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Tamoxifen

Warning

Tamoxifen has rarely caused very serious (possibly fatal) strokes, blood clots in the lungs/legs, and cancer of the uterus. If you are taking tamoxifen to reduce the risk of breast cancer, or if your cancer is limited to the milk ducts (ductal carcinoma in situ-DCIS), then discuss the benefits and risks of taking this medication with your doctor. However, if you are taking tamoxifen to treat breast cancer, then the benefits of taking tamoxifen are greater than the risks of side effects.

Get medical help right away if you develop symptoms of a stroke or blood clots in the lungs/legs, such as weakness on one side of the body, trouble speaking, sudden vision changes, confusion, shortness of breath, chest pain, or calf pain/swelling.

Tell your doctor right away if you develop symptoms of cancer of the uterus, such as unusual changes in your monthly period (such as the amount or timing of bleeding), unusual vaginal discharge, or pain/pressure below your "belly button" (navel).

Precautions

Before taking tamoxifen, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood clots (such as deep vein thrombosis, pulmonary embolism, stroke), certain heart problems (fast/slow/irregular heartbeat, QT prolongation in the EKG), high cholesterol/triglycerides, limited or no ability to walk (immobility), diabetes, high blood pressure, smoking, cataracts, liver disease.

Before having surgery (especially breast reconstruction), tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using tamoxifen. Tamoxifen may harm an unborn baby. Women using this medication should ask about reliable non-hormonal forms of birth control (such as condoms, diaphragms with spermicide) during treatment and for 2 months after the last dose. Men using this medication should ask about reliable forms of birth control during treatment and for 6 months after the last dose. If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this medication and for 3 months after the last dose. Consult your doctor before breastfeeding.

Side Effects

See also Warning section.

Hot flashes, nausea, leg cramps, muscle aches, hair thinning, headache, and numb/tingling skin may occur. A loss of sexual ability/interest may occur in men. If these effects last or get worse, tell your doctor promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: vision changes (such as blurred vision), eye pain, easy bruising/bleeding, mental/mood changes, swelling of ankles/feet, unusual tiredness, signs of infection (such as sore throat that doesn't go away, fever), signs of liver disease (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.