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U.S. Department of Health and Human Services

Safety

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Daytrana (methylphenidate) transdermal system

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

 

Summary View

 

WARNINGS 

Contact Sensitization
  • In an open-label study of 305 subjects conducted to characterize dermal reactions in children with ADHD treated with Daytrana using a 9-hour wear time, one subject (0.3%) was confirmed by patch testing to be sensitized to methylphenidate (allergic contact dermatitis). This subject experienced erythema and edema at Daytrana application sites with concurrent urticarial lesions on the abdomen and legs resulting in treatment discontinuation. This subject was not transitioned to oral methylphenidate.

ADVERSE REACTIONS

Skin Irritation
  • In an open-label study of 305 subjects conducted to characterize dermal reactions in children with ADHD treated with Daytrana using a 9-hour wear time, one subject (0.3%) was confirmed by patch testing to be sensitized to methylphenidate (allergic contact dermatitis). This subject experienced erythema and edema at Daytrana application sites with concurrent urticarial lesions on the abdomen and legs resulting in treatment discontinuation. The subject was not transitioned to oral methylphenidate. Confirmation of a diagnosis of allergic contact dermatitis may require further diagnostic testing.

MEDICATION GUIDE

What are possible side effects of Daytrana?
  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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