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FDA Black Box Warning

Meaning

An FDA Black Box Warning, officially known as a Boxed Warning, is the strictest warning that the U.S. Food and Drug Administration mandates be placed on the labeling of prescription drugs or biological products. This prominent warning is reserved for drugs that carry significant, life-threatening, or disabling adverse effects that cannot be mitigated by dose adjustment alone. Its purpose is to draw immediate attention from prescribers and patients to the serious risks associated with the medication, ensuring a careful risk-benefit analysis is conducted before prescription. This warning is a critical communication tool for drug safety and public health.