Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Fosphenytoin
Drug ID BADD_D00970
Description Fosphenytoin is a water-soluble phenytoin prodrug used only in hospitals for the treatment of epileptic seizures. It works by slowing down impulses in the brain that cause seizures. Its main mechanism is to block frequency-dependent, use-dependent and voltage-dependent neuronal sodium channels, and therefore limit repetitive firing of action potentials.
Indications and Usage Fosphenytoin is indicated for the treatment of generalized tonic-clonic status epilepticus and for the prevention and treatment of seizures occurring during neurosurgery in adult patients. It can also be substituted, short-term, for oral phenytoin in patients aged two years and older when oral phenytoin administration is not possible.[L20619]
Marketing Status approved; investigational
ATC Code N03AB05
DrugBank ID DB01320
KEGG ID D07993
MeSH ID C043114
PubChem ID 56339
TTD Drug ID D0J5YC
NDC Product Code 70121-1381; 70121-1390
UNII B4SF212641
Synonyms fosphenytoin | 3-(hydroxymethyl)phenytoin phosphate ester | ACC 9653 | ACC-9653 | Prodilantin | fosphenytoin sodium | fosphenytoin, disodium salt | 3-(hydroxymethyl)phenytoin disodium phosphate | HMPDP | Cerebyx
Chemical Information
Molecular Formula C16H15N2O6P
CAS Registry Number 93390-81-9
SMILES C1=CC=C(C=C1)C2(C(=O)N(C(=O)N2)COP(=O)(O)O)C3=CC=CC=C3
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)
Hypoxia22.02.02.003--
Ileus07.13.01.001--
Infection11.01.08.002---
Influenza11.05.03.001; 22.07.02.001---
Injection site haemorrhage08.02.03.005; 12.07.03.005; 24.07.01.010---
Injection site inflammation08.02.03.008; 12.07.03.009---
Injection site oedema08.02.03.024; 12.07.03.024---
Injection site pain08.02.03.010; 12.07.03.011---
Injection site reaction08.02.03.014; 12.07.03.015--
Injury12.01.08.004---
Insomnia17.15.03.002; 19.02.01.002--
Intracranial pressure increased17.07.02.002---
Ketosis14.01.01.001---
Leukocytosis01.02.01.002--
Leukopenia01.02.02.001---
Liver function test abnormal13.03.04.030---
Lymphadenopathy01.09.01.002---
Malaise08.01.01.003--
Meningitis11.01.03.001; 17.06.03.001--
Migraine17.14.02.001; 24.03.05.003---
Muscle spasms15.05.03.004--
Muscle twitching15.05.03.005---
Muscular weakness15.05.06.001; 17.05.03.005--
Myalgia15.05.02.001--
Mydriasis06.05.03.004; 17.02.11.003---
Myoclonus17.02.05.008---
Myopathy15.05.05.001---
Nausea07.01.07.001--
Nervousness19.06.02.003---
Neurosis19.06.01.001---
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