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tamoxifen Images

Generic Name: tamoxifen

Brand Names: Tamoxifen Citrate, Soltamox, Nolvadex

There is an FDA Alert for this drug. Click here to view it.

  • For women with ductal carcinoma in situ (DCIS) and women at high risk for breast cancer: serious and life-threatening events associated with tamoxifen in the risk reduction setting include uterine malignancies, stroke, and pulmonary embolism. Incidence rates for these events have been estimated from the NSABP P-1 trial (median length of follow-up 6.9 years).

    Uterine malignancies consist of both endometrial adenocarcinoma (incidence rate per 1000 women-years of 2.2 for tamoxifen versus 0.71 for placebo) and uterine sarcoma (incidence rate per 1000 women-years of 0.17 for tamoxifen versus 0 for placebo).

    For stroke, the incidence rate per 1000 women-years was 1.43 for tamoxifen versus 1 for placebo.

    For pulmonary embolism, the incidence rate per 1000 women-years was 0.75 for tamoxifen versus 0.25 for placebo.

  • Health care providers should discuss the potential benefits versus the potential risks of these serious events with women at high risk of breast cancer and women with DCIS considering tamoxifen to reduce their risk of developing breast cancer.
  • The benefits of tamoxifen outweigh its risks in women already diagnosed with breast cancer.

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