Vigabatrin is an anti-epileptic agent indicated for the treatment of refractory Complex Partial Seizures as adjunctive therapy in patients 2 years of age and older who have responded inadequately to several alternative treatments, among other approved uses. MedsAcross supplies Vigabatrin for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
SABRIL is indicated for the treatment of: Refractory Complex Partial Seizures as adjunctive therapy in patients 2 years of age and older who have responded inadequately to several alternative treatments, SABRIL is not indicated as a first line agent. Infantile Spasms - monotherapy in infants 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss
Source: US FDA prescribing information
The precise mechanism of vigabatrin’s anti-seizure effect is unknown, but it is believed to be the result of its action as an irreversible inhibitor of γ-aminobutyric acid transaminase (GABA-T), the enzyme responsible for the metabolism of the inhibitory neurotransmitter GABA. This action results in increased levels of GABA in the central nervous system. No direct correlation between plasma concentration and efficacy has been established. The duration of drug effect is presumed to be dependent on the rate of enzyme re-synthesis rather than on the rate of elimination of the drug from the systemic circulation.
Source: US FDA prescribing information
Refractory Complex Partial Seizures Adults (17 years of age and older): Initiate at 1000 mg/day (500 mg twice daily), increase total daily dose weekly in 500 mg/day increments, to the recommended dose of 3000 mg/day (1500 mg twice daily). Pediatric (2 to 16 years of age): The recommended dosage is based on body weight and administered as two divided doses. The dosage may be increased in weekly intervals, depending on response. Dose patients weighing more than 60 kg according to adult recommendations. Infantile Spasms Initiate at a daily dose of 50 mg/kg (25 mg/kg twice daily), increase total daily dose every 3 days, in increments of 25 mg/kg/day to 50 mg/kg/day, up to a maximum daily dose of 150 mg/kg (75 mg/kg twice daily). Renal Impairment: Dose adjustment recommended
Source: US FDA prescribing information
None. None
Source: US FDA prescribing information
Boxed warning (permanent vision loss sabril): can cause permanent bilateral concentric visual field constriction including tunnel vision that can result in disability. In some cases, SABRIL also can damage the central retina and may decrease visual acuity. The onset of vision loss from SABRIL is unpredictable, and can occur within weeks of starting treatment or sooner, or at any time after starting treatment, even after months or years. Abnormal MRI signal changes and intramyelinic edema have been reported in some infants with Infantile Spasms receiving SABRIL. Suicidal behavior and ideation: Antiepileptic drugs, including SABRIL, increase the risk of suicidal thoughts and behavior. Withdrawal of AEDs: Taper dose to avoid withdrawal seizures. Anemia: Monitor for symptoms of anemia.
Source: US FDA prescribing information
The following serious and otherwise important adverse reactions are described elsewhere in labeling: Permanent Vision Loss Magnetic Resonance Imaging (MRI) Abnormalities in Infants Neurotoxicity Suicidal Behavior and Ideation Withdrawal of Antiepileptic Drugs (AEDs) Anemia Somnolence and Fatigue Peripheral Neuropathy Weight Gain Edema Refractory Complex Partial Seizures Most common adverse reactions in controlled studies include (incidence ≥5% over placebo): Adults: blurred vision, somnolence, dizziness, abnormal coordination, tremor, and fatigue. Pediatric patients (3 to 16 years of age): weight gain. Infantile Spasms (incidence >5% and greater than on placebo) Somnolence, bronchitis, ear infection, and acute otitis media
Source: US FDA prescribing information
Decreased phenytoin plasma levels: dosage adjustment may be needed Antiepileptic Drugs Phenytoin Although phenytoin dose adjustments are not routinely required, dose adjustment of phenytoin should be considered if clinically indicated, since SABRIL may cause a moderate reduction in total phenytoin plasma levels. Clonazepam SABRIL may moderately increase the C max of clonazepam resulting in an increase of clonazepam-associated adverse reactions. Other AEDs There are no clinically significant pharmacokinetic interactions between SABRIL and either phenobarbital or sodium valproate. Based on population pharmacokinetics, carbamazepine, clorazepate, primidone, and sodium valproate appear to have no effect on plasma concentrations of vigabatrin.
Source: US FDA prescribing information
Store at 20°C to 25°C (68°F to 77°F). See USP controlled room temperature.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
9 presentations of Vigabatrin, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Vigabatrin 500 mg tabletOralGeneric name | — | US FDA | Available on request |
| Vigabatrin 50 mg/mL powder for oral solutionOralGeneric name | — | US FDA | Available on request |
| Vigabatrin 500 mg powder for oral solutionOralGeneric name | — | US FDA | Available on request |
| Sabril 50 mg/mL powder for oral solutionOral | Lundbeck Pharmaceuticals | US FDA | Available on request |
| Sabril 500 mg tabletOral | Lundbeck Pharmaceuticals | US FDA | Available on request |
| Vigabatrin 500 mg/mL powder for oral solutionOralGeneric name | — | US FDA | Available on request |
| Vigadrone 50 mg/mL powder for oral solutionOral | Upsher-Smith Laboratories | US FDA | Available on request |
| Vigadrone 500 mg tabletOral | Upsher-Smith Laboratories | US FDA | Available on request |
| Vigafyde 100 mg/mL oral solutionOral | Upsher-Smith Laboratories | US FDA | Available on request |
3 brand names across 1 markets.
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Conditions linked to Vigabatrin in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 9 presentations of Vigabatrin and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 3 brand names for Vigabatrin, including Sabril, Vigadrone, Vigafyde.
Yes. The US FDA first approved Vigabatrin on 21 August 2009, according to Drugs@FDA.
Yes. Vigabatrin has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Vigabatrin is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Vigabatrin is classified under ATC code N03AG04 (Vigabatrin).
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