UROKINASE: 55 Adverse Event Reports & Safety Profile
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55
Total FAERS Reports
8 (14.5%)
Deaths Reported
27
Hospitalizations
55
As Primary/Secondary Suspect
8
Life-Threatening
1
Disabilities
Discontinued
Status
FDA Application: 021846 ·
First Report: 20130204 · Latest Report: 20240409
What Are the Most Common UROKINASE Side Effects?
#1 Most Reported
Drug ineffective
15 reports (27.3%)
#2 Most Reported
Haemorrhagic transformation stroke
5 reports (9.1%)
#3 Most Reported
Gastrointestinal haemorrhage
4 reports (7.3%)
All UROKINASE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Drug ineffective | 15 | 27.3% | 1 | 9 |
| Haemorrhagic transformation stroke | 5 | 9.1% | 1 | 0 |
Who Reports UROKINASE Side Effects? Age & Gender Data
Gender: 25.5% female, 74.5% male. Average age: 44.7 years. Most reports from: CN. View detailed demographics →
Is UROKINASE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2013 | 3 | 0 | 2 |
| 2014 | 2 | 0 | 2 |
| 2015 | 2 | 1 | 0 |
| 2016 | 2 | 0 | 2 |
| 2017 | 2 | 0 | 2 |
| 2018 | 2 | 2 | 0 |
| 2020 | 1 | 0 | 1 |
| 2022 | 2 | 0 | 0 |
| 2024 | 2 | 0 | 2 |
What Is UROKINASE Used For?
| Indication | Reports |
|---|---|
| Ischaemic stroke | 6 |
| Product used for unknown indication | 5 |
Official FDA Label for UROKINASE
Official prescribing information from the FDA-approved drug label.