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 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 D00512
MeSH ID D010672
PubChem ID 1775
TTD Drug ID D0E4DW
NDC Product Code 0615-8260; 0904-7079; 51672-4069; 70518-1967; 66064-1030; 60687-156; 60687-275; 17349-0007; 51927-1216; 59762-0531; 0615-8424; 70518-3353; 59762-5210; 12711-4444; 17856-4070; 66689-775; 0121-0892; 0009-0488; 0071-0007; 66689-036; 49452-5340; 51672-4146; 51552-0553; 70518-0841; 66993-372; 52119-007; 62991-1691; 0071-2214
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
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Adverse drug reactionCytochrome P450 3A4P08684T3784810901705; 16359177; 9305589; 12018981
Adverse drug reactionCytochrome P450 3A4P08684T3784810609607; 9435993; 1644052
Cleft palateAtrial natriuretic peptide receptor 1P16066T712302519305; 11283972; 2253386; 6389029; 1687470; 7385055; 7635930; 6648822; 1549630; 3525322; 10069438; 3885248; 3722339; 2227380; 2966993; 6183668; 14580893; 9144220; 7022463; 6897299
Cleft palateMajor histocompatibility complex H-2E beta chainO19448Not Available6439630; 4044790; 6389029; 3885248; 7079749; 6897299; 2867743; 7275225
HepatotoxicityCytochrome P450 2C19P33261Not Available12228186; 1599495; 15788366; 11990081
HepatotoxicityCytochrome P450 3A4P08684T3784810901705; 16359177; 9305589; 12018981
HepatotoxicityCytochrome P450 2C19P33261Not Available10901705; 16359177; 9305589; 12018981
HepatotoxicityCytochrome P450 3A4P08684T3784810609607; 9435993; 1644052
HepatotoxicityCytochrome P450 2C9P11712T1924410901705; 16359177; 9305589; 12018981
HypotensionCytochrome P450 2B6P20813T1179316440513; 15462150; 16749537; 16208529; 12785750; 718486; 9757415
JaundiceAlkaline phosphatase, tissue-nonspecific isozymeP05186T095386648747; 6518350; 3510392; 7049029
JaundiceGlutathione hydrolase 7Q9UJ14T251226648747; 6518350; 3510392; 7049029
JaundiceAlanine aminotransferase 1P24298Not Available6648747; 6518350; 3510392; 7049029
Poisoning and toxicityCytochrome P450 2C19P33261Not Available10901705; 16359177; 9305589; 12018981
Poisoning and toxicityCytochrome P450 2D6P10635T5739212228186; 1599495; 15788366; 11990081
Poisoning and toxicityCytochrome P450 2C19P33261Not Available12228186; 1599495; 15788366; 11990081
ThrombocytopeniaBifunctional epoxide hydrolase 2P34913T357348326296; 3966212; 3614578; 9101005
Toxicity to various agentsCytochrome P450 2C9P11712T1924410901705; 16359177; 9305589; 12018981
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal discomfort07.01.06.001--Not Available
Abdominal pain07.01.05.002--
Abdominal pain upper07.01.05.003--
Acidosis14.01.03.002--
Acute hepatic failure09.01.03.0010.000962%Not Available
Ageusia17.02.07.001; 07.14.03.003--Not Available
Aggression19.05.01.0010.002458%Not Available
Agitation19.06.02.001; 17.02.05.0120.005735%
Agranulocytosis01.02.03.0010.002867%Not Available
Akathisia19.06.02.006; 17.01.02.002--
Alanine aminotransferase increased13.03.01.003--
Albuminuria20.02.01.001--Not Available
Alkalosis14.01.02.001--
Altered state of consciousness17.02.04.001; 19.07.01.0030.004096%Not Available
Alveolitis allergic22.01.01.002; 10.01.03.0080.000819%Not Available
Amblyopia06.02.01.001--Not Available
Ammonia increased13.03.01.0230.000819%Not Available
Amnesia19.20.01.001; 17.03.02.0010.003277%
Anaemia01.03.02.001--
Anaemia macrocytic14.12.01.002; 01.03.02.0020.000819%Not Available
Anaemia megaloblastic14.12.01.003; 01.03.02.003--Not Available
Anaphylactic shock24.06.02.004; 10.01.07.002--Not Available
Anaphylactoid reaction24.06.03.007; 10.01.07.003--Not Available
Angioedema23.04.01.001; 10.01.05.0090.003687%Not Available
Anxiety19.06.02.002--
Aphasia19.21.01.001; 17.02.03.0010.003687%
Aplastic anaemia01.03.03.0020.000819%Not Available
Apnoea22.02.01.0010.000641%
Areflexia17.02.01.0010.000427%Not Available
Arrhythmia02.03.02.001--Not Available
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