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Drug Profile

The information on this site is intended to supplement and enhance, not replace, the advice of a physician who is familiar with your medical history. Decisions about your health should always be made ONLY after detailed conversation with your doctor.

Limited Use [what does this mean?]
Generic drug name: raloxifene (ra LOX i feen)
Brand name(s): EVISTA
GENERIC: not available FAMILY: Selective Estrogen Receptor Modulators
Find the drug label by searching at DailyMed.

Pregnancy and Breast-feeding Warnings [top]

Pregnancy Warning

Raloxifene caused delayed or abnormal development and/or death in the young of animals exposed to it during pregnancy. If you are pregnant or thinking of becoming pregnant, you should not take raloxifene because of the potential danger to the fetus.

Breast-feeding Warning

It is likely that this drug, like many others, is excreted in human milk, and because of the potential for adverse effects in nursing infants, you should not take this drug while nursing.

Safety Warnings For This Drug [top]

FDA BLACK BOX WARNING

WARNING: INCREASED RISK OF VENOUS THROMBOEMBOLISM AND DEATH FROM STROKE

  • Increased risk of deep vein thrombosis (blood clots that form in large veins of the body, most often in the legs) and pulmonary embolism (blood clots that form elsewhere in the body and travel to the lungs) have been reported with raloxifene. Women with active or past history of venous thromboembolism should not take raloxifene.
  • Increased risk of death due to stroke occurred in a trial in postmenopausal women with documented coronary heart disease or at increased risk for major coronary events. Consider risk-benefit balance in women at risk for stroke.

Things You Can Do to Prevent Falls

Falls, of course, will increase your chances of a fracture. Ask your doctor to review your continued need for and dose of any drug that causes you to be dizzy or drowsy. Check the list of drugs that can cause falls. Check your home for situations that can lead to falls such as areas that are not well lit or loose rugs on hardwood floors.

What You Can Do to Prevent Osteoporosis

Diet and Exercise

Many women are not at risk of developing hip or other types of fractures. Women who are thin or small-boned, particularly if they are Asian or white, and women who drink more than two alcoholic drinks per day are at higher risk of osteoporosis. Black women, heavy women, and women who get lots of exercise are at a lower risk. There are steps women can take to prevent osteoporosis; for instance, a lot of calcium in the diet from early adulthood and weight-bearing exercise such as jogging, walking, tennis, and bicycling. You should be receiving from 800 to 1,200 milligrams of calcium per day in your diet, depending on your age. Women who are postmenopausal require an average of 1,500 milligrams per day of calcium (see Calcium Content of Some Foods table in Osteoporosis). These two steps (diet and exercise) are enough to prevent osteoporosis in many adults.

Facts About This Drug [top]

Raloxifene (EVISTA) is approved for the prevention and treatment of osteoporosis in postmenopausal women. It is also approved to reduce the risk of invasive breast cancer in postmenopausal women with osteoporosis and in postmenopausal women at high risk for invasive breast cancer. We list EVISTA as Limited Use for prevention and treatment of osteoporosis.

The drug belongs to the selective estrogen receptor modulators (SERMs) family, which acts like estrogen in bone and some other tissues...

Raloxifene (EVISTA) is approved for the prevention and treatment of osteoporosis in postmenopausal women. It is also approved to reduce the risk of invasive breast cancer in postmenopausal women with osteoporosis and in postmenopausal women at high risk for invasive breast cancer. We list EVISTA as Limited Use for prevention and treatment of osteoporosis.

The drug belongs to the selective estrogen receptor modulators (SERMs) family, which acts like estrogen in bone and some other tissues but antagonizes estrogen in reproductive tissues.[1] Whether this is important in terms of long-term adverse effects is unknown.

Raloxifene should not be used for the primary or secondary prevention of cardiovascular disease.[2],[3]

Raloxifene should be used with caution in patients with moderate to severe kidney problems.[2],[3]

Raloxifene should not be taken by women until after menopause. Safety and effectiveness have not been studied in men or children.

Side effects

Commonly reported side effects of raloxifene include hot flashes and leg cramps. Hot flashes are especially common in women near menopause, and raloxifene increases their incidence. Other side effects include flu symptoms, peripheral edema (swelling in the feet and legs), fluid in the endometrial cavity (inside the uterus) and high blood sugar.

The long-term effects of raloxifene, such as safety for more than two years or effects on the pituitary gland, are unknown.

Raloxifene and osteoporosis

When raloxifene is compared to the bisphosphonate family of drugs used for osteoporosis, the bisphosphonates are more effective in increasing bone mineral density (BMD), but there is no evidence from a head-to-head trial that either is superior in reducing the risk of fractures. Neither raloxifene nor bisphosphonates — except for alendronate, a bisphosphonate that reduces the risk of hip and wrist fractures in women with previous vertebral fractures — significantly reduce the risk of nonvertebral fractures compared to a placebo. Vertebral fracture is a spinal fracture that may or may not be symptomatic.

In a three-year treatment study in postmenopausal women, raloxifene increased bone mineral density of the lumbar spine and hip (the only two sites measured). However, of these two sites, raloxifene decreased the risk of fractures only in the spine. Indeed, the authors stated that, as in previous studies, “the effect of fracture reduction is not clearly related to the increase in bone mineral density.”[4] Of 12 kinds of nonspinal fractures tracked in this study, only ankle fractures were statistically reduced (1.1 percent versus 0.7 percent, a difference of only 0.4 percent). There was no reduction in the incidence of fractures of the hip, the site of most importance.[5],[6],[7]

Raloxifene was most effective on the risk of spinal fracture. For the group of patients without a history of spinal fractures, the incidence of new spinal fractures, as detected by X-ray, was reduced by 2.4 percent for a relative risk reduction of 55 percent, the number most often seen in descriptions of this study. Spinal fractures occurred in 4.3 percent of placebo patients and 1.9 percent of raloxifene-treated patients. In the group of patients who had had a previous spinal fracture, there was a 6 percent reduction in spinal fractures as detected by X-ray: 20 percent in the placebo group and 14 percent in the raloxifene-treated group.[8]

The patients most in need of treatment were those who had had a painful spinal fracture (not just one found on X-ray). In this group, the difference between treated and untreated was only 1.3 percent (3.1 percent of placebo patients and 1.8 percent of raloxifene-treated patients had new painful spinal fractures over three years).[8]

Raloxifene and breast cancer

A clinical trial found that raloxifene was comparable to tamoxifen (NOLVADEX) in preventing breast cancer in postmenopausal women considered to be at a higher-than-average risk. However, in May 2006, the Medical Letter on Drugs and Therapeutics reviewed the limited data available and concluded:

It is not clear how the lower incidence of uterine cancer with raloxifene equates with the lower incidence of non-invasive breast cancer with tamoxifen. Longer studies to evaluate mortality are needed. No data are available on the efficacy or risk, if any, of switching from tamoxifen to raloxifene.

In May 2006, drug manufacturer Eli Lilly Canada Inc. issued a “Dear Health Care Professional” letter and a public communication regarding an association between raloxifene use and an increased risk of death due to stroke in postmenopausal women at increased risk for heart disease.[9],[10]

This is one of a limited number of drugs for which the FDA requires an FDA-approved Medication Guide to be dispensed when the prescription is filled. (By clicking here you can see the Medication Guide for this drug.)

Regulatory actions surrounding raloxifene

2007: Raloxifene’s labeling was updated by the Food and Drug Administration (FDA) to include information that an increased risk of death due to stroke occurred in a trial in postmenopausal women with documented coronary heart disease or at an increased risk for major coronary events.[11]

Before You Use This Drug [top]

Do not use if you have or have had:

  • deep vein thrombosis
  • pulmonary embolism
  • retinal vein thrombosis

Tell your doctor if you have or have had:

  • allergies
  • cancer
  • congestive heart failure
  • diabetes[5]
  • liver problems, such as cirrhosis
  • pregnancy or are breast-feeding

Tell your doctor about any other drugs you take, including aspirin, herbs, vitamins, and other nonprescription products.

When You Use This Drug [top]

  • Get regular, preferably weight-bearing exercise, such as bicycling, jogging, tennis, or walking.
  • Eat a diet adequate in calcium. You may need to take a calcium supplement. If you do not live in a sunny climate, you may need to take vitamin D, particularly during the winter or if you do not go outdoors.
  • Avoid alcohol and sedatives, which increase the risk of falls and fractures.
  • Stop smoking, which increases the risk of osteoporosis.
  • Prevent falls by using handrails on stairs, adequate lighting, and avoiding throw rugs and electric cords in your path. Use proper lifting techniques.
  • Ask your doctor whether to continue raloxifene if you will be inactive for long periods, such as on an extensive plane trip.
  • See your doctor regularly.
  • Stop your medication immediately and check with your doctor if you suspect you might be pregnant.
  • Tell your doctor if you have vaginal bleeding, breast pain, or swelling of hands or feet.
  • Tell any doctor, dentist, emergency help, pharmacist, or surgeon you see that you take raloxifene. If you have planned surgery, including dental, your doctor will usually discontinue raloxifene 72 hours prior to the surgery. Raloxifene should not be resumed until after you are able to be up and walking around.

How to Use This Drug [top]

  • If you miss a dose, take it as soon as you remember, but skip it if it is almost time for the next dose. Do not take double doses.
  • Do not share your medication with others.
  • Take the drug at the same time(s) each day.
  • Take with or without food.
  • Store tablets at room temperature with lid on tightly. Do not store in the bathroom. Do not expose to heat, moisture, or strong light. Keep out of reach of children.

Interactions with Other Drugs [top]

The following drugs, biologics (e.g., vaccines, therapeutic antibodies), or foods are listed in Evaluations of Drug Interactions 2003 as causing “highly clinically significant” or “clinically significant” interactions when used together with any of the drugs in this section. In some sections with multiple drugs, the interaction may have been reported for one but not all drugs in this section, but we include the interaction because the drugs in this section are similar to one another. We have also included potentially serious interactions listed in the drug’s FDA-approved professional package insert or in published medical journal articles. There may be other drugs, especially those in the families of drugs listed below, that also will react with this drug to cause severe adverse effects. Make sure to tell your doctor and pharmacist the drugs you are taking and tell them if you are taking any of these interacting drugs:

chlorotrianisene, cholestyramine, conjugated estrogens, DELESTROGEN, DES, diethylstilbestrol, esterified estrogens, ESTINYL, ESTRACE, ESTRADERM, estradiol, estradiol transdermal, estriol, estrogens, estrone, estropipate, ethinyl estradiol, MENEST, mestranol, NORETHINDRONE, NORINYL, OGEN, ORTHO-EST, ORTHO-NOVUM, polyestradiol, PREMARIN, LOCHOLEST, QUESTRAN, quinestrol

If you take these drugs your doctor may or may not change your doses: COUMADIN, diazepam, diazoxide, lidocaine, VALIUM, warfarin, XYLOCAINE.

Adverse Effects [top]

Call your doctor immediately if you experience:

  • severely painful abdomen
  • appetite loss
  • breast pain
  • difficulty breathing
  • chest pain
  • coughing up blood
  • severe diarrhea
  • endometrial disorder
  • flulike symptoms, such as body aches or pains, cough, fever, hoarseness or voice loss, runny nose, sinus congestion, dry or sore throat
  • headache or migraine headache
  • incoordination
  • infection
  • leg cramps
  • numbness in arms, chest, or legs
  • pneumonia
  • skin rash
  • difficulty swallowing
  • swelling of ankles, feet, or hands
  • difficult, painful, or burning urination, or bloody or cloudy urine
  • vaginal bleeding or itching
  • vision changes
  • weakness

Call your doctor if you continue to experience:

  • mental depression
  • gas
  • hot flashes
  • indigestion
  • trouble sleeping
  • pain in muscles or joints
  • nausea or vomiting
  • profuse sweating
  • swollen joints
  • white vaginal discharge
  • unexplained weight gain

Periodic Tests[top]

Ask your doctor which of these tests should be done periodically while you are taking this drug:

  • physical exam with special attention to breasts and uterus
  • triglycerides blood test
  • bone mineral density

last reviewed July 31, 2021