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	1475.09	12.69	919	29811	128590	53189746
Status epilepticus	672.79	12.69	272	30458	14912	53303424
Toxicity to various agents	496.01	12.69	620	30110	218978	53099358
Drug reaction with eosinophilia and systemic symptoms	476.04	12.69	273	30457	32527	53285809
Ataxia	460.09	12.69	206	30524	14531	53303805
Anticonvulsant drug level increased	440.00	12.69	112	30618	1308	53317028
Epilepsy	429.73	12.69	235	30495	25532	53292804
Drug interaction	372.09	12.69	539	30191	218790	53099546
Generalised tonic-clonic seizure	363.64	12.69	219	30511	28539	53289797
Nystagmus	344.52	12.69	130	30600	5906	53312430
Anticonvulsant drug level decreased	317.28	12.69	84	30646	1156	53317180
Drug hypersensitivity	283.11	12.69	529	30201	264713	53053623
Stevens-Johnson syndrome	264.59	12.69	169	30561	24413	53293923
Purple glove syndrome	226.79	12.69	46	30684	167	53318169
Anticonvulsant drug level above therapeutic	212.63	12.69	51	30679	456	53317880
Multiple-drug resistance	211.50	12.69	77	30653	3158	53315178
Anticonvulsant drug level below therapeutic	196.47	12.69	49	30681	523	53317813
Cerebellar atrophy	183.66	12.69	48	30682	626	53317710
Drug level decreased	153.65	12.69	76	30654	6698	53311638
Toxic epidermal necrolysis	153.17	12.69	119	30611	23431	53294905
Partial seizures	123.92	12.69	61	30669	5319	53313017
Electroencephalogram abnormal	102.19	12.69	48	30682	3773	53314563
Drug level increased	98.94	12.69	87	30643	20334	53298002
Pain	95.12	12.69	120	30610	588278	52730058
Arthralgia	93.84	12.69	70	30660	439713	52878623
Product complaint	90.88	12.69	67	30663	12190	53306146
Rheumatoid arthritis	90.64	12.69	34	30696	314497	53003839
Diarrhoea	87.82	12.69	141	30589	625405	52692931
Rash maculo-papular	84.94	12.69	95	30635	29654	53288682
Diplopia	84.07	12.69	80	30650	20685	53297651
Dyspnoea	77.75	12.69	137	30593	586095	52732241
Fatigue	77.42	12.69	194	30536	730312	52588024
Gingival hypertrophy	77.09	12.69	30	30700	1481	53316855
Focal dyscognitive seizures	76.02	12.69	36	30694	2881	53315455
Anticonvulsant drug level abnormal	75.42	12.69	14	30716	27	53318309
Drug ineffective	74.71	12.69	757	29973	816488	52501848
Drug ineffective for unapproved indication	73.02	12.69	74	30656	20646	53297690
Drug resistance	71.64	12.69	72	30658	19890	53298446
Alopecia	71.60	12.69	23	30707	234560	53083776
Joint swelling	69.88	12.69	24	30706	234614	53083722
Renal ischaemia	69.44	12.69	22	30708	586	53317750
Dysarthria	68.84	12.69	100	30630	40468	53277868
Encephalopathy	67.27	12.69	94	30636	36714	53281622
Intra-abdominal pressure increased	66.26	12.69	17	30713	205	53318131
Coma	65.25	12.69	123	30607	61660	53256676
Abdominal discomfort	65.15	12.69	23	30707	221039	53097297
Diabetes insipidus	64.55	12.69	31	30699	2560	53315776
Arthropathy	62.62	12.69	5	30725	141448	53176888
Cerebellar ataxia	60.49	12.69	22	30708	899	53317437
Porphyria acute	59.24	12.69	19	30711	527	53317809
Pneumatosis	58.59	12.69	18	30712	432	53317904
Erythema multiforme	58.12	12.69	48	30682	10301	53308035
PO2 increased	57.39	12.69	21	30709	873	53317463
Drug level below therapeutic	56.57	12.69	32	30698	3701	53314635
PCO2 increased	54.08	12.69	22	30708	1221	53317115
Dyskinesia	53.33	12.69	78	30652	31755	53286581
Sinusitis	50.58	12.69	17	30713	168547	53149789
Bradycardia neonatal	49.87	12.69	19	30711	885	53317451
Brain oedema	48.82	12.69	49	30681	13509	53304827
Respiratory disorder neonatal	48.21	12.69	19	30711	970	53317366
Necrosis ischaemic	47.19	12.69	18	30712	841	53317495
Multiple organ dysfunction syndrome	47.01	12.69	101	30629	55576	53262760
Nausea	46.20	12.69	252	30478	755839	52562497
Neurodegenerative disorder	46.18	12.69	14	30716	321	53318015
Neurotoxicity	45.50	12.69	50	30680	15299	53303037
Choreoathetosis	45.46	12.69	15	30715	456	53317880
Stupor	45.22	12.69	28	30702	3823	53314513
Pemphigus	45.15	12.69	4	30726	104027	53214309
Injection site pain	45.05	12.69	6	30724	113385	53204951
Weight gain poor	44.15	12.69	17	30713	815	53317521
Blood bicarbonate decreased	43.83	12.69	25	30705	2937	53315399
Blood pH decreased	43.83	12.69	24	30706	2606	53315730
Foetal anticonvulsant syndrome	43.78	12.69	15	30715	513	53317823
Encephalitis autoimmune	43.25	12.69	19	30711	1277	53317059
Glossodynia	43.14	12.69	4	30726	100287	53218049
Respiratory acidosis	43.09	12.69	33	30697	6355	53311981
Infusion related reaction	42.98	12.69	18	30712	155939	53162397
Eosinophilia	42.78	12.69	57	30673	21278	53297058
Contraindicated product administered	41.88	12.69	13	30717	135616	53182720
Drug level changed	41.63	12.69	11	30719	150	53318186
Balance disorder	41.63	12.69	114	30616	73093	53245243
Selective eating disorder	41.54	12.69	21	30709	1937	53316399
Cytomegalovirus hepatitis	41.51	12.69	13	30717	333	53318003
Product substitution issue	40.78	12.69	48	30682	15818	53302518
Discomfort	40.55	12.69	4	30726	95468	53222868
Acute hepatic failure	40.37	12.69	49	30681	16671	53301665
Hyperammonaemia	40.10	12.69	29	30701	5120	53313216
Angiofibroma	39.73	12.69	10	30720	111	53318225
Foetal death	39.72	12.69	37	30693	9310	53309026
Oxygen saturation abnormal	39.28	12.69	23	30707	2839	53315497
Hepatitis	37.68	12.69	69	30661	33825	53284511
Haemophagocytic lymphohistiocytosis	36.59	12.69	35	30695	9102	53309234
Lymphangioleiomyomatosis	35.91	12.69	10	30720	168	53318168
Brain herniation	35.90	12.69	23	30707	3333	53315003
Nervous system disorder	35.54	12.69	47	30683	17417	53300919
Somnolence	34.57	12.69	189	30541	167545	53150791
Angiomyolipoma	34.51	12.69	10	30720	195	53318141
Overdose	34.44	12.69	138	30592	107598	53210738
Wound	33.73	12.69	6	30724	91551	53226785
Myoclonus	32.97	12.69	43	30687	15721	53302615
Intestinal ischaemia	32.46	12.69	30	30700	7472	53310864
Pain in extremity	32.16	12.69	73	30657	284977	53033359
Porphyria	31.58	12.69	9	30721	165	53318171
Cardiac arrest neonatal	31.29	12.69	8	30722	95	53318241
Anti-erythropoietin antibody negative	31.29	12.69	8	30722	95	53318241
Peripheral swelling	31.14	12.69	44	30686	206064	53112272
Drug intolerance	30.92	12.69	44	30686	205449	53112887
Laryngeal stenosis	30.79	12.69	13	30717	793	53317543
Systemic lupus erythematosus	30.70	12.69	17	30713	125397	53192939
Propofol infusion syndrome	30.69	12.69	13	30717	799	53317537
Brain injury	30.44	12.69	27	30703	6378	53311958
Aggression	30.36	12.69	51	30679	23352	53294984
Myoclonic epilepsy	30.35	12.69	14	30716	1055	53317281
Hyperreflexia	29.90	12.69	25	30705	5455	53312881
Seizure cluster	29.78	12.69	9	30721	204	53318132
Urine copper increased	29.36	12.69	5	30725	4	53318332
Hypotension	29.32	12.69	248	30482	253828	53064508
Bronchitis	29.12	12.69	14	30716	111885	53206451
Nasopharyngitis	29.10	12.69	41	30689	192254	53126082
Back pain	28.91	12.69	57	30673	234190	53084146
Urine delta aminolevulinate increased	28.84	12.69	5	30725	5	53318331
Aura	27.98	12.69	13	30717	996	53317340
Asthma	27.80	12.69	14	30716	108958	53209378
Ultrasound ovary abnormal	27.63	12.69	7	30723	80	53318256
Drug level fluctuating	27.51	12.69	10	30720	408	53317928
Psoriasis	27.51	12.69	8	30722	87081	53231255
Depressed level of consciousness	27.28	12.69	81	30649	54347	53263989
Atonic seizures	26.94	12.69	11	30719	616	53317720
Bradyarrhythmia	26.94	12.69	16	30714	2027	53316309
Dermatitis exfoliative	26.19	12.69	24	30706	5912	53312424
Mental status changes	25.94	12.69	65	30665	39506	53278830
Coordination abnormal	25.62	12.69	33	30697	11918	53306418
Abdominal pain upper	25.61	12.69	35	30695	166256	53152080
Cerebral atrophy	25.60	12.69	22	30708	4982	53313354
Ischaemic cerebral infarction	24.76	12.69	13	30717	1297	53317039
Abdominal pain	24.63	12.69	71	30659	255832	53062504
Malabsorption	24.55	12.69	20	30710	4208	53314128
Rash morbilliform	24.55	12.69	18	30712	3245	53315091
Dehydration	24.40	12.69	37	30693	168373	53149963
Hyperammonaemic encephalopathy	24.31	12.69	15	30715	2036	53316300
Clonus	24.29	12.69	20	30710	4271	53314065
Oropharyngeal oedema	24.22	12.69	8	30722	244	53318092
Vomiting projectile	24.01	12.69	13	30717	1380	53316956
Ophthalmoplegia	23.66	12.69	12	30718	1115	53317221
Hypertension	23.61	12.69	60	30670	225371	53092965
Musculoskeletal pain	23.58	12.69	7	30723	75193	53243143
Drug level above therapeutic	23.46	12.69	19	30711	3965	53314371
Speech disorder	23.25	12.69	62	30668	39119	53279217
Petit mal epilepsy	23.21	12.69	18	30712	3530	53314806
Lymphadenopathy	23.18	12.69	59	30671	36196	53282140
Osteoarthritis	23.15	12.69	6	30724	70480	53247856
Confusional state	23.14	12.69	191	30539	194030	53124306
Injection site erythema	22.79	12.69	8	30722	77241	53241095
Lower respiratory tract infection	22.74	12.69	12	30718	90969	53227367
Creutzfeldt-Jakob disease	22.63	12.69	6	30724	83	53318253
Porphyrins stool increased	22.59	12.69	5	30725	30	53318306
Left ventricular dysfunction	22.49	12.69	30	30700	11207	53307129
Product dose omission issue	22.47	12.69	48	30682	191572	53126764
Paranoia	22.10	12.69	30	30700	11394	53306942
Pericarditis	22.10	12.69	5	30725	64401	53253935
Unresponsive to stimuli	22.00	12.69	55	30675	33371	53284965
Chest pain	22.00	12.69	48	30682	190137	53128199
Autism spectrum disorder	21.96	12.69	10	30720	732	53317604
Perforation	21.73	12.69	11	30719	1018	53317318
Systemic inflammatory response syndrome	21.38	12.69	21	30709	5639	53312697
Arthritis	21.12	12.69	12	30718	87286	53231050
Enterocolitis	20.95	12.69	23	30707	7029	53311307
Palpitations	20.84	12.69	17	30713	102331	53216005
Plasmodium falciparum infection	20.52	12.69	5	30725	48	53318288
Encephalitis	20.36	12.69	24	30706	7920	53310416
Chronic graft versus host disease	20.30	12.69	16	30714	3212	53315124
Torticollis	20.21	12.69	13	30717	1897	53316439
Pyrexia	20.14	12.69	335	30395	402858	52915478
Calcinosis	20.11	12.69	13	30717	1913	53316423
Malaise	19.68	12.69	123	30607	357494	52960842
Hypotonia	19.65	12.69	25	30705	8916	53309420
Cerebellar cognitive affective syndrome	19.38	12.69	3	30727	0	53318336
Blood alkaline phosphatase increased	19.26	12.69	60	30670	41302	53277034
Ammonia increased	19.23	12.69	18	30712	4555	53313781
Psychotic disorder	19.17	12.69	43	30687	24342	53293994
Cross sensitivity reaction	19.16	12.69	13	30717	2074	53316262
Aplasia pure red cell	19.15	12.69	18	30712	4578	53313758
Cognitive disorder	19.08	12.69	63	30667	44715	53273621
Areflexia	18.99	12.69	15	30715	3021	53315315
Euthyroid sick syndrome	18.87	12.69	5	30725	69	53318267
Adverse drug reaction	18.72	12.69	4	30726	53621	53264715
Intensive care unit acquired weakness	18.72	12.69	9	30721	745	53317591
Altered state of consciousness	18.64	12.69	43	30687	24793	53293543
Blood magnesium decreased	18.42	12.69	28	30702	11786	53306550
Mucosal erosion	18.27	12.69	11	30719	1428	53316908
Muscle spasms	18.22	12.69	31	30699	134764	53183572
Chorea	18.22	12.69	11	30719	1436	53316900
Psoriatic arthropathy	18.09	12.69	3	30727	48187	53270149
Illusion	18.09	12.69	10	30720	1106	53317230
Linear IgA disease	18.06	12.69	11	30719	1459	53316877
Gamma-glutamyltransferase increased	17.83	12.69	51	30679	33504	53284832
Hypersensitivity	17.77	12.69	62	30668	210603	53107733
Disease recurrence	17.67	12.69	38	30692	20908	53297428
Idiopathic pneumonia syndrome	17.62	12.69	7	30723	365	53317971
Weight increased	17.39	12.69	60	30670	204507	53113829
Loss of consciousness	17.36	12.69	119	30611	114093	53204243
Intention tremor	17.35	12.69	7	30723	380	53317956
Rasmussen encephalitis	17.30	12.69	3	30727	3	53318333
Neonatal seizure	17.25	12.69	7	30723	386	53317950
Left ventricular hypertrophy	17.21	12.69	18	30712	5205	53313131
Ventricular dysfunction	17.17	12.69	14	30716	2949	53315387
Incoherent	17.03	12.69	17	30713	4655	53313681
Swelling	16.97	12.69	55	30675	191050	53127286
Intestinal dilatation	16.96	12.69	11	30719	1627	53316709
Cardiac arrest	16.95	12.69	102	30628	93565	53224771
Lip erosion	16.87	12.69	9	30721	928	53317408
Posterior reversible encephalopathy syndrome	16.83	12.69	32	30698	16128	53302208
Influenza like illness	16.79	12.69	7	30723	60852	53257484
Cerebellar syndrome	16.73	12.69	15	30715	3592	53314744
CSF oligoclonal band present	16.60	12.69	5	30725	112	53318224
Asterixis	16.50	12.69	10	30720	1314	53317022
Hallucination, tactile	16.45	12.69	6	30724	247	53318089
Epileptic psychosis	16.27	12.69	4	30726	40	53318296
Medication error	16.24	12.69	52	30678	36313	53282023
Intensive care unit delirium	16.18	12.69	4	30726	41	53318295
Drug withdrawal convulsions	16.17	12.69	10	30720	1362	53316974
Musculoskeletal stiffness	16.10	12.69	29	30701	123339	53194997
Oromandibular dystonia	15.90	12.69	7	30723	473	53317863
Lactose intolerance	15.82	12.69	13	30717	2768	53315568
Hirsutism	15.76	12.69	9	30721	1059	53317277
Lethargy	15.70	12.69	67	30663	53693	53264643
Constipation	15.67	12.69	60	30670	198352	53119984
Cachexia	15.61	12.69	17	30713	5147	53313189
Hospitalisation	15.47	12.69	11	30719	71001	53247335
Herpes zoster	15.44	12.69	12	30718	74007	53244329
Epileptic encephalopathy	15.44	12.69	6	30724	295	53318041
Magnetic resonance imaging head abnormal	15.39	12.69	11	30719	1907	53316429
Chest discomfort	15.32	12.69	21	30709	99674	53218662
Injection site swelling	15.26	12.69	3	30727	42625	53275711
Periorbital oedema	15.21	12.69	17	30713	5298	53313038
Enzyme induction	15.04	12.69	4	30726	56	53318280
Infrequent bowel movements	14.74	12.69	9	30721	1199	53317137
Potentiating drug interaction	14.63	12.69	15	30715	4238	53314098
Abnormal behaviour	14.41	12.69	36	30694	21830	53296506
Weight decreased	14.41	12.69	78	30652	234870	53083466
Hallucination, auditory	14.40	12.69	25	30705	11748	53306588
Low birth weight baby	14.37	12.69	18	30712	6319	53312017
Hypoventilation	14.35	12.69	15	30715	4334	53314002
Haemodynamic instability	14.30	12.69	21	30709	8573	53309763
Tachycardia	14.29	12.69	109	30621	108103	53210233
Gastrooesophageal reflux disease	14.18	12.69	16	30714	82647	53235689
Dyspnoea exertional	14.12	12.69	7	30723	54993	53263343
Hypersensitivity vasculitis	14.09	12.69	15	30715	4428	53313908
Biopsy brain	14.01	12.69	3	30727	15	53318321
Tongue ulceration	13.99	12.69	13	30717	3259	53315077
Coagulation time prolonged	13.98	12.69	9	30721	1315	53317021
Impaired healing	13.92	12.69	10	30720	64195	53254141
Coma scale abnormal	13.86	12.69	16	30714	5162	53313174
Dystonia	13.83	12.69	26	30704	12995	53305341
Cough	13.78	12.69	89	30641	256804	53061532
Influenza	13.76	12.69	21	30709	95358	53222978
Respiratory failure	13.69	12.69	102	30628	100410	53217926
Diabetes mellitus	13.63	12.69	7	30723	53892	53264444
Myalgia	13.60	12.69	36	30694	133455	53184881
Brain neoplasm	13.34	12.69	14	30716	4064	53314272
Intentional overdose	13.34	12.69	75	30655	67130	53251206
Anaemia	13.30	12.69	99	30631	276619	53041717
Oedema peripheral	13.26	12.69	52	30678	170735	53147601
Central nervous system infection	13.18	12.69	7	30723	715	53317621
Allodynia	13.15	12.69	7	30723	718	53317618
Impaired self-care	13.06	12.69	10	30720	1925	53316411
Post-traumatic epilepsy	13.03	12.69	3	30727	22	53318314
Drug level abnormal	12.98	12.69	4	30726	97	53318239
Pyroglutamate increased	12.91	12.69	6	30724	460	53317876
Behaviour disorder	12.81	12.69	11	30719	2489	53315847
Injection site pruritus	12.80	12.69	4	30726	41585	53276751

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	1534.95	13.15	1022	28116	102832	32381556
Status epilepticus	832.87	13.15	336	28802	11670	32472718
Nystagmus	664.97	13.15	222	28916	4440	32479948
Toxicity to various agents	595.29	13.15	762	28376	177279	32307109
Anticonvulsant drug level increased	569.34	13.15	153	28985	1385	32483003
Drug reaction with eosinophilia and systemic symptoms	523.96	13.15	339	28799	32146	32452242
Ataxia	497.12	13.15	238	28900	12503	32471885
Anticonvulsant drug level above therapeutic	374.98	13.15	88	29050	425	32483963
Anticonvulsant drug level decreased	298.25	13.15	84	29054	918	32483470
Generalised tonic-clonic seizure	276.28	13.15	192	28946	20447	32463941
Drug interaction	260.94	13.15	591	28547	217594	32266794
Epilepsy	211.31	13.15	168	28970	21941	32462447
Cerebellar atrophy	178.58	13.15	48	29090	434	32483954
Stevens-Johnson syndrome	176.27	13.15	141	28997	18568	32465820
Anticonvulsant drug level below therapeutic	164.38	13.15	48	29090	602	32483786
Drug level decreased	163.04	13.15	90	29048	6356	32478032
Partial seizures	145.15	13.15	72	29066	4078	32480310
Drug ineffective	129.69	13.15	680	28458	382797	32101591
Diarrhoea	121.81	13.15	90	29048	364712	32119676
Drug hypersensitivity	120.40	13.15	227	28911	73173	32411215
Purple glove syndrome	114.93	13.15	23	29115	41	32484347
Dysarthria	108.33	13.15	141	28997	33060	32451328
Multiple-drug resistance	107.42	13.15	57	29081	3718	32480670
Dyspnoea	104.12	13.15	103	29035	361942	32122446
Hyperammonaemia	102.74	13.15	65	29073	5904	32478484
Gingival hypertrophy	95.57	13.15	41	29097	1658	32482730
Drug resistance	93.42	13.15	109	29029	22856	32461532
Drug level fluctuating	91.22	13.15	29	29109	492	32483896
Sudden unexplained death in epilepsy	89.83	13.15	28	29110	444	32483944
Drug level below therapeutic	88.40	13.15	52	29086	4143	32480245
Drug level increased	87.90	13.15	99	29039	19981	32464407
Product complaint	82.33	13.15	56	29082	5747	32478641
Coordination abnormal	78.55	13.15	61	29077	7687	32476701
Drug level above therapeutic	70.04	13.15	41	29097	3237	32481151
Anaemia	68.39	13.15	60	29078	223564	32260824
Sedation	64.05	13.15	81	29057	18445	32465943
Brain oedema	62.08	13.15	67	29071	12893	32471495
Foetal anticonvulsant syndrome	61.22	13.15	26	29112	1025	32483363
Gait disturbance	59.83	13.15	183	28955	80225	32404163
Cerebellar syndrome	59.64	13.15	32	29106	2134	32482254
Confusional state	57.36	13.15	267	28871	142848	32341540
Mental status changes	56.00	13.15	113	29025	38224	32446164
Somnolence	55.90	13.15	212	28926	103585	32380803
Depressed level of consciousness	54.51	13.15	116	29022	40731	32443657
Acute kidney injury	54.09	13.15	114	29024	293354	32191034
Intensive care unit acquired weakness	53.61	13.15	23	29115	930	32483458
Pain	51.86	13.15	55	29083	187501	32296887
Arthralgia	51.47	13.15	35	29103	148413	32335975
Rash maculo-papular	51.35	13.15	91	29047	27931	32456457
Toxic epidermal necrolysis	50.08	13.15	76	29062	20517	32463871
Chest pain	49.06	13.15	25	29113	124112	32360276
Fatigue	48.05	13.15	158	28980	350543	32133845
Urine copper increased	47.94	13.15	9	29129	9	32484379
Anticonvulsant drug level abnormal	47.40	13.15	10	29128	26	32484362
Febrile neutropenia	45.88	13.15	25	29113	119541	32364847
Cerebellar ataxia	45.59	13.15	21	29117	1007	32483381
Myocardial infarction	44.40	13.15	29	29109	125647	32358741
Cough	42.67	13.15	37	29101	138780	32345608
Completed suicide	42.61	13.15	180	28958	92337	32392051
Death	41.68	13.15	189	28949	382328	32102060
Cross sensitivity reaction	41.41	13.15	22	29116	1438	32482950
Hypotonia	40.84	13.15	42	29096	7645	32476743
Lethargy	40.65	13.15	104	29034	41124	32443264
Drug level changed	39.26	13.15	14	29124	342	32484046
Myalgia	39.23	13.15	12	29126	81218	32403170
Dehydration	38.87	13.15	35	29103	128923	32355465
Stupor	37.91	13.15	27	29111	2982	32481406
Asterixis	37.80	13.15	20	29118	1296	32483092
Encephalopathy	37.56	13.15	90	29048	34167	32450221
Porphyrins stool increased	37.28	13.15	7	29131	7	32484381
Pneumonia	36.63	13.15	179	28959	355073	32129315
Necrosis ischaemic	36.48	13.15	12	29126	228	32484160
Petit mal epilepsy	36.39	13.15	26	29112	2886	32481502
Diabetes insipidus	36.39	13.15	25	29113	2607	32481781
Cerebral atrophy	36.11	13.15	31	29107	4496	32479892
Choreoathetosis	36.05	13.15	18	29120	1033	32483355
Blood homocysteine increased	35.13	13.15	12	29126	257	32484131
Postictal paralysis	34.74	13.15	11	29127	184	32484204
Gaze palsy	34.41	13.15	19	29119	1341	32483047
Hyperammonaemic encephalopathy	34.26	13.15	22	29116	2049	32482339
Dysmetria	34.20	13.15	13	29125	382	32484006
Inhibitory drug interaction	33.91	13.15	20	29118	1601	32482787
Acidosis hyperchloraemic	33.81	13.15	12	29126	289	32484099
Balance disorder	33.32	13.15	94	29044	39365	32445023
Ophthalmoplegia	33.26	13.15	19	29119	1432	32482956
Hypoplastic left heart syndrome	32.50	13.15	11	29127	229	32484159
Hippocampal sclerosis	32.23	13.15	9	29129	95	32484293
Focal dyscognitive seizures	31.93	13.15	18	29120	1323	32483065
Nausea	31.72	13.15	164	28974	320685	32163703
Extensor plantar response	31.67	13.15	14	29124	609	32483779
Dystonia	31.37	13.15	43	29095	10580	32473808
Cardiac failure	31.23	13.15	22	29116	91651	32392737
Hyperreflexia	31.21	13.15	24	29114	2980	32481408
Idiosyncratic drug reaction	31.08	13.15	13	29125	493	32483895
Overdose	30.90	13.15	157	28981	86920	32397468
Malaise	30.75	13.15	71	29067	177067	32307321
Erythema multiforme	30.57	13.15	39	29099	8953	32475435
Product substitution issue	30.46	13.15	42	29096	10394	32473994
Chills	30.42	13.15	16	29122	78068	32406320
Past-pointing	30.13	13.15	7	29131	32	32484356
Unresponsive to stimuli	29.69	13.15	72	29066	27537	32456851
Drug withdrawal convulsions	28.62	13.15	16	29122	1157	32483231
Fall	28.20	13.15	284	28854	195917	32288471
Joint swelling	28.12	13.15	6	29132	51729	32432659
Cardiac failure congestive	28.07	13.15	21	29117	84831	32399557
Intention tremor	27.91	13.15	11	29127	357	32484031
Oedema peripheral	27.71	13.15	37	29101	114054	32370334
Blood albumin decreased	27.60	13.15	45	29093	12908	32471480
Abdominal pain	27.53	13.15	58	29080	149471	32334917
Interstitial lung disease	27.33	13.15	12	29126	64989	32419399
Atrial fibrillation	27.19	13.15	39	29099	116665	32367723
Intestinal ischaemia	26.99	13.15	33	29105	7258	32477130
Back pain	26.99	13.15	36	29102	111017	32373371
Aggression	26.82	13.15	87	29051	39302	32445086
Atonic seizures	26.74	13.15	9	29129	184	32484204
Pain in extremity	26.47	13.15	41	29097	118860	32365528
Labelled drug-drug interaction medication error	26.28	13.15	43	29095	12370	32472018
Constipation	25.89	13.15	46	29092	126327	32358061
Eosinophilia	25.68	13.15	64	29074	24894	32459494
Superinfection	25.62	13.15	18	29120	1946	32482442
Coagulopathy	25.41	13.15	55	29083	19522	32464866
Aura	25.36	13.15	10	29128	325	32484063
Neonatal respiratory depression	25.33	13.15	11	29127	458	32483930
Postictal psychosis	25.15	13.15	8	29130	136	32484252
Haemophagocytic lymphohistiocytosis	25.00	13.15	40	29098	11295	32473093
Hyperchloraemia	24.94	13.15	11	29127	476	32483912
Gamma-glutamyltransferase increased	24.69	13.15	72	29066	30710	32453678
Macule	24.68	13.15	14	29124	1041	32483347
Asthma	24.18	13.15	5	29133	44060	32440328
Haemoglobin decreased	24.11	13.15	44	29094	119627	32364761
Autonomic nervous system imbalance	23.47	13.15	19	29119	2541	32481847
Gingival disorder	23.12	13.15	15	29123	1422	32482966
Blood glucose increased	23.09	13.15	15	29123	65226	32419162
Gingival atrophy	23.08	13.15	6	29132	47	32484341
Simple partial seizures	23.07	13.15	9	29129	284	32484104
Porphyria acute	22.82	13.15	7	29131	105	32484283
Obliterative bronchiolitis	22.76	13.15	14	29124	1209	32483179
Hepatitis fulminant	22.66	13.15	23	29115	4120	32480268
Excessive eye blinking	22.66	13.15	10	29128	433	32483955
Diplopia	22.65	13.15	44	29094	14468	32469920
Muscle twitching	22.18	13.15	33	29105	8751	32475637
Impetigo	21.84	13.15	12	29126	839	32483549
Cytokine storm	21.79	13.15	11	29127	646	32483742
Mucosal erosion	21.52	13.15	12	29126	863	32483525
Pulmonary embolism	21.48	13.15	26	29112	83633	32400755
Urine delta aminolevulinate increased	21.30	13.15	4	29134	4	32484384
Barbiturates positive	21.30	13.15	4	29134	4	32484384
Vasogenic cerebral oedema	21.15	13.15	10	29128	509	32483879
Mucosal ulceration	21.07	13.15	12	29126	899	32483489
Agitation	20.85	13.15	104	29034	57132	32427256
Intellectual disability	20.85	13.15	13	29125	1150	32483238
Plasma cell myeloma	20.73	13.15	13	29125	57601	32426787
Tonic convulsion	20.37	13.15	12	29126	958	32483430
Hypothermia	20.05	13.15	34	29104	10069	32474319
Nervous system disorder	20.01	13.15	41	29097	14008	32470380
Chest discomfort	19.99	13.15	10	29128	50220	32434168
Acute generalised exanthematous pustulosis	19.88	13.15	27	29111	6586	32477802
Blood ketone body increased	19.72	13.15	9	29129	422	32483966
Dyskinesia	19.70	13.15	56	29082	23547	32460841
General physical health deterioration	19.34	13.15	47	29091	115212	32369176
Cognitive disorder	19.28	13.15	59	29079	25835	32458553
Encephalomalacia	19.25	13.15	10	29128	624	32483764
Haematuria traumatic	19.01	13.15	7	29131	188	32484200
Glioblastoma multiforme	18.92	13.15	11	29127	857	32483531
Cerebral palsy	18.70	13.15	6	29132	105	32484283
Nephritis allergic	18.62	13.15	9	29129	481	32483907
Propofol infusion syndrome	18.55	13.15	11	29127	889	32483499
Brain herniation	18.51	13.15	20	29118	3851	32480537
Cardiac arrest	18.43	13.15	149	28989	96627	32387761
Syncope	18.27	13.15	33	29105	90091	32394297
Soft tissue swelling	18.23	13.15	8	29130	342	32484046
Unmasking of previously unidentified disease	18.20	13.15	10	29128	699	32483689
Methylenetetrahydrofolate reductase deficiency	18.06	13.15	3	29135	0	32484388
Aphasia	17.95	13.15	50	29088	20778	32463610
Lymphocyte morphology abnormal	17.92	13.15	9	29129	523	32483865
Anxiety	17.86	13.15	37	29101	95968	32388420
Ammonia increased	17.83	13.15	21	29117	4443	32479945
Personality disorder	17.80	13.15	12	29126	1213	32483175
Areflexia	17.65	13.15	17	29121	2859	32481529
Injection site pain	17.63	13.15	4	29134	33054	32451334
Pulmonary vasculitis	17.59	13.15	6	29132	128	32484260
Neurodegenerative disorder	17.51	13.15	7	29131	236	32484152
Malabsorption	17.43	13.15	15	29123	2182	32482206
Mydriasis	17.41	13.15	25	29113	6421	32477967
Psoriasis	17.16	13.15	10	29128	46113	32438275
Encephalitis	17.12	13.15	26	29112	7018	32477370
COVID-19	16.82	13.15	4	29134	32011	32452377
Retinal vein occlusion	16.71	13.15	13	29125	1641	32482747
Malignant neoplasm progression	16.58	13.15	28	29110	78468	32405920
Learning disorder	16.45	13.15	10	29128	846	32483542
Acute hepatic failure	16.33	13.15	36	29102	12933	32471455
White blood cell count decreased	16.25	13.15	36	29102	91162	32393226
Dysmorphism	16.19	13.15	16	29122	2777	32481611
Ascites	16.00	13.15	8	29130	40183	32444205
Nasopharyngeal reflux	15.98	13.15	3	29135	3	32484385
Soft tissue haemorrhage	15.96	13.15	6	29132	171	32484217
Lymphocytosis	15.88	13.15	14	29124	2103	32482285
Rash morbilliform	15.85	13.15	16	29122	2848	32481540
Drug ineffective for unapproved indication	15.73	13.15	37	29101	13875	32470513
Pneumonitis	15.38	13.15	4	29134	30130	32454258
Intracranial pressure increased	15.33	13.15	18	29120	3795	32480593
Familial periodic paralysis	15.20	13.15	5	29133	95	32484293
Muscle spasms	14.98	13.15	25	29113	70393	32413995
Hyperkinesia	14.98	13.15	14	29124	2268	32482120
Feeling of despair	14.84	13.15	10	29128	1010	32483378
Chemical burn	14.69	13.15	6	29132	214	32484174
Phalangeal hypoplasia	14.45	13.15	3	29135	7	32484381
Hypertension	14.32	13.15	65	29073	131685	32352703
Open angle glaucoma	14.19	13.15	6	29132	234	32484154
Ischaemic hepatitis	14.18	13.15	12	29126	1707	32482681
Chorea	14.12	13.15	10	29128	1095	32483293
Pancytopenia	13.92	13.15	39	29099	91196	32393192
Lid lag	13.90	13.15	3	29135	9	32484379
Orthostatic hypotension	13.89	13.15	3	29135	25647	32458741
Coma	13.83	13.15	75	29063	42537	32441851
Prescribed overdose	13.82	13.15	28	29110	9491	32474897
Neurotoxicity	13.80	13.15	37	29101	15033	32469355
Gastrooesophageal reflux disease	13.70	13.15	7	29131	34731	32449657
Epistaxis	13.66	13.15	18	29120	55837	32428551
Symblepharon	13.59	13.15	5	29133	134	32484254
Posture abnormal	13.53	13.15	13	29125	2180	32482208
Maternal exposure during pregnancy	13.42	13.15	18	29120	4339	32480049
Streptococcus test positive	13.38	13.15	9	29129	906	32483482
Treatment noncompliance	13.34	13.15	54	29084	27148	32457240
Prostate cancer	13.31	13.15	4	29134	27402	32456986
Bone metabolism disorder	13.28	13.15	6	29132	275	32484113
Coronary artery disease	13.23	13.15	15	29123	49691	32434697
Apallic syndrome	13.20	13.15	6	29132	279	32484109
Weight decreased	13.18	13.15	90	29048	164728	32319660

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
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	Na channel blocker
CHEBI has role	CHEBI:50905	teratogen
CHEBI has role	CHEBI:88188	allergenic drug
FDA EPC	N0000175753	Anti-epileptic Agent
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 9 subunit alpha	Ion channel	Q15858	SCN9A_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 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
Sodium channel protein type 8 subunit alpha	Ion channel	Q9UQD0	SCN8A_HUMAN	BLOCKER			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
DB00252	DRUGBANK_ID
CHEMBL1611	ChEMBL_ID
D010672	MESH_DESCRIPTOR_UI
416	INN_ID
1775	PUBCHEM_CID
2624	IUPHAR_LIGAND_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	26 sections
Phenytek	HUMAN PRESCRIPTION DRUG LABEL	1	0378-2670	CAPSULE, EXTENDED RELEASE	200 mg	ORAL	ANDA	26 sections
Phenytek	HUMAN PRESCRIPTION DRUG LABEL	1	0378-3750	CAPSULE, EXTENDED RELEASE	300 mg	ORAL	ANDA	26 sections
Phenytoin	HUMAN PRESCRIPTION DRUG LABEL	1	0378-3850	TABLET, CHEWABLE	50 mg	ORAL	ANDA	26 sections
Phenytoin Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	0404-9932	INJECTION	50 mg	INTRAMUSCULAR	ANDA	16 sections
Phenytoin Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	0404-9933	INJECTION	250 mg	INTRAMUSCULAR	ANDA	16 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	17856-4070	SUSPENSION	125 mg	ORAL	ANDA	28 sections
Phenytoin Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	21695-167	CAPSULE, EXTENDED RELEASE	100 mg	ORAL	ANDA	21 sections
PHENYTOIN SODIUM	HUMAN PRESCRIPTION DRUG LABEL	1	42192-614	INJECTION	50 mg	INTRAMUSCULAR	ANDA	17 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