Pharmacologic class (EPC) · 2 drug pages

Interleukin-12 antagonist: adverse event reports filed with FDA

95,243 reports list a drug in this class as a suspect or interacting product, 2009–2026.

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.

95,243
reports across the class: 0.5% of all reports; 5,639
reports, 12 months to June 2026: 7,617 in the 12 months before; 58.5%
marked serious by the reporter: 57.4% across all reports; 2
drugs with a page: brand and generic names counted separately

Interleukin-12 antagonist is a pharmacologic class (an FDA Established Pharmacologic Class) with 2 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 95,243 adverse event reports received by FDA, 0.5% of the database, from October 2009 to June 2026.

5,639 reports arrived in the 12 months to June 2026, down 26% from 7,617 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 58.5% of the class's reports are marked serious, 6.7% record death among the outcomes and 21.8% record hospitalisation, as reported.

Across the class the reactions recorded most often are drug ineffective (14.7%), off label use (13.4%) and product dose omission issue (10.4%). 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
StelaraUstekinumab	brand	86,538	3,243	54.7%	Drug ineffective
Ustekinumab	generic	8,705	2,396	96.2%	Drug ineffective

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

Drug ineffectivethe medicine did not work as expected14.7%13,985
Off label useused for a purpose or in a way not on the label13.4%12,801
Product dose omission issuea dose was missed10.4%9,950
Fatiguetiredness6.9%6,586
Painpain, site not specified6.1%5,857
Rashskin rash6%5,747
Product use issuea problem in how the product was used6%5,730
Arthralgiajoint pain5.9%5,654
Psoriasispsoriasis, a skin condition5.9%5,588
Infusion related reactiona reaction during or soon after an infusion5.7%5,433
Condition aggravatedthe condition being treated got worse5.5%5,264
Crohn's disease5.5%5,235
Headachehead pain5.4%5,103
Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease5.3%5,045
Synovitis5.1%4,883
Hypersensitivityan allergic-type reaction5.1%4,836
Joint swellinga swollen joint5%4,776
Alopeciahair loss5%4,766
Hepatic enzyme increasedraised liver enzymes4.9%4,710
Drug intolerancethe medicine was not tolerated4.9%4,634
Abdominal discomfortstomach discomfort4.7%4,485
Systemic lupus erythematosuslupus, an autoimmune disease4.7%4,462
Wound4.6%4,373
Diarrhoealoose or frequent stools4.6%4,339
General physical health deteriorationgeneral decline in health4.5%4,313

Solid bar: share of all class reports. Hollow bar: the median share across the 2 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death6.7%6,343

Life-threatening6.4%6,096

Hospitalisation (initial or prolonged)21.8%20,765

Disability6.8%6,485

Congenital anomaly2.3%2,191

Other serious43.8%41,755

Not serious41.5%39,519

Patient age

Under 20.1%107

2 to 110.3%302

12 to 171.3%1,240

18 to 4422.7%21,631

45 to 6421.6%20,578

65 to 746.4%6,136

75 and over3.1%2,926

Age not given44.4%42,323

Who reported

Physician19.1%18,238

Pharmacist8.3%7,891

Other health professional37.1%35,346

Lawyer0%30

Consumer or non-health professional34%32,424

Not given1.4%1,314

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-12 antagonist reports

Which drugs are in the Interleukin-12 antagonist class on this site?

Stelara and Ustekinumab. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

95,243 reports through June 2026, 5,639 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?

drug ineffective (14.7%), off label use (13.4%), product dose omission issue (10.4%), fatigue (6.9%) and pain (6.1%).

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.