Taltz: adverse event reports filed with FDA

33,889

reports as suspect product

0.2% of all reports · about 3,256 a year

1,851

reports, 12 months to June 2026

3,566 in the 12 months before

17.9%

marked serious by the reporter

36% across the class

1.4%

record death among outcomes, as reported

483 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 Taltz reports recording the termmedian drug in interleukin-17a antagonist

1. Injection site painpain where the injection was given11.3%3,813
2. Psoriasispsoriasis, a skin condition8.4%2,837
3. Drug ineffectivethe medicine did not work as expected7.9%2,686
4. Injection site erythemaredness where the injection was given6.4%2,155
5. Injection site reactiona reaction where the injection was given5.1%1,734
6. Injection site swellingswelling where the injection was given4.8%1,622
7. Incorrect dose administeredthe wrong dose was given3.3%1,134
8. Product dose omission issuea dose was missed2.5%861
9. Covid-19COVID-19 infection2.5%854
10. Therapy interrupted2.4%810
11. Injection site pruritusitching where the injection was given2.3%778
12. Rashskin rash2.2%740
13. Arthralgiajoint pain2.1%695
14. Painpain, site not specified2%670
15. Injection site urticaria2%661
16. Diarrhoealoose or frequent stools1.9%654
17. Pruritusitching1.9%634
18. Injection site mass1.8%600
19. Nauseafeeling sick1.8%597
20. Injection site haemorrhagebleeding where the injection was given1.8%594
21. Inappropriate schedule of product administrationthe product was taken at the wrong times1.7%592
22. Nasopharyngitisa cold1.7%574
23. Psoriatic arthropathy1.6%547
24. Injection site rash1.6%531
25. Fatiguetiredness1.5%520
26. Urticariahives1.5%503
27. Injection site warmth1.4%479
28. Malaisegeneral feeling of being unwell1.4%472
29. Injection site bruisingbruising where the injection was given1.4%462
30. Sinusitissinus infection1.4%460

Top 30 of 1,333 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. 91.7% 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 33,889 reports.

Drugs most often listed in the same reports

Other products listed in reports where Taltz 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 Taltz as a suspect or interacting product; reports listing it only as a concomitant medication (1,625) 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.