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Zavesca (Miglustat): Uses, Side Effects and Dosage

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Facts
Status:
Prescription (Rx)
Strength:
100 mg
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Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Zavesca

What is ZAVESCA?

ZAVESCA is a prescription medicine used alone to treat adults with mild to moderate type 1 Gaucher disease. ZAVESCA is used only in people who cannot be treated with enzyme replacement therapy.

It is not known if ZAVESCA is safe and effective in children under 18 years of age.

Before taking ZAVESCA, tell your healthcare provider about all of your medical conditions, including if you:

  • have kidney problems

  • are pregnant or plan to become pregnant. ZAVESCA may harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with ZAVESCA.

  • are breastfeeding or plan to breastfeed. It is not known if ZAVESCA can pass into your breast milk and may harm your baby . Do not breastfeed during treatment with ZAVESCA. Talk to your healthcare provider about the best way to feed your baby during treatment with ZAVESCA.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. ZAVESCA may affect how other medicines work.

How should I take ZAVESCA?

  • Take ZAVESCA exactly as your healthcare provider tells you to.
  • Take ZAVESCA at the same time each day.
  • If you miss a dose of ZAVESCA, skip that dose. Take the next ZAVESCA capsule at the usual time.

What are the possible side effects of ZAVESCA?

ZAVESCA may cause serious side effects including:

  • Numbness, tingling, pain, or burning in your hands or feet (peripheral neuropathy). Call your healthcare provider right away if you get numbness, tingling, pain, or burning in your hands or feet.
  • Your healthcare provider may test your nerves (neurological exam) before you start ZAVESCA and during treatment with ZAVESCA.
  • New or worsening hand tremors (shaky movements). Tremors are common with ZAVESCA and may begin within the first month of starting treatment. Sometimes the tremors may go away between 1 to 3 months with continued treatment. Your healthcare provider may lower your dose or stop ZAVESCA if you develop new or worsening hand tremors. Call your healthcare provider right away if you get new hand tremors during treatment with ZAVESCA or if the hand tremors you already have get worse.
  • Diarrhea is common with ZAVESCA and sometimes can be serious. Your healthcare provider may prescribe another medicine (anti-diarrheal) to treat diarrhea if it is a problem for you and may recommend changes to your diet, such as avoiding foods high in carbohydrates. Talk with your healthcare provider about your diet if you have diarrhea.
  • Weight loss is common with ZAVESCA and sometimes can be serious. You may lose weight when you start treatment with ZAVESCA.
  • Low platelet count is common with ZAVESCA and can be serious. Your healthcare provider may do blood tests to monitor your blood platelet count during treatment with ZAVESCA.

The most common side effects of ZAVESCA include:

  • weight loss
  • stomach pain
  • gas
  • nausea and vomiting
  • headache, including migraine
  • back pain
  • constipation
  • dry mouth
  • heaviness in arms and legs
  • memory loss
  • unsteady walking
  • leg cramps
  • dizziness
  • weakness
  • vision problems
  • muscle cramps
  • loss of appetite
  • indigestion
  • numbness, tingling, pain, or burning of your skin
  • stomach bloating
  • stomach pain not related to food
  • menstrual changes

These are not all of the possible side effects of ZAVESCA.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store ZAVESCA?

  • Store ZAVESCA at room temperature between 68°F to 77°F (20°C to 25°C).

Keep ZAVESCA and all medicines out of the reach of children.

General information about the safe and effective use of ZAVESCA.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use ZAVESCA for a condition for which it was not prescribed. Do not give ZAVESCA to other people, even if they have the same symptoms you have. It may harm them.

You can ask your healthcare provider or pharmacist for information about ZAVESCA that is written for health professionals.

What are the ingredients in ZAVESCA?

Active ingredient: miglustat

Inactive ingredients: sodium starch glycolate, povidone (K30), and magnesium stearate.

The capsule shell contains: gelatin and titanium dioxide; the edible printing ink contains black iron oxide and shellac.

Manufactured for: Actelion Pharmaceuticals US, Inc.,

a Janssen Pharmaceutical Company

Titusville, NJ 08560, USA

© 2003–2017 Actelion Pharmaceuticals US, Inc.

JN202200808

For more information, call Janssen at 1-800-526-7736 (1-800- JANSSEN) or go to www.ZAVESCA.com

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA 021348 · View the label on DailyMed

Revision date stated in the text: January 2021

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Zavesca

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Glucosylceramide Synthase Inhibitor
Active ingredient Miglustat 100 mg
Dosage form Capsule
Route Oral
Marketing status listed in the FDA NDC Directory
Company (applicant) ACTELION
FDA approval NDA 021348New Drug Application (NDA) Approved July 31, 2003
Reference listed drug This is the reference listed drug (RLD) that generics are compared with.
Therapeutic equivalence (TE) code ABCodes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book).
Generics Miglustat, Yargesa with the same TE code
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
100 mg – 15 in 1 blister pack / 6 in 1 carton NDC 66215-201-15

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.