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)
Multiple organ dysfunction syndrome08.01.03.057--
Atonic seizures17.12.03.0200.000187%Not Available
Head banging19.11.03.0070.000697%Not Available
Hemianopia homonymous17.17.01.024; 06.02.07.0070.000374%Not Available
Infantile spasms19.21.02.011; 17.12.03.0270.003549%Not Available
Psychogenic seizure17.12.03.042; 19.24.01.0070.000187%Not Available
Infantile spitting up18.04.11.006; 07.01.07.0140.003088%Not Available
Excessive eye blinking17.17.02.010; 06.05.01.0040.000635%Not Available
Seizure cluster17.12.03.0290.000374%Not Available
Poor feeding infant18.04.06.006; 14.03.02.0220.000760%Not Available
Change in seizure presentation17.12.03.0220.000249%Not Available
Congenital musculoskeletal disorder of limbs15.11.07.028; 03.11.07.028--Not Available
Cortical visual impairment17.17.01.029; 06.02.10.0090.000125%Not Available
Disease complication08.01.03.0870.000125%Not Available
Early infantile epileptic encephalopathy with burst-suppression17.12.03.032; 19.21.02.0140.000125%Not Available
Epileptic encephalopathy19.21.02.015; 17.12.03.0330.000125%Not Available
Intramyelinic oedema17.16.02.008; 12.03.01.0660.000187%Not Available
Ocular dysmetria17.02.02.021; 06.05.02.0280.000125%Not Available
Quadrantanopia17.17.01.031; 06.02.07.0100.000187%Not Available
Therapeutic response changed08.06.01.0590.000125%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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