Vigadrone (vigabatrin powder and tablets)

Short answer: Vigadrone is a generic vigabatrin from Upsher-Smith. The powder for oral solution (500 mg packets) was approved on 21 June 2018, and 500 mg tablets on 29 June 2023.^1,2 Like Sabril, it treats infantile spasms in babies 1 month to 2 years old and, as an add-on, refractory complex partial seizures from age 2.³ It carries the same boxed warning about permanent vision loss and is dispensed only through the Vigabatrin REMS.³

What is Vigadrone?

From Drugs@FDA and the DailyMed labels.^1,2,3,4

Both labels give the same uses as Sabril, word for word: infantile spasms as the only seizure medicine, and refractory complex partial seizures as an add-on that "is not indicated as a first line agent."^3,4

Vigadrone vs Sabril

Vigadrone is approved through an abbreviated new drug application, the route for generics. Its powder and tablet have the same 500 mg strength as the Sabril brand.^1,2

• Same medicine and uses. Both contain vigabatrin, with identical indications.^3,5
• Same mixing. Both powders use 10 mL of water per packet, at 50 mg per mL, made fresh each dose.^3,6
• Same warnings. Both carry the boxed warning, the same vision-check schedule and the same REMS.³
• What can differ: the maker, the support program, and how your insurance covers each.

How to mix Vigadrone powder

From the label, for each dose:^3,6

1. Empty each 500 mg packet into a clean cup.
2. Add 10 mL of cold or room-temperature water per packet and dissolve. Doses up to 500 mg use one packet; up to 1,000 mg, two packets and 20 mL; up to 1,500 mg, three packets and 30 mL.
3. Check that the solution is clear. Throw it away if it is not.
4. Draw up the prescribed number of mL with an oral syringe, give it right away, and throw away the rest.

The oral syringes come separately from the pharmacy.³ The label asks prescribers to confirm that caregivers understand how to mix it and give the right dose.³ Step-by-step pictures and common mistakes are on powder sachets.

A 2025 lab study by authors from Upsher-Smith and Aucta found the mixed powder stayed stable for 48 hours in the fridge in water, juice, milk or formula. The label still says to use water and mix each dose fresh.⁷

Vigadrone tablets

Vigadrone tablets are white to off-white, oval, film-coated, marked "ZNV" on one side and scored on the other, in bottles of 100.⁴ Dosing by weight, splitting and kidney adjustments for 500 mg tablets are covered in the vigabatrin tablets guide.

Vigadrone vs the ready-to-use liquid

For babies, the alternative to mixed powder is Vigafyde, a ready-to-use liquid at 100 mg per mL. It needs no mixing, each dose is half the volume, and an opened bottle keeps 90 days. It is labeled only for infantile spasms from 1 month to 2 years.⁸

In one small study run by employees of Pyros, which holds the liquid's FDA application, all ready-to-use doses were within 5% of the target, while 7 of 30 mixed-powder doses missed by more than 10%. The powder in that study was Sabril, which is prepared the same way as Vigadrone.^3,9 The study had real limits.

If your baby switches from powder to the liquid, the same dose is half the number of mL. Get the new volume in writing.⁸

Ready-to-use liquid, 100 mg/mL

7.5 mL

Drawn straight from the bottle. Fits in one 10 mL oral syringe.

Mixed powder, 50 mg/mL

15 mL

Two packets dissolved in 20 mL of water; 15 mL is given and 5 mL is thrown away. More than one 10 mL syringe-full.

Scale marks every 1 mL, 0–20 mL. Volumes from the FDA dosing tables for each product. Twice daily.

Vigadrone side effects

The Vigadrone label lists the same most common side effects as Sabril:³

• Adults: blurred vision, sleepiness, dizziness, poor coordination, tremor and fatigue.
• Children 3 to 16: weight gain.
• Babies with infantile spasms: sleepiness, bronchitis, ear infection and acute middle-ear infection.

The most serious risk is permanent loss of side vision. Vision is checked at baseline (no later than 4 weeks after starting), at least every 3 months on treatment, and about 3 to 6 months after stopping.³ Do not stop it suddenly; the label says it "should be withdrawn gradually."³

Vigadrone and the REMS

Vigadrone is available only through the shared Vigabatrin REMS Program, which covers every vigabatrin product.^3,10 Prescribers must be certified, patients enrolled and pharmacies certified.⁸

Does Medicare cover Vigadrone?

It depends on your Medicare drug plan. Medicare.gov says "each plan has its own formulary," that is, its own list of covered drugs.¹¹ To check, look up Vigadrone or vigabatrin on your plan's drug list, or call the plan.

• Tiers. Many plans place drugs in cost tiers, and each plan divides its tiers differently. In Medicare's example, tier 1 holds most generic drugs and a specialty tier holds very high-cost drugs. A drug in a lower tier generally costs you less.¹²
• Rules. A plan may need prior authorization before it covers a drug, may require step therapy, or may limit the quantity over a period.¹³
• Exceptions. You or your prescriber can ask the plan for an exception. The prescriber gives a statement that the drug is medically necessary.¹³
• Changes. Plans can change their drug lists during the year, and must tell you about changes that affect a drug you take.¹²

Vigadrone price, cost and coupons

We do not publish prices, because they change and what each family pays differs. What you pay depends on your plan, its tier for Vigadrone, any prior authorization, and the pharmacy. Package math and questions to ask are in our guide to vigabatrin costs.

Promise of Support. Upsher-Smith's program for Vigadrone helps from REMS enrollment to the first shipment. It checks whether a patient is covered, uninsured, needs prior authorization, or is "Eligible for the co-pay assistance program." During prior authorization it sends a starter or bridge supply. The prescription then ships from its specialty pharmacy partner.¹⁴ The program's phone line is 1-866-923-1954, Monday to Friday.¹⁴

Ask the program whether its co-pay assistance applies to your type of insurance, including Medicare or Medicaid, before you count on it. This site is independent and does not run or endorse any program.