Secukinumab: adverse event reports filed with FDA

4,206

reports as suspect product

0% of all reports · about 341 a year

558

reports, 12 months to June 2026

586 in the 12 months before

96.6%

marked serious by the reporter

36% across the class

14.7%

record death among outcomes, as reported

618 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 Secukinumab reports recording the termmedian drug in interleukin-17a antagonist

1. Drug ineffectivethe medicine did not work as expected26.4%1,110
2. Painpain, site not specified15.8%665
3. Arthralgiajoint pain15.1%634
4. Off label useused for a purpose or in a way not on the label14.8%621
5. Psoriatic arthropathy14.7%619
6. Psoriasispsoriasis, a skin condition13.5%566
7. Fatiguetiredness12.9%543
8. Condition aggravatedthe condition being treated got worse12.3%517
9. Headachehead pain12.1%508
10. Drug intolerancethe medicine was not tolerated11.4%479
11. Rashskin rash11.3%475
12. Treatment failurethe treatment did not work11%464
13. Joint swellinga swollen joint10.9%459
14. Diarrhoealoose or frequent stools10.9%458
15. Musculoskeletal stiffnessstiffness in muscles or joints10.7%451
16. Malaisegeneral feeling of being unwell10.2%429
17. Synovitis10.2%427
18. Alopeciahair loss9.9%418
19. Systemic lupus erythematosuslupus, an autoimmune disease9.9%416
20. Pyrexiafever9.7%410
21. Abdominal discomfortstomach discomfort9.6%404
22. Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease9.5%401
23. Arthropathy9.4%397
24. Hypersensitivityan allergic-type reaction9.4%396
25. Infectionan infection, type not specified9.2%387
26. Pain in extremitypain in an arm or leg9.2%386
27. Nauseafeeling sick9.1%383
28. Pemphigus9%379
29. Product use in unapproved indicationused for a purpose not on the label9%378
30. Contraindicated product administered9%377

Top 30 of 1,095 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 4 drugs in the interleukin-17a 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 190,442 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. 8.2% 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 4,206 reports.

Drugs most often listed in the same reports

Other products listed in reports where Secukinumab 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-17a 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 Secukinumab as a suspect or interacting product; reports listing it only as a concomitant medication (699) 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.