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Boxed warning

Also called: Black box warning

The FDA's strongest safety warning, placed at the top of a drug's prescribing information. Trazodone carries the antidepressant-class boxed warning about increased suicidal thoughts and behaviors in children, adolescents, and young adults.

This boxed warning applies to trazodone because it is an antidepressant, not because of a trazodone-specific finding — the FDA requires it on all antidepressants based on pooled clinical trial data showing a modest increase in suicidal thinking in patients under 25 during the early weeks of treatment. It does not mean trazodone is more dangerous than other antidepressants in this respect.