vigabatrin
Brand names: Sabril
Vigabatrin (Sabril) is a medicine used to treat certain types of seizures in adults and children. It is also used to treat infantile spasms in babies.
Drug Shortage Alert
vigabatrin is currently listed as to be discontinued by the FDA. Affected manufacturer: Pyros Pharmaceuticals, Inc..
View all drug shortages →What it does
Vigabatrin is used as an add-on treatment for complex partial seizures in adults and children 2 years and older when other treatments haven't worked well enough.
Common side effects
Blurred vision, Sleepiness, Dizziness
Key warnings
Vigabatrin can cause permanent vision loss.
How It Works
Vigabatrin is an anticonvulsant that works by increasing the amount of a chemical called GABA in the brain. GABA helps to reduce the activity of nerve cells, which can help to control seizures. By increasing GABA levels, vigabatrin can help to reduce the frequency and severity of seizures.
How to Take It
Take vigabatrin tablets by mouth, with or without food. For adults with complex partial seizures, the starting dose is usually 1,000 mg per day, divided into two doses. Your doctor may increase the dose each week by 500 mg until you reach the recommended dose of 3,000 mg per day. For infantile spasms, the starting dose is 50 mg/kg per day, divided into two doses, and may be increased every 3 days up to 150 mg/kg per day.
Pregnancy & Breastfeeding
Vigabatrin may cause harm to an unborn baby. If you are pregnant or plan to become pregnant, talk to your doctor. There is a pregnancy registry for women who take anti-epileptic drugs like vigabatrin during pregnancy. Vigabatrin passes into breast milk, so talk to your doctor about whether to breastfeed.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is close to your next dose, skip the missed dose and continue with your regular schedule.
Storage
Store vigabatrin tablets at room temperature, between 68° to 77°F (20° to 25°C).
Side Effects (from patient reports)
Based on 8,552 FDA adverse event reports.
FDA Adverse Event Report Analysis
Detailed analysis of 14,085 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.
Total Reports
14,085
Death-Related Reports
1,350
Hospitalization Reports
4,439
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | SEIZURE | 2,570 |
| 2 | DRUG INEFFECTIVE | 1,374 |
| 3 | DRUG DOSE OMISSION | 990 |
| 4 | DEATH | 855 |
| 5 | SOMNOLENCE | 553 |
| 6 | PNEUMONIA | 523 |
| 7 | DRUG WITHDRAWAL CONVULSIONS | 465 |
| 8 | VOMITING | 457 |
| 9 | OFF LABEL USE | 431 |
| 10 | PRODUCT DOSE OMISSION ISSUE | 334 |
| 11 | HOSPITALISATION | 312 |
| 12 | INFANTILE SPASMS | 297 |
| 13 | EPILEPSY | 296 |
| 14 | CONDITION AGGRAVATED | 281 |
| 15 | IRRITABILITY | 273 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Vigabatrin can cause permanent vision loss. This includes tunnel vision, which can be disabling. The risk of vision loss increases with higher doses and longer use. Vision loss may not be noticed until it is severe. Regular vision checks are needed while taking this medicine. Because of the risk of permanent vision loss, vigabatrin is only available through a special program called the Vigabatrin REMS Program.
Known Drug Interactions
Clonazepam VIGADRONE may moderately increase the C max of clonazepam resulting in an increase of clonazepam-associated adverse reactions [see Clinical Pharmacology (12.3) ].
Mechanism: Vigabatrin can raise the peak levels of clonazepam in your blood, which might lead to more side effects.
What to do: Tell your doctor if you notice more side effects while taking both drugs, as your dose may need to be adjusted.
Other AEDs There are no clinically significant pharmacokinetic interactions between vigabatrin 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 [see Clinical Pharmacology (12.3) ].
Mechanism: There is no major change in how these two drugs work together or affect each other's levels.
What to do: You can usually take these medicines together without needing to change your dosage.
Based on population pharmacokinetics, carbamazepine, clorazepate, primidone, and sodium valproate appear to have no effect on plasma concentrations of vigabatrin [see Clinical Pharmacology (12.3) ].
Mechanism: Carbamazepine does not change the amount of vigabatrin that is present in your blood.
What to do: No dose changes for vigabatrin are typically needed when it is used with carbamazepine.
Other AEDs There are no clinically significant pharmacokinetic interactions between vigabatrin and either phenobarbital or sodium valproate.
Mechanism: These two drugs do not have a significant effect on how the body processes either medication.
What to do: You can take these drugs together without special changes to your treatment plan.
Based on population pharmacokinetics, carbamazepine, clorazepate, primidone, and sodium valproate appear to have no effect on plasma concentrations of vigabatrin [see Clinical Pharmacology (12.3) ].
Mechanism: Primidone does not change how much vigabatrin stays in your blood. These two drugs do not seem to interfere with each other's levels.
What to do: No dosage changes are usually needed when taking these drugs together. Your doctor will continue to monitor your condition as usual.
Common Questions
What should I do if I experience vision problems while taking vigabatrin?
Can I drive while taking vigabatrin?
How often will I need to have my vision checked?
What if I want to stop taking vigabatrin?
Does vigabatrin interact with other medications?
Can vigabatrin affect my liver?
What is the REMS program?
How long does it take for vigabatrin to start working?
Can vigabatrin cause weight gain?
What should I do if I have suicidal thoughts while taking vigabatrin?
What are the common side effects of vigabatrin?
Does vigabatrin interact with other medications?
What drug class is vigabatrin?
Is vigabatrin safe during pregnancy?
Is vigabatrin currently in shortage?
Related Medications in Anticonvulsant (GABA Transaminase Inhibitor)
Other drugs grouped near vigabatrin — same-class peers and common alternatives.
brivaracetam
Briviact
Brivaracetam is a medicine used to treat partial-onset seizures.
Compare with vigabatrin →
cannabidiol
Epidiolex
Epidiolex is a medicine that contains cannabidiol.
Compare with vigabatrin →
carbamazepine
Tegretol
Carbamazepine is a medicine used to control seizures and treat nerve pain.
Compare with vigabatrin →
cenobamate
Xcopri
Xcopri is a medicine used to treat partial-onset seizures in adults.
Compare with vigabatrin →
clobazam
Onfi, Sympazan
Clobazam oral suspension is a medicine used with other medicines to treat seizures caused by Lennox-Gastaut syndrome.
Compare with vigabatrin →
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What the FDA Data Shows for vigabatrin
The FDA label for vigabatrin (sold under brand names such as Sabril) classifies it as a prescription-only medication in the Anticonvulsant (GABA Transaminase Inhibitor) class. Vigabatrin is used as an add-on treatment for complex partial seizures in adults and children 2 years and older when other treatments haven't worked well enough. Official labeling lists 9 commonly reported side effects, including Blurred vision, Sleepiness, Dizziness.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 8,552 voluntary reports. The database also lists 6 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated minor severity. Acquisition-cost data is surveyed weekly by CMS and updated as manufacturers report changes.
Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Shortage status: FDA Drug Shortages Database.
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: November 18, 2024
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- FDA Orange Book — approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed — NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) — post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm — standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files — federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database — current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages