raloxifene

What is the most important information I should know about raloxifene?

Raloxifene can also increase your risk of a stroke, which can be fatal. This risk is highest if you have certain risk factors (such as smoking, having heart problems or high blood pressure, or if you have ever had a heart attack or a stroke).

Although this medicine is for use only in postmenopausal women, you should not take raloxifene if you are pregnant or breastfeeding.

What is raloxifene?

Raloxifene is used to treat osteoporosis in postmenopausal women.

Raloxifene is not for use in men.

Raloxifene may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking raloxifene?

Raloxifene can increase your risk of a stroke, which can be fatal. Tell your doctor if you have ever had:

• heart problems, irregular heartbeats;
• a heart attack or stroke, including "mini-stroke";
• high blood pressure;
• cancer; or
• if you smoke.

Tell your doctor if you have ever had:

• a blood clot;
• high triglycerides caused by using estrogen;
• liver or kidney disease;
• endometriosis;
• abnormal vaginal bleeding; or
• if you have not gone through menopause.

How should I take raloxifene?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take the medicine at the same time each day, with or without food.

Raloxifene is only part of a complete program of treatment that may also include diet changes, exercise, bone mineral density testing, and taking calcium and vitamin D supplements. Follow your doctor's instructions very closely.

Your doctor should check your progress on a regular basis. Self-examine your breasts for lumps on a monthly basis, and have regular mammograms.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Get your prescription refilled before you run out of medicine completely.

What happens if I overdose?

What should I avoid while taking raloxifene?

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

What are the possible side effects of raloxifene?

• swelling, tenderness, or other changes in your breasts;
• signs of a stroke --sudden numbness or weakness (especially on one side of the body), slurred speech, vision problems;
• signs of a blood clot in the lung --chest pain, trouble breathing, coughing up blood; or
• signs of a blood clot deep in the body --swelling, warmth, or redness in an arm or leg.

Common side effects may include:

• hot flashes;
• leg cramps;
• swelling in your hands, feet, or ankles;
• joint pain;
• flu symptoms; or
• increased sweating.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect raloxifene?

Tell your doctor about all your other medicines, especially:

• cholestyramine;
• warfarin (Coumadin, Jantoven); or
• birth control pills or hormone replacement therapy.

This list is not complete. Other drugs may affect raloxifene, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Where can I get more information?

Your pharmacist can provide more information about raloxifene.