Cosentyxsecukinumab
According to the FDA label: COSENTYX is a human interleukin-17A antagonist indicated for the treatment of: moderate to severe plaque psoriasis (PsO) in adults and pediatric patients 6 years and older who are candidates for systemic therapy or phototherapy. ( 1.1 ) active psoriatic arthritis (PsA) in adults and pediatric patients 2 years of age and older. ( 1.2 ) active ankylosing spondylitis (AS) in adults and pediatric patients 12 years of age and older.
158,767 adverse event reports submitted to the FDA (2012–2026)
Top Reported Adverse Events
The most frequently reported events in association with Cosentyx 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 28,950 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 →Psoriasis 22,709 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 16,387 reports
A general report of physical discomfort, used when no more specific location is given.
Full definition in the glossary →Arthralgia 14,685 reports
Fatigue 10,379 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Psoriatic Arthropathy 9,987 reports
A form of joint disease linked to psoriasis, often called psoriatic arthritis, causing joint pain and swelling. It often appears in reports as a condition being treated.
Full definition in the glossary →Pruritus 9,301 reports
Malaise 9,286 reports
A general feeling of being unwell or uncomfortable, without a specific symptom.
Full definition in the glossary →Rash 8,890 reports
An area of irritated, red, or bumpy skin.
Full definition in the glossary → See all drugs reporting this event →Condition Aggravated 8,349 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 →Diarrhoea 7,840 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 →Nasopharyngitis 7,647 reports
The medical term for the common cold, an infection of the nose and throat.
Full definition in the glossary →Pain in Extremity 7,208 reports
Pain in an arm or leg.
Full definition in the glossary →Headache 7,101 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →Off Label Use 6,547 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 →
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 | 91,447 |
| Male | 55,771 |
| Unknown | 10 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 497 |
| 18-34 | 6,390 |
| 35-49 | 20,353 |
| 50-64 | 24,590 |
| 65-74 | 8,917 |
| 75+ | 3,275 |
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 Cosentyx. 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 | 95,610 |
| Other Serious | 50,177 |
| Hospitalization | 21,205 |
| Death | 8,114 |
| Life-Threatening | 7,287 |
| Disability | 6,984 |
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 Cosentyx. 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 |
|---|---|
| 2012 | 1 |
| 2013 | 3 |
| 2014 | 11 |
| 2015 | 2,812 |
| 2016 | 6,260 |
| 2017 | 11,695 |
| 2018 | 20,874 |
| 2019 | 21,466 |
| 2020 | 22,593 |
| 2021 | 17,028 |
| 2022 | 17,156 |
| 2023 | 17,260 |
| 2024 | 11,050 |
| 2025 | 9,183 |
| 2026 (partial) | 1,375 |
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 Cosentyx
In FDA adverse event reports that mention Cosentyx, these medications appeared most often in the same report.
- Methotrexate (21,365 reports)
- Adalimumab (15,986 reports)
- Etanercept (11,711 reports)
- Prednisone (10,612 reports)
- Leflunomide (10,495 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