Aleve Gelcapsnaproxen
According to the FDA label: Naproxen tablets and naproxen sodium tablets are indicated for: the relief of the signs and symptoms of: • rheumatoid arthritis • osteoarthritis • ankylosing spondylitis • Polyarticular Juvenile Idiopathic Arthritis Naproxen tablets and naproxen sodium tablets are also indicated for: the relief of signs and symptoms of: • tendonitis • bursitis • acute gout the management of: • pain • primary dysmenorrhea Naproxen tablets and naproxen sodium tablets are non-steroidal anti-inflammatory drugs…
65,569 adverse event reports submitted to the FDA (2002–2026)
Top Reported Adverse Events
The most frequently reported events in association with Aleve Gelcaps in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
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Drug Ineffective 10,943 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Fatigue 4,930 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Product Use Issue 4,716 reports
A general report that there was some problem in how the medication was used.
Full definition in the glossary →Pain 4,552 reports
A general report of physical discomfort, used when no more specific location is given.
Full definition in the glossary →Nausea 4,141 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Arthralgia 3,945 reports
Headache 3,917 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →Off Label Use 3,865 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →Dizziness 3,810 reports
A feeling of being lightheaded, unsteady, or like the room is spinning.
Full definition in the glossary → See all drugs reporting this event →Diarrhoea 3,792 reports
Loose or watery bowel movements, often frequent. Also spelled diarrhea in American English.
Full definition in the glossary → See all drugs reporting this event →Rash 3,400 reports
An area of irritated, red, or bumpy skin.
Full definition in the glossary → See all drugs reporting this event →Vomiting 3,316 reports
Throwing up the contents of the stomach.
Full definition in the glossary → See all drugs reporting this event →Drug Hypersensitivity 3,207 reports
An allergic-type reaction to a medication.
Full definition in the glossary →Abdominal Pain Upper 3,038 reports
Pain in the upper part of the belly, above the navel.
Full definition in the glossary →Abdominal Discomfort 3,016 reports
A general unease or mild pain in the belly area.
Full definition in the glossary →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 39,084 |
| Male | 16,973 |
| Unknown | 83 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 1,102 |
| 18-34 | 2,922 |
| 35-49 | 7,579 |
| 50-64 | 10,284 |
| 65-74 | 7,189 |
| 75+ | 7,448 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Aleve Gelcaps. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Non-Serious | 38,872 |
| Other Serious | 19,827 |
| Hospitalization | 11,838 |
| Death | 4,673 |
| Disability | 4,384 |
| Life-Threatening | 4,379 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Aleve Gelcaps. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2002 | 1 |
| 2003 | 1 |
| 2004 | 644 |
| 2005 | 773 |
| 2006 | 632 |
| 2007 | 658 |
| 2008 | 3,280 |
| 2009 | 1,851 |
| 2010 | 786 |
| 2011 | 1,013 |
| 2012 | 1,807 |
| 2013 | 1,661 |
| 2014 | 3,773 |
| 2015 | 7,071 |
| 2016 | 6,836 |
| 2017 | 5,774 |
| 2018 | 4,827 |
| 2019 | 4,618 |
| 2020 | 3,572 |
| 2021 | 3,013 |
| 2022 | 2,897 |
| 2023 | 2,814 |
| 2024 | 3,524 |
| 2025 | 3,237 |
| 2026 (partial) | 506 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Aleve Gelcaps
In FDA adverse event reports that mention Aleve Gelcaps, these medications appeared most often in the same report.
- Acetaminophen (9,474 reports)
- Ergocalciferol (8,066 reports)
- Prednisone (7,566 reports)
- Ibuprofen (7,014 reports)
- Methotrexate (6,700 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026