Box Warnings

Author: Allyson Distel, MPH
Last Reviewed: November 10, 2023

What are box warnings?

Box warnings (which used to be called black box warnings) are for your safety! Box warnings are major safety risks of medications. They are often not common but can be serious. As research into a medication continues, these warnings may change.

Where do I find box warnings?

Box warnings are often found at the top of the package insert for a medication. They are in bold and sometimes capital letters on medication boxes, bottles, or handouts from your pharmacy. Box warnings are meant to teach patients and providers about medication safety risks. These warnings may also provide education about the use of the medication with other medications and/or alcohol. It is important to look out for these.

What do I do if I am having a box warning side effect?

First, you should call your provider or pharmacist. They will be able to tell you what to do to manage the side effect and if you should stop taking the medication. You can also ask your provider if you should contact MedWatch, the FDA’s online reporting tool that tracks when a major safety risk is experienced.

When taking any medication, it is important to take it exactly as your provider has prescribed it. Review your medication list with your providers and let them know if there is a change in what you are taking. Don’t forget to talk about any over-the-counter medications or supplements. Box warning side effects can be serious, and talking with your providers may help lessen these side effects.

Delong, C., Preuss, C. V. (2023). Box warning. National Library of Medicine.

Family Medicine (2019). What does it mean if my medication has a ‘black box warning’? Cleveland Clinic.

Llamas, M. (2023). Black box warnings. Drugwatch.

U.S Food and Drug Administration (2021). Medwatch Online Voluntary Reporting Form.

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