Stelaraustekinumab
According to the FDA label: STELARA is a human interleukin-12 and -23 antagonist indicated for the treatment of: Moderate to severe plaque psoriasis in adult and pediatric patients 6 years of age and older who are candidates for phototherapy or systemic therapy. ( 1.1 ) Active psoriatic arthritis in adults and pediatric patients 6 years of age and older. ( 1.2 ) Moderately to severely active Crohn's disease in adult and pediatric patients 2 years of age and older.
100,048 adverse event reports submitted to the FDA (2009–2026)
Top Reported Adverse Events
The most frequently reported events in association with Stelara in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
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Drug Ineffective 14,580 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Off Label Use 12,462 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →Product Dose Omission Issue 9,924 reports
A report that a dose of the medication was missed or skipped.
Full definition in the glossary →Fatigue 6,701 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Psoriasis 6,500 reports
A condition where skin cells build up and form itchy, scaly patches. It often appears in reports because it is a condition being treated.
Full definition in the glossary →Pain 6,127 reports
A general report of physical discomfort, used when no more specific location is given.
Full definition in the glossary →Arthralgia 5,719 reports
Crohn's Disease 5,686 reports
A long-term condition that causes inflammation of the digestive tract. It often appears in reports as a condition being treated.
Full definition in the glossary →Rash 5,535 reports
An area of irritated, red, or bumpy skin.
Full definition in the glossary → See all drugs reporting this event →Product Use Issue 5,367 reports
A general report that there was some problem in how the medication was used.
Full definition in the glossary →Headache 5,198 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →Condition Aggravated 5,134 reports
A report that the person's existing health condition got worse. This describes a worsening of something the person already had, not necessarily a new problem caused by the drug.
Full definition in the glossary →Infusion Related Reaction 5,041 reports
A reaction that happens during or shortly after a medication is given through an IV infusion.
Full definition in the glossary →Rheumatoid Arthritis 4,730 reports
An autoimmune condition where the immune system attacks the joints, causing pain and swelling. It often appears in reports because it is a condition being treated, not always a reaction.
Full definition in the glossary →Joint Swelling 4,634 reports
Swelling in or around a joint.
Full definition in the glossary →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 51,733 |
| Male | 34,887 |
| Unknown | 192 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 3,885 |
| 18-34 | 9,953 |
| 35-49 | 16,520 |
| 50-64 | 16,503 |
| 65-74 | 6,447 |
| 75+ | 2,731 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Stelara. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Other Serious | 43,994 |
| Non-Serious | 40,921 |
| Hospitalization | 21,794 |
| Death | 5,684 |
| Disability | 5,662 |
| Life-Threatening | 5,532 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Stelara. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2009 | 34 |
| 2010 | 339 |
| 2011 | 835 |
| 2012 | 1,457 |
| 2013 | 1,849 |
| 2014 | 1,704 |
| 2015 | 5,305 |
| 2016 | 4,517 |
| 2017 | 6,660 |
| 2018 | 8,727 |
| 2019 | 10,236 |
| 2020 | 13,324 |
| 2021 | 7,738 |
| 2022 | 9,890 |
| 2023 | 10,036 |
| 2024 | 9,230 |
| 2025 | 7,105 |
| 2026 (partial) | 1,062 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Stelara
In FDA adverse event reports that mention Stelara, these medications appeared most often in the same report.
- Adalimumab (14,681 reports)
- Methotrexate (14,012 reports)
- Infliximab (11,590 reports)
- Etanercept (10,198 reports)
- Prednisone (9,868 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026