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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

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

YearReportsDeathsHosp.
2011 1 0 0
2013 3 0 3
2014 3 1 2

View full timeline →

What Is ROZEREM Used For?

IndicationReports
Insomnia 5

Official FDA Label for ROZEREM

Official prescribing information from the FDA-approved drug label.