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Label Changes for:

Pulmicort Flexhaler (budesonide inhalation powder) For Oral Inhalation Only

April 2008

Changes have been made to the PRECAUTIONS, 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) -- April 2008


The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.

Summary View

Sections Modified


  • General
    • Initial Paragraph
      • Pulmicort Flexhaler contains small amounts of lactose...
  • Information for Patients


  • Adverse Event Reports from Other Sources
    • Postmarketing Experience


  • Before Using Your Pulmicort Flexhaler
  • What are the ingredients in Pulmicort Flexhaler?