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)
Mental disability26.01.01.001--Not Available
Mental impairment19.21.02.003; 17.03.03.002--Not Available
Middle insomnia19.02.01.003; 17.15.03.0030.000847%Not Available
Mood altered19.04.02.0070.002242%Not Available
Mood swings19.04.03.0010.001756%Not Available
Movement disorder17.01.02.0100.000984%Not Available
Muscle rigidity15.05.04.001; 17.05.02.0050.000398%Not Available
Muscle spasms15.05.03.004--
Muscle spasticity17.05.03.007; 15.05.04.0110.000187%
Muscle twitching15.05.03.0050.001756%Not Available
Myalgia15.05.02.001--
Myoclonus17.02.05.0080.000336%Not Available
Nasal congestion22.04.04.0010.000735%
Nasopharyngitis22.07.03.002; 11.01.13.002--Not Available
Nausea07.01.07.001--
Nephrolithiasis20.04.01.0020.000311%
Nervous system disorder17.02.10.0010.000249%Not Available
Nervousness19.06.02.003--Not Available
Neuropathy peripheral17.09.03.003--Not Available
Neurotoxicity17.02.10.002; 12.03.01.011--Not Available
Nystagmus17.02.02.006; 06.05.02.0060.001694%
Oedema14.05.06.010; 08.01.07.006--Not Available
Oedema peripheral08.01.07.007; 02.05.04.007; 14.05.06.011--
Oesophagitis07.08.05.001--
Optic atrophy06.09.02.0010.002304%Not Available
Optic neuritis10.02.01.097; 17.04.05.001; 06.04.08.002--Not Available
Osteoarthritis15.01.04.001--Not Available
Otitis media11.01.05.004; 04.05.01.001--
Otitis media acute11.01.05.005; 04.05.01.002--Not Available
Pain08.01.08.004--
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ADReCS-Target
Drug Name ADR Term Target
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