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)
Congenital hydronephrosis03.06.02.001; 20.01.05.002--Not Available
Viral diarrhoea11.05.04.012; 07.19.02.008--Not Available
Respiratory tract congestion22.02.07.0030.000486%Not Available
Lymphatic disorder01.09.01.003--Not Available
Detachment of retinal pigment epithelium06.09.03.0110.000125%Not Available
Musculoskeletal discomfort15.03.04.001--Not Available
Affect lability19.04.01.001--Not Available
Myoclonic epilepsy17.12.03.0070.000187%Not Available
Cerebral disorder17.02.10.0170.000436%Not Available
Muscle relaxant therapy25.16.01.001--Not Available
Congenital genital malformation male21.15.01.002; 03.03.01.002--Not Available
Neurological symptom17.02.05.0100.000125%Not Available
Adverse event08.06.01.0100.005056%Not Available
Brain neoplasm17.20.01.003; 16.30.01.0030.000249%Not Available
Breast disorder21.05.04.004--Not Available
Congenital oral malformation07.11.04.002; 03.04.03.001--Not Available
Connective tissue disorder10.04.04.026; 15.06.01.006--Not Available
Eye movement disorder17.02.05.025; 06.05.02.0080.001831%Not Available
Ocular toxicity12.03.01.031; 06.11.01.0060.000623%Not Available
Feeding disorder19.09.01.003; 14.03.02.0030.000461%Not Available
Hamartoma16.02.02.008; 03.02.01.006--Not Available
Infestation23.11.01.002; 11.09.01.001--Not Available
Malnutrition14.03.02.004--Not Available
Mental disorder19.07.01.002--Not Available
Optic nerve disorder17.04.05.004; 06.02.08.0010.000311%
Partial seizures17.12.03.0100.000498%Not Available
Abnormal behaviour19.01.01.0010.007023%Not Available
Decreased appetite14.03.01.005; 08.01.09.028--
Erectile dysfunction21.03.01.007; 19.08.04.001--
Ill-defined disorder08.01.03.049--Not Available
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ADReCS-Target
Drug Name ADR Term Target
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