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)
Mood altered19.04.02.0070.000664%Not Available
Mood swings19.04.03.0010.000460%Not Available
Mouth ulceration07.05.06.0040.000255%Not Available
Movement disorder17.01.02.0100.002163%Not Available
Mucosal inflammation08.01.06.0020.000170%Not Available
Multiple fractures12.04.02.009; 15.08.02.005--Not Available
Muscle contractions involuntary17.05.03.001; 15.05.03.008--Not Available
Muscle rigidity17.05.02.005; 15.05.04.0010.000170%Not Available
Muscle twitching15.05.03.0050.000715%Not Available
Muscular weakness17.05.03.005; 15.05.06.0010.000630%
Mutism19.19.01.001; 17.02.08.0070.000170%Not Available
Myalgia15.05.02.001--
Mydriasis06.05.03.004; 17.02.11.0030.000255%Not Available
Myoclonus17.02.05.0080.000596%Not Available
Nail dystrophy23.02.05.0030.000255%Not Available
Nasopharyngitis22.07.03.002; 11.01.13.002--Not Available
Nausea07.01.07.001--
Nephrolithiasis20.04.01.0020.000170%
Nervous system disorder17.02.10.0010.000170%Not Available
Nervousness19.06.02.0030.002742%Not Available
Neuralgia17.02.07.005--
Neurotoxicity12.03.01.011; 17.02.10.0020.000170%Not Available
Neutropenia01.02.03.004--Not Available
Nightmare19.02.03.003--Not Available
Nystagmus17.02.02.006; 06.05.02.0060.000426%
Ocular hyperaemia06.04.05.0040.000170%Not Available
Oculogyric crisis17.01.03.002; 06.05.02.002--Not Available
Oedema14.05.06.010; 08.01.07.0060.000341%Not Available
Oedema peripheral14.05.06.011; 08.01.07.007; 02.05.04.007--
Oesophagitis07.08.05.001--
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ADReCS-Target
Drug Name ADR Term Target
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