Diclofenac: adverse event reports filed with FDA

27,760

reports as suspect product

0.1% of all reports · about 1,239 a year

2,842

reports, 12 months to June 2026

2,957 in the 12 months before

91.6%

marked serious by the reporter

71.8% across the class

16.1%

record death among outcomes, as reported

4,475 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 Diclofenac reports recording the termmedian drug in nonsteroidal anti-inflammatory drug

1. Drug ineffectivethe medicine did not work as expected19.5%5,412
2. Painpain, site not specified16.8%4,677
3. Fatiguetiredness15.3%4,237
4. Rashskin rash13.9%3,845
5. Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease13.2%3,663
6. Abdominal discomfortstomach discomfort13.1%3,643
7. Arthralgiajoint pain13.1%3,634
8. Off label useused for a purpose or in a way not on the label12.8%3,564
9. Joint swellinga swollen joint12.6%3,496
10. Pemphigus12.3%3,405
11. Systemic lupus erythematosuslupus, an autoimmune disease11.9%3,299
12. Glossodynia11.8%3,289
13. Alopeciahair loss11.8%3,288
14. Drug intolerancethe medicine was not tolerated11.6%3,225
15. Swellingswelling11.3%3,144
16. Hypersensitivityan allergic-type reaction11%3,051
17. Synovitis11%3,041
18. Arthropathy10.9%3,027
19. Hand deformity10.9%3,013
20. Infusion related reactiona reaction during or soon after an infusion10.8%2,998
21. Hepatic enzyme increasedraised liver enzymes10.7%2,980
22. Wound10.6%2,947
23. Pericarditisinflammation of the sac around the heart10.6%2,946
24. Dyspnoeashortness of breath10.3%2,855
25. Discomfortdiscomfort10.3%2,851
26. Anti-cyclic citrullinated peptide antibody positive9.6%2,652
27. Maternal exposure during pregnancythe mother took the medicine during pregnancy9.4%2,615
28. Duodenal ulcer perforation9.4%2,608
29. Contraindicated product administered9.4%2,596
30. Nauseafeeling sick9.3%2,579

Top 30 of 2,792 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. 15.4% 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 27,760 reports.

Drugs most often listed in the same reports

Other products listed in reports where Diclofenac 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 Diclofenac as a suspect or interacting product; reports listing it only as a concomitant medication (28,001) 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.