15.13	22	24953	4880	79714533
Tonic convulsion	38.04	15.13	17	24958	2203	79717210
Contraindicated product administered	37.98	15.13	3	24972	157535	79561878
Mitral valve disease	37.93	15.13	19	24956	3178	79716235
Depressed level of consciousness	37.32	15.13	89	24886	96563	79622850
Posture abnormal	37.31	15.13	20	24955	3846	79715567
Porphyria acute	37.09	15.13	15	24960	1520	79717893
Benzodiazepine drug level decreased	36.95	15.13	7	24968	35	79719378
Tachycardia	36.88	15.13	131	24844	177637	79541776
Choreoathetosis	36.77	15.13	15	24960	1555	79717858
Myoclonus	36.20	15.13	44	24931	27616	79691797
Pain in extremity	35.60	15.13	37	24938	364501	79354912
Hepatic adenoma	35.53	15.13	10	24965	330	79719083
Altered state of consciousness	35.11	15.13	55	24920	43767	79675646
Headache	34.77	15.13	98	24877	653674	79065739
Laryngeal stenosis	34.68	15.13	13	24962	1075	79718338
Testicular atrophy	34.67	15.13	10	24965	361	79719052
Ammonia increased	33.75	15.13	24	24951	7611	79711802
Eosinophilia	33.70	15.13	55	24920	45290	79674123
Macroglossia	33.65	15.13	13	24962	1168	79718245
Cardiac arrest	33.31	15.13	124	24851	171972	79547441
Hypothermia	32.76	15.13	38	24937	22708	79696705
Cross sensitivity reaction	32.48	15.13	18	24957	3694	79715719
Therapeutic product effect decreased	32.48	15.13	6	24969	163857	79555556
Gingival hypertrophy	32.43	15.13	17	24958	3125	79716288
Arthropathy	32.02	15.13	8	24967	177103	79542310
Back pain	31.86	15.13	29	24946	304151	79415262
Left ventricular hypertrophy	31.64	15.13	27	24948	11164	79708249
Drug level decreased	31.37	15.13	30	24945	14372	79705041
Perforation	31.27	15.13	13	24962	1413	79718000
Hypotension	31.10	15.13	240	24735	440077	79279336
Hypertonia	30.29	15.13	22	24953	7210	79712203
Hepatitis fulminant	30.21	15.13	22	24953	7240	79712173
Paraesthesia	29.94	15.13	9	24966	176314	79543099
Stomatitis	29.90	15.13	5	24970	146752	79572661
Cardio-respiratory arrest	29.77	15.13	88	24887	108422	79610991
Unmasking of previously unidentified disease	29.75	15.13	14	24961	2043	79717370
Seizure cluster	29.55	15.13	9	24966	393	79719020
Febrile infection-related epilepsy syndrome	29.03	15.13	6	24969	50	79719363
Blood pressure increased	28.98	15.13	15	24960	211345	79508068
Swelling	28.81	15.13	16	24959	216695	79502718
Product use issue	28.73	15.13	136	24839	209686	79509727
Abdominal pain	28.41	15.13	49	24926	389520	79329893
Encephalitis autoimmune	28.30	15.13	14	24961	2280	79717133
Muscle mass	28.28	15.13	9	24966	455	79718958
Fanconi syndrome	28.19	15.13	15	24960	2841	79716572
Rhesus incompatibility	28.18	15.13	5	24970	16	79719397
Product administered to patient of inappropriate age	28.18	15.13	19	24956	5534	79713879
Ehlers-Danlos syndrome	28.08	15.13	7	24968	143	79719270
Febrile neutropenia	28	15.13	19	24956	230980	79488433
Anticonvulsant drug level therapeutic	27.51	15.13	5	24970	19	79719394
Ventricular hypokinesia	27.49	15.13	23	24952	9256	79710157
Intentional overdose	27.25	15.13	84	24891	105876	79613537
Hyperchloraemia	27.24	15.13	11	24964	1110	79718303
Malignant neoplasm progression	26.91	15.13	5	24970	135985	79583428
Rhabdomyolysis	26.75	15.13	82	24893	103049	79616364
Asthma	26.66	15.13	5	24970	135090	79584323
Sinusitis	26.62	15.13	14	24961	195487	79523926
Discomfort	26.22	15.13	4	24971	125613	79593800
Cerebral ataxia	26.07	15.13	5	24970	27	79719386
Product use in unapproved indication	25.82	15.13	150	24825	250209	79469204
Euthyroid sick syndrome	25.81	15.13	6	24969	90	79719323
Blood zinc increased	25.51	15.13	4	24971	4	79719409
Suicide attempt	25.41	15.13	70	24905	82862	79636551
Chest pain	24.99	15.13	31	24944	282273	79437140
Intentional product misuse	24.99	15.13	76	24899	95089	79624324
Systemic lupus erythematosus	24.97	15.13	4	24971	121145	79598268
Coma blister	24.79	15.13	7	24968	234	79719179
Temporal lobe epilepsy	24.52	15.13	8	24967	438	79718975
Nasopharyngitis	24.51	15.13	26	24949	253855	79465558
Systolic dysfunction	24.22	15.13	15	24960	3780	79715633
Behaviour disorder	23.74	15.13	18	24957	6295	79713118
Hepatic function abnormal	23.70	15.13	63	24912	73044	79646369
Withdrawal syndrome	23.33	15.13	35	24940	26819	79692594
Haemodynamic instability	23.31	15.13	28	24947	17354	79702059
Coagulopathy	23.22	15.13	41	24934	35965	79683448
Electrocardiogram ST segment elevation	23.21	15.13	20	24955	8377	79711036
Developmental delay	22.94	15.13	10	24965	1221	79718192
Intensive care unit delirium	22.86	15.13	5	24970	56	79719357
Hypoaesthesia	22.76	15.13	14	24961	179338	79540075
Idiopathic generalised epilepsy	22.70	15.13	5	24970	58	79719355
Electrocardiogram repolarisation abnormality	22.64	15.13	12	24963	2255	79717158
Hepatitis	22.25	15.13	52	24923	55675	79663738
Calcinosis	22.16	15.13	12	24963	2353	79717060
Poor feeding infant	22.03	15.13	6	24969	175	79719238
Eye movement disorder	21.98	15.13	19	24956	7992	79711421
Haematuria traumatic	21.53	15.13	6	24969	191	79719222
Hyponatraemia	21.30	15.13	111	24864	177737	79541676
Dermatitis exfoliative	20.69	15.13	21	24954	10808	79708605
Foetal anticonvulsant syndrome	20.31	15.13	6	24969	236	79719177
Neurodegenerative disorder	19.80	15.13	7	24968	490	79718923
Myocardial fibrosis	19.76	15.13	10	24965	1708	79717705
Aggression	19.74	15.13	47	24928	50911	79668502
Ovarian cancer stage III	19.72	15.13	6	24969	261	79719152
Injection site pain	19.68	15.13	8	24967	129830	79589583
Hyperplasia	19.66	15.13	9	24966	1234	79718179
Wound	19.59	15.13	6	24969	116173	79603240
Hyperlipasaemia	19.58	15.13	9	24966	1245	79718168
Acidosis hyperchloraemic	19.56	15.13	8	24967	834	79718579
Cough	19.44	15.13	55	24920	366734	79352679
Drug level increased	19.22	15.13	40	24935	39611	79679802
Ileus paralytic	19.01	15.13	19	24956	9601	79709812
Selective eating disorder	18.84	15.13	6	24969	304	79719109
Dysmorphism	18.73	15.13	7	24968	574	79718839
Dizziness	18.73	15.13	93	24882	526348	79193065
Drug monitoring procedure not performed	18.15	15.13	8	24967	1003	79718410
Asterixis	18.04	15.13	11	24964	2696	79716717
Anaemia	17.98	15.13	75	24900	444940	79274473
Brain oedema	17.91	15.13	30	24945	25233	79694180
Impaired healing	17.82	15.13	3	24972	87652	79631761
Dyspnoea exertional	17.66	15.13	3	24972	87070	79632343
Peritoneal perforation	17.59	15.13	5	24970	171	79719242
Sedation complication	17.44	15.13	23	24952	15646	79703767
Impulsive behaviour	17.35	15.13	11	24964	2889	79716524
Microcephaly	17.32	15.13	5	24970	181	79719232
Autism spectrum disorder	17.15	15.13	8	24967	1144	79718269
Toxic epidermal necrolysis	17.14	15.13	41	24934	44540	79674873
Circulatory collapse	17.10	15.13	37	24938	37631	79681782
Chills	17.09	15.13	15	24960	160219	79559194
Contusion	17.02	15.13	13	24962	148763	79570650
Rash maculo-papular	16.85	15.13	47	24928	56031	79663382
Myalgia	16.83	15.13	20	24955	185621	79533792
Drug intolerance	16.81	15.13	36	24939	264083	79455330
Weight increased	16.69	15.13	39	24936	277347	79442066
Stress cardiomyopathy	16.66	15.13	19	24956	11147	79708266
Hypertension	16.54	15.13	51	24924	330941	79388472
COVID-19	16.53	15.13	15	24960	157659	79561754
Foetal exposure during pregnancy	16.43	15.13	14	24961	5776	79713637
Acquired macroglossia	16.38	15.13	5	24970	220	79719193
Pancreatitis	16.37	15.13	53	24922	68522	79650891
No adverse event	16.28	15.13	36	24939	37156	79682257
Pruritus	16.26	15.13	66	24909	394582	79324831
Cellulitis	16.08	15.13	7	24968	109053	79610360
Salivary hypersecretion	16.02	15.13	21	24954	14203	79705210
Unresponsive to stimuli	16.02	15.13	46	24929	55742	79663671
Arthritis	15.97	15.13	8	24967	114872	79604541
Labelled drug-drug interaction medication error	15.94	15.13	30	24945	27620	79691793
Fever neonatal	15.84	15.13	3	24972	15	79719398
Inappropriate antidiuretic hormone secretion	15.74	15.13	29	24946	26284	79693129
Urticaria	15.70	15.13	21	24954	185180	79534233
Diabetes insipidus	15.56	15.13	13	24962	5224	79714189
General physical health deterioration	15.53	15.13	40	24935	275198	79444215
Conjunctival hyperaemia	15.32	15.13	12	24963	4401	79715012
Urine amphetamine positive	15.28	15.13	4	24971	100	79719313
Inhibitory drug interaction	15.22	15.13	12	24963	4441	79714972
Respiratory arrest	15.14	15.13	46	24929	57504	79661909

FDA Adverse Event Reporting System (Pediatric)

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
Drug ineffective	124.35	34.47	62	244	990	88496
Off label use	38.82	34.47	25	281	621	88865

Pharmacologic Action:

Source	Code	Description
ATC	N03AA02	NERVOUS SYSTEM ANTIEPILEPTICS ANTIEPILEPTICS Barbiturates and derivatives
MeSH PA	D018757	GABA Modulators
MeSH PA	D000927	Anticonvulsants
MeSH PA	D002491	Central Nervous System Agents
MeSH PA	D002492	Central Nervous System Depressants
MeSH PA	D065695	Cytochrome P-450 CYP2B6 Inducers
MeSH PA	D065701	Cytochrome P-450 CYP3A Inducers
MeSH PA	D018691	Excitatory Amino Acid Antagonists
MeSH PA	D018682	GABA Agents
MeSH PA	D006993	Hypnotics and Sedatives
MeSH PA	D065606	Metabolic Side Effects of Drugs and Substances
MeSH PA	D018377	Neurotransmitter Agents
CHEBI has role	CHEBI:35623	anticonvulsants
CHEBI has role	CHEBI:35717	hypnotics
CHEBI has role	CHEBI:60798	EAA receptor antagonists
CHEBI has role	CHEBI:88188	allergenic drug

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

Disease	Relation	SNOMED_ID	DOID
Migraine	indication	37796009	DOID:6364
Tonic-clonic seizure	indication	54200006
Epilepsy	indication	84757009	DOID:1826
Bipolar disorder in remission	indication	85248005
Vascular headache	indication	128187005
Cluster headache syndrome	indication	193031009
Lennox-Gastaut syndrome	indication	230418006
Tonic-clonic epilepsy	indication	352818000	DOID:7725
Epilepsy characterized by intractable complex partial seizures	indication	442481002
Simple partial seizure	indication	117891000119100
Cluster Headache Prevention	indication
Hyperbilirubinemia	off-label use	14783006	DOID:2741
Postmenopausal osteoporosis	off-label use	102447009
Seizure disorder	off-label use	128613002
Alcohol withdrawal syndrome	off-label use	191480000
Bipolar affective disorder, current episode depression	off-label use	191627008	DOID:3312
Status epilepticus	off-label use	230456007	DOID:1824
Neuropathic pain	off-label use	247398009
Rapid Cycling Bipolar Affective Disorder	off-label use
Brain damage	contraindication	2470005
Necrotizing enterocolitis in fetus OR newborn	contraindication	2707005
Goiter	contraindication	3716002	DOID:12176
Gastritis	contraindication	4556007	DOID:4029
Osteomalacia	contraindication	4598005	DOID:10573
Tachyarrhythmia	contraindication	6285003
Suicidal thoughts	contraindication	6471006
Urinary tract obstruction	contraindication	7163005	DOID:5200
Alcoholism	contraindication	7200002
Hyperammonemia	contraindication	9360008
Peptic ulcer	contraindication	13200003	DOID:750
Chronic obstructive lung disease	contraindication	13645005	DOID:3083
Hepatic encephalopathy	contraindication	13920009	DOID:13413
Hyperkalemia	contraindication	14140009
Disorder of thyroid gland	contraindication	14304000	DOID:50
Severe chronic ulcerative colitis	contraindication	14311001
Disorder of autonomic nervous system	contraindication	15241006
Agranulocytosis	contraindication	17182001	DOID:12987
Pulmonary edema	contraindication	19242006	DOID:11396
Hashimoto thyroiditis	contraindication	21983002
Myocardial infarction	contraindication	22298006	DOID:5844
Glaucoma	contraindication	23986001	DOID:1686
Acute tuberculosis	contraindication	25629007
Alcohol intoxication	contraindication	25702006
Shock	contraindication	27942005
Toxic megacolon	contraindication	28536002	DOID:1770
Atony of colon	contraindication	29479008
Lymphadenopathy	contraindication	30746006
Sarcoidosis	contraindication	31541009	DOID:11335
Bronchitis	contraindication	32398004	DOID:6132
Dehydration	contraindication	34095006
Hyperthyroidism	contraindication	34486009	DOID:7998
Depressive disorder	contraindication	35489007
Acute hepatitis	contraindication	37871000
Hypertensive disorder	contraindication	38341003	DOID:10763
Hypovolemic shock	contraindication	39419009
Gastrointestinal ulcer	contraindication	40845000
Hypothyroidism	contraindication	40930008	DOID:1459
Complete trisomy 21 syndrome	contraindication	41040004	DOID:14250
Third trimester pregnancy	contraindication	41587001
Hyperactive behavior	contraindication	44548000
Conduction disorder of the heart	contraindication	44808001
Low blood pressure	contraindication	45007003
Achalasia of esophagus	contraindication	45564002	DOID:9164
Chronic heart failure	contraindication	48447003
Retroperitoneal fibrosis	contraindication	49120005
Disorder of cardiovascular system	contraindication	49601007	DOID:1287
Fibrosis of lung	contraindication	51615001	DOID:3770
Vitamin K deficiency	contraindication	52675005	DOID:11249
Nasal polyp	contraindication	52756005
Megaloblastic anemia	contraindication	53165003	DOID:13382
Systemic lupus erythematosus	contraindication	55464009	DOID:9074
Paralytic ileus	contraindication	55525008	DOID:8442
Heart disease	contraindication	56265001	DOID:114
Peptic reflux disease	contraindication	57643001
Multiple organ failure	contraindication	57653000
Acute nephropathy	contraindication	58574008
Hepatic failure	contraindication	59927004
Diarrhea	contraindication	62315008
Thrombophlebitis	contraindication	64156001	DOID:3875
Ulcerative colitis	contraindication	64766004	DOID:8577
Poisoning by phenobarbital	contraindication	64921004
Drug AND/OR toxin-induced diarrhea	contraindication	65979008
Substance abuse	contraindication	66214007
Hypercalcemia	contraindication	66931009	DOID:12678
Hyperparathyroidism	contraindication	66999008	DOID:13543
Psychotic disorder	contraindication	69322001
Poisoning by acetaminophen	contraindication	70273001
Agoraphobia	contraindication	70691001	DOID:593
Incontinence of feces	contraindication	72042002
Hepatic coma	contraindication	72836002	DOID:12550
Diabetes mellitus	contraindication	73211009	DOID:9351
Sleep apnea	contraindication	73430006	DOID:0050847
Factor II deficiency	contraindication	73975000
Reye's syndrome	contraindication	74351001	DOID:14525
Appendicitis	contraindication	74400008	DOID:8337
Gastrointestinal hemorrhage	contraindication	74474003
Thrombotic thrombocytopenic purpura	contraindication	78129009	DOID:10772
Spastic paralysis	contraindication	78403003
Disturbance of salivary secretion	contraindication	78948009
Hyperglycemia	contraindication	80394007	DOID:4195
Cor pulmonale	contraindication	83291003	DOID:8515
Hiatal hernia	contraindication	84089009	DOID:12642
Leukopenia	contraindication	84828003	DOID:615
Gout	contraindication	90560007	DOID:13189
Kidney disease	contraindication	90708001	DOID:557
Hemophilia	contraindication	90935002
Myasthenia gravis	contraindication	91637004	DOID:437
Kidney stone	contraindication	95570007
Dermatitis herpetiformis	contraindication	111196000	DOID:8505
Anemia due to enzyme deficiency	contraindication	111577008
Gastrointestinal obstruction	contraindication	126765001
Pancytopenia	contraindication	127034005	DOID:12450
von Willebrand disorder	contraindication	128105004	DOID:12531
Autonomic dysreflexia	contraindication	129618003
Bleeding	contraindication	131148009
Cystic fibrosis	contraindication	190905008	DOID:1485
Obsessive-compulsive disorder	contraindication	191736004	DOID:10933
Insomnia	contraindication	193462001
Angina pectoris	contraindication	194828000
Impaired renal function disorder	contraindication	197663003
Osteolysis	contraindication	203522001
Non-infective meningitis	contraindication	230155003
Myocardial dysfunction	contraindication	233928007
Peripheral ischemia	contraindication	233958001
Gastroesophageal reflux disease	contraindication	235595009	DOID:8534
Disease of liver	contraindication	235856003	DOID:409
Bladder outflow obstruction	contraindication	236645006
Sepsis syndrome	contraindication	238150007
Hypocomplementemic urticarial vasculitis	contraindication	239945009
Pyloric obstruction	contraindication	244815007
Sleep automatism	contraindication	247962006
Raynaud's phenomenon	contraindication	266261006
Benign prostatic hyperplasia	contraindication	266569009
Dyspnea	contraindication	267036007
Retention of urine	contraindication	267064002
Anemia	contraindication	271737000	DOID:2355
Continuous fever	contraindication	271751000
Drowsy	contraindication	271782001
Cerebral ischemia	contraindication	287731003
Pregnancy, function	contraindication	289908002
Thrombocytopenic disorder	contraindication	302215000	DOID:1588
Neutropenic disorder	contraindication	303011007	DOID:1227
Aplastic anemia	contraindication	306058006	DOID:12449
Osteopenia	contraindication	312894000
Panic disorder	contraindication	371631005	DOID:594
Smoking cessation assistance	contraindication	384742004
Angle-closure glaucoma	contraindication	392291006	DOID:13550
Gastric ulcer	contraindication	397825006	DOID:10808
Peripheral vascular disease	contraindication	400047006
Respiratory insufficiency	contraindication	409623005
Breastfeeding (mother)	contraindication	413712001
Chronic lung disease	contraindication	413839001
Chronic myocardial ischemia	contraindication	413844008	DOID:3393
Disorder of coronary artery	contraindication	414024009
Myocardial ischemia	contraindication	414795007	DOID:3393
Granulocytopenic disorder	contraindication	417672002
Myocardial infarction in recovery phase	contraindication	418044006
Porphyria	contraindication	418470004
Fever greater than 100.4 Fahrenheit	contraindication	426000000
Hyperplasia of gingiva	contraindication	441798003
Fibrosis of pleura	contraindication	442110002
Acute erosive gastritis	contraindication	444926003
Smokes tobacco daily	contraindication	449868002
Acute exacerbation of asthma	contraindication	708038006
Ergot Alkaloid Toxicity	contraindication
Severe Pruritus	contraindication
HLA-B 1502 Positive Status	contraindication
Theophylline Toxicity	contraindication
Severe Hypoxemia	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	7.56	acidic
pKa2	9.25	acidic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
100MG/VIAL	SEZABY	SUN PHARM INDS INC	N215910	Nov. 17, 2022	RX	POWDER	INTRAVENOUS	Nov. 17, 2029	TREATMENT OF NEONATAL SEIZURES IN TERM AND PRETERM INFANTS

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Nuclear receptor subfamily 1 group I member 3	Nuclear hormone receptor	Q14994	NR1I3_HUMAN					WOMBAT-PK
Nuclear receptor subfamily 1 group I member 2	Nuclear hormone receptor	O75469	NR1I2_HUMAN					WOMBAT-PK
GABA-A receptor alpha-1/beta-2/gamma-2	Ion channel	P14867 P18507 P47870	GBRA1_HUMAN GBRG2_HUMAN GBRB2_HUMAN					WOMBAT-PK
Sodium channel alpha subunits; brain (Types I, II, III)	Ion channel		SCN1A_RAT SCN2A_RAT SCN3A_RAT		IC50	5.60		CHEMBL

External reference:

ID	Source
4017422	VUID
N0000145810	NUI
D00506	KEGG_DRUG
57-30-7	SECONDARY_CAS_RN
4017422	VANDF
4017423	VANDF
C0031412	UMLSCUI
CHEBI:8069	CHEBI
UQA	PDB_CHEM_ID
CHEMBL40	ChEMBL_ID
DB01174	DRUGBANK_ID
CHEMBL149972	ChEMBL_ID
D010634	MESH_DESCRIPTOR_UI
4763	PUBCHEM_CID
2804	IUPHAR_LIGAND_ID
414	INN_ID
YQE403BP4D	UNII
8134	RXNORM
2390	MMSL
33817	MMSL
4349	MMSL
5272	MMSL
5273	MMSL
d00340	MMSL
001406	NDDF
001407	NDDF
373505007	SNOMEDCT_US
51073002	SNOMEDCT_US
76898000	SNOMEDCT_US
4172	INN_ID

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Phenobarbital	HUMAN PRESCRIPTION DRUG LABEL	1	0121-0531	SOLUTION	20 mg	ORAL	unapproved drug other	29 sections
Phenobarbital Oral Solution	HUMAN PRESCRIPTION DRUG LABEL	1	0121-0942	SOLUTION	20 mg	ORAL	unapproved drug other	14 sections
Phenobarbital Oral Solution	HUMAN PRESCRIPTION DRUG LABEL	1	0121-0942	SOLUTION	20 mg	ORAL	unapproved drug other	14 sections
Phenobarbital Oral Solution	HUMAN PRESCRIPTION DRUG LABEL	1	0121-1884	SOLUTION	30 mg	ORAL	unapproved drug other	14 sections
Phenobarbital Oral Solution	HUMAN PRESCRIPTION DRUG LABEL	1	0121-1884	SOLUTION	30 mg	ORAL	unapproved drug other	14 sections
Phenobarbital Oral Solution	HUMAN PRESCRIPTION DRUG LABEL	1	0121-2826	SOLUTION	60 mg	ORAL	unapproved drug other	14 sections
Phenobarbital Oral Solution	HUMAN PRESCRIPTION DRUG LABEL	1	0121-2826	SOLUTION	60 mg	ORAL	unapproved drug other	14 sections
Phenobarbital	HUMAN PRESCRIPTION DRUG LABEL	1	0143-1445	TABLET	15 mg	ORAL	UNAPPROVED DRUG OTHER	17 sections
Phenobarbital	HUMAN PRESCRIPTION DRUG LABEL	1	0143-1450	TABLET	30 mg	ORAL	UNAPPROVED DRUG OTHER	17 sections
Phenobarbital	HUMAN PRESCRIPTION DRUG LABEL	1	0143-1455	TABLET	60 mg	ORAL	UNAPPROVED DRUG OTHER	17 sections
Phenobarbital	HUMAN PRESCRIPTION DRUG LABEL	1	0143-1458	TABLET	100 mg	ORAL	UNAPPROVED DRUG OTHER	17 sections
Phenobarbital	HUMAN PRESCRIPTION DRUG LABEL	1	0143-1495	TABLET	15 mg	ORAL	UNAPPROVED DRUG OTHER	17 sections
Phenobarbital	HUMAN PRESCRIPTION DRUG LABEL	1	0143-1500	TABLET	30 mg	ORAL	UNAPPROVED DRUG OTHER	17 sections
Belladonna Alkaloids with Phenobartbital	HUMAN PRESCRIPTION DRUG LABEL	4	0440-7183	TABLET	16.20 mg	ORAL	UNAPPROVED DRUG OTHER	14 sections
Phenobarbital	HUMAN PRESCRIPTION DRUG LABEL	1	0463-6145	TABLET	30 mg	ORAL	UNAPPROVED DRUG OTHER	17 sections
Phenobarbital	HUMAN PRESCRIPTION DRUG LABEL	1	0463-6151	TABLET	60 mg	ORAL	UNAPPROVED DRUG OTHER	17 sections
Phenobarbital	HUMAN PRESCRIPTION DRUG LABEL	1	0463-6160	TABLET	15 mg	ORAL	UNAPPROVED DRUG OTHER	17 sections
Phenobarbital	HUMAN PRESCRIPTION DRUG LABEL	1	0463-6170	TABLET	100 mg	ORAL	UNAPPROVED DRUG OTHER	17 sections
Phenobarbital	HUMAN PRESCRIPTION DRUG LABEL	1	0603-1508	ELIXIR	20 mg	ORAL	UNAPPROVED DRUG OTHER	22 sections
Phenobarbital	HUMAN PRESCRIPTION DRUG LABEL	1	0603-1508	ELIXIR	20 mg	ORAL	UNAPPROVED DRUG OTHER	22 sections
Phenobarbital	HUMAN PRESCRIPTION DRUG LABEL	1	0603-5165	TABLET	16.20 mg	ORAL	UNAPPROVED DRUG OTHER	22 sections
Phenobarbital	HUMAN PRESCRIPTION DRUG LABEL	1	0603-5165	TABLET	16.20 mg	ORAL	UNAPPROVED DRUG OTHER	22 sections
Phenobarbital	HUMAN PRESCRIPTION DRUG LABEL	1	0603-5166	TABLET	32.40 mg	ORAL	UNAPPROVED DRUG OTHER	22 sections
Phenobarbital	HUMAN PRESCRIPTION DRUG LABEL	1	0603-5166	TABLET	32.40 mg	ORAL	UNAPPROVED DRUG OTHER	22 sections
Phenobarbital	HUMAN PRESCRIPTION DRUG LABEL	1	0603-5167	TABLET	64.80 mg	ORAL	UNAPPROVED DRUG OTHER	22 sections
Phenobarbital	HUMAN PRESCRIPTION DRUG LABEL	1	0603-5167	TABLET	64.80 mg	ORAL	UNAPPROVED DRUG OTHER	22 sections
Phenobarbital	HUMAN PRESCRIPTION DRUG LABEL	1	0603-5168	TABLET	97.20 mg	ORAL	UNAPPROVED DRUG OTHER	22 sections
Phenobarbital	HUMAN PRESCRIPTION DRUG LABEL	1	0603-5168	TABLET	97.20 mg	ORAL	UNAPPROVED DRUG OTHER	22 sections
Phenobarbital Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	0641-0476	INJECTION	65 mg	INTRAMUSCULAR	UNAPPROVED DRUG OTHER	19 sections
Phenobarbital Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	0641-0476	INJECTION	65 mg	INTRAMUSCULAR	UNAPPROVED DRUG OTHER	19 sections