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In North American clinical trials, the most commonly observed side effects with FARESTON® versus tamoxifen were hot flashes, sweating, nausea, and vaginal discharge; these side effects occurred at similar grades and frequency in each treatment group.

During clinical trials involving 1157 patients treated with FARESTON® or tamoxifen, there was a low incidence of serious side effects including cardiac events, stroke, and elevated standard liver tests.

As with other antiestrogens, tumor flare, hypercalcemia, and vaginal bleeding have been reported in some breast cancer patients being treated with FARESTON®. Patients with a history of thromboembolic disease should generally not be treated with FARESTON®.

Since most toremifene trials have been conducted in patients with metastatic disease, adequate data on the potential endometrial tumorigenicity of long-term treatment with FARESTON® are not available. Endometrial hyperplasia has been reported. Some patients treated with FARESTON® have developed endometrial cancer, but circumstances (short duration of treatment or prior antiestrogen treatment or premalignant conditions) make it difficult to establish the role of FARESTON®.

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