Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Phenytoin
Drug ID BADD_D01765
Description Phenytoin is classified as a hydantoin derivative and despite its narrow therapeutic index, it is one of the most commonly used anticonvulsants.[A33595,A188832,A189219] Since it's introduction about 80 years ago, phenytoin has not only been established as an effective anti-epileptic, but has also been investigated for several other indications such as bipolar disorder, retina protection, and wound healing.[A188826,A188832] Clinicians are advised to initiate therapeutic drug monitoring in patients who require phenytoin since even small deviations from the recommended therapeutic range can lead to suboptimal treatment, or adverse effects.[A189219,A35884] Both parenteral and oral formulations of phenytoin are available on the market.[A189219]
Indications and Usage Phenytoin is indicated to treat grand mal seizures, complex partial seizures, and to prevent and treat seizures during or following neurosurgery.[L9362] Injectable phenytoin and [Fosphenytoin], which is the phosphate ester prodrug formulation of phenytoin[A188571], are indicated to treat tonic-clonic status epilepticus, and for the prevention and treatment of seizures occurring during neurosurgery.[L10740]
Marketing Status approved; vet_approved
ATC Code N03AB02
DrugBank ID DB00252
KEGG ID D00512
MeSH ID D010672
PubChem ID 1775
TTD Drug ID D0E4DW
NDC Product Code 51552-0553; 66064-1030; 60687-275; 0615-8424; 51927-0300; 51927-1216; 52119-007; 51672-4069; 60687-156; 66689-036; 70518-1967; 12711-4444; 70518-0841; 66993-372; 0615-8260; 62991-1691; 17856-4070; 0121-0892; 51672-4146; 66689-775; 0009-0488; 59762-0531; 0904-7199; 49452-5340; 0071-2214; 17349-0007; 0071-0007; 0904-7079; 59762-5210
UNII 6158TKW0C5
Synonyms Phenytoin | Fenitoin | Diphenylhydantoin | 5,5-diphenylimidazolidine-2,4-dione | 5,5-Diphenylhydantoin | Difenin | Dihydan | Phenhydan | Epamin | Epanutin | Hydantol | Phenytoin Sodium | Sodium Diphenylhydantoinate | Diphenylhydantoinate, Sodium | Antisacer | Dilantin
Chemical Information
Molecular Formula C15H12N2O2
CAS Registry Number 57-41-0
SMILES C1=CC=C(C=C1)C2(C(=O)NC(=O)N2)C3=CC=CC=C3
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Neurological decompensation17.02.05.0300.000956%Not Available
Drug-induced liver injury12.03.01.044; 09.01.07.0230.002677%Not Available
Substance-induced psychotic disorder19.03.01.007; 12.03.01.0530.000191%Not Available
White matter lesion24.04.06.027; 17.11.01.0090.000191%Not Available
Hepatocellular carcinoma16.07.02.005; 09.04.02.0100.000574%Not Available
Drug reaction with eosinophilia and systemic symptoms10.01.01.021; 12.03.01.064; 23.03.05.0050.012218%Not Available
Respiratory symptom22.12.02.0130.000956%Not Available
Sinus node dysfunction02.03.03.0170.000382%
Multiple organ dysfunction syndrome08.01.03.0570.001338%
Frustration tolerance decreased19.04.02.0160.000421%Not Available
Depersonalisation/derealisation disorder19.14.01.004--Not Available
Anaemia folate deficiency14.12.02.009; 01.03.01.005--Not Available
Coagulation disorder neonatal18.04.03.003; 01.01.02.0170.000191%Not Available
Dermatitis exfoliative generalised23.03.07.002; 10.01.01.0290.000191%Not Available
Epileptic aura17.12.03.024--Not Available
Gliosis17.06.01.0040.000382%Not Available
Post inflammatory pigmentation change23.05.03.0020.000191%Not Available
Reading disorder19.21.05.0030.000191%Not Available
Symblepharon06.06.02.0120.000382%Not Available
Throat cancer16.19.02.007; 22.08.02.0080.000191%Not Available
Ventricular asystole02.03.04.0180.000287%Not Available
Tongue biting17.02.05.064; 12.01.17.023; 07.14.01.0130.000287%Not Available
Neurodegenerative disorder17.02.10.0240.000956%Not Available
Opsoclonus myoclonus17.13.02.010; 06.05.02.0220.000287%Not Available
Carnitine deficiency14.08.04.0220.000191%Not Available
Psychogenic seizure17.12.03.042; 19.24.01.0070.000421%Not Available
Stress cardiomyopathy24.04.04.026; 02.04.01.0120.000191%Not Available
Vasogenic cerebral oedema17.07.02.0080.000382%Not Available
Skin plaque23.03.03.0440.000191%Not Available
Overlap syndrome23.03.02.018; 15.06.01.016; 10.04.04.0160.000478%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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