EVISTA- raloxifene hydrochloride tablet 
Eli Lilly and Company

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Medication Guide

EVISTA® (Ē-VISS-tah)

(raloxifene hydrochloride tablets)
Tablets for Oral Use

Read the Medication Guide that comes with EVISTA 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 EVISTA when you start taking it and at regular checkups.

What is the most important information I should know about EVISTA?

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

  1. Before starting EVISTA, 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 EVISTA 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.
  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 EVISTA?)

What is EVISTA?

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

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

Who should not take EVISTA?

Do not take EVISTA if you:

What should I tell my doctor before taking EVISTA?

EVISTA may not be right for you. Before taking EVISTA, 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*:

EVISTA should not be taken with cholestyramine or estrogens.

How should I take EVISTA?

What should I avoid while taking EVISTA?

What are the possible side effects of EVISTA?

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

See What is the most important information I should know about EVISTA?

The most common side effects of EVISTA 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 EVISTA. Tell your doctor about any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What else should I know about EVISTA?

How should I store EVISTA?

General Information about the safe and effective use of EVISTA

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use EVISTA for a condition for which it was not prescribed. Do not give your EVISTA 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 EVISTA. If you would like more information about EVISTA, talk with your doctor. You can ask your doctor or pharmacist for information about EVISTA that is written for health professionals. For more information, call 1-800-545-5979 (toll-free).

What are the ingredients in EVISTA?

Active Ingredient: raloxifene hydrochloride

Inactive Ingredients: anhydrous lactose, carnauba wax, crospovidone, FD&C Blue No. 2 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, modified pharmaceutical glaze, polyethylene glycol, polysorbate 80, povidone, propylene glycol, and titanium dioxide.

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

*The brands listed are trademarks of their respective owners and are not trademarks of Eli Lilly and Company. The makers of these brands are not affiliated with and do not endorse Eli Lilly and Company or its products.

Medication Guide revised August 1, 2014

Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, USA

Copyright © 1997, 2014, Eli Lilly and Company. All rights reserved.

EVS-0001-MG-20140801

Revised: 1/2020
Eli Lilly and Company