FORTESTA: 54 Adverse Event Reports & Safety Profile
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54
Total FAERS Reports
1 (1.9%)
Deaths Reported
4
Hospitalizations
54
As Primary/Secondary Suspect
3
Life-Threatening
4
Disabilities
First Report: 2012 · Latest Report: 20140612
What Are the Most Common FORTESTA Side Effects?
#1 Most Reported
Drug ineffective
15 reports (27.8%)
#2 Most Reported
Application site erythema
9 reports (16.7%)
#3 Most Reported
Application site rash
7 reports (13.0%)
All FORTESTA Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Drug ineffective | 15 | 27.8% | 0 | 0 |
| Application site erythema | 9 | 16.7% | 0 | 0 |
| Application site rash | 7 | 13.0% | 0 | 0 |
| Application site pain | 6 | 11.1% | 0 | 0 |
| Cerebrovascular accident | 6 | 11.1% | 0 | 2 |
Who Reports FORTESTA Side Effects? Age & Gender Data
Average age: 59.9 years. Most reports from: US. View detailed demographics →
Is FORTESTA Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2012 | 1 | 0 | 0 |
| 2013 | 36 | 1 | 3 |
| 2014 | 4 | 0 | 1 |
What Is FORTESTA Used For?
| Indication | Reports |
|---|---|
| Blood testosterone decreased | 26 |
| Product used for unknown indication | 17 |
| Hypogonadism | 5 |
Official FDA Label for FORTESTA
Official prescribing information from the FDA-approved drug label.