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)
Muscle twitching15.05.03.005--Not Available
Muscular weakness17.05.03.005; 15.05.06.001--
Myalgia15.05.02.001--
Mydriasis06.05.03.004; 17.02.11.003--Not Available
Myoclonus17.02.05.008--Not Available
Myopathy15.05.05.001--Not Available
Nausea07.01.07.001--
Nervousness19.06.02.003--Not Available
Neurosis19.06.01.001--Not Available
Nystagmus17.02.02.006; 06.05.02.006--
Oedema genital21.10.01.011--
Oliguria20.01.03.004--Not Available
Orthostatic hypotension24.06.03.004; 17.05.01.020--Not Available
Osteoarthritis15.01.04.001--Not Available
Palpitations02.11.04.012--
Paraesthesia23.03.03.094; 17.02.06.005--
Paralysis17.01.04.004--Not Available
Parosmia22.04.03.007; 17.04.04.002--Not Available
Pelvic pain21.10.01.001; 20.02.03.007; 07.01.06.012--
Personality disorder19.05.02.002--Not Available
Petechiae23.06.01.003; 01.01.03.002; 24.07.06.004--Not Available
Pharyngitis22.07.03.004; 11.01.13.003; 07.05.07.004--
Photophobia17.17.02.006; 06.01.01.004--
Photosensitivity reaction23.03.09.003--
Pneumonia11.01.09.003; 22.07.01.003--Not Available
Pneumonia aspiration22.07.01.015; 11.01.09.019--Not Available
Pneumothorax22.05.02.003--
Polyuria20.02.03.002--Not Available
Proctalgia07.03.02.001--
Pruritus23.03.12.001--
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