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)
Small for dates baby18.04.02.0020.000341%Not Available
Speech disorder developmental19.19.01.003; 17.02.08.0110.000170%Not Available
Tongue biting17.02.05.064; 07.14.01.013; 12.01.17.0230.000255%Not Available
Neuroendocrine tumour16.24.01.009; 05.08.01.0130.000170%Not Available
Splenic lesion01.09.02.0170.000170%Not Available
Eosinophilic colitis01.02.04.015; 07.08.01.0190.000170%Not Available
Multi-organ disorder08.01.03.0740.000170%Not Available
Sopor19.02.04.002; 17.02.04.0210.000255%Not Available
Fear of death19.06.03.0060.000170%Not Available
Seizure cluster17.12.03.0290.000170%Not Available
Hypoosmolar state14.05.01.0100.000170%Not Available
Selective eating disorder19.09.01.012; 14.03.02.0240.000341%Not Available
Attention deficit hyperactivity disorder19.21.04.0040.000460%Not Available
CSWS syndrome19.22.02.004; 17.12.03.0310.000255%Not Available
Dilated cardiomyopathy02.04.01.0170.000170%Not Available
Fixed eruption23.03.05.008; 10.01.01.037; 08.01.06.0250.000170%Not Available
Focal dyscognitive seizures17.12.02.0050.000341%Not Available
Gait inability17.02.05.069; 08.01.02.0110.000255%Not Available
Graves' disease10.04.08.014; 06.09.04.009; 05.02.02.0090.000255%Not Available
Haemophagocytic lymphohistiocytosis01.05.01.026; 10.02.01.077; 16.32.03.0380.000341%Not Available
Heavy menstrual bleeding21.01.03.005--Not Available
Hippocampal sclerosis17.11.01.0200.000170%Not Available
Intermenstrual bleeding21.01.01.0150.000664%Not Available
Therapeutic product effect decreased08.06.01.0500.001090%Not Available
Therapeutic response changed08.06.01.0590.000170%Not Available
Therapy non-responder08.06.01.0630.000715%Not Available
Therapy partial responder08.06.01.0640.000170%Not Available
Treatment noncompliance08.06.01.067; 12.09.02.0060.000630%Not Available
Vulvovaginal inflammation21.14.02.014--Not Available
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ADReCS-Target
Drug Name ADR Term Target
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