SERESTA: 55 Adverse Event Reports & Safety Profile
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55
Total FAERS Reports
4 (7.3%)
Deaths Reported
48
Hospitalizations
55
As Primary/Secondary Suspect
7
Life-Threatening
First Report: 201212 · Latest Report: 20140507
What Are the Most Common SERESTA Side Effects?
#1 Most Reported
Fall
11 reports (20.0%)
#2 Most Reported
Coma
9 reports (16.4%)
#3 Most Reported
Somnolence
7 reports (12.7%)
All SERESTA Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Fall | 11 | 20.0% | 0 | 11 |
| Coma | 9 | 16.4% | 0 | 6 |
| Somnolence | 7 | 12.7% | 0 | 7 |
| Confusional state | 6 | 10.9% | 0 | 6 |
| Electrocardiogram qt prolonged | 5 | 9.1% | 0 | 3 |
Who Reports SERESTA Side Effects? Age & Gender Data
Average age: 68.9 years. Most reports from: FR. View detailed demographics →
Is SERESTA Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2012 | 2 | 0 | 2 |
| 2013 | 24 | 0 | 23 |
| 2014 | 27 | 4 | 22 |
What Is SERESTA Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 24 |
Official FDA Label for SERESTA
Official prescribing information from the FDA-approved drug label.