FRONTAL: 24 Adverse Event Reports & Safety Profile
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24
Total FAERS Reports
0
Deaths Reported
4
Hospitalizations
24
As Primary/Secondary Suspect
First Report: 1971 · Latest Report: 201404
What Are the Most Common FRONTAL Side Effects?
#1 Most Reported
Depression
5 reports (20.8%)
#2 Most Reported
Off label use
3 reports (12.5%)
#3 Most Reported
Head injury
3 reports (12.5%)
All FRONTAL Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Depression | 5 | 20.8% | 0 | 0 |
Who Reports FRONTAL Side Effects? Age & Gender Data
Average age: 65.0 years. Most reports from: BR. View detailed demographics →
Is FRONTAL Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2004 | 1 | 0 | 0 |
| 2007 | 1 | 0 | 0 |
| 2009 | 1 | 0 | 0 |
| 2012 | 5 | 0 | 0 |
| 2013 | 1 | 0 | 0 |
| 2014 | 5 | 0 | 2 |
What Is FRONTAL Used For?
| Indication | Reports |
|---|---|
| Sleep disorder | 7 |
| Anxiety | 6 |
| Depression | 5 |
Official FDA Label for FRONTAL
Official prescribing information from the FDA-approved drug label.