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U.S. Department of Health and Human Services


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Symbicort (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol for Oral Inhalation Only July 2008

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


  • Information for Patients
    • ...Patients should be instructed about the differences between Symbicort and their other inhaled medications including the differences in intended use and physical appearance.


  • How do I use Symbicort?
    • ...Note the differences between Symbicort and your
      other inhaled medications, including the differences in prescribed use and physical appearance.
  • General Information about Symbicort
    • ...Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088...