Important Safety Information
Tamoxifen carries serious risks including increased incidence of uterine malignancies (endometrial cancer and uterine sarcoma), which have been reported in association with tamoxifen treatment. In the NSABP P-1 trial, there was a statistically significant increase in the incidence of endometrial cancer among participants randomized to tamoxifen compared to placebo.
Tamoxifen also increases the risk of blood clots in veins or lungs and stroke. These can cause serious problems, including death. Blood clots may occur up to 2 to 3 months after stopping tamoxifen. Tamoxifen should not be taken by women who are pregnant or breastfeeding, as it may harm the unborn baby.
Important
Non-Medical Use
Non-medical use of tamoxifen falls outside approved indications. Clinical guidelines explicitly state that approved indications in male athletes do not exist, and use carries serious risks. Product purity does not establish that non-medical use is safe or appropriate.
Potential Adverse Effects
The most common side effect of tamoxifen is hot flashes, which is not a sign of a serious problem. The next most common side effect is vaginal discharge; if the discharge is bloody, it could be a sign of a serious problem.
Less common but serious side effects include changes in the endometrium or body of the uterus (endometrial cancer), blood clots in veins or lungs, stroke, cataracts or increased chance of needing cataract surgery, and liver problems including jaundice.
Other potential side effects include hypercalcemia in breast cancer patients with bone metastases. In the NSABP P-1 trial, tamoxifen increased the risk of developing cataracts or needing cataract surgery.
Conditions Requiring Medical Evaluation
Tamoxifen is not appropriate for everyone. It should not be taken to reduce breast cancer risk if the patient has ever had a blood clot needing medical treatment, is taking blood thinners, has limited mobility, or is at high risk for blood clots. Tamoxifen is contraindicated in pregnancy and breastfeeding.
Patients with a history of endometrial cancer, uterine sarcoma, or other serious conditions should discuss these with their healthcare provider before considering tamoxifen.
Monitoring During Therapy
Medically supervised tamoxifen therapy involves regular monitoring for signs of endometrial cancer, blood clots, and liver problems. Patients should report signs of changes in the uterus including vaginal bleeding, change in monthly bleeding, or pelvic pain. Signs of blood clots include sudden chest pain, shortness of breath, coughing up blood, or pain/tenderness/swelling in one or both legs.
Signs of stroke include sudden weakness or numbness, confusion, trouble seeing, trouble walking, or severe headache. Slow blurring of vision may indicate cataracts.
Product Care
Storage & Handling
Store tablets in a cool, dry place in the original packaging. Keep out of reach of children. Swallow tablets whole with water or another non-alcoholic liquid. Tamoxifen can be taken with or without food. Inspect tablets before use and do not use if they appear damaged or compromised.
Further Safety Information