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
