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U.S. Department of Health and Human Services

Safety

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Danocrine brand of Danazol capsules

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

 

Summary View

 

WARNINGS and PRECAUTIONS

  • include information regarding the risk of ovarian cancer in patients treated with Danocrine for endometriosis.

 

PRECAUTIONS

Geriatric Use
  • Clinical studies of Danocrine did not include sufficient numbers of subjects aged 65 and over to determine the safety and effectiveness of Danocrine in elderly patients.

Drug Interactions

  • regarding increased risk of myopathy and rhabdomyolysis with concomitant administration of danazol with statins.

 

ADVERSE REACTIONS

  • splenic peliosis