OpenClaim

Migalastat Side Effects

The most commonly reported side effects of migalastat include product dose omission issue, renal impairment, and off label use, based on 552 FDA adverse event reports from 2004 to 2025. 3.4% of reports found the drug to be ineffective.

Migalastat side effects

Percentages show how often each reaction appears relative to total reports for migalastat.

1
Product Dose Omission Issue7.4%41
2
Renal Impairment7.1%39
3
Off Label Use5.8%32
4
Death5.6%31
5
Cerebrovascular Accident4.9%27
6
Headache4.7%26
7
Fatigue4.7%26
8
Nausea4.0%22
9
Dyspnoea3.6%20
10
Pain3.6%20
11
Drug Ineffective3.4%19
12
Covid-193.4%19
13
Malaise3.1%17
14
Diarrhoea3.1%17
15
Inappropriate Schedule Of Product Administration3.1%17

These are voluntary reports and do not establish that migalastat caused these reactions.

Report severity

81.7%Serious451 reports
35.1%Hospitalizations194 reports
13.4%Fatal74 reports

Seriousness is determined by the reporter, not by OpenClaim.

Migalastat drug interactions

Other drugs that appear in adverse event reports alongside migalastat. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Pemetrexed3.8%21
2
Agalsidase-beta3.4%19
3
Carboplatin1.4%8
4
Cisplatin1.4%8
5
Tacrolimus1.4%8
6
Methylprednisolone1.1%6
7
Dexamethasone0.9%5
8
Bevacizumab0.7%4
9
Nivolumab0.4%2
10
Valbenazine0.4%2
11
Morphine-sulfate0.4%2
12
Naltrexone0.4%2
13
Oxycodone0.4%2
14
Buprenorphine0.4%2
15
Naloxone-hydrochloride0.4%2

Taken alongside

1
Aspirin13.4%74
2
Ergocalciferol11.8%65
3
Levothyroxine-sodium9.1%50
4
Acetaminophen8.9%49
5
Metoprolol8.7%48
6
Atorvastatin-calcium8.3%46
7
Lisinopril7.2%40
8
Furosemide7.1%39
9
Albuterol5.6%31
10
Ondansetron5.4%30
11
Magnesium-acetate-tetrahydrate5.1%28
12
Apixaban5.1%28
13
Metformin4.7%26
14
Omeprazole4.7%26
15
Gabapentin4.5%25

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports migalastat side effects

51.3% of migalastat adverse event reports involve female patients and 42.2% involve male patients. The largest age group is adult at 69%. These figures reflect who reports side effects, not underlying risk.

Sex

Female51.3%
Male42.2%
Unknown6.5%

Age group

< 20.0%
2–110.0%
12–170.6%
18–6469.0%
65+30.4%

What is migalastat used for

Conditions and purposes for which patients were taking migalastat when the adverse event was reported.

Cardiac DisorderFabry^s DiseaseFabry^s DiseaseGlycogen Storage Disease Type IvIllnessKrabbe^s DiseaseKrabbe^s DiseaseLipidosisLipidosisMucopolysaccharidosisNiemann-pick DiseasePolyneuropathyPremedicationProduct Used For Unknown IndicationProphylaxis

Showing 15 of 17 indications

Migalastat brand names and reporting trend

Migalastat is sold under the brand name Galafold.

Brand names

Galafold15

Quarterly reports (20042025)

2005201020202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking migalastat with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.