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Understanding Trazodone's Boxed Warning

What the FDA boxed warning on trazodone actually says, who it applies to, and what it does and doesn't mean.

Editorially reviewed
Key points
  • Applies to the entire antidepressant class, not trazodone specifically
  • Highest risk window: early treatment and after dose changes
  • Applies specifically to patients under 25
  • Close monitoring during early treatment is the practical takeaway

Trazodone carries the FDA's strongest form of safety warning — a boxed warning — regarding increased risk of suicidal thoughts and behaviors in children, adolescents, and young adults up to age 24, especially during the early weeks of treatment or after a dose change.

This warning applies to trazodone because it is an antidepressant, not because of a trazodone-specific finding. The FDA requires this warning on the entire antidepressant class based on pooled clinical trial data. It does not mean trazodone is unusually dangerous compared with other antidepressants in this respect — but it does mean close monitoring, especially of younger patients, matters in the early phase of treatment.

References

  1. Trazodone: MedlinePlus Drug Information. U.S. National Library of Medicine (MedlinePlus). View source (opens in a new tab) Accessed August 8, 2026
  2. Trazodone Hydrochloride Tablets — FDA Prescribing Information. DailyMed / U.S. Food & Drug Administration. View source (opens in a new tab) Accessed August 8, 2026
Not medical advice. This article is educational and does not replace guidance from your prescriber or pharmacist. If you think you're having a serious reaction, see our emergency resources page.

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