Skyrizirisankizumab
76,587 adverse event reports submitted to the FDA (2015–2026)
Top Reported Adverse Events
The most frequently reported events in association with Skyrizi 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.
Show these terms with plain-language definitions
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Psoriasis 7,578 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 →Drug Ineffective 3,382 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 →Pain 3,019 reports
A general report of physical discomfort, used when no more specific location is given.
Full definition in the glossary →Fatigue 2,890 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Arthralgia 2,866 reports
Pruritus 2,600 reports
COVID-19 2,234 reports
The illness caused by the SARS-CoV-2 coronavirus.
Full definition in the glossary →Surgery 2,061 reports
A report noting that a surgical procedure occurred. This may be recorded as part of a person's medical history or treatment.
Full definition in the glossary →Death 2,022 reports
A report that the person died. A death appearing in reports for a drug does not mean the drug caused it. Reports record that a death occurred while the medication was being used, which can happen for many unrelated reasons.
Full definition in the glossary →Fall 2,003 reports
A report that the person fell down. Falls are tracked because they can signal issues like dizziness, weakness, or balance problems.
Full definition in the glossary →Device Issue 1,913 reports
A general report of a problem with a medical device, used when no more specific issue is named.
Full definition in the glossary →Diarrhoea 1,828 reports
Loose or watery bowel movements, often frequent. Also spelled diarrhea in American English.
Full definition in the glossary → See all drugs reporting this event →Headache 1,796 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →Crohn's Disease 1,782 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 1,414 reports
An area of irritated, red, or bumpy skin.
Full definition in the glossary → See all drugs reporting this event →
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 | 41,380 |
| Male | 31,557 |
| Unknown | 4 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 125 |
| 18-34 | 4,070 |
| 35-49 | 6,832 |
| 50-64 | 13,000 |
| 65-74 | 8,995 |
| 75+ | 4,827 |
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 Skyrizi. 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 | 36,064 |
| Non-Serious | 26,615 |
| Hospitalization | 16,875 |
| Death | 2,682 |
| Disability | 307 |
| Life-Threatening | 237 |
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 Skyrizi. 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 |
|---|---|
| 2015 | 1 |
| 2016 | 1 |
| 2018 | 1 |
| 2019 | 357 |
| 2020 | 1,930 |
| 2021 | 4,103 |
| 2022 | 16,392 |
| 2023 | 15,174 |
| 2024 | 14,504 |
| 2025 | 19,551 |
| 2026 (partial) | 4,573 |
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 Skyrizi
In FDA adverse event reports that mention Skyrizi, these medications appeared most often in the same report.
- Ergocalciferol (1,277 reports)
- Adalimumab (1,054 reports)
- Aspirin (971 reports)
- Metformin (882 reports)
- Omeprazole (874 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