ARIPIPRAZOLE - aripiprazole tablet 
Aurobindo Pharma Limited

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MEDICATION GUIDE


Aripiprazole Tablets USP

 (ar'' i pip' ra zole)

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


(For other side effects, also see What are the possible side effects of aripiprazole tablets?”).


Serious side effects may happen when you take aripiprazole tablets, including: 


1. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.

2. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) suicidal thoughts or actions. 

3. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member? 

 Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:

What else do I need to know about antidepressant medicines? 

What are aripiprazole tablets? 

It is not known if aripiprazole tablets are safe or effective in children:

Do not take aripiprazole tablets if you are allergic to aripiprazole or any of the ingredients in aripiprazole tablets. See the end of this Medication Guide for a complete list of ingredients in aripiprazole tablets.


Before taking aripiprazole tablets, tell your healthcare provider about all your medical conditions, including if you have or had: 

Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.


Aripiprazole tablets and other medicines may affect each other causing possible serious side effects. Aripiprazole tablets may affect the way other medicines work, and other medicines may affect how aripiprazole tablets work.


Your healthcare provider can tell you if it is safe to take aripiprazole tablets with your other medicines. Do not start or stop any medicines while taking aripiprazole tablets without talking to your healthcare provider first. Know the medicines you take. Keep a list of your medicines to show your healthcare provider and pharmacist when you get a new medicine.


How should I take aripiprazole tablets? 

What should I avoid while taking aripiprazole tablets?

What are the possible side effects of aripiprazole tablets?


Aripiprazole tablets may cause serious side effects, including: 

        Call your healthcare provider if you have any of these symptoms of high blood sugar while receiving aripiprazole tablets:

                    •    feel very thirsty

                    •    need to urinate more than usual

                    •    feel very hungry

                    •    feel weak or tired

                    •    feel sick to your stomach

                    •    feel confused, or your breath smells fruity

        •    Increased fat levels (cholesterol and triglycerides) in your blood.

        •    Weight gain. You and your healthcare provider should check your weight regularly.

The most common side effects of aripiprazole tablets in adults include:



The most common side effects of aripiprazole tablets in children include: 


These are not all the possible side effects of aripiprazole 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 aripiprazole tablets?


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


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

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use aripiprazole tablets for a condition for which it was not prescribed. Do not give aripiprazole tablets to other people, even if they have the same symptoms you have. They may harm them. You can ask your healthcare provider or pharmacist for information about aripiprazole tablets that was written for healthcare professionals.


What are the ingredients in aripiprazole tablets?


Active ingredient: aripiprazole

Inactive ingredients: colloidal silicon dioxide, corn starch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. In addition the 2 mg strength contains FD&C Blue No. 2 and ferric oxide (sicovit yellow 10) and 5 mg contains FD&C Blue No. 2.

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

Additional pediatric use information is approved for Otsuka America Pharmaceutical, Inc.’s ABILIFY® (aripiprazole) product. However, due to Otsuka America Pharmaceutical, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.

ABILIFY is a trademark of Otsuka Pharmaceutical Company.

Dispense with Medication Guide available at: www.aurobindousa.com/product-medication-guides


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

Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 038, India
 

Revised: 02/2020

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


Revised: 5/2021
Aurobindo Pharma Limited