ULINASTATIN: 32 Adverse Event Reports & Safety Profile
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32
Total FAERS Reports
3 (9.4%)
Deaths Reported
15
Hospitalizations
32
As Primary/Secondary Suspect
5
Life-Threatening
First Report: 20140124 · Latest Report: 20250902
What Are the Most Common ULINASTATIN Side Effects?
#1 Most Reported
Off label use
4 reports (12.5%)
#2 Most Reported
Anaphylactic shock
4 reports (12.5%)
#3 Most Reported
Premature rupture of membranes
3 reports (9.4%)
All ULINASTATIN Side Effects by Frequency
No side effect data available.
Who Reports ULINASTATIN Side Effects? Age & Gender Data
Gender: 48.4% female, 51.6% male. Average age: 49.6 years. Most reports from: CN. View detailed demographics →
Is ULINASTATIN Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2014 | 1 | 0 | 1 |
| 2015 | 2 | 0 | 2 |
| 2016 | 1 | 1 | 0 |
| 2017 | 3 | 0 | 0 |
| 2018 | 2 | 0 | 2 |
| 2020 | 2 | 0 | 2 |
| 2022 | 2 | 0 | 0 |
| 2023 | 1 | 0 | 1 |
| 2025 | 1 | 0 | 1 |
What Is ULINASTATIN Used For?
| Indication | Reports |
|---|---|
| Pancreatitis acute | 5 |
| Product used for unknown indication | 5 |
Official FDA Label for ULINASTATIN
Official prescribing information from the FDA-approved drug label.