Actemra: adverse event reports filed with FDA

80,095

reports as suspect product

0.4% of all reports · about 4,514 a year

3,726

reports, 12 months to June 2026

5,018 in the 12 months before

73.6%

marked serious by the reporter

70.4% across the class

9%

record death among outcomes, as reported

7,179 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 Actemra reports recording the termmedian drug in interleukin-6 receptor antagonist

1. Drug ineffectivethe medicine did not work as expected37.3%29,876
2. Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease24.6%19,672
3. Painpain, site not specified21.9%17,565
4. Arthralgiajoint pain18.8%15,033
5. Joint swellinga swollen joint18.2%14,576
6. Off label useused for a purpose or in a way not on the label16.7%13,385
7. Fatiguetiredness16.3%13,047
8. Rashskin rash14.7%11,803
9. Drug intolerancethe medicine was not tolerated14.5%11,635
10. Contraindicated product administered13.8%11,063
11. Arthropathy11.8%9,438
12. Swellingswelling11.5%9,218
13. Alopeciahair loss11.5%9,215
14. Synovitis11.4%9,144
15. Abdominal discomfortstomach discomfort11.4%9,135
16. Hypersensitivityan allergic-type reaction10.9%8,726
17. Treatment failurethe treatment did not work10.9%8,700
18. Systemic lupus erythematosuslupus, an autoimmune disease10.4%8,306
19. Infusion related reactiona reaction during or soon after an infusion10.3%8,219
20. Headachehead pain10.1%8,060
21. Condition aggravatedthe condition being treated got worse9.9%7,924
22. Peripheral swellingswelling of the arms or legs9.9%7,916
23. Pemphigus9.8%7,856
24. Drug hypersensitivityan allergic-type reaction to a medicine9.8%7,852
25. Hepatic enzyme increasedraised liver enzymes9.3%7,478
26. Glossodynia9.1%7,264
27. Therapeutic product effect decreased8.9%7,115
28. Hand deformity8.6%6,867
29. Infectionan infection, type not specified8.5%6,830
30. Nauseafeeling sick8.4%6,723

Top 30 of 2,875 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 5 drugs in the interleukin-6 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 134,236 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. 37.5% 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 80,095 reports.

Drugs most often listed in the same reports

Other products listed in reports where Actemra 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-6 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 Actemra as a suspect or interacting product; reports listing it only as a concomitant medication (5,063) 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.