ELAPRASE: 48 Adverse Event Reports & Safety Profile
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48
Total FAERS Reports
13 (27.1%)
Deaths Reported
24
Hospitalizations
48
As Primary/Secondary Suspect
4
Life-Threatening
First Report: 20070911 · Latest Report: 201406
What Are the Most Common ELAPRASE Side Effects?
#1 Most Reported
Infusion related reaction
11 reports (22.9%)
#2 Most Reported
Pyrexia
7 reports (14.6%)
#3 Most Reported
Respiratory failure
4 reports (8.3%)
All ELAPRASE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Infusion related reaction | 11 | 22.9% | 0 | 4 |
| Pyrexia | 7 | 14.6% | 1 | 3 |
Who Reports ELAPRASE Side Effects? Age & Gender Data
Average age: 13.2 years. Most reports from: US. View detailed demographics →
Is ELAPRASE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2007 | 1 | 0 | 1 |
| 2012 | 5 | 1 | 1 |
| 2013 | 6 | 3 | 3 |
| 2014 | 25 | 5 | 15 |
What Is ELAPRASE Used For?
| Indication | Reports |
|---|---|
| Mucopolysaccharidosis ii | 38 |
| Product used for unknown indication | 6 |
Official FDA Label for ELAPRASE
Official prescribing information from the FDA-approved drug label.