Tremfyaguselkumab
According to the FDA label: TREMFYA is an interleukin-23 antagonist indicated for the treatment of: adults and pediatric patients 6 years of age and older who also weigh at least 40 kg with moderate-to-severe plaque psoriasis and who are candidates for systemic therapy or phototherapy. ( 1.1 ) adults and pediatric patients 6 years of age and older who also weigh at least 40 kg with active psoriatic arthritis. ( 1.2 ) adults with moderately to severely active ulcerative colitis.
33,064 adverse event reports submitted to the FDA (2016–2026)
Top Reported Adverse Events
The most frequently reported events in association with Tremfya 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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Product Dose Omission Issue 10,625 reports
A report that a dose of the medication was missed or skipped.
Full definition in the glossary →Accidental Exposure to Product 3,315 reports
A report that someone was unintentionally exposed to a medication, for example a child or another person who was not the patient. This is a safety-tracking category.
Full definition in the glossary →Drug Ineffective 2,328 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 →- Needle Issue 2,164 reports
Psoriasis 2,140 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 →Device Issue 1,836 reports
A general report of a problem with a medical device, used when no more specific issue is named.
Full definition in the glossary →Device Malfunction 1,550 reports
A report that a medical device did not work as intended.
Full definition in the glossary →Off Label Use 1,420 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 Storage Error 1,209 reports
A report that a medication was stored incorrectly, for example at the wrong temperature. This is a handling category, not a sign of a problem with the drug.
Full definition in the glossary →- Device Deployment Issue 1,194 reports
Inappropriate Schedule of Product Administration 942 reports
A report that the medication was taken on the wrong schedule, such as too often, not often enough, or at the wrong time. This is a usage category, not a sign of a problem with the drug.
Full definition in the glossary →Arthralgia 889 reports
- Device Leakage 856 reports
Pneumonia 807 reports
An infection that inflames the air sacs in the lungs, which can cause cough, fever, and difficulty breathing.
Full definition in the glossary →- Device Defective 788 reports
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 | 15,429 |
| Male | 10,867 |
| Unknown | 3 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 598 |
| 18-34 | 2,289 |
| 35-49 | 4,420 |
| 50-64 | 6,365 |
| 65-74 | 2,264 |
| 75+ | 1,014 |
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 Tremfya. 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 |
|---|---|
| Non-Serious | 24,210 |
| Other Serious | 6,098 |
| Hospitalization | 2,483 |
| Death | 436 |
| Life-Threatening | 204 |
| Disability | 83 |
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 Tremfya. 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 |
|---|---|
| 2016 | 2 |
| 2017 | 84 |
| 2018 | 1,199 |
| 2019 | 2,086 |
| 2020 | 2,193 |
| 2021 | 3,115 |
| 2022 | 5,058 |
| 2023 | 5,778 |
| 2024 | 5,014 |
| 2025 | 6,803 |
| 2026 (partial) | 1,732 |
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 Tremfya
In FDA adverse event reports that mention Tremfya, these medications appeared most often in the same report.
- Methotrexate (662 reports)
- Secukinumab (557 reports)
- Adalimumab (542 reports)
- Apremilast (523 reports)
- Ustekinumab (390 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