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)
Back pain15.03.04.005--
Blepharospasm17.17.02.001; 06.05.01.0010.000338%Not Available
Blindness17.17.01.003; 06.02.02.0010.002366%Not Available
Blindness cortical17.17.01.017; 06.02.02.0040.000507%Not Available
Body temperature increased13.15.01.001--Not Available
Bradycardia02.03.02.002--Not Available
Breast mass21.05.04.0020.000338%Not Available
Bronchiolitis11.05.04.008; 22.03.02.0040.000845%Not Available
Bronchitis22.07.01.001; 11.01.09.0010.001352%
Bruxism19.11.03.001; 07.01.06.0080.000338%Not Available
Cardiac arrest02.03.04.001--
Cardio-respiratory arrest22.02.06.007; 02.03.04.0020.000309%Not Available
Cataract06.06.01.001--
Cerebral atrophy17.11.01.0010.000338%Not Available
Cerebrovascular accident24.03.05.001; 17.08.01.007--
Chest pain08.01.08.002; 02.02.02.011; 22.02.08.003--Not Available
Chills08.01.09.001; 15.05.03.016--
Cholestasis09.01.01.001--Not Available
Chorea17.01.01.0010.000507%Not Available
Coagulopathy01.01.02.0010.000338%Not Available
Confusional state19.13.01.001; 17.02.03.005--
Congenital anomaly03.02.01.001--Not Available
Congenital vesicoureteric reflux20.03.05.001; 03.06.03.001--Not Available
Conjunctivitis06.04.01.002; 11.01.06.0120.001352%
Constipation07.02.02.0010.004395%
Coordination abnormal17.02.02.0040.000338%Not Available
Cough22.02.03.001--
Croup infectious22.07.03.023; 11.01.13.0200.000088%Not Available
Crying19.04.02.002; 17.02.05.013; 12.02.11.001; 08.01.03.0050.003380%Not Available
Cyanosis24.03.01.007; 22.02.02.007; 02.01.02.0020.000845%
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