Note: This document contains side effect information about migalastat. Some dosage forms listed on this page may not apply to the brand name Galafold.

Applies to migalastat: oral capsule.

Serious side effects of Galafold

Along with its needed effects, migalastat (the active ingredient contained in Galafold) 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 migalastat:

More common

• Bladder pain
• bloody or cloudy urine
• difficult, burning, or painful urination
• frequent urge to urinate
• lower back or side pain

Other side effects of Galafold

Some side effects of migalastat 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
• cough
• diarrhea
• fever
• headache
• muscle aches
• nausea
• nosebleed
• sore throat
• stomach pain
• stuffy or runny nose
• unusual tiredness or weakness

For Healthcare Professionals

Applies to migalastat: oral capsule.

General

The more commonly reported adverse effects have included headache, nasopharyngitis, urinary tract infection, nausea, and pyrexia.^[Ref]

Nervous system

Very common (10% or more): Headache (35%)

Common (1% to 10%): Paresthesia, dizziness, hypoesthesia

Respiratory

Very common (10% or more): Nasopharyngitis (18%)

Common (1% to 10%): Cough, epistaxis, dyspnea

Renal

Common (1% to 10%): Proteinuria

Gastrointestinal

Very common (10% or more): Nausea (12%)

Common (1% to 10%): Abdominal pain, diarrhea, vomiting, constipation, dry mouth, defection urgency, dyspepsia

Musculoskeletal

Common (1% to 10%): Back pain, muscle spasms, myalgia, torticollis, extremity pain, increased blood creatine phosphokinase

Metabolic

Common (1% to 10%): Increased weight

Genitourinary

Very common (10% or more): Urinary tract infection (15%)

Urinary tract infection includes cystitis, and kidney infection.

Other

Common (1% to 10%): Pyrexia, vertigo, fatigue

Psychiatric

Common (1% to 10%): Depression

Cardiovascular

Common (1% to 10%): Palpitations

Dermatologic

Common (1% to 10%): Rash, pruritus