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)
Respiratory symptom22.02.08.0160.000338%Not Available
Multiple organ dysfunction syndrome08.01.03.057--
Atonic seizures17.12.03.0200.000507%Not Available
Head banging19.11.03.0070.000507%Not Available
Hemianopia homonymous17.17.01.024; 06.02.07.0070.001014%Not Available
Infantile spasms17.12.03.027; 19.21.02.0110.007944%Not Available
Nuclear magnetic resonance imaging abnormal13.18.03.0030.000338%Not Available
Nuclear magnetic resonance imaging brain abnormal13.07.07.0010.001690%Not Available
Respiratory syncytial virus bronchiolitis22.07.05.009; 11.05.13.0030.000338%Not Available
Lissencephaly17.19.03.007; 03.10.03.0080.000088%Not Available
Clostridium difficile infection11.02.02.0090.000845%Not Available
Shunt infection12.02.05.050; 11.01.15.0050.000338%Not Available
Psychogenic seizure19.24.01.0070.000507%Not Available
Rhinovirus infection11.05.26.0010.001183%Not Available
Brain scan abnormal13.07.07.0020.000338%Not Available
Infantile spitting up18.04.11.006; 07.01.07.0140.002704%Not Available
Excessive eye blinking17.17.02.010; 06.05.01.0040.000507%Not Available
Gastrointestinal viral infection07.19.02.011; 11.05.04.0160.000338%Not Available
Seizure cluster17.12.03.0290.001014%Not Available
Poor feeding infant18.04.06.006; 14.03.02.0220.000676%Not Available
Change in seizure presentation17.12.03.0220.000676%Not Available
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