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U.S. Department of Health and Human Services

Safety

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Metadate CD (methylphenidate HCl, USP) 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg Extended-Release Capsules

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

 

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. Read about the new physician labeling format.


Summary View

 

Brand (Generic) Name

Sections Modified

Metadate CD (methylphenidate HCl, USP) 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg Extended-Release Capsules

ADVERSE REACTIONS

  • Adverse Events With Other Marketed Methylphenidate HCl Products
    • and obsessive-compulsive disorder
  • Postmarketing Experience
    • migraine, obsessive-compulsive disorder