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EVISTA is not right for everyone, and serious and life-threatening side effects can occur while taking EVISTA. Increased risk of blood clots in the legs (deep vein thrombosis) and lungs (pulmonary embolism) have been reported with EVISTA. Women who have or have had blood clots in the legs, lungs, or eyes should not take EVISTA. Also, being still for a long time, like sitting still during a long car or airplane trip, or being in bed after surgery, can increase your risk of blood clots.

Women who have had a heart attack or are at risk for a heart attack may have an increased risk of dying from stroke when taking EVISTA.

Common Side Effects
Signs of Blood Clots
Questions or Concerns

Common Side Effects
Hot flashes, leg cramps, swelling, flu-like symptoms, joint pain, and sweating are side effects that have been reported by postmenopausal women taking EVISTA. Hot flashes are more common during the first 6 months after starting treatment.

Signs of Blood Clots
Stop taking your medication and call your healthcare professional right away if you have or have had any of the following signs of blood clots in the veins of the legs, lungs, or eyes:

  • Leg pain or a feeling of warmth in the calves
  • Swelling of the legs, hands, or feet
  • Sudden chest pain, shortness of breath, or coughing up blood
  • Sudden change in your vision, such as loss of vision or blurred vision

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Questions or Concerns
These are not all the side effects of EVISTA. Tell your healthcare professional about any side effect that bothers you or that does not go away. If you have any problems or questions that concern you while taking EVISTA, ask your healthcare professional or pharmacist for more information.

Stop taking EVISTA at least 3 days before a planned surgery or before you plan on being still for a long time.

For more safety information about EVISTA, and important information for individuals taking EVISTA, see the Medication Guide and full Prescribing Information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

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Indication for EVISTA® (raloxifene HCI tablets)
EVISTA is indicated for the treatment of osteoporosis and for the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis.

If you already have or have had breast cancer, EVISTA does not treat it or prevent its return, and it does not reduce the risk of all forms of breast cancer.

Indication for EVISTA® (raloxifene HCI tablets)
EVISTA is indicated for the treatment and prevention of osteoporosis in postmenopausal women.

Indication for EVISTA® (raloxifene HCI tablets)
EVISTA is indicated for the reduction in risk of invasive breast cancer in postmenopausal women at high risk for invasive breast cancer.

If you already have or have had breast cancer, EVISTA does not treat it or prevent its return, and it does not reduce the risk of all forms of breast cancer.

Indications for EVISTA® (raloxifene HCI tablets)
EVISTA is indicated for:

  • The treatment and prevention of osteoporosis in postmenopausal women
  • The reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis
  • The reduction in risk of invasive breast cancer in postmenopausal women at high risk for invasive breast cancer

If you already have or have had breast cancer, EVISTA does not treat it or prevent its return, and it does not reduce the risk of all forms of breast cancer.

Important Safety Information About EVISTA

You should not take EVISTA if you have had or are at risk for getting blood clots in the legs, lungs or eyes, as it may increase the risk of blood clots. Stop taking EVISTA and call your doctor if you have leg pain or warmth, swelling of the legs, hands or feet, chest pain, shortness of breath or a sudden vision change, as these may be signs of a blood clot. Being unable to move around for long periods may increase this risk. If you will need to be still for a long time, talk to your doctor about ways to reduce the risk of blood clots.

EVISTA does not increase the risk of a heart attack or stroke in women who have had or are at risk for a heart attack; however; EVISTA increases the likelihood of dying from stroke in these women, should one occur. Before taking EVISTA tell your doctor if you have had a stroke, a mini-stroke, irregular heartbeat, high blood pressure, heart attack, history of smoking, or believe you have other risk factors for stroke or a heart attack.

Before Taking EVISTA

EVISTA is not right for everyone. You should only take prescription EVISTA if you are past menopause. Before taking EVISTA, talk to your doctor about all your medical conditions. If you are pregnant, nursing or may become pregnant, do not take EVISTA, as it may cause fetal harm. Women with liver or kidney disease should use EVISTA with caution. EVISTA should not be taken with estrogens in the form of pills, patches or injections.

Side Effects

Side effects may include hot flashes, leg cramps, swelling, flu-like symptoms, joint pain, and sweating. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For more safety information, please see the Medication Guide and full Prescribing Information.