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)
Gait disturbance17.02.05.016; 08.01.02.002; 15.03.05.0130.004531%
Gastritis07.08.02.001--
Gastrointestinal disorder07.11.01.001--Not Available
Gastrointestinal haemorrhage24.07.02.009; 07.12.02.001--Not Available
Generalised oedema08.01.07.004; 14.05.06.0070.000287%
Generalised tonic-clonic seizure17.12.01.0020.003767%Not Available
Gingival bleeding24.07.02.010; 07.09.07.0010.000516%Not Available
Gingival disorder07.09.13.0040.001166%Not Available
Gingival hypertrophy07.09.13.0080.002524%Not Available
Gingival swelling07.09.13.0130.000191%Not Available
Gingivitis07.09.10.002; 11.01.04.013--
Granulocytopenia01.02.03.003--Not Available
Granulomatous liver disease09.01.07.0010.000574%Not Available
Gynaecomastia21.05.04.003; 05.05.02.003--
Haemoglobin13.01.05.018--Not Available
Haemolytic anaemia01.06.03.0020.000191%Not Available
Haemoptysis02.11.04.009; 24.07.01.006; 22.02.03.004--Not Available
Hallucination19.10.04.003--
Hallucination, auditory19.10.04.0040.000669%Not Available
Hallucination, tactile19.10.04.0060.000191%Not Available
Hallucinations, mixed19.10.04.0080.000191%Not Available
Headache17.14.01.001--
Hemiparesis17.01.04.0010.000765%
Hemiplegia17.01.04.0020.000191%Not Available
Hepatic encephalopathy09.01.03.006; 17.13.01.0030.000287%Not Available
Hepatic failure09.01.03.0020.001243%
Hepatic fibrosis09.01.04.002; 24.08.06.0020.000191%Not Available
Hepatic function abnormal09.01.02.0010.001759%Not Available
Hepatic necrosis09.01.07.0020.000574%
Hepatic steatosis14.08.04.005; 09.01.07.0030.000191%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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