Enbrel: adverse event reports filed with FDA

561,339

reports as suspect product

2.7% of all reports · about 24,955 a year

4,674

reports, 12 months to June 2026

7,072 in the 12 months before

33.3%

marked serious by the reporter

56.2% across the class

2.4%

record death among outcomes, as reported

13,621 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 Enbrel reports recording the termmedian drug in tumor necrosis factor blocker

1. Drug ineffectivethe medicine did not work as expected12.3%68,980
2. Injection site painpain where the injection was given10%56,264
3. Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease7.8%43,845
4. Arthralgiajoint pain7.5%42,044
5. Injection site erythemaredness where the injection was given7.3%40,863
6. Painpain, site not specified7.2%40,164
7. Fatiguetiredness5%27,964
8. Pain in extremitypain in an arm or leg4.3%24,252
9. Joint swellinga swollen joint4.2%23,590
10. Psoriasispsoriasis, a skin condition4.2%23,575
11. Injection site swellingswelling where the injection was given4.1%23,168
12. Headachehead pain4.1%22,890
13. Injection site pruritusitching where the injection was given3.9%21,990
14. Injection site reactiona reaction where the injection was given3.7%20,644
15. Off label useused for a purpose or in a way not on the label3.6%20,226
16. Nasopharyngitisa cold3.5%19,642
17. Condition aggravatedthe condition being treated got worse3.4%19,181
18. Rashskin rash3.3%18,745
19. Nauseafeeling sick3.1%17,260
20. Malaisegeneral feeling of being unwell3%16,956
21. Sinusitissinus infection2.8%15,923
22. Drug intolerancethe medicine was not tolerated2.7%15,292
23. Drug hypersensitivityan allergic-type reaction to a medicine2.5%13,855
24. Injection site bruisingbruising where the injection was given2.4%13,562
25. Arthropathy2.4%13,480
26. Alopeciahair loss2.4%13,253
27. Musculoskeletal stiffnessstiffness in muscles or joints2.4%13,218
28. Peripheral swellingswelling of the arms or legs2.3%13,128
29. Hypersensitivityan allergic-type reaction2.3%13,021
30. Contraindicated product administered2.2%12,388

Top 30 of 5,575 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 17 drugs in the tumor necrosis factor blocker 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 1,064,042 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. 81.6% 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 561,339 reports.

Drugs most often listed in the same reports

Other products listed in reports where Enbrel 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 tumor necrosis factor blocker 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 Enbrel as a suspect or interacting product; reports listing it only as a concomitant medication (14,780) 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.