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)
Skin exfoliation23.03.07.0030.000426%Not Available
Skin lesion23.03.03.0100.000255%Not Available
Sleep disorder19.02.04.0010.000545%Not Available
Sleep paralysis19.02.02.004; 17.15.02.0050.000375%Not Available
Sneezing22.12.03.0240.000460%
Somnolence19.02.05.003; 17.02.04.0060.005978%
Speech disorder22.12.03.027; 19.19.02.002; 17.02.08.0030.000886%Not Available
Splenomegaly01.09.02.001--Not Available
Status epilepticus17.12.03.0050.001448%Not Available
Stevens-Johnson syndrome10.01.01.045; 23.03.01.007; 12.03.01.014; 11.07.01.0050.001618%
Stillbirth18.01.02.002; 08.04.01.0060.000426%Not Available
Stomatitis07.05.06.005--
Stress19.06.02.0040.000545%Not Available
Stupor19.02.05.004; 17.02.04.007--Not Available
Suicidal ideation19.12.01.003--
Suicide attempt19.12.01.0040.001703%
Swelling face23.04.01.018; 08.01.03.100; 10.01.05.0180.000630%Not Available
Syncope02.11.04.015; 24.06.02.012; 17.02.04.0080.000766%
Systemic lupus erythematosus23.03.02.006; 15.06.02.003; 10.04.03.0040.000255%Not Available
Tachycardia02.03.02.007--Not Available
Tension19.06.02.0050.000255%Not Available
Tetany15.05.03.013; 14.04.01.005; 05.04.02.003--Not Available
Therapeutic response unexpected08.06.01.0010.000460%Not Available
Thinking abnormal19.10.03.001; 17.02.05.023--Not Available
Thirst14.03.02.007; 08.01.09.021--Not Available
Throat irritation22.12.03.029; 07.05.05.0370.000920%Not Available
Thrombocytopenia01.08.01.0020.000852%Not Available
Thyroid function test abnormal13.10.06.001--Not Available
Tinnitus17.04.07.004; 04.04.01.002--
Toothache07.09.06.001--
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ADReCS-Target
Drug Name ADR Term Target
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