Atomoxetine

What are the side effects of Strattera (Atomoxetine)?

• Nausea
• vomiting
• fatigue
• decreased appetite
• abdominal pain
• somnolence.

Adult Clinical Trials –

• Constipation
• dry mouth
• nausea
• fatigue
• decreased appetite
• insomnia
• erectile dysfunction,
• urinary hesitation and/or urinary retention and/or dysuria
• dysmenorrhea
• hot flush

Monoamine Oxidase Inhibitors.

• CYP2D6 Inhibitors – Concomitant use may increase atomoxetine steadystate plasma concentrations in EMs.

• Pressor Agents – Possible effects on blood pressure.

• Albuterol (or other beta2 agonists) – Action of albuterol on cardiovascular system can be potentiated.

Suicidal Ideation – Monitor for suicidality, clinical worsening, and unusual changes in behavior.

• Severe Liver Injury – Should be discontinued and not restarted in patients with jaundice or laboratory evidence of liver injury.

• Serious Cardiovascular Events – Sudden death, stroke and myocardial infarction have been reported in association with atomoxetine treatment. Patients should have a careful history and physical exam to assess for presence of cardiovascular disease. STRATTERA generally should not be used in children or adolescents with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems that may place them at increased vulnerability to its noradrenergic effects. Consideration should be given to not using STRATTERA in adults with clinically significant cardiac abnormalities.

• Emergent Cardiovascular Symptoms – Patients should undergo prompt cardiac evaluation.

• Effects on Blood Pressure and Heart Rate – Can increase blood pressure and heart rate; orthostasis, syncope and Raynaud’s phenomenon may occur. Use with caution in patients with hypertension, tachycardia, or cardiovascular or cerebrovascular disease.

• Emergent Psychotic or Manic Symptoms – Consider discontinuing treatment if such new symptoms occur.

• Bipolar Disorder – Screen patients to avoid possible induction of a mixed/manic episode.

• Aggressive behavior or hostility should be monitored.

• Possible allergic reactions, including anaphylactic reactions, angioneurotic edema, urticaria, and rash.

• Effects on Urine Outflow – Urinary hesitancy and retention may occur.

• Priapism – Prompt medical attention is required in the event of suspected priapism.

• Growth – Height and weight should be monitored in pediatric patients.

• Concomitant Use of Potent CYP2D6 Inhibitors or Use in patients known to be CYP2D6 PMs – Dose adjustment of STRATTERA may be necessary.