Pulmicort Flexhaler (budesonide inhalation powder) For Oral Inhalation Only

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. Read about the new physician labeling format.

Summary View

Sections Modified

PRECAUTIONS

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

ADVERSE REACTIONS

• Adverse Event Reports from Other Sources
  • Postmarketing Experience

PATIENT PACKAGE INSERT

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