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)
Electroencephalogram abnormal13.07.03.001---
Encephalopathy17.13.02.0010.000934%
Endocrine disorder05.09.01.001---
Epilepsy17.12.03.0020.001270%-
Epistaxis22.04.03.001; 24.07.01.0050.002242%
Erythema multiforme10.01.03.015; 23.03.01.003--
Eye disorder06.08.03.0010.001557%-
Eye pain06.08.03.002--
Face oedema08.01.07.003; 10.01.05.002; 23.04.01.004--
Failure to thrive14.03.02.008; 18.04.01.003; 19.07.05.0010.000187%-
Fatigue08.01.01.002--
Febrile convulsion08.05.02.009; 17.12.03.0040.000560%-
Feeling abnormal08.01.09.014---
Flat affect19.04.01.0040.000274%-
Gait disturbance08.01.02.002; 15.03.05.013; 17.02.05.016--
Gastroenteritis viral07.19.03.005; 11.05.04.005---
Gastrointestinal disorder07.11.01.001---
Gastrointestinal haemorrhage07.12.02.001; 24.07.02.009---
Gastrointestinal pain07.01.05.005--
Generalised tonic-clonic seizure17.12.01.0020.000710%-
Glaucoma06.03.01.0020.000125%
Haemangioma congenital03.07.03.002; 16.02.01.004; 24.03.06.005---
Haematemesis07.12.02.002; 24.07.02.0110.000311%-
Hair growth abnormal23.02.06.0060.000423%-
Hallucination19.10.04.003--
Headache17.14.01.001--
Hemiparesis17.01.04.0010.000187%
Hepatomegaly09.01.05.0010.000125%-
Hydrocephalus17.07.01.0010.000125%
Hyperkinesia17.01.02.008---
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ADReCS-Target
Drug Name ADR Term Target
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