Label Changes for:

Vyvanse (lisdexamfetamine dimesylate) 20mg, 30mg, 40mg, 50mg, 60mg, 70mg capsules

May 2009

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

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

ADVERSE REACTIONS

Clinical Studies Experience
  • In addition, adverse reactions observed at a rate of less than 2% included decreased libido and erectile dysfunction.
Postmarketing Reports
  • Eye Disorders- vision blurred
  • Nervous System Disorder- psychotic episodes, mania, hallucination, aggression
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