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 an antiepileptic drug which can be useful in the treatment of epilepsy. The primary site of action appears to be the motor cortex where spread of seizure activity is inhibited. Phenytoin reduces the maximal activity of brain stem centers responsible for the tonic phase of tonic-clonic (grand mal) seizures. Phenytoin acts to dampen the unwanted, runaway brain activity seen in seizure by reducing electrical conductance among brain cells. It lacks the sedation effects associated with phenobarbital. There are some indications that phenytoin has other effects, including anxiety control and mood stabilization, although it has never been approved for those purposes by the FDA. Phenytoin is primarily metabolized by CYP2C9.
Marketing Status Prescription; Discontinued
ATC Code N03AB02
DrugBank ID DB00252
KEGG ID D02103
MeSH ID D010672
PubChem ID 657302
TTD Drug ID D0E4DW
NDC Product Code 12711-4466; 0378-1560; 50090-2089; 0641-2555; 0378-3750; 63629-2369; 52119-006; 51079-905; 53747-082; 51927-1838; 0641-6139; 50090-5700; 70859-008; 70518-0107; 51552-0532; 63629-6382; 55154-5496; 68084-376; 58118-4111; 71335-0913; 63629-6364; 0404-9932; 52584-493; 0615-8020; 53002-2501; 0904-6187; 0641-6138; 61919-815; 57664-808; 63629-8529; 49452-5344; 42192-614; 51672-4111; 52584-555; 62756-299; 62756-432; 0404-9933; 42291-772; 63187-891; 53002-1501; 71610-479; 43063-492; 17349-0004; 70518-1776; 0641-0493; 50090-3539; 51662-1250; 70518-2293; 0009-0087; 65862-692; 50090-3165; 71335-1349; 55154-7979; 38779-0216; 51662-1251; 67544-517; 71335-0232; 65162-212; 70518-2227; 66064-6001
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
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Adverse drug reactionCytochrome P450 3A4P08684T37848Not Available
Cleft palateMajor histocompatibility complex H-2E beta chainO19448Not AvailableNot Available
Cleft palateAtrial natriuretic peptide receptor 1P16066T71230Not Available
HepatotoxicityCytochrome P450 3A4P08684T37848Not Available
HepatotoxicityCytochrome P450 2C19P33261Not AvailableNot Available
HepatotoxicityCytochrome P450 2C9P11712T19244Not Available
HypotensionCytochrome P450 2B6P20813T11793Not Available
JaundiceAlkaline phosphatase, tissue-nonspecific isozymeP05186T09538Not Available
JaundiceGlutathione hydrolase 7Q9UJ14T25122Not Available
JaundiceAlanine aminotransferase 1P24298Not AvailableNot Available
Poisoning and toxicityCytochrome P450 2C19P33261Not AvailableNot Available
Poisoning and toxicityCytochrome P450 2D6P10635T57392Not Available
ThrombocytopeniaBifunctional epoxide hydrolase 2P34913T35734Not Available
Toxicity to various agentsCytochrome P450 2C9P11712T19244Not Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Agranulocytosis01.02.03.001--Not Available
Akathisia19.06.02.006; 17.01.02.002--
Anaemia megaloblastic14.12.01.003; 01.03.02.003--Not Available
Anaphylactic reaction24.06.03.006; 10.01.07.001--
Anaphylactoid reaction24.06.03.007; 10.01.07.003--Not Available
Asterixis17.01.06.001; 09.01.03.004--Not Available
Ataxia17.02.02.001; 08.01.02.004--
Chorea17.01.01.001--Not Available
Confusional state17.02.03.005; 19.13.01.001--
Constipation07.02.02.001--
Coordination abnormal17.02.02.004--Not Available
Dermatitis23.03.04.002--Not Available
Dermatitis bullous23.03.01.002--
Dermatitis exfoliative23.03.07.001; 10.01.01.004--
Dizziness02.01.02.004; 24.06.02.007; 17.02.05.003--
Dysarthria19.19.03.001; 17.02.08.001--
Dysgeusia17.02.07.003; 07.14.03.001--
Dyskinesia17.01.02.006--
Dyspnoea22.02.01.004; 02.01.03.002--
Dystonia17.01.03.001--Not Available
Fracture15.08.02.001; 12.04.02.001--
Gingival hyperplasia07.09.03.002--Not Available
Granulocytopenia01.02.03.003--Not Available
Headache17.14.01.001--
Hepatitis toxic12.03.01.016; 09.01.07.017--Not Available
Hodgkin's disease01.16.01.001; 16.31.01.001--Not Available
Hypersensitivity10.01.03.003--
Hypertrichosis23.02.04.002--
Hypocalcaemia14.04.01.004--
Hypophosphataemia14.04.03.001--
The 1th Page    1 2 3    Next   Last    Total 3 Pages