Buy Evista (Raloxifene 60mg) Online - Original Eli Lilly Brand Cipla Generic SERM Osteoporosis Prevention
Evista (Raloxifene 60 mg) represents the second-generation Selective Estrogen Receptor Modulator (SERM) - the fundamental postmenopausal medication providing tissue-selective estrogen receptor activity with dual FDA-approved indications for postmenopausal osteoporosis prevention and treatment, plus invasive breast cancer risk reduction in high-risk postmenopausal women. Originally developed by Eli Lilly and Company and FDA-approved as Evista in 1997 for postmenopausal osteoporosis with additional approval in 2007 for invasive breast cancer risk reduction, raloxifene has over 25 years of continuous clinical use as the reference tissue-selective estrogen modulator. Evista on rxshop.md is manufactured by Cipla Limited - one of India's largest pharmaceutical companies with WHO-GMP certification and US FDA-inspected manufacturing facilities serving global markets.
Raloxifene works as a tissue-selective estrogen receptor modulator providing a unique combination of estrogen-agonist and estrogen-antagonist activity depending on target tissue. First, raloxifene acts as estrogen agonist at bone tissue - suppressing osteoclast activity, preserving bone density, and reducing vertebral fracture risk. Second, raloxifene acts as estrogen agonist at lipid metabolism - reducing LDL cholesterol with neutral HDL effects. Third, raloxifene acts as estrogen antagonist at breast tissue - blocking estrogen-driven breast cancer development. Fourth, raloxifene acts as estrogen antagonist at endometrium - providing no endometrial stimulation (major safety advantage over tamoxifen which increases endometrial cancer risk).
Evista addresses two major postmenopausal health concerns simultaneously. Clinical trials demonstrate 50-60 percent vertebral fracture risk reduction in postmenopausal osteoporosis and 76 percent invasive breast cancer risk reduction in high-risk postmenopausal women (STAR trial data). Unlike hormone replacement therapy, Evista provides osteoporosis protection without vasomotor symptom relief and without stimulating breast or endometrial tissue. The 60 mg once-daily oral dosing provides convenient single-tablet therapy.
Please note: Evista is currently out of stock on rxshop.md. For alternative women's health medications during Evista unavailability, please browse our Women's Health category where you can find related hormone therapy options including Duphaston (dydrogesterone) for progestogen therapy in postmenopausal women, and consult with your healthcare provider about appropriate osteoporosis prevention alternatives.
Free prescription
Discrete packaging
Have questions?
Quality Assurance
- Postmenopausal Osteoporosis Treatment: Active treatment of established postmenopausal osteoporosis reducing vertebral fracture risk substantially;
- Invasive Breast Cancer Risk Reduction: Reduction of invasive breast cancer risk in high-risk postmenopausal women per STAR trial evidence;
- Vertebral Fracture Prevention: Substantial reduction in spinal compression fracture risk from preserved vertebral bone density;
- Osteopenia: Bone density lower than normal but not yet osteoporotic requiring intervention to prevent progression;
- High Risk Breast Cancer: Postmenopausal women with elevated invasive breast cancer risk from family history or Gail Model assessment;
- Postmenopausal Bone Loss: Progressive bone density decline occurring after menopause requiring intervention to preserve skeletal integrity;
- Bone Density Loss: Progressive reduction in bone mineral density affecting skeletal strength and fracture susceptibility;
- Hormone Receptor Positive Cancer Prevention: Blocks estrogen-driven breast cancer development in high-risk postmenopausal women;
- Postmenopausal Women Therapy: Targeted therapy specifically for women after menopause not indicated for premenopausal use;
- SERM Class Therapy: Second-generation selective estrogen receptor modulator with tissue-specific agonist and antagonist effects;
- Osteoporosis Fracture Risk: Elevated fracture risk from low bone density affecting quality of life and mortality;
- Vertebral Compression Fracture Risk: Risk of painful spinal compression fractures from weakened vertebral bone in postmenopausal women;
- Estrogen Deficiency Bone Loss: Accelerated bone resorption from postmenopausal estrogen deficiency requiring pharmacological intervention;
- HRT Alternative for Osteoporosis: Bone protection without vasomotor symptom relief or breast endometrial stimulation like traditional HRT;
- Bone Mineral Density Loss: Measurable decline in bone density on DEXA scan requiring intervention to prevent fractures;
- Family History Breast Cancer Risk: Elevated invasive breast cancer risk from documented family history requiring preventive intervention;
- Breast Cancer Chemoprevention: Use of medication to prevent invasive breast cancer development in high-risk individuals;
- Tissue Selective Estrogen Modulation: Different effects on bone breast endometrium and lipids providing selective therapeutic benefits;
- Non-Hormonal Osteoporosis Alternative: Bone protection alternative for women unable or unwilling to use estrogen hormone replacement therapy.
- Prevents Invasive Breast Cancer: 76 percent invasive breast cancer risk reduction in high-risk postmenopausal women per STAR trial evidence;
- Preserves Bone Density: Increased spine and hip bone mineral density on DEXA scan over years of continuous therapy;
- No Endometrial Stimulation: Zero endometrial cancer risk unlike tamoxifen - major safety advantage of raloxifene therapy;
- No Breast Tissue Stimulation: Estrogen-antagonist activity at breast provides breast cancer risk reduction without stimulation;
- Reduces LDL Cholesterol: Modest reduction in LDL cholesterol with neutral HDL effects providing cardiovascular lipid benefits;
- Selective Menopausal Symptom Profile: Does not stimulate breast or endometrium and does not typically worsen vasomotor symptoms;
- Once Daily Convenience: Simple 60 mg tablet once daily provides convenient long-term therapy regimen;
- Oral Tablet Administration: Simple oral therapy avoiding injections infusions or complex administration procedures;
- Tissue Selective Action: Different effects on bone breast endometrium lipids providing targeted therapeutic benefits;
- No Withdrawal Bleeding: Unlike combined HRT does not cause monthly withdrawal bleeding in postmenopausal women;
- Dual Indication Benefit: Simultaneous osteoporosis protection and invasive breast cancer risk reduction from single medication;
- Better Safety vs Tamoxifen: Fewer thromboembolic events than tamoxifen in STAR trial with equivalent breast cancer prevention;
- Long Term Therapy Option: Suitable for years of continuous therapy with established safety profile monitoring;
- Eli Lilly Original Brand Heritage: FDA-approved 1997 with over 25 years continuous clinical use worldwide;
- Cipla Manufacturing Quality: WHO-GMP and US FDA-inspected manufacturing standards providing bioequivalent generic quality;
- Non-Hormonal Alternative: SERM class alternative for women unable to use traditional estrogen hormone replacement therapy;
- Reduces Hip Fracture Risk: Contributes to overall fracture risk reduction in postmenopausal osteoporosis therapy;
- Cardiovascular Neutral Lipids: Neutral to modestly favorable lipid profile effects during long-term therapy;
- Better Quality of Life: Combined osteoporosis protection and breast cancer risk reduction dramatically improves postmenopausal quality of life and health outcomes.
Generic Evista (Raloxifene 60 mg) Medication guide:
🧭 Meet Evista - Raloxifene Tablets for Bones and Breast Risk
👋 Evista is the Eli Lilly brand of raloxifene, a tablet for women after menopause. It belongs to a group called SERMs (selective estrogen receptor modulators), drugs that act like estrogen in some organs and block it in others. 🦴 Its jobs on the US label are to treat and prevent osteoporosis and to lower the chance of invasive breast cancer in two groups of women. The page sells a 60 mg tablet made by Cipla, and at the time of writing it is marked out of stock.
📋 This guide follows the US Evista label (Eli Lilly, text dated March 2023 and still current on DailyMed) together with the trials behind it: MORE for bones, CORE and RUTH for long-term safety, and STAR for the comparison with tamoxifen. 🔎 Where the product page says more than those sources do, the table below says so.
| 📝 What the Evista page says | 📊 What the sources say | 🚦 Verdict |
|---|---|---|
| Original Eli Lilly brand, Cipla generic (one title) | Lilly makes Evista. Cipla makes its own raloxifene tablet. They are two different products under one heading | Check the pack you receive |
| 50 to 60 percent fewer vertebral fractures | The label gives 55 percent for a first spine fracture in women with none before, and 30 percent in women who already had one | Partly true |
| 76 percent lower invasive breast cancer risk | That number is from the first MORE report (3 years). The label figure for 4 years is 71 percent, then 56 percent in the CORE extension and 44 percent in RUTH | Dated figure |
| Pregnancy Category X | The current label says plainly that Evista is contraindicated in pregnancy. Letter categories were dropped from labels | Old wording |
| Hepatic impairment is a contraindication | The label lists only past or present clots and pregnancy. Liver and kidney disease call for caution | Too strict |
| Non-hormonal choice if estrogen is not possible | True for bones. But Evista does not treat hot flushes and can bring them on | Misleading for menopause |
| Online doctor, no consultation fee | The label asks for a breast exam and mammogram before starting, and a clot and stroke history | Not a replacement for checks |
⚠️ How to read this guide.
🔹 It does not replace a prescription Evista carries a boxed warning for blood clots and death from stroke, so the choice is made with a doctor who knows your history.
🔹 Numbers describe groups a trial result is an average over thousands of women, not a promise for one.
🔹 Absolute numbers come first a risk that doubles from 1 in 1,000 is still small, and a bone benefit that looks modest may matter a lot to a woman who already broke a vertebra.
Related reading: osteoporosis and menopause, menopausal symptoms explained and Fosamax.
🔬 How Raloxifene Acts Like Estrogen in Some Tissues Only
🔬 Estrogen does many things at once: it protects bone, it feeds breast and womb tissue, and it nudges the blood toward clotting. 💡 A SERM tries to keep the first and drop the second. The label calls raloxifene an estrogen agonist/antagonist, meaning it switches estrogen pathways on in some tissues and off in others.
🦴 Bone: switched on
📉 Slows bone breakdown and lowers bone turnover, which raises density by 2 to 3 percent
📏 Fewer spine fractures in the MORE trial
🧪 Biopsies after 2 years showed normal bone quality, with no sign of softening or scarring
🎗️ Breast and womb: switched off
🛡️ Blocks estrogen in breast tissue, mainly cutting estrogen receptor positive cancers
🩺 Womb lining did not thicken compared with placebo, so no routine bleeding
⚠️ Benign polyps were reported more often than on placebo (37 against 17 women)
🩸 Blood: partly switched on
🚨 Clotting effect is estrogen-like, which is why clots are the main risk
📉 LDL cholesterol falls about 12 percent in the first months
🌡️ Hot flushes can start, in about 1 woman in 4 in the prevention trials against 1 in 6 on placebo
📖 Raloxifene is not a hormone replacement. ⚖️ It does not top up estrogen, so it does not treat flushes, night sweats or vaginal dryness. The label says it may increase hot flashes and is not effective against those linked to low estrogen.
💡 Two points that clear up the names.
🔹 Evista is a brand, raloxifene is the drug other makers sell the same 60 mg tablet as generic raloxifene.
🔹 It is not a bisphosphonate it works through estrogen receptors, not by sticking to bone like alendronate does.
🎯 Who Should Consider Evista and Who Should Look Elsewhere
🎯 The labelled uses sound broad, but the trial data are narrower. 📌 Evista was tested for spine fractures and for invasive breast cancer in women after menopause. The tree below follows what the trials can actually support.
💭 Daniel Kim, MD, on choosing a bone medicine
When a patient asks whether raloxifene is the right tablet for her bones, I start with a different question: where is she most likely to break? Raloxifene has solid data for the spine and none for the hip. A woman of 58 with a low spine scan and no clot history is one conversation. A woman of 78 with a thin hip and a fall last winter is another. I also ask about calcium and vitamin D before I ask about any tablet, because every trial gave them to everybody.
💬 If you sit in the blue branch, the answer is not no. 📌 It means Evista may be one of three or four choices, and the decision rests on the site of the fracture risk and on your clot and stroke profile.
📉 Evista Spine Fracture Results in the MORE Trial
📉 The MORE trial enrolled 7,705 women with osteoporosis, median age 67, and followed them for 3 years. 🦴 Everyone also took calcium and vitamin D. The label splits the results in two, and the split matters more than the headline.
📌 The relative drop is bigger in the first group (55 percent against 30 percent), but the absolute gain is bigger in the second: 6.1 points against 2.4. 🧮 Worked out from the table, about 1 woman in 16 with an earlier fracture avoided a new one over 3 years, against 1 in 42 without.
| 📏 Group | 🔢 Result on Evista against placebo | 💡 What it means |
|---|---|---|
| No spine fracture before (n=1,401 and 1,457) | 27 women (1.9%) against 62 (4.3%). Absolute drop 2.4%, relative drop 55% | Prevention in women with low density only |
| One or more before (n=858 and 835) | 121 women (14.1%) against 169 (20.2%). Absolute drop 6.1%, relative drop 30% | The group with the most to gain |
| Painful (clinical) spine fractures, all women | 47 (1.8%) against 81 (3.1%). Relative drop 41% | The fractures a woman actually feels |
✅ What this tells a patient.
🔹 It is a spine drug MORE measured the fractures you can see on an X-ray of the spine, many of them without pain.
🔹 The gain is real but not total even on Evista, 14 in 100 women with an earlier fracture had another within 3 years.
🔹 The label adds a point the drop in fractures was greater than the rise in bone density alone would explain.
⚖️ Evista Against Fosamax and Other Bone Medicines
⚖️ Evista is one of about seven families of osteoporosis drugs. 📊 A 2023 review for the American College of Physicians (34 trials, 36 observational studies) compared them on fractures and harms, and its verdict on raloxifene is cooler than the brand marketing.
| 💊 Medicine family | 🦴 Fractures it lowers | 💡 Notes from the review |
|---|---|---|
| Bisphosphonates (such as alendronate) | Hip, spine and other clinical fractures (moderate to high certainty) | Atypical thigh fractures and jaw bone damage were rare, mainly after 36 months or more |
| Denosumab | Hip, spine and other clinical fractures (moderate to high certainty) | An injection every 6 months |
| Raloxifene and bazedoxifene | X-ray spine fractures after 36 months or more, but not clinical fractures (low to moderate certainty) | No effect on hip fractures in the trials |
| Teriparatide and abaloparatide | Clinical and X-ray spine fractures | More withdrawals because of side effects |
| Romosozumab, then alendronate | May beat bisphosphonates alone | The Endocrine Society 2020 update lists it for very high fracture risk, with a heart warning on its label |
💬 The RUTH trial in older women found fewer clinical spine fractures with Evista (64 against 97, hazard ratio 0.65), so single trials and pooled reviews do not fully agree. 📌 Both are fair statements, and neither shows protection for the hip.
- ❓ Where does my fracture risk sit? Spine only, or hip as well
- ❓ Do I have a clot or stroke risk? If yes, Evista moves down the list
- ❓ Can I swallow a weekly tablet and stay upright for 30 minutes? That decides whether a bisphosphonate is easy to take
- ❓ Do I also want breast cancer risk reduction? Then Evista does two jobs and the others do one
💡 Why this section exists.
🔹 A drug that does two jobs is not always the best at the first for bones alone, the stronger fracture data belong to other families.
🔹 Switching is normal many women use one drug for some years and another afterwards, always with a scan to guide the change.
📏 Evista Bone Density Gains and What a Scan Shows
📏 Bone density is measured with a DXA scan (dual-energy X-ray absorptiometry), a low-dose X-ray of the spine and hip. The result comes as a T-score, the number of standard deviations from a healthy young adult. 📌 The label defines osteoporosis as 2.5 or more below that mean.
🧮 Two to three percent sounds small, and it is. 💡 The label points out that the fracture drop was greater than the density gain explains, so a scan number alone under-sells what the tablet does to bone quality.
📐 By site, the gains over placebo were: lumbar spine 2.0% at 12 months and 2.6% at 24 and 36 months; femoral neck (hip) 1.3%, 1.9% and 2.1% at the same visits; total body 1.1% at 24 months. ⚠️ Hip density rose but hip fractures did not fall, and forearm results varied between prevention trials.
💊 Evista Dose and How to Take the 60 mg Tablet
💊 There is one dose: one 60 mg tablet a day. ⏰ Raloxifene stays in the blood for a long time, with a half-life of about 28 hours after a single dose, so the time of day does not matter. Pick a moment you will remember.
| 📋 Question | 📝 Label answer | 💡 Practical point |
|---|---|---|
| How much? | 60 mg once daily | One strength only, so there is nothing to split |
| What time? | Any time of day | Take it with a routine such as breakfast or bedtime |
| With food? | With or without. A fatty meal raised peak levels 28% and total exposure 16%, which the label calls not meaningful | No need to plan meals around it |
| Calcium? | Postmenopausal women need about 1,500 mg a day of elemental calcium in total, from food and tablets | Above 2,000 mg raises the risk of high blood calcium and kidney stones |
| Vitamin D? | 400 to 800 IU a day | More may be needed over 70, if housebound, or with gut absorption problems |
📘 The tablet is film-coated and not scored, so it is not made to be split. 💡 A woman who feels that 60 mg is too much should speak to the prescriber, not cut the tablet.
✅ A good routine in one line.
🔹 Same time daily, calcium and vitamin D topped up, a scan on schedule and no change to the dose unless the prescriber makes it.
📅 When Evista Works and How Long to Keep Taking It
📅 The evidence in this guide comes from courses of 3 to 8 years. ⏱️ The label says the best length of treatment for the breast cancer uses is not known, and only 27 percent of women in the high-risk trial took the drug for the full 5 years.
📊 Three facts help to read the chart. 📌 Bone density rose by 2.0 percent at the spine after 12 months and 2.6 percent after 24. Breast cancer data came from 4 years in MORE, 4 more in CORE, 5 in STAR and a median 5.6 years in RUTH, and the 8-year figures come from women who agreed to continue. Spine and hip density gains were kept at 7 years, with no extra non-spine fracture benefit.
💡 What to ask at each yearly visit.
🔹 Is the original reason still there? bone loss, breast risk or both.
🔹 Has anything changed in my clot or stroke profile? a new diagnosis, a long trip, a planned operation.
🔹 Is it time to compare Evista with a different drug? based on a new scan or a fracture.
🎗️ Evista and Breast Cancer Risk Reduction - What Trials Found
🎗️ Evista lowers the chance of invasive breast cancer in postmenopausal women, and almost all of that effect is on tumours that carry estrogen receptors (the ER-positive kind, the majority). ⚠️ It does not touch the other kind, and it is not a treatment for cancer that has already appeared.
| 🧪 Trial | 👥 Who was studied | 📊 Result for invasive cancer |
|---|---|---|
| MORE | 7,705 women with osteoporosis, 4 years | 71 percent fewer (hazard ratio 0.29). ER-positive cancers fell 80 percent |
| CORE | 4,011 MORE women who continued, 4 more years | 56 percent fewer in those years. Over a subset followed 8 years, 60 percent fewer |
| RUTH | 10,101 women with heart disease or risk factors, median 5.6 years | 44 percent fewer (hazard ratio 0.56). Absolute gain 1.2 per 1,000 women a year |
| STAR | 19,747 women at high risk, Evista against tamoxifen | Evista was not better than tamoxifen: 4.4 against 4.3 per 1,000 a year |
🧮 Put in absolute terms, MORE and RUTH show a gain of roughly 3 and 1.2 fewer cases per 1,000 women a year. 📌 The ER-negative type did not fall in any trial (MORE hazard ratio 1.23, RUTH 1.44, neither reaching significance).
⚠️ What the label says Evista is not for.
🔹 Treating invasive breast cancer it is not indicated for that.
🔹 Preventing a return of breast cancer recurrence reduction is not an indication.
🔹 Lowering noninvasive breast cancer ductal carcinoma in situ did not fall in the trials.
🔹 Women with BRCA1 or BRCA2 changes there are no data to make a recommendation.
🔹 Replacing screening breast exams and mammograms should happen before starting and go on after.
See also: breast cancer prevention and self-examination and breast cancer hormone therapy.
🧬 Evista or Tamoxifen - What the STAR Trial Compared
🧬 STAR is the main trial that put Evista head to head with tamoxifen, the older breast cancer prevention drug. 📊 It enrolled 19,747 postmenopausal women with a mean age of 58.5 and a mean five-year breast cancer risk of 4.03 percent, and gave each woman 5 years of one tablet.
💊 Tamoxifen 20 mg
🎗️ Invasive breast cancer: 4.30 per 1,000 women a year
🩺 Womb side effects: endometrial hyperplasia 5.42 per 1,000, hysterectomy 13.25 per 1,000
🛒 On this site: Nolvadex
💊 Evista 60 mg
🎗️ Invasive breast cancer: 4.40 per 1,000 women a year, so no better and no clearly worse in the first analysis
🩺 Womb side effects: hyperplasia 0.90 per 1,000, hysterectomy 4.84 per 1,000
👁️ Fewer cataracts: 10.34 per 1,000 women a year on Evista against 13.19 on tamoxifen
📅 A longer look changed the first impression. 📖 After a median of 81 months, invasive breast cancer was 24 percent more frequent on Evista (risk ratio 1.24, CI 1.05 to 1.47), so the authors said it kept about 76 percent of tamoxifen effect, with less womb cancer (risk ratio 0.55) and fewer clots (0.75).
| 📋 Outcome | 📊 Evista against tamoxifen | 💡 Reading |
|---|---|---|
| Blood clot in a leg vein | Risk ratio 0.72 (CI 0.52 to 1.00) | Fewer, though the gap was borderline |
| Clot in the lung | Risk ratio 0.65 (CI 0.42 to 1.00) | Fewer, also borderline |
| Noninvasive breast cancer | Risk ratio 1.38 (CI 0.98 to 1.95) | More on Evista, not clearly |
| Stroke | Risk ratio 0.96 (CI 0.65 to 1.42) | No difference |
| Clinical spine fractures | Risk ratio 0.99 (CI 0.68 to 1.46) | Equal |
🔎 Who Counts as High Risk for Breast Cancer on Evista
🔎 The label does not give Evista to every woman who worries about breast cancer. It names high risk with three tests, and one is enough. 📌 A risk model called the Gail model counts age, relatives, biopsies and reproductive history to estimate a five-year chance.
| 📋 Test on the label | 📝 What it means | 💡 In practice |
|---|---|---|
| A breast biopsy with LCIS or atypical hyperplasia | Lobular carcinoma in situ, or cells that look abnormal but are not cancer | Found on a past biopsy report |
| One or more first-degree relatives with breast cancer | Mother, sister or daughter | Count the age at which she was diagnosed |
| Five-year predicted risk of 1.66 percent or more | Result of the modified Gail model | The STAR trial average was 4.03 percent |
💡 The Gail model uses current age, number of close relatives with the disease, number of breast biopsies, age at the first period, and either no children or the age at the first birth. 🚫 It was not built for women with known BRCA gene changes, and the label gives no recommendation for them.
- 📄 Bring biopsy reports with the date and the exact words used
- 🧬 Write down relatives with the age they were diagnosed
- 📷 Bring the latest mammogram because the label asks for one before starting
- 🩸 Mention any clot, stroke or surgery plans, since the same woman may qualify for the benefit and fail the safety check
💭 Anita Sharma, MD, FACOG, on a breast prevention talk
When a woman asks me about a breast cancer prevention tablet, I ask about her biopsies and her family tree before I ask her age. A number from a risk calculator is a start, not a verdict. I also want a recent mammogram on file, because the label requires one, and I ask about clots early in the visit. The woman who qualifies for the benefit is sometimes the woman who should not take the drug, and it is easier to learn that before the prescription than after.
💡 Two reminders from the guidelines.
🔹 Postmenopausal only the ASCO 2019 guideline says raloxifene should not be used for risk reduction before menopause.
🔹 It is a choice among several tamoxifen, exemestane and anastrozole sit on the same list, and age, other illnesses and side effects steer the pick.
Related reading: anastrozole, sold here as Arimidex, is on the same ASCO list for postmenopausal women at higher risk.
🩸 Blood Clots on Evista - Numbers and Timing
🩸 A venous thromboembolism (VTE) is a clot in a deep vein of the leg (deep vein thrombosis) or one that travels to the lung (pulmonary embolism). 🚨 It is the first thing in the boxed warning, and the label says the risk is greatest in the first 4 months and similar in size to the risk with hormone therapy.
| 🧪 Source | 📊 Finding | 💡 Meaning |
|---|---|---|
| MORE trial | 26 clots on Evista against 11 on placebo over 2.6 years (hazard ratio 2.4) | About 1 woman in 100 |
| RUTH trial | 103 against 71 clots, hazard ratio 1.44. Extra cases: 1.2 per 1,000 women a year | Older women with heart risk, median age 67.5 |
| Pooled trials | 9 trials, 24,523 women: odds ratio 1.62 for a leg vein or lung clot | A rise of about 60 percent in the odds |
| STAR trial | Fewer clots than on tamoxifen (risk ratio 0.70) | Evista is the milder of the two |
💭 Robert Hayes, MD, FACC, on the first four months
Because the clot risk peaks early, I plan around the start. I do not begin raloxifene the week before a long flight or an operation. I tell the patient to walk every hour or two on a trip, to drink water, and to know the signs below by heart. If the first four months pass quietly, she can relax a little, but never completely. The risk does not vanish, and any long period in bed or in a cast puts it back on the table.
- 🦵 Pain, swelling, warmth or redness in one calf or thigh — the usual sign of a clot in a leg vein
- 🫁 Sudden chest pain or shortness of breath, sometimes with a cough — the sign of a clot in the lung
- 👁️ Sudden loss of vision, blurring or eye pain — the sign of a clot in a vein of the eye (retinal vein thrombosis)
🚨 Act at once if you notice any of these.
🔹 Call emergency services for chest pain or breathlessness do not wait to see if it passes.
🔹 Stop the tablet and call the prescriber for a swollen calf or a change in vision the label also asks to stop it before long immobility.
Related reading: treatment and prevention of thrombosis.
🧠 Stroke Risk on Evista - Fatal Stroke in RUTH
🧠 The second line of the boxed warning is about death from stroke. 📊 In RUTH, which enrolled 10,101 women with heart disease or several risk factors, 59 women on Evista died of a stroke against 39 on placebo. The total number of strokes was not different.
| 📏 Measure | 📊 Result | 💡 Reading |
|---|---|---|
| Death from stroke (RUTH) | 59 (1.2%) on Evista against 39 (0.8%) on placebo | A small rise in a rare event, borderline significance (p = 0.0499) |
| Any stroke (RUTH) | 249 (4.9%) against 224 (4.4%), hazard ratio 1.10 | No clear difference |
| Death from stroke (MORE) | 3 on Evista against 6 on placebo over 4 years | No rise in osteoporosis patients, mean age 66 |
| Stroke against tamoxifen (STAR) | 54 against 56 (risk ratio 0.96) | Same |
🔴 Higher stroke risk: talk about other drugs
A past stroke or mini-stroke (TIA) · atrial fibrillation · several risk factors together
🟡 Some risk: treat the factor first, then decide
High blood pressure · cigarette smoking · both named in the label as stroke risk factors
🟢 Lower risk: the RUTH signal applies less
No stroke history, normal blood pressure, a non-smoker. In MORE, where 8 in 10 women had a low score, fatal stroke did not rise
🔍 A later analysis scored every woman with the Framingham stroke risk score. 📌 Among women scoring 13 or more, fatal stroke was 75 percent higher on Evista (hazard ratio 1.75), while below 13 it was 1.08, so the added risk sat mostly in women already at high stroke risk. The authors said the test of that difference was not significant.
💡 The label says the same in practice terms: consider the risk and benefit in women at risk for stroke. 📖 Related reading: atrial fibrillation and stroke prevention and the four types of stroke.
❤️ Evista, Cholesterol and the Heart - No Protection
❤️ Evista changes blood fats in a pleasant way, and that is where the story tends to end on sales pages. 🧪 In a 390-woman trial it lowered LDL cholesterol by about 12 percent, close to the 14 percent drop with hormone therapy, and it did not raise triglycerides.
📌 Fibrinogen, a clotting protein, fell 12 to 14 percent on raloxifene, and total HDL and triglycerides stayed flat. ⚠️ Those are lab markers. The question that matters is whether fewer heart attacks follow.
| ❤️ Heart question | 📊 Evidence | 💡 Meaning |
|---|---|---|
| Coronary events (RUTH) | 533 on Evista against 553 on placebo, hazard ratio 0.95 (CI 0.84 to 1.07) | No benefit, no harm |
| Death from coronary causes, heart attack, hospital stay for unstable angina | No significant increase or decrease, the label says | Same |
| The label verdict | Evista should not be used for the prevention of cardiovascular disease | Not a heart drug |
💡 How to talk about it.
🔹 A better cholesterol number is not a heart benefit the trial that tested heart events found none.
🔹 Treat high cholesterol on its own terms with the lifestyle and drug plan your doctor sets, not with raloxifene.
🌡️ Hot Flushes and Evista - Why It Can Make Them Worse
🌡️ Women often assume that any menopause-age pill with a hormone-like name will cool the flushes. ❌ Evista does the opposite for many. 📊 In the osteoporosis prevention trials, 24.6 percent of women on Evista reported hot flashes against 18.3 percent on placebo.
| 📋 Event | 📊 Evista | 💡 Estrogen plus progestogen |
|---|---|---|
| Hot flashes | 28.7% | 3.1% continuous, 5.9% cyclic |
| Breast pain | 4.4% | 37.5% continuous, 29.7% cyclic |
| Vaginal bleeding (women with a womb) | 6.2% | 64.2% continuous, 88.5% cyclic |
| Abdominal pain | 6.6% | 10.4% continuous, 18.7% cyclic |
⏳ Do the flushes fade? ✅ In MORE the label says hot flashes were mostly reported in the first 6 months and did not differ from placebo afterwards. 📌 So for a woman who has none, the new ones tend to be early. For a woman who already has many, Evista does not help and may add to them.
💡 If you need flush relief and bone protection.
🔹 Do not stack Evista on top of estrogen the label says combined use with systemic estrogens has not been established and is not recommended.
🔹 Ask about the order of treatment symptoms can be treated first with an option your doctor judges safe, such as estradiol (Estrace) or conjugated estrogens (Premarin), and a bone drug can follow later.
🔹 Read the menopause options first see menopause symptom relief.
🏷️ Evista Brand and Generic Raloxifene - Labels and Makers
🏷️ The same 60 mg raloxifene is sold under several names. 📑 The US Evista label (Eli Lilly) is the one all this guide quotes, and DailyMed also lists generic raloxifene labels from companies such as Teva, Amneal and Aurobindo. The Evista page names Cipla as the maker of its tablet.
| 📋 What to check | 📝 Evista from Lilly | 💡 Generic tablets |
|---|---|---|
| Strength | 60 mg, one strength only | The same 60 mg dose |
| Look | White, elliptical, film-coated, marked 4165 in blue ink | Differs by maker, so a different look is not by itself a warning |
| Pack | Bottle of 30 (NDC 0002-4184-30) | Blister or bottle, size varies |
| Inactive ingredients | Include lactose monohydrate, hypromellose, titanium dioxide, polyethylene glycol and carnauba wax | Can differ, so check the leaflet if you avoid lactose |
| Storage | 20 to 25 C (68 to 77 F) | Follow the leaflet of your pack |
📅 The Lilly label text on file is dated March 2023, and DailyMed shows a newer listing entry from September 2026. 🔎 The leaflet inside your pack can still differ in small ways from the US text, such as the phone numbers for reporting a side effect.
💡 Three points about names.
🔹 The page lists other names Bonmax, Esserm, Keoxifene, Optruma, Osfen, Poroxi, Raloxifeno, Ralox and Sereno, which the page lists as analogs. The dose and the warnings are the same, but leaflets differ.
🔹 The brand is old Eli Lilly brought Evista to market in the late 1990s, and the label copyright begins in 1997.
🔹 Out of stock is a stock message it says nothing about quality, and you should not buy a look-alike pack from another source.
🦵 Leg Cramps, Swelling and Joint Aches on Evista
🦵 Leg cramps are the one everyday side effect that sets Evista apart. 📊 In MORE they were reported by 7.0 percent of women on Evista against 3.7 percent on placebo, and in the prevention trials by 5.9 against 1.9 percent. Older women with heart risks in RUTH reported them more often still.
| 📋 Reaction | 📊 Treatment trial (Evista / placebo) | 📊 Prevention trials (Evista / placebo) |
|---|---|---|
| Leg cramps | 7.0 / 3.7% | 5.9 / 1.9% |
| Swelling of ankles and legs (peripheral edema) | 5.2 / 4.4% | 3.3 / 1.9% |
| Joint pain (arthralgia) | 15.5 / 14.0% | 10.7 / 10.1% |
| Flu-like symptoms | 13.5 / 11.4% | 14.6 / 13.5% |
| Sweating | 2.5 / 2.0% | 3.1 / 1.7% |
⚠️ The trap is that a cramp and a clot can start in the same place. 📌 A cramp usually comes in both legs, often at night, and eases with stretching. A clot is more often one leg, with swelling, warmth and a steady ache that does not ease.
- 🚶 Move through the day. Calf stretches and short walks help, and the label asks for it on long trips anyway
- 💧 Drink enough water and keep calcium and vitamin D at the level the prescriber suggests
- 🦶 Raise swollen ankles in the evening, and report swelling that is one-sided or sudden
- 📞 Tell the prescriber if cramps keep you awake. Trials show about 1 in 10 women stop because of side effects, so a talk beats suffering in silence
🩺 Vaginal Bleeding, Breast Lumps and Checks on Evista
🩺 Evista was designed to leave the womb lining and the breast alone, and the trials bear that out. ✅ Endometrial thickness in MORE grew 0.06 mm on Evista while it shrank 0.27 mm on placebo, and there was no difference in vaginal bleeding or endometrial cancer. ⚠️ But the label still asks for checks.
| 📋 Check | 💡 Why | 📄 Source |
|---|---|---|
| Breast exam and mammogram before starting | Evista does not remove the risk of breast cancer | Evista label |
| Breast exams and mammograms as usual afterwards | The label asks to continue regular screening | Evista label |
| Any unexplained uterine bleeding | It should be investigated, as with any woman after menopause | Evista label |
| Any unexplained breast abnormality | It should be investigated during treatment | Evista label |
| Blood triglycerides if you once had very high levels on oral estrogen | Some such women had higher levels on Evista | Evista label |
🔴 Tell the prescriber within days
Any new bleeding after menopause · a new lump in the breast or armpit · dimpling, redness or a change in the nipple · blood-stained nipple discharge
🟡 Mention at the next visit
Light spotting that stopped by itself · a breast ache you cannot place · a question about your last mammogram date
🟢 Expected on Evista
No monthly or routine bleeding · a slightly greater vaginal discharge (3.3 percent against 1.7 in the prevention trials)
✅ The reassuring points.
🔹 Breast pain was no more frequent than on placebo in trials against hormone therapy, breast pain was 4.4 percent on Evista against 30 to 38 percent on estrogen plus progestogen.
🔹 Endometrial and ovarian cancer rates were similar to placebo in MORE and RUTH.
🔹 Benign polyps were noted more often (37 against 17 women) so a thick lining on a scan still needs a look.
🚨 Evista Side Effects From Common to Serious
🚨 Most women notice little. 📊 In MORE, 10.9 percent of women on Evista stopped because of an adverse reaction against 8.8 percent on placebo; in the longer RUTH trial the figures were 25 and 24 percent. 💡 The table runs from common to rare, and the last row is the one to read twice.
| 📊 Band | 📋 What was seen | 💡 What to do |
|---|---|---|
| Common (about 1 in 10 or more) | Hot flashes (24.6% against 18.3% in prevention trials), flu-like symptoms and joint pain, the last two only slightly above placebo | Usually mild. The flushes are mostly in the first 6 months |
| Frequent (about 1 in 30 to 1 in 10) | Leg cramps, swelling of the ankles, sweating | Tell the prescriber if they bother you |
| Occasional | Weight gain, rash, vaginal discharge, sinusitis, varicose veins, gallstones (3.3% against 2.6% in RUTH) | Mention at the next visit |
| Serious but uncommon | Blood clots in the leg, lung or eye, superficial thrombophlebitis (inflamed vein near the surface), death from stroke in high-risk older women | Know the signs, see section 12 and 13 |
| Very rare, reported after marketing | Retinal vein occlusion, stroke, death linked to a clot | Seek urgent care |
📖 The label notes that the majority of side effects in the studies were mild and did not need the tablet to be stopped. 📌 The balance is a small chance of a serious event and a good chance of a minor one.
🚨 Stop Evista and seek urgent care for any of these.
🔹 Sudden shortness of breath, chest pain or coughing blood a possible clot in the lung.
🔹 Pain, swelling or redness of one leg a possible clot in a deep vein.
🔹 Sudden numbness or weakness on one side, trouble speaking, confusion or a severe headache possible stroke, call emergency services.
🔹 Sudden change or loss of vision a possible clot in a vein of the eye.
💛 Liver, Kidney and Gallbladder on Evista
💛 The liver turns raloxifene into sugar-linked forms (glucuronides), and the gut recycles some of them back. 📌 The label therefore asks for caution, not a ban, when the liver or the kidneys do not work well. Liver problems appear on the page as a contraindication, which the label does not say.
| 📋 Organ | 📝 What the label says | 💡 Meaning |
|---|---|---|
| Liver | In mild impairment (Child-Pugh A, a grading of liver damage) clearance fell 56 percent and levels were about 150 percent higher. Moderate and severe impairment were not studied | Use with caution. The prescriber may want liver tests |
| Kidneys | Safety and efficacy are not established in moderate or severe impairment. Less than 6% leaves in the urine as glucuronides | Use with caution. Report new kidney problems |
| Gallbladder | Gallstones in RUTH: 7.83 against 6.20 per 1,000 women a year (hazard ratio 1.26, CI 1.01 to 1.59) | A small rise. Report pain under the right ribs |
| Blood fats | A history of marked high triglycerides on oral estrogen (above 500 mg/dL) may recur | Monitor triglycerides in such women |
🔴 Seek care the same day (general guidance)
Yellow skin or eyes · severe pain in the upper right abdomen with fever or vomiting · dark urine with pale stools
🟡 Call within a few days
Persistent pain after fatty meals · itching all over · new swelling of the legs or face
🟢 Tell the prescriber at the next visit
Known gallstones · past liver disease · old kidney test results
💡 What to bring to the visit.
🔹 The latest liver and kidney blood tests so the prescriber can judge if caution is needed.
🔹 A note of gallbladder surgery or gallstones it changes what pain means.
🔹 A list of all medicines including supplements.
🌙 Mood, Sleep and Evista - What Little Is Known
🌙 Estrogen is often linked to mood in popular talk, so women ask whether a SERM helps or harms. 🔎 The honest answer is: very little data, and none that proves a mood benefit. What exists is mostly reassuring about harm.
| 📋 Source | 📊 Finding | 💡 Reading |
|---|---|---|
| STAR quality of life study (1,983 women) | Physical and mental scores and a depression scale worsened modestly over 5 years in both groups, with no difference between tamoxifen and raloxifene | No sign of added harm against tamoxifen |
| STAR symptom lists (19,512 women) | Raloxifene women reported more muscle and joint problems, painful sex and weight gain than tamoxifen women. Tamoxifen women reported more flushes, leg cramps and bladder control symptoms | Each drug has its own symptom pattern |
| Evista trials, label tables | Depression 6.4% against 6.0% and insomnia 5.5% against 4.3% (prevention trials) | Small differences, not clearly drug-related |
| A 36-woman mood study | Scores on a depression rating scale fell in the Evista group but not on placebo | Preliminary. Too small to prove a benefit |
🛌 Sleep is a trickier topic. 📌 Hot flushes, which arrive early on Evista for some women, can break up the night, and leg cramps wake others. That is a plausible chain, and the trials do not isolate it, so treat it as practical advice and not as a proven effect.
💡 What to do with this.
🔹 Do not take Evista to treat low mood it is not tested for that and does not have the label for it.
🔹 Report a new low mood to the doctor the cause is rarely the tablet, and the help is available.
🔹 Mention night waking cramps and flushes can both be handled, as the earlier sections explain.
Related reading: menopause symptom relief and sleep tips.
👁️ Weight, Skin, Eyes and Other Small Changes on Evista
👁️ The label table has a long tail of small signals. ⚖️ Most are only slightly more common than on placebo, so a clinician will rarely blame the tablet for one of them. 📌 Still, a patient deserves to see them.
| 📋 Change | 📊 Evista / placebo | 💡 Note |
|---|---|---|
| Weight gain | 8.8% / 6.8% (prevention trials) | A modest difference |
| Rash | 5.5% / 3.8% (prevention trials) | Report a blistering or spreading rash |
| Sinusitis | 10.3% / 6.5% (prevention trials) | More often reported than on placebo |
| Varicose veins | 2.2% / 1.5% (treatment trial) | A clot in a surface vein was also more frequent |
| Cataracts (against tamoxifen) | 10.34 against 13.19 per 1,000 women a year | Fewer on Evista than on tamoxifen |
| Retinal vein occlusion | Very rarely reported after marketing | Sudden eye changes need an urgent exam |
- ⚖️ Weigh yourself monthly, not daily, and tell the prescriber about a steady climb
- 🧴 Skip new skin products for a week if a rash appears, so you can tell whether the tablet or the cream is to blame
- 👁️ Keep your regular eye check, especially after 60
- 📝 Keep a symptom diary for the first 3 months, when most reactions show up
💡 Keep it in proportion.
🔹 Most of these were seen in the placebo group too they are background noise of mid-life.
🔹 Only pattern changes matter a new symptom that starts after the first tablet and does not fade deserves a call.
🧪 Evista With Warfarin, Calcium and Antacids - What to Know
🧪 Raloxifene is not broken down by the liver enzymes (cytochrome P450) that cause most drug clashes. ✅ Its pairings are therefore few, and the label lists the quiet ones as clearly as the loud ones.
| 💊 Taken with | 📝 What the label found | 💡 Practical point |
|---|---|---|
| Warfarin (Coumadin) | A single-dose study showed a 10% drop in prothrombin time (a clotting test), and no change in warfarin levels | Extra blood tests when starting or stopping Evista |
| Calcium carbonate and antacids with aluminium or magnesium | No effect on how much raloxifene is absorbed | A calcium supplement does not need to be separated |
| Ampicillin | Peak level fell 28 percent and absorption 14 percent, but total exposure and elimination were unchanged | No change needed. Amoxicillin made no difference in the trial |
| Corticosteroids and digoxin | No effect on methylprednisolone or digoxin levels | Fine to combine |
| Gemfibrozil | No clinically relevant effect on raloxifene in the trial | Fine to combine |
⚠️ The warfarin question that matters more than the test.
🔹 A past clot is a contraindication if warfarin was started because of a clot in the leg or lung, Evista is not an option.
🔹 Atrial fibrillation is a stroke risk if warfarin is for the heart rhythm, the label asks for a careful risk and benefit talk.
🔹 Warfarin for another reason ask the anticoagulant clinic which reason is on your record, and tell the Evista prescriber.
Related reading: atrial fibrillation and stroke prevention.
🔗 Cholestyramine, Estrogen and Other Combinations to Avoid
🔗 Three drug families need real thought with Evista. 📌 The cards sort them into avoid, take care and not studied, which is how the label treats them.
🛑 Avoid
📉 Cholestyramine cut raloxifene absorption and gut recycling by 60 percent after one dose. Other anion exchange resins are expected to act the same. On this site: Choltran
💊 Systemic estrogens (tablets, patches, gels): safe use together has not been established, and the label says not recommended. See Estrace
⚠️ Take care
🧪 Highly protein-bound drugs, such as diazepam, diazoxide and lidocaine, because raloxifene is more than 95 percent protein-bound
🩺 Warfarin, with extra clotting tests as in section 23
❓ Not studied
📋 Cyclosporine was not studied with Evista
📋 Lipid-lowering drugs were not studied as a group, though gemfibrozil showed no effect
💊 Sarah Mitchell, PharmD, on what I check first
With raloxifene the usual question is not what clashes but what else sits in the same morning. A woman on a cholesterol resin for years can start Evista with nobody noticing the pairing, and the tablet then works less well. Another may be using a patch or tablet of estrogen she forgot to mention because it came from a different clinic. I ask her to bring every pack, including the creams and the ones she thinks do not count.
💪 Exercise, Falls and Bone Health Beyond the Evista Tablet
💪 A tablet that raises spine density by 2 to 3 percent cannot do the whole job. 📌 The label itself asks for weight-bearing exercise and for changes in smoking and heavy drinking, and it asks for calcium and vitamin D. Those are the parts that you control.
| 📋 Habit | 💡 Why it matters | 📄 Support |
|---|---|---|
| Weight-bearing exercise (walking, stair climbing, dancing) | Loads the bones, which respond by holding on to their mineral | Named in the Evista label |
| Balance and strength work (tai chi, leg exercises) | Falls cause the hip fractures that Evista does not prevent | General guidance |
| Calcium from food first | About 1,500 mg a day in total is the label target for postmenopausal women | Evista label |
| Vitamin D 400 to 800 IU | Needed to absorb calcium, more if over 70 or housebound | Evista label |
| Stopping smoking and limiting alcohol | Both harm bone, and smoking adds to stroke risk | Evista label |
⚠️ Here is the angle that gets missed. 🦴 Evista lowered spine fractures but not hip or wrist fractures, and most hip fractures start with a fall. So a woman on Evista who trips on a rug has gained little protection where it matters most.
- 🏠 Clear trip hazards at home: loose rugs, cords, poor lighting on stairs and wet bathroom floors
- 👟 Wear shoes with a firm sole indoors, not socks on a polished floor
- 👁️ Check your eyesight and your medicines for anything that causes dizziness
- 🦵 Ask for a balance test if you have already fallen once this year
- 📏 Measure your height once a year. A loss of 2 cm or more can signal a spine fracture that did not hurt
✅ A realistic weekly plan.
🔹 Walk briskly most days short sessions count, and the label does not set a number.
🔹 Add two short strength and balance sessions ten minutes each is a start.
🔹 Review your tablet and your habits at each yearly visit bone health is a combination, not a pill.
Related reading: osteoporosis and menopause.
🍷 Alcohol, Smoking and Evista - What Matters for Bones and Clots
🍷 The Evista label has no warning about drinking alcohol with the tablet, and raloxifene does not interact with alcohol in any way the label records. ⚠️ But the label names cigarette smoking and excessive alcohol as habits to change for bone health, and it counts smoking among the stroke risk factors.
| 📋 Habit | 💡 Effect for a woman on Evista | 🛠️ What to do |
|---|---|---|
| Smoking | Adds to stroke risk, which the boxed warning cares about, and harms bone | Ask for help to stop. This is the most useful change on the list |
| Regular heavy drinking | Raises the risk of falls, can harm the liver (caution is advised with liver disease) and weakens bone | Keep to low amounts, or avoid it |
| An occasional drink | No interaction recorded with the tablet | Fine for most women. Common public advice is no more than one standard drink a day for women (general guidance) |
| Alcohol with sedatives or sleep aids | Can raise the risk of unsteadiness and falls | Avoid the combination |
⏱️ Timing does not matter with Evista. 📌 You can take the tablet in the morning and drink in the evening, or the reverse. What matters is the total amount and how steady you are on your feet afterwards.
⚠️ Who should be more careful.
🔹 Women with liver disease the label asks for caution with Evista, and alcohol adds a second load.
🔹 Women with atrial fibrillation it is a named stroke risk factor, and alcohol can set off episodes (general guidance).
🔹 Women who take warfarin alcohol can make clotting tests swing, see section 23.
🔹 Women who have fallen before alcohol makes the next fall more likely.
💡 Signs to report.
🔹 A fall with pain in the back, hip or wrist get it checked, even if you can walk.
🔹 Yellow skin or dark urine see the liver section.
🔹 Unusual drowsiness or confusion talk to a doctor soon.
✈️ Evista Travel, Surgery and Sitting Still - The 72 Hour Rule
✈️ Sitting still raises the risk of a clot on its own, and Evista adds to it. 📌 The label therefore gives a rule: stop Evista at least 72 hours before and during prolonged immobilisation, and restart only when you are fully walking again.
| 📋 Situation | 📝 What the label says | 🛠️ What to do |
|---|---|---|
| Planned surgery | Stop at least 72 hours before. Resume when fully ambulatory | Tell the surgeon and the anaesthetist about the tablet at the first visit |
| Prolonged bed rest or an injury with a cast | Stop during the period of immobility | Ask the doctor to confirm the date to stop and restart |
| Long car, bus or air travel | Move about periodically during the trip | Walk every hour or two, stretch your calves, drink water |
| Dental work | Not mentioned in the label | A normal visit needs no change, ask the dentist if a long sedation is planned (general guidance) |
- 📆 Write the surgery date on the pack and count back three days
- 📞 Ask the surgical team whether they want a longer break
- 🚶 Get up as soon as the team allows after the operation, because early movement lowers clot risk
- 🔁 Restart only after you are walking normally. Do not restart on the day you leave hospital by default
⚠️ Trips that need extra thought.
🔹 A flight of 4 hours or more in the first 4 months of treatment the clot risk is highest then, so ask the prescriber if the trip can wait.
🔹 A long drive with few stops plan stops, since the label asks to move about periodically.
🔹 A trip to a remote place know the signs of a clot and where the nearest hospital is.
⏰ Missed Doses, Stopping Evista and What Happens to Bone
⏰ Missing a tablet now and then does little harm, because raloxifene stays in the body for more than a day. 📌 The leaflet rule is simple: take the missed tablet as soon as you remember, unless it is almost time for the next one. In that case skip the missed tablet.
| 📋 Situation | 📝 What to do | 📄 Source |
|---|---|---|
| You remember a few hours late | Take the tablet now | Medication Guide |
| It is almost time for the next tablet | Skip the missed one and take the next at the usual time | Medication Guide |
| You nearly doubled up | Do not take two tablets at the same time | Medication Guide |
| You took several tablets by mistake | Call a poison centre or the prescriber. 600 mg a day was tolerated for 8 weeks in 63 women, and doses of 180 mg or more caused leg cramps and dizziness in about half | Evista label, overdosage |
🛑 Stopping is a different matter. 📌 The label gives no taper schedule, and the stop rules for surgery are in section 27. 🦴 What it does not describe is the effect on bone afterwards. In general, bone gains from a drug like this fade once it is stopped, so the stopping talk should include a plan for the next medicine (general guidance, not from the label).
- 📋 Book a bone scan around the time of stopping, so you have a fresh baseline
- 💊 Ask what comes next, if bone risk is still high
- 🧀 Keep calcium and vitamin D going after the last tablet
- 🎗️ Keep breast screening on schedule. Evista does not eliminate breast cancer risk
💡 A few points that can be misread.
🔹 Stopping because of a clot or stroke sign is urgent, not a planned stop.
🔹 Stopping for a trip needs the doctor, not a guess.
🔹 The breast cancer benefit after 5 years the label says the best length of treatment is not known.
🌱 Evista in Pregnancy, Breastfeeding and Women Who Can Still Conceive
🌱 Evista is for women after menopause. 🚫 The label is blunt: it is contraindicated in pregnancy, not indicated for women who can still become pregnant, and use before menopause is not recommended. Animal studies at doses at or below the human dose caused abortion, fetal anomalies and delayed birth.
| 📋 Situation | 📝 What the label says | 🛠️ What to do |
|---|---|---|
| Pregnant | Contraindicated. It may block the roles estrogen plays through pregnancy | Do not take it. Call your doctor if you become pregnant |
| Can still conceive (periods continue) | Not indicated. Use is not recommended | Choose another medicine |
| Premenopausal with osteoporosis | Safety was not established | Ask a specialist about treatments studied in younger women |
| Breastfeeding | No data in human milk. It may block estrogen in milk glands, and the Medication Guide says not to take it while nursing | Do not take it |
| Menopause not certain | The label does not define it. A missed period alone is not enough | Ask the doctor to confirm with your age and history |
- 🗓️ Menopause is usually confirmed after 12 months without a period (general guidance), and a woman in her early 40s with no period for several months needs a proper work-up
- 🧪 A pregnancy test is reasonable before starting if there is any chance, even when periods are irregular
- 📞 Tell the prescriber about plans for pregnancy long before they happen
🛑 If you find you are pregnant on Evista.
🔹 Stop the tablet and call your doctor the same day.
🔹 Do not wait for the next period to be sure the label warns about harm in all stages of pregnancy.
Related reading: early menopause when the menopause arrives before 45.
🕰️ Evista in Women Over 65, Over 75 and With Kidney Problems
🕰️ Most of the women in the Evista trials were older. 📊 In the placebo-controlled studies, 61 percent were 65 or over and 15.5 percent were 75 or over, and the label found no overall difference in safety or benefit by age. It also sets no dose change for older women.
| 📋 Group | 📝 Evidence | 🛠️ Practical point |
|---|---|---|
| 65 and over | No age difference in safety or effect in the label analysis. Greater sensitivity in some individuals cannot be ruled out | Same dose of 60 mg |
| 75 and over | 15.5% of trial women. RUTH included ages 55 to 92 | Check stroke and clot risk first, because older women have more of both |
| Frail, housebound or in a care home | Vitamin D need is higher. Long immobility raises clot risk | Discuss with a doctor who knows the daily routine |
| Moderate or severe kidney disease | Safety and efficacy not established. Use with caution | Ask for a kidney test before starting |
| Liver disease | Caution, mild impairment gave 150 percent higher levels | Ask for liver tests |
⚠️ Age is not the main issue, but what comes with age is. 📌 A woman of 72 with a normal blood pressure, a good walking pace and a recent mammogram has a very different risk from a woman of 72 who has had an irregular heartbeat and a stroke.
💡 A short checklist for an older patient.
🔹 Review all medicines especially ones that make you dizzy or drowsy.
🔹 Check blood pressure and the heart rhythm both are stroke risks.
🔹 Ask what the fracture risk really is a risk score such as FRAX can help the doctor.
🔹 Plan for mobility not sitting for hours without movement.
⚠️ One caution about the RUTH result.
🔹 The extra stroke deaths were seen in women with heart disease or several risk factors and the average age was 67.5.
🔹 A healthier woman of the same age may carry less risk but the trials cannot say by how much.
📦 Evista Stock, Tablet Strengths and Storage
📦 The page marks Evista as out of stock. 📌 That is a message about supply, and it says nothing about the quality of the drug or the demand. Raloxifene tablets exist in one strength only, so the first thing to check on any pack is 60 mg.
| 📋 Question | 📝 Answer | 📄 Source |
|---|---|---|
| How many strengths? | One: 60 mg | Evista label |
| How should I store it? | At controlled room temperature, 20 to 25 C (68 to 77 F). Short excursions between 15 and 30 C are allowed | Evista label |
| Is the tablet scored? | No. It is film-coated and not scored | Evista label |
| Where to keep it? | In a dry cupboard, away from children (general guidance) | General guidance |
| What if a child swallows tablets? | Call a poison centre at once. Two toddlers swallowed 180 mg each and had unsteadiness, dizziness, vomiting, rash, diarrhoea, tremor and flushing. There is no specific antidote | Evista label |
💡 When stock runs out before the next order.
🔹 Do not stop on your own call the prescriber, who may suggest a generic pack of the same 60 mg dose.
🔹 Do not borrow tablets the dose, the history and the clot risk are personal.
🔹 Check the pack on arrival name, strength and batch should match the prescription.
✅ The Evista Page Claims - What We Checked
✅ The product page makes many numerical claims. 📊 The table keeps the ones that matter to a patient. 📌 Verdicts compare each claim with the US Evista label and the trials, and some are marked as not checked because the sources used here did not cover them.
| 📝 Page claim | 📊 What the sources say | 🚦 Verdict |
|---|---|---|
| Reduces vertebral fractures 50 to 60 percent | 55 percent in women without earlier fracture, 30 percent in those with one (label) | Partly true |
| Reduces breast cancer risk 76 percent per STAR evidence | The 76 percent figure belongs to the first MORE report. STAR had no placebo group and found Evista no better than tamoxifen | Mixed up |
| Raises clot risk about 3-fold | MORE reported 3.1 times in the first report and 2.4 in the label analysis, then 1.44 in RUTH and 1.62 in a pooled analysis of 9 trials | True for MORE only |
| Greatest clot risk in the first 4 months; stop 72 hours before immobility | Stated in the label | True |
| Bioavailability about 2 percent, about 60 percent absorbed, 95 percent protein bound, half-life 27 to 32 hours | All appear in the label. Time to peak, steady state and the 90 percent stool figure were not checked | Mostly true |
| Cholestyramine reduces absorption by 60 percent | Stated in the label | True |
| Hot flashes about 25 percent | 24.6 percent in prevention trials, 9.7 percent in MORE | True for prevention trials |
| Leg cramps about 12 percent | 12.1 percent in RUTH, 7.0 percent in MORE | True for RUTH only |
| Calcium 1,200 mg and vitamin D 800 to 1,000 IU | The label gives about 1,500 mg of calcium in total and 400 to 800 IU of vitamin D | Differs |
| No dose change for age, kidney or moderate liver disease | No change by age. The label asks for caution in moderate or severe kidney disease and in liver disease | Partly true |
| Hepatic impairment is a contraindication; Pregnancy Category X | The label lists clots and pregnancy as contraindications and uses no letter category | Outdated |
| Approved by the FDA in 1997, for breast cancer risk in 2007, generic in 2013 | The label copyright starts in 1997. The other two dates were not checked here | Not checked |
| DXA scan every 1 to 2 years | The label gives no interval | Common practice |
| Original Eli Lilly brand, Cipla generic | Two different manufacturers | Needs a fix |
⚠️ What the owner of the page can fix quickly.
🔹 One clear title either the Lilly brand or the Cipla tablet, not both.
🔹 Update the breast cancer and fracture figures use the label wording with the two-group split.
🔹 Replace Pregnancy Category X with the sentence that Evista is contraindicated in pregnancy.
🔹 Check the stock status in the structured data an out of stock page should say OutOfStock.
⛔ Evista Contraindications When to Avoid Raloxifene
⛔ The label has two absolute contraindications and a longer list of situations that call for a risk and benefit talk. 📌 The three boxes below separate them, and the third box matters too: it names what does not rule Evista out.
🛑 Do not take Evista if any of these is true.
🔹 You have had a blood clot in a leg, a lung or an eye deep vein thrombosis, pulmonary embolism or retinal vein thrombosis, now or in the past.
🔹 You are pregnant or could become pregnant it may cause fetal harm.
🔹 You are breastfeeding the Medication Guide says not to take it.
📋 Needs a doctor and a risk and benefit talk.
🔹 Stroke risk factors a past stroke or mini-stroke, atrial fibrillation, high blood pressure, smoking.
🔹 Liver or kidney disease caution, since safety is not established in moderate or severe disease.
🔹 Taking systemic estrogen or cholestyramine the label does not recommend either combination.
🔹 A past breast cancer Evista has not been adequately studied and is not a treatment for it.
🔹 Very high triglycerides on past estrogen treatment blood fat tests are advised.
🔹 Planned surgery or a long period of bed rest the tablet must be stopped at least 72 hours earlier.
✅ What does not rule Evista out.
🔹 Age over 65 or over 75 the label found no age difference.
🔹 Having a womb the lining was not thickened in the trials, and the trials gave no progestogen.
🔹 Taking calcium, antacids, digoxin or corticosteroids no effect on raloxifene levels.
🔹 A family history of breast cancer it is one of the reasons for the breast cancer use.
📚 Drug Description Sources:
The information in this Evista guide is compiled from authoritative medical, pharmacological and regulatory sources covering the US prescribing information for Evista (raloxifene hydrochloride), the MORE, CORE, RUTH and STAR randomised trials, the analyses of blood clots, stroke, fractures and quality of life that followed them, the 2019 ASCO guideline on endocrine therapy for breast cancer risk reduction, and pooled reviews of osteoporosis treatments. Regulatory text changes over time and differs between makers, so the leaflet in your pack and the advice of your doctor govern product specific details such as dose, tablet appearance, storage and batch information.
🏛️ Regulatory and government agencies
- Evista (raloxifene hydrochloride) tablets, 60 mg, prescribing information (Eli Lilly and Company; DailyMed; label text dated March 2023) - boxed warning on venous thromboembolism and death from stroke, dose of 60 mg once daily, contraindications in clot history and pregnancy, and the adverse reaction tables of the MORE, RUTH and STAR trials
- Evista prescribing information, Clinical Studies (sections 14.1 to 14.5) - first spine fracture in 1.9 against 4.3 percent and 14.1 against 20.2 percent; invasive breast cancer lower by 71 percent in MORE, 56 percent in CORE and 44 percent in RUTH; death from stroke 59 against 39 in RUTH
- Evista prescribing information, Clinical Pharmacology and Drug Interactions (sections 7 and 12) - absolute bioavailability of 2 percent, half-life of 27.7 hours, 60 percent lower absorption with cholestyramine, a 10 percent fall in prothrombin time with warfarin, and no effect of calcium carbonate or antacids
- Evista Medication Guide (patient section of the Evista label) - the missed dose rule, who should not take Evista, stopping at least 3 days before long immobility, and the warning signs of clots and stroke
- National medicines regulator reporting systems - the routes for reporting a suspected adverse reaction or a faulty batch
📚 Professional societies and clinical guidelines
- Visvanathan K, Fabian CJ, Bantug E, et al; American Society of Clinical Oncology. Use of endocrine therapy for breast cancer risk reduction: ASCO clinical practice guideline update. J Clin Oncol 2019;37:3152-3165 - raloxifene 60 mg a day listed with tamoxifen, exemestane and anastrozole for postmenopausal women at increased risk, and not for premenopausal women
- Shoback D, Rosen CJ, Black DM, Cheung AM, Murad MH, Eastell R; Endocrine Society. Pharmacological management of osteoporosis in postmenopausal women: an Endocrine Society guideline update. J Clin Endocrinol Metab 2020;105:dgaa048 - update on romosozumab for women at very high fracture risk, with its cardiovascular boxed warning
- Ayers C, Kansagara D, Lazur B, Fu R, Kwon A, Harrod C. Effectiveness and safety of treatments to prevent fractures in people with low bone mass or primary osteoporosis: a living systematic review and network meta-analysis for the American College of Physicians. Ann Intern Med 2023;176:182-195 - 34 randomised trials; raloxifene reduced X-ray spine fractures but not clinical fractures (low to moderate certainty)
🔬 Landmark clinical research
- Ettinger B, Black DM, Mitlak BH, et al; Multiple Outcomes of Raloxifene Evaluation (MORE) Investigators. Reduction of vertebral fracture risk in postmenopausal women with osteoporosis treated with raloxifene: results from a 3-year randomized clinical trial. JAMA 1999;282:637-645 - 7,705 women; spine fractures 6.6 against 10.1 percent (relative risk 0.7); no reduction in non-spine fractures
- Cummings SR, Eckert S, Krueger KA, et al. The effect of raloxifene on risk of breast cancer in postmenopausal women: results from the MORE randomized trial. JAMA 1999;281:2189-2197 - 13 against 27 breast cancers; relative risk 0.24; 126 women treated to prevent one case
- Martino S, Cauley JA, Barrett-Connor E, et al; CORE Investigators. Continuing outcomes relevant to Evista: breast cancer incidence in postmenopausal osteoporotic women in a randomized trial of raloxifene. J Natl Cancer Inst 2004;96:1751-1761 - four more years of treatment; invasive breast cancer lower by 59 percent (hazard ratio 0.41)
- Siris ES, Harris ST, Eastell R, et al; CORE Investigators. Skeletal effects of raloxifene after 8 years: results from the Continuing Outcomes Relevant to Evista (CORE) study. J Bone Miner Res 2005;20:1514-1524 - non-spine fractures 22.8 against 22.9 percent; bone density gains kept at 7 years
- Barrett-Connor E, Mosca L, Collins P, et al; RUTH Trial Investigators. Effects of raloxifene on cardiovascular events and breast cancer in postmenopausal women. N Engl J Med 2006;355:125-137 - 10,101 women; coronary events hazard ratio 0.95, invasive breast cancer 0.56, fatal stroke 1.49, venous thromboembolism 1.44
- Ensrud KE, Stock JL, Barrett-Connor E, et al. Effects of raloxifene on fracture risk in postmenopausal women: the Raloxifene Use for the Heart Trial. J Bone Miner Res 2008;23:112-120 - clinical spine fractures 64 against 97 (hazard ratio 0.65); no change in non-spine or hip fractures
- Vogel VG, Costantino JP, Wickerham DL, et al; NSABP. Effects of tamoxifen vs raloxifene on the risk of developing invasive breast cancer and other disease outcomes: the NSABP Study of Tamoxifen and Raloxifene (STAR) P-2 trial. JAMA 2006;295:2727-2741 - 19,747 women; invasive breast cancer risk ratio 1.02; fewer clots (0.70) and less uterine cancer (0.62) than with tamoxifen
- Vogel VG, Costantino JP, Wickerham DL, et al. Update of the NSABP Study of Tamoxifen and Raloxifene (STAR) P-2 Trial: preventing breast cancer. Cancer Prev Res 2010;3:696-706 - median follow-up of 81 months; risk ratio 1.24 for invasive disease, and about 76 percent of the effect of tamoxifen kept
- Land SR, Wickerham DL, Costantino JP, et al. Patient-reported symptoms and quality of life during treatment with tamoxifen or raloxifene for breast cancer prevention: the NSABP STAR P-2 trial. JAMA 2006;295:2742-2751 - 1,983 women in the quality of life study; no difference between the two drugs in physical, mental or depression scores
- Walsh BW, Kuller LH, Wild RA, et al. Effects of raloxifene on serum lipids and coagulation factors in healthy postmenopausal women. JAMA 1998;279:1445-1451 - 390 women; LDL cholesterol lowered by 12 percent, fibrinogen by 12 to 14 percent, triglycerides unchanged
- Delmas PD, Bjarnason NH, Mitlak BH, et al. Effects of raloxifene on bone mineral density, serum cholesterol concentrations, and uterine endometrium in postmenopausal women. N Engl J Med 1997;337:1641-1647 - 601 women; spine density 2.4 percent above placebo at 24 months; endometrium not stimulated
- Adomaityte J, Farooq M, Qayyum R. Effect of raloxifene therapy on venous thromboembolism in postmenopausal women: a meta-analysis. Thromb Haemost 2008;99:338-342 - 9 trials, 24,523 women; odds ratio 1.62 for deep vein thrombosis or pulmonary embolism
- Barrett-Connor E, Cox DA, Song J, Mitlak B, Mosca L, Grady D. Raloxifene and risk for stroke based on the Framingham stroke risk score. Am J Med 2009;122:754-761 - fatal stroke hazard ratio 1.75 in women with a score of 13 or more and 1.08 below that
- Jarkova NB, Martenyi F, Masanauskaite D, Walls EL, Smetnik VP, Pavo I. Mood effect of raloxifene in postmenopausal women. Maturitas 2002;42:71-75 - 36 women; preliminary data showing no worsening of mood
📖 Medical references and textbooks
- Evista prescribing information, Use in Specific Populations (sections 8.1 to 8.7) - contraindication in pregnancy, no data in human milk, 61 percent of trial women aged 65 or over, and caution in liver and kidney impairment
- Evista prescribing information, Overdosage and How Supplied (sections 10 and 16) - 600 mg a day tolerated for 8 weeks in 63 women, the white elliptical tablet marked 4165, and storage at 20 to 25 C
Note: This information is educational and does not replace consultation with qualified healthcare providers. Raloxifene is a prescription medicine with a boxed warning, and the decision to start it, the checks before and during treatment, and the plan for stopping must be made with a doctor who knows your history, your scans and your risks.
🩺 Medical Expert Review:
Content reviewed for accuracy by authorities in osteoporosis research, breast cancer prevention, women health epidemiology and drug safety with particular expertise in raloxifene. The following experts represent authoritative research perspectives on the benefits and risks of raloxifene for bone and for breast cancer risk reduction.
Steven R. Cummings
Department of Medicine, University of California San Francisco — San Francisco, USA (at the time of the study)
First author of the JAMA report on breast cancer in the MORE trial of 7,705 women, which found 13 cases on raloxifene against 27 on placebo and a relative risk of 0.24 after a median of 40 months.
Victor G. Vogel
Magee-Womens Hospital, University of Pittsburgh School of Medicine — Pittsburgh, USA (at the time of the study)
First author of the STAR P-2 trial of 19,747 women comparing raloxifene with tamoxifen, and of its 81 month update, which showed that raloxifene kept about 76 percent of the effect of tamoxifen with fewer clots and less uterine cancer.
Silvana Martino
Cancer Institute Medical Group — Santa Monica, USA (at the time of the study)
First author of the CORE extension study, which followed women from MORE for four more years and found invasive breast cancer lower by 59 percent on raloxifene with no new safety concerns.
Kristine E. Ensrud
Center for Chronic Disease Outcomes Research, Veterans Affairs Medical Center — Minneapolis, USA (at the time of the study)
First author of the fracture analysis of the RUTH trial of 10,101 women, which found fewer clinical spine fractures and no difference in non-spine or hip fractures with raloxifene.
Ethel S. Siris
Toni Stabile Osteoporosis Center, Columbia University College of Physicians and Surgeons — New York, USA (at the time of the study)
First author of the 8 year skeletal report from the CORE study, which found that bone density gains were kept at 7 years but that non-spine fractures were the same on raloxifene and placebo.
Disclosure: Expert names and credentials are cited for educational reference. This content is not endorsed by named experts. Content prepared by RXshop editorial team based on published literature and regulatory documents.
More Women's Health Medications
