Voltaren: adverse event reports filed with FDA

653

reports as suspect product

0% of all reports · about 29 a year

0

reports, 12 months to June 2026

0 in the 12 months before

94%

marked serious by the reporter

71.8% across the class

7.8%

record death among outcomes, as reported

51 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

Reactions recorded in the reports

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

1. Drug administered at inappropriate site32.6%213
2. Off label useused for a purpose or in a way not on the label21.6%141
3. Wrong technique in drug usage processthe medicine was used in the wrong way18.8%123
4. Therapeutic response unexpected16.1%105
5. Underdoseless than the intended dose11.8%77
6. Painpain, site not specified6%39
7. Drug ineffective for unapproved indication5.2%34
8. Arthritis4.3%28
9. Deaththe patient died; cause not stated by this term4.3%28
10. Falla fall4.3%28
11. Arthralgiajoint pain3.8%25
12. Rashskin rash3.5%23
13. Therapeutic response changed3.5%23
14. Back painback pain3.1%20
15. Dyspnoeashortness of breath3.1%20
16. Pain in extremitypain in an arm or leg3.1%20
17. Expired drug administered2.8%18
18. Erythemaskin redness2.6%17
19. Pruritusitching2.5%16
20. Drug dispensed to wrong patient2.3%15
21. Drug ineffectivethe medicine did not work as expected2.3%15
22. Inappropriate schedule of drug administrationthe medicine was taken at the wrong times2.3%15
23. Abasia2%13
24. Abdominal pain upperupper stomach pain2%13
25. Local swelling2%13
26. Malaisegeneral feeling of being unwell2%13
27. Blistera blister1.8%12
28. Concomitant disease aggravated1.8%12
29. Condition aggravatedthe condition being treated got worse1.8%12
30. Feeling abnormalfeeling odd or not right1.8%12

Top 30 of 254 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. 83% 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 653 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 Voltaren as a suspect or interacting product; reports listing it only as a concomitant medication (621) 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.