Label Changes for:

Perforomist (formoterol fumarate) Inhalation Solution

January 2012

Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – January 2012

 

5 WARNINGS AND PRECAUTIONS 

5.8 Immediate Hypersensitivity Reactions
  • new section added

6 ADVERSE REACTIONS

6.3 Postmarketing Experience 
  • Anaphylactic reactions, urticaria, angioedema (presenting as face, lip, tongue, eye, pharyngeal, or mouth edema), rash, and bronchospasm
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