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:
• Increased risk of death in elderly patients with dementia-related psychosis: Medicines like aripiprazole tablets can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). Aripiprazole tablets are 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:
- thoughts about suicide or dying
- attempts to commit suicide
- new or worse depression
- new or worse anxiety
- feeling very agitated or restless
- panic attacks
- trouble sleeping (insomnia)
- new or worse irritability
- acting aggressive, being angry, or violent
- acting on dangerous impulses
- an extreme increase in activity and talking (mania)
- other unusual changes in behavior or mood
What else do I need to know about antidepressant medicines?
- Never stop an antidepressant medicine without first talking to a healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms.
- Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants.
- Antidepressant medicines have other side effects. Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member.
- Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member take. Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider.
- Not all antidepressant medicines prescribed for children are FDA approved for use in children. Talk to your child’s healthcare provider for more information.
What are aripiprazole tablets?
- Aripiprazole tablets are prescription medicine used to treat:
It is not known if aripiprazole tablets are safe or effective in children:
- under 13 years of age with schizophrenia
- under 6 years of age with Tourette’s disorder
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:
- diabetes or high blood sugar in you or your family; your healthcare provider should check your blood sugar before you start aripiprazole tablets and also during therapy.
- seizures (convulsions).
- low or high blood pressure.
- heart problems or stroke.
- pregnancy or plans to become pregnant. It is not known if aripiprazole tablets will harm your unborn baby.
- breast-feeding or plans to breast-feed. Aripiprazole passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you receive aripiprazole tablets.
- low white blood cell count.
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 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?
- Take aripiprazole tablets exactly as your healthcare provider tells you to take it. Do not change the dose or stop taking aripiprazole tablets yourself.
- Aripiprazole tablets can be taken with or without food.
- Aripiprazole tablets should be swallowed whole.
- If you miss a dose of aripiprazole tablets, take the missed dose as soon as you remember. If it is almost time for the next dose, just skip the missed dose and take your next dose at the regular time. Do not take two doses of aripiprazole tablets at the same time.
- If you take too much aripiprazole tablets, call your healthcare provider or poison control center at 1-800-222-1222 right away, or go to the nearest hospital emergency room.
What should I avoid while taking aripiprazole tablets?
- Do not drive, operate heavy machinery, or do other dangerous activities until you know how aripiprazole tablets affects you. Aripiprazole tablets may make you drowsy.
- Avoid getting over-heated or dehydrated.
What are the possible side effects of aripiprazole tablets?
Aripiprazole tablets may cause serious side effects, including:
- See “What is the most important information I should know about aripiprazole tablets?”
- 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 tablets 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 tablets. Tardive dyskinesia may also start after you stop receiving aripiprazole tablets.
- Problems with your metabolism such as:
- Unusual urges. Some people taking aripiprazole tablets have had unusual urges, such as gambling, binge eating or eating that you cannot control (compulsive), compulsive shopping and sexual urges.
If you or your family members notice that you are having unusual urges or behaviors, talk to your healthcare provider.
- Orthostatic hypotension (decreased blood pressure): Lightheadedness or fainting may happen when rising too quickly from a sitting or lying position.
- Falls. Aripiprazole tablets may make you sleepy or dizzy, may cause a decrease in your blood pressure when changing position and can slow your thinking and motor skills which may lead to falls that can cause fractures or other injuries.
- Low white blood cell count
- Seizures (convulsions)
- Problems with control of your body temperature especially when you exercise a lot or are in an area that is very hot. It is important for you to drink water to avoid dehydration. See “What should I avoid while receiving aripiprazole tablets?”
The most common side effects of aripiprazole tablets in adults include:
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The most common side effects of aripiprazole tablets in children include:
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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?
Store aripiprazole tablets at 68º to 77ºF (20º to 25º C).
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. It may harm them. You can ask your healthcare provider or pharmacist for information about aripiprazole tablets that was written for healthcare professionals.
For more information, call 1-866-495-1995.
What are the ingredients in aripiprazole tablets?
Active ingredient: aripiprazole USP
Inactive ingredients: corn starch, FD&C Blue #2/Indigo Carmine Al, ferric oxide red, ferric oxide yellow, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and microcrystalline cellulose
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.
Manufactured by:
Ascent Pharmaceuticals, Inc.
Central Islip, NY 11722
Manufactured for:
XLCare Pharmaceuticals, Inc.
242 South Culver Street, Suite 202
Lawrenceville, GA 30046
This Medication Guide has been approved by the U.S. Food and Drug Administration Revised: 06/2023