Evista Side Effects: What to Expect and When to Call Your Doctor

Evista (raloxifene) is an effective medication for postmenopausal osteoporosis and breast cancer risk reduction, but like all medications, it comes with possible side effects. Most patients tolerate Evista well, but knowing what to expect — and when a symptom requires immediate attention — is essential. Here's a comprehensive overview.

Boxed Warning: Blood Clots and Stroke Risk

Evista carries an FDA boxed warning — the strongest level of safety warning — for two serious risks:

Venous thromboembolism (VTE): Evista increases the risk of blood clots in the veins, including deep vein thrombosis (DVT), pulmonary embolism (PE), and retinal vein thrombosis. In clinical trials, VTE occurred in about 1 in 100 patients taking Evista over approximately 2.5 years, with the highest risk in the first several months of treatment.

Stroke risk: An increased risk of death due to stroke was observed in clinical trials in postmenopausal women with documented coronary heart disease or at elevated risk for major coronary events. Evista should be used with caution in women with these risk factors, and the benefit-risk balance should be carefully considered.

Evista is contraindicated in women with an active or past history of VTE. If you have had a blood clot, do not take Evista.

Common Side Effects of Evista

These side effects are the most commonly reported and are generally considered manageable:

Hot flashes (25–28% of patients): The most common Evista-related side effect. They're most common during the first 6 months of treatment and tend to diminish over time. Evista does NOT relieve existing menopausal hot flashes — it may actually cause them in some women.

Leg cramps (about 1 in 14 patients): Usually mild. Adequate hydration and stretching can help reduce this.

Peripheral edema/fluid retention (14.1%): Swelling in the hands, feet, or ankles. Usually mild but worth monitoring.

Joint pain (arthralgia): Reported by some patients on Evista. Over-the-counter pain relievers may help.

Flu-like symptoms: Mild and usually transient.

Vaginal dryness: Evista blocks estrogen in vaginal tissue. If this is bothersome, discuss options with your provider.

Serious Side Effects: Call Your Doctor Immediately

Seek emergency care or call 911 if you experience any of these symptoms:

Signs of blood clot (DVT): Leg pain, swelling, redness, or warmth in the calf — these can indicate a deep vein thrombosis

Signs of pulmonary embolism: Chest pain, shortness of breath, or coughing up blood

Signs of stroke: Sudden weakness or numbness on one side of the body, slurred speech, vision changes, severe headache

Signs of retinal vein thrombosis: Sudden vision changes or vision loss in one eye

Signs of severe allergic reaction: Hives, difficulty breathing, swelling of the face, lips, tongue, or throat

Gallbladder symptoms: Jaundice (yellowing skin or eyes), severe upper right abdominal pain — may indicate cholecystitis or gallstones

Side Effects Evista Does NOT Cause

Evista is notable for what it does NOT do:

Does NOT increase the risk of uterine/endometrial cancer (unlike tamoxifen)

Does NOT stimulate uterine or breast tissue

Does NOT cause the GI side effects (heartburn, esophageal irritation) associated with bisphosphonates

Does NOT require fasting or special positioning when taken (unlike oral bisphosphonates)

Special Safety Precautions

Before surgery or prolonged bed rest: Stop Evista at least 3 days before major surgery or planned extended immobility. Restart only when you are fully mobile again.

During travel: Avoid sitting still for prolonged periods. Get up and walk regularly on long flights or road trips.

For information on medications and substances that can affect Evista's safety, see our post on Evista drug interactions.