Bolded Warning and Important Safety Information

EVISTA is not for everyone. Serious side effects can occur while taking EVISTA.

EVISTA may cause an increased risk of blood clots. You should not take EVISTA if you have had or are at risk for getting blood clots in the legs, lungs, or eyes. Stop taking EVISTA and call your doctor if you have swelling or feeling of warmth in your legs, chest pain, shortness of breath, coughing up blood or sudden changes in vision, 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 healthcare professional about ways to reduce the risk of blood clots.

In a study of women past menopause who were at high risk for heart attack, EVISTA increased the risk of dying from a stroke. However, EVISTA did not increase the risk of heart attack, stroke, or dying from other causes. Before taking EVISTA, tell your healthcare professional if you have had a stroke, 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.

You should not take EVISTA if you are nursing, pregnant, or may become pregnant, as it may harm your baby. If you have kidney or liver problems, you should talk to your healthcare professional about these conditions before taking EVISTA. Do not take EVISTA with estrogen in the form of pills, patches, or injections.

The most common side effects are hot flashes, leg cramps, swelling, flu-like symptoms, joint pain, and sweating. In clinical trials, side effects were usually mild enough that most women did not stop taking EVISTA.

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, and important information for patients taking EVISTA, see the Medication Guide.