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Yargesa (Miglustat): Uses, Side Effects and Dosage

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

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

What is YARGESA ?

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

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

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

  • have kidney problems

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

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

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

How should I take YARGESA ?

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

What are the possible side effects of YARGESA ?

YARGESA 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 YARGESA and during treatment with YARGESA.
  • New or worsening hand tremors (shaky movements).Tremors are common with YARGESA 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 YARGESA if you develop new or worsening hand tremors. Call your healthcare provider right away if you get new hand tremors during treatment with YARGESA or if the hand tremors you already have get worse.
  • Diarrheais common with YARGESA 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 lossis common with YARGESA and sometimes can be serious. You may lose weight when you start treatment with YARGESA.
  • Low platelet countis common with YARGESA and can be serious. Your healthcare provider may do blood tests to monitor your blood platelet count.

The most common side effects of YARGESA 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 the possible side effects of YARGESA. For more information, ask your healthcare provider or pharmacist.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 YARGESA ?

  • Store YARGESA at room temperature between 68ºF to 77ºF (20ºC to 25ºC)

Keep YARGESA and all medicines out of the reach of children

General information about the safe and effective use of YARGESA .

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet.

Do not use YARGESA for a condition for which it was not prescribed. Do not give YARGESA 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 YARGESA that is written for health professionals.

What are the ingredients in YARGESA ?

Active ingredient : miglustat

Inactive ingredients:sodium starch glycolate (type A, potato), povidone (K-29/32), and magnesium stearate.

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

and propylene glycol.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Manufactured for:

Edenbridge Pharmaceuticals, LLC

DBA Dexcel Pharma USA

Parsippany, NJ 07054

877-381-3336

Revised: 07/2024

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: ANDA 209821 · View the label on DailyMed

Revision date stated in the text: July 2024

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 Yargesa

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Enzyme Stabilizer, Glucosylceramide Synthase Inhibitor
Active ingredient Miglustat 100 mg
Dosage form Capsule
Route Oral
Marketing status listed in the FDA NDC Directory
Company (applicant) EDENBRIDGE PHARMS
FDA approval ANDA 209821Abbreviated New Drug Application (ANDA) – generic drug Approved August 6, 2020
Therapeutic equivalence (TE) code ABCodes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book).
Generics Miglustat, Zavesca 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 42799-709-01
100 mg – 15 in 1 blister pack / 1 in 1 carton NDC 42799-709-15

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.