Pharmacologic class (EPC) · 5 drug pages

Interleukin-23 antagonist: adverse event reports filed with FDA

116,972 reports list a drug in this class as a suspect or interacting product, 2016–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

116,972
reports across the class: 0.6% of all reports; 27,826
reports, 12 months to June 2026: 22,645 in the 12 months before; 53.2%
marked serious by the reporter: 57.4% across all reports; 5
drugs with a page: brand and generic names counted separately

Interleukin-23 antagonist is a pharmacologic class (an FDA Established Pharmacologic Class) with 5 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 116,972 adverse event reports received by FDA, 0.6% of the database, from March 2016 to June 2026.

27,826 reports arrived in the 12 months to June 2026, up 23% from 22,645 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 53.2% of the class's reports are marked serious, 3% record death among the outcomes and 17.6% record hospitalisation, as reported.

Across the class the reactions recorded most often are product dose omission issue (10.1%), psoriasis (8.4%) and drug ineffective (5.1%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is 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."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
SkyriziRisankizumab-rzaa	brand	79,784	19,301	66.3%	Psoriasis
TremfyaGuselkumab	brand	32,029	6,351	24.8%	Product dose omission issue
IlumyaTildrakizumab-asmn	brand	2,290	700	21.8%	Product dose omission issue
Guselkumab	generic	2,093	1,181	23.5%	Product dose omission issue
OmvohMirikizumab-mrkz	brand	776	293	49.6%	Colitis ulcerative

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."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Product dose omission issuea dose was missed10.1%11,871
Psoriasispsoriasis, a skin condition8.4%9,811
Drug ineffectivethe medicine did not work as expected5.1%5,988
Device issuea problem with the device3.7%4,352
Arthralgiajoint pain3.4%3,957
Painpain, site not specified3.2%3,729
Accidental exposure to product3%3,534
Fatiguetiredness2.9%3,421
Pruritusitching2.8%3,267
Covid-19COVID-19 infection2.3%2,733
Deaththe patient died; cause not stated by this term2.3%2,636
Diarrhoealoose or frequent stools2.1%2,427
Headachehead pain2.1%2,400
Needle issuea problem with the needle2%2,385
Off label useused for a purpose or in a way not on the label2%2,375
Surgeryan operation2%2,336
Falla fall1.9%2,270
Product storage errorthe product was stored wrongly1.9%2,187
Rashskin rash1.8%2,111
Pneumonialung infection1.8%2,098
Crohn's disease1.8%2,051
Nauseafeeling sick1.4%1,676
Device malfunctionthe device did not work properly1.4%1,670
Nasopharyngitisa cold1.3%1,574
Condition aggravatedthe condition being treated got worse1.3%1,538

Solid bar: share of all class reports. Hollow bar: the median share across the 5 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death3%3,505

Life-threatening0.4%439

Hospitalisation (initial or prolonged)17.6%20,578

Disability0.3%407

Congenital anomaly0.1%79

Other serious38.2%44,711

Not serious46.8%54,747

Patient age

Under 20%33

2 to 110%34

12 to 170.1%138

18 to 4412.4%14,456

45 to 6421.2%24,838

65 to 7410.3%12,105

75 and over5.6%6,580

Age not given50.3%58,788

Who reported

Physician8.5%9,913

Pharmacist3.6%4,236

Other health professional15.8%18,441

Lawyer0%19

Consumer or non-health professional71.4%83,475

Not given0.8%888

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Interleukin-23 antagonist reports

Which drugs are in the Interleukin-23 antagonist class on this site?

Skyrizi, Tremfya, Ilumya, Guselkumab and Omvoh. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

116,972 reports through June 2026, 27,826 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

product dose omission issue (10.1%), psoriasis (8.4%), drug ineffective (5.1%), device issue (3.7%) and arthralgia (3.4%).

Can the members table be used to rank the drugs?

No. 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." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. See the guide on how to report.

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 class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. 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.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.