Miglustat Side Effects

It is possible that some side effects of miglustat may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to miglustat: oral capsule

Along with its needed effects, miglustat 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
  • 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

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
  • 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 common serious side effect was peripheral neuropathy. Diarrhea and tremor were the side effects that required intervention most often.

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.

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
Frequency not reported: Dysphagia

Metabolic

Very common (10% or more): Weight decrease (up to 67%)
Common (1% to 10%): Anorexia

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%), leg cramps (up to 11%)
Common (1% to 10%): Unsteady gait, paresthesia, migraine, peripheral neuropathy
Frequency not reported: Gait abnormal, gait spastic, ataxia, hyperreflexia

Other

Very common (10% or more): Generalized weakness (up to 17%)
Common (1% to 10%): Abdominal distension, back pain, heaviness in limbs, pain
Frequency not reported: Abdominal distension with gas, fatigue, lacerations

Ocular

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

Musculoskeletal

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

Psychiatric

Common (1% to 10%): Memory loss
Frequency not reported: Insomnia, decreased appetite, depression

Hematologic

Common (1% to 10%): Thrombocytopenia
Frequency not reported: Mild reduction in platelet count

Genitourinary

Common (1% to 10%): Menstrual disorder

Respiratory

Frequency not reported: Nasopharyngitis, cough, sinusitis

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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