What the label lists and what reports show
Migalastat side effects
Migalastat's FDA label: “Most common adverse drug reactions ≥ 10% are: headache, nasopharyngitis, urinary tract infection, nausea, and pyrexia.” FAERS holds 534 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is renal impairment (42 reports).
- No generic listed
Check it at the source: the migalastat FDA label on DailyMed (effective August 28, 2025, Amicus Therapeutics US, LLC); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of GALAFOLD?The most common side effects of GALAFOLD include: • headache • stuffy or runny nose and sore throat • urinary tract infection • nausea • fever These are not all the possible side effects of GALAFOLD. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Amicus Therapeutics at 1-877-426-4287.
Source: FDA drug label, Amicus Therapeutics US, LLC, effective August 28, 2025 (SPL set 66dbd928-0f1c-48b1-a832-54e4abd9f1db), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse drug reactions ≥ 10% are: headache, nasopharyngitis, urinary tract infection, nausea, and pyrexia.
Table 1: Adverse Reactions* in Patients with Fabry Disease (Study 1)
| Adverse Reaction | GALAFOLD % (N = 34) | Placebo % (N = 33) |
|---|---|---|
| Headache | 35% | 21% |
| Nasopharyngitis | 18% | 6% |
| Urinary tract infection | 15% | 0 |
| Nausea | 12% | 6% |
| Pyrexia | 12% | 3% |
| Abdominal pain | 9% | 3% |
| Back pain | 9% | 0 |
| Cough | 9% | 0 |
| Diarrhea | 9% | 3% |
| Epistaxis | 9% | 3% |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedMost common adverse drug reactions ≥ 10% are: headache, nasopharyngitis, urinary tract infection, nausea, and pyrexia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Amicus Therapeutics at 1-877-4AMICUS or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In clinical trials, 139 patients with Fabry disease (79 females, 60 males, 92% Caucasian, ages 16 to 72 years), who were naïve to GALAFOLD or previously treated with enzyme replacement therapy, were exposed to at least one dose of GALAFOLD. Of the 139 patients, 127 patients were exposed to GALAFOLD 123 mg every other day for 6 months and 123 patients were exposed for greater than one year. The clinical trials included one randomized, double-blind, placebo-controlled clinical trial of 6 months duration followed by a 6-month open-label treatment phase (Study 1) [see Clinical Studies (14) ]. …
Source: FDA drug label, Amicus Therapeutics US, LLC, effective August 28, 2025 (SPL set 66dbd928-0f1c-48b1-a832-54e4abd9f1db), via openFDA; the full label on DailyMed
What do FAERS reports show?
534 reports list migalastat among the medicines taken, each a report of something that happened, not proof the medicine caused it; 71 are coded as a death and 172 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 19 reactions below, 3 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Migalastat: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions