Raloxifene Side Effects

Medically reviewed by Drugs.com. Last updated on Nov 17, 2024.

Applies to raloxifene: oral tablet.

Precautions

It is very important that you keep your appointments with your doctor even if you feel well.

Before you have any kind of surgery, tell the medical doctor in charge that you are using this medicine. Discuss discontinuing use of raloxifene 3 days before you think you will have a long period of inactivity, sitting, or bed rest, such as after having surgery or going on a long trip. The doctor may have you start the medicine again after you are back on your feet and fully mobile. If you are going on a trip and stay on raloxifene, you should walk regularly or move about when possible. Remaining still for long periods may cause blood clots for some people, and raloxifene may rarely worsen their condition.

If you are able to become pregnant, stop using the medicine immediately if you think you have become pregnant and check with your doctor. Raloxifene is recommended for women who are past menopause.

Raloxifene does not act like an estrogen to stimulate the uterus or breast. If you experience vaginal bleeding, breast pain or enlargement, or swelling of hands or feet while on raloxifene, you should report it to your doctor.

Other ways that may be used with raloxifene to help prevent or treat bone loss are taking calcium plus vitamin D supplements and getting weight-bearing exercise. You may want to discuss these options with your doctor.

Serious side effects of raloxifene

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:

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

Other side effects of raloxifene

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:

For healthcare professionals

Applies to raloxifene: oral tablet.

Cardiovascular adverse events

• Very 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^[Ref]

Other

• Very common (10% or more): Flu syndrome (16.2%), infection (15.1%), peripheral edema (14.1%)
• Common (1% to 10%): Chest pain, fever^[Ref]

Musculoskeletal

• Very common (10% or more): Arthralgia (15.5%), muscle spasms/leg cramps (12.1%)
• Common (1% to 10%): Myalgia, arthritis, tendon disorder^[Ref]

Respiratory

• Very common (10% or more): Sinusitis (10.3%), rhinitis (10.2%)
• Common (1% to 10%): Bronchitis, pharyngitis, increased cough, pneumonia, laryngitis^[Ref]

Dermatologic

• Common (1% to 10%): Rash, sweating^[Ref]

Endocrine

• Common (1% to 10%): Breast pain/tenderness/enlargement^[Ref]

Gastrointestinal

• Common (1% to 10%): Nausea, diarrhea, dyspepsia, vomiting, flatulence, gastrointestinal disorder, gastroenteritis, abdominal pain^[Ref]

Genitourinary

• Common (1% to 10%): Vaginitis, urinary tract infection, cystitis, leukorrhea, uterine disorder, vaginal bleeding, endometrial disorder, vaginal hemorrhage, urinary tract disorder^[Ref]

Hepatic

• Common (1% to 10%): Cholelithiasis, cholecystectomy
• Frequency not reported: Slightly decreased platelet counts, moderate increases in AST and/or ALT^[Ref]

Metabolic

• Common (1% to 10%): Weight gain^[Ref]

Nervous system

• Common (1% to 10%): Headache/migraine, syncope, vertigo, neuralgia, hypesthesia, stroke, death related to stroke^[Ref]

Ocular

• Common (1% to 10%): Conjunctivitis
• Postmarketing reports: Retinal vein occlusion^[Ref]

Psychiatric

• Common (1% to 10%): Depression, insomnia^[Ref]

Hematologic

• Uncommon (0.1% to 1%): Thrombocytopenia^[Ref]

Oncologic

• Uncommon (0.1% to 1%): Benign endometrial polyps
• Frequency not reported: Endometrial cancer, ovarian cancer, endometrial atrophy^[Ref]

See also:

Frequently asked questions

• How does Evista (raloxifene) work?

Further information

Raloxifene side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer