Raloxifene
Warning
Raloxifene may rarely cause serious blood clots, especially in the legs or lungs. Women who have or had blood clots (including in the legs, lungs, or eyes) should not take raloxifene. Also, women who have had a heart attack or are at risk for a heart attack may rarely have an increased risk of dying from a stroke while taking raloxifene. Before starting treatment with raloxifene, tell your doctor if you have or had blood clots in your legs/lungs/eyes, a stroke, mini-stroke (TIA), heart disease, heart attack, high cholesterol, irregular heartbeat called atrial fibrillation, high blood pressure, or if you smoke. Discuss these risks and the benefits of using raloxifene with your doctor.
Precautions
See also Warning section.
Before taking raloxifene, tell your doctor or pharmacist if you are allergic to it, or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood clots (including in the legs/lungs/eyes), stroke, mini-stroke (TIA), heart disease (blocked blood vessels in the heart), heart attack, high cholesterol, irregular heartbeat called atrial fibrillation, high blood pressure, smoking, kidney disease, liver disease, heart failure, cancer, high blood fat (triglyceride) levels caused by estrogen treatment.
Tell your doctor if you just had or will be having surgery or if you will be confined to a bed or chair for a long time (such as a long plane flight). These conditions increase your risk of getting blood clots, especially if you are using raloxifene. You may need to stop this medication for a time or take special precautions.
This medication must not be used during pregnancy. It may harm an unborn baby. If you become pregnant or think you may be pregnant, tell your doctor right away.
It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.
Side Effects
Hot flashes or leg cramps may occur. If either of these effects lasts or gets worse, tell your doctor or pharmacist promptly.
Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Get medical help right away if you have any very serious side effects, including: signs of a blood clot (such as sudden pain/swelling/redness/warmth in the leg or arm, chest pain, trouble breathing, coughing up blood, sudden vision changes like blurred vision/loss of vision), signs of a stroke (such as weakness on one side of the body, trouble speaking, sudden vision changes, confusion).
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
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