HIGH-VOLUME · SEX-BALANCED
naproxen Side Effects
naproxen (also sold as Aleve, Naprosyn) is HIGH-VOLUME in this FAERS book #97 of 524 by FAERS report count. Signature opener: SEX-BALANCED - 67% of sex-coded reports are female (46,198 F / 22,842 M).
Data updated 2026-05-15
- 75,912
- FAERS reports
FAERS voluntary reports, 2004 to 2025. High volume tracks exposure and reporting culture; see methodology for de-dup rules.
naproxen reporting skew - 67% of sex-coded reports are female (46,198 F / 22,842 M). Volume band HIGH-VOLUME #97 of 524 by FAERS report count; caseload CASELOAD.
High-report extract for naproxen (Aleve): 75,912 FAERS rows (2004-2025). Top named reactions: PAIN, FATIGUE, ARTHRALGIA. Outcome stamps DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED. FAERS is voluntary signal detection, not incidence.
Counts from the openFDA FAERS extract (2004–2025). Stamps CASELOAD · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
PAIN leads 8,756 of 75,912 reports
Who reports · age peak 45-64 (SEX-BALANCED)
Sex coding · SEX-BALANCED
Age peak 45-64 (22,657 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death-mentioned subset is HEAVY here (7,527 reports, 9.9%). Top co-reported reactions in that subset - voluntary, not causal.
| 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
Hospitalization is HEAVY (25,220, 33.2% of the book). Top reactions in those rows:
| 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 |
How to read naproxen FAERS figures (CASELOAD · DEATH-HEAVY · HOSP-HEAVY)
FAERS holds 75,912 voluntary reports linked to naproxen (Aleve, Naprosyn), 2004-2025. Death is listed on 7,527 (9.9%). Hospitalization appears on 25,220 (33.2%). Top co-reported indication: Product Used For Unknown Indication.
CASELOAD books overweight common drugs and loud reporting cultures; SEX-BALANCED is the page opener, not a per-patient risk.
Read with naproxen
Peers ranked by ABS(total_reports), then an ABS(death_share) pole; guide hop follows DEATH-HEAVY · HOSP-HEAVY stamps.
ABS(total_reports) peer at 76,270 FAERS cases (Δ 358 heavier vs naproxen); DEATH-HEAVY · HOSP-MID · FEMALE-LED vs this page's CASELOAD · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 78,359 FAERS cases (Δ 2,447 heavier vs naproxen); DEATH-MARKED · HOSP-MID · SEX-BALANCED vs this page's CASELOAD · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 73,430 FAERS cases (Δ 2,482 lighter vs naproxen); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's CASELOAD · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 72,798 FAERS cases (Δ 3,114 lighter vs naproxen); DEATH-MARKED · HOSP-MID · FEMALE-LED vs this page's CASELOAD · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 52.2 pp vs naproxen's DEATH-HEAVY): CASELOAD · HOSP-MID.
naproxen stamps DEATH-HEAVY · HOSP-HEAVY; FAERS outcome shares are signal-detection rates, not incidence. Read them next to caseload CASELOAD and the label guide.