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Raloxifene

Pronunciation

Generic Name: raloxifene (ral-OX-i-feen)
Brand Name: Evista

Raloxifene may increase the risk of serious blood clots. Do not take raloxifene if you have a history of serious blood clots (eg, in the lung, leg, or eye).

Raloxifene 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 raloxifene outweigh the risks.


Raloxifene is used for:

Treating and preventing 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 for other conditions as determined by your doctor.

Raloxifene is a selective estrogen receptor modulator (SERM). It works in osteoporosis by decreasing bone breakdown and thinning that may occur in women after menopause. It works to decrease the risk of invasive breast cancer by blocking estrogen in breast and uterine tissue.

Do NOT use raloxifene if:

  • you are allergic to any ingredient in raloxifene
  • you are pregnant, could become pregnant, or are breast-feeding
  • you have not yet gone through menopause
  • you have a history of blood clots in your legs, lungs, or eyes
  • you are taking an anion exchange resin (eg, cholestyramine, colestipol) or estrogen

Contact your doctor or health care provider right away if any of these apply to you.

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Before using raloxifene:

Some medical conditions may interact with raloxifene. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of liver problems, kidney problems, breast cancer, or any other type of cancer
  • if you have a history of stroke, transient ischemic attack (TIA), blood vessel problems, heart problems, (eg, heart failure, irregular heartbeat), or high blood pressure
  • if you are at risk for stroke or heart problems
  • if you will be having surgery, you smoke or drink alcohol, you are not able to absorb nutrients properly (gastrointestinal malabsorption syndrome), or you have very poor health
  • if you are taking an estrogen or have a history of high triglyceride levels while taking an estrogen
  • if anyone in your family has a history of serious blood clots

Some MEDICINES MAY INTERACT with raloxifene. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Anion exchange resins (eg, cholestyramine) because they may decrease raloxifene's effectiveness
  • Diazepam, diazoxide, or lidocaine because the risk of their side effects may be increased by raloxifene.
  • Anticoagulants (eg, warfarin) because their effectiveness may be decreased by raloxifene

This may not be a complete list of all interactions that may occur. Ask your health care provider if raloxifene may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use raloxifene:

Use raloxifene as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Raloxifene comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get raloxifene refilled.
  • Take raloxifene by mouth with or without food.
  • Take raloxifene on a regular schedule to get the most benefit from it. Taking raloxifene at the same time each day will help you remember to take it.
  • Continue to take raloxifene even if you feel well. Do not miss any doses.
  • If you miss a dose of raloxifene, use 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 use 2 doses at once.

Ask your health care provider any questions you may have about how to use raloxifene.

Important safety information:

  • 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 raloxifene.
  • Talk with your doctor about the use of weight-bearing exercises to help prevent weak bones.
  • Raloxifene 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 (eg, long car ride, long plane flight, bedrest, illness). Tell your doctor or dentist that you take raloxifene before you receive any medical or dental care, emergency care, or surgery. 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 (eg, 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.
  • Raloxifene is not recommended for use in men.
  • Lab tests and medical exams, including bone density, breast exams, and mammograms, may be performed while you use raloxifene. They may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Raloxifene should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Do not use raloxifene if you are pregnant. It may cause harm to the fetus. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. It is not known if raloxifene is found in breast milk. Do not breast-feed while taking raloxifene.

Possible side effects of raloxifene:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Hot flashes; increased sweating; joint aches; leg cramps.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal vaginal bleeding; back or side pain; blurred vision, loss of vision, or other vision changes; breast pain, tenderness, swelling, lump or discharge; chest pain; coughing up blood; confusion; flu-like symptoms; leg or calf pain, warmth, or swelling; one-sided weakness; shortness of breath; slurred speech; swelling of the hands, arms, legs or feet; unexplained bleeding.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include diarrhea; dizziness; flushing; loss of coordination; severe leg cramps; tremor; vomiting.

Proper storage of raloxifene:

Store raloxifene at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep raloxifene out of the reach of children and away from pets.

General information:

  • If you have any questions about raloxifene, please talk with your doctor, pharmacist, or other health care provider.
  • Raloxifene is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take raloxifene or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about raloxifene. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to raloxifene. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using raloxifene.

Issue Date: December 3, 2014
Database Edition 14.4.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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