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)
Mental status changes19.07.01.0010.002237%Not Available
Tubulointerstitial nephritis20.05.02.0020.000765%Not Available
Lip disorder07.05.01.008--Not Available
Cardiotoxicity02.11.01.009; 12.03.01.0070.000478%Not Available
Infusion site erythema23.03.06.016; 12.07.05.009; 08.02.05.0080.000516%Not Available
Acute generalised exanthematous pustulosis23.03.10.002; 12.03.01.005; 11.07.01.018; 10.01.01.0340.001243%Not Available
Paradoxical drug reaction08.06.01.0140.000287%Not Available
Brain oedema17.07.02.003; 12.01.10.010--
Autoimmune thyroiditis10.04.08.006; 05.02.04.0020.000669%Not Available
Bradyarrhythmia02.03.02.0150.000191%Not Available
Balance disorder08.01.03.081; 17.02.02.0070.002983%Not Available
Idiosyncratic drug reaction08.06.01.0020.000191%Not Available
Central nervous system lesion17.02.10.0110.000382%Not Available
Systemic inflammatory response syndrome24.06.03.008; 10.02.01.008; 08.01.05.0050.000191%Not Available
Conjunctival hyperaemia06.04.01.0040.000382%Not Available
Lymphoid tissue hyperplasia01.09.01.009--Not Available
Haemodynamic instability24.03.02.0060.000191%Not Available
Oscillopsia06.02.06.0090.000421%Not Available
Lymphatic disorder01.09.01.003--Not Available
Epigastric discomfort07.01.02.004--Not Available
Musculoskeletal discomfort15.03.04.001--Not Available
Injection site swelling08.02.03.017; 12.07.03.0180.000421%Not Available
Infusion site warmth12.07.05.012; 08.02.05.0110.000191%Not Available
Infusion site swelling12.07.05.003; 08.02.05.0020.000650%Not Available
Acquired haemophilia01.01.01.0020.000191%Not Available
Affect lability19.04.01.001--Not Available
Skin burning sensation23.03.03.021; 17.02.06.0090.000650%Not Available
Cerebral disorder17.02.10.0170.000191%Not Available
Dysphemia17.02.08.010; 19.19.03.005--Not Available
Haemorrhage24.07.01.002--Not Available
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ADReCS-Target
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