Etodolac: adverse event reports filed with FDA

1,045

reports as suspect product

0% of all reports · about 46 a year

22

reports, 12 months to June 2026

21 in the 12 months before

75.9%

marked serious by the reporter

71.8% across the class

14.5%

record death among outcomes, as reported

152 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 Etodolac reports recording the termmedian drug in nonsteroidal anti-inflammatory drug

1. Drug hypersensitivityan allergic-type reaction to a medicine9.6%100
2. Drug ineffectivethe medicine did not work as expected6.7%70
3. Gastrointestinal haemorrhagebleeding in the stomach or bowel4.4%46
4. Dyspnoeashortness of breath3.9%41
5. Nauseafeeling sick3.8%40
6. Rashskin rash3.7%39
7. Completed suicidedeath by suicide3.6%38
8. Dizzinesslight-headedness or unsteadiness3.2%33
9. Diarrhoealoose or frequent stools3.1%32
10. Toxicity to various agentspoisoning or toxic effect of one or more substances3%31
11. Renal failure acute2.9%30
12. Anaemialow red blood cells2.7%28
13. Painpain, site not specified2.4%25
14. Fatiguetiredness2.3%24
15. Oedema peripheralswelling of the legs, ankles or hands2.3%24
16. Pruritusitching2.3%24
17. Gastric ulcera stomach ulcer2.2%23
18. Abdominal pain upperupper stomach pain2.1%22
19. Headachehead pain2.1%22
20. Hypotensionlow blood pressure2.1%22
21. Arthralgiajoint pain2%21
22. Chest painchest pain2%21
23. Pyrexiafever2%21
24. Astheniaweakness or lack of energy1.9%20
25. Deaththe patient died; cause not stated by this term1.9%20
26. Pain in extremitypain in an arm or leg1.9%20
27. Rectal haemorrhage1.9%20
28. Urticariahives1.9%20
29. Vomitingbeing sick1.9%20
30. Gastric haemorrhage1.8%19

Top 30 of 303 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. 65.9% 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 1,045 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 Etodolac as a suspect or interacting product; reports listing it only as a concomitant medication (4,977) 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.