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Label Changes for:

Focalin (dexmethylphenidate hydrochloride)

May 2012

Changes have been made to the CONTRAINDICATIONS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – May 2012




Hypersensitivity to Methylphenidate
  • Focalin is contraindicated in patients known to be hypersensitive to methylphenidate or other components of the product. Hypersensitivity reactions, including angioedema and anaphylactic reactions, have been observed in patients treated with methylphenidate


Adverse Events from Postmarketing Experience
  • new section added


Other serious side effects include:
  • Serious allergic reactions (symptoms can be difficulty breathing, swelling of the face, neck and throat, rashes and hives, fever)
  • slowing of growth (height and weight) in children
  • seizures, mainly in patients with a history of seizures
  • eyesight changes or blurred vision