Cimzia: adverse event reports filed with FDA

87,221

reports as suspect product

0.4% of all reports · about 4,399 a year

4,932

reports, 12 months to June 2026

9,297 in the 12 months before

54.9%

marked serious by the reporter

56.2% across the class

5.7%

record death among outcomes, as reported

4,957 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 Cimzia reports recording the termmedian drug in tumor necrosis factor blocker

1. Drug ineffectivethe medicine did not work as expected25.4%22,162
2. Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease18.3%15,978
3. Painpain, site not specified15.3%13,361
4. Fatiguetiredness12.8%11,141
5. Rashskin rash11.2%9,736
6. Off label useused for a purpose or in a way not on the label10.7%9,339
7. Alopeciahair loss10.5%9,133
8. Arthralgiajoint pain10%8,719
9. Abdominal discomfortstomach discomfort9.9%8,618
10. Joint swellinga swollen joint9.8%8,583
11. Systemic lupus erythematosuslupus, an autoimmune disease9.6%8,398
12. Pemphigus9.3%8,126
13. Contraindicated product administered9.1%7,934
14. Maternal exposure during pregnancythe mother took the medicine during pregnancy9%7,893
15. Drug intolerancethe medicine was not tolerated9%7,856
16. Swellingswelling9%7,814
17. Glossodynia8.5%7,451
18. Hypersensitivityan allergic-type reaction8.3%7,278
19. Arthropathy8.2%7,117
20. Synovitis7.6%6,627
21. Hand deformity7.5%6,579
22. Wound6.9%6,033
23. Condition aggravatedthe condition being treated got worse6.8%5,933
24. Infusion related reactiona reaction during or soon after an infusion6.5%5,651
25. Headachehead pain6.4%5,577
26. Hepatic enzyme increasedraised liver enzymes6.4%5,539
27. Treatment failurethe treatment did not work6.2%5,423
28. Therapeutic product effect decreased6.2%5,399
29. Pruritusitching6.1%5,342
30. Infectionan infection, type not specified6.1%5,325

Top 30 of 2,471 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. 67% 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 87,221 reports.

Drugs most often listed in the same reports

Other products listed in reports where Cimzia 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 Cimzia as a suspect or interacting product; reports listing it only as a concomitant medication (5,810) 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.