Evista Side Effects

Generic name: raloxifene

Please note - some side effects for Evista may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Evista - for the consumer

Evista

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Evista:

Hot flashes; increased sweating; joint aches; leg cramps.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal vaginal bleeding; back or side pain; blurred vision, loss of vision, or other vision changes; breast pain, tenderness, swelling, lump or discharge; chest pain; coughing up blood; confusion; flu-like symptoms; leg or calf pain, warmth, or swelling; one-sided weakness; shortness of breath; slurred speech; swelling of the hands, arms, legs or feet; unexplained bleeding.

By body system

General side effects

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 side effects

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.

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 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)

Genitourinary side effects

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.

Dermatologic side effects

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

Gastrointestinal side effects

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

Metabolic side effects

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

Metabolic effects of raloxifene 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.

Musculoskeletal side effects

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

Nervous system side effects

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 side effects

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

Ocular side effects

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

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