Label Changes for:

Singulair (montelukast sodium) Tablets, Chewable Tablets, and Oral Granules

December 2013

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) 

 

December 2013

ADVERSE REACTIONS

  • Pulmonary Eosinophilia
     

 

September 2012

ADVERSE REACTIONS

Postmarketing Experience
  • added ..... Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN)  

 

 

December 2011 

 

ADVERSE REACTIONS

Postmarketing Experience
  • erythema multiforme

 

PATIENT PACKAGE INSERT

Other side effects with Singulair include
  • severe skin reactions (erythema multiforme) that may occur without warning

 

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