Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Fosphenytoin sodium
Drug ID BADD_D00971
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 D02096
MeSH ID C043114
PubChem ID 56338
TTD Drug ID D0J5YC
NDC Product Code 0641-6136; 64679-730; 0641-6137; 65162-998; 29902-0023; 62331-027; 0069-6001; 0143-9782; 65162-999; 63323-403; 0143-9788; 14998-0018; 0069-5471; 72375-0005; 0069-5474; 64679-729; 52952-005; 82019-0002
UNII 7VLR55452Z
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 C16H13N2Na2O6P
CAS Registry Number 92134-98-0
SMILES C1=CC=C(C=C1)C2(C(=O)N(C(=O)N2)COP(=O)([O-])[O-])C3=CC=CC=C3.[Na+].[Na+]
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)
Hypokalaemia14.05.03.002--
Hypokinesia17.01.02.009--Not Available
Hypophosphataemia14.04.03.001--
Hyporeflexia17.02.01.003--
Hypotension24.06.03.002--
Hypotonia15.05.04.008; 17.05.02.002--Not Available
Hypoxia22.02.02.003--
Ileus07.13.01.001--
Infection11.01.08.002--Not Available
Influenza22.07.02.001; 11.05.03.001--Not Available
Injection site haemorrhage24.07.01.010; 12.07.03.005; 08.02.03.005--Not Available
Injection site inflammation08.02.03.008; 12.07.03.009--Not Available
Injection site oedema12.07.03.024; 08.02.03.024--Not Available
Injection site pain12.07.03.011; 08.02.03.010--Not Available
Injection site reaction12.07.03.015; 08.02.03.014--
Injury12.01.08.004--Not Available
Insomnia19.02.01.002; 17.15.03.002--
Intracranial pressure increased17.07.02.002--Not Available
Ketosis14.01.01.001--Not Available
Leukocytosis01.02.01.002--
Leukopenia01.02.02.001--Not Available
Liver function test abnormal13.03.04.030--Not Available
Loss of consciousness17.02.04.004--Not Available
Lymphadenopathy01.09.01.002--Not Available
Malaise08.01.01.003--
Meningitis17.06.03.001; 11.01.03.001--
Mental disability26.01.01.001--Not Available
Migraine24.03.05.003; 17.14.02.001--Not Available
Mood swings19.04.03.001--Not Available
Muscle spasms15.05.03.004--
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