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)
Toxic epidermal necrolysis23.03.01.008; 12.03.01.015; 11.07.01.006; 10.01.01.0060.000681%
Tremor17.01.06.0020.002674%
Trigeminal neuralgia17.04.08.0010.000630%Not Available
Upper respiratory tract infection22.07.03.011; 11.01.13.009--
Urinary incontinence17.05.01.008; 20.02.02.0100.000255%
Urinary tract disorder20.08.01.0010.000375%Not Available
Urinary tract infection20.08.02.001; 11.01.14.004--
Urticaria23.04.02.001; 10.01.06.001--
Vaginal discharge21.08.02.002--
Vaginal infection21.14.02.002; 11.01.10.002--
Vascular purpura23.06.01.008; 24.07.06.011; 01.01.04.007--Not Available
Ventricular fibrillation02.03.04.0080.000170%
Vertigo04.04.01.003; 17.02.12.0020.000920%
Viral infection11.05.04.001--Not Available
Vision blurred17.17.01.010; 06.02.06.0070.000766%
Visual acuity reduced06.02.10.012; 17.17.01.0110.000170%
Visual field defect17.17.01.001; 06.02.07.003--Not Available
Visual impairment06.02.10.0130.001294%Not Available
Vitiligo23.05.02.004; 10.04.02.004--Not Available
Vomiting07.01.07.0030.004479%
Weight decreased13.15.01.005--
Weight increased13.15.01.006--
Withdrawal syndrome08.06.02.012; 19.07.06.0230.000341%Not Available
Xerophthalmia14.12.03.002; 06.06.03.008--Not Available
Mental status changes19.07.01.0010.000426%Not Available
Tubulointerstitial nephritis20.05.02.002--Not Available
Mobility decreased15.03.05.023; 17.02.05.018; 08.01.03.0300.000255%Not Available
Musculoskeletal disorder15.03.05.0250.000170%Not Available
Acute generalised exanthematous pustulosis11.07.01.018; 10.01.01.034; 23.03.10.002; 12.03.01.005--Not Available
Brain oedema17.07.02.003; 12.01.10.0100.000170%
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ADReCS-Target
Drug Name ADR Term Target
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