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U.S. Department of Health and Human Services


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Daytrana (methylphenidate transdermal system)

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- February 2008


The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.

Summary View

Sections Modified


  • Information for Patients
    • Skin redness or itching is common with Daytrana, and small bumps on the skin may also occur in some patients. If any swelling or blistering occurs the patch should not be worn and the patient should be seen by the prescriber...


  • Postmarketing Reports
    • Cardiac Disorders
      • Palpitation
    • Eye Disorders
      • Visual Disturbances
      • Blurred Vision
      • Mydriasis
      • Accommodation Disorder
    • Gastrointestinal Disorders
      • Abdominal Pain
    • General Disorders & Administration Site Disorders
      • Application Site Reactions
      • Bruising
      • Burn...
    • Immune System Disorders
      • Hypersensitivity Reactions including Generalized Erythematous and Urticarial Rashes, Allergic Contact Dermatitis...
    • Investigations
      • Heart Rate Increased
      • Blood Pressure Increased
    • Nervous System Disorders
      • Convulsion
      • Dizziness
    • Psychiatric Disorders
      • Transient Depressed Mood
      • Hallucination
      • Nervousness
    • Skin and Subcutaneous Tissue Disorders
      • Alopecia


  • Before You Apply Daytrana
  • How To Remove And Discard Daytrana