Diclofenac sodium gel: adverse event reports filed with FDA

919

reports as suspect product

0% of all reports · about 90 a year

0

reports, 12 months to June 2026

0 in the 12 months before

0.3%

marked serious by the reporter

71.8% across the class

0%

record death among outcomes, as reported

0 reports · not verified by FDA

Reports by month, five years

No report listing Diclofenac sodium gel was received in the five years to June 2026; the latest was received in September 2020.

By year received

Reactions recorded in the reports

share of Diclofenac sodium gel reports recording the termmedian drug in nonsteroidal anti-inflammatory drug

1. Off label useused for a purpose or in a way not on the label38.6%355
2. Product administered at inappropriate site26.2%241
3. Product use in unapproved indicationused for a purpose not on the label21.9%201
4. Drug ineffectivethe medicine did not work as expected12.5%115
5. Wrong technique in product usage processthe product was used in the wrong way12.1%111
6. Drug effective for unapproved indication10%92
7. Drug administered at inappropriate site8.9%82
8. Drug ineffective for unapproved indication6.4%59
9. Inappropriate schedule of product administrationthe product was taken at the wrong times6.4%59
10. Inappropriate schedule of drug administrationthe medicine was taken at the wrong times6.2%57
11. Incorrect dose administeredthe wrong dose was given6%55
12. Product use issuea problem in how the product was used4.5%41
13. Contraindicated product administered3.6%33
14. Expired product administeredthe product was used past its expiry date3.4%31
15. Prescription drug used without a prescription2.9%27
16. Accidental exposure to product2.8%26
17. Product complaint2.7%25
18. Rashskin rash2.7%25
19. Condition aggravatedthe condition being treated got worse2.2%20
20. Pruritusitching2.1%19
21. Adverse drug reactiona harmful or unpleasant reaction reported to a medicine2%18
22. Application site pain1.8%17
23. Application site rash1.6%15
24. Incorrect dosage administered1.6%15
25. Product quality issuea problem with the product itself1.6%15
26. Erythemaskin redness1.5%14
27. Therapeutic response unexpected1.5%14
28. Circumstance or information capable of leading to medication errora situation that could lead to a medication error1.4%13
29. Burning sensationa burning feeling1.3%12
30. Nauseafeeling sick1.3%12

Top 30 of 106 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. 100% 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 919 reports.

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 sodium gel as a suspect or interacting product; reports listing it only as a concomitant medication (14) 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.