RALOXIFENE HYDROCHLORIDE- raloxifene hydrochloride tablet, film coated 


Medication Guide

Raloxifene (ra-LOX-i-feen) HCl Tablets for Oral Use

Read the Medication Guide that comes with raloxifene HCl before you start taking it and each time you refill your prescription. The information may have changed. This Medication Guide does not take the place of talking with your doctor about your medical condition or treatment. Talk with your doctor about raloxifene HCl when you start taking it and at regular checkups.

What is the most important information I should know about raloxifene HCl?

Serious and life-threatening side effects can occur while taking raloxifene HCl. These include blood clots and dying from stroke:

1. Before starting raloxifene HCl, 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.

2. Stop taking raloxifene HCl and call your doctor if you have:

3. 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 HCl?”)

What is raloxifene HCl?

Raloxifene HCl is a type of prescription medicine called a Selective Estrogen Receptor Modulator (SERM). Raloxifene HCl is for women after menopause, and has more than one use:

• Osteoporosis: Raloxifene HCl treats and prevents osteoporosis by helping make your bones stronger and less likely to break.

• Invasive Breast Cancer: If you have osteoporosis or are at high risk for breast cancer, raloxifene HCl can be used to lower your chance of getting invasive breast cancer. Raloxifene HCl will not totally get rid of your chance of getting breast cancer. Your doctor can estimate your risk of breast cancer by asking you about risk factors, including:

You and your doctor should talk about whether the possible benefit of raloxifene HCl in lowering your chance of getting invasive breast cancer is greater than its possible risks.

Raloxifene HCl is not for use in premenopausal women (women who have not passed menopause).

Who should not take raloxifene HCl?

Do not take raloxifene HCl if you:

What should I tell my doctor before taking raloxifene HCl?

Raloxifene HCl may not be right for you. Before taking raloxifene HCl, tell your doctor about all your medical conditions, including if you:

Tell your doctor about all medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist each time you get a new medicine. Especially tell your doctor if you take*:

If you are taking warfarin or other coumarin blood thinners, your doctor may need to do a blood test when you first start or if you need to stop taking raloxifene HCl. Names for this test include “prothrombin time,” “pro-time,” or “INR.” Your doctor may need to adjust the dose of your warfarin or other coumarin blood thinner.

Raloxifene HCl should not be taken with cholestyramine or estrogens.

How should I take raloxifene HCl?

What should I avoid while taking raloxifene HCl?

What are the possible side effects of raloxifene HCl?

Serious and life-threatening side effects can occur while taking raloxifene HCl. These include blood clots and dying from stroke:

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See “What is the most important information I should know about raloxifene HCl?”

The most common side effects of raloxifene HCl are hot flashes, leg cramps, swelling of the feet, ankles and legs, flu syndrome, joint pain and sweating. Hot flashes are more common during the first 6 months after starting treatment.

These are not all the side effects of raloxifene HCl. Tell your doctor about any side effect that bothers you or that does not go away. If you have any problems or questions that concern you while taking raloxifene HCl, ask your doctor or pharmacist for more information.

What else should I know about raloxifene HCl?

How should I store raloxifene HCl tablets?

General Information about the safe and effective use of raloxifene HCl

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use raloxifene HCl for a condition for which it was not prescribed. Do not give your raloxifene HCl 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 HCl. If you would like more information about raloxifene HCl, talk with your doctor. You can ask your doctor or pharmacist for information about raloxifene HCl that is written for health professionals. For more information, call 1-855-361-3993 (toll free) or go to the following website: www.avkare.com.

What are the ingredients in raloxifene HCl tablets?

Active Ingredient: raloxifene hydrochloride, USP

Inactive Ingredients: anhydrous lactose, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, silicon dioxide and titanium dioxide.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

* Trademarks are the property of their respective owners.

Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478

Mfg. Rev. 05-2016-01
AV 06/18 (P)

Revised: 1/2022