ROZEREM: 13 Adverse Event Reports & Safety Profile
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13
Total FAERS Reports
1 (7.7%)
Deaths Reported
7
Hospitalizations
13
As Primary/Secondary Suspect
2
Life-Threatening
2
Disabilities
First Report: 201102 · Latest Report: 201404
What Are the Most Common ROZEREM Side Effects?
#1 Most Reported
Hypoaesthesia
4 reports (30.8%)
#2 Most Reported
Drug hypersensitivity
4 reports (30.8%)
#3 Most Reported
Pruritus
3 reports (23.1%)
All ROZEREM Side Effects by Frequency
No side effect data available.
Who Reports ROZEREM Side Effects? Age & Gender Data
Average age: 65.3 years. Most reports from: JP. View detailed demographics →
Is ROZEREM Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2011 | 1 | 0 | 0 |
| 2013 | 3 | 0 | 3 |
| 2014 | 3 | 1 | 2 |
What Is ROZEREM Used For?
| Indication | Reports |
|---|---|
| Insomnia | 5 |
Official FDA Label for ROZEREM
Official prescribing information from the FDA-approved drug label.