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U.S. Department of Health and Human Services

Safety

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Voltaren (diclofenac sodium enteric-coated tablets) and Voltaren-XR (diclofenac sodium extended-release) tablets

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

Summary View

 

PRECAUTIONS

Drug Interactions
  • CYP2C9 Inhibitors or Inducers: Diclofenac is metabolized by cytochrome P450 enzymes, predominantly by CYP2C9. Co-administration of diclofenac with CYP2C9 inhibitors (e.g. voriconazole) may enhance the exposure and toxicity of diclofenac whereas co-administration with CYP2C9 inducers (e.g. rifampin) may lead to compromised efficacy of diclofenac. Use caution when dosing diclofenac with CYP2C9 inhibitors or inducers, a dosage adjustment may be warranted

ADVERSE REACTIONS

  • Digestive System: ... fulminant hepatitis with and without jaundice, liver necrosis
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