Definition:
A black box warning is issued by the U.S. Food and Drug Administration (FDA) to inform physicians and patients about any important safety concerns, such as serious side effects or life-threatening risks.
Also called a “black label warning” or “boxed warning,” a black box warning is named for the black border surrounding the text that appears on the package insert, label, and marketing materials that describe the medication. It is the most serious medication warning required by FDA.
