Short answer: In the label's 3-year osteoporosis treatment trial, Evista side effects included arthralgia (15.5% vs 14.0% on placebo), flu syndrome (13.5% vs 11.4%), hot flashes (9.7% vs 6.4%) and leg cramps (7.0% vs 3.7%). Hot flashes were 24.6% vs 18.3% in the prevention trials. Evista has a boxed warning on blood clots and on death from stroke in women with heart disease.
What Evista is approved for: Evista is an estrogen agonist/antagonist approved to treat and prevent osteoporosis in postmenopausal women, and to reduce the risk of invasive breast cancer in postmenopausal women with osteoporosis or at high risk of invasive breast cancer (sections 1.1 to 1.3). It is not approved to treat breast cancer, to lower the risk of it coming back, or to lower the risk of noninvasive breast cancer.
Source
EVISTA (raloxifene hydrochloride) tablet for oral use, prescribing information and Medication Guide. Eli Lilly and Company. DailyMed, version published September 2, 2026. DailyMed setid fcaaa6dc-74e8-4fb8-800c-5574bf0f8de9
WARNING: INCREASED RISK OF VENOUS THROMBOEMBOLISM AND DEATH FROM STROKE
A higher risk of blood clots in the legs (deep vein thrombosis) and lungs (pulmonary embolism) has been reported with Evista, and women with current or past blood clots should not take it. In a trial of postmenopausal women with documented coronary heart disease or at higher risk of major coronary events, the risk of dying from a stroke was higher on Evista. The label says the balance of risk and benefit is considered in women at risk for stroke.
These are the label's own numbers from the Adverse Reactions section. Where the label compares with placebo (a dummy treatment), both columns are shown, so you can see how much more often a reaction happened on Evista.
| Adverse reaction | Treatment: Evista (N=2557) % | Treatment: Placebo (N=2576) % | Prevention: Evista (N=581) % | Prevention: Placebo (N=584) % |
|---|---|---|---|---|
| Infection | A | A | 15.1 | 14.6 |
| Flu Syndrome | 13.5 | 11.4 | 14.6 | 13.5 |
| Headache | 9.2 | 8.5 | A | A |
| Leg Cramps | 7.0 | 3.7 | 5.9 | 1.9 |
| Chest Pain | A | A | 4.0 | 3.6 |
| Fever | 3.9 | 3.8 | 3.1 | 2.6 |
| Hot Flashes | 9.7 | 6.4 | 24.6 | 18.3 |
| Migraine | A | A | 2.4 | 2.1 |
| Syncope | 2.3 | 2.1 | B | B |
| Varicose Vein | 2.2 | 1.5 | A | A |
| Nausea | 8.3 | 7.8 | 8.8 | 8.6 |
| Diarrhea | 7.2 | 6.9 | A | A |
| Dyspepsia | A | A | 5.9 | 5.8 |
| Vomiting | 4.8 | 4.3 | 3.4 | 3.3 |
| Flatulence | A | A | 3.1 | 2.4 |
| Gastrointestinal Disorder | A | A | 3.3 | 2.1 |
| Gastroenteritis | B | B | 2.6 | 2.1 |
| Weight Gain | A | A | 8.8 | 6.8 |
| Peripheral Edema | 5.2 | 4.4 | 3.3 | 1.9 |
| Arthralgia | 15.5 | 14.0 | 10.7 | 10.1 |
| Myalgia | A | A | 7.7 | 6.2 |
| Arthritis | A | A | 4.0 | 3.6 |
| Tendon Disorder | 3.6 | 3.1 | A | A |
| Depression | A | A | 6.4 | 6.0 |
| Insomnia | A | A | 5.5 | 4.3 |
| Vertigo | 4.1 | 3.7 | A | A |
| Neuralgia | 2.4 | 1.9 | B | B |
| Hypesthesia | 2.1 | 2.0 | B | B |
| Sinusitis | 7.9 | 7.5 | 10.3 | 6.5 |
| Rhinitis | 10.2 | 10.1 | A | A |
| Bronchitis | 9.5 | 8.6 | A | A |
| Pharyngitis | 5.3 | 5.1 | 7.6 | 7.2 |
| Cough Increased | 9.3 | 9.2 | 6.0 | 5.7 |
| Pneumonia | A | A | 2.6 | 1.5 |
| Laryngitis | B | B | 2.2 | 1.4 |
| Rash | A | A | 5.5 | 3.8 |
| Sweating | 2.5 | 2.0 | 3.1 | 1.7 |
| Conjunctivitis | 2.2 | 1.7 | A | A |
| Vaginitis | A | A | 4.3 | 3.6 |
| Urinary Tract Infection | A | A | 4.0 | 3.9 |
| Cystitis | 4.6 | 4.5 | 3.3 | 3.1 |
| Leukorrhea | A | A | 3.3 | 1.7 |
| Uterine Disorder | 3.3 | 2.3 | A | A |
| Endometrial Disorder | B | B | 3.1 | 1.9 |
| Vaginal Hemorrhage | 2.5 | 2.4 | A | A |
| Urinary Tract Disorder | 2.5 | 2.1 | A | A |
Treatment: the 3-year MORE trial. Prevention: five placebo-controlled prevention trials. "A" means the placebo rate was equal to or higher than Evista; "B" means under 2% and more frequent with Evista. The label's body-system heading rows are left out. Uterine and endometrial rows count only women with an intact uterus; "uterine disorder" mostly meant endometrial fluid.
| Adverse reaction | Evista (N=317) % | Hormone therapy, continuous combined (N=96) % | Hormone therapy, cyclic (N=219) % |
|---|---|---|---|
| Breast Pain | 4.4 | 37.5 | 29.7 |
| Vaginal Bleeding | 6.2 | 64.2 | 88.5 |
| Flatulence | 1.6 | 12.5 | 6.4 |
| Hot Flashes | 28.7 | 3.1 | 5.9 |
| Infection | 11.0 | 0 | 6.8 |
| Abdominal Pain | 6.6 | 10.4 | 18.7 |
| Chest Pain | 2.8 | 0 | 0.5 |
Three prevention trials, blinded and open-label. Continuous combined hormone therapy is 0.625 mg conjugated estrogens plus 2.5 mg medroxyprogesterone acetate daily; cyclic adds a progestin for part of each 28-day cycle. Vaginal bleeding counts only women with an intact uterus.
| Outcome | Evista (N=9,751), n (IR) | Tamoxifen (N=9,736), n (IR) | RR (95% CI) |
|---|---|---|---|
| Invasive breast cancer | 173 (4.40) | 168 (4.30) | 1.02 (0.82, 1.27) |
| Noninvasive breast cancer | 83 (2.12) | 60 (1.54) | 1.38 (0.98, 1.95) |
| Uterine cancer | 23 (1.21) | 37 (1.99) | 0.61 (0.34, 1.05) |
| Endometrial hyperplasia | 17 (0.90) | 100 (5.42) | 0.17 (0.09, 0.28) |
| Hysterectomy | 92 (4.84) | 246 (13.25) | 0.37 (0.28, 0.47) |
| Deep vein thrombosis | 67 (1.69) | 92 (2.35) | 0.72 (0.52, 1.00) |
| Pulmonary embolism | 38 (0.96) | 58 (1.47) | 0.65 (0.42, 1.00) |
| Stroke | 54 (1.36) | 56 (1.42) | 0.96 (0.65, 1.42) |
| Cataracts | 343 (10.34) | 435 (13.19) | 0.78 (0.68, 0.91) |
| Edema | 741 (18.66) | 664 (16.83) | 1.11 (1.00, 1.23) |
| Hot flashes | 6748 (169.91) | 7170 (181.71) | 0.94 (0.90, 0.97) |
STAR trial: 19,747 postmenopausal women at high risk of invasive breast cancer, randomized and double-blind, run by the National Surgical Adjuvant Breast and Bowel Project and sponsored by the National Cancer Institute; median follow-up 4.3 years. IR is the yearly rate per 1,000 women; RR compares Evista with tamoxifen. Uterine rows include only women with a uterus; cataract rows only women free of cataracts at the start.
STAR trial: Evista was not superior to tamoxifen in reducing invasive breast cancer (4.4 vs 4.3 per 1,000 women per year). The label says the results are consistent with Evista potentially losing up to 35% of the tamoxifen effect, and fewer noninvasive breast cancers occurred on tamoxifen.
MORE treatment trial: stopping because of side effects was 10.9% on Evista vs 8.8% on placebo. Blood clots occurred in about 1 in 100 women over an average 2.6 years of use (26 on Evista vs 11 on placebo, hazard ratio 2.4), highest in the first months.
Hot flashes occurred in about 1 in 10 women on Evista in the treatment trial, mostly in the first 6 months, and about 1 in 4 vs 1 in 6 on placebo in the prevention trials. Leg cramps occurred in about 1 in 14. Stopping because of hot flashes: 1.7% vs 2.2% on placebo.
RUTH trial (10,101 women with heart disease or risk factors, median 5.1 years of use): peripheral edema 14.1% vs 11.7% on placebo, muscle spasms or leg cramps 12.1% vs 8.3%, hot flashes 7.8% vs 4.7%, blood clots 2.0% vs 1.4%, gallstones 3.3% vs 2.6%.
In RUTH, over an average 5.6 years, 59 women on Evista (1.2%) died of stroke vs 39 on placebo (0.8%), 22 vs 15 per 10,000 women-years (hazard ratio 1.49). The overall rate of stroke did not differ significantly: 4.9% vs 4.4%.
Breast pain on Evista was no different from placebo across placebo-controlled trials. Endometrial and ovarian cancer rates were similar on Evista and placebo.
Reported very rarely after approval: retinal vein occlusion, stroke, and death linked to blood clots.
The Warnings and Precautions part of the label lists these. Each line gives the label's heading and what it means in plain words.
Blood clots. Evista raises the risk of deep vein thrombosis and pulmonary embolism, most in the first 4 months, at a level similar to hormone therapy. It is stopped at least 72 hours before and during long immobilization, such as recovery from surgery or bed rest, and restarted only once fully walking. Moving about during long trips is advised.
Death from stroke. In women with coronary heart disease or at higher risk of coronary events, more women died of stroke on Evista. Risk and benefit are weighed in women at risk for stroke, such as after a prior stroke or mini-stroke, or with atrial fibrillation, high blood pressure or smoking.
Not for heart disease prevention. Evista showed no heart benefit after 5 years and is not used to prevent heart disease.
Before menopause and in men. Evista is not recommended before menopause, where safety is not established and pregnancy exposure is a concern. It is not recommended for men (5.10).
Liver and kidney problems. Evista is used with caution in liver impairment and in moderate or severe kidney impairment, where safety and efficacy are not established (5.5, 5.8).
With estrogen. Use with systemic estrogens has not been shown to be safe and is not recommended.
High triglycerides. Women whose triglycerides rose sharply (over 500 mg/dL) on estrogen may see a rise on Evista and have triglycerides monitored.
Uterine bleeding and breast changes. Unexplained uterine bleeding and any unexplained breast abnormality are investigated. Evista does not eliminate the risk of breast cancer, and it has not been adequately studied in women with past breast cancer (5.9, 5.12).
Who should not use it. Women with current or past blood clots, including deep vein thrombosis, pulmonary embolism and retinal vein thrombosis, and women who are pregnant.
From the Medication Guide that comes with Evista:
Dose Track has a side-effect log. Each entry records the symptom, a severity (none, mild, moderate, severe or life-threatening), the date and an optional note, and can be tied to a specific dose or logged on its own. The history screen shows what you logged over time, which makes it easier to tell your prescriber when a reaction started and whether it is easing. The app records what you enter; it does not judge whether a symptom is serious. For anything on the label's call-your-doctor list, call your doctor.
This page is what the FDA label says, in plain words. It is not medical advice. Follow your prescriber, and ask them or your pharmacist about anything here.