HIV/AIDS Glossary

Boxed Warning

The strongest form of warning required by the Food and Drug Administration (FDA) for prescription drug labeling. A boxed warning alerts health care providers and consumers to increased risk of serious adverse reactions associated with use of a drug or to restrictions on use of a drug. The boxed warning is presented in a box surrounded by a black border and is placed on the drug label and any package inserts or promotional materials intended for the prescriber or patient.