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%-
Adverse drug reaction08.06.01.0090.004396%-
Psychotic disorder19.03.01.002--
Hepatobiliary disease09.01.08.003---
Sinus disorder22.04.06.0020.000274%
Congenital genital malformation03.03.02.002; 21.15.02.001---
Anomaly of external ear congenital03.13.01.001; 04.06.01.001---
Poor quality sleep17.15.04.002; 19.02.05.0050.001756%-
Increased bronchial secretion22.12.01.0020.000125%-
Facial spasm17.04.03.0100.000336%-
Metamorphopsia06.02.06.014; 17.17.01.0200.000336%-
Hypophagia07.01.06.010; 14.03.01.006; 19.09.01.0040.000461%-
Autism spectrum disorder17.03.05.003; 19.22.02.0020.000187%-
Sudden unexplained death in epilepsy08.04.01.012; 17.12.03.0190.000187%-
Cardiac septal defect02.04.02.024; 03.07.02.003---
Renal aplasia03.06.01.002; 20.01.02.001---
Head titubation17.01.06.0060.000336%-
Suicidal behaviour19.12.01.006---
Dysmorphism03.11.06.001; 15.11.06.001---
Foetal anticonvulsant syndrome03.02.02.001; 12.03.03.001; 18.03.03.001---
Treatment failure08.06.01.0170.001855%-
Cytotoxic oedema17.07.02.006---
Adverse reaction08.06.01.0180.000274%-
Intellectual disability17.03.07.001; 19.21.06.001---
Hypoxic-ischaemic encephalopathy17.13.02.006; 22.02.02.011; 24.04.06.0210.000125%-
Macular pigmentation06.09.03.0150.000125%-
Developmental hip dysplasia03.11.07.014; 15.11.07.014---
Candida infection11.03.03.021--
Language disorder17.02.08.015; 19.19.01.006---
Respiratory symptom22.12.02.0130.000125%-
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ADReCS-Target
Drug Name ADR Term Target
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