What does a boxed warning on a medicine mean?

A boxed warning is the most prominent warning the FDA requires on a prescribing label. It is used to draw attention to a serious risk, and it appears at the top of the label inside a border, which is where the name comes from.

It is not a statement that a medicine is unsafe or should not be used. Many widely prescribed medicines carry one. What it signals is that there is a specific risk serious enough that prescribers and patients should have it in front of them, sometimes alongside monitoring or a restriction on who should take it.

If a medicine you have been prescribed carries one, the useful response is to read what it actually says on the label and ask your prescriber how it applies to you. Stopping a prescribed medicine because of a warning you read about, without that conversation, carries its own risks.