Singulair (montelukast sodium) Granule

 

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- April 2008 and April 2011

 

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.

 

April 2011

Summary View

 

ADVERSE REACTIONS

• "thrombocytopenia" added

 

PATIENT PACKAGE INSERT

Possible side effects:

• "thrombocytopenia" added

 

April 2008 

Summary View

 

Sections Modified

ADVERSE REACTIONS

• Postmarketing Experience
  • Psychiatric Disorders
    • Anxiousness
    • Suicidal thinking and behavior (including suicide)

PATIENT PACKAGE INSERT

• Less common side effects that have happened with Singulair include:
  • Behavior and Mood related changes
    • Feeling anxious
    • Suicidal thoughts and actions (including suicide)...