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Pegunigalsidase Side Effects

The most commonly reported side effects of pegunigalsidase include fatigue, off label use, and nausea, based on 252 FDA adverse event reports from 2022 to 2025.

Pegunigalsidase side effects

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

1
Fatigue13.1%33
2
Off Label Use10.3%26
3
Nausea7.5%19
4
Pain6.7%17
5
Ill-defined Disorder5.6%14
6
Pyrexia5.2%13
7
Asthenia4.8%12
8
Product Dose Omission Issue4.8%12
9
Vomiting4.4%11
10
Chills4.4%11
11
Infusion Related Reaction4.0%10
12
Chest Pain4.0%10
13
Pain In Extremity3.6%9
14
Burning Sensation3.2%8
15
Headache2.8%7

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

Report severity

38.1%Serious96 reports
20.6%Hospitalizations52 reports
2.8%Fatal7 reports

Seriousness is determined by the reporter, not by OpenClaim.

Pegunigalsidase drug interactions

Other drugs that appear in adverse event reports alongside pegunigalsidase. 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
Agalsidase-beta1.2%3
2
Calcium0.4%1
3
Denosumab0.4%1
4
Tacrolimus0.4%1
5
Diphenhydramine0.4%1

Taken alongside

1
Acetaminophen8.3%21
2
Diphenhydramine5.6%14
3
Atorvastatin-calcium2.8%7
4
Losartan-potassium2.8%7
5
Cetirizine-hydrochloride2.8%7
6
Pregabalin2.8%7
7
Ergocalciferol2.4%6
8
Sodium-chloride2.4%6
9
Methylprednisolone2.4%6
10
Aspirin2.0%5
11
Gabapentin2.0%5
12
Loratadine2.0%5
13
Levothyroxine-sodium1.6%4
14
Epinephrine1.6%4
15
Fluoxetine-hydrochloride1.6%4

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 pegunigalsidase side effects

42.1% of pegunigalsidase adverse event reports involve female patients and 55.2% involve male patients. The largest age group is adult at 92%. These figures reflect who reports side effects, not underlying risk.

Sex

Female42.1%
Male55.2%
Unknown2.8%

Age group

< 20.0%
2–110.0%
12–172.2%
18–6491.8%
65+6.0%

What is pegunigalsidase used for

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

Alpha-mannosidosisFabry^s DiseaseProduct Used For Unknown Indication

Pegunigalsidase brand names and reporting trend

Pegunigalsidase is sold under the brand name Elfabrio.

Brand names

Elfabrio2

Quarterly reports (20222025)

202220242025

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

Taking pegunigalsidase with another medication?

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