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

Stem definitionDrug idCAS RN
antiepileptics, hydantoin derivatives 2152 57-41-0

Description:

MoleculeDescription

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:

DoseUnitRoute
0.30 g O
0.30 g P

ADMET properties:

PropertyValueReference
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 ┬ÁM/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:

DateAgencyCompanyOrphan
Jan. 6, 1953 FDA PARKE DAVIS

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
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 termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
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:

SourceCodeDescription
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)

DiseaseRelationSNOMED_IDDOID
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 levelDissociation constantType (acidic/basic)
pKa1 7.8 acidic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Sodium channel protein type 8 subunit alpha Ion channel BLOCKER CHEMBL CHEMBL
Sodium channel protein type 5 subunit alpha Ion channel BLOCKER WOMBAT-PK CHEMBL
Sodium channel protein type 1 subunit alpha Ion channel BLOCKER CHEMBL CHEMBL
Sodium channel protein type 9 subunit alpha Ion channel BLOCKER CHEMBL CHEMBL
Sodium channel protein type 2 subunit alpha Ion channel BLOCKER IC50 4.90 IUPHAR CHEMBL
Sodium channel protein type 3 subunit alpha Ion channel BLOCKER CHEMBL CHEMBL
Sodium channel protein type 4 subunit alpha Ion channel BLOCKER Ki 4.62 CHEMBL CHEMBL
Nuclear receptor subfamily 1 group I member 3 Nuclear hormone receptor WOMBAT-PK
Sodium channel alpha subunits; brain (Types I, II, III) Ion channel IC50 4.40 CHEMBL
Sodium channel protein type 2 subunit alpha Ion channel IC50 4.66 CHEMBL

External reference:

IDSource
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:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
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