Skip to main content

Zavesca Side Effects

Generic name: miglustat

Medically reviewed by Drugs.com. Last updated on Apr 30, 2023.

Note: This document contains side effect information about miglustat. Some dosage forms listed on this page may not apply to the brand name Zavesca.

Applies to miglustat: oral capsule.

Serious side effects of Zavesca

Along with its needed effects, miglustat (the active ingredient contained in Zavesca) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking miglustat:

More common

Less common

Other side effects of Zavesca

Some side effects of miglustat may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Less common

For Healthcare Professionals

Applies to miglustat: oral capsule.

General

The most commonly reported adverse reactions included diarrhea, flatulence, abdominal pain, weight loss, and tremor; the most common serious adverse reaction was peripheral neuropathy; diarrhea and tremor were the side effects that most commonly required intervention.[Ref]

Gastrointestinal

Osmotic diarrhea appears to be due to inhibitory activity of miglustat (the active ingredient contained in Zavesca) on intestinal disaccharidases leading to reduced absorption of dietary disaccharides in the small intestine. Diarrhea decreased over time with continued therapy.[Ref]

Very common (10% or more): Diarrhea (including osmotic diarrhea; up to 100%), abdominal pain (up to 67%), flatulence (up to 50%), nausea (up to 22%), vomiting (up to 11%)

Common (1% to 10%): Constipation, dry mouth, dyspepsia, epigastric pain not food-related, bloating, stomach pain, gas, abdominal distension/discomfort

Frequency not reported: Dysphagia, indigestion, dry mouth[Ref]

Metabolic

Weight loss has been observed in approximately 55% to 65% of patients. Peak weight loss occurs between 6 and 12 months, with a mean weight loss of 6% to 7% of body weight. It is unclear if weight loss results from the diarrhea and associated gastrointestinal complaints, a decrease in food intake, or a combination of these or other factors. There is a trend to return to baseline weight after the first year.[Ref]

Very common (10% or more): Weight decrease (up to 67%)

Common (1% to 10%): Anorexia[Ref]

Nervous system

The most common serious adverse reaction in clinical trials was peripheral neuropathy. Tremor, and worsening tremor were very commonly reported. Compared to the general population, patients with type 1 Gaucher disease are more likely to have peripheral neuropathy. A patient should be evaluated for tremor and neuropathy prior to starting therapy.[Ref]

Very common (10% or more): Tremor/exacerbation of existing tremor (about 30%), headache (up to 22%), tremor (up to 17%), dizziness (up to 11%)

Common (1% to 10%): Unsteady gait, paresthesia, migraine, peripheral neuropathy, ataxia, hypoesthesia

Frequency not reported: Gait abnormal, gait spastic, hyperreflexia[Ref]

Other

Very common (10% or more): Generalized weakness (up to 17%)

Common (1% to 10%):Fatigue, asthenia, chills, malaise, pain

Frequency not reported: Fatigue, lacerations[Ref]

Ocular

Very common (10% or more): Visual disturbances (up to 17%)[Ref]

Musculoskeletal

Very common (10% or more): Cramps (up to 11%)

Common (1% to 10%): Muscle spasms

Frequency not reported: Leg cramps, muscle cramps, back pain, heaviness in arms and legs[Ref]

Psychiatric

Common (1% to 10%): Memory loss

Frequency not reported: Insomnia, decreased appetite, depression, decreased libido[Ref]

Hematologic

Common (1% to 10%): Thrombocytopenia

Frequency not reported: Mild reduction in platelet count[Ref]

Genitourinary

Common (1% to 10%): Menstrual disorder[Ref]

Respiratory

Frequency not reported: Nasopharyngitis, cough, sinusitis[Ref]

References

1. Product Information. Zavesca (miglustat). Actelion Pharmaceuticals US Inc. 2003.

2. Cerner Multum, Inc. UK Summary of Product Characteristics.

3. Cerner Multum, Inc. Australian Product Information.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.