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Remember that your doctor has prescribed this medication because he or she 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.
Raloxifene may infrequently cause stroke or serious blood clots to form in the legs, lungs, or eyes. Seek immediate medical attention if any of these unlikely but serious side effects occur: leg swelling/pain, trouble breathing, chest pain, sudden vision changes, severe headache, weakness on one side of the body, confusion.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention 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.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the Evista (raloxifene) Side Effects Center for a complete guide to possible side effects
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.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: active or past history of blood clots (e.g., deep venous thrombosis, pulmonary embolism, retinal vein thrombosis).
Lack of movement may increase the risk for blood clots. Your doctor will instruct you to stop taking this medication at least 3 days before surgery or during long periods of inactivity (e.g., bedrest). Do not start taking raloxifene until you are routinely and actively moving again. During long periods of travel, walk or move periodically to keep the blood flowing through your body.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, high blood pressure, smoking, heart/blood vessel disease (e.g., congestive heart failure, atrial fibrillation, stroke, transient ischemic attack), cancer, high blood cholesterol levels, history of high blood fat (triglyceride) levels due to estrogen treatment.
This medication must not be used during pregnancy because it may cause harm to an unborn baby. If you become pregnant or think you may be pregnant, inform your doctor immediately.
It is not known whether this drug passes into breast milk. Breast-feeding while using this medication is not recommended. Consult your doctor before breast-feeding.
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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