Raloxifene
Raloxifene is an estrogen agonist/antagonist (a selective estrogen receptor modulator, or SERM) used to treat and prevent osteoporosis and to lower the risk of invasive breast cancer in certain postmenopausal women.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 25 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Raloxifene (Evista) is a SERM (selective estrogen receptor modulator) that acts like estrogen in bone but blocks it in breast and uterine tissue, used to treat and prevent osteoporosis and lower invasive breast cancer risk in certain postmenopausal women; on the market since about 1997 and available as a generic, it is usually chosen after bisphosphonates, the standard first-choice bone drugs. Most women tolerate it well, and hot flashes and leg cramps are what people notice most. The one thing to respect is its boxed warning for blood clots and death from stroke, and anyone who has ever had a clot in a vein should not take it.
Clinical pearls
- Stop it at least 72 hours before surgery or long bed rest, and restart only once you are fully up and moving.
- Clot risk is highest in the first 4 months, so on long flights or drives, get up and move regularly.
- Sudden vision loss in one eye can signal a clot in an eye vein and needs emergency care.
- Warfarin users need closer prothrombin time (clotting test) checks when raloxifene starts or stops, and cholestyramine is not recommended with it.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Raloxifene raises the risk of dangerous blood clots in the legs (deep vein thrombosis) and lungs (pulmonary embolism). Women who have or have ever had a blood clot in a vein should not take it.
It also raised the risk of death from stroke in a trial of postmenopausal women with heart disease or a higher risk of major heart problems. If you are at risk for stroke, talk with your doctor about whether the benefits outweigh the risks. Watch for leg pain or swelling, sudden shortness of breath, chest pain, or signs of stroke, and get emergency help if they occur.
Patient information guide A plain-language walkthrough of Raloxifene, written from its FDA label.
What Raloxifene is used for
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Raloxifene is used in postmenopausal women for these purposes:
- Treating osteoporosis
- Preventing osteoporosis
- Lowering the risk of invasive breast cancer in women with osteoporosis
- Lowering the risk of invasive breast cancer in women at high risk for it
The Evista and raloxifene hydrochloride tablet labels list these same uses. It is not for treating invasive breast cancer, preventing its return, or lowering the risk of noninvasive breast cancer.
How Raloxifene works
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Raloxifene is a selective estrogen receptor modulator (SERM). It binds to estrogen receptors and turns estrogen pathways on in some tissues and blocks them in others.
In bone, it acts like estrogen. It slows bone breakdown and turnover, raises bone mineral density and lowers fractures. In breast and uterine tissue, it blocks estrogen.
Raloxifene dosage
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Raloxifene tablets are taken by mouth once a day. You can take them any time of day, with or without food.
- Take it exactly as your prescriber and label direct.
- If your diet is low in calcium or vitamin D, supplements may be added.
- For breast cancer risk reduction, the best length of treatment is not known.
Dosing details from the FDA-approved label
From the Raloxifene prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Recommended dosing (osteoporosis treatment or prevention; risk of invasive breast cancer)
- 60 mg tablet orally once daily
- May be administered any time of day without regard to meals
- For the indications in risk of invasive breast cancer the optimum duration of treatment is not known
- Calcium and vitamin D supplementation (osteoporosis treatment or prevention)
- Supplemental calcium and/or vitamin D should be added to the diet if daily intake is inadequate
- Postmenopausal women require an average of 1500 mg/day of elemental calcium
- Recommended vitamin D intake is 400-800 IU daily
- Maximum: Total daily calcium intake above 1500 mg has not demonstrated additional bone benefits; intake above 2000 mg has been associated with increased risk of adverse effects, including hypercalcemia and kidney stones
- Patients at increased risk for vitamin D insufficiency (over age 70, nursing home bound, chronically ill) may need additional vitamin D; patients with gastrointestinal malabsorption syndromes may require higher doses of vitamin D
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION 60 mg tablet orally once daily. ( 2.1 ) 2.1 Recommended Dosing The recommended dosage is one 60 mg EVISTA (raloxifene hydrochloride tablets) tablet daily, which may be administered any time of day without regard to meals [see Clinical Pharmacology ( 12.3 )] . For the indications in risk of invasive breast cancer the optimum duration of treatment is not known [see Clinical Studies ( 14.3 , 14.4 )] . 2.2 Recommendations for Calcium and Vitamin D Supplementation For either osteoporosis treatment or prevention, supplemental calcium and/or vitamin D should be added to the diet if daily intake is inadequate. Postmenopausal women require an average of 1500 mg/day of elemental calcium. Total daily intake of calcium above 1500 mg has not demonstrated additional bone benefits while daily intake above 2000 mg has been associated with increased risk of adverse effects, including hypercalcemia and kidney stones. The recommended intake of vitamin D is 400-800 IU daily. Patients at increased risk for vitamin D insufficiency (e.g., over the age of 70 years, nursing home bound, or chronically ill) may need additional vitamin D supplements. Patients with gastrointestinal malabsorption syndromes may require higher doses of vitamin D supplementation and measurement of 25-hydroxyvitamin D should be considered.
Read the full Dosage and Administration section on DailyMed →
Raloxifene side effects
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Common side effects seen in studies include:
Common side effects
- Hot flashes
- Leg cramps
- Swelling in the hands, feet or legs (peripheral edema)
- Flu-like symptoms
- Joint pain (arthralgia)
- Sweating
When to get medical help
- Call your doctor right away or get emergency help for sudden leg pain, swelling or warmth, which can signal a blood clot in the leg (deep vein thrombosis).
- Get emergency help for sudden shortness of breath or chest pain, which can signal a clot in the lungs (pulmonary embolism).
- Get emergency help for sudden vision changes or vision loss in one eye, which can signal a clot in a vein of the eye.
- Get emergency help for signs of stroke, such as sudden weakness, trouble speaking or severe headache.
- Tell your doctor about any unexplained vaginal bleeding.
- Tell your doctor about any new breast lump or other breast change.
Raloxifene warnings and precautions
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Blood clots and stroke are the biggest risks. Clot risk is highest in the first 4 months. Stop raloxifene at least 72 hours before and during prolonged immobility, such as after surgery or on bed rest.
- Do not use it to prevent heart disease or stroke.
- It does not eliminate breast cancer risk, so keep up breast exams and mammograms.
- Report unexplained uterine bleeding or breast changes.
- Use caution with liver or moderate to severe kidney problems.
Raloxifene interactions
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Some medicines can change how raloxifene works or how your body handles other drugs.
- Cholestyramine: cuts absorption by about 60%, so avoid it.
- Warfarin: your clotting test needs closer monitoring when raloxifene is started or stopped.
- Diazepam, diazoxide, lidocaine: raloxifene is highly protein-bound and might affect these drugs, so use caution.
- Systemic estrogens: safety together is not established, so this is not recommended.
Interactions listed in the FDA-approved label
From the Raloxifene prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Cholestyramine and other anion exchange resins: Cholestyramine causes a 60% reduction in the absorption and enterohepatic cycling of raloxifene after a single dose; other anion exchange resins are anticipated to have a similar effect. Concomitant use is not recommended; should not be co-administered with other anion exchange resins.
- Warfarin and other warfarin derivatives: Raloxifene had no effect on the pharmacokinetics of warfarin in a single-dose study, but a 10% decrease in prothrombin time was observed. Monitor prothrombin time more closely when starting or stopping raloxifene.
- Other highly protein-bound drugs (diazepam, diazoxide, lidocaine): Raloxifene is more than 95% bound to plasma proteins and might affect the protein binding of other drugs, although this was not examined. Use with caution.
- Systemic estrogens: The safety of concomitant use with systemic estrogens has not been established. Use is not recommended.
- Ampicillin and amoxicillin: Peak concentrations of raloxifene and overall extent of absorption are reduced 28% and 14%, respectively, with ampicillin; systemic exposure and elimination rate were not affected; amoxicillin showed no discernible differences in plasma raloxifene concentrations. Can be concomitantly administered.
- Antacids (calcium carbonate, aluminum and magnesium hydroxide): Does not affect the systemic exposure of raloxifene. Can be concomitantly administered.
- Corticosteroids: Chronic raloxifene administration has no effect on the pharmacokinetics of single oral dose methylprednisolone. Can be concomitantly administered.
- Digoxin: Raloxifene has no effect on the pharmacokinetics of digoxin. Can be concomitantly administered.
- Cyclosporine: Concomitant administration with raloxifene has not been studied.
- Lipid-lowering agents: Concomitant administration with raloxifene has not been studied.
Read the label’s full interactions text
7 DRUG INTERACTIONS • Cholestyramine : Use with raloxifene hydrochloride is not recommended. Reduces the absorption and enterohepatic cycling of raloxifene. ( 7.1 , 12.3 ) • Warfarin : Monitor prothrombin time when starting or stopping raloxifene hydrochloride. ( 7.2 , 12.3 ) • Highly Protein-Bound Drugs : Use with raloxifene hydrochloride with caution. Highly protein-bound drugs include diazepam, diazoxide, and lidocaine. Raloxifene hydrochloride is more than 95% bound to plasma proteins. ( 7.3 , 12.3 ) 7.1 Cholestyramine Concomitant administration of cholestyramine with raloxifene hydrochloride is not recommended. Although not specifically studied, it is anticipated that other anion exchange resins would have a similar effect. Raloxifene hydrochloride should not be co-administered with other anion exchange resins [see Clinical Pharmacology ( 12.3 )] . 7.2 Warfarin If raloxifene hydrochloride is given concomitantly with warfarin or other warfarin derivatives, prothrombin time should be monitored more closely when starting or stopping therapy with raloxifene hydrochloride [see Clinical Pharmacology ( 12.3 )] . 7.3 Other Highly Protein-Bound Drugs Raloxifene hydrochloride should be used with caution with certain other highly protein-bound drugs such as diazepam, diazoxide, and lidocaine. Although not examined, raloxifene hydrochloride might affect the protein binding of other drugs. Raloxifene is more than 95% bound to plasma proteins [see Clinical Pharmacology ( 12.3 )] . 7.4 Systemic Estrogens The safety of concomitant use of raloxifene hydrochloride with systemic estrogens has not been established and its use is not recommended. 7.5 Other Concomitant Medications Raloxifene hydrochloride can be concomitantly administered with ampicillin, amoxicillin, antacids, corticosteroids, and digoxin [see Clinical Pharmacology ( 12.3 )] . The concomitant use of raloxifene hydrochloride and lipid-lowering agents has not been studied.
Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Raloxifene
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- Do not take it with an active or past blood clot in the legs, lungs or eyes.
- Do not take it if pregnant, possibly pregnant or breastfeeding. It may cause fetal harm.
- Not recommended before menopause or in men.
- Tell your doctor if you have stroke risks, heart failure or active cancer.
- Use caution with liver disease or moderate to severe kidney disease.
- Not studied in children. Older adults need no dose change.
Raloxifene overdose
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Overdose has been reported very rarely. Reactions in adults who took large amounts included leg cramps and dizziness. Two toddlers who swallowed it had symptoms such as unsteadiness, dizziness, vomiting, rash, diarrhea, tremor and flushing. There is no specific antidote, so call poison control or seek medical care.
What Raloxifene does in the body
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After menopause, falling estrogen speeds up bone loss. Raloxifene reduces bone resorption (breakdown) and bone turnover, as shown by lower blood and urine bone markers by 3 months. It slightly lowers some blood levels, such as calcium and platelets, but less than estrogen does for some of these.
How your body processes Raloxifene
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Raloxifene is absorbed quickly after you swallow it, but very little reaches the bloodstream unchanged because the body processes it heavily on first pass. It is not broken down by the usual cytochrome P450 liver pathways. Its half-life is about 28 hours after one dose. Most of it leaves in the stool, and very little leaves in urine. Food does not meaningfully change how much your body gets.
How to store Raloxifene
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Store at controlled room temperature, 20º to 25ºC (68º to 77ºF) .
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Raloxifene
18 supplements and herbal products have documented interactions with Raloxifene in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 1
- Moderate · 8
- Minor · 9
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Raloxifene: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Raloxifene — the kind of thing our pharmacy team would talk through with you at the counter.
What is raloxifene for?
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How do I take it?
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What side effects should I expect?
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What warning signs should I never ignore?
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Do I need to stop it before surgery or a long trip?
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Can I take it with my other medicines?
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Is Raloxifene available over the counter?
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When was Raloxifene first available?
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Who makes Raloxifene?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Raloxifene on HelloPharmacist
Raloxifene forms and strengths (how it comes)
Raloxifene is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Raloxifene inactive ingredients by manufacturer.
Tablet
How this form is used
- Evista and raloxifene hydrochloride tablets treat and prevent osteoporosis in postmenopausal women.
- Evista and raloxifene hydrochloride tablets lower the risk of invasive breast cancer in postmenopausal women with osteoporosis or at high risk of invasive breast cancer.
- Evista and raloxifene hydrochloride tablets are taken by mouth once daily, any time of day, with or without food.
- For breast cancer risk reduction, the best length of treatment with Evista and raloxifene hydrochloride tablets is not known.
Raloxifene on the U.S. market: products, makers and brands
How Raloxifene appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
18 companies list 23 Raloxifene product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 1997. Brand names on the directory include Evista; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (13) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Raloxifene is used (Medicaid data)
A general measure of how commonly Raloxifene is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Raloxifene is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Raloxifene prescribed? Of the 1,601 medications we measure, Raloxifene ranks #795 by Medicaid prescriptions — more than 50% of them.
Utilization by Raloxifene product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
raloxifene hydrochloride 60 MG Oral Tablet
Summed across the 18 of 87 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1490065
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Raloxifene, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 18 of 87 listed Raloxifene NDCs with Medicaid activity.
Compare Raloxifene products
A representative set of FDA-listed product records for Raloxifene — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Tablet | ||||
| 60 mg | Oral | A-S Medication Solutions × 2 listings | ANDA | View NDC → |
| 60 mg | Oral | American Health Packaging | ANDA | View NDC → |
| 60 mg | Oral | Amneal Pharmaceuticals LLC | ANDA | View NDC → |
| 60 mg | Oral | Aphena Pharma Solutions - Tennessee, LLC × 2 listings | ANDA | View NDC → |
| 60 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 60 mg | Oral | AvPAK | ANDA | View NDC → |
| 60 mg | Oral | Bryant Ranch Prepack × 4 listings | ANDA | View NDC → |
| 60 mg | Oral | Cadila Pharmaceuticals Limited | ANDA | View NDC → |
| 60 mg | Oral | Cipla USA Inc. | ANDA | View NDC → |
| 60 mg | Oral | Dr.Reddys Laboratories Inc | ANDA | View NDC → |
| 60 mg | Oral | Eli Lilly and Company | NDA | View NDC → |
| 60 mg | Oral | Exelan Pharmaceuticals, Inc. | ANDA | View NDC → |
| 60 mg | Oral | Glenmark Pharmaceuticals Inc., USA | ANDA | View NDC → |
| 60 mg | Oral | Major Pharmaceuticals | ANDA | View NDC → |
| 60 mg | Oral | Modavar Pharmaceuticals LLC | ANDA | View NDC → |
| 60 mg | Oral | NorthStar Rx LLC | ANDA | View NDC → |
| 60 mg | Oral | ScieGen Pharmaceuticals Inc | ANDA | View NDC → |
| 60 mg | Oral | Teva Pharmaceuticals USA, Inc. | ANDA | View NDC → |
Showing 23 of 23 products — FDA National Drug Code Directory. See every product, package size and price: browse all 23 Raloxifene NDCs →
Raloxifene side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Raloxifene — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Raloxifene in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Raloxifene FDA approval history
How Raloxifene went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Raloxifene recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Raloxifene recalls since July 2021.
✅No Raloxifene recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 72143 1 dose form · 1 strength
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Dose form (SCDF) Oral Tablet RxCUI 373747In current FDA listingsClinical drug / strength (SCD) hydrochloride 60 MGRxCUI 1490065
Look up RxCUI 72143 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Raloxifene supply and shortage status
Whether Raloxifene is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
💵 What Raloxifene costs pharmacies (NADAC benchmark)
The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.
| Form | Strength | Pharmacy acquisition benchmark | |
|---|---|---|---|
| Tablet, Film Coated · Oral | 60 mg | $0.223 per tablet | NDC details & price history |
| Tablet · Oral | 60 mg | $6.34 per tablet | NDC details & price history |
| Tablet, Film Coated | 60 mg | $0.223 per tablet | NDC details & price history |
Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.
Raloxifene brand names
Raloxifene is sold under one brand name in the FDA directory — Evista. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Raloxifene: manufacturers and labelers
18 companies list Raloxifene products with the FDA. By number of product records, the largest are Bryant Ranch Prepack, A-S Medication Solutions, Aphena Pharma Solutions - Tennessee, LLC. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Raloxifene drug class (RxNorm)
Raloxifene belongs to the Estrogen Agonist/Antagonist class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Raloxifene page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. American Health Packaging is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →