Miglustat Side Effects

Some side effects of miglustat may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to miglustat: oral capsule

Nerve problems such as numbness, tingling, and tremor (shaking) of the hands have been reported by some people taking miglustat. Contact your doctor immediately if you experience new or worsening numbness, tingling, or burning in the hands, arms, legs, or feet or tremor in the hands.

Seek emergency medical attention if you experience a rare but serious allergic reaction to miglustat including difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives.

Other less serious side effects may be more likely to occur. Continue to take miglustat and talk to your doctor if you experience:

• diarrhea;

• decreased appetite or weight loss;

• gas or abdominal pain;

• constipation;

• muscle cramps or weakness;

• headache;

• dizziness; or

• vision problems.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to miglustat: oral capsule

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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