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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

PEGUNIGALSIDASE ALFA-IWXJ: 202 Adverse Event Reports & Safety Profile

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202
Total FAERS Reports
3 (1.5%)
Deaths Reported
43
Hospitalizations
202
As Primary/Secondary Suspect
2
Life-Threatening
2
Disabilities
Prescription
Status

FDA Application: 761161 ·

First Report: 20221101 · Latest Report: 20250906

What Are the Most Common PEGUNIGALSIDASE ALFA-IWXJ Side Effects?

#1 Most Reported
Fatigue
30 reports (14.9%)
#2 Most Reported
Off label use
25 reports (12.4%)
#3 Most Reported
Nausea
16 reports (7.9%)

All PEGUNIGALSIDASE ALFA-IWXJ Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Fatigue 30 14.9% 0 1
Off label use 25 12.4% 1 5
Nausea 16 7.9% 0 1
Ill-defined disorder 13 6.4% 1 13
Asthenia 11 5.5% 1 3
Chills 11 5.5% 0 3
Infusion related reaction 10 5.0% 0 2
Pain 10 5.0% 0 3
Product dose omission issue 10 5.0% 0 3
Pyrexia 10 5.0% 0 0
Vomiting 10 5.0% 0 1
Burning sensation 8 4.0% 0 0
Chest pain 8 4.0% 0 2
Pain in extremity 7 3.5% 0 2
Urticaria 7 3.5% 0 0
Abdominal pain 6 3.0% 0 2
Gastrointestinal disorder 6 3.0% 0 0
Headache 6 3.0% 0 0
Abdominal pain upper 5 2.5% 0 1
Condition aggravated 5 2.5% 0 1

Who Reports PEGUNIGALSIDASE ALFA-IWXJ Side Effects? Age & Gender Data

Gender: 41.4% female, 58.6% male. Average age: 40.4 years. Most reports from: US. View detailed demographics →

Is PEGUNIGALSIDASE ALFA-IWXJ Getting Safer? Reports by Year

YearReportsDeathsHosp.
2022 1 0 0
2023 34 2 14
2024 73 1 16
2025 48 0 10

View full timeline →

What Is PEGUNIGALSIDASE ALFA-IWXJ Used For?

IndicationReports
Fabry's disease 161
Product used for unknown indication 40

PEGUNIGALSIDASE ALFA-IWXJ vs Alternatives: Which Is Safer?

PEGUNIGALSIDASE ALFA-IWXJ vs PEGVALIASE-PQPZ PEGUNIGALSIDASE ALFA-IWXJ vs PEGVISOMANT PEGUNIGALSIDASE ALFA-IWXJ vs PEGZEREPOETIN ALFA PEGUNIGALSIDASE ALFA-IWXJ vs PEMBROLIZUMAB PEGUNIGALSIDASE ALFA-IWXJ vs PEMETREXED PEGUNIGALSIDASE ALFA-IWXJ vs PEMIGATINIB PEGUNIGALSIDASE ALFA-IWXJ vs PENICILLAMINE PEGUNIGALSIDASE ALFA-IWXJ vs PENICILLIN PEGUNIGALSIDASE ALFA-IWXJ vs PENICILLIN G PEGUNIGALSIDASE ALFA-IWXJ vs PENICILLIN G BENZATHINE

Official FDA Label for PEGUNIGALSIDASE ALFA-IWXJ

Official prescribing information from the FDA-approved drug label.