ALDURAZYME: 63 Adverse Event Reports & Safety Profile
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63
Total FAERS Reports
16 (25.4%)
Deaths Reported
30
Hospitalizations
63
As Primary/Secondary Suspect
5
Life-Threatening
First Report: 20091008 · Latest Report: 20140513
What Are the Most Common ALDURAZYME Side Effects?
#1 Most Reported
Pneumonia
8 reports (12.7%)
#2 Most Reported
Dyspnoea
7 reports (11.1%)
#3 Most Reported
Death
6 reports (9.5%)
All ALDURAZYME Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Pneumonia | 8 | 12.7% | 2 | 7 |
| Dyspnoea | 7 | 11.1% | 2 | 2 |
| Death | 6 | 9.5% | 6 | 3 |
| Pyrexia | 5 | 7.9% | 3 | 2 |
Who Reports ALDURAZYME Side Effects? Age & Gender Data
Average age: 15.4 years. Most reports from: US. View detailed demographics →
Is ALDURAZYME Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2009 | 2 | 0 | 0 |
| 2012 | 1 | 1 | 0 |
| 2013 | 16 | 0 | 8 |
| 2014 | 20 | 5 | 11 |
What Is ALDURAZYME Used For?
| Indication | Reports |
|---|---|
| Mucopolysaccharidosis i | 62 |
Official FDA Label for ALDURAZYME
Official prescribing information from the FDA-approved drug label.