OFLOCET: 30 Adverse Event Reports & Safety Profile
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30
Total FAERS Reports
6 (20.0%)
Deaths Reported
21
Hospitalizations
30
As Primary/Secondary Suspect
5
Life-Threatening
1
Disabilities
First Report: 20001208 · Latest Report: 20140512
What Are the Most Common OFLOCET Side Effects?
#1 Most Reported
Toxic epidermal necrolysis
5 reports (16.7%)
#2 Most Reported
Renal failure acute
4 reports (13.3%)
#3 Most Reported
Hypoglycaemic coma
4 reports (13.3%)
All OFLOCET Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Toxic epidermal necrolysis | 5 | 16.7% | 5 | 1 |
Who Reports OFLOCET Side Effects? Age & Gender Data
Average age: 55.7 years. Most reports from: FR. View detailed demographics →
Is OFLOCET Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2000 | 1 | 0 | 1 |
| 2005 | 1 | 0 | 1 |
| 2008 | 1 | 1 | 0 |
| 2013 | 14 | 0 | 13 |
| 2014 | 13 | 5 | 6 |
What Is OFLOCET Used For?
| Indication | Reports |
|---|---|
| Prostatitis | 6 |
| Product used for unknown indication | 5 |
Official FDA Label for OFLOCET
Official prescribing information from the FDA-approved drug label.