Tocilizumab: adverse event reports filed with FDA

25,705

reports as suspect product

0.1% of all reports · about 1,264 a year

1,767

reports, 12 months to June 2026

2,480 in the 12 months before

95%

marked serious by the reporter

70.4% across the class

21.6%

record death among outcomes, as reported

5,544 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 Tocilizumab reports recording the termmedian drug in interleukin-6 receptor antagonist

1. Off label useused for a purpose or in a way not on the label31.6%8,116
2. Drug ineffectivethe medicine did not work as expected23.8%6,112
3. Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease17.5%4,495
4. Painpain, site not specified16.2%4,159
5. Fatiguetiredness14%3,590
6. Rashskin rash13.6%3,488
7. Contraindicated product administered13.5%3,465
8. Drug intolerancethe medicine was not tolerated11.8%3,036
9. Product use issuea problem in how the product was used11.7%3,004
10. Arthropathy11.6%2,978
11. Alopeciahair loss11.5%2,952
12. Systemic lupus erythematosuslupus, an autoimmune disease11.5%2,950
13. Pemphigus11.2%2,873
14. Hypersensitivityan allergic-type reaction11.2%2,869
15. Treatment failurethe treatment did not work11.1%2,845
16. Arthralgiajoint pain11%2,835
17. Abdominal discomfortstomach discomfort11%2,833
18. Infusion related reactiona reaction during or soon after an infusion11%2,830
19. Joint swellinga swollen joint10.8%2,774
20. Synovitis10.7%2,742
21. Glossodynia10.3%2,647
22. Condition aggravatedthe condition being treated got worse10%2,566
23. Wound9.9%2,544
24. Swellingswelling9.8%2,530
25. Hand deformity9.8%2,511
26. Headachehead pain9.5%2,445
27. Hepatic enzyme increasedraised liver enzymes9.5%2,432
28. Maternal exposure during pregnancythe mother took the medicine during pregnancy8.8%2,262
29. Nauseafeeling sick8.7%2,232
30. Intentional product use issuedeliberate use not as intended8.5%2,197

Top 30 of 2,332 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. 14.1% 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 25,705 reports.

Drugs most often listed in the same reports

Other products listed in reports where Tocilizumab 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 Tocilizumab as a suspect or interacting product; reports listing it only as a concomitant medication (4,724) 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.