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 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 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 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:

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
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)

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 9 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 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
Sodium channel protein type 8 subunit alpha Ion channel BLOCKER 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
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:

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 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