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Precautions and Warnings With Ospemifene

Specific Ospemifene Precautions and Warnings

Some warnings and precautions to be aware of prior to taking this drug include the following:
 
  • This medication may increase your risk for having a stroke or getting blood clots. Smoking, being overweight, and having certain other medical problems, such as high blood pressure, high cholesterol, or diabetes, may also increase your risk for blood clots and strokes. Your healthcare provider should appropriately manage these risks, especially while you are taking ospemifene.
 
  • Certain surgeries and prolonged immobility, such as prolonged bed rest, also increase your chance of getting a blood clot. Therefore, ospemifene should be stopped at least four to six weeks before a surgery that may increase the risk for blood clots, or before long periods of immobility.
 
  • Ospemifene acts like estrogen on the lining of the uterus (the endometrium), and may cause it to grow and thicken. This could increase your chance of getting endometrial cancer. The risk may be higher the longer you use the medication. Unexplained vaginal bleeding may be a sign of endometrial cancer. Therefore, you should report any unusual vaginal bleeding to your healthcare provider.
 
  • Women with severe liver disease should not be treated with ospemifene.
 
  • It is unknown if this medicine is safe for use in women with breast cancer, as it has not been adequately studied in such women. Ospemifene should not be used in women who have breast cancer, or women who have had breast cancer in the past.
   
  • Ospemifene is a pregnancy Category X medication. This means it is not safe for use during pregnancy (see Osphena and Pregnancy).
 
  • It is unknown if ospemifene passes through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to taking the drug (see Osphena and Breastfeeding).
 
Last reviewed by: Kristi Monson, PharmD
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