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raloxifene

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Brand names: Evista

Selective Estrogen Receptor Modulator (SERM) Rx

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.

Feeling tired
143
Joint pain
109
Diarrhea
109
Falling down
107
Feeling sick to your stomach
106
Medicine not working
102
Headache
97
Using the medicine for something it's not approved for
96
Feeling dizzy
88
Pain
85

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

Female 2,091 (98%)
Male 34 (2%)

Age Distribution

0–17 8
18–44 21
45–64 338
65–74 540
75+ 500

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

DEATH 69
CARDIO-RESPIRATORY ARREST 9
DYSPNOEA 9
PNEUMONIA 9
DIARRHOEA 8
ASTHENIA 7
COMPLETED SUICIDE 7
FATIGUE 7
ATRIAL FIBRILLATION 6
NAUSEA 6

Reactions in Hospitalization Reports

FALL 44
PNEUMONIA 39
DIARRHOEA 32
DYSPNOEA 29
NAUSEA 27
PULMONARY EMBOLISM 25
FATIGUE 23
DIZZINESS 22
URINARY TRACT INFECTION 22
ASTHENIA 21

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

moderate diazepam

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.

moderate diazoxide

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.

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Common Questions

Can men take raloxifene?
No, raloxifene is only for use in women after menopause.
Will raloxifene get rid of my risk of breast cancer completely?
No, raloxifene does not eliminate the risk of breast cancer. You should still get regular breast exams and mammograms.
How long will I need to take raloxifene?
The best length of treatment is not known. Talk to your doctor about how long you should take it.
Can I take estrogen with raloxifene?
No, it is not recommended to take raloxifene with estrogen.
What should I do before starting raloxifene?
You should have a breast exam and mammogram before starting raloxifene.
Does raloxifene have other benefits besides bone and breast health?
Raloxifene is not meant to prevent heart disease.
What if I need surgery?
Stop taking raloxifene at least 72 hours (3 days) before any surgery or if you will be immobile for a long time. You can start taking it again once you are fully active.
Will raloxifene stop my hot flashes completely?
Raloxifene can cause hot flashes, especially in the first 6 months of treatment.
Do I need to take calcium and vitamin D with raloxifene?
You may need to take extra calcium and vitamin D if you don't get enough in your diet. Most women after menopause need 1500 mg of calcium and 400-800 IU of vitamin D daily.
What if I am over 70?
If you are over 70, you may need more Vitamin D.
What are the common side effects of raloxifene?
The most commonly reported side effects of raloxifene include Hot flashes, Leg cramps, Swelling in your legs or feet, Flu-like symptoms, Joint pain. Based on 1,042 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
Does raloxifene interact with other medications?
Yes, raloxifene has 7 known drug interactions. Notable interactions include diazepam, diazoxide, cholestyramine. Always inform your doctor about all medications you are taking.
What drug class is raloxifene?
raloxifene belongs to the Selective Estrogen Receptor Modulator (SERM) drug class. It requires a prescription (Rx). This medicine is used to treat and prevent osteoporosis in women after menopause.
Is there a generic version of raloxifene?
Yes, generic raloxifene is available from 7 manufacturers. The generic costs $0.24 per unit compared to $6.32 for the brand version, saving approximately 96%. Pricing is based on NADAC (National Average Drug Acquisition Cost) data from CMS.
Is raloxifene safe during pregnancy?
You should not take this medicine if you are pregnant or could become pregnant. It may harm your unborn baby. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.

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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

All federal data sources used on this page