Label Changes for:
Singulair (montelukast sodium) Tablets, Chewable Tablets, and Oral Granules
December 2011
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) – 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
