ACTILYSE: 65 Adverse Event Reports & Safety Profile
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65
Total FAERS Reports
26 (40.0%)
Deaths Reported
11
Hospitalizations
65
As Primary/Secondary Suspect
4
Life-Threatening
4
Disabilities
First Report: 20100913 · Latest Report: 20140331
What Are the Most Common ACTILYSE Side Effects?
#1 Most Reported
Cerebral haemorrhage
12 reports (18.5%)
#2 Most Reported
Death
10 reports (15.4%)
#3 Most Reported
Drug ineffective
9 reports (13.8%)
All ACTILYSE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Cerebral haemorrhage | 12 | 18.5% | 9 | 1 |
| Death | 10 | 15.4% | 10 | 0 |
| Drug ineffective | 9 | 13.9% | 1 | 2 |
| Haemorrhagic transformation stroke | 7 | 10.8% | 4 | 0 |
Who Reports ACTILYSE Side Effects? Age & Gender Data
Average age: 62.5 years. Most reports from: US. View detailed demographics →
Is ACTILYSE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2010 | 1 | 1 | 0 |
| 2011 | 5 | 5 | 0 |
| 2012 | 1 | 1 | 0 |
| 2013 | 8 | 2 | 1 |
| 2014 | 3 | 1 | 1 |
What Is ACTILYSE Used For?
| Indication | Reports |
|---|---|
| Ischaemic stroke | 26 |
| Cerebral infarction | 10 |
Official FDA Label for ACTILYSE
Official prescribing information from the FDA-approved drug label.