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.
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