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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.

AGALSIDASE ALFA: 108 Adverse Event Reports & Safety Profile

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108
Total FAERS Reports
9 (8.3%)
Deaths Reported
75
Hospitalizations
108
As Primary/Secondary Suspect
3
Life-Threatening
2
Disabilities

First Report: 20080118 · Latest Report: 20250507

What Are the Most Common AGALSIDASE ALFA Side Effects?

#1 Most Reported
Inappropriate schedule of product administration
40 reports (37.0%)
#2 Most Reported
Fatigue
40 reports (37.0%)
#3 Most Reported
Malaise
28 reports (25.9%)

All AGALSIDASE ALFA Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Fatigue 40 37.0% 3 23
Inappropriate schedule of product administration 40 37.0% 2 31
Malaise 28 25.9% 1 21
Headache 27 25.0% 0 21
Cough 26 24.1% 2 19
Nausea 26 24.1% 0 18
Blood pressure decreased 25 23.2% 2 22
Covid-19 25 23.2% 1 19
Dizziness 25 23.2% 0 18
Pain 25 23.2% 1 20
Nasopharyngitis 24 22.2% 2 19
Pyrexia 23 21.3% 1 17
Weight decreased 21 19.4% 3 19
Weight increased 21 19.4% 2 18
Product dose omission issue 20 18.5% 2 16
Blood pressure increased 19 17.6% 3 13
Pain in extremity 19 17.6% 1 10
Peritonitis 19 17.6% 0 19
Anxiety 18 16.7% 0 15
Diarrhoea 18 16.7% 2 10

Who Reports AGALSIDASE ALFA Side Effects? Age & Gender Data

Gender: 54.9% female, 45.1% male. Average age: 51.4 years. Most reports from: CA. View detailed demographics →

Is AGALSIDASE ALFA Getting Safer? Reports by Year

YearReportsDeathsHosp.
2008 2 0 2
2009 1 1 1
2010 1 0 0
2011 3 0 2
2014 1 0 0
2015 5 2 0
2016 3 0 1
2017 1 0 1
2018 1 0 1
2019 4 0 3
2020 12 1 10
2021 7 0 6
2022 9 0 8
2023 9 1 5
2024 2 1 1
2025 1 0 0

View full timeline →

What Is AGALSIDASE ALFA Used For?

IndicationReports
Fabry's disease 71
Product used for unknown indication 19

AGALSIDASE ALFA vs Alternatives: Which Is Safer?

AGALSIDASE ALFA vs AGALSIDASE BETA AGALSIDASE ALFA vs AGOMELATINE AGALSIDASE ALFA vs ALAWAY AGALSIDASE ALFA vs ALBENDAZOLE AGALSIDASE ALFA vs ALBIGLUTIDE AGALSIDASE ALFA vs ALBUMIN AGALSIDASE ALFA vs ALBUMIN HUMAN AGALSIDASE ALFA vs ALBUTEROL AGALSIDASE ALFA vs ALBUTEROL\BUDESONIDE AGALSIDASE ALFA vs ALBUTEROL\IPRATROPIUM

Official FDA Label for AGALSIDASE ALFA

Official prescribing information from the FDA-approved drug label.