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Drug ReportsFosphenytoin
Fosphenytoin
Cerebyx, Fosphenytoin (fosphenytoin) is a small molecule pharmaceutical. Fosphenytoin was first approved as Cerebyx on 1996-08-05. It is used to treat epilepsy, seizures, and status epilepticus in the USA.
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Financial
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Cerebyx, Fosphenytoin (discontinued: Fosphenytoin, Sesquient)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Fosphenytoin sodium
Tradename
Company
Number
Date
Products
CEREBYXPfizerN-020450 RX1996-08-05
1 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
cerebyxNew Drug Application2025-08-28
fosphenytoinANDA2023-03-31
fosphenytoin sodiumANDA2026-02-18
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
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FDA Information
Fosphenytoin Sodium, Sesquient, Lupin
94935822033-02-27DP
76357732029-03-13DP
84100772029-03-13DP
92000882029-03-13DP
97508222029-03-13DP
ATC Codes
N: Nervous system drugs
— N03: Antiepileptics
— N03A: Antiepileptics
— N03AB: Hydantoin derivatives, antiepileptics
— N03AB05: Fosphenytoin
HCPCS
Code
Description
Q2009
Injection, fosphenytoin, 50 mg phenytoin equivalent
S0078
Injection, fosphenytoin sodium, 750 mg
Clinical
Clinical Trials
16 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SeizuresD012640—G40.4—1—225
Traumatic brain injuriesD000070642—S06———213
Brain injuriesD001930—S06.9———213
Status epilepticusD013226EFO_0008526G41——21—3
HemorrhageD006470MP_0001914R58———112
Subarachnoid hemorrhageD013345EFO_0000713I60———112
EmergenciesD004630—————1—1
Intracranial hemorrhagesD020300EFO_0000551I62———1—1
StrokeD020521EFO_0000712I63.9———1—1
Brain ischemiaD002545EFO_0003883I67.82———1—1
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
EpilepsyD004827EFO_0000474G40.9——2——2
Acute painD059787—R52——1——1
Herpes zosterD006562EFO_0006510B02——1——1
Herpes simplexD006561—B00——1——1
Indications Phases 2
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
GlioblastomaD005909EFO_0000515—1————1
GliomaD005910EFO_0000520—1————1
GliosarcomaD018316——1————1
AstrocytomaD001254EFO_0000271—1————1
OligodendrogliomaD009837EFO_0000631—1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Brain diseasesD001927—G93.40————11
NeuralgiaD009437EFO_0009430—————11
Trigeminal neuralgiaD014277EFO_1001219G50.0————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameFosphenytoin
INNfosphenytoin
Description
Fosphenytoin is an imidazolidine-2,4-dione.
Classification
Small molecule
Drug classphosphoro-derivatives; antiepileptics (hydantoin derivatives)
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Structure (InChI/SMILES or Protein Sequence)
O=C1NC(c2ccccc2)(c2ccccc2)C(=O)N1COP(=O)(O)O
Identifiers
PDB—
CAS-ID93390-81-9
RxCUI—
ChEMBL IDCHEMBL1201336
ChEBI ID5165
PubChem CID56339
DrugBankDB01320
UNII IDB4SF212641 (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 2,040 documents
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Safety
Black-box Warning
Black-box warning for: Cerebyx, Fosphenytoin, Fosphenytoin sodium
Adverse Events
Top Adverse Reactions
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1,940 adverse events reported
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