Label Changes for:
Pulmicort Respules (budesonide) inhalation suspension
October 2009
Changes have been made to the WARNINGS, 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) -- October 2009
WARNINGS
Hypersensitivity Reactions Including Anaphylaxis
- Hypersensitivity reactions including anaphylaxis, rash, contact dermatitis, urticaria, angioedema, and bronchospasm have been reported with use of Pulmicort Respules. Discontinue Pulmicort Respules if such reactions occur
ADVERSE REACTIONS
- immediate and delayed hypersensitivity reactions including anaphylaxis
PATIENT PACKAGE INSERT
What are the Possible Side Effects of Pulmicort Respules?
- Hypersensitivity reactions including anaphylaxis. Tell your doctor if you have a sudden skin rash, severe itching, breathing problems, skin redness or swelling.
