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U.S. Department of Health and Human Services


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Strattera (atomoxetine hydrochloride) 10mg, 18mg, 25mg, 40mg, 60mg, 80mg, 100mg capsules

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- June 2009


Summary View



Severe Liver Injury 
  • Reported cases of liver injury occurred within 120 days of initiation of atomoxetine in the majority of cases and some patients presented with markedly elevated liver enzymes [>20 X upper limit of normal (ULN)], and jaundice with significantly elevated bilirubin levels (>2 X ULN), followed by recovery upon atomoxetine discontinuation. 
Effects on Blood Pressure and Heart Rate 
  • Orthostatic hypotension and syncope have been reported in patients taking Strattera. ... Strattera should be used with caution in any condition that may predispose patients to hypotension, or conditions associated with abrupt heart rate or blood pressure changes. 


Postmarketing Spontaneous Reports 

Unless otherwise specified, these adverse reactions have occurred in adults and children and adolescents. 

  • General disorders and administration site conditions — Lethargy. 
  • Nervous system disorders — Hypoaesthesia, paraesthesia in children and adolescents; sensory disturbances. 
  • Urogenital system — urinary hesitation in children and adolescents; urinary retention in children and adolescents.