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U.S. Department of Health and Human Services

Safety

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

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

 

April 2014

Summary View

4 CONTRAINDICATIONS

  • Coadministration of standard doses of voriconazole with efavirenz doses of  400 mg q24h or higher is contraindicated, because efavirenz  significantly decreases plasma voriconazole concentrations in healthy subjects at these doses. Voriconazole also significantly increases efavirenz plasma concentrations [see Drug Interactions (7), and Clinical Pharmacology (12.3)].

7 DRUG INTERACTIONS

Table 8

  • added .....Everolimus 

 

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