Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Eslicarbazepine acetate
Drug ID BADD_D00812
Description Eslicarbazepine acetate (ESL) is an anticonvulsant medication approved for use in Europe, the United States and Canada as an adjunctive therapy for partial-onset seizures that are not adequately controlled with conventional therapy. Eslicarbazepine acetate is a prodrug that is rapidly converted to eslicarbazepine, the primary active metabolite in the body. Eslicarbazepine's mechanism of action is not well understood, but it is known that it does exert anticonvulsant activity by inhibiting repeated neuronal firing and stabilizing the inactivated state of voltage-gated sodium channels, thus preventing their return to the activated state during which seizure activity can occur. Eslicarbazepine acetate is marketed as Aptiom in North America and Zebinix or Exalief in Europe. It is available in 200, 400, 600, or 800mg tablets that are taken once daily, with or without food. Eslicarbazepine acetate is associated with numerous side effects including dizziness, drowsiness, nausea, vomiting, diarrhea, headache, aphasia, lack of concentration, psychomotor retardation, speech disturbances, ataxia, depression and hyponatremia. It is recommended that patients taking eslicarbazepine acetate be monitored for suicidality.
Indications and Usage Eslicarbazepine acetate is indicated as adjunctive therapy in the treatment of partial-onset seizures that are not adequately controlled with conventional therapy in epileptic patients.
Marketing Status approved
ATC Code Not Available
DrugBank ID DB09119
KEGG ID D09612
MeSH ID C416835
PubChem ID 179344
TTD Drug ID Not Available
NDC Product Code 66406-0204; 66406-0222; 42419-026; 65372-1170; 63402-206; 66406-0327; 59651-482; 69766-051; 63402-204; 52076-6269; 55111-933; 66406-0203; 63402-202; 63402-208; 63402-248; 70966-0007; 76072-1005
UNII BEA68ZVB2K
Synonyms eslicarbazepine acetate | 10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide | BIA 2-093 | BIA-2-093 | Zebinix | Aptiom
Chemical Information
Molecular Formula C17H16N2O3
CAS Registry Number 236395-14-5
SMILES CC(=O)OC1CC2=CC=CC=C2N(C3=CC=CC=C13)C(=O)N
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)
Abdominal discomfort07.01.06.001--Not Available
Abdominal distension07.01.04.001--
Abdominal pain07.01.05.002--
Agitation19.06.02.001; 17.02.05.012--
Alopecia23.02.02.001--
Amnesia19.20.01.001; 17.03.02.001--
Anaemia01.03.02.001--
Anaphylactic reaction24.06.03.006; 10.01.07.001--
Anaphylactic shock24.06.02.004; 10.01.07.002--Not Available
Angioedema22.04.02.008; 23.04.01.001; 10.01.05.009--Not Available
Anxiety19.06.02.002-
Apathy19.04.04.002--Not Available
Aphasia19.21.01.001; 17.02.03.001--
Application site pain12.07.01.004; 08.02.01.004--Not Available
Arrhythmia02.03.02.001--Not Available
Asthenia08.01.01.001--Not Available
Ataxia17.02.02.001; 08.01.02.004-
Atrioventricular block02.03.01.002--Not Available
Blood chloride decreased13.11.01.004--Not Available
Blood cholesterol increased13.12.01.002--
Blood creatine phosphokinase increased13.04.01.001--
Blood pressure increased13.14.03.005--Not Available
Blood triglycerides13.12.03.004--Not Available
Body temperature increased13.15.01.001--Not Available
Bradycardia02.03.02.002--Not Available
Burning sensation17.02.06.001; 08.01.09.029--Not Available
Cerebellar syndrome17.02.02.002--Not Available
Chest pain22.12.02.003; 08.01.08.002; 02.02.02.011--Not Available
Chills15.05.03.016; 08.01.09.001-
Chromatopsia06.02.05.001--Not Available
The 1th Page    1 2 3 4 5    Next   Last    Total 8 Pages