How does this medication work? What will it do for me?

Raloxifene belongs to a family of medications called selective estrogen receptor modifiers (SERMs). It is used to treat and prevent osteoporosis in postmenopausal women.

SERMs are not hormones. However, raloxifene acts like estrogen in some parts of the body (including the bones), but not like estrogen in other parts of the body.

Raloxifene works by slowing the breakdown of bone and promoting the building of new bone. Bone density improvements and declines can be detected within one year by a procedure known as a bone mineral density test.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

Each white, elliptical, film-coated tablet, imprinted on one side with the tablet code "4165" in blue ink, contains raloxifene HCl 60 mg. Nonmedicinal ingredients: anhydrous lactose, crospovidone, FD&C Blue No. 2 Aluminum Lake, hydroxypropyl methylcellulose, lactose monohydrate, macrogol 400, magnesium stearate, polysorbate 80, povidone, and titanium dioxide E171.

How should I use this medication?

The recommended adult dose of raloxifene is 60 mg daily at the same time each day, with or without food.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Raloxifene should not be taken by anyone who:

  • is allergic to raloxifene or to any of the ingredients of the medication
  • is breast-feeding
  • is pregnant or could become pregnant
  • has had thrombosis (blood clots)

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • flu-like symptoms
  • hot flashes, including sudden sweating and feelings of warmth

Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • leg cramping
  • swelling of hands, ankles, or feet
  • symptoms of high blood sugar levels (e.g., weakness, increased thirst, increase urination)

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • a sudden change in vision
  • symptoms of blood clots in the lungs (e.g., sudden chest pain or shortness of breath)
  • symptoms of blood clots in the veins (e.g., redness, swelling, heat or pain in your legs and calves)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Blood clots: A blood clot in the vein is a possible side effect of raloxifene. If you have a history of blood clots, including in the legs, lungs, or eyes, taking this medication may increase the risk of getting blood clots. Talk to your doctor if you have any concerns. If you experience any symptoms of blood clots (see "What side effects are possible with this medication?"), stop taking the medication and contact your doctor as soon as possible.

Calcium and vitamin D: It is important that you are receiving the recommended amount of calcium and vitamin D each day. If you are not getting enough from your diet, your health care provider may recommend you take vitamin D and calcium supplements. Talk to your health care provider about the amount of calcium and vitamin D you should be receiving.

Effect on uterus, breast, and mental function: Raloxifene is not associated with side effects on the uterus, breast, or mental function. Therefore, if you experience unexplained uterine bleeding, breast pain, breast enlargement, changes in mood, or deterioration of mental function, contact your doctor as soon as possible.

Liver: People who have liver disease should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Men: This medication is not for use by men.

Prolonged inactivity: Because of an increased risk of blood clots, raloxifene should be stopped at least 72 hours before and during long periods of inactivity (e.g., after surgery, prolonged bed rest).

Stroke and heart disease: Women taking raloxifene and who have had a heart attack or are at risk for a heart attack may have an increased risk dying from stroke. Talk to your doctor if you have any concerns.

Women who have not reached menopause: The safety and effectiveness of using this medication have not been established for women who have not reached menopause. This medication should not be used by premenopausal women.

Pregnancy: This medication should not be used during pregnancy.

Breast-feeding: It is not known if raloxifene passes into breast milk. This medication should not be used by women who are breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children. This medication should not be used by children.

What other drugs could interact with this medication?

There may be an interaction between raloxifene and any of the following:

  • cholestyramine
  • estrogens
  • warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.