ACTIVASE: 87 Adverse Event Reports & Safety Profile
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87
Total FAERS Reports
27 (31.0%)
Deaths Reported
31
Hospitalizations
87
As Primary/Secondary Suspect
8
Life-Threatening
2
Disabilities
First Report: 2012 · Latest Report: 20140422
What Are the Most Common ACTIVASE Side Effects?
#1 Most Reported
Haemorrhage intracranial
16 reports (18.4%)
#2 Most Reported
Angioedema
11 reports (12.6%)
#3 Most Reported
Haemorrhage
10 reports (11.5%)
All ACTIVASE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Haemorrhage intracranial | 16 | 18.4% | 3 | 2 |
| Angioedema | 11 | 12.6% | 1 | 8 |
| Haemorrhage | 10 | 11.5% | 4 | 3 |
| Death | 8 | 9.2% | 8 | 1 |
| Cerebrovascular accident | 5 | 5.8% | 2 | 2 |
| Haemorrhagic transformation stroke | 5 | 5.8% | 4 | 1 |
Who Reports ACTIVASE Side Effects? Age & Gender Data
Average age: 67.3 years. Most reports from: US. View detailed demographics →
Is ACTIVASE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2012 | 6 | 1 | 3 |
| 2013 | 9 | 6 | 2 |
| 2014 | 11 | 2 | 8 |
What Is ACTIVASE Used For?
| Indication | Reports |
|---|---|
| Cerebrovascular accident | 28 |
| Product used for unknown indication | 21 |
| Ischaemic stroke | 20 |
Official FDA Label for ACTIVASE
Official prescribing information from the FDA-approved drug label.