FEBUXOSTAT - febuxostat tablet 
Aurobindo Pharma Limited

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MEDICATION GUIDE

Febuxostat Tablets, for oral use

(fe bux’ oh stat)

Read the Medication Guide that comes with febuxostat tablets before you start taking them and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or your treatment.

What is the most important information that I should know about febuxostat tablets?

Febuxostat tablets may cause serious side effects, including:

Heart-related deaths.

Call your doctor or get emergency medical help right away if you have any of the following symptoms, especially if they are new, worse, or worry you:

What are febuxostat tablets?


Febuxostat tablets are a prescription medicine called a xanthine oxidase (XO) inhibitor used to lower blood uric acid levels in adult patients with gout when allopurinol has not worked well enough or when allopurinol is not right for you.


Febuxostat tablets is not for use in people who do not have symptoms of high blood uric acid levels.


It is not known if febuxostat tablets are safe and effective in children.

Who should not take febuxostat tablets?

Do not take febuxostat tablets if you:
 

What should I tell my doctor before taking febuxostat tablets?


Before taking febuxostat tablets tell your doctor about all of your medical conditions, including if you:


Tell your doctor about all the medicines you take, including prescription and over-the­-counter medicines, vitamins, and herbal supplements. Febuxostat tablets may affect the way other medicines work, and other medicines may affect how febuxostat tablets work.


Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.


How should I take febuxostat tablets? 

Your doctor may do certain tests while you take febuxostat tablets.


What are the possible side effects of febuxostat tablets?


Febuxostat tablets may cause serious side effects, including:

The most common side effects of febuxostat tablets include:

These are not all of the possible side effects of febuxostat tablets.


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

How should I store febuxostat tablets? 

Keep febuxostat tablets and all medicines out of the reach of children.

General information about the safe and effective use of febuxostat tablets.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use febuxostat tablets for a condition for which it was not prescribed. Do not give febuxostat tablets to other people, even if they have the same symptoms that you have. It may harm them.


You can ask your doctor or pharmacist for information about febuxostat tablets that is written for health professionals.


What are the ingredients in febuxostat tablets?


Active ingredient: febuxostat


Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, iron oxide yellow, lactose monohydrate, macrogol, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, talc and titanium dioxide.

Distributed by:
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520

Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 032, India

The brands listed are trademarks of their respective owners and are not trademarks of Aurobindo Pharma Limited.

For more information, call Aurobindo Pharma USA, Inc. at 1-866-850-2876.

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

Issued: April 2023

Revised: 5/2024
Aurobindo Pharma Limited