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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.
raloxifene may increase your risk of a blood clot in your leg, your lung, or your eye. You should not take raloxifene if you have ever had this type of blood clot.
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.
This medicine may increase your risk of a blood clot in your leg, your lung, or your eye. You should not take raloxifene if you have ever had this type of blood clot.
This medicine is for use only in women who can no longer get pregnant. Raloxifene can harm an unborn baby. Do not use if you are pregnant or may become pregnant.
Do not breastfeed while 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.
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.
If you need major surgery or will be on long-term bed rest, you will need to stop taking raloxifene at least 3 days ahead of time. You may not be able to restart the medicine until you are active again. Tell any doctor or surgeon who treats you that you take raloxifene.
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.
Store at room temperature away from moisture and heat.
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.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
If you take calcium supplements, do not take more than your doctor has prescribed. Taking more calcium than recommended will not provide extra protection for your bones, and may cause serious side effects including kidney stones.
Avoid sitting still for long periods of time during travel while you are taking raloxifene.
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using raloxifene and call your doctor at once if you have:
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.
Usual Adult Dose for Osteoporosis:
60 mg orally per day
Comments:
-For treatment or prevention of osteoporosis, advise patients to add supplemental calcium and/or vitamin D if daily intake is inadequate.
-When this drug is used to reduce the risk of invasive breast cancer, the optimum duration of treatment is not known.
Uses:
-Treatment and prevention of osteoporosis in postmenopausal women.
-Reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis and/or at high risk of invasive breast cancer.
Usual Adult Dose for Prevention of Osteoporosis:
60 mg orally per day
Comments:
-For treatment or prevention of osteoporosis, advise patients to add supplemental calcium and/or vitamin D if daily intake is inadequate.
-When this drug is used to reduce the risk of invasive breast cancer, the optimum duration of treatment is not known.
Uses:
-Treatment and prevention of osteoporosis in postmenopausal women.
-Reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis and/or at high risk of invasive breast cancer.
Usual Adult Dose for Prevention of Breast Cancer:
60 mg orally per day
Comments:
-For treatment or prevention of osteoporosis, advise patients to add supplemental calcium and/or vitamin D if daily intake is inadequate.
-When this drug is used to reduce the risk of invasive breast cancer, the optimum duration of treatment is not known.
Uses:
-Treatment and prevention of osteoporosis in postmenopausal women.
-Reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis and/or at high risk of invasive breast cancer.
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.
Further informationRemember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Raloxifene Hydrochloride (www.drugs.com/mtm/raloxifene.html).
Commonly reported side effects of raloxifene include: infection, flu-like symptoms, hot flash, and sinusitis. Other side effects include: lower limb cramp. See below for a comprehensive list of adverse effects.
For the ConsumerApplies to raloxifene: oral tablet
Oral route (Tablet)
Increased risk of deep vein thrombosis and pulmonary embolism have been reported. Women with active or past history of venous thromboembolism should not take raloxifene hydrochloride. 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.
Along with its needed effects, raloxifene may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Stop taking raloxifene and get emergency help immediately if any of the following effects occur:
Rare
Check with your doctor as soon as possible if any of the following side effects occur while taking raloxifene:
More common
Less common
Some side effects of raloxifene may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
For Healthcare Professionals
Applies to raloxifene: oral tablet
CardiovascularVery common (10% or more): Hot flashes/hot flushes/vasodilation (28.7%), increased blood pressure
Common (1% to 10%): Varicose vein, venous thromboembolism (VTE)
Postmarketing reports: Death related to VTE
OtherVery common (10% or more): Flu syndrome (16.2%), infection (15.1%), peripheral edema (14.1%)
Common (1% to 10%): Chest pain, fever
MusculoskeletalVery common (10% or more): Arthralgia (15.5%), muscle spasms/leg cramps (12.1%)
Common (1% to 10%): Myalgia, arthritis, tendon disorder
RespiratoryVery common (10% or more): Sinusitis (10.3%), rhinitis (10.2%)
Common (1% to 10%): Bronchitis, pharyngitis, increased cough, pneumonia, laryngitis
DermatologicCommon (1% to 10%): Rash, sweating
EndocrineCommon (1% to 10%): Breast pain/tenderness/enlargement
GastrointestinalCommon (1% to 10%): Nausea, diarrhea, dyspepsia, vomiting, flatulence, gastrointestinal disorder, gastroenteritis, abdominal pain
GenitourinaryCommon (1% to 10%): Vaginitis, urinary tract infection, cystitis, leukorrhea, uterine disorder, vaginal bleeding, endometrial disorder, vaginal hemorrhage, urinary tract disorder
HepaticCommon (1% to 10%): Cholelithiasis, cholecystectomy
Frequency not reported: Slightly decreased platelet counts, moderate increases in AST and/or ALT
MetabolicCommon (1% to 10%): Weight gain
Nervous systemCommon (1% to 10%): Headache/migraine, syncope, vertigo, neuralgia, hypesthesia, stroke, death related to stroke
OcularCommon (1% to 10%): Conjunctivitis
Postmarketing reports: Retinal vein occlusion
PsychiatricCommon (1% to 10%): Depression, insomnia
HematologicUncommon (0.1% to 1%): Thrombocytopenia
OncologicUncommon (0.1% to 1%): Benign endometrial polyps
Frequency not reported: Endometrial cancer, ovarian cancer, endometrial atrophy
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Raloxifene Hydrochloride (www.drugs.com/mtm/raloxifene.html).
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