Definition:
A black box warning is a warning mandated by the U.S. Food and Drug Administration (FDA) to appear on the full prescribing information of a prescription medication. Such a warning is required to be printed inside a box with a black outline at the top of the information sheet used by doctors and pharmacists. A modified version of the same warning will appear on the patient information sheet.
These warnings alert the doctors and pharmacists to serious matters regarding the use of the given medication. For example, most antidepressant and antipsychotic medications are required to have black box warnings.
Examples of black box warnings:
