Naproxen: adverse event reports filed with FDA

23,872

reports as suspect product

0.1% of all reports · about 1,061 a year

2,147

reports, 12 months to June 2026

2,521 in the 12 months before

90.7%

marked serious by the reporter

71.8% across the class

20.9%

record death among outcomes, as reported

4,979 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Naproxen reports recording the termmedian drug in nonsteroidal anti-inflammatory drug

1. Drug ineffectivethe medicine did not work as expected16.6%3,972
2. Off label useused for a purpose or in a way not on the label13%3,099
3. Painpain, site not specified12.9%3,090
4. Nauseafeeling sick12.4%2,971
5. Vomitingbeing sick11.3%2,699
6. Arthralgiajoint pain11%2,631
7. Diarrhoealoose or frequent stools10.9%2,606
8. Fatiguetiredness10.8%2,583
9. Rashskin rash10.4%2,476
10. Dizzinesslight-headedness or unsteadiness9.7%2,315
11. Drug hypersensitivityan allergic-type reaction to a medicine9.2%2,200
12. Abdominal discomfortstomach discomfort8.9%2,130
13. Drug intolerancethe medicine was not tolerated8.9%2,128
14. Dyspnoeashortness of breath8.9%2,118
15. Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease8.9%2,118
16. Synovitis8.8%2,104
17. Abdominal pain upperupper stomach pain8.8%2,093
18. Malaisegeneral feeling of being unwell8.6%2,063
19. Headachehead pain8.4%2,012
20. Condition aggravatedthe condition being treated got worse8.2%1,949
21. Peripheral swellingswelling of the arms or legs8%1,906
22. Joint swellinga swollen joint7.7%1,831
23. Alopeciahair loss7.3%1,742
24. Pericarditisinflammation of the sac around the heart7%1,678
25. Swellingswelling7%1,669
26. Arthropathy6.8%1,620
27. Contraindicated product administered6.7%1,588
28. Hypoaesthesianumbness6.5%1,560
29. Infusion related reactiona reaction during or soon after an infusion6.5%1,549
30. Pyrexiafever6.4%1,532

Top 30 of 2,414 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 47 drugs in the nonsteroidal anti-inflammatory drug class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 548,672 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 32.6% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 23,872 reports.

Drugs most often listed in the same reports

Other products listed in reports where Naproxen is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the nonsteroidal anti-inflammatory drug class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Naproxen as a suspect or interacting product; reports listing it only as a concomitant medication (56,472) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.