Safety Considerations for Atomoxetine (Strattera)

Suicidal Ideation Risk

• The FDA requires a black‑box warning that atomoxetine may increase the risk of suicidal thoughts in children and adolescents, especially during the first few months of therapy or when the dose is changed. This safety alert is based on pharmacovigilance data reviewed by the FDA. 1

Cardiovascular Effects

• Atomoxetine can cause modest elevations in heart rate and blood pressure; therefore, clinicians should assess for cardiovascular contraindications (e.g., severe cardiac disease, pheochromocytoma, narrow‑angle glaucoma) and monitor vital signs throughout treatment. This recommendation follows FDA safety guidance. 1