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Aripiprazole is a prescription medication used to treat schizophrenia, bipolar disorder, and autism. It can also be used in combination with an antidepressant to treat depression. Aripiprazole belongs to a group of drugs called atypical antipsychotics. These medications work by altering the activity of certain natural substances in the brain.
This medication comes as a tablet, as an orally disintegrating tablet, a tablet with an Ingestible Event Marker (IEM) sensor, and in oral solution form and is usually taken once a day, with or without food.
This medication is also available in immediate and extended-release injectable forms to be given directly into the muscle (IM) by a healthcare professional.
The extended-release injectable form is approved to treat symptoms of schizophrenia and is also approved for acute schizophrenia relapse in adults.
Common side effects of aripiprazole include insomnia, fatigue, and an inner sense of restlessness or need to move.
CYP2D6 is a protein in your body that is involved in the elimination of aripiprazole and other drugs from your body. Some patients have less of this protein in their bodies, affecting how much of the drug gets eliminated. Levels of CYP2D6 can vary greatly between individuals, and those having less of this protein are known as “poor metabolizers.”
CYP2D6 testing is done to determine whether you are a poor metabolizer. If you are a poor metabolizer, the levels of aripiprazole in your blood can become too high. As a result you may be at an increased risk of having more side effects from aripiprazole.
Your doctor may adjust your dose of aripiprazole if you are a poor metabolizer.
Oral and Immediate-Release Injectable:
Aripiprazole is a prescription medication used to treat:
This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
Aripiprazole tablet with a sensor is a prescription medication used to treat:
This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
Aripiprazole may be found in some form under the following brand names:
Aripiprazole is part of the drug class:
Oral tablet, oral tablet with sensor, and immediate-release injectable:
Common side effects in adults include the following:
Common side effects in children include the following:
The most common side effect includes feeling like you need to move to stop unpleasant feelings in your legs (restless leg syndrome or akathisia).
This is not a complete list of aripiprazole side effects. Ask your doctor or pharmacist for more information.
Serious side effects have been reported with aripiprazole. See “Aripiprazole Precautions” section.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Tell your doctor about all the medicines you take including prescription and nonprescription medications, vitamins, and herbal supplements. Especially tell your doctor if you take:
This is not a complete list of aripiprazole drug interactions. Ask your doctor or pharmacist for more information.
Serious side effects have been reported with aripiprazole including the following
Important information about antidepressant medicines:
Do not drive, operate heavy machinery, or do other dangerous activities until you know how aripiprazole affects you. Aripiprazole may make you drowsy. Do not drink alcohol while taking aripiprazole.
Grapefruit and grapefruit juice may interact with aripiprazole and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.
Before you receive aripiprazole, tell your healthcare provider if you:
Tell your doctor about all the medicines that you take including prescription medicines, non-prescription medicines, herbal supplements, and vitamins.
Tell your doctor if you are pregnant or plan to become pregnant.
The FDA categorizes medications based on safety for use during pregnancy. Five categories – A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.
This medication falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.
Tell your doctor if you are breastfeeding or plan to breastfeed.
Aripiprazole has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from aripiprazole, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.
Take aripiprazole exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. The recommended dose varies depending upon which condition is being treated as well as other factors.
Aripiprazole tablets and oral solution
Aripiprazole immediate-release injection
Aripiprazole orally disintegrating tablet
Aripiprazole extended-release injection
Aripiprazole with Ingestible Event Marker (IEM) sensor
If you take too much aripiprazole call your healthcare provider or local Poison Control Center or seek emergency medical attention right away.
If aripiprazole is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if an overdose is suspected, seek emergency medical attention.
Talk to your doctor or your pharmacist about the following black box warning for this medication:
WARNINGS: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDALITY AND ANTIDEPRESSANT DRUGS
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Aripiprazole is not approved for the treatment of patients with dementia-related psychosis.
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of adjunctive aripiprazole or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Aripiprazole is not approved for use in pediatric patients with depression.
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