Prescription medicine
Vigabatrin Brand names: Sabril, Vigafyde, Vigadrone
Vigabatrin (Sabril) is a prescription medicine with an FDA approval on record since 2009. FDA's NDC Directory lists it from 15 generic labelers.
- Generic listed
- A presentation discontinued
- Boxed warning
Check it at the source: the vigabatrin FDA label on DailyMed (effective October 20, 2021, Lundbeck Pharmaceuticals LLC); the NDA 20427 record on Drugs@FDA; every vigabatrin label on DailyMed.
Highlights of the record
FDA label of October 20, 2021; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
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 [see Warnings and Precautions ( 5.1 )]. 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. Symptoms of vision loss from SABRIL are unlikely to be recognized by patients or caregivers before vision loss is severe. Vision loss of milder severity, while often unrecognized by the patient or caregiver, can still adversely affect function. The risk of vision loss increases with increasing dose and cumulative exposure, but there is no dose or exposure known to be free of risk of vision loss. Vision assessment is recommended at baseline (no later than 4 weeks after starting SABRIL), at least every 3 months during therapy, and about 3 to 6 months after the discontinuation of therapy. Once detected, vision loss due to SABRIL is not reversible. It is expected that, even with frequent monitoring, some patients will develop severe vision loss. Consider drug discontinuation, balancing benefit and risk, if visual loss is documented. Risk of new or worsening vision loss continues as long as SABRIL is used. […]
Used for
From the label: indications and usageSABRIL 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;
Forms and strengths
- 500 mg
- 50 mg/ml
- 100 mg/ml
- 500 mg/10ml
- 500 mg/ml
Powder for solution; film-coated tablet; tablet; for solution; solution.
On the market
- Earliest approval on file
- August 21, 2009 Sabril, Lundbeck Pharms Llc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 27 first April 27, 2017; 18 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 16 of which 15 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- June 8, 2043 Vigafyde oral solution; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- None current 1 past records
- Recalls by its makers (FDA)
- 3 since 2023 1 Class I among all firms' recalls; latest November 17, 2023
- FAERS reports
- 14,491 through July 30, 2026
What is vigabatrin used for?
From the label: indications and usageSABRIL 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; […]
FDA pharmacologic class: Anti-epileptic Agent.
Source: FDA drug label (SABRIL), Lundbeck Pharmaceuticals LLC, effective October 20, 2021 (SPL set a88ac1b4-e2c9-45c0-b321-4785902172e3), via openFDA; the full label on DailyMed
Is there a generic for vigabatrin (Sabril)?
The FDA approved the first generic vigabatrin on April 27, 2017. 27 generic applications are approved; 18 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists vigabatrin from 15 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Sabril tablets; a patent listed only for Vigafyde oral solution runs to June 8, 2043. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2009 earliest approval on file
- 2017 first generic approved
- 2043 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Is vigabatrin in shortage?
No vigabatrin presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 1 record is all marked to be discontinued, the latest updated October 16, 2025. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Vigpoder, Oral Solution, 50 mg/1 mL (NDC 80789-117-50) | Pyros Pharmaceuticals, Inc. | To Be Discontinued | October 16, 2025 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has vigabatrin been recalled?
The FDA's Enforcement Report lists 3 recalls naming vigabatrin since 2023: 1 Class I (the most serious), 1 Class II, 1 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| November 17, 2023 | Class I | InvaGen Pharmaceuticals, Inc. | Defective Container: powder may leak out of the pouch |
| August 17, 2023 | Class III | Lundbeck LLC | Cross contamination with other products |
| February 7, 2023 | Class II | Accord Healthcare, Inc. | CGMP Deviations: recalling drug products following an FDA inspection. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the vigabatrin label say about other medicines?
The vigabatrin label names 6 other medicines in its interaction, contraindication or warning sections. The labels of 2 other medicines name vigabatrin. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Carbamazepine | drug interactions | 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 )]. |
| Clonazepam | drug interactions | Clonazepam SABRIL may moderately increase the C max of clonazepam resulting in an increase of clonazepam-associated adverse reactions [see Clinical Pharmacology ( 12.3 )]. |
| Clorazepate | drug interactions | 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 )]. |
| Phenobarbital | drug interactions | Other AEDs There are no clinically significant pharmacokinetic interactions between SABRIL and either phenobarbital or sodium valproate. |
| Phenytoin | drug interactions | DRUG INTERACTIONS Decreased phenytoin plasma levels: dosage adjustment may be needed |
| Primidone | drug interactions | 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 )]. |
Source: FDA drug label (SABRIL), Lundbeck Pharmaceuticals LLC, effective October 20, 2021 (SPL set a88ac1b4-e2c9-45c0-b321-4785902172e3), via openFDA; the full label on DailyMed
What do FAERS reports show for vigabatrin?
The FDA Adverse Event Reporting System holds 14,491 reports that list vigabatrin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,381 are coded as a death and 4,609 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other anti-seizure medicines
- the pharmacologic class, with prices and generics
- Vigabatrin side effects
- the label's list beside FAERS reports
- Vigabatrin shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other