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U.S. Department of Health and Human Services

Safety

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Azasite (azithromycin) ophthalmic solution

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

 

July 2012

Summary View

CONTRAINDICATIONS

  • Hypersensitivity to any component of this product 

 

March 2011 

Summary View

 

WARNINGS and PRECAUTIONS (modified)

Anaphylaxis and Hypersensitivity with Systemic Use of Azithromycin
  • In patients receiving systemically administered azithromycin, serious allergic reactions, including angioedema, anaphylaxis, and dermatologic reactions including Stevens Johnson Syndrome and toxic epidermal necrolysis have been reported rarely in patients on azithromycin therapy. Although rare, fatalities have been reported. The potential for anaphylaxis or other hypersensitivity reactions should be considered based on known hypersensitivity to azithromycin when administered systemically.

ADVERSE REACTIONS

  • Section strengthened.