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Drug ReportsPhenytoin
Phenytoin
Dilantin, Phenytek, Phenytoin (phenytoin) is a small molecule pharmaceutical. Phenytoin was first approved as Dilantin-125 on 1982-01-01. It is used to treat epilepsy, status epilepticus, temporal lobe epilepsy, and tonic-clonic epilepsy in the USA. The pharmaceutical is active against sodium channel protein type 2 subunit alpha.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Dilantin, Extended phenytoin, Phenytek, Phenytoin (discontinued: Dilantin, Diphenylan, Extended phenytoin, Phenytek, Phenytex, Phenytoin, Prompt phenytoin)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Phenytoin sodium
Tradename
Company
Number
Date
Products
DILANTINPfizerN-010151 DISCN1982-01-01
1 products
Hide discontinued
Phenytoin
Tradename
Company
Number
Date
Products
DILANTIN-125ViatrisN-008762 RX1982-01-01
1 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
dilantinANDA2024-09-25
dilantin infatabsANDA2025-01-14
dilantin kapseals2009-05-28
dilantin-125New Drug Application2023-02-02
extended phenytoin sodiumANDA2024-10-18
phenytekANDA2024-10-15
phenytoinANDA2025-01-13
phenytoin infatabsANDA2024-07-26
phenytoin sodiumANDA2025-01-03
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
epilepsyEFO_0000474D004827G40.9
status epilepticusEFO_0008526D013226G41
temporal lobe epilepsyEFO_0000773D004833—
tonic-clonic epilepsyEFO_0007262D004830—
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
N: Nervous system drugs
— N03: Antiepileptics
— N03A: Antiepileptics
— N03AB: Hydantoin derivatives, antiepileptics
— N03AB02: Phenytoin
— N03AB52: Phenytoin, combinations
HCPCS
Code
Description
J1165
Injection, phenytoin sodium, per 50 mg
Q2009
Injection, fosphenytoin, 50 mg phenytoin equivalent
S0078
Injection, fosphenytoin sodium, 750 mg
Clinical
Clinical Trials
113 clinical trials
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Indications Phases 4
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Indications Phases 3
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Indications Phases 2
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———1————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common namePhenytoin
INNphenytoin
Description
Phenytoin is a imidazolidine-2,4-dione that consists of hydantoin bearing two phenyl substituents at position 5. It has a role as an anticonvulsant, a teratogenic agent, a drug allergen and a sodium channel blocker. It is functionally related to a hydantoin.
Classification
Small molecule
Drug classantiepileptics (hydantoin derivatives)
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
O=C1NC(=O)C(c2ccccc2)(c2ccccc2)N1
Identifiers
PDB—
CAS-ID57-41-0
RxCUI—
ChEMBL IDCHEMBL16
ChEBI ID8107
PubChem CID1775
DrugBankDB00252
UNII ID6158TKW0C5 (ChemIDplus, GSRS)
Target
Agency Approved
SCN2A
SCN2A
Organism
Homo sapiens
Gene name
SCN2A
Gene synonyms
HBA, NAC2, SCN2A1, SCN2A2
NCBI Gene ID
6326
Protein name
sodium channel protein type 2 subunit alpha
Protein synonyms
HBSC II, Sodium channel protein brain II subunit alpha, Sodium channel protein type II subunit alpha, sodium channel protein, brain type 2 alpha subunit, sodium channel, voltage-gated, type II, alpha 1 polypeptide, sodium channel, voltage-gated, type II, alpha 2 polypeptide, sodium channel, voltage-gated, type II, alpha subunit, voltage-gated sodium channel subtype II, Voltage-gated sodium channel subunit alpha Nav1.2, voltage-gated sodium channel type II alpha subunit
Uniprot ID
Q9BZD0
Mouse ortholog
—
—
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
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Estimated US medical usage
Phenytoin
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 33,152 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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29,767 adverse events reported
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