Adverse Drug Reaction Classification System

         

Pharmaceutical Information
Drug Name Oxcarbazepine
Drug ID BADD_D01637
Description Oxcarbazepine is an anti-epileptic medication used in the treatment of partial onset seizures that was first approved for use in the United States in 2000.[L8627,L8630,L863] It is a structural derivative of [carbamazepine][A186101] and exerts a majority of its activity via a pharmacologically active metabolite, MHD, which exists as a racemate in the blood - a pro-drug of the more active (S)-enantiomer is also marketed as a separate anti-epileptic under the name [eslicarbazepine].[A186011] Compared to other anti-epileptic drugs, which are generally metabolized via the cytochrome P450 system, oxcarbazepine has a reduced propensity for involvement in drug-drug interactions owing to its primarily reductive metabolism.[A186032]
Indications and Usage In the United States, oxcarbazepine is indicated as monotherapy in the treatment of partial-onset seizures in patients 4 years of age and older, and as adjunctive therapy in the treatment of partial-onset seizures in patients 2 years of age and older.[L8627] In Canada, oxcarbazepine is indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in patients 6 years of age and older.[L8630]
Marketing Status approved
ATC Code N03AF02
DrugBank ID DB00776
KEGG ID D00533
MeSH ID D000078330
PubChem ID 34312
TTD Drug ID D0QL3P
NDC Product Code 72888-089; 55512-0023; 0078-0457; 50268-649; 51672-4106; 65162-649; 68071-2973; 70518-3197; 71428-007; 72888-088; 48087-0114; 55512-0008; 55512-0018; 72761-033; 76047-001; 31722-024; 50383-312; 60429-062; 62756-183; 71335-0090; 58159-088; 65372-1104; 17772-122; 50268-679; 60429-061; 63629-6834; 68462-139; 69452-125; 0615-8292; 60687-733; 63629-3816; 68084-845; 68462-138; 68788-7866; 70518-2370; 70518-3237; 72189-339; 0615-8448; 72888-074; 0904-7263; 42419-029; 48087-0157; 66406-0244; 66406-0246; 69766-055; 51672-4105; 51672-4107; 55154-8187; 62756-184; 68084-867; 70518-2276; 70518-3127; 71335-0505; 0615-8153; 48087-0115; 62512-0058; 70966-0004; 0078-0456; 17772-123; 50268-681; 68084-853; 70518-1027; 70518-1842; 70518-2254; 42419-006; 51508-008; 31722-025; 60687-711; 63629-9186; 70518-0894; 70518-2377; 0615-8447; 55512-0017; 82334-001; 0078-0357; 31722-023; 51991-294; 60429-063; 68094-123; 68462-137; 70518-1055; 0904-7264; 48087-0046; 48087-0158; 55512-0007; 0078-0337; 55154-2138; 60687-722; 63629-2075; 63629-4987; 0054-0199; 71205-411; 72888-087; 0781-6270; 48087-0118; 55512-0006; 42806-600; 50268-680; 51991-292; 62756-185; 70518-1980; 70518-2253; 71335-0144; 0904-7262; 55512-0016; 66039-905; 66406-0245; 17772-121; 51991-293; 55154-8198
UNII VZI5B1W380
Synonyms Oxcarbazepine | 10,11-Dihydro-10-oxo-5H-dibenz(b,f)azepine-5-carboxamide | Trileptal | Timox | GP 47680
Chemical Information
Molecular Formula C15H12N2O2
CAS Registry Number 28721-07-5
SMILES C1C2=CC=CC=C2N(C3=CC=CC=C3C1=O)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)
Hypophagia19.09.01.004; 14.03.01.006; 07.01.06.0100.000255%Not Available
Autism spectrum disorder17.03.05.003; 19.22.02.0020.000426%Not Available
Sudden unexplained death in epilepsy17.12.03.019; 08.04.01.0120.000341%Not Available
Oral mucosal exfoliation07.05.05.0110.000170%Not Available
Bone marrow failure01.03.03.005--
Suicidal behaviour19.12.01.006--Not Available
Liver injury12.01.17.012; 09.01.07.0220.000341%Not Available
Regurgitation07.01.07.0040.000170%Not Available
Hyperammonaemic encephalopathy17.13.01.005; 14.10.01.0060.000341%Not Available
Low birth weight baby18.04.02.0030.000341%Not Available
Brain injury17.11.01.003; 19.07.03.0070.000255%Not Available
Intellectual disability19.21.06.001; 17.03.07.0010.000255%Not Available
Oropharyngeal pain22.12.03.016; 07.05.05.0040.000426%
Craniocerebral injury17.11.01.007; 12.01.10.012--Not Available
Slow speech19.19.02.004; 17.02.08.0160.000375%Not Available
Drug-induced liver injury12.03.01.044; 09.01.07.0230.000596%Not Available
Drug reaction with eosinophilia and systemic symptoms12.03.01.064; 23.03.05.005; 10.01.01.0210.002895%Not Available
Language disorder19.19.01.006; 17.02.08.0150.000170%Not Available
Feeding intolerance18.04.11.003; 14.02.01.0060.000170%Not Available
Multiple organ dysfunction syndrome08.01.03.0570.000341%
Coeliac disease14.02.01.007; 10.04.04.012; 07.17.01.0080.000426%Not Available
Dermatitis exfoliative generalised23.03.07.002; 10.01.01.0290.000170%Not Available
Epileptic aura17.12.03.0240.000170%Not Available
Immunodeficiency common variable10.03.01.0060.000426%Not Available
Infantile spasms19.21.02.011; 17.12.03.0270.000170%Not Available
Neonatal respiratory distress syndrome22.11.02.010; 18.04.10.0030.000255%Not Available
Normal newborn18.08.06.0010.000170%Not Available
Oral lichen planus23.03.08.012; 07.05.01.0180.000170%Not Available
Post-traumatic stress disorder19.06.06.0020.000170%Not Available
Renal hypertension20.01.08.005; 24.08.08.0020.000170%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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