Drug side effects
naproxen Side Effects
The reactions most often reported to the FDA for naproxen (also sold as Aleve, Naprosyn), with demographics, serious outcomes, and reporting trends.
Data updated 2026-05-15
- 75,912
- FAERS reports
Data from the FDA Adverse Event Reporting System (FAERS), 2004 to 2025. A FAERS report records a temporal association, not proof of cause. See our methodology for how figures are compiled and de-duplicated.
The most commonly reported side effects of naproxen come from 75,912 reports to the FDA, broken down here by frequency, patient demographics, and serious outcomes.
This page analyzes 75,912 reports to the FDA Adverse Event Reporting System (FAERS) for naproxen (Aleve): the reactions reported most often, who reported them, serious outcomes such as hospitalization, and year-over-year trends. A FAERS report does not prove the drug caused the effect, and report volume tracks how widely a drug is used, not how likely an effect is for any one person. Educational information, not medical advice.
Total Reports
75,912
Reports Mentioning Death
7,527
9.9% of reports — not proof the medicine caused the death
Hospitalizations
25,220
33.2% of reports
Top Indication
Product Used For Unknown Indication
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 7,527 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 1,314 |
| COMPLETED SUICIDE | 1,194 |
| SYSTEMIC LUPUS ERYTHEMATOSUS | 1,175 |
| PAIN | 1,166 |
| RASH | 1,152 |
| SYNOVITIS | 1,142 |
| TYPE 2 DIABETES MELLITUS | 1,142 |
| SWELLING | 1,089 |
| PEMPHIGUS | 1,084 |
| WOUND | 1,082 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 1,076 |
| GLOSSODYNIA | 1,076 |
| INFUSION RELATED REACTION | 1,072 |
| RHEUMATOID ARTHRITIS | 1,071 |
| PSORIATIC ARTHROPATHY | 1,064 |
| VOMITING | 1,050 |
| HYPOAESTHESIA | 1,038 |
| PERICARDITIS | 1,038 |
| FOLLICULITIS | 1,017 |
Reactions in Hospitalization Reports
Top reactions in 25,220 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| PAIN | 3,636 |
| NAUSEA | 3,029 |
| FATIGUE | 2,923 |
| ARTHRALGIA | 2,751 |
| VOMITING | 2,736 |
| DIARRHOEA | 2,581 |
| RASH | 2,496 |
| DYSPNOEA | 2,305 |
| HEADACHE | 2,273 |
| MALAISE | 2,186 |
| DIZZINESS | 2,090 |
| SYNOVITIS | 2,084 |
| RHEUMATOID ARTHRITIS | 2,067 |
| CONDITION AGGRAVATED | 2,010 |
| PAIN IN EXTREMITY | 1,915 |
| ARTHROPATHY | 1,900 |
| JOINT SWELLING | 1,898 |
| PNEUMONIA | 1,854 |
Nearby, Related Medications
What the FAERS Data Reveals About naproxen Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 75,912 voluntary reports linked to naproxen and its brand equivalents (Aleve, Naprosyn), spanning 2004 through 2025. Of those, 7,527 (9.9%) listed death as an outcome and 25,220 (33.2%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 67% were female and 33% male; age distribution skews toward 45-64, with 22,657 reports in that bracket. The single most reported reaction is pain with 8,756 submissions, followed by fatigue and arthralgia.
How to read these numbers
FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice, speak with a licensed clinician about any side-effect concerns.
Drugs With a Similar FAERS Report Volume
Other medications with a total FDA adverse-event report count closest to naproxen's 75,912.
Read our methodology - how this data is sourced, computed, and verified.