phenytoin Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
antiepileptics, hydantoin derivatives	2152	57-41-0

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: fenitoin sodium diphenylhydantoinate phenytoin diphantoin diphenylan diphenylhydantoin phenytoine phenytoinum phenytoin sodium	An anticonvulsant that is used to treat a wide variety of seizures. It is also an anti-arrhythmic and a muscle relaxant. The mechanism of therapeutic action is not clear, although several cellular actions have been described including effects on ion channels, active transport, and general membrane stabilization. The mechanism of its muscle relaxant effect appears to involve a reduction in the sensitivity of muscle spindles to stretch. Phenytoin has been proposed for several other therapeutic uses, but its use has been limited by its many adverse effects and interactions with other drugs. Molecular weight: 252.27 Formula: C15H12N2O2 CLOGP: 2.08 LIPINSKI: 0 HAC: 4 HDO: 2 TPSA: 58.20 ALOGS: -3.55 ROTB: 2 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

fenitoin
sodium diphenylhydantoinate
phenytoin
diphantoin
diphenylan
diphenylhydantoin
phenytoine
phenytoinum
phenytoin sodium

An anticonvulsant that is used to treat a wide variety of seizures. It is also an anti-arrhythmic and a muscle relaxant. The mechanism of therapeutic action is not clear, although several cellular actions have been described including effects on ion channels, active transport, and general membrane stabilization. The mechanism of its muscle relaxant effect appears to involve a reduction in the sensitivity of muscle spindles to stretch. Phenytoin has been proposed for several other therapeutic uses, but its use has been limited by its many adverse effects and interactions with other drugs.

Molecular weight: 252.27
Formula: C15H12N2O2
CLOGP: 2.08
LIPINSKI: 0
HAC: 4
HDO: 2
TPSA: 58.20
ALOGS: -3.55
ROTB: 2

Status: OFP

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

Drug dosage:

Dose	Unit	Route
0.30	g	O
0.30	g	P

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	0.02 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	2 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	19.82 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	90 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	0.43 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	0.37 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.13 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	16.80 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
Jan. 6, 1953	FDA	PARKE DAVIS

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
Seizure	2096.42	11.24	1271	36109	121783	46526899
Anticonvulsant drug level increased	628.02	11.24	159	37221	1261	46647421
Status epilepticus	585.65	11.24	265	37115	13714	46634968
Generalised tonic-clonic seizure	450.83	11.24	277	37103	26845	46621837
Anticonvulsant drug level decreased	446.59	11.24	118	37262	1126	46647556
Ataxia	412.24	11.24	208	37172	13722	46634960
Drug reaction with eosinophilia and systemic symptoms	406.97	11.24	268	37112	29280	46619402
Toxicity to various agents	397.50	11.24	651	36729	211115	46437567
Epilepsy	378.14	11.24	236	37144	23502	46625180
Anticonvulsant drug level below therapeutic	334.37	11.24	81	37299	523	46648159
Nystagmus	300.19	11.24	127	37253	5572	46643110
Stevens-Johnson syndrome	284.09	11.24	196	37184	23101	46625581
Drug interaction	263.02	11.24	532	36848	202562	46446120
Anticonvulsant drug level above therapeutic	251.22	11.24	62	37318	437	46648245
Product complaint	243.81	11.24	140	37240	11961	46636721
Drug hypersensitivity	242.21	11.24	574	36806	243251	46405431
Purple glove syndrome	201.78	11.24	44	37336	163	46648519
Drug level decreased	179.89	11.24	90	37290	5822	46642860
Cerebellar atrophy	170.38	11.24	48	37332	593	46648089
Toxic epidermal necrolysis	140.29	11.24	127	37253	22151	46626531
Partial seizures	131.37	11.24	69	37311	4941	46643741
Multiple-drug resistance	127.91	11.24	55	37325	2510	46646172
Drug level increased	123.78	11.24	109	37271	18332	46630350
Diarrhoea	107.66	11.24	177	37203	559425	46089257
Anticonvulsant drug level abnormal	106.42	11.24	20	37360	25	46648657
Electroencephalogram abnormal	102.14	11.24	53	37327	3701	46644981
Drug level changed	100.56	11.24	24	37356	144	46648538
Arthralgia	93.08	11.24	93	37287	364510	46284172
Rheumatoid arthritis	93.03	11.24	38	37342	240177	46408505
Drug level below therapeutic	90.29	11.24	46	37334	3091	46645591
Focal dyscognitive seizures	82.94	11.24	42	37338	2786	46645896
Dyspnoea	79.20	11.24	186	37194	515362	46133320
Diplopia	76.76	11.24	86	37294	19319	46629363
Gingival hypertrophy	75.75	11.24	32	37348	1397	46647285
Pain	73.28	11.24	172	37208	476776	46171906
Drug level fluctuating	71.16	11.24	22	37358	382	46648300
Diabetes insipidus	68.81	11.24	34	37346	2140	46646542
Rash maculo-papular	66.45	11.24	96	37284	27778	46620904
Renal ischaemia	66.35	11.24	23	37357	580	46648102
Dysarthria	62.94	11.24	110	37270	37388	46611294
Coma	61.59	11.24	141	37239	58208	46590474
Fatigue	61.57	11.24	265	37115	608432	46040250
Encephalopathy	60.94	11.24	102	37278	33487	46615195
Intra-abdominal pressure increased	60.86	11.24	17	37363	203	46648479
Alopecia	60.74	11.24	27	37353	162387	46486295
Porphyria acute	59.76	11.24	19	37361	363	46648319
Joint swelling	58.44	11.24	30	37350	166043	46482639
PO2 increased	54.18	11.24	22	37358	868	46647814
Drug ineffective for unapproved indication	53.70	11.24	66	37314	16347	46632335
Pneumatosis	53.57	11.24	18	37362	412	46648270
Nausea	52.26	11.24	330	37050	687124	45961558
Erythema multiforme	50.88	11.24	50	37330	9654	46639028
Cerebellar ataxia	50.45	11.24	21	37359	883	46647799
Injection site pain	50.26	11.24	12	37368	107140	46541542
Product substitution issue	50.07	11.24	61	37319	14970	46633712
PCO2 increased	50.03	11.24	23	37357	1231	46647451
Mental status changes	49.32	11.24	100	37280	37988	46610694
Dyskinesia	47.44	11.24	84	37296	28841	46619841
Balance disorder	47.40	11.24	136	37244	64385	46584297
Bradycardia neonatal	47.13	11.24	18	37362	602	46648080
Aura	45.19	11.24	20	37360	979	46647703
Necrosis ischaemic	45.05	11.24	19	37361	826	46647856
Sinusitis	43.37	11.24	25	37355	129743	46518939
Arthropathy	42.77	11.24	8	37372	84692	46563990
Coordination abnormal	42.40	11.24	48	37332	10901	46637781
Neurodegenerative disorder	41.81	11.24	14	37366	317	46648365
Blood bicarbonate decreased	41.70	11.24	27	37353	2858	46645824
Choreoathetosis	41.56	11.24	15	37365	427	46648255
Foetal anticonvulsant syndrome	41.10	11.24	15	37365	441	46648241
Pain in extremity	40.64	11.24	92	37288	258588	46390094
Brain oedema	40.53	11.24	50	37330	12428	46636254
Respiratory disorder neonatal	40.12	11.24	18	37362	910	46647772
Encephalitis autoimmune	39.85	11.24	19	37361	1105	46647577
Peripheral swelling	39.45	11.24	41	37339	158030	46490652
Blood pH decreased	38.99	11.24	25	37355	2602	46646080
Drug resistance	38.76	11.24	58	37322	17310	46631372
Hepatitis	38.68	11.24	82	37298	32133	46616549
Cytomegalovirus hepatitis	38.07	11.24	13	37367	313	46648369
Weight gain poor	37.58	11.24	16	37364	712	46647970
Petit mal epilepsy	36.67	11.24	26	37354	3194	46645488
Respiratory acidosis	36.64	11.24	34	37346	6114	46642568
Psoriasis	36.47	11.24	9	37371	78595	46570087
Angiofibroma	36.47	11.24	10	37370	111	46648571
Oxygen saturation abnormal	35.79	11.24	24	37356	2694	46645988
Eosinophilia	35.71	11.24	59	37321	19158	46629524
Selective eating disorder	34.63	11.24	20	37360	1725	46646957
Product dose omission issue	34.40	11.24	51	37329	168469	46480213
Multiple organ dysfunction syndrome	34.17	11.24	105	37275	51605	46597077
Contraindicated product administered	33.68	11.24	11	37369	79936	46568746
Abdominal discomfort	33.62	11.24	43	37337	151122	46497560
Nervous system disorder	33.37	11.24	52	37328	16077	46632605
Foetal death	33.30	11.24	38	37342	8705	46639977
Drug ineffective	33.01	11.24	741	36639	677097	45971585
Lymphangioleiomyomatosis	32.65	11.24	10	37370	168	46648514
Stupor	32.39	11.24	25	37355	3495	46645187
Back pain	31.92	11.24	76	37304	209963	46438719
Haemophagocytic lymphohistiocytosis	31.33	11.24	36	37344	8306	46640376
Porphyria	31.24	11.24	9	37371	121	46648561
Angiomyolipoma	31.21	11.24	10	37370	196	46648486
Anti-erythropoietin antibody negative	30.89	11.24	8	37372	70	46648612
Neurotoxicity	30.89	11.24	46	37334	13671	46635011
Therapeutic response unexpected	30.45	11.24	49	37331	15567	46633115
Infusion related reaction	30.40	11.24	22	37358	101186	46547496
Somnolence	29.81	11.24	221	37159	156300	46492382
Aggression	29.78	11.24	60	37320	22684	46625998
Nasopharyngitis	29.16	11.24	49	37331	153949	46494733
Brain herniation	28.98	11.24	22	37358	3001	46645681
Laryngeal stenosis	28.61	11.24	13	37367	677	46648005
Anaemia	28.46	11.24	107	37273	255672	46393010
Confusional state	28.35	11.24	222	37158	159670	46489012
Urine copper increased	27.72	11.24	5	37375	4	46648678
Brain injury	27.35	11.24	29	37351	6121	46642561
Musculoskeletal pain	27.25	11.24	11	37369	70117	46578565
Urine delta aminolevulinate increased	27.19	11.24	5	37375	5	46648677
Injection site erythema	26.83	11.24	13	37367	74414	46574268
Depressed level of consciousness	26.38	11.24	91	37289	47478	46601204
Intestinal ischaemia	26.20	11.24	30	37350	6895	46641787
Drug level above therapeutic	26.09	11.24	22	37358	3487	46645195
Asthma	26.08	11.24	21	37359	91521	46557161
Cerebral atrophy	26.04	11.24	25	37355	4691	46643991
Bronchitis	25.85	11.24	28	37352	105951	46542731
Unresponsive to stimuli	25.76	11.24	70	37310	32104	46616578
Ophthalmoplegia	25.52	11.24	13	37367	873	46647809
Aplasia pure red cell	25.46	11.24	24	37356	4401	46644281
Speech disorder	25.36	11.24	75	37305	36092	46612590
Ultrasound ovary abnormal	25.34	11.24	7	37373	80	46648602
Lethargy	25.07	11.24	94	37286	51077	46597605
Myoclonic epilepsy	25.02	11.24	13	37367	910	46647772
Cardiac arrest neonatal	24.95	11.24	7	37373	85	46648597
Bradyarrhythmia	24.72	11.24	17	37363	1989	46646693
Acute hepatic failure	24.45	11.24	43	37337	14678	46634004
Seizure cluster	24.41	11.24	8	37372	169	46648513
Hyperammonaemia	24.17	11.24	24	37356	4692	46643990
Propofol infusion syndrome	24.08	11.24	12	37368	769	46647913
Atonic seizures	23.58	11.24	11	37369	609	46648073
Pemphigus	23.45	11.24	4	37376	45270	46603412
Clonus	23.23	11.24	22	37358	4058	46644624
Abdominal pain	23.20	11.24	100	37280	229931	46418751
Blood alkaline phosphatase increased	23.05	11.24	77	37303	39532	46609150
Glioblastoma multiforme	22.78	11.24	12	37368	864	46647818
Myoclonus	22.66	11.24	41	37339	14311	46634371
Rash morbilliform	22.65	11.24	19	37361	2990	46645692
Drug intolerance	22.49	11.24	53	37327	146996	46501686
Chorea	22.45	11.24	13	37367	1127	46647555
Malaise	22.04	11.24	165	37215	331067	46317615
Dermatitis exfoliative	22.03	11.24	25	37355	5691	46642991
Euthyroid sick syndrome	21.93	11.24	6	37374	66	46648616
Injection site pruritus	21.75	11.24	3	37377	39740	46608942
Cognitive disorder	21.72	11.24	72	37308	36811	46611871
Lymphadenopathy	21.19	11.24	67	37313	33421	46615261
Autism spectrum disorder	21.13	11.24	10	37370	572	46648110
Disease recurrence	21.00	11.24	46	37334	18425	46630257
Porphyrins stool increased	20.95	11.24	5	37375	30	46648652
Abdominal pain upper	20.95	11.24	54	37326	145251	46503431
Malabsorption	20.78	11.24	20	37360	3763	46644919
Discomfort	20.41	11.24	6	37374	46664	46602018
Vomiting projectile	20.28	11.24	13	37367	1352	46647330
Herpes zoster	20.06	11.24	15	37365	67857	46580825
Injection site swelling	19.95	11.24	4	37376	40323	46608359
Left ventricular dysfunction	19.75	11.24	32	37348	10223	46638459
Calcinosis	19.49	11.24	14	37366	1755	46646927
Chest pain	19.44	11.24	74	37306	176250	46472432
Plasmodium falciparum infection	18.89	11.24	5	37375	48	46648634
Ischaemic cerebral infarction	18.86	11.24	12	37368	1233	46647449
Medication error	18.79	11.24	61	37319	30850	46617832
Perforation	18.76	11.24	11	37369	976	46647706
Hallucination, tactile	18.62	11.24	7	37373	224	46648458
Hyperreflexia	18.61	11.24	22	37358	5232	46643450
Areflexia	18.56	11.24	17	37363	3006	46645676
Cerebellar cognitive affective syndrome	18.39	11.24	3	37377	0	46648682
Palpitations	18.31	11.24	30	37350	95229	46553453
Hyperammonaemic encephalopathy	18.07	11.24	14	37366	1968	46646714
Chronic graft versus host disease	18.06	11.24	16	37364	2709	46645973
Pyrexia	18.03	11.24	385	36995	348417	46300265
Psychotic disorder	17.89	11.24	49	37331	22572	46626110
Lower respiratory tract infection	17.85	11.24	11	37369	55078	46593604
Blood albumin decreased	17.68	11.24	36	37344	13709	46634973
Paranoia	17.66	11.24	31	37349	10566	46638116
Mucosal erosion	17.59	11.24	12	37368	1386	46647296
Ventricular dysfunction	17.53	11.24	16	37364	2816	46645866
Acute kidney injury	17.38	11.24	114	37266	235741	46412941
Enterocolitis	17.33	11.24	23	37357	6145	46642537
Brain operation	17.30	11.24	8	37372	434	46648248
Intensive care unit acquired weakness	17.29	11.24	9	37371	632	46648050
Torticollis	17.25	11.24	13	37367	1754	46646928
Cough	17.11	11.24	111	37269	230138	46418544
Febrile neutropenia	17.09	11.24	31	37349	94596	46554086
Aphasia	17.03	11.24	56	37324	28511	46620171
Gamma-glutamyltransferase increased	16.97	11.24	60	37320	31680	46617002
Dehydration	16.91	11.24	68	37312	159472	46489210
Blood magnesium decreased	16.84	11.24	31	37349	10961	46637721
Fluid retention	16.81	11.24	10	37370	51036	46597646
Encephalitis	16.80	11.24	25	37355	7423	46641259
Systemic inflammatory response syndrome	16.61	11.24	21	37359	5350	46643332
Neonatal seizure	16.52	11.24	7	37373	308	46648374
Dry mouth	16.41	11.24	12	37368	54914	46593768
Loss of consciousness	16.34	11.24	145	37235	108093	46540589
Influenza	16.34	11.24	29	37351	89241	46559441
Arthritis	16.15	11.24	23	37357	77293	46571389
Aplastic anaemia	16.12	11.24	24	37356	7129	46641553
Chest discomfort	15.92	11.24	30	37350	90239	46558443
Epileptic psychosis	15.87	11.24	4	37376	31	46648651
Adverse drug reaction	15.60	11.24	8	37372	44354	46604328
Blood calcium decreased	15.57	11.24	37	37343	15636	46633046
Osteoarthritis	15.55	11.24	16	37364	62009	46586673
Illusion	15.55	11.24	10	37370	1046	46647636
Intention tremor	15.54	11.24	7	37373	357	46648325
Linear IgA disease	15.52	11.24	11	37369	1350	46647332
Lip erosion	15.44	11.24	9	37371	790	46647892
Idiopathic pneumonia syndrome	15.40	11.24	7	37373	365	46648317
Brain neoplasm	15.21	11.24	17	37363	3807	46644875
Overdose	15.08	11.24	136	37244	101843	46546839
Dyspnoea exertional	15.00	11.24	11	37369	50278	46598404
Ammonia increased	14.96	11.24	18	37362	4359	46644323
Pneumonia	14.89	11.24	212	37168	376108	46272574
Intensive care unit delirium	14.88	11.24	4	37376	41	46648641
Injection site bruising	14.83	11.24	5	37375	35631	46613051
Hallucination, auditory	14.83	11.24	29	37351	10727	46637955
Respiratory tract infection	14.77	11.24	3	37377	29969	46618713
Wound	14.64	11.24	8	37372	42794	46605888
Incoherent	14.52	11.24	18	37362	4494	46644188
Tongue ulceration	14.50	11.24	15	37365	3078	46645604
Periorbital oedema	14.49	11.24	19	37361	5016	46643666
Central nervous system infection	14.47	11.24	8	37372	634	46648048
Epileptic encephalopathy	14.44	11.24	6	37374	251	46648431
Disorientation	14.25	11.24	63	37317	36855	46611827
Posterior reversible encephalopathy syndrome	14.24	11.24	35	37345	15106	46633576
Asterixis	14.16	11.24	10	37370	1221	46647461
Abnormal behaviour	14.13	11.24	43	37337	21015	46627667
Hypotension	14.09	11.24	263	37117	232326	46416356
Cardiac failure congestive	14.08	11.24	33	37347	91717	46556965
Intestinal dilatation	13.92	11.24	11	37369	1591	46647091
Atrial fibrillation	13.80	11.24	40	37340	103550	46545132
Enzyme induction	13.74	11.24	4	37376	56	46648626
Lactose intolerance	13.74	11.24	13	37367	2396	46646286
Gait disturbance	13.68	11.24	177	37203	145086	46503596
Hirsutism	13.63	11.24	9	37371	985	46647697
Drug level abnormal	13.61	11.24	4	37376	58	46648624
Coagulation time prolonged	13.57	11.24	10	37370	1304	46647378
Drug withdrawal convulsions	13.39	11.24	10	37370	1331	46647351
Potentiating drug interaction	13.19	11.24	16	37364	3907	46644775
Left ventricular hypertrophy	13.17	11.24	18	37362	4945	46643737
Hospitalisation	13.10	11.24	19	37361	63366	46585316
Cerebellar syndrome	13.09	11.24	15	37365	3450	46645232
Bone pain	13.05	11.24	11	37369	46879	46601803
Biopsy brain	13.03	11.24	3	37377	15	46648667
Insomnia	13.02	11.24	78	37302	164846	46483836
Mental impairment	13.02	11.24	30	37350	12426	46636256
Impaired self-care	12.97	11.24	11	37369	1757	46646925
Toxic encephalopathy	12.89	11.24	18	37362	5044	46643638
Glossodynia	12.86	11.24	10	37370	44363	46604319
Epileptic aura	12.75	11.24	4	37376	73	46648609
Infrequent bowel movements	12.74	11.24	9	37371	1099	46647583
Myalgia	12.71	11.24	53	37327	123035	46525647
Hypoventilation	12.60	11.24	16	37364	4094	46644588
Death	12.58	11.24	191	37189	335357	46313325
Staring	12.57	11.24	10	37370	1460	46647222
Post-traumatic epilepsy	12.57	11.24	3	37377	18	46648664
Hemiparesis	12.56	11.24	40	37340	20029	46628653
White matter lesion	12.50	11.24	9	37371	1132	46647550
General physical health deterioration	12.48	11.24	49	37331	115720	46532962
Hypotonia	12.35	11.24	23	37357	8206	46640476
Reflexes abnormal	12.22	11.24	7	37373	594	46648088
Cachexia	12.13	11.24	17	37363	4782	46643900
Muscle spasms	12.10	11.24	54	37326	123059	46525623
Systemic lupus erythematosus	12.08	11.24	21	37359	65159	46583523
Psychogenic seizure	12.03	11.24	9	37371	1201	46647481
Gastrooesophageal reflux disease	12.00	11.24	26	37354	74318	46574364
Apallic syndrome	11.99	11.24	7	37373	616	46648066
Extensor plantar response	11.86	11.24	9	37371	1227	46647455
CSF oligoclonal band present	11.73	11.24	4	37376	96	46648586
Productive cough	11.71	11.24	14	37366	50701	46597981
Plasma cell myeloma	11.70	11.24	11	37369	44467	46604215
C-reactive protein increased	11.68	11.24	18	37362	58572	46590110
Pyroglutamate increased	11.51	11.24	6	37374	423	46648259
Myoglobinuria	11.39	11.24	5	37375	240	46648442
Rash erythematous	11.33	11.24	56	37324	34294	46614388
Postictal state	11.28	11.24	8	37372	983	46647699

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
Seizure	2142.95	12.03	1355	33121	97120	29820882
Status epilepticus	719.10	12.03	318	34158	10754	29907248
Anticonvulsant drug level increased	684.80	12.03	186	34290	1329	29916673
Nystagmus	618.49	12.03	220	34256	4118	29913884
Anticonvulsant drug level decreased	526.17	12.03	139	34337	880	29917122
Toxicity to various agents	503.96	12.03	801	33675	176382	29741620
Ataxia	484.76	12.03	245	34231	11217	29906785
Drug reaction with eosinophilia and systemic symptoms	468.35	12.03	331	34145	28157	29889845
Anticonvulsant drug level above therapeutic	374.62	12.03	88	34388	313	29917689
Generalised tonic-clonic seizure	313.84	12.03	224	34252	19327	29898675
Anticonvulsant drug level below therapeutic	271.17	12.03	75	34401	577	29917425
Product complaint	250.92	12.03	126	34350	5680	29912322
Drug level decreased	216.25	12.03	114	34362	5691	29912311
Drug interaction	214.63	12.03	607	33869	198961	29719041
Stevens-Johnson syndrome	197.80	12.03	163	34313	17393	29900609
Epilepsy	188.02	12.03	168	34308	20001	29898001
Cerebellar atrophy	157.96	12.03	45	34431	390	29917612
Partial seizures	137.52	12.03	73	34403	3694	29914308
Diarrhoea	123.50	12.03	122	34354	333981	29584021
Drug level fluctuating	115.99	12.03	36	34440	430	29917572
Purple glove syndrome	114.58	12.03	24	34452	41	29917961
Dysarthria	109.05	12.03	154	34322	30336	29887666
Drug level below therapeutic	107.89	12.03	60	34416	3332	29914670
Drug hypersensitivity	107.46	12.03	241	34235	68278	29849724
Coordination abnormal	102	12.03	77	34399	7228	29910774
Dyspnoea	101.36	12.03	142	34334	333153	29584849
Drug level increased	99.42	12.03	114	34362	18240	29899762
Drug level above therapeutic	88.08	12.03	50	34426	2889	29915113
Sudden unexplained death in epilepsy	84.25	12.03	28	34448	422	29917580
Gingival hypertrophy	84.21	12.03	40	34436	1593	29916409
Hyperammonaemia	83.37	12.03	61	34415	5459	29912543
Drug level changed	82.76	12.03	26	34450	324	29917678
Mental status changes	77.64	12.03	147	34329	36932	29881070
Multiple-drug resistance	74.84	12.03	45	34431	2896	29915106
Anaemia	68.84	12.03	83	34393	207909	29710093
Gait disturbance	64.50	12.03	211	34265	74566	29843436
Acute kidney injury	62.85	12.03	139	34337	273703	29644299
Foetal anticonvulsant syndrome	62.61	12.03	26	34450	748	29917254
Anticonvulsant drug level abnormal	61.78	12.03	13	34463	23	29917979
Confusional state	60.73	12.03	311	34165	134523	29783479
Brain oedema	60.48	12.03	73	34403	12325	29905677
Drug resistance	58.09	12.03	92	34384	20041	29897961
Arthralgia	57.99	12.03	43	34433	135748	29782254
Toxic epidermal necrolysis	55.98	12.03	85	34391	17855	29900147
Lethargy	55.30	12.03	133	34343	39386	29878616
Drug ineffective	53.91	12.03	613	33863	339774	29578228
Cerebellar syndrome	53.20	12.03	32	34444	2060	29915942
Sedation	53.12	12.03	79	34397	16294	29901708
Product substitution issue	52.10	12.03	61	34415	9974	29908028
Somnolence	51.32	12.03	234	34242	96529	29821473
Fatigue	50.12	12.03	195	34281	320478	29597524
Febrile neutropenia	49.25	12.03	31	34445	106662	29811340
Rash maculo-papular	48.59	12.03	97	34379	25321	29892681
Pneumonia	47.46	12.03	211	34265	334095	29583907
Death	46.91	12.03	232	34244	357051	29560951
Therapeutic response unexpected	46.02	12.03	54	34422	8849	29909153
Balance disorder	45.97	12.03	118	34358	36375	29881627
Urine copper increased	45.69	12.03	9	34467	9	29917993
Focal dyscognitive seizures	43.88	12.03	24	34452	1289	29916713
Cough	42.72	12.03	49	34427	125593	29792409
Depressed level of consciousness	42.50	12.03	118	34358	38104	29879898
Aura	41.92	12.03	15	34461	285	29917717
Cerebellar ataxia	41.46	12.03	21	34455	963	29917039
Joint swelling	39.66	12.03	4	34472	46942	29871060
Cerebral atrophy	39.45	12.03	36	34440	4397	29913605
Stupor	38.74	12.03	30	34446	2923	29915079
Simple partial seizures	38.27	12.03	14	34462	284	29917718
Intensive care unit acquired weakness	37.88	12.03	19	34457	853	29917149
Barbiturates positive	37.22	12.03	7	34469	4	29917998
Choreoathetosis	36.48	12.03	19	34457	924	29917078
Fall	36.46	12.03	344	34132	181528	29736474
Interstitial lung disease	36.30	12.03	12	34464	60185	29857817
Cardiac failure	36.12	12.03	26	34450	83392	29834610
Porphyrins stool increased	35.54	12.03	7	34469	7	29917995
Postictal paralysis	35.31	12.03	11	34465	133	29917869
Hypotonia	34.03	12.03	41	34435	6907	29911095
Asterixis	33.95	12.03	20	34456	1239	29916763
Necrosis ischaemic	33.63	12.03	12	34464	226	29917776
Myalgia	33.06	12.03	24	34452	76643	29841359
Blood homocysteine increased	32.37	12.03	12	34464	253	29917749
Glioblastoma multiforme	32.28	12.03	17	34459	846	29917156
Diabetes insipidus	32.14	12.03	24	34452	2215	29915787
Chest pain	31.85	12.03	54	34422	117573	29800429
Acidosis hyperchloraemic	31.32	12.03	12	34464	278	29917724
Myocardial infarction	31.05	12.03	61	34415	125564	29792438
Erythema multiforme	31.02	12.03	42	34434	7943	29910059
Petit mal epilepsy	30.81	12.03	25	34451	2606	29915396
Nausea	30.75	12.03	208	34268	296749	29621253
Ophthalmoplegia	30.73	12.03	19	34457	1285	29916717
Hippocampal sclerosis	30.53	12.03	9	34467	89	29917913
Hypoplastic left heart syndrome	30.36	12.03	11	34465	217	29917785
Encephalopathy	29.66	12.03	93	34383	32112	29885890
Extensor plantar response	29.62	12.03	14	34462	551	29917451
Dehydration	28.83	12.03	62	34414	123477	29794525
Past-pointing	28.39	12.03	7	34469	32	29917970
Plasma cell myeloma	28.36	12.03	13	34463	53449	29864553
Pain	28.16	12.03	103	34373	172538	29745464
Idiosyncratic drug reaction	28.11	12.03	13	34463	487	29917515
Blood albumin decreased	27.68	12.03	51	34425	12541	29905461
Inhibitory drug interaction	27.54	12.03	19	34457	1549	29916453
Dystonia	27.43	12.03	44	34432	9683	29908319
Aggression	27.29	12.03	99	34377	36808	29881194
Hyperreflexia	27.13	12.03	24	34452	2815	29915187
Back pain	26.95	12.03	48	34428	102548	29815454
Unresponsive to stimuli	26.87	12.03	79	34397	26340	29891662
Overdose	26.49	12.03	177	34299	84160	29833842
Intention tremor	26.37	12.03	11	34465	320	29917682
Agitation	25.88	12.03	127	34349	53946	29864056
Gingival disorder	25.85	12.03	17	34459	1280	29916722
Malaise	25.68	12.03	102	34374	166860	29751142
Encephalomalacia	25.57	12.03	13	34463	601	29917401
Porphyria acute	25.51	12.03	8	34468	99	29917903
Abdominal pain	25.51	12.03	76	34400	135578	29782424
Dysmetria	25.34	12.03	11	34465	354	29917648
Drug withdrawal convulsions	25.09	12.03	16	34460	1143	29916859
Superinfection	24.74	12.03	18	34458	1596	29916406
Atrial fibrillation	24.61	12.03	55	34421	108069	29809933
Coagulopathy	24.54	12.03	61	34415	18426	29899576
Nervous system disorder	23.93	12.03	49	34427	13020	29904982
Constipation	23.66	12.03	60	34416	112846	29805156
Haemoglobin decreased	23.62	12.03	61	34415	114037	29803965
Intestinal ischaemia	23.41	12.03	34	34442	6863	29911139
Dyskinesia	22.88	12.03	66	34410	21768	29896234
Hyperchloraemia	22.86	12.03	11	34465	451	29917551
Learning disorder	22.55	12.03	11	34465	465	29917537
Labelled drug-drug interaction medication error	22.31	12.03	42	34434	10496	29907506
Cerebral palsy	22.30	12.03	7	34469	87	29917915
Blood ketone body increased	21.89	12.03	10	34466	364	29917638
Atonic seizures	21.79	12.03	8	34468	164	29917838
Muscle twitching	21.79	12.03	36	34440	8119	29909883
Intellectual disability	21.78	12.03	13	34463	825	29917177
Cardiac failure congestive	21.71	12.03	40	34436	84367	29833635
Gingival atrophy	21.59	12.03	6	34470	47	29917955
Psoriasis	21.53	12.03	11	34465	42495	29875507
Postictal psychosis	21.47	12.03	7	34469	99	29917903
Pain in extremity	21.26	12.03	61	34415	110160	29807842
Mucosal ulceration	21.22	12.03	13	34463	865	29917137
Postictal state	21.12	12.03	12	34464	694	29917308
Hemiparesis	20.88	12.03	50	34426	14752	29903250
Neonatal respiratory depression	20.49	12.03	10	34466	423	29917579
Asthma	20.46	12.03	8	34468	36166	29881836
Cytokine storm	20.42	12.03	11	34465	573	29917429
Eosinophilia	20.41	12.03	64	34412	22096	29895906
Urine delta aminolevulinate increased	20.31	12.03	4	34472	4	29917998
Injection site pain	20.19	12.03	5	34471	30305	29887697
Obliterative bronchiolitis	19.83	12.03	14	34462	1184	29916818
Completed suicide	19.79	12.03	188	34288	99304	29818698
Treatment noncompliance	19.74	12.03	69	34407	25184	29892818
Impetigo	19.66	12.03	12	34464	793	29917209
Influenza like illness	19.63	12.03	3	34473	25602	29892400
Blood creatinine increased	19.57	12.03	48	34428	91327	29826675
Pulmonary vasculitis	19.54	12.03	6	34470	69	29917933
Oedema peripheral	19.38	12.03	60	34416	105772	29812230
Vasogenic cerebral oedema	19.34	12.03	10	34466	479	29917523
Speech disorder	19.18	12.03	67	34409	24445	29893557
Blood glucose increased	18.80	12.03	26	34450	61504	29856498
Dysstasia	18.77	12.03	39	34437	10466	29907536
Cognitive disorder	18.75	12.03	65	34411	23625	29894377
Nephritis allergic	18.68	12.03	9	34467	370	29917632
Soft tissue swelling	18.62	12.03	8	34468	251	29917751
Areflexia	18.40	12.03	19	34457	2700	29915302
Brain herniation	18.20	12.03	22	34454	3718	29914284
Aphasia	17.77	12.03	56	34420	19383	29898619
Hypothermia	17.67	12.03	36	34440	9531	29908471
Ammonia increased	17.54	12.03	23	34453	4218	29913784
Pneumonitis	17.39	12.03	5	34471	27449	29890553
General physical health deterioration	17.37	12.03	58	34418	99886	29818116
Methylenetetrahydrofolate reductase deficiency	17.31	12.03	3	34473	0	29918002
Dysmorphism	17.21	12.03	16	34460	2001	29916001
Epistaxis	16.58	12.03	22	34454	52959	29865043
Autonomic nervous system imbalance	16.53	12.03	17	34459	2404	29915598
Hospitalisation	16.48	12.03	16	34460	44303	29873699
Hyperammonaemic encephalopathy	16.46	12.03	15	34461	1829	29916173
Condition aggravated	16.44	12.03	236	34240	137630	29780372
Propofol infusion syndrome	16.41	12.03	11	34465	855	29917147
Chills	16.28	12.03	37	34439	72301	29845701
Chest discomfort	16.25	12.03	17	34459	45463	29872539
Rash morbilliform	16.07	12.03	17	34459	2485	29915517
Angina pectoris	15.93	12.03	7	34469	29511	29888491
Neurodegenerative disorder	15.85	12.03	7	34469	235	29917767
C-reactive protein increased	15.81	12.03	16	34460	43457	29874545
Ascites	15.79	12.03	11	34465	35910	29882092
White blood cell count decreased	15.79	12.03	47	34429	83900	29834102
Diplopia	15.77	12.03	43	34433	13729	29904273
Personality disorder	15.73	12.03	12	34464	1143	29916859
Melaena	15.54	12.03	9	34467	32428	29885574
Decreased appetite	15.46	12.03	105	34371	149805	29768197
Encephalitis	15.33	12.03	27	34449	6409	29911593
Coma	15.25	12.03	89	34387	40360	29877642
Nasopharyngeal reflux	15.23	12.03	3	34473	3	29917999
Acute generalised exanthematous pustulosis	15.07	12.03	26	34450	6072	29911930
Fluid retention	15.03	12.03	5	34471	24993	29893009
Electroencephalogram abnormal	15.01	12.03	16	34460	2358	29915644
Syncope	14.93	12.03	49	34427	84854	29833148
Mydriasis	14.93	12.03	26	34450	6117	29911885
Unmasking of previously unidentified disease	14.83	12.03	9	34467	589	29917413
Hyperkinesia	14.81	12.03	15	34461	2083	29915919
Gamma-glutamyltransferase increased	14.80	12.03	70	34406	29280	29888722
Haematuria traumatic	14.77	12.03	6	34470	163	29917839
Product dose omission issue	14.70	12.03	55	34421	91576	29826426
Intracranial pressure increased	14.54	12.03	19	34457	3471	29914531
Ischaemic hepatitis	14.54	12.03	13	34463	1546	29916456
Retinal vein occlusion	14.54	12.03	13	34463	1546	29916456
Soft tissue haemorrhage	14.53	12.03	6	34470	170	29917832
Hepatic necrosis	14.52	12.03	20	34456	3843	29914159
Gliosis	14.50	12.03	6	34470	171	29917831
Hepatitis fulminant	14.21	12.03	20	34456	3921	29914081
Tonic convulsion	14.19	12.03	10	34466	843	29917159
Familial periodic paralysis	14.07	12.03	5	34471	93	29917909
Weight decreased	13.97	12.03	109	34367	150812	29767190
Neutropenia	13.77	12.03	89	34387	128451	29789551
Lymphocytosis	13.76	12.03	14	34462	1956	29916046
Chemical burn	13.74	12.03	6	34470	196	29917806
Phalangeal hypoplasia	13.70	12.03	3	34473	7	29917995
Acute myocardial infarction	13.68	12.03	25	34451	52914	29865088
Pancytopenia	13.67	12.03	51	34425	85001	29833001
Acute hepatic failure	13.62	12.03	37	34439	11790	29906212
Infusion related reaction	13.57	12.03	16	34460	40548	29877454
Feeling of despair	13.32	12.03	10	34466	930	29917072
Lymphocyte morphology abnormal	13.30	12.03	8	34468	515	29917487
Prescribed overdose	13.26	12.03	30	34446	8531	29909471
Lid lag	13.16	12.03	3	34473	9	29917993
Symblepharon	13.08	12.03	5	34471	115	29917887
Dyspnoea exertional	12.93	12.03	13	34463	35417	29882585
Crystalluria	12.80	12.03	7	34469	376	29917626
Open angle glaucoma	12.79	12.03	6	34470	232	29917770
Arthropathy	12.72	12.03	4	34472	20723	29897279
Haemophagocytic lymphohistiocytosis	12.67	12.03	32	34444	9759	29908243
Eye movement disorder	12.66	12.03	19	34457	3949	29914053
Abdominal pain upper	12.51	12.03	34	34442	62517	29855485
Spina bifida occulta	12.49	12.03	3	34473	12	29917990
Pulmonary embolism	12.46	12.03	47	34429	78088	29839914
Cerebral arteriovenous malformation haemorrhagic	12.44	12.03	4	34472	54	29917948
Muscle spasms	12.41	12.03	36	34440	64802	29853200
Coronary artery disease	12.38	12.03	24	34452	49688	29868314
Hypoglycaemia	12.37	12.03	25	34451	50956	29867046
Enzyme level increased	12.20	12.03	5	34471	139	29917863
Pleural effusion	12.17	12.03	44	34432	74022	29843980
Bacterial toxaemia	12.17	12.03	5	34471	140	29917862
Abnormal behaviour	12.12	12.03	60	34416	25563	29892439
Bone metabolism disorder	12.12	12.03	6	34470	262	29917740
Drug abuse	12.06	12.03	51	34425	82021	29835981

Pharmacologic Action:

Source	Code	Description
ATC	N03AB02	NERVOUS SYSTEM ANTIEPILEPTICS ANTIEPILEPTICS Hydantoin derivatives
ATC	N03AB52	NERVOUS SYSTEM ANTIEPILEPTICS ANTIEPILEPTICS Hydantoin derivatives
FDA PE	N0000008486	Decreased Central Nervous System Disorganized Electrical Activity
FDA EPC	N0000175753	Anti-epileptic Agent
MeSH PA	D000927	Anticonvulsants
MeSH PA	D002317	Cardiovascular Agents
MeSH PA	D002491	Central Nervous System Agents
MeSH PA	D065694	Cytochrome P-450 CYP1A2 Inducers
MeSH PA	D049990	Membrane Transport Modulators
MeSH PA	D065606	Metabolic Side Effects of Drugs and Substances
MeSH PA	D026941	Sodium Channel Blockers
MeSH PA	D061567	Voltage-Gated Sodium Channel Blockers
CHEBI has role	CHEBI:35623	antiepileptic
CHEBI has role	CHEBI:38633	sodium channel blockers
CHEBI has role	CHEBI:50905	teratogen
CHEBI has role	CHEBI:88188	allergenic drug
FDA MoA	N0000185507	Cytochrome P450 2C9 Inducers
FDA MoA	N0000185607	Cytochrome P450 2C19 Inducers
FDA MoA	N0000187063	Cytochrome P450 2C8 Inducers
FDA MoA	N0000187064	Cytochrome P450 2B6 Inducers
FDA MoA	N0000190118	Cytochrome P450 3A Inducers
FDA MoA	N0000191266	Cytochrome P450 1A2 Inducers
FDA MoA	N0000191267	Cytochrome P450 2D6 Inducers

Drug Use (View source of the data)

Disease	Relation	SNOMED_ID	DOID
Tonic-clonic seizure	indication	54200006
Epilepsy	indication	84757009	DOID:1826
Bipolar disorder in remission	indication	85248005
Localization-related epilepsy	indication	230381009	DOID:2234
Lennox-Gastaut syndrome	indication	230418006
Status epilepticus	indication	230456007	DOID:1824
Motor cortex epilepsy	indication	267592003
Tonic-clonic epilepsy	indication	352818000	DOID:7725
Epilepsy characterized by intractable complex partial seizures	indication	442481002
Simple partial seizure	indication	117891000119100
Seizures in Neurosurgery	indication
Prevention of Seizures following Cranial Trauma or Surgery	indication
Bipolar affective disorder, current episode depression	off-label use	191627008	DOID:3312
Wound care	off-label use	225358003
Neuropathic pain	off-label use	247398009
Rapid Cycling Bipolar Affective Disorder	off-label use
Osteomalacia	contraindication	4598005	DOID:10573
Suicidal thoughts	contraindication	6471006
Alcoholism	contraindication	7200002
Hyperammonemia	contraindication	9360008
Hepatic encephalopathy	contraindication	13920009	DOID:13413
Disorder of thyroid gland	contraindication	14304000	DOID:50
Agranulocytosis	contraindication	17182001	DOID:12987
Hyperphosphatemia	contraindication	20165001	DOID:0050459
Myocardial infarction	contraindication	22298006	DOID:5844
Alcohol intoxication	contraindication	25702006
Complete atrioventricular block	contraindication	27885002
Lymphadenopathy	contraindication	30746006
Torsades de pointes	contraindication	31722008
Depressive disorder	contraindication	35489007
Conduction disorder of the heart	contraindication	44808001
Low blood pressure	contraindication	45007003
Stokes-Adams syndrome	contraindication	46935006
Sinus bradycardia	contraindication	49710005
Megaloblastic anemia	contraindication	53165003	DOID:13382
Systemic lupus erythematosus	contraindication	55464009	DOID:9074
Acute nephropathy	contraindication	58574008
Hepatic failure	contraindication	59927004
Sinus node dysfunction	contraindication	60423000
Poisoning by phenobarbital	contraindication	64921004
Substance abuse	contraindication	66214007
Hepatic coma	contraindication	72836002	DOID:12550
Diabetes mellitus	contraindication	73211009	DOID:9351
Sleep apnea	contraindication	73430006	DOID:0050847
Hyperglycemia	contraindication	80394007	DOID:4195
Decreased respiratory function	contraindication	80954004
Leukopenia	contraindication	84828003	DOID:615
Kidney disease	contraindication	90708001	DOID:557
Prolonged QT interval	contraindication	111975006
Hypoalbuminemia	contraindication	119247004
Pancytopenia	contraindication	127034005	DOID:12450
Purple glove syndrome	contraindication	129576003
Second degree atrioventricular block	contraindication	195042002
Decompensated cardiac failure	contraindication	195111005
Non-infective meningitis	contraindication	230155003
Disease of liver	contraindication	235856003	DOID:409
Dyspnea	contraindication	267036007
Anemia	contraindication	271737000	DOID:2355
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
Breastfeeding (mother)	contraindication	413712001
Granulocytopenic disorder	contraindication	417672002
Porphyria	contraindication	418470004
Fever greater than 100.4 Fahrenheit	contraindication	426000000
Hyperplasia of gingiva	contraindication	441798003
Congenital long QT syndrome	contraindication	442917000
HLA-B 1502 Positive Status	contraindication

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	7.8	acidic

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])	Bioact source	MoA source
Sodium channel protein type 8 subunit alpha	Ion channel	Q9UQD0	SCN8A_HUMAN	BLOCKER			CHEMBL	CHEMBL
Sodium channel protein type 5 subunit alpha	Ion channel	Q14524	SCN5A_HUMAN	BLOCKER			WOMBAT-PK	CHEMBL
Sodium channel protein type 1 subunit alpha	Ion channel	P35498	SCN1A_HUMAN	BLOCKER			CHEMBL	CHEMBL
Sodium channel protein type 9 subunit alpha	Ion channel	Q15858	SCN9A_HUMAN	BLOCKER			CHEMBL	CHEMBL
Sodium channel protein type 2 subunit alpha	Ion channel	Q99250	SCN2A_HUMAN	BLOCKER	IC50	4.90	IUPHAR	CHEMBL
Sodium channel protein type 3 subunit alpha	Ion channel	Q9NY46	SCN3A_HUMAN	BLOCKER			CHEMBL	CHEMBL
Sodium channel protein type 4 subunit alpha	Ion channel	P35499	SCN4A_HUMAN	BLOCKER	Ki	4.62	CHEMBL	CHEMBL
Nuclear receptor subfamily 1 group I member 3	Nuclear hormone receptor	Q14994	NR1I3_HUMAN				WOMBAT-PK
Sodium channel alpha subunits; brain (Types I, II, III)	Ion channel		SCN1A_RAT SCN2A_RAT SCN3A_RAT		IC50	4.40	CHEMBL
Sodium channel protein type 2 subunit alpha	Ion channel		SCN2A_RAT		IC50	4.66	CHEMBL

External reference:

ID	Source
4017856	VUID
N0000146211	NUI
D00512	KEGG_DRUG
630-93-3	SECONDARY_CAS_RN
4017856	VANDF
4017857	VANDF
C0031507	UMLSCUI
CHEBI:8107	CHEBI
CHEMBL16	ChEMBL_ID
CHEMBL1611	ChEMBL_ID
DB00252	DRUGBANK_ID
D010672	MESH_DESCRIPTOR_UI
1775	PUBCHEM_CID
2624	IUPHAR_LIGAND_ID
416	INN_ID
6158TKW0C5	UNII
71227	RXNORM
1366	MMSL
5292	MMSL
5293	MMSL
72015	MMSL
d00143	MMSL
001617	NDDF
001619	NDDF
387220006	SNOMEDCT_US
387416005	SNOMEDCT_US
40556005	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Dilantin Infatabs	HUMAN PRESCRIPTION DRUG LABEL	1	0071-0007	TABLET, CHEWABLE	50 mg	ORAL	ANDA	27 sections
Dilantin	HUMAN PRESCRIPTION DRUG LABEL	1	0071-0369	CAPSULE	100 mg	ORAL	ANDA	28 sections
Dilantin-125	HUMAN PRESCRIPTION DRUG LABEL	1	0071-2214	SUSPENSION	125 mg	ORAL	NDA	28 sections
Dilantin	HUMAN PRESCRIPTION DRUG LABEL	1	0071-3740	CAPSULE	30 mg	ORAL	ANDA	28 sections
Phenytoin	HUMAN PRESCRIPTION DRUG LABEL	1	0121-0892	SUSPENSION	125 mg	ORAL	ANDA	27 sections
Phenytoin Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	0378-1560	CAPSULE, EXTENDED RELEASE	100 mg	ORAL	ANDA	25 sections
Phenytek	HUMAN PRESCRIPTION DRUG LABEL	1	0378-2670	CAPSULE, EXTENDED RELEASE	200 mg	ORAL	ANDA	25 sections
Phenytek	HUMAN PRESCRIPTION DRUG LABEL	1	0378-3750	CAPSULE, EXTENDED RELEASE	300 mg	ORAL	ANDA	25 sections
Phenytoin	HUMAN PRESCRIPTION DRUG LABEL	1	0378-3850	TABLET, CHEWABLE	50 mg	ORAL	ANDA	26 sections
Phenytoin	HUMAN PRESCRIPTION DRUG LABEL	1	0615-7764	TABLET, CHEWABLE	50 mg	ORAL	ANDA	24 sections
Phenytoin Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8020	CAPSULE, EXTENDED RELEASE	100 mg	ORAL	ANDA	26 sections
Phenytoin Infatabs	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8260	TABLET, CHEWABLE	50 mg	ORAL	ANDA	26 sections
Phenytoin Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	0641-0493	INJECTION	50 mg	INTRAMUSCULAR	ANDA	25 sections
Phenytoin Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	0641-2555	INJECTION	50 mg	INTRAMUSCULAR	ANDA	25 sections
Phenytoin Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	0641-6138	INJECTION	50 mg	INTRAMUSCULAR	ANDA	25 sections
Phenytoin Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	0641-6139	INJECTION	50 mg	INTRAMUSCULAR	ANDA	25 sections
Extended Phenytoin Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	0904-6187	CAPSULE	100 mg	ORAL	ANDA	23 sections
Phenytoin	HUMAN PRESCRIPTION DRUG LABEL	1	0904-7079	SUSPENSION	100 mg	ORAL	ANDA	27 sections
Extended Phenytoin Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	10135-603	CAPSULE, EXTENDED RELEASE	100 mg	ORAL	ANDA	23 sections
PHENYTOINER	HUMAN PRESCRIPTION DRUG LABEL	1	16590-815	CAPSULE	100 mg	ORAL	ANDA	3 sections
Phenytoin	HUMAN PRESCRIPTION DRUG LABEL	1	17856-0067	SUSPENSION	125 mg	ORAL	ANDA	21 sections
Phenytoin	HUMAN PRESCRIPTION DRUG LABEL	1	17856-4069	SUSPENSION	125 mg	ORAL	ANDA	24 sections
Phenytoin Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	21695-167	CAPSULE, EXTENDED RELEASE	100 mg	ORAL	ANDA	21 sections
Extended Phenytoin Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	42291-772	CAPSULE	100 mg	ORAL	ANDA	23 sections
Extended Phenytoin Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	43063-492	CAPSULE	100 mg	ORAL	ANDA	23 sections
Dilantin	HUMAN PRESCRIPTION DRUG LABEL	1	43353-131	CAPSULE, EXTENDED RELEASE	100 mg	ORAL	ANDA	24 sections
Dilantin	HUMAN PRESCRIPTION DRUG LABEL	1	50090-0029	CAPSULE, EXTENDED RELEASE	100 mg	ORAL	ANDA	26 sections
Extended Phenytoin Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	50090-2089	CAPSULE	100 mg	ORAL	ANDA	23 sections
Extended Phenytoin Sodium	Human Prescription Drug Label	1	50090-3165	CAPSULE	100 mg	ORAL	ANDA	25 sections
Phenytoin Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	50090-3539	CAPSULE, EXTENDED RELEASE	100 mg	ORAL	ANDA	25 sections