• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Safety

  • Print
  • Share
  • E-mail
?
-

Resources for You

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