OLIPUDASE ALFA-RPCP: 96 Adverse Event Reports & Safety Profile
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96
Total FAERS Reports
1 (1.0%)
Deaths Reported
13
Hospitalizations
96
As Primary/Secondary Suspect
Prescription
Status
FDA Application: 761261 ·
First Report: 20220101 · Latest Report: 20250509
What Are the Most Common OLIPUDASE ALFA-RPCP Side Effects?
#1 Most Reported
Incorrect dose administered
10 reports (10.4%)
#2 Most Reported
Headache
8 reports (8.3%)
#3 Most Reported
Fatigue
7 reports (7.3%)
All OLIPUDASE ALFA-RPCP Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Incorrect dose administered | 10 | 10.4% | 1 | 2 |
| Headache | 8 | 8.3% | 0 | 1 |
| Fatigue | 7 | 7.3% | 0 | 0 |
| Erythema | 5 | 5.2% | 0 | 1 |
| Pyrexia | 5 | 5.2% | 1 | 3 |
| Sinusitis | 5 | 5.2% | 0 | 0 |
| Weight increased | 5 | 5.2% | 0 | 0 |
Who Reports OLIPUDASE ALFA-RPCP Side Effects? Age & Gender Data
Gender: 71.0% female, 29.0% male. Average age: 12.9 years. Most reports from: US. View detailed demographics →
Is OLIPUDASE ALFA-RPCP Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2022 | 8 | 0 | 2 |
| 2023 | 23 | 1 | 5 |
| 2024 | 17 | 0 | 4 |
| 2025 | 8 | 0 | 1 |
What Is OLIPUDASE ALFA-RPCP Used For?
| Indication | Reports |
|---|---|
| Niemann-pick disease | 80 |
Official FDA Label for OLIPUDASE ALFA-RPCP
Official prescribing information from the FDA-approved drug label.