Safety

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

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

November 2014

Summary View

ADVERSE REACTIONS

  • enuresis in children

 

December 2013

Summary View

ADVERSE REACTIONS

  • Pulmonary Eosinophilia

 

September 2012

Summary View

ADVERSE REACTIONS

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

  

December 2011 

Summary View

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