Prescription medicine
Raloxifene Brand names: Evista
Raloxifene (Evista) is a prescription medicine with an FDA approval on record since 1997. FDA's NDC Directory lists it from 17 generic labelers, and pharmacies paid $0.223 per raloxifene HCl 60 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the raloxifene FDA label on DailyMed (effective April 14, 2026, Amneal Pharmaceuticals LLC); the NDA 20815 record on Drugs@FDA; every raloxifene label on DailyMed.
Highlights of the record
FDA label of April 14, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
INCREASED RISK OF VENOUS THROMBOEMBOLISM AND DEATH FROM STROKE.
Increased risk of deep vein thrombosis and pulmonary embolism have been reported with raloxifene hydrochloride [see Warnings and Precautions (5.1) ]. Women with active or past history of venous thromboembolism should not take raloxifene hydrochloride [see Contraindications (4.1) ]. Increased risk of death due to stroke occurred in a trial in postmenopausal women with documented coronary heart disease or at increased risk for major coronary events. Consider risk-benefit balance in women at risk for stroke [see Warnings and Precautions (5.2) and Clinical Studies (14.5) ]. WARNING: INCREASED RISK OF VENOUS THROMBOEMBOLISM AND DEATH FROM STROKE See full prescribing information for complete boxed warning. Increased risk of deep vein thrombosis and pulmonary embolism has been reported with raloxifene hydrochloride (5.1). Women with active or past history of venous thromboembolism should not take raloxifene hydrochloride (4.1). Increased risk of death due to stroke occurred in a trial in postmenopausal women with documented coronary heart disease or at increased risk for major coronary events. Consider risk-benefit balance in women at risk for stroke (5.2, 14.5).
Used for
From the label: indications and usageRaloxifene hydrochloride tablets are an estrogen agonist/antagonist indicated for: Treatment and prevention of osteoporosis in postmenopausal women.
Forms and strengths
- 60 mg
Film-coated tablet; coated tablet; tablet.
On the market
- Earliest approval on file
- December 9, 1997 Evista, Lilly; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 8 first March 4, 2014; 8 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 18 of which 17 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.223 per tablet Raloxifene HCl 60 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2013 0 Class I among all firms' recalls; latest December 4, 2019; 1 more by firms not listed as its makers
- FAERS reports
- 16,046 through July 30, 2026
What is raloxifene used for?
From the label: indications and usageRaloxifene hydrochloride tablets are an estrogen agonist/antagonist indicated for: Treatment and prevention of osteoporosis in postmenopausal women. (1.1) Reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis. (1.2) Reduction in risk of invasive breast cancer in postmenopausal women at high risk for invasive breast cancer. (1.3) Important Limitations: Raloxifene hydrochloride tablets are not indicated for the treatment of invasive breast cancer, reduction of the risk of recurrence of breast cancer, or reduction of risk of noninvasive breast cancer. […]
Conditions named in the indications of raloxifene's FDA labels, with every medicine labeled for each:
From other raloxifene labelsBreast cancer: Risk of Invasive Breast Cancer in Postmenopausal Women with Osteoporosis Raloxifene hydrochloride tablets are indicated for the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis [see Clinical Studies …
FDA pharmacologic class: Estrogen Agonist/Antagonist.
Source: FDA drug label (Raloxifene Hydrochloride), Amneal Pharmaceuticals LLC, effective April 14, 2026 (SPL set 3798c70b-a4b0-4811-9788-e4c9cff47ebe), via openFDA; the full label on DailyMed
What does the patient leaflet for raloxifene say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about raloxifene hydrochloride?Serious and life-threatening side effects can occur while taking raloxifene hydrochloride. These include blood clots and dying from stroke: Increased risk of blood clots in the legs (deep vein thrombosis) and lungs (pulmonary embolism) have been reported with raloxifene hydrochloride. Women who have or have had blood clots in the legs, lungs, or eyes should not take raloxifene hydrochloride. Women who have had a heart attack or are at risk for a heart attack may have an increased risk of dying from stroke when taking raloxifene hydrochloride. Before starting raloxifene hydrochloride, tell your doctor if you have had blood clots in your legs, lungs, or eyes, a stroke, mini-stroke (transient ischemic attack), or have an irregular heartbeat. Stop taking raloxifene hydrochloride and call your doctor if you have: leg pain or a feeling of warmth in the lower leg (calf). swelling of the legs, hands, or feet. sudden chest pain, shortness of breath, or coughing up blood. sudden change in your vision, such as loss of vision or blurred vision. Being still for a long time (such as sitting still during a long car or airplane trip or being in bed after surgery) can increase your risk of blood clots. (See “What should I avoid if I am taking raloxifene hydrochloride?” )
From the patient leaflet: What should I avoid while taking raloxifene hydrochloride?Being still for a long time (such as during long trips or being in bed after surgery) can increase the risk of blood clots. Raloxifene hydrochloride may add to this risk. If you will need to be still for a long time, talk with your doctor about ways to reduce the risk of blood clots. On long trips, move around periodically. Stop taking raloxifene hydrochloride at least 3 days before a planned surgery or before you plan on being still for a long time. You should start taking raloxifene hydrochloride again when you return to your normal activities. Some medicines should not be taken with raloxifene hydrochloride (see “What should I tell my doctor before taking raloxifene hydrochloride?” ).
From the patient leaflet: How should I store raloxifene hydrochloride tablets?Store raloxifene hydrochloride tablets at 68°F to 77°F (20°C to 25°C). Keep raloxifene hydrochloride and all medicines out of the reach of children. General Information about the safe and effective use of raloxifene hydrochloride Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use raloxifene hydrochloride for a condition for which it was not prescribed. Do not give your raloxifene hydrochloride to other people, even if they have the same symptoms you have. It may harm them. This Medication Guide is a summary of the most important information about raloxifene hydrochloride. If you would like more information about raloxifene hydrochloride, talk with your doctor. You can ask your doctor or pharmacist for information about raloxifene hydrochloride that is written for health professionals. […]
Source: FDA drug label (Raloxifene Hydrochloride), Amneal Pharmaceuticals LLC, effective April 14, 2026 (SPL set 3798c70b-a4b0-4811-9788-e4c9cff47ebe), via openFDA; the full label on DailyMed
Is there a generic for raloxifene (Evista)?
The FDA approved the first generic raloxifene on March 4, 2014. 8 generic applications are approved; 8 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists raloxifene from 17 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1997 earliest approval on file
- 2014 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for raloxifene (Evista)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.223 per Raloxifene HCl 60 mg tablet, down 11% from $0.250 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Raloxifene HCl 60 mg tablet (generic)
- Evista 60 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Raloxifene HCl 60 mg tablet | Generic | $0.223 per tablet | $6.70 | -11% |
| Evista 60 mg tablet | Brand | $6.34 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $190.29 | +0.1% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has raloxifene been recalled?
The FDA's Enforcement Report lists 2 recalls naming raloxifene since 2013: 0 Class I (the most serious), 2 Class II, 0 Class III; 0 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of raloxifene and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| December 4, 2019 | Class II | American Health Packaging | Failed Dissolution Specifications: Low out of specification results obtained during stability testing. |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup: RALOXIFENE HCL, Tablet, 60 mg may be potentially mis-labeled as following drug: ISOSORBIDE MONONITRATE, Tablet, 20 mg, NDC 62175010701; … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the raloxifene label say about other medicines?
The raloxifene label names 8 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name raloxifene. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Amoxicillin | drug interactions | Raloxifene hydrochloride can be concomitantly administered with ampicillin, amoxicillin, antacids, corticosteroids, and digoxin [see Clinical Pharmacology (12.3) ]. |
| Ampicillin | drug interactions | Raloxifene hydrochloride can be concomitantly administered with ampicillin, amoxicillin, antacids, corticosteroids, and digoxin [see Clinical Pharmacology (12.3) ]. |
| Cholestyramine | drug interactions | DRUG INTERACTIONS Cholestyramine: Use with raloxifene hydrochloride is not recommended. |
| Diazepam | drug interactions | Raloxifene hydrochloride should be used with caution with certain other highly protein-bound drugs such as diazepam, diazoxide, and lidocaine. |
| Diazoxide | drug interactions | Raloxifene hydrochloride should be used with caution with certain other highly protein-bound drugs such as diazepam, diazoxide, and lidocaine. |
| Digoxin | drug interactions | Raloxifene hydrochloride can be concomitantly administered with ampicillin, amoxicillin, antacids, corticosteroids, and digoxin [see Clinical Pharmacology (12.3) ]. |
| Lidocaine | drug interactions | Raloxifene hydrochloride should be used with caution with certain other highly protein-bound drugs such as diazepam, diazoxide, and lidocaine. |
| Warfarin | drug interactions | Reduces the absorption and enterohepatic cycling of raloxifene. (7.1, 12.3) Warfarin: Monitor prothrombin time when starting or stopping raloxifene hydrochloride. |
Other labels that name raloxifene
Source: FDA drug label (Raloxifene Hydrochloride), Amneal Pharmaceuticals LLC, effective April 14, 2026 (SPL set 3798c70b-a4b0-4811-9788-e4c9cff47ebe), via openFDA; the full label on DailyMed
What do FAERS reports show for raloxifene?
The FDA Adverse Event Reporting System holds 16,046 reports that list raloxifene among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 649 are coded as a death and 3,825 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as raloxifene?
7 other medicines are given the same way (oral) and in the same FDA class as raloxifene or labeled mainly for the same use (osteoporosis), the same class first. Osteoporosis lists all 16 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Tamoxifen | Breast cancer | 10 labelers | $0.277 per tablet 20 mg tablet | No current entry |
| Toremifene | Breast cancer | 2 labelers | $19.60 per tablet 60 mg tablet | No current entry |
| Bazedoxifene and estrogens conjugated | Osteoporosis | none listed | $6.48 per tablet 0.45-20 mg tablet | No current entry |
| Alendronate | Osteoporosis | 16 labelers | $0.256 per tablet 70 mg tablet | No current entry |
| Risedronate | Osteoporosis | 8 labelers | $12.91 per tablet 150 mg tablet | No current entry |
| Ibandronate | Osteoporosis | 6 labelers | $2.68 per tablet 150 mg tablet | No current entry |
| Alendronate and cholecalciferol | Osteoporosis | none listed | $52.51 per unit 70 mg-5600 unit | No current entry |
Every medicine labeled for the same conditions as raloxifene
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does raloxifene compare with medicines for the same use?
3 side-by-side pages set raloxifene beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to raloxifene
- 7 medicines for the same use
- Other estrogen agonist/antagonists
- the pharmacologic class, with prices and generics
- Raloxifene side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other