• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Safety

  • Print
  • Share
  • E-mail

Pulmicort Respules (budesonide) inhalation suspension

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- October 2009

 

Summary View

 

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.