Orencia: adverse event reports filed with FDA

108,772

reports as suspect product

0.5% of all reports · about 5,372 a year

8,143

reports, 12 months to June 2026

9,463 in the 12 months before

53.1%

marked serious by the reporter

60.2% across the class

6.2%

record death among outcomes, as reported

6,719 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 Orencia reports recording the termmedian drug in selective t cell costimulation modulator

1. Drug ineffectivethe medicine did not work as expected31.9%34,719
2. Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease20.1%21,884
3. Painpain, site not specified17.8%19,378
4. Joint swellinga swollen joint17.6%19,142
5. Arthralgiajoint pain17.2%18,727
6. Contraindicated product administered12.4%13,523
7. Fatiguetiredness11.7%12,768
8. Drug intolerancethe medicine was not tolerated11.5%12,554
9. Rashskin rash11.3%12,333
10. Off label useused for a purpose or in a way not on the label9.9%10,748
11. Arthropathy9.4%10,260
12. Alopeciahair loss9.4%10,197
13. Synovitis9.1%9,942
14. Abdominal discomfortstomach discomfort9%9,746
15. Treatment failurethe treatment did not work8.6%9,390
16. Swellingswelling8.5%9,236
17. Systemic lupus erythematosuslupus, an autoimmune disease8.4%9,137
18. Hypersensitivityan allergic-type reaction8.3%9,041
19. Pemphigus8%8,686
20. Condition aggravatedthe condition being treated got worse7.7%8,338
21. Glossodynia7.4%8,021
22. Headachehead pain7.4%8,002
23. Drug hypersensitivityan allergic-type reaction to a medicine7.3%7,915
24. Hepatic enzyme increasedraised liver enzymes7%7,622
25. Hand deformity6.9%7,478
26. Infectionan infection, type not specified6.8%7,366
27. Therapeutic product effect decreased6.7%7,332
28. Peripheral swellingswelling of the arms or legs6.7%7,326
29. Infusion related reactiona reaction during or soon after an infusion6.5%7,093
30. Nauseafeeling sick6.4%6,951

Top 30 of 2,470 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 selective t cell costimulation modulator 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 130,919 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. 57.3% 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 108,772 reports.

Drugs most often listed in the same reports

Other products listed in reports where Orencia 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 selective t cell costimulation modulator 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 Orencia as a suspect or interacting product; reports listing it only as a concomitant medication (6,664) 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.