Guselkumab: adverse event reports filed with FDA

2,093

reports as suspect product

0% of all reports · about 222 a year

1,181

reports, 12 months to June 2026

583 in the 12 months before

23.5%

marked serious by the reporter

53.2% across the class

0.9%

record death among outcomes, as reported

19 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 Guselkumab reports recording the termmedian drug in interleukin-23 antagonist

1. Product dose omission issuea dose was missed43.7%914
2. Device deployment issuethe device did not deploy properly35.8%750
3. Accidental exposure to product14.8%310
4. Needle issuea problem with the needle14%294
5. Device issuea problem with the device9.5%199
6. Device defective9.1%190
7. Device leakagethe device leaked5.8%122
8. Drug ineffectivethe medicine did not work as expected5.7%120
9. Incorrect dose administeredthe wrong dose was given4.2%88
10. Off label useused for a purpose or in a way not on the label4%84
11. Psoriasispsoriasis, a skin condition3.8%80
12. Injection site haemorrhagebleeding where the injection was given3.2%66
13. Injection site painpain where the injection was given2.9%61
14. Underdoseless than the intended dose2.8%59
15. Device mechanical issue2.8%58
16. Inappropriate schedule of product administrationthe product was taken at the wrong times2.7%57
17. Psoriatic arthropathy2.2%46
18. Pneumonialung infection1.7%36
19. Treatment failurethe treatment did not work1.5%32
20. Arthralgiajoint pain1.3%27
21. Device occlusionthe device blocked1.3%27
22. Painpain, site not specified1.2%26
23. Product leakage1.2%25
24. Device malfunctionthe device did not work properly1.1%24
25. Diarrhoealoose or frequent stools1.1%23
26. Arthritis0.9%19
27. Incorrect dose administered by devicethe device gave the wrong dose0.9%19
28. Therapeutic product effect incomplete0.9%19
29. Wrong technique in product usage processthe product was used in the wrong way0.9%19
30. Device failurethe device failed0.9%18

Top 30 of 266 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-23 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 116,972 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. 42.9% 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 2,093 reports.

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-23 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 Guselkumab as a suspect or interacting product; reports listing it only as a concomitant medication (225) 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.