Miglustat Side Effects

Please note - some side effects for Miglustat may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Miglustat - for the Consumer

Miglustat

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Miglustat:

Back pain; constipation; cramps; diarrhea; dizziness; dry mouth; unsteady gait; gas; headache; heavy limbs; indigestion; leg cramps; loss of appetite; menstrual disorders; migraine; nausea; stomach bloating, pain, or upset; vomiting; weakness; weight loss.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); burning, numbness, or tingling sensation of the hands, arms, legs, or feet; memory loss; tremor or a worsening of existing tremor in your hands; unusual bleeding or bruising; vision problems.

Side Effects by Body System

Gastrointestinal

Osmotic diarrhea appears to be the result of the disaccharidase inhibitory activity of miglustat.

Gastrointestinal side effects have included diarrhea (67% to 89%), flatulence (29% to 70%), abdominal pain (18% to 50%), nausea (14% to 35%), vomiting (30% to 33%), dysphagia (20% to 25%), and abdominal distension (20%). Epigastric pain not food-related, dyspepsia, dry mouth, constipation, anorexia, and bloating have also been reported.

Nervous system

Nervous system side effects have included headache (30% to 45%), tremors (30% to 40%), gait abnormal (33%), exacerbation of existing tremor (25% to 30%), gait spastic (25%), ataxia (25%), hyperreflexia (25%), and paresthesia (20%). Dizziness, cramps in legs, unsteady gait, and migraine have also been reported.

Metabolic

Metabolic side effects including weight decrease has been reported in 25% to 65% of patients.

Ocular

Ocular side effects have included visual disturbances.

Hematologic

Hematologic side effects have included thrombocytopenia.

Genitourinary

Genitourinary side effects have included menstrual disorder in the female patient.

General

General side effects have included abdominal distension (20%), abdominal distension with gas, generalized weakness, back pain, and heaviness in limbs.

Respiratory

Respiratory side effects have included nasopharyngitis (33% to 35%), cough 33%, and sinusitis (25%).

Psychiatric

Psychiatric side effects have included insomnia (30%), decreased appetite (25%), and depression (20%).

Other

Other side effects have included fatigue (35% to 42%) and lacerations (20%).

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