Prescription medication · Selective Estrogen Receptor Modulator (SERM)
raloxifene
Also sold as Evista. This medicine is used to treat and prevent osteoporosis in women after menopause.
Data updated 2026-05-15
- 2,311
- FDA reportsLightly reported
- 7
- InteractionsFew interactions
- 96% less
- Generic vs brandHuge savings
- $6.32
- Brand price (NADAC)
What the data shows
raloxifene (Evista) is a prescription Selective Estrogen Receptor Modulator (SERM), among the least-reported drugs the FDA tracks (2,311 FDA reports), whose generic costs a fraction of the brand (about 96% less).
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
raloxifene (Evista) is a prescription Selective Estrogen Receptor Modulator (SERM). This medicine is used to treat and prevent osteoporosis in women after menopause.
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.
Verify with FDA → · CMS NADAC pricing →
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).
The sections below are summarized in plain English from raloxifene's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
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.
Side Effects (from patient reports)
Based on 2,311 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for raloxifene, by number of reports
- Fatigue
Fatigue
143 reports
- Arthralgia
Arthralgia
109 reports
- Diarrhoea
Diarrhoea
109 reports
- Fall
Fall
107 reports
- Nausea
Nausea
106 reports
- Headache
Headache
97 reports
- Dizziness
Dizziness
88 reports
- Pain
Pain
85 reports
- Dyspnoea
Dyspnoea
82 reports
- Back Pain
Back Pain
80 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for raloxifene each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where raloxifene sits
raloxifene has more FDA adverse-event reports than 15% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is raloxifene; the line is the median (50th percentile).
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
Reports Mentioning Death
155
6.7% of reports — not proof of cause
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 |
| 7 | HEADACHE | 97 |
| 9 | DIZZINESS | 88 |
| 10 | PAIN | 85 |
| 11 | DYSPNOEA | 82 |
| 12 | BACK PAIN | 80 |
| 13 | PRURITUS | 76 |
| 14 | PAIN IN EXTREMITY | 73 |
| 15 | ASTHENIA | 69 |
| 16 | DEATH | 69 |
| 17 | RASH | 65 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: 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.
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.
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.
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.
(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.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
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?
What pregnancy or breastfeeding source fields are listed for raloxifene?
Related Medications in Selective Estrogen Receptor Modulator (SERM)
Other drugs grouped near raloxifene - same-class peers and common alternatives.
abiraterone
Zytiga
Abiraterone (Zytiga) is a medicine used with prednisone to treat prostate cancer that has spread.
Compare with raloxifene →
anastrozole
Arimidex
Anastrozole is a medicine used to treat breast cancer in women after menopause.
Compare with raloxifene →
bazedoxifene/conjugated estrogens
Duavee
Duavee is a combination medicine containing estrogen and a drug that blocks estrogen in some parts of the body.
Compare with raloxifene →
cabergoline
Dostinex
Cabergoline is a medicine that helps lower the amount of prolactin in your body.
Compare with raloxifene →
clomiphene
Clomid, Serophene
Clomiphene citrate is a medicine that helps women ovulate.
Compare with raloxifene →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for raloxifene: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 2,311.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 6.71%.
- oxcarbazepine Δ 0.02 pts · 31,347 reports · Anticonvulsant 6.73%death share
- ibuprofen Δ 0.04 pts · 262,453 reports · Nonsteroidal Anti-Inflammatory Drug (NSAID) 6.66%death share
- cefixime Δ 0.05 pts · 2,824 reports · Third-Generation Cephalosporin 6.66%death share
- ziprasidone Δ 0.05 pts · 17,328 reports · Atypical Antipsychotic 6.76%death share
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
Save on raloxifene
Compare prices and find discounts at pharmacies near you. Free coupons can save up to 80% on prescriptions.
Disclosure: This link may earn us a commission at no extra cost to you. See our terms.
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 2,311 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 are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
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. This registry does not provide medication decisions.
Last updated: February 17, 2024
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
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