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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 CAPLET: 1,242 Adverse Event Reports & Safety Profile

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1,242
Total FAERS Reports
7 (0.6%)
Deaths Reported
14
Hospitalizations
1,242
As Primary/Secondary Suspect
6
Life-Threatening

First Report: 1984 · Latest Report: 20140626

What Are the Most Common ALEVE CAPLET Side Effects?

#1 Most Reported
Drug ineffective
377 reports (30.4%)
#2 Most Reported
Incorrect drug administration duration
278 reports (22.4%)
#3 Most Reported
Extra dose administered
151 reports (12.2%)

All ALEVE CAPLET Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug ineffective 377 30.4% 0 0
Incorrect drug administration duration 278 22.4% 1 4
Extra dose administered 151 12.2% 0 2
Intentional product misuse 102 8.2% 0 0
Off label use 75 6.0% 0 0
Therapeutic response changed 50 4.0% 0 0
Intentional drug misuse 49 4.0% 0 0
Abdominal discomfort 34 2.7% 0 0
Abdominal pain upper 33 2.7% 0 0
Incorrect dose administered 32 2.6% 0 0
Nausea 31 2.5% 0 0
Dyspepsia 24 1.9% 0 0
Drug hypersensitivity 23 1.9% 0 1
Inappropriate schedule of drug administration 23 1.9% 0 0
Therapeutic response unexpected 23 1.9% 0 0
Pruritus 22 1.8% 0 0
Dizziness 19 1.5% 0 0
Expired product administered 19 1.5% 1 0
Medication error 17 1.4% 0 0
Vomiting 17 1.4% 0 1

Who Reports ALEVE CAPLET Side Effects? Age & Gender Data

Average age: 64.1 years. Most reports from: US. View detailed demographics →

Is ALEVE CAPLET Getting Safer? Reports by Year

YearReportsDeathsHosp.
2001 2 0 0
2002 1 0 1
2004 3 0 0
2005 1 0 0
2006 4 0 0
2007 4 0 0
2008 4 0 0
2009 7 0 0
2010 7 0 0
2011 16 1 1
2012 27 1 1
2013 113 1 3
2014 444 0 2

View full timeline →

What Is ALEVE CAPLET Used For?

IndicationReports
Arthritis 195
Analgesic therapy 137
Back pain 129
Pain 77
Arthralgia 58
Headache 58
Migraine 47
Myalgia 28
Inflammation 27
Toothache 26

ALEVE CAPLET vs Alternatives: Which Is Safer?

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

Official FDA Label for ALEVE CAPLET

Official prescribing information from the FDA-approved drug label.