Well tolerated in children & adolescents, aged 6 - 18 years

In controlled clinical trials, fewer than 1% of children and adolescents discontinued taking CONCERTA^® due to adverse events.

 

Additionally, safety was demonstrated for up to 2 years in 229 children:

• In a long-term, open-label study only 1 patient had a clinically significant change in vital signs and discontinued during month 4 due to elevated blood pressure¹
• Minimal effect on growth after 21 months of therapy: patients were a mean 0.23cm shorter and a mean 1.23 kg less than expected for their ages¹

IMPORTANT SAFETY INFORMATION

Long-term usefulness of treatment should be periodically reevaluated. Patients should be monitored for changes in blood pressure and heart rate. Growth should be monitored during treatment to determine if patients are growing and gaining weight as expected, and treatment adjusted as appropriate.

Reference: 1. Wilens T, McBurnett K, Stein M, Lerner M, Spencer T, Wolraich M. ADHD treatment with once-daily OROS® methylphenidate: final results from a long-term open-label study. J Am Acad Child Adolesc Psychiatry. 2005;44:1015-1023.