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)
Myalgia15.05.02.001--
Nausea07.01.07.001--
Nervous system disorder17.02.10.001--Not Available
Nervousness19.06.02.003--Not Available
Neuritis17.09.03.001--Not Available
Neuropathy peripheral17.09.03.003--Not Available
Nystagmus06.05.02.006; 17.02.02.006--
Ocular hyperaemia06.04.05.004--Not Available
Oedema14.05.06.010; 08.01.07.006--Not Available
Oedema peripheral14.05.06.011; 08.01.07.007; 02.05.04.007--
Optic neuritis06.04.08.002; 10.02.01.097; 17.04.05.001--Not Available
Orthostatic hypotension24.06.03.004; 17.05.01.020--Not Available
Osteoarthritis15.01.04.001--Not Available
Osteoporosis15.02.03.002; 14.04.04.002--
Pain in extremity15.03.04.010--
Pallor24.03.04.001; 23.03.03.031; 08.01.03.032--Not Available
Palpitations02.11.04.012--
Pancreatitis07.18.01.001--
Pancytopenia01.03.03.003--Not Available
Paraesthesia23.03.03.094; 17.02.06.005--
Parosmia22.04.03.007; 17.04.04.002--Not Available
Peripheral coldness23.06.04.008; 24.04.03.006; 08.01.09.010--Not Available
Petechiae24.07.06.004; 23.06.01.003; 01.01.03.002--Not Available
Pollakiuria20.02.02.007-
Pruritus23.03.12.001--
Psychomotor retardation19.15.02.002--Not Available
Purpura01.01.04.003; 24.07.06.005; 23.06.01.004--
Rash23.03.13.001-Not Available
Rash maculo-papular23.03.13.004-
Sedation17.02.04.005--Not Available
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