Evista

What is the most important information I should know about Evista (Raloxifene)?

You should not use this medication if you are allergic Blue Diamond to raloxifene, if you are pregnant or breast-feeding, or if you have ever had a blood clot.

Although it is not likely that a postmenopausal woman would be pregnant, raloxifene can cause birth defects and should not be used during pregnancy. Tell your doctor right away if you become pregnant during treatment.

Before taking raloxifene, tell your doctor if you smoke or if you have coronary artery disease, heart disease, high blood pressure, liver or kidney disease, a history of stroke or TIA, high triglycerides, if you have not gone through menopause, or if you have had breast cancer in the past.

If you need to have any type of surgery or will be on bed rest, you will need to stop taking raloxifene for at least 72 hours before your surgery or before you plan to be immobile. Any doctor or surgeon who treats you should know that you are taking raloxifene.

Avoid sitting still for long periods of time during travel while you are taking raloxifene.

What should I discuss with my healthcare provider before taking Evista (Raloxifene)?

You should not use this medication if you are allergic to raloxifene, if you are pregnant or breast-feeding, or if you have ever had a blood clot.

Before taking this medication, tell your doctor if you smoke or if you have:

• coronary artery disease (atherosclerosis)
• heart disease
• high blood pressure
• liver or kidney disease
• a history of stroke or TIA ("mini-stroke")
• high triglycerides (often occurs with high cholesterol)
• if you have not gone through menopause; or
• if you have had breast cancer in the past

If you have any of these conditions, you may need a dose adjustment or special tests to safely take raloxifene.

FDA pregnancy category X. Although it is not likely that a postmenopausal woman would be pregnant, raloxifene can cause birth defects and should not be used during pregnancy. Tell your doctor right away if you become pregnant during treatment.

It is not known whether raloxifene passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

What are the possible side effects of Evista (Raloxifene)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• sudden numbness or weakness, especially on one side of the body
• sudden headache, confusion, problems with vision, speech, or balance
• chest pain, sudden cough, wheezing, rapid breathing, fast heart rate
• pain or swelling in one or both legs
• swelling in your hands or feet
• fever, chills, sore throat, body aches, flu symptoms
• unusual vaginal bleeding
• breast pain, tenderness, or lump
• pain or burning when you urinate; or
• severe pain in your lower back

Less serious side effects may include:

• hot flashes
• headache, dizziness, spinning sensation
• leg pain
• joint pain
• increased sweating
• nausea, vomiting, stomach pain; or
• runny or stuffy nose

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.