Prescription medication · Anticonvulsant (GABA Transaminase Inhibitor)
vigabatrin
Also sold as Sabril. 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.
Data updated 2026-05-15
- 14,085
- FDA reportsModerately reported
- 6
- InteractionsFew interactions
- In shortage
- FDA status
What the data shows
vigabatrin (Sabril) is a prescription Anticonvulsant (GABA Transaminase Inhibitor), reported less often than most tracked drugs (14,085 FDA reports), with 6 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
vigabatrin (Sabril) is a prescription Anticonvulsant (GABA Transaminase Inhibitor). 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.
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.
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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.
The sections below are summarized in plain English from vigabatrin's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
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.
Side Effects (from patient reports)
Based on 14,085 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for vigabatrin, by number of reports
- Seizure
Seizure
2,570 reports
- Drug Dose Omission 990
Drug Dose Omission
990 reports
- Death 855
Death
855 reports
- Somnolence 553
Somnolence
553 reports
- Pneumonia 523
Pneumonia
523 reports
- Drug Withdrawal Convulsions 465
Drug Withdrawal Convulsions
465 reports
- Vomiting 457
Vomiting
457 reports
- Hospitalisation 312
Hospitalisation
312 reports
- Infantile Spasms 297
Infantile Spasms
297 reports
- Epilepsy 296
Epilepsy
296 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for vigabatrin each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where vigabatrin sits
vigabatrin has more FDA adverse-event reports than 47% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is vigabatrin; the line is the median (50th percentile).
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
Reports Mentioning Death
1,350
9.6% of reports — not proof of cause
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 |
| 3 | DRUG DOSE OMISSION | 990 |
| 4 | DEATH | 855 |
| 5 | SOMNOLENCE | 553 |
| 6 | PNEUMONIA | 523 |
| 7 | DRUG WITHDRAWAL CONVULSIONS | 465 |
| 8 | VOMITING | 457 |
| 11 | HOSPITALISATION | 312 |
| 12 | INFANTILE SPASMS | 297 |
| 13 | EPILEPSY | 296 |
| 14 | CONDITION AGGRAVATED | 281 |
| 15 | IRRITABILITY | 273 |
| 16 | CONVULSION | 267 |
| 17 | PYREXIA | 267 |
| 18 | STATUS EPILEPTICUS | 252 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: 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.
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.
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.
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.
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.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
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?
What pregnancy or breastfeeding source fields are listed for vigabatrin?
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 →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for vigabatrin: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 14,085.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 9.58%.
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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 14,085 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 are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
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. This registry does not provide medication decisions.
Last updated: November 18, 2024
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
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