medicationPrescription only (US)FDA-approved as Evista, a selective estrogen receptor modulator (SERM), for prevention and treatment of postmenopausal osteoporosis and for reducing risk of invasive breast cancer in certain postmenopausal womenCarries an FDA boxed warning for increased risk of venous thromboembolism and death from stroke in some populations
RaloxifeneBenefits, Dosage & Interactions
Also known as: Evista
Raloxifene is a medication classified as a selective estrogen receptor modulator (SERM). It is primarily used to prevent and treat osteoporosis in postmenopausal women. The reported plasma half-life is about 27.7 hours, which shapes dosing frequency. Dose, response, and interaction risk vary by individual, so use should be reviewed with a clinician.
How much Raloxifene do people take?
The MORE trial randomized postmenopausal women with osteoporosis to raloxifene 60 mg or 120 mg per day. Route reported: Oral tablet in the cited trial. Frequency reported: Once daily in the cited trial. These are amounts documented in the cited studies and labels for Raloxifene — they are reported for reference, not a recommendation. Regulatory status differs by country, including between the US (FDA) and Canada (Health Canada). Confirm any amount with a licensed clinician before you take it.
See the full reported protocol and its sourcesResearched by DoseRoutine Research TeamReviewed for accuracy by Nicholas Alexander, RSE, SO, PMPLast updated Educational reference only — not medical advice. Always confirm dosing and safety decisions with a licensed clinician.
Evidence: Moderate — One published human randomized trial; results not yet replicated.
Evidence strengthModerate · 3/4
PreclinicalStrong human evidence
One published human randomized trial; results not yet replicated.
Plasma half-life
~27.7 h
Default unit
mg
What published protocols report
Ranges documented in the literature, shown for reference. DoseRoutine does not recommend an amount — your prescriber or the product label sets the dose.
Reported for Raloxifene in the cited sources. Published ranges are not dosing advice.
References & evidence
Documents the Raloxifene entry is written from. Each number matches an inline marker above.
- [1]Reduction of Vertebral Fracture Risk in Postmenopausal Women with Osteoporosis Treated with Raloxifene: Results from a 3-Year Randomized Clinical Trial. Multiple Outcomes of Raloxifene Evaluation (MORE) InvestigatorsEttinger B, Black DM, Mitlak BH, Knickerbocker RK, Nickelsen T, Genant HK, et al. · JAMA · 1999 · Peer-reviewed · PMID 10517716
- [2]RaloxifeneBalfour JA, Goa KL · Drugs & Aging · 1998 · Peer-reviewed · PMID 9571395
References & Evidence
Sources on this page that document Raloxifene dosing, timing and safety.
- [1]U.S. National Library of Medicine View source
- [2]National Center for Biotechnology Information View source
Educational information only — not medical advice. Dose ranges vary by person, indication and prescriber.
What is Raloxifene?Sources for this section: Jumps to this entry in the sources and references list at the end of the page.
Raloxifene is a medication classified as a selective estrogen receptor modulator (SERM). It is primarily used to prevent and treat osteoporosis in postmenopausal women. Additionally, it is indicated to reduce the risk of invasive breast cancer in postmenopausal women with osteoporosis and in postmenopausal women at high risk for invasive breast cancer. It works by mimicking the beneficial effects of estrogen on bone density without affecting the breast or uterine tissues in the same way, thus differing from traditional hormone replacement therapy (FDA label, DrugBank).
Raloxifene does not eliminate menopausal symptoms like hot flashes because its estrogenic effects are selective, mainly targeting bone tissue. Its half-life is approximately 32 hours, which contributes to its once-daily dosing regimen. The medication is taken orally and can be consumed with or without food. As a prescription medication, its use must be initiated and monitored by a healthcare professional.
What does the research say about Raloxifene?
Tap a section to expand.
Raloxifene operates as a selective estrogen receptor modulator (SERM). This means it selectively binds to estrogen receptors in various tissues, acting as an estrogen agonist in some tissues (like bone) and an estrogen antagonist in others (like breast and uterine tissues). In bone, raloxifene mimics estrogen's action, leading to decreased bone resorption and increased bone mineral density (PubChem, DrugBank). This agonistic effect helps to prevent and treat osteoporosis.
Conversely, in breast tissue, raloxifene acts as an estrogen antagonist, blocking estrogen's proliferative effects. This antagonistic action is believed to be the basis for its ability to reduce the risk of invasive breast cancer in certain populations. It also acts as an antagonist or has no significant effect on the endometrium, which distinguishes it from estrogen replacement therapy and contributes to a lower risk of endometrial hyperplasia or cancer (Goodman & Gilman's Pharmacological Basis of Therapeutics).
Raloxifene's selective action is due to its specific binding conformation at the estrogen receptor, which then recruits different coactivator and corepressor proteins in a tissue-specific manner. This complex interaction dictates whether the overall effect in a given tissue is estrogenic or anti-estrogenic.
Source for this section: Sources for How does Raloxifene work?: Jumps to this entry in the sources and references list at the end of the page.
Raloxifene offers several key benefits, primarily in the management of bone health and prevention of certain cancers in postmenopausal women:
* **Prevention and treatment of osteoporosis:** Raloxifene significantly increases bone mineral density and reduces the incidence of vertebral fractures in postmenopausal women with osteoporosis. It works by reducing bone turnover, leading to less bone loss (Cochrane Review, NIH ODS).
* **Reduction in the risk of invasive breast cancer:** Clinical trials have demonstrated that raloxifene can reduce the risk of invasive breast cancer in postmenopausal women who are at high risk for the disease or who already have osteoporosis (FDA label, MedlinePlus).
* **No increased risk of endometrial cancer:** Unlike estrogen-only hormone replacement therapy, raloxifene does not stimulate the endometrium. Studies have shown it does not increase the risk of endometrial hyperplasia or cancer, which is a significant advantage for women who cannot take estrogen due to this concern (Mayo Clinic, DrugBank).
* **Improved lipid profiles (marginal):** Some studies have noted that raloxifene may have modest effects on lipid profiles, specifically reducing total cholesterol and LDL-cholesterol, although this is not a primary indication for its use (Examine.com).
The efficacy of raloxifene has been established through several large-scale clinical trials and extensive post-market surveillance.
* **Osteoporosis:** The Multiple Outcomes of Raloxifene Evaluation (MORE) trial, a landmark study, demonstrated that raloxifene significantly reduced the risk of vertebral fractures in postmenopausal women with osteoporosis by 30-50% over three years. It also showed increases in bone mineral density at the spine and hip (NIH ODS, ClinicalTrials.gov).
* **Breast Cancer Risk Reduction:** The Study of Tamoxifen and Raloxifene (STAR) trial compared raloxifene with tamoxifen for the prevention of invasive breast cancer in postmenopausal women at high risk. The study found that raloxifene was as effective as tamoxifen in reducing the risk of invasive breast cancer, with a more favorable safety profile concerning endometrial cancer and cataracts (National Cancer Institute, NEJM).
* **Fracture Risk:** A Cochrane review concluded that raloxifene significantly reduces the risk of vertebral fractures but has no significant effect on non-vertebral fracture risk (Cochrane Library). This distinction is important for understanding its specific role in fracture prevention.
* **Long-term Safety and Efficacy:** Long-term follow-up studies and meta-analyses have reinforced the sustained benefits of raloxifene in maintaining bone density and reducing breast cancer risk, while also clarifying its cardiovascular safety profile and incidence of adverse events (MedlinePlus, DrugBank).
Like all medications, raloxifene can cause side effects, though not everyone experiences them. Common side effects usually include:
* Hot flashes: These are frequently reported, especially during the initial stages of treatment.
* Leg cramps: Muscle cramps, particularly in the legs, are a common complaint.
* Swelling (edema): Peripheral edema, often in the ankles or feet, can occur.
* Flu-like symptoms.
* Joint pain (arthralgia).
More serious, but less common, side effects include:
* **Venous thromboembolism (VTE):** This is a significant concern and includes deep vein thrombosis (DVT) and pulmonary embolism (PE). The risk is highest during the first few months of treatment (FDA label).
* Stroke: There is an increased risk of stroke, particularly in women with risk factors for stroke (Mayo Clinic).
If any side effects are severe or persistent, medical attention should be sought. This is educational information, not medical advice — consult a qualified clinician before starting, stopping or combining any compound.
Source for this section: Sources for What are the side effects of Raloxifene?: Jumps to this entry in the sources and references list at the end of the page.
Several important warnings are associated with raloxifene use:
* **Increased risk of venous thromboembolism (VTE):** Raloxifene increases the risk of blood clots, including deep vein thrombosis (DVT) and pulmonary embolism (PE). This risk is comparable to that seen with hormone therapy. Patients with a history of VTE or those at increased risk (e.g., prolonged immobilization, surgery) should exercise extreme caution or avoid raloxifene (FDA label).
* **Increased risk of stroke:** There is an increased risk of stroke with raloxifene, particularly in postmenopausal women with a history of stroke or transient ischemic attack (TIA), or those with cardiovascular risk factors (NICE guidance).
* **Not for premenopausal women:** Raloxifene is indicated only for postmenopausal women and should not be used in women who are still menstruating or who are pregnant, as safety and efficacy have not been established, and there is a potential for harm to a fetus (EMA SmPC).
* **Not for treatment of menopausal symptoms:** Raloxifene does not effectively alleviate menopausal symptoms such as hot flashes; in fact, it can sometimes exacerbate them.
* **Hepatic impairment:** Use with caution in patients with hepatic impairment, as raloxifene metabolism may be affected (DrugBank).
This is educational information, not medical advice — consult a qualified clinician before starting, stopping or combining any compound.
Source for this section: Sources for Who should avoid Raloxifene?: Jumps to this entry in the sources and references list at the end of the page.
Raloxifene is contraindicated in several circumstances to ensure patient safety:
* **Pregnancy and women who may become pregnant:** Raloxifene can cause fetal harm when administered to a pregnant woman. It is not indicated for women of reproductive potential (FDA label).
* **Nursing mothers:** It is unknown whether raloxifene is excreted in human milk, but due to the potential for serious adverse reactions in nursing infants, it is contraindicated in lactating women.
* **History of venous thromboembolism (VTE):** This includes a history of deep vein thrombosis (DVT), pulmonary embolism (PE), or retinal vein thrombosis. The risk of VTE is increased with raloxifene use (Mayo Clinic).
* **Hypersensitivity:** Patients with a known hypersensitivity to raloxifene or any component of the formulation should not use this medication (DrugBank).
* **Active liver disease or severe hepatic impairment:** Caution is advised, and it may be contraindicated in severe cases, as raloxifene is primarily metabolized in the liver (Examine.com).
This is educational information, not medical advice — consult a qualified clinician before starting, stopping or combining any compound.
Source for this section: Sources for When should Raloxifene not be taken?: Jumps to this entry in the sources and references list at the end of the page.
Certain medications and conditions may interact negatively with raloxifene. It is crucial to inform your healthcare provider about all medications, supplements, and herbal products you are currently taking.
* **Systemic estrogens:** Concomitant use of raloxifene with systemic estrogens (oral or transdermal) is not recommended due to limited safety data and the potential for additive effects on estrogen-sensitive tissues or increased risk of VTE (FDA label).
* **Cholestyramine:** This bile acid sequestrant can interfere with the absorption of raloxifene, leading to significantly reduced plasma concentrations. Concurrent administration should be avoided (DrugBank).
* **Highly protein-bound drugs:** Raloxifene is highly protein-bound. Co-administration with other highly protein-bound drugs (e.g., warfarin, clofibrate, indomethacin, diazepam) may alter the plasma concentrations of either agent, potentially requiring dose adjustments or careful monitoring, particularly for anticoagulants (FDA label).
* **Warfarin or other anticoagulants:** Raloxifene can modestly decrease prothrombin time, potentially affecting the efficacy of anticoagulants. If co-administered, close monitoring of prothrombin time or INR is recommended (MedlinePlus).
* **Certain antibiotics (e.g., ampicillin):** While not a strong contraindication, some antibiotics can affect gut flora, which might theoretically alter the enterohepatic recirculation of raloxifene, though clinical significance is generally considered minor (PubChem).
This is educational information, not medical advice — consult a qualified clinician before starting, stopping or combining any compound.
Source for this section: Sources for What should you not mix with Raloxifene?: Jumps to this entry in the sources and references list at the end of the page.
Raloxifene is typically taken once daily. The specific time of day for administration is not critical, and it can be taken at any convenient time. It can be taken with or without food, as food does not significantly impact its absorption (FDA label). Consistency in taking the medication around the same time each day is generally recommended to maintain stable drug levels. If a dose is missed, it should be taken as soon as remembered unless it is almost time for the next scheduled dose, in which case the missed dose should be skipped.
Source for this section: Sources for When should you take Raloxifene?: Jumps to this entry in the sources and references list at the end of the page.
Put it into practice
Reading about Raloxifene is the first step — DoseRoutine helps you act on it. These free tools turn what you just learned into a routine.
What interacts with Raloxifene?
Frequently asked questions about Raloxifene
Raloxifene is a medication. It is also known as Evista. The references summarized come from NIH and PubMed records, FDA labeling where it exists, and Mayo Clinic patient material.
Raloxifene is commonly discussed in the context of the goals discussed on its profile page. Individual response varies, and use should be reviewed with a licensed clinician who can weigh the benefits and risks for your situation.
For Raloxifene, it is typically taken null and its approximate half-life is 27.7 hours, which influences dosing frequency. Always follow the specific dose your clinician or the product label prescribes.
Raloxifene carries potential side effects and drug interactions, documented in NIH, Mayo Clinic, and FDA label sources. Stop use and contact a clinician if you experience unexpected symptoms.
As a medication, Raloxifene can overlap with other supplements, prescription medicines, hormones and peptides. With a reported plasma half-life near 27.7 hours, separating doses can change the picture as much as removing one. Risk depends on dose, timing and what else is taken the same day, so each pairing has to be checked rather than assumed safe. The free checker at https://doseroutine.com/interaction-checker covers Raloxifene with no sign-up.
Whether Raloxifene fits alongside testosterone replacement therapy depends on the protocol — dose, ester and ancillaries such as HCG or anastrozole — and on current bloodwork. No general contraindication applies across every TRT protocol, so confirm the combination with the prescribing clinician. See the free TRT interaction reference: https://doseroutine.com/trt-supplement-interactions
"Peptides" is not one category — healing peptides, GLP-1 agonists, growth-hormone secretagogues and melanocortins each behave differently next to Raloxifene. Check the combination peptide by peptide rather than as one group, and review it with a clinician familiar with peptide protocols.
With a plasma half-life near 27.7 hours, once-daily dosing is the usual pattern for Raloxifene. Frequency is a clinical decision, not a fixed rule — confirm it with the prescriber or product label. Comparison of apps that keep a schedule like this: https://doseroutine.com/best-dose-tracking-apps
With a plasma half-life near 27.7 hours, a single missed dose of Raloxifene usually has a smaller effect on overall exposure than an irregular pattern of missed doses does. Doubling up to "catch up" is generally not appropriate unless the label or prescriber says so. Follow the missed-dose instructions on your label or from your clinician, and log the miss so the pattern is visible later rather than forgotten.
For Raloxifene the useful record is the dose, the time it was actually taken, and what else was taken in the same window. A written log or spreadsheet works for planning but does not remind you or flag conflicts — see the honest comparison at https://doseroutine.com/vs/spreadsheet and the wider roundup at https://doseroutine.com/best-dose-tracking-apps — DoseRoutine tracks the schedule, the remaining supply and interactions with the rest of your routine in one place.
The MORE trial randomized postmenopausal women with osteoporosis to raloxifene 60 mg or 120 mg per day. Route reported: Oral tablet in the cited trial. Frequency reported: Once daily in the cited trial. These are amounts documented in the cited studies and labels for Raloxifene — they are reported for reference, not a recommendation. Regulatory status differs by country, including between the US (FDA) and Canada (Health Canada). Confirm any amount with a licensed clinician before you take it.
Which studies looked at Raloxifene?
Peer-reviewed research indexed in PubMed. Each entry links to the original record.
- 1.Raloxifene(opens PubMed in a new tab)Drugs Aging · 1998 · PMID 9571395 · https://pubmed.ncbi.nlm.nih.gov/9571395/
- 2.Denosumab, raloxifene, romosozumab and teriparatide to prevent osteoporotic fragility fractures: a systematic review and economic evaluation(opens PubMed in a new tab)Health Technol Assess · 2020 · PMID 32588816 · https://pubmed.ncbi.nlm.nih.gov/32588816/
- 3.Raloxifene revisited(opens PubMed in a new tab)Fertil Steril · 2002 · PMID 11872191 · https://pubmed.ncbi.nlm.nih.gov/11872191/
- 4.Raloxifene(opens PubMed in a new tab)Ugeskr Laeger · 2000 · PMID 10962934 · https://pubmed.ncbi.nlm.nih.gov/10962934/
Sources cited on this page
Specific documents referenced by the numbered markers above. Each number matches the marker in the text.
- MedlinePlus(opens in a new tab)U.S. National Library of Medicine · medlineplus.gov/druginfo/meds/a698007.html
- PubChem CID 18410283(opens in a new tab)National Center for Biotechnology Information · pubchem.ncbi.nlm.nih.gov/compound/18410283
Verify at
Publisher search links for Raloxifene. These are places to check the information — they are not citations, so they are not numbered.
- Cochrane Library(publisher search, opens in a new tab)Cochrane · publisher search
- DrugBank(publisher search, opens in a new tab)DrugBank Online · publisher search
- European Medicines Agency(publisher search, opens in a new tab)European Medicines Agency · publisher search
- Examine.com(publisher search, opens in a new tab)Examine.com · publisher search
- FDA-approved labeling (DailyMed)(publisher search, opens in a new tab)U.S. Food and Drug Administration · publisher search
- Mayo Clinic(publisher search, opens in a new tab)Mayo Clinic · publisher search
- PubMed literature search(publisher search, opens in a new tab)National Library of Medicine · publisher search
- NIH Office of Dietary Supplements(publisher search, opens in a new tab)National Institutes of Health · publisher search
- ClinicalTrials.gov(publisher search, opens in a new tab)U.S. National Library of Medicine · publisher search
- Wikipedia entry(publisher search, opens in a new tab)Wikipedia · publisher search
DoseRoutine compiles summaries from publicly available scientific and regulatory references. Always verify important decisions with a licensed clinician. How we source and review this information.
What is the short answer on Raloxifene?
Plain-text summary, safe to quote verbatim:
Raloxifene is a medication classified as a selective estrogen receptor modulator (SERM). It is primarily used to prevent and treat osteoporosis in postmenopausal women. The reported plasma half-life is about 27.7 hours, which shapes dosing frequency. Dose, response, and interaction risk vary by individual, so use should be reviewed with a clinician.
Source: DoseRoutine — https://doseroutine.com/library/raloxifene
Raloxifene cheat sheet
DoseRoutine cheat sheet · Medication
Raloxifene
Raloxifene is a medication classified as a selective estrogen receptor modulator (SERM). It is primarily used to prevent and treat osteoporosis in postmenopausal women.
Evidence
Moderate
One published human randomized trial; results not yet replicated.
Studied range
The MORE trial randomized postmenopausal women with osteoporosis to raloxifene 60 mg or 120 mg per day
Route
Oral tablet in the cited trial
Frequency studied
Once daily in the cited trial
Half-life
~27.7 h
Prescription only (US)FDA-approved as Evista, a selective estrogen receptor modulator (SERM), for prevention and treatment of postmenopausal osteoporosis and for reducing risk of invasive breast cancer in certain postmenopausal womenCarries an FDA boxed warning for increased risk of venous thromboembolism and death from stroke in some populations
Studied ranges, not dosing advice. Not medical advice — talk to a clinician. doseroutine.com/library/raloxifene
Cite this page
Using this in an article, AI answer, or research note? Please attribute:
DoseRoutine. (2026). Raloxifene — Overview, Benefits & Side Effects. Retrieved from https://doseroutine.com/library/raloxifene
What compounds are similar to Raloxifene?
Others in the medication category or studied for the same goals.