Learn more about usage, cautions, and possible side effects .
Chemical Name: RALOXIFENE (ral-OX-I-feen)
This medicine is a selective estrogen receptor modulator (SERM) used to treat and prevent osteoporosis (bone thinning) in women who are past menopause. It is also used to reduce the risk of invasive breast cancer in certain women who are past menopause. It may also be used to treat other conditions as determined by your doctor.
WARNING: THIS MEDICINE MAY INCREASE THE RISK OF SERIOUS BLOOD CLOTS. Do not take this medicine if you have a history of serious blood clots (such as in the lung, leg, or eye). THIS MEDICINE MAY INCREASE THE RISK OF DEATH FROM STROKE IN PATIENTS WHO HAVE CORONARY HEART DISEASE OR WHO ARE AT RISK FOR CERTAIN SERIOUS HEART PROBLEMS. If you have heart problems or are at risk for a serious heart problem, talk with your doctor to be sure that the benefits of using this medicine outweigh the risks. Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. DO NOT TAKE THIS MEDICINE if you are also taking an anion exchange resin (such as cholestyramine, colestipol) or estrogen. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking anticoagulants (such as warfarin), diazepam, diazoxide, or lidocaine. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor if you are at risk for stroke or heart problems, if you will be having surgery, or if you smoke or drink alcohol. Inform your doctor if you have a history of high triglyceride levels while taking an estrogen, or if anyone in your family has a history of serious blood clots. Inform your doctor of any other medical conditions including a history of liver problems, kidney problems, breast cancer or any other type of cancer, stroke, transient ischemic attack (TIA), blood vessel problems, heart problems, (such as heart failure, irregular heartbeat), high blood pressure; nutrient absorption problems (gastrointestinal malabsorption syndrome); very poor health; allergies; pregnancy; or breast-feeding. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have not yet gone through menopause or if you have a history of blood clots in your legs, lungs, or eyes. Contact your doctor or pharmacist if you have any questions or concerns about taking this medicine.
Follow the directions for using this medicine provided by your doctor. This medicine comes with a MEDICATION GUIDE approved by the U.S. Food and Drug Administration. Read it carefully each time you refill this medicine. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine. This medicine may be taken on an empty stomach or with food. STORE THIS MEDICINE at room temperature between 68 and 77 degrees F (20 and 25 degrees C), away from heat, moisture, and light. Brief storage between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Take this medicine regularly to receive the most benefit from it. Taking this medicine at the same time each day will help you to remember. CONTINUE TO TAKE THIS MEDICINE even if you feel well. Do not miss any doses. IF YOU MISS A DOSE OF THIS MEDICINE, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. DO NOT take 2 doses at once.
DO NOT TAKE THIS MEDICINE if you have had an allergic reaction to it or if you are allergic to any ingredient in this product. THIS MEDICINE IS NOT RECOMMENDED FOR USE IN MEN. Follow the diet and exercise program given to you by your health care provider. Talk with your doctor about whether you should take a calcium and vitamin D supplement while you use this medicine. Talk to your doctor about the use of weight-bearing exercises to help prevent weak bones. This medicine should be stopped at least 72 hours before surgery or any time you will be confined to a bed or chair for a long period of time (such as a long car ride, long plane flight, bedrest, illness). Tell your doctor if you will be traveling, or any other time you may be confined to a bed or chair. If you are traveling (such as a long car ride or plane ride), try to avoid sitting in one place for a long time. Be sure to get up and move around as often as possible to help avoid the risk of blood clots. Laboratory tests and/or medical exams, including bone density, breast exams, and mammograms may be performed to monitor your progress or to check for side effects. KEEP ALL DOCTOR AND LABORATORY APPOINTMENTS while you are taking this medicine. BEFORE YOU HAVE ANY MEDICAL TREATMENTS, EMERGENCY CARE, OR SURGERY, tell the doctor that you are using this medicine. BEFORE YOU BEGIN TAKING ANY NEW MEDICINE, either prescription or over-the-counter, check with your doctor or pharmacist. FOR WOMEN: DO NOT USE THIS MEDICINE if you are pregnant. It may cause harm to the fetus. Avoid becoming pregnant while you are taking it. IF YOU SUSPECT THAT YOU COULD BE PREGNANT, contact your doctor immediately. IT IS UNKNOWN IF THIS MEDICINE IS EXCRETED in breast milk. DO NOT BREAST-FEED while taking this medicine.
SIDE EFFECTS that may occur while taking this medicine include hot flashes, increased sweating, joint aches, or leg cramps. If they continue or are bothersome, check with your doctor. CHECK WITH YOUR DOCTOR AS SOON AS POSSIBLE if you experience breast pain, tenderness, swelling, lump or discharge; or flu-like symptoms. CONTACT YOUR DOCTOR IMMEDIATELY if you experience abnormal vaginal bleeding; back or side pain; blurred vision, loss of vision, or other vision changes; chest pain; coughing up blood; confusion; leg or calf pain, warmth, or swelling; one-sided weakness; shortness of breath; slurred speech; swelling of the hands, arms, legs or feet; or unexplained bleeding. An allergic reaction to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash, itching, swelling, dizziness, or trouble breathing. If you notice other effects not listed above, contact your doctor, nurse, or pharmacist. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your healthcare provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Drug interactions can result in unwanted side effects or prevent a medicine from doing its job. Use our drug interaction checker to find out if your medicines interact with each other. Check drug interactions
If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include diarrhea, dizziness, flushing, loss of coordination, severe leg cramps, tremor, or vomiting.
DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. KEEP THIS MEDICINE out of the reach of children. IF USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, obtain refills before your supply runs out.