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)
Rectal tenesmus15.05.03.011; 07.03.03.001--Not Available
Loss of proprioception17.02.07.0190.000191%Not Available
Paraesthesia oral07.05.05.035; 17.02.06.008--Not Available
Bipolar disorder19.16.01.0030.000382%Not Available
Cognitive disorder19.21.02.001; 17.03.03.0030.001147%
Toxic skin eruption23.03.05.003; 10.01.01.008; 12.03.01.0730.000287%Not Available
Purple glove syndrome24.04.05.010; 15.03.02.0130.002772%Not Available
Pulseless electrical activity02.03.04.0200.000191%Not Available
Muscle relaxant therapy25.16.01.001--Not Available
Epidermal necrosis23.03.03.0350.000287%Not Available
Urine output increased13.13.03.002--Not Available
Neurological symptom17.02.05.0100.000382%Not Available
Breast disorder21.05.04.004--Not Available
Connective tissue disorder10.04.04.026; 15.06.01.0060.000191%Not Available
Eye movement disorder17.02.05.025; 06.05.02.0080.000574%Not Available
Eyelid disorder23.03.03.028; 06.08.03.0100.000191%Not Available
Feeding disorder19.09.01.003; 14.03.02.0030.000421%Not Available
Inflammation10.02.01.089; 08.01.05.007--Not Available
Limb discomfort15.03.04.0140.001166%Not Available
Ischaemia24.04.02.0040.000287%Not Available
Mucosal erosion08.01.06.0090.000191%Not Available
Partial seizures17.12.03.0100.000765%Not Available
Abnormal behaviour19.01.01.0010.001358%Not Available
Decreased appetite14.03.01.005; 08.01.09.028--
Conjunctival disorder06.06.02.0040.000191%Not Available
Psychiatric symptom19.01.02.0010.000421%Not Available
Ill-defined disorder08.01.03.049--Not Available
Blood disorder01.05.01.004--Not Available
Disease recurrence08.01.03.0500.000478%Not Available
Drug intolerance08.06.01.0130.004340%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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