Label Changes for:

Singulair (montelukast sodium) Granule

April 2008

Changes have been made to the ADVERSE REACTIONS and PATIENT PACKAGE INSERT sections of the safety label.


 

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.


 

April 2011

 

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)...
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