Evista Side Effects

Generic name: raloxifene

Note: This document contains side effect information about raloxifene. Some of the dosage forms listed on this page may not apply to the brand name Evista.

Some side effects of Evista may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to raloxifene: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking raloxifene (the active ingredient contained in Evista) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• sudden numbness or weakness, especially on one side of the body;

• sudden headache, confusion, problems with vision, speech, or balance;

• chest pain, sudden cough, wheezing, rapid breathing, fast heart rate;

• pain or swelling in one or both legs;

• swelling in your hands or feet;

• fever, chills, sore throat, body aches, flu symptoms;

• unusual vaginal bleeding;

• breast pain, tenderness, or lump;

• pain or burning when you urinate; or

• severe pain in your lower back.

Less serious side effects of raloxifene may include:

• hot flashes;

• headache, dizziness, spinning sensation;

• leg pain;

• joint pain;

• increased sweating;

• nausea, vomiting, stomach pain; or

• runny or stuffy nose.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

For Healthcare Professionals

Applies to raloxifene: oral tablet

General

General side effects have included infection (11% to 15%), flu syndrome (15%), and abdominal pain (7%). The most common general side effects were hot flashes (25%) and leg cramps (6%). Hot flashes or flushes tended to occur during the first six months of therapy.

Cardiovascular

Raloxifene should be discontinued at least 72 hours prior to and during periods of immobilization. Therapy should be resumed only after the patient is fully ambulatory. Patients should be advised to avoid prolonged restrictions of movement during travel. The use of raloxifene (the active ingredient contained in Evista) in women predisposed to thromboembolic disease, such as women with congestive heart failure and malignancy, should be carefully considered.

A large (7,705 women), 3.3 year study reported raloxifene was associated with an increased risk for venous thromboembolism (relative risk 2.1, 95% confidence interval 1.2-3.8)

Cardiovascular side effects have included decreased fibrinogen 12% (versus 2% with estrogen) and Plasminogen Activator Inhibitor-1 2% (versus 9% with estrogen). However, analysis of clinical study data revealed an increased risk of venous thromboembolic events, such as deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis associated with use of raloxifene. The greatest risk of these events occurs within the first four months of treatment.

Chest pain occurred in 4% of raloxifene treated patients.

Genitourinary

Genitourinary side effects have included vaginal bleeding (6% versus HRT 64%), vaginitis (4%), UTI (4%), cystitis (3%), leukorrhea (3%), endometrial disorder (uterine-related) (3%), and breast pain (4% versus HRT 38%).

Endometrial proliferation or an increased risk of breast cancer has not been reported with raloxifene (the active ingredient contained in Evista)

Dermatologic

Dermatologic side effects have included rash (6%) and sweating (3%).

Gastrointestinal

Gastrointestinal side effects have included nausea (9%), vomiting (3%), dyspepsia (6%), flatulence (2% to 3%), GI disorder (3%), and gastroenteritis (3%).

Metabolic

Metabolic effects of raloxifene (the active ingredient contained in Evista) therapy have resulted in a less positive effect on lipids than conjugated estrogen. High density lipoprotein (HDL) is increased 15% (versus 33% with estrogen). Lipoprotein (a) is decreased 7% (versus 19% with estrogen). Low density lipoprotein (LDL) is decreased 12% (versus 14% with estrogen.

Limited clinical data suggest that women with a history of marked hypertriglyceridemia (>5.6 mmol/L or >500 mg/dL) in response to treatment with oral estrogen or estrogen plus progestin may develop increased levels of triglycerides when treated with raloxifene.

Metabolic side effects have included weight gain (9%) and peripheral edema (3%).

Musculoskeletal

Musculoskeletal side effects have included arthralgia (11%), myalgia (8%), leg cramps (6%), and arthritis (4%).

Nervous system

Nervous system side effects have included depression (6%), insomnia (6%) and fever (3%), hot flashes (25% to 29% versus HRT 3% and placebo 18%), and migraine headaches (2%).

Respiratory

Respiratory side effects have included sinusitis (10%), pharyngitis (8%), cough increased (6%), pneumonia (3%), and laryngitis (2%).

Ocular

Ocular side effects have included very rare reports of retinal vein occlusion.

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