Adverse Drug Reaction Classification System

         

Pharmaceutical Information
Drug Name Phenytoin sodium
Drug ID BADD_D01766
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 D02103
MeSH ID D010672
PubChem ID 657302
TTD Drug ID D0E4DW
NDC Product Code 42291-772; 63629-8529; 70518-0980; 57664-808; 62756-299; 65862-692; 0615-8020; 0641-0493; 52119-006; 66064-6001; 42192-614; 51662-1250; 63187-891; 63629-2369; 0404-9933; 71335-0232; 12711-4466; 17349-0004; 51672-4111; 53002-1501; 58118-4111; 0378-3750; 71610-479; 0009-0087; 51927-0301; 70859-008; 43063-492; 70518-1776; 51552-0532; 51662-1251; 0404-9932; 70518-2293; 0641-2555; 0904-6187; 49452-5344; 53747-082; 29300-379; 50090-3165; 50090-5700; 53002-4501; 62756-432; 65162-212; 68084-376; 70518-0107; 70518-2227; 0641-6139; 55154-7979; 0641-6138; 71335-0913; 38779-0216
UNII 4182431BJH
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 C15H11N2NaO2
CAS Registry Number 630-93-3
SMILES C1=CC=C(C=C1)C2(C(=O)[N-]C(=O)N2)C3=CC=CC=C3.[Na+]
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)
Immunoglobulins abnormal13.06.05.002---
Insomnia17.15.03.002; 19.02.01.002--
Leukopenia01.02.02.001---
Lip swelling07.05.04.005; 10.01.05.005; 23.04.01.007---
Lymphadenopathy01.09.01.002---
Lymphoma01.12.01.001; 16.20.01.001---
Macrocytosis01.07.02.003---
Muscle twitching15.05.03.005---
Nausea07.01.07.001--
Nervousness19.06.02.003---
Nystagmus06.05.02.006; 17.02.02.006--
Osteomalacia14.04.04.001; 15.02.03.001; 20.01.01.002---
Osteoporosis14.04.04.002; 15.02.03.002--
Pancytopenia01.03.03.003---
Paraesthesia17.02.06.005; 23.03.03.094--
Peyronie's disease21.12.01.002---
Polyarteritis nodosa10.02.02.001; 15.06.01.003; 20.01.02.004; 24.12.04.019---
Polyneuropathy17.09.03.012---
Pseudolymphoma01.09.01.016---
Purpura01.01.04.003; 23.06.01.004; 24.07.06.005--
Rash morbilliform23.03.13.005---
Rash scarlatiniform23.03.13.006---
Skin reaction10.01.03.019; 23.03.03.013---
Somnolence17.02.04.006; 19.02.05.003--
Stevens-Johnson syndrome10.01.01.045; 11.07.01.005; 12.03.01.014; 23.03.01.007--
Systemic lupus erythematosus10.04.03.004; 15.06.02.003; 23.03.02.006---
Thrombocytopenia01.08.01.002---
Toxic epidermal necrolysis10.01.01.006; 11.07.01.006; 12.03.01.015; 23.03.01.008--
Tremor17.01.06.002--
Vomiting07.01.07.003--
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