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)
Sinus bradycardia02.03.03.009--
Sinusitis22.07.03.007; 11.01.13.005--
Skin discolouration23.03.03.005--Not Available
Somnolence19.02.05.003; 17.02.04.006--
Speech disorder19.19.02.002; 17.02.08.003; 22.12.03.027--Not Available
Sputum increased22.02.03.007--Not Available
Stupor19.02.05.004; 17.02.04.007--Not Available
Subdural haematoma24.07.04.005; 17.08.05.002; 12.01.10.003--Not Available
Syncope17.02.04.008; 02.11.04.015; 24.06.02.012--
Tachycardia02.03.02.007--Not Available
Thinking abnormal19.10.03.001; 17.02.05.023--Not Available
Thrombocytopenia01.08.01.002--Not Available
Thrombophlebitis24.01.02.001--Not Available
Tinnitus04.04.01.002; 17.04.07.004--
Tongue disorder07.14.01.002--Not Available
Tongue oedema23.04.01.009; 10.01.05.008; 07.14.02.007--Not Available
Tremor17.01.06.002--
Urethral pain20.02.02.014--Not Available
Urinary incontinence17.05.01.008; 20.02.02.010--
Urinary retention20.02.02.011--
Urticaria23.04.02.001; 10.01.06.001--
Vaginal infection21.14.02.002; 11.01.10.002--
Vasodilatation24.03.02.003; 23.06.05.006--Not Available
Ventricular extrasystoles02.03.04.007--Not Available
Vertigo04.04.01.003; 17.02.12.002--
Visual field defect17.17.01.001; 06.02.07.003--Not Available
Vomiting07.01.07.003--
Vulvovaginal candidiasis21.14.02.003; 11.03.03.005--Not Available
Brain oedema17.07.02.003; 12.01.10.010--
Affect lability19.04.01.001--Not Available
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