Label Changes for:

Veramyst (fluticasone furoate) nasal spray

July 2009

Changes have been made to the CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

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

CONTRAINDICATIONS

  • Veramyst nasal spray is contraindicated in patients with hypersensitivity to any of its ingredients.

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions Including Anaphylaxis
  • Hypersensitivity reactions including anaphylaxis angioedema, rash, and urticaria, may occur after administration of Veramyst Nasal Spray. Discontinue Veramyst nasal spray if such reactions occur

ADVERSE REACTIONS

Postmarketing Experience/Immune System Disorders
  • hypersensitivity reactions including anaphylaxis, angioedema, rash and urticaria
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