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)
Obstructive airways disorder22.03.01.0110.000191%Not Available
Psychotic disorder19.03.01.002--
Haemorrhage neonatal24.07.01.026; 18.04.01.0050.000191%Not Available
Hepatic lesion09.01.08.0050.000191%Not Available
Hepatobiliary disease09.01.08.003--Not Available
Knee deformity15.10.03.0020.000287%Not Available
Sinus disorder22.04.06.0020.000516%
Poor quality sleep19.02.05.005; 17.15.04.0020.000746%Not Available
Increased bronchial secretion22.12.01.002--Not Available
Brain stem syndrome17.02.10.0160.000191%Not Available
Exfoliative rash23.03.07.0060.000191%Not Available
Oral mucosa erosion07.05.06.0090.000191%Not Available
Infusion site extravasation12.07.05.008; 08.02.05.0070.004474%
Vulvovaginal mycotic infection21.14.02.004; 11.03.05.004--Not Available
Head titubation17.01.06.0060.000382%Not Available
Infusion site thrombosis24.01.01.022; 12.07.05.007; 08.02.05.006--Not Available
Bone marrow failure01.03.03.005--
Soft tissue necrosis24.04.02.007; 15.03.02.0020.000191%
Mixed liver injury09.01.07.0150.000574%Not Available
Liver injury12.01.17.012; 09.01.07.0220.001530%Not Available
Hyperammonaemic encephalopathy17.13.01.005; 14.10.01.0060.000478%Not Available
Organising pneumonia22.01.02.0080.000956%Not Available
Oral disorder07.05.01.0050.000382%Not Available
Skin mass23.07.04.014--Not Available
Renal cell carcinoma16.08.02.002; 20.01.04.0030.000191%Not Available
Brain injury19.07.03.007; 17.11.01.0030.000287%Not Available
Cholestatic liver injury09.01.07.0160.000287%Not Available
Traumatic liver injury12.01.17.027; 09.01.08.010--Not Available
Intellectual disability17.03.07.001; 19.21.06.0010.000191%Not Available
Anorectal discomfort07.03.03.003--Not Available
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ADReCS-Target
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