ARIPIPRAZOLE- aripiprazole tablet
Aripiprazole Tablets, USP
What is the most important information I should know about aripiprazole?
(For other side effects, also see “What are the possible side effects of aripiprazole?”).
Serious side effects may happen when you take aripiprazole, including:
Increased risk of death in elderly patients with dementia-related psychosis: Medicines like aripiprazole can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). Aripiprazole is not approved for the treatment of patients with dementia-related psychosis.
Risk of suicidal thoughts or actions: Antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions:
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 is aripiprazole?
It is not known if aripiprazole is safe or effective in children:
Do not take aripiprazole if you are allergic to aripiprazole or any of the ingredients in aripiprazole. See the end of this Medication Guide for a complete list of ingredients in aripiprazole.
Before taking aripiprazole, 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 and other medicines may affect each other causing possible serious side effects. Aripiprazole 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 with your other medicines. Do not start or stop any medicines while taking aripiprazole 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?
What should I avoid while taking aripiprazole?
What are the possible side effects of aripiprazole?
Aripiprazole may cause serious side effects, including:
See “What is the most important information I should know about aripiprazole?”
Stroke in elderly people (cerebrovascular problems) that can lead to death
Neuroleptic malignant syndrome (NMS). Tell your healthcare provider right away if you have some or all of the following symptoms: high fever, stiff muscles, confusion, sweating, changes in pulse, heart rate, and blood pressure. These may be symptoms of a rare and serious condition that can lead to death. Call your healthcare provider right away if you have any of these symptoms.
Uncontrolled body movements (tardive dyskinesia). Aripiprazole may cause movements that you cannot control in your face, tongue, or other body parts. Tardive dyskinesia may not go away, even if you stop receiving aripiprazole. Tardive dyskinesia may also start after you stop receiving aripiprazole.
Problems with your metabolism such as:
High blood sugar (hyperglycemia) and diabetes. Increases in blood sugar can happen in some people who take aripiprazole. Extremely high blood sugar can lead to coma or death. If you have diabetes or risk factors for diabetes (such as being overweight or a family history of diabetes), your healthcare provider should check your blood sugar before you start aripiprazole and during your treatment.
Call your healthcare provider if you have any of these symptoms of high blood sugar while receiving aripiprazole:
If you or your family members notice that you are having unusual urges or behaviors, talk to your healthcare provider.
The most common side effects of aripiprazole in adults include:
The most common side effects of aripiprazole in children include:
These are not all the possible side effects of aripiprazole.
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.
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
croscarmellose sodium, microcrystalline cellulose, magnesium stearate, and tartaric acid. Colorants include Indigotine Aluminum Lake (FD&C Blue no. 2) (for 2 mg and 5 mg), iron oxide red (for 10 mg and 30 mg) and iron oxide yellow (for 2 mg and 15 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.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Call your doctor for medical advice about side effects. You may report side effects to Apotex Corp. at 1-800-706-5575 or to FDA at 1-800-FDA-1088.
All registered trademarks are the property of their respective owners.
ARIPIPRAZOLE TABLETS, USP
2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg
|Manufactured by||Manufactured for|
|Apotex Inc.||Apotex Corp.|
|Toronto, Ontario||Weston, Florida|
|Canada M9L 1T9||USA 33326|
Revised: August 2019