ARIPIPRAZOLE- aripiprazole tablet
Accord Healthcare, Inc.

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MEDICATION GUIDE

Aripiprazole Tablets
(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) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions.
  3. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?
    • Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.
    • Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
    • Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.

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?

Aripiprazole tablets are prescription medicines used to treat:

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

Do not take aripiprazole tablets if you are allergic to aripiprazole or any 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 works.

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


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

• nausea • dizziness
• vomiting • anxiety
• constipation • insomnia
• headache • restlessness
• blurred vision • inner sense of restlessness/need to move (akathisia)
• upper respiratory illness

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

• feeling sleepy • insomnia
• headache • nausea
• vomiting • stuffy nose
• fatigue • weight gain
• increased or decreased appetite • uncontrolled movement such as restlessness, tremor
• increased saliva or drooling • muscle stiffness

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 for a condition for which it was not prescribed. Do not give aripiprazole to other people, even if they have the same symptoms you have. It 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: hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, maize starch and microcrystalline cellulose. Colorants include ferric oxide red (10 mg and 30 mg), ferric oxide yellow (2 mg and 15 mg), and FD&C Blue No. 2 aluminum lake (2 mg and 5 mg).

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.

For more information about aripiprazole tablets, visit www.accordhealthcare.us or call Accord Healthcare Inc. at 1-866-941-7875.

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

ABILIFY ® is a trademark of Otsuka Pharmaceutical Company.

Manufactured For:
Accord Healthcare, Inc.,
1009, Slater Road,
Suite 210-B,
Durham, NC 27703,
USA

Manufactured By:
Intas Pharmaceuticals Limited.
Plot No. 5 to 12, Pharmez,
Sarkhej-Bavla, National Highway No 8-A,
Near Village Matoda, Tal Sanand,
Ahmedabad - 382213, Gujarat, India

51 1878 0 712890

Issued March 2017

Revised: 10/2019
Accord Healthcare, Inc.