Strattera (atomoxetine) Prescribing Information (2026)

Government Record · Current FDA label via DailyMed · October 2026

Strattera’s boxed warning reports average suicidal-ideation risk of 0.4% (5/1,357) versus none among 851 placebo patients, with no suicides. The pooled basis was 12 trials involving more than 2,200 pediatric patients.

STRATTERA (atomoxetine) increased the risk of suicidal ideation in short-term studies in children or adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD).

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Strattera’s boxed warning reports average suicidal-ideation risk of 0.4% (5/1,357) versus none among 851 placebo patients, with no suicides. The pooled basis was 12 trials involving more than 2,200 pediatric patients.

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