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
