PREDONINE: 74 Adverse Event Reports & Safety Profile
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74
Total FAERS Reports
19 (25.7%)
Deaths Reported
50
Hospitalizations
74
As Primary/Secondary Suspect
11
Life-Threatening
3
Disabilities
First Report: 20090425 · Latest Report: 20140413
What Are the Most Common PREDONINE Side Effects?
#1 Most Reported
Sepsis
6 reports (8.1%)
#2 Most Reported
Disseminated intravascular coagulation
6 reports (8.1%)
#3 Most Reported
Renal impairment
4 reports (5.4%)
All PREDONINE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Disseminated intravascular coagulation | 6 | 8.1% | 4 | 5 |
| Sepsis | 6 | 8.1% | 5 | 3 |
Who Reports PREDONINE Side Effects? Age & Gender Data
Average age: 57.8 years. Most reports from: JP. View detailed demographics →
Is PREDONINE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2009 | 1 | 1 | 1 |
| 2010 | 1 | 1 | 0 |
| 2011 | 5 | 2 | 4 |
| 2012 | 17 | 4 | 11 |
| 2013 | 30 | 9 | 20 |
| 2014 | 9 | 0 | 6 |
What Is PREDONINE Used For?
| Indication | Reports |
|---|---|
| Rheumatoid arthritis | 19 |
Official FDA Label for PREDONINE
Official prescribing information from the FDA-approved drug label.