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Miglustat Side Effects

For the Consumer

Applies to miglustat: oral capsule

In addition to its needed effects, some unwanted effects may be caused by miglustat. In the event that any of these side effects do occur, they may require medical attention.

Severity: Major

You should check with your doctor immediately if any of these side effects occur when taking miglustat:

More common:
  • Black, tarry stools
  • bleeding gums
  • blood in the urine or stools
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • diarrhea
  • pinpoint red spots on the skin
  • trembling or shaking in the hands
  • unsteadiness or awkwardness
  • unusual bleeding or bruising
  • weakness in the arms, hands, legs, or feet
  • weight loss

Severity: Minor

Some of the side effects that can occur with miglustat may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common:
  • Back pain
  • bloated or full feeling
  • blurred or loss of vision
  • difficulty having a bowel movement (stool)
  • disturbed color perception
  • dizziness
  • double vision
  • dry mouth
  • excess air or gas in the stomach or intestines
  • halos around lights
  • headache
  • heartburn
  • heaviness in the limbs
  • indigestion
  • leg cramps
  • loss of appetite
  • memory loss
  • menstrual changes
  • nausea
  • pain or discomfort in the chest, upper stomach, or throat
  • passing gas
  • stomach discomfort, upset or pain
  • swelling of the abdominal or stomach area
  • tunnel vision
  • unsteady walk
  • vomiting

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 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

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]

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]

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. Cerner Multum, Inc. "Australian Product Information." O 0

2. "Product Information. Zavesca (miglustat)." Acetelion Pharmaceuticals US, Inc, South San Francisco, CA.

3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Not all side effects for miglustat may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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