Note: This document contains side effect information about miglustat. Some of the dosage forms listed on this page may not apply to the brand name Zavesca.
Applies to miglustat: oral capsule
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:
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:
Applies to miglustat: oral capsule
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.
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.
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
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.
Very common (10% or more): Weight decrease (up to 67%)
Common (1% to 10%): Anorexia
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
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.
Very common (10% or more): Generalized weakness (up to 17%)
Common (1% to 10%):Fatigue, asthenia, chills, malaise, pain
Frequency not reported: Fatigue, lacerations
Very common (10% or more): Visual disturbances (up to 17%)
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
Common (1% to 10%): Memory loss
Frequency not reported: Insomnia, decreased appetite, depression, decreased libido
Common (1% to 10%): Thrombocytopenia
Frequency not reported: Mild reduction in platelet count
Common (1% to 10%): Menstrual disorder
Frequency not reported: Nasopharyngitis, cough, sinusitis
Medically reviewed by BestRx Medical Team Last updated on 1/1/2020.
Source: Drugs.com Zavesca