raloxifene
Brand names: Evista
Raloxifene (Evista) is a medicine that can help treat and prevent bone loss (osteoporosis) in women after menopause. It can also lower the chance of getting a certain type of breast cancer.
Drug Pricing (NADAC)
Brand Price
$6.32/unit
Generic Price
$0.24/unit
Generic Savings
96%
Generic Available
Yes (7 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
This medicine is used to treat and prevent osteoporosis in women after menopause.
Common side effects
Hot flashes, Leg cramps, Swelling in your legs or feet
Key warnings
Raloxifene can increase your risk of blood clots in your veins (deep vein thrombosis) and lungs (pulmonary embolism).
How It Works
Raloxifene belongs to a class of drugs called Selective Estrogen Receptor Modulators (SERMs). It works like estrogen in some parts of the body, such as bones, which helps to prevent bone loss. But it blocks estrogen's effects in other parts of the body, like the breast, which can help prevent certain types of breast cancer.
How to Take It
Take one 60 mg tablet once a day. You can take it at any time of day. You can take it with or without food. Keep taking it for as long as your doctor tells you to.
Pregnancy & Breastfeeding
You should not take this medicine if you are pregnant or could become pregnant. It may harm your unborn baby. Do not use this medicine if you are breastfeeding.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take your next dose at the regular time.
Storage
Store at room temperature, between 68° to 77°F.
Side Effects (from patient reports)
Based on 1,042 FDA adverse event reports.
FDA Adverse Event Report Analysis
Detailed analysis of 2,311 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.
Total Reports
2,311
Death-Related Reports
155
Hospitalization Reports
632
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | FATIGUE | 143 |
| 2 | ARTHRALGIA | 109 |
| 3 | DIARRHOEA | 109 |
| 4 | FALL | 107 |
| 5 | NAUSEA | 106 |
| 6 | DRUG INEFFECTIVE | 102 |
| 7 | HEADACHE | 97 |
| 8 | OFF LABEL USE | 96 |
| 9 | DIZZINESS | 88 |
| 10 | PAIN | 85 |
| 11 | DYSPNOEA | 82 |
| 12 | BACK PAIN | 80 |
| 13 | PRURITUS | 76 |
| 14 | PAIN IN EXTREMITY | 73 |
| 15 | ASTHENIA | 69 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Raloxifene can increase your risk of blood clots in your veins (deep vein thrombosis) and lungs (pulmonary embolism). If you have had blood clots in the past, you should not take this medicine. Raloxifene can also increase the risk of death from stroke in women who have heart disease or are at risk for heart problems. Talk to your doctor about the risks and benefits of taking raloxifene if you are at risk for stroke.
Known Drug Interactions
Highly protein-bound drugs include diazepam, diazoxide, and lidocaine. 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.
Mechanism: Both of these drugs like to attach to the same proteins in your blood. Because they compete for the same spots, one drug might get pushed off, leading to higher levels of active medicine in your system.
What to do: Use this combination with caution. Your doctor should monitor you closely for any increased side effects from either medication.
Highly protein-bound drugs include diazepam, diazoxide, and lidocaine. 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.
Mechanism: These drugs compete for the same binding spots on proteins in your bloodstream. This competition can change how much of each drug is active in your body at one time.
What to do: Use this combination with caution. Your healthcare provider may need to monitor your response to these medications more frequently.
7 DRUG INTERACTIONS Cholestyramine : Use with raloxifene hydrochloride is not recommended. (7.3 , 12.3) 7.1 Cholestyramine Concomitant administration of cholestyramine with raloxifene hydrochloride is not recommended.
Mechanism: Cholestyramine can stick to other medicines in your digestive tract and prevent them from being absorbed into your body. This makes the other medicine, like raloxifene, much less effective.
What to do: You should not take these two medications together. Ask your doctor if there is a different treatment option or a specific way to time your doses.
7.5 Other Concomitant Medications Raloxifene hydrochloride can be concomitantly administered with ampicillin, amoxicillin, antacids, corticosteroids, and digoxin [see Clinical Pharmacology (12.3) ] .
Mechanism: These two drugs do not have a known interaction and can be used at the same time without interfering with each other.
What to do: You can continue taking both medications together as directed by your healthcare provider.
(7.1 , 12.3) Warfarin : Monitor prothrombin time when starting or stopping raloxifene hydrochloride. 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) ] .
Mechanism: Raloxifene can affect how warfarin thins your blood, which might change your risk of bleeding or blood clots.
What to do: Your doctor should monitor your blood clotting tests more closely when you start or stop taking raloxifene.
Common Questions
Can men take raloxifene?
Will raloxifene get rid of my risk of breast cancer completely?
How long will I need to take raloxifene?
Can I take estrogen with raloxifene?
What should I do before starting raloxifene?
Does raloxifene have other benefits besides bone and breast health?
What if I need surgery?
Will raloxifene stop my hot flashes completely?
Do I need to take calcium and vitamin D with raloxifene?
What if I am over 70?
What are the common side effects of raloxifene?
Does raloxifene interact with other medications?
What drug class is raloxifene?
Is there a generic version of raloxifene?
Is raloxifene safe during pregnancy?
Related Medications in Selective Estrogen Receptor Modulator (SERM)
Other drugs grouped near raloxifene — same-class peers and common alternatives.
abiraterone
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anastrozole
Arimidex
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bazedoxifene/conjugated estrogens
Duavee
Duavee is a combination medicine containing estrogen and a drug that blocks estrogen in some parts of the body.
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cabergoline
Dostinex
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clomiphene
Clomid, Serophene
Clomiphene citrate is a medicine that helps women ovulate.
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What the FDA Data Shows for raloxifene
The FDA label for raloxifene (sold under brand names such as Evista) classifies it as a prescription-only medication in the Selective Estrogen Receptor Modulator (SERM) class. This medicine is used to treat and prevent osteoporosis in women after menopause. Official labeling lists 6 commonly reported side effects, including Hot flashes, Leg cramps, Swelling in your legs or feet.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 1,042 voluntary reports. The database also lists 7 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. NADAC pricing from CMS shows a generic unit cost of $0.24 versus $6.32 for the brand — a 96% generic savings.
Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: February 17, 2024
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- FDA Orange Book — approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed — NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) — post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm — standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files — federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database — current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages