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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: 435 Adverse Event Reports & Safety Profile

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435
Total FAERS Reports
2 (0.5%)
Deaths Reported
17
Hospitalizations
435
As Primary/Secondary Suspect
2
Life-Threatening
4
Disabilities

First Report: 1990 · Latest Report: 20141217

What Are the Most Common ALEVE Side Effects?

#1 Most Reported
Drug ineffective
120 reports (27.6%)
#2 Most Reported
Incorrect drug administration duration
109 reports (25.1%)
#3 Most Reported
Extra dose administered
58 reports (13.3%)

All ALEVE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug ineffective 120 27.6% 0 1
Incorrect drug administration duration 109 25.1% 0 1
Extra dose administered 58 13.3% 0 0
Off label use 23 5.3% 0 1
Intentional product misuse 22 5.1% 0 0
Drug hypersensitivity 19 4.4% 0 0
Incorrect dose administered 15 3.5% 0 0
Nausea 15 3.5% 0 1
Headache 13 3.0% 0 0
Abdominal pain upper 12 2.8% 0 0
Inappropriate schedule of drug administration 12 2.8% 0 0
Dizziness 11 2.5% 0 2
Dyspepsia 11 2.5% 0 0
Dyspnoea 10 2.3% 0 1
Insomnia 10 2.3% 0 0
Intentional drug misuse 10 2.3% 0 0
Swelling face 9 2.1% 1 0
Urticaria 9 2.1% 0 1
Abdominal discomfort 8 1.8% 0 0
Blood pressure increased 8 1.8% 0 1

Who Reports ALEVE Side Effects? Age & Gender Data

Average age: 63.2 years. Most reports from: US. View detailed demographics →

Is ALEVE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2004 1 0 0
2006 4 0 0
2007 1 0 0
2008 2 0 0
2009 5 0 0
2010 8 0 0
2011 5 0 1
2012 12 0 4
2013 72 1 3
2014 217 0 5

View full timeline →

What Is ALEVE Used For?

IndicationReports
Arthritis 75
Back pain 65
Analgesic therapy 52
Pain 36
Arthralgia 24
Headache 21
Myalgia 13
Product used for unknown indication 12
Pain in extremity 6
Inflammation 5

ALEVE vs Alternatives: Which Is Safer?

ALEVE vs ALEVE CAPLET ALEVE vs ALEVE LIQUID ALEVE vs ALFACALCIDOL ALEVE vs ALFENTANIL ALEVE vs ALFUZOSIN ALEVE vs ALGLUCOSIDASE ALFA ALEVE vs ALIMTA ALEVE vs ALIROCUMAB ALEVE vs ALISKIREN ALEVE vs ALISKIREN HEMIFUMARATE

Official FDA Label for ALEVE

Official prescribing information from the FDA-approved drug label.