Singulair (montelukast sodium) tablets, chewable tables and oral granules January 2009

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

ADVERSE REACTIONS

• Post-Marketing Experience
  • epistaxis added

PATIENT PACKAGE INSERT

• Less Common Side Effects
  • nosebleed, palpitations