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Does Cosentyx have a black box warning?

Medically reviewed by Leigh Ann Anderson, PharmD. Last updated on Oct 9, 2024.

Official Answer by Drugs.com

No, Cosentyx does not contain a Boxed Warning, also commonly called a “black box warning”. A Boxed Warning is the most serious safety drug warning issued by the U.S. Food and Drug Administration (FDA).

A Boxed Warning details important or life-threatening risks or side effects that may occur with treatment. Boxed warnings appear prominently at the top of the package insert as well as in the Patient Medication Guide.

This does not mean there are not important warnings and side effects with the use of Cosentyx (secukinumab). Important safety concerns and warnings, some of which may be serious, include:

This is not a complete listing of warnings, precaution and side effects. Discuss important safety information with your doctor before you start treatment with Cosentyx.

Learn more: Use, warnings, side effects and drug interactions with Cosentyx

Cosentyx is an immunosuppressant prescription medicine approved to treat:

Cosentyx may improve these conditions but may also lower your ability to fight infections.

This is not all the information you need to know about Cosentyx (secukinumab) for safe and effective use and does not take the place of talking to your doctor about your treatment. Review the full Cosentyx information, and discuss this information and any questions you have with your doctor or other health care provider.

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References
  • A Guide to Drug Safety Terms at FDA. US Food and Drug Administration (FDA). Accessed August 2, 2021 at https://www.fda.gov/media/74382/download
  • Cosentyx (secukinumab). Prescribing information / Medication Guide. Novartis. Revised May 2021. Accessed August 2, 2021 at https://www.drugs.com/pro/cosentyx.html

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