KOGENATE FS: 60 Adverse Event Reports & Safety Profile
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60
Total FAERS Reports
2 (3.3%)
Deaths Reported
25
Hospitalizations
60
As Primary/Secondary Suspect
1
Disabilities
First Report: 2012 · Latest Report: 20140303
What Are the Most Common KOGENATE FS Side Effects?
#1 Most Reported
Haemorrhage
24 reports (40.0%)
#2 Most Reported
Haemarthrosis
5 reports (8.3%)
#3 Most Reported
Anti factor viii antibody positive
3 reports (5.0%)
All KOGENATE FS Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Haemorrhage | 24 | 40.0% | 0 | 3 |
| Haemarthrosis | 5 | 8.3% | 0 | 1 |
Who Reports KOGENATE FS Side Effects? Age & Gender Data
Average age: 31.7 years. Most reports from: AU. View detailed demographics →
Is KOGENATE FS Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2012 | 16 | 0 | 5 |
| 2013 | 13 | 1 | 8 |
| 2014 | 4 | 0 | 2 |
What Is KOGENATE FS Used For?
| Indication | Reports |
|---|---|
| Factor viii deficiency | 5 |
Official FDA Label for KOGENATE FS
Official prescribing information from the FDA-approved drug label.