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U.S. Department of Health and Human Services

Safety

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Concerta (methylphenidate HCl) Extended-Release tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – June 2013

Summary View

 

*Raynaud’s phenomenon
 

WARNINGS AND PRECAUTIONS

Peripheral Vasculopathy, including Raynaud’s phenomenon
  • Stimulants, includingConcerta, used to treat ADHD are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Signs and symptoms are usually intermittent and mild; however, very rare sequelae include digital ulceration and/or soft tissue breakdown. Effects of peripheral vasculopathy, including Raynaud’s phenomenon, were observed in post-marketing reports at different times and at therapeutic doses in all age groups throughout the course of treatment. Signs and symptoms generally improve after reduction in dose or discontinuation of drug. Careful observation for digital changes is necessary during treatment with ADHD stimulants. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients.
 

MEDICATION GUIDE

What is the most important information I shouldknow about Concerta?
  • Circulation problems in fingers and toes [Peripheral vasculopathy, including Raynaud’s phenomenon]:
  • Fingers or toes may feel numb, cool, painful
  • Fingers or toes may change color from pale, to blue, to red
  • Tell your doctor if you have or your child has numbness, pain, skin color change, or sensitivity to temperature in your fingers or toes.
  • Call your doctor right away if you have or your child has any signs of unexplained wounds appearing on fingers or toes while taking Concerta.