Label Changes for:
Singulair (Montelukast Sodium) 10 mg Tablets, 5 mg and 4 mg Chewable Tablets, and 4mg Oral Granules
September 2012
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)
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
