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 For use as an adjunct in treatment resistant epilepsy, refractory complex partial seizures, and secondary generalized seizures. It is also used as monotherapy in infantile spasms in West syndrome.
Marketing Status Prescription
ATC Code N03AG04
DrugBank ID DB01080
KEGG ID D00535
MeSH ID D020888
PubChem ID 5665
TTD Drug ID D0R3QY
NDC Product Code 67877-674; 0245-0556; 59651-366; 59651-364; 0591-3851; 76055-0033; 67651-0294; 0591-3955; 14501-0081; 68621-0046; 16729-521; 70771-1654; 43598-651; 68180-521; 0054-0702; 62331-042; 67386-111; 31722-009; 67386-211; 71886-434; 49884-358; 72158-101; 69238-1425; 69097-964; 43598-697; 65977-0106; 70710-1287; 62207-975
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
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Generalised tonic-clonic seizure17.12.01.0020.001352%Not Available
Glaucoma06.03.01.0020.000338%
Haemangioma congenital24.03.06.005; 16.02.01.004; 03.07.03.002--Not Available
Haematemesis07.12.02.002; 24.07.02.0110.000845%Not Available
Haematochezia24.07.02.012; 07.12.02.003--Not Available
Haemoglobin decreased13.01.05.003--Not Available
Haemoptysis24.07.01.006; 22.02.03.004; 02.01.02.006--Not Available
Hair growth abnormal23.02.06.0060.000338%Not Available
Hallucination19.10.02.002--
Headache17.14.01.001--
Heart rate abnormal13.14.04.0060.000338%Not Available
Heart rate increased13.14.04.002--Not Available
Hemiparesis17.01.04.0010.000507%
Hepatomegaly09.01.05.0010.000338%Not Available
Hip fracture15.08.03.001; 12.04.01.001--
Hydrocephalus17.07.01.0010.000338%
Hyperhidrosis23.02.03.004; 08.01.03.028--
Hyperkinesia17.01.02.008--Not Available
Hyperreflexia17.02.01.002--Not Available
Hypersensitivity10.01.03.003--
Hypersomnia19.02.05.001; 17.15.01.0010.001183%
Hyperthermia malignant08.05.01.002--Not Available
Hypertonia17.05.02.001; 15.05.04.007--Not Available
Hypoaesthesia17.02.06.023--Not Available
Hypomania19.16.02.001--Not Available
Hyporeflexia17.02.01.003--
Hypotension24.06.03.002--
Hypothermia12.05.03.001; 08.05.01.0030.000676%
Hypotonia17.05.02.002; 15.05.04.0080.001183%Not Available
Hypovitaminosis14.12.01.0010.000338%Not Available
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