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U.S. Department of Health and Human Services

Safety

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Ortho Evra (norelgestromin and ethinyl estradiol) transdermal system

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

 

Summary View

 

CONTRAINDICATIONS 

  • Known thrombophilic conditions 

PRECAUTIONS 

  • Addition of non-nucleoside reverse transcriptase inhibitors as a class of drugs that can significantly change (increase or decrease) the plasma concentrations of estrogen and progestin 
  • Addition of voriconazole, fluconazole, grapefruit juice, and rosuvastatin as additional examples of drugs or foods that may increase the plasma concentration of ethinyl estradiol 

ADVERSE REACTIONS 

Postmarketing Experience 
  • dysguesia

PATIENT LABEL 

Who Should Not Use Ortho Evra? 
  • An inherited problem that makes your blood clot more than normal 
Other Side Effects 
  • abnormal taste 
Drug Interactions
  • herbal products