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U.S. Department of Health and Human Services

Safety

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VFEND (voriconazole) Tablets, I.V. for Infusion and Oral Suspension

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – November 2011

 

Summary View

WARNINGS AND PRECAUTIONS

Skeletal Adverse Events
  • Fluorosis and periostitis have been reported during long-term voriconazole therapy. If a patient develops skeletal pain and radiologic findings compatible with fluorosis or periostitis, voriconazole should be discontinued

ADVERSE REACTIONS

Postmarketing Experience
  • The following adverse reactions have been identified during post approval use of voriconazole. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
    • Skeletal: fluorosis and periostitis have been reported during long-term voriconazole therapy