Vigabatrin: uses, dosing, side effects & brands
Vigabatrin is an anti-epileptic agent sold in the U.S. under 3 brand and generic names, for infantile spasms and complex partial epilepsy. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Anti-Epileptic Agent
- Treats (across its forms)
- Infantile Spasms and Complex Partial Epilepsy
- Available as
- Powder · Tablet · Solution
- Sold as
- 3 products — Sabril, Vigabatrin and Vigafyde
- Prescription?
- Prescription only
- Generic available?
- Yes
- Boxed warning
- Boxed warning
How Sabril is dosed
From the FDA label for Sabril (application NDA020427). Other vigabatrin products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
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) ( 2.2 ) Pediatric (2 to 16 years of age): The recommended dosage is based on body weight and administered as two divided doses ( 2.2 ) The dosage may be increased in weekly intervals, depending on response ( 2.2 ) Dose patients weighing more than 60 kg according to adult recommendations ( 2.2 ) 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) ( 2.3 ) Renal Impairment : Dose adjustment recommended ( 2.4 , 8.5 , 8.6 ) 2.1 Important Dosing and Administration Instructions Dosing Use the lowest dosage and shortest exposure to SABRIL consistent with clinical objectives [see Warnings and Precautions ( 5.1 )]. The SABRIL dosing regimen depends on the indication, age group, weight, and dosage form (tablets or for oral solution) [see Dosage and Administration ( 2.2 , 2.3 )]. Patients with impaired renal function require dose adjustment [see Dosage and Administration ( 2.4 )]. Monitoring of SABRIL plasma concentrations to optimize therapy is not helpful. Administration SABRIL is…
Everything below is the FDA label for Sabril (powder, tablet). Vigabatrin is also sold as solution, and those are different medicines to take — follow the label for the one you were prescribed.
Sabril side effects
The following serious and otherwise important adverse reactions are described elsewhere in labeling: Permanent Vision Loss [see BOXED WARNING and Warnings and Precautions ( 5.1 ) ] Magnetic Resonance Imaging (MRI) Abnormalities in Infants [see Warnings and Precautions ( 5.3 ) ] Neurotoxicity [see Warnings and Precautions ( 5.4 )] Suicidal Behavior and Ideation [see Warnings and Precautions ( 5.5 ) ] Withdrawal of Antiepileptic Drugs (AEDs) [see Warnings and Precautions ( 5.6 ) ] Anemia [see Warnings and Precautions ( 5.7 ) ] Somnolence and Fatigue [see Warnings and Precautions ( 5.8 ) ] Peripheral Neuropathy [see Warnings and Precautions ( 5.9 )] Weight Gain [see Warnings and Precautions ( 5.10 ) ] Edema [see Warnings and Precautions ( 5.11 )] 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 ( 6.1 ) Pediatric patients (3 to 16 years of age): weight gain ( 6.1 ) Infantile Spasms (incidence >5% and greater than on placebo) Somnolence, bronchitis, ear infection, and acute otitis media ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lundbeck at 1-800-455-1141 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions,…
Who shouldn’t take Sabril
None. None ( 4 )
Sabril drug interactions
Decreased phenytoin plasma levels: dosage adjustment may be needed ( 7.1 ) 7.1 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 [see Clinical Pharmacology ( 12.3 )]. Clonazepam SABRIL may moderately increase the C max of clonazepam resulting in an increase of clonazepam-associated adverse reactions [see Clinical Pharmacology ( 12.3 )]. 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 [see Clinical Pharmacology ( 12.3 )]. 7.2 Oral Contraceptives SABRIL is unlikely to affect the efficacy of steroid oral contraceptives [see Clinical Pharmacology ( 12.3 ) ] . 7.3 Drug-Laboratory Test Interactions SABRIL decreases alanine transaminase (ALT) and aspartate transaminase (AST) plasma activity in up to 90% of patients. In some patients, these enzymes become undetectable. The suppression of ALT and AST activity by SABRIL may preclude the use of these markers, especially ALT, to detect early hepatic injury. SABRIL may increase the amount of amino acids in the urine, possibly leading to a false positive test for certain rare genetic metabolic diseases (e.g., alpha aminoadipic aciduria).
Every vigabatrin product we track (3)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Pharmacy pays | |
|---|---|---|---|---|---|---|---|
| 1 | Not yet rated | Prescription | Solution | No data | — | View → | |
| 2 | Not yet rated | Prescription | Solution | No data | — | View → | |
| 3 | Not yet rated | Prescription | Solution | No data | — | View → |
What vigabatrin pills look like
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| N126 | 500 mg | white | oval | — |
How long vigabatrin keeps
The date on a sealed pack is not the only one: some vigabatrin labels start a second clock once the product is opened or mixed, as short as 90 days.
Does vigabatrin expire? The in-use limits and storage rules from its labelsVigabatrin and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for vigabatrin: levels in milk, effects in breastfed infants, and the drugs it would consider insteadLimited information indicates that maternal doses of vigabatrin up to 2000 mg daily produce low levels in milk. Vigabatrin is approved for use in infants in one month and older and amounts in milk are far less than the approved infant dosage. Vigabatrin would not be expected to cause any adverse effects in breastfed infants.
National Institute of Child Health and Human Development, record revised February 20, 2022. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about vigabatrin
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 5,010 reports naming vigabatrin, and the FDA flagged 81% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- seizure936 reports
- hospitalisation313 reports
- adverse event246 reports
- epilepsy203 reports
- magnetic resonance imaging head abnormal184 reports
- multiple-drug resistance176 reports
- somnolence168 reports
- status epilepticus164 reports
Read these as a signal, not a rate. A report does not mean vigabatrin caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved August 26, 2026.
Related calculators
Frequently asked questions
What is Sabril?
SABRIL (vigabatrin) is an oral antiepileptic drug and is available as white film-coated 500 mg tablets and as a white to off-white granular powder for oral solution in packets of 500 mg.
What kind of drug is vigabatrin?
The FDA classifies vigabatrin as an anti-epileptic agent. Anti-epileptic (anticonvulsant) drugs calm the abnormal, excessive electrical activity that triggers seizures. They do this by stabilizing overactive sodium or calcium channels in nerve cells, boosting the brain's natural calming chemical GABA, or dampening excitatory signals, which makes nerves less likely to fire uncontrollably. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take vigabatrin with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run vigabatrin against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is vigabatrin sold under?
We track 3 vigabatrin-containing products in the U.S.: Sabril, Vigabatrin and Vigafyde. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does vigabatrin come in?
Across the brands we track, vigabatrin is currently marketed as powder, tablet and solution, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic vigabatrin?
Yes. Our catalog lists 1 generic vigabatrin product alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.
Cite this page
- APA
- pharmaranks. (2026, July 24). Vigabatrin: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/vigabatrin
- MLA
- “Vigabatrin: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/vigabatrin.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for vigabatrin on DailyMed (NIH) ↗ — including its boxed warning in full.