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)
Dyspnoea22.02.01.004; 02.01.03.002--
Dystonia17.01.03.0010.000507%Not Available
Ear disorder04.03.01.001--Not Available
Ear infection11.01.05.001; 04.03.01.0060.003549%Not Available
Ear pain04.03.01.003--
Eating disorder14.03.01.008; 19.09.01.0080.001014%Not Available
Eczema23.03.04.0060.001183%
Electroencephalogram abnormal13.07.03.0010.000845%Not Available
Emotional disorder19.04.02.0050.000507%Not Available
Encephalopathy17.13.02.001--
Endocrine disorder05.09.01.001--Not Available
Epilepsy17.12.03.0020.002197%Not Available
Epistaxis24.07.01.005; 22.04.03.0010.002028%
Erythema multiforme23.03.01.003; 10.01.03.015--
Eye disorder06.08.03.0010.002197%Not Available
Eye infection11.01.06.001; 06.04.05.0070.000507%
Eye pain06.08.03.002--
Face oedema23.04.01.004; 10.01.05.002; 08.01.07.003--
Failure to thrive19.07.05.001; 18.04.01.003; 14.03.02.0080.000132%Not Available
Fatigue08.01.01.002--
Febrile convulsion17.12.03.004; 08.05.02.0090.001014%Not Available
Feeling abnormal08.01.09.014--Not Available
Flat affect19.04.01.0040.000338%Not Available
Gait disturbance17.02.05.016; 08.01.02.002--
Gastrooesophageal reflux disease07.02.02.003--
Gastroenteritis11.01.07.004; 07.19.03.0010.000507%Not Available
Gastroenteritis viral11.05.04.005; 07.19.03.0050.001521%Not Available
Gastrointestinal disorder07.11.01.001--Not Available
Gastrointestinal haemorrhage24.07.02.009; 07.12.02.001--Not Available
Gastrointestinal pain07.01.05.005--
The 4th Page    First    Pre   4 5 6 7 8    Next   Last    Total 14 Pages