RETEPLASE: 40 Adverse Event Reports & Safety Profile
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40
Total FAERS Reports
22 (55.0%)
Deaths Reported
14
Hospitalizations
40
As Primary/Secondary Suspect
11
Life-Threatening
Prescription
Status
FDA Application: 103786 ·
First Report: 20030805 · Latest Report: 20200128
What Are the Most Common RETEPLASE Side Effects?
#1 Most Reported
Cerebral haemorrhage
9 reports (22.5%)
#2 Most Reported
Cardiac arrest
7 reports (17.5%)
#3 Most Reported
Drug ineffective
6 reports (15.0%)
All RETEPLASE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Cerebral haemorrhage | 9 | 22.5% | 9 | 3 |
| Cardiac arrest | 7 | 17.5% | 7 | 1 |
| Brain herniation | 6 | 15.0% | 6 | 0 |
| Drug ineffective | 6 | 15.0% | 1 | 1 |
Who Reports RETEPLASE Side Effects? Age & Gender Data
Gender: 21.6% female, 78.4% male. Average age: 58.1 years. Most reports from: CN. View detailed demographics →
Is RETEPLASE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2003 | 1 | 1 | 0 |
| 2004 | 4 | 3 | 0 |
| 2005 | 1 | 0 | 1 |
| 2006 | 2 | 1 | 1 |
| 2015 | 4 | 4 | 0 |
| 2016 | 2 | 2 | 0 |
| 2020 | 1 | 0 | 0 |
What Is RETEPLASE Used For?
| Indication | Reports |
|---|---|
| Acute myocardial infarction | 20 |
| Thrombolysis | 8 |
Official FDA Label for RETEPLASE
Official prescribing information from the FDA-approved drug label.