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Galafold Side Effects

Generic Name: migalastat

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

For the Consumer

Applies to migalastat: oral capsule

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

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

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

Urinary tract infection includes cystitis, and kidney infection.

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

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

References

1. "Product Information. Galafold (migalastat)." Amicus Therapeutics U.S., Inc., Cranbury, NJ.

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

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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