Vigabatrin
Vigabatrin is a prescription anti-seizure medicine used for infantile spasms and for refractory complex partial seizures when other treatments haven't worked well enough.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 27 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Vigabatrin is a specialist anti-seizure medicine that raises GABA, the brain’s calming messenger, by blocking the enzyme that breaks it down; available since about 2007 and now as a generic, it is a first-choice option for infantile spasms and a later add-on for complex partial (focal) seizures that other medicines have not controlled. Day to day it is reasonably well tolerated, with sleepiness, tiredness and dizziness the effects people notice most. The real concern is its boxed warning for permanent vision loss, mostly narrowed side vision that goes unnoticed until severe, so it comes only through a restricted safety program (REMS) requiring regular vision checks during and after treatment.
Clinical pearls
- Never stop it abruptly, since a sudden halt can trigger withdrawal seizures; the dose is tapered down instead.
- If spasms are not clearly better in 2 to 4 weeks, or focal seizures in 3 months, it should be stopped.
- It lowers the liver blood tests ALT and AST, so normal results can hide early liver injury.
- If you also take phenytoin, expect a level check, since vigabatrin can lower it; clonazepam side effects may also increase.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Vigabatrin can cause permanent vision loss. It typically narrows side (peripheral) vision, sometimes to tunnel vision, and can also damage the central retina and reduce sharpness of vision.
It can start within weeks or after months or years of use. People usually don't notice it until it is severe. Risk rises with higher doses and longer use, and no dose is known to be safe. Once vision loss occurs it cannot be reversed, and it may worsen even after stopping.
Vision should be checked within 4 weeks of starting, at least every 3 months during treatment, and about 3 to 6 months after stopping. Testing can't always prevent damage. Because of this risk, vigabatrin is available only through the Vigabatrin REMS restricted program. The lowest dose for the shortest time should be used.
Patient information guide A plain-language walkthrough of Vigabatrin, written from its FDA label.
What Vigabatrin is used for
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Vigabatrin is used for two kinds of seizures.
- Refractory complex partial seizures: add-on treatment for people 2 years and older who haven't responded well to several other treatments. Not a first-line drug. Labeled for Sabril, Vigadrone, and vigabatrin tablets and oral solution.
- Infantile spasms: used alone in infants 1 month to 2 years old when the benefits outweigh the risk of vision loss. Labeled for all products, including Vigafyde, which is labeled only for this use.
How Vigabatrin works
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Vigabatrin permanently blocks an enzyme called GABA transaminase, which breaks down GABA, a calming chemical in the brain. That raises GABA levels in the central nervous system.
The exact way this stops seizures isn't known. How long the effect lasts depends on how fast the body makes new enzyme, not on how fast the drug leaves the body.
Vigabatrin dosage
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Vigabatrin is taken by mouth as a tablet or a liquid, usually split into two doses a day. Doses depend on the condition, age and weight, and are adjusted over time. Kidney problems require lower doses.
- Food slightly slows absorption but doesn't change how much is absorbed.
- Vigafyde is a concentrated liquid and can be given by mouth or G tube.
- Don't stop suddenly. It should be tapered to avoid withdrawal seizures.
- Follow your prescriber's and the label's directions.
Dosing details from the FDA-approved label
From the Vigabatrin prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Refractory Complex Partial Seizures - Adults (17 years of age and older)
- Initiate at 1000 mg/day (500 mg twice daily)
- Total daily dose may be increased in 500 mg increments at weekly intervals, depending on response, to the recommended dose of 3000 mg/day (1500 mg twice daily)
- Maximum: A 6000 mg/day dose has not been shown to confer additional benefit compared to the 3000 mg/day dose and is associated with an increased incidence of adverse events
- Withdraw if substantial clinical benefit is not observed within 3 months of initiating treatment; dose adjustment needed in renal impairment
- Refractory Complex Partial Seizures - Pediatric (2 to 16 years of age)
- Based on body weight, given as two divided doses
- May be increased in weekly intervals to the total daily maintenance dosage, depending on response
- Starting/maintenance total daily dose: 10 kg to 15 kg 350 mg/1,050 mg
- Greater than 15 kg to 20 kg 450 mg/1,300 mg
- Greater than 20 kg to 25 kg 500 mg/1,500 mg
- Greater than 25 kg to 60 kg 500 mg/2,000 mg
- Patients weighing more than 60 kg should be dosed according to adult recommendations; maintenance dose is based on 3000 mg/day adult-equivalent dose
- Infantile Spasms
- Initial daily dose 50 mg/kg/day given in two divided doses (25 mg/kg twice daily)
- May be titrated by 25 mg/kg/day to 50 mg/kg/day increments every 3 days
- Maximum: 150 mg/kg/day given in 2 divided doses (75 mg/kg twice daily)
- Withdraw if substantial clinical benefit is not observed within 2 to 4 weeks; renal impairment dose information in infants is unavailable
- Renal impairment - adult and pediatric patients 2 years and older
- Mild (CLcr >50 to 80 mL/min): decrease dose by 25%
- Moderate (CLcr >30 to 50 mL/min): decrease dose by 50%
- Severe (CLcr >10 to 30 mL/min): decrease dose by 75%
- Eliminated primarily through the kidney
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION 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 administer 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 vigabatrin for oral solution consistent with clinical objectives [see Warnings and Precautions ( 5.1 )]. The vigabatrin for oral solution dosing regimen depends on the indication, age group, weight, and dosage form (tablets or powder 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 vigabatrin for oral solution plasma concentrations to optimize therapy is not helpful. Administration Vigabatrin for oral solution is given orally with or without food. Vigabatrin powder for oral solution should be mixed with water prior to administration [ see Dosage and Administration (2.5) ]. A calibrated measuring device is recommended to measure and deliver the prescribed dose accurately. A household teaspoon or tablespoon is not an adequate measuring device. If a decision is made to discontinue vigabatrin for oral solution, the dose should be gradually reduced [see Dosage and Administration (2.2 , 2.3) and Warnings and Precautions (5.6) ]. 2.2 Refractory Complex Partial Seizures Adults (Patients 17 Years of Age and Older) Treatment should be initiated at 1000 mg/day (500 mg twice daily). Total daily dose may be increased in 500 mg increments at weekly intervals, depending on response. The recommended dose of vigabatrin for oral solution in adults is 3000 mg/day (1500 mg twice daily).
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Vigabatrin side effects
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Common side effects include:
Common side effects
- Sleepiness and fatigue
- Dizziness
- Blurred or double vision
- Tremor and poor coordination
- Headache
- Weight gain
- Nausea or diarrhea
- Colds and ear infections (more common in infants)
When to get medical help
- Call your doctor right away about any change in vision, or if you or your child seems to be having vision problems. Vision loss can be hard to notice.
- Get help for new or worse depression, suicidal thoughts, or unusual mood or behavior changes.
- Tell the doctor if seizures get worse or if there is no clear benefit. The drug may need to be stopped.
- Report signs of anemia, such as unusual tiredness or weakness.
- Report new movement problems, unusual muscle tone, or behavior changes in an infant, which could relate to MRI changes.
- Seek urgent help for a severe skin rash or swelling of the face or throat.
Vigabatrin warnings and precautions
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- Permanent vision loss is the biggest risk. Regular eye testing is needed, but it can't always prevent damage.
- Abnormal MRI changes and brain swelling (intramyelinic edema) have been seen in some infants.
- Seizure medicines raise the risk of suicidal thoughts and behavior.
- Stopping suddenly can cause withdrawal seizures.
- Anemia, sleepiness, fatigue, nerve problems, weight gain and swelling can occur.
- Available only through the Vigabatrin REMS Program.
Vigabatrin interactions
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Vigabatrin can affect other medicines and lab tests.
- Phenytoin: levels may drop, so dose changes may be needed.
- Clonazepam: peak levels may rise, increasing its side effects.
- Drugs that harm the eyes (retinopathy or glaucoma): avoid unless benefits clearly outweigh risks.
- Liver blood tests (ALT/AST): vigabatrin lowers them, which can hide early liver injury.
- Urine amino acid tests: may give false positives for some rare diseases.
Interactions listed in the FDA-approved label
From the Vigabatrin prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Phenytoin: Vigabatrin may cause a moderate reduction in total phenytoin plasma levels. Phenytoin dose adjustments are not routinely required, but dose adjustment should be considered if clinically indicated.
- Clonazepam: Vigabatrin may moderately increase the Cmax of clonazepam, resulting in an increase of clonazepam-associated adverse reactions.
- Phenobarbital and sodium valproate: There are no clinically significant pharmacokinetic interactions between vigabatrin and either phenobarbital or sodium valproate.
- Carbamazepine, clorazepate, primidone, and sodium valproate: Based on population pharmacokinetics, these appear to have no effect on plasma concentrations of vigabatrin.
- Steroid oral contraceptives: Vigabatrin is unlikely to affect the efficacy of steroid oral contraceptives.
- Laboratory tests (ALT and AST): Vigabatrin decreases ALT and AST plasma activity in up to 90% of patients, and in some patients these enzymes become undetectable. Suppression may preclude the use of these markers, especially ALT, to detect early hepatic injury.
- Laboratory tests (urine amino acids): Vigabatrin 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).
Read the label’s full interactions text
7 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 vigabatrin may cause a moderate reduction in total phenytoin plasma levels [ see Clinical Pharmacology ( 12.3 ) ]. Clonazepam Vigabatrin 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 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 ) ]. 7.2 Oral Contraceptives Vigabatrin is unlikely to affect the efficacy of steroid oral contraceptives [ see Clinical Pharmacology ( 12.3 ) ]. 7.3 Drug-Laboratory Test Interactions Vigabatrin 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 vigabatrin may preclude the use of these markers, especially ALT, to detect early hepatic injury. Vigabatrin 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).
7.1 Antiepileptic Drugs Phenytoin Although phenytoin dose adjustments are not routinely required, dose adjustment of phenytoin should be considered if clinically indicated, since vigabatrin may cause a moderate reduction in total phenytoin plasma levels [ see Clinical Pharmacology ( 12.3 ) ].
Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Vigabatrin
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- The label lists no absolute contraindications.
- Be cautious with existing eye disease or other irreversible vision loss.
- Pregnancy: animal studies show possible fetal harm. Join the NAAED Pregnancy Registry if pregnant.
- Breastfeeding is not recommended.
- Kidney problems, including in older adults, need lower doses and careful dose selection.
- Not established for complex partial seizures under age 2 or infantile spasms under 1 month.
Vigabatrin overdose
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Overdoses have caused drowsiness, unconsciousness or coma, and less often dizziness (vertigo), psychosis, slowed breathing, slow heart rate, agitation, confusion and worse seizures. No overdoses in the label resulted in death, and symptoms resolved with supportive care. There is no specific antidote, so seek emergency help right away.
What Vigabatrin does in the body
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By blocking the enzyme that breaks down GABA, vigabatrin increases GABA in the nervous system. In a study of healthy volunteers, single doses up to 6 grams showed no sign of affecting the heart's QT interval (electrical rhythm).
How your body processes Vigabatrin
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Vigabatrin is almost completely absorbed after being swallowed, reaching peak levels in about 1 hour in older children and adults and about 2.5 hours in infants. It isn't significantly broken down by the liver and leaves mainly through the kidneys, largely unchanged. Its half-life is about 10.5 hours in adults and shorter in children and infants. Kidney problems and older age slow its clearance. Tablets and oral solution are bioequivalent.
How to store Vigabatrin
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Store at 20°C to 25°C (68°F to 77°F).
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Vigabatrin
107 supplements and herbal products have documented interactions with Vigabatrin in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 7
- Moderate · 84
- Minor · 16
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Nutrient depletion considerations
Vigabatrin has been associated with lower levels of 1 nutrient in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.
Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.
Vigabatrin: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Vigabatrin — the kind of thing our pharmacy team would talk through with you at the counter.
What is vigabatrin used for?
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Why do I need regular eye exams?
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How do I take it?
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What side effects should I expect?
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Does it interact with my other medicines?
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Is it safe in pregnancy or breastfeeding?
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Is Vigabatrin available over the counter?
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When was Vigabatrin first available?
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Who makes Vigabatrin?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Vigabatrin on HelloPharmacist
Vigabatrin forms and strengths (how it comes)
Vigabatrin is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Vigabatrin inactive ingredients by manufacturer.
Oral solution
How this form is used
- Sabril, Vigadrone and vigabatrin for oral solution are used for infantile spasms and as add-on treatment for refractory complex partial seizures.
- Vigafyde is used only for infantile spasms in infants 1 month to 2 years old.
- Vigafyde is a concentrated 100 mg/mL solution, so the strength and dose should be double-checked.
- Vigafyde can be given by mouth or through a gastrostomy (G) tube, and needs no mixing or dilution.
- Vigafyde doses given through a gastrojejunal (GJ) tube must go through the G-port.
Tablet
How this form is used
- Sabril, Vigadrone and vigabatrin tablets are used for infantile spasms and as add-on treatment for refractory complex partial seizures.
- Sabril, Vigadrone and vigabatrin tablets are taken by mouth, with dosing individualized by the prescriber.
Vigabatrin on the U.S. market: products, makers and brands
How Vigabatrin appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
16 companies list 25 Vigabatrin product records with the FDA, mostly as oral solution, tablet; the earliest marketing or approval year on record is 2007. Brand names on the directory include Sabril, Vigadrone, Vigpoder and 1 more; the rest are generics.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (10) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Vigabatrin is used (Medicaid data)
A general measure of how commonly Vigabatrin is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Vigabatrin is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Vigabatrin prescribed? Of the 1,601 medications we measure, Vigabatrin ranks #791 by Medicaid prescriptions — more than 51% of them.
Utilization by Vigabatrin product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
vigabatrin 500 MG Powder for Oral Solution Most dispensed
Summed across the 7 of 25 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 250820
vigabatrin 100 MG/ML Oral Solution
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2685217
vigabatrin 500 MG Oral Tablet
Summed across the 5 of 11 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 199521
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Vigabatrin, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 13 of 37 listed Vigabatrin NDCs with Medicaid activity.
Compare Vigabatrin products
A representative set of FDA-listed product records for Vigabatrin — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Oral solution | ||||
| 50 mg/mL | Oral | Actavis Pharma, Inc. | ANDA | View NDC → |
| 500 mg | Oral | Amneal Pharmaceuticals NY LLC × 2 listings | ANDA | View NDC → |
| 50 mg/mL | Oral | Ascend Laboratories, LLC | ANDA | View NDC → |
| 500 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 50 mg/mL | Oral | Camber Pharmaceuticals, Inc. | ANDA | View NDC → |
| 500 mg/mL | Oral | Cipla USA, Inc. | ANDA | View NDC → |
| 50 mg/mL | Oral | Dr. Reddys Laboratories Inc., | ANDA | View NDC → |
| 50 mg/mL | Oral | Lundbeck Pharmaceuticals LLC | NDA | View NDC → |
| 50 mg/mL | Oral | Novadoz Pharmaceuticals LLC | ANDA | View NDC → |
| 50 mg/mL | Oral | Par Health USA, LLC | ANDA | View NDC → |
| 50 mg/mL | Oral | Upsher-Smith Laboratories, LLC | ANDA | View NDC → |
| 100 mg/mL | Oral | Upsher-Smith Laboratories, LLC | NDA | View NDC → |
| 500 mg/10 mL | Oral | Zydus Lifesciences Limited | ANDA | View NDC → |
| 500 mg/10 mL | Oral | Zydus Pharmaceuticals (USA) Inc. | ANDA | View NDC → |
| 💊Tablet | ||||
| 500 mg | Oral | Actavis Pharma, Inc. | ANDA | View NDC → |
| 500 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 500 mg | Oral | Carnegie Pharmaceuticals LLC | ANDA | View NDC → |
| 500 mg | Oral | Dr. Reddys Laboratories Inc., | ANDA | View NDC → |
| 500 mg | Oral | Edenbridge Pharmaceuticals LLC. | ANDA | View NDC → |
| 500 mg | Oral | Hikma Pharmaceuticals USA Inc | ANDA | View NDC → |
| 500 mg | Oral | Lundbeck Pharmaceuticals LLC | NDA | View NDC → |
| 500 mg | Oral | Upsher-Smith Laboratories, LLC | ANDA | View NDC → |
| 500 mg | Oral | Zydus Lifesciences Limited | ANDA | View NDC → |
| 500 mg | Oral | Zydus Pharmaceuticals (USA) Inc. | ANDA | View NDC → |
Showing 25 of 25 products — FDA National Drug Code Directory. See every product, package size and price: browse all 25 Vigabatrin NDCs →
Vigabatrin side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Vigabatrin — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Vigabatrin in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Vigabatrin FDA approval history
How Vigabatrin went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Vigabatrin recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list 2 Vigabatrin recalls since July 2021. None of them is still listed as ongoing. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.
- Vigabatrin for Oral Solution, USP 500 mg per packet, 50 packets per box, Rx Only, Manufactured by: InvaGen Pharmaceuticals, Inc., (a subsidiary of Cipla Ltd.), Hauppauge, NY, 11788, Manufactured for:… Lots: Lot #: NB301030, Exp. Date 03/31/2025 FDA record D-0220-2024 →
- Sabril (vigabatrin) for Oral Solution, 500 mg, 50 Packets, Rx only, Manufactured by: Patheon, Cincinnati, OH 45237, NDC 67386-211-65 Lots: Lot#: 3207333A, 3207334A, Exp 03/2027; 3214707A, 3214709A, 3214710A, Exp 02/2028 . FDA record D-1142-2023 →
Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 14851 3 dose forms · 3 strengths
-
Dose form (SCDF) Oral Solution RxCUI 2685216In current FDA listingsClinical drug / strength (SCD) 100 MG/MLRxCUI 2685217 -
Dose form (SCDF) Oral Tablet RxCUI 374291In current FDA listingsClinical drug / strength (SCD) 500 MGRxCUI 199521 -
Dose form (SCDF) Powder for Oral Solution RxCUI 1946399In current FDA listingsClinical drug / strength (SCD) 500 MGRxCUI 250820
Look up RxCUI 14851 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Vigabatrin supply and shortage status
Whether Vigabatrin is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Vigabatrin brand names
Vigabatrin is sold under 4 brand names in the FDA directory — Sabril, Vigadrone, Vigpoder, Vigafyde. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Vigabatrin: manufacturers and labelers
16 companies list Vigabatrin products with the FDA. By number of product records, the largest are Upsher-Smith Laboratories, LLC, Actavis Pharma, Inc., Amneal Pharmaceuticals NY LLC. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Vigabatrin drug class (RxNorm)
Vigabatrin belongs to the Anti-epileptic Agent class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Vigabatrin page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Lundbeck Pharmaceuticals LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →