Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Vigabatrin
Drug ID BADD_D02355
Description Vigabatrin is an analog of gamma-aminobutyric acid ([GABA]), the main inhibitory neurotransmitter in the central nervous system, used in the treatment of refractory seizures and infantile spasms.[L13616] It irreversibly inhibits the enzyme responsible for GABA metabolism, thereby increasing levels of circulating GABA. Although administered as a racemic mixture, only the S(+) enantiomer is pharmacologically active.[A202037] It was first introduced as an antiepileptic agent in the United Kingdom in 1989 and was used extensively until 1997, when an association with vision loss became apparent.[A202124] Its use is now generally reserved for patients who have failed alternative therapies, and its US approval by the FDA in 2009 mandated the creation of a drug registry to monitor patients for visual deficits.[L13661,A202124]
Indications and Usage Vigabatrin is indicated as adjunctive therapy in the treatment of refractory complex partial seizures in patients 2 years of age and older who have had inadequate responses to multiple previous treatments (i.e. not to be used for first-line therapy).[L13616] It is also indicated as monotherapy in the treatment of infantile spasms in patients between 1 month and 2 years of age for whom the potential benefits outweigh the risk of vision loss.[L13616]
Marketing Status approved
ATC Code N03AG04
DrugBank ID DB01080
KEGG ID D00535
MeSH ID D020888
PubChem ID 5665
TTD Drug ID D0R3QY
NDC Product Code 0591-3851; 60219-1424; 67386-111; 70710-1287; 14501-0081; 43598-651; 67877-674; 69238-1424; 70771-1654; 59651-364; 49884-358; 0054-0702; 0591-3955; 62207-975; 71886-434; 69238-1425; 0245-0556; 0054-0652; 65977-0106; 67651-0294; 42799-950; 43598-697; 67386-211; 68180-521; 70377-089; 42765-059; 68621-0046; 76055-0033; 69097-964; 72205-093; 59651-366; 59651-367; 62331-042; 31722-009; 0245-6001
UNII GR120KRT6K
Synonyms Vigabatrin | gamma-Vinyl-gamma-Aminobutyric Acid | gamma Vinyl gamma Aminobutyric Acid | gamma-Vinyl-GABA | gamma Vinyl GABA | Sabrilex | Sabril
Chemical Information
Molecular Formula C6H11NO2
CAS Registry Number 68506-86-5
SMILES C=CC(CCC(=O)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)
Blood disorder01.05.01.0040.000125%Not Available
Adverse drug reaction08.06.01.0090.004396%Not Available
Psychotic disorder19.03.01.002--
Hepatobiliary disease09.01.08.003--Not Available
Sinus disorder22.04.06.0020.000274%
Congenital genital malformation21.15.02.001; 03.03.02.002--Not Available
Anomaly of external ear congenital04.06.01.001; 03.13.01.001--Not Available
Poor quality sleep19.02.05.005; 17.15.04.0020.001756%Not Available
Increased bronchial secretion22.12.01.0020.000125%Not Available
Facial spasm17.04.03.0100.000336%Not Available
Metamorphopsia17.17.01.020; 06.02.06.0140.000336%Not Available
Hypophagia14.03.01.006; 07.01.06.010; 19.09.01.0040.000461%Not Available
Autism spectrum disorder17.03.05.003; 19.22.02.0020.000187%Not Available
Sudden unexplained death in epilepsy08.04.01.012; 17.12.03.0190.000187%Not Available
Cardiac septal defect03.07.02.003; 02.04.02.024--Not Available
Renal aplasia20.01.02.001; 03.06.01.002--Not Available
Head titubation17.01.06.0060.000336%Not Available
Suicidal behaviour19.12.01.006--Not Available
Dysmorphism15.11.06.001; 03.11.06.001--Not Available
Foetal anticonvulsant syndrome18.03.03.001; 12.03.03.001; 03.02.02.001--Not Available
Treatment failure08.06.01.0170.001855%Not Available
Cytotoxic oedema17.07.02.006--Not Available
Adverse reaction08.06.01.0180.000274%Not Available
Intellectual disability19.21.06.001; 17.03.07.001--Not Available
Hypoxic-ischaemic encephalopathy24.04.06.021; 17.13.02.006; 22.02.02.0110.000125%Not Available
Macular pigmentation06.09.03.0150.000125%Not Available
Developmental hip dysplasia15.11.07.014; 03.11.07.014--Not Available
Candida infection11.03.03.021--
Language disorder17.02.08.015; 19.19.01.006--Not Available
Respiratory symptom22.12.02.0130.000125%Not Available
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ADReCS-Target
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