Anakinra: adverse event reports filed with FDA

5,639

reports as suspect product

0% of all reports · about 251 a year

466

reports, 12 months to June 2026

625 in the 12 months before

96.3%

marked serious by the reporter

66.3% across the class

13.8%

record death among outcomes, as reported

779 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 Anakinra reports recording the termmedian drug in interleukin-1 receptor antagonist

1. Drug ineffectivethe medicine did not work as expected47.1%2,656
2. Off label useused for a purpose or in a way not on the label36.9%2,078
3. Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease20.2%1,140
4. Condition aggravatedthe condition being treated got worse17.2%970
5. Painpain, site not specified16%905
6. Drug intolerancethe medicine was not tolerated15.9%897
7. Joint swellinga swollen joint14.6%822
8. Contraindicated product administered12.8%720
9. Arthropathy10.9%613
10. Therapeutic product effect decreased10.2%574
11. Mobility decreasedreduced ability to move about10.1%572
12. Treatment failurethe treatment did not work9.9%559
13. Arthralgiajoint pain9.6%544
14. Drug hypersensitivityan allergic-type reaction to a medicine9.5%537
15. Red blood cell sedimentation rate increased9.5%537
16. Nauseafeeling sick9.2%521
17. Synovitis9%507
18. Diarrhoealoose or frequent stools8.7%490
19. C-reactive protein increased8.5%480
20. Loss of consciousnesspassing out8.5%477
21. Septic shockshock arising from infection8.3%470
22. Adrenal insufficiencythe adrenal glands produce too little hormone8.1%458
23. Psoriasispsoriasis, a skin condition7.9%446
24. Vomitingbeing sick7.5%422
25. Polyarthritis7.4%417
26. Obesity7.2%408
27. Intentional product use issuedeliberate use not as intended7.1%401
28. Infectionan infection, type not specified7.1%398
29. Arthritis7%396
30. Renal failurekidney failure6.8%386

Top 30 of 1,006 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 2 drugs in the interleukin-1 receptor antagonist 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 14,178 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. 21.5% 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 5,639 reports.

Drugs most often listed in the same reports

Other products listed in reports where Anakinra 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 interleukin-1 receptor antagonist 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 Anakinra as a suspect or interacting product; reports listing it only as a concomitant medication (1,977) 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.