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Agalsidase Side Effects

The most commonly reported side effects of agalsidase include malaise, pain, and pyrexia, based on 8,824 FDA adverse event reports from 2004 to 2025.

Agalsidase side effects

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

1
Malaise4.9%428
2
Pain4.8%421
3
Pyrexia4.6%404
4
Fatigue4.1%363
5
Nausea3.7%326
6
Dyspnoea3.4%298
7
Weight Decreased3.3%293
8
Headache3.3%289
9
Chills3.2%284
10
Vomiting3.0%262
11
Pain In Extremity2.8%249
12
Weight Increased2.7%242
13
Cough2.4%214
14
Dizziness2.4%210
15
Infusion Related Reaction2.3%206

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

Report severity

52.7%Serious4,647 reports
27.7%Hospitalizations2,443 reports
7.9%Fatal693 reports

Seriousness is determined by the reporter, not by OpenClaim.

Agalsidase drug interactions

Other drugs that appear in adverse event reports alongside agalsidase. 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
Amiodarone-hydrochloride0.7%62
2
Gemfibrozil0.6%57
3
Aspirin0.6%56
4
Citalopram-hydrobromide0.6%55
5
Pregabalin0.6%54
6
Lansoprazole0.6%54
7
Perindopril0.5%48
8
Nebivolol-hydrochloride0.5%47
9
Albuterol0.4%35
10
Acetaminophen0.4%34
11
Diphenhydramine0.3%23
12
Clopidogrel-bisulfate0.3%23
13
Tacrolimus0.2%21
14
Atorvastatin-calcium0.2%20
15
Sertraline-hydrochloride0.2%16

Taken alongside

1
Acetaminophen18.0%1,590
2
Diphenhydramine16.4%1,451
3
Epinephrine13.4%1,183
4
Sodium-chloride11.8%1,039
5
Sterile10.1%891
6
Aspirin8.2%723
7
Ammonium6.3%559
8
Ergocalciferol5.2%460
9
Heparin4.5%401
10
Prednisone4.4%386
11
Gabapentin4.2%368
12
Furosemide4.0%349
13
Metoprolol3.8%339
14
Carbamazepine3.7%323
15
Atorvastatin-calcium3.6%314

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 agalsidase side effects

36.5% of agalsidase adverse event reports involve female patients and 55.7% involve male patients. The largest age group is adult at 82%. These figures reflect who reports side effects, not underlying risk.

Sex

Female36.5%
Male55.7%
Unknown7.8%

Age group

< 20.4%
2–113.6%
12–176.2%
18–6481.8%
65+8.0%

What is agalsidase used for

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

Abdominal DiscomfortAccidental ExposureAccidental Exposure To ProductAnaemiaAbdominal Pain LowerAdenocarcinoma Of ColonAnaemiaArginase DeficiencyAsthmaBiopsy KidneyBreast NeoplasmCardiac DisorderChronic Kidney DiseaseComplement Deficiency DiseaseComplications Of Transplanted Kidney

Showing 15 of 91 indications

Agalsidase brand names and reporting trend

Agalsidase is sold under the brand name Fabrazyme.

Brand names

Fabrazyme1,026

Quarterly reports (20042025)

20052010201520202025

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

Taking agalsidase with another medication?

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