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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.

ALEVE GELCAPS: 84 Adverse Event Reports & Safety Profile

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84
Total FAERS Reports
0
Deaths Reported
1
Hospitalizations
84
As Primary/Secondary Suspect
1
Life-Threatening
1
Disabilities

First Report: 1994 · Latest Report: 20140603

What Are the Most Common ALEVE GELCAPS Side Effects?

#1 Most Reported
Incorrect drug administration duration
29 reports (34.5%)
#2 Most Reported
Drug ineffective
29 reports (34.5%)
#3 Most Reported
Extra dose administered
15 reports (17.9%)

All ALEVE GELCAPS Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug ineffective 29 34.5% 0 0
Incorrect drug administration duration 29 34.5% 0 0
Extra dose administered 15 17.9% 0 0
Intentional product misuse 5 6.0% 0 0
Off label use 5 6.0% 0 0

Who Reports ALEVE GELCAPS Side Effects? Age & Gender Data

Average age: 65.5 years. Most reports from: US. View detailed demographics →

Is ALEVE GELCAPS Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 1 0 0
2005 1 0 0
2010 2 0 0
2011 1 0 0
2012 3 0 0
2013 13 0 1
2014 44 0 0

View full timeline →

What Is ALEVE GELCAPS Used For?

IndicationReports
Arthritis 23
Analgesic therapy 18
Back pain 11
Pain 6
Arthralgia 5

Official FDA Label for ALEVE GELCAPS

Official prescribing information from the FDA-approved drug label.