What is Aripiprazole (Abilify) approved for?

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Last updated: April 16, 2025View editorial policy

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From the Guidelines

Aripiprazole is approved for treating several psychiatric conditions, including schizophrenia, bipolar I disorder, irritability associated with autism spectrum disorder, Tourette's disorder, and as an adjunctive treatment for major depressive disorder. The medication works as a partial agonist at dopamine D2 and serotonin 5-HT1A receptors, and as an antagonist at serotonin 5-HT2A receptors, which gives it a unique mechanism compared to other antipsychotics 1. This receptor profile helps reduce psychotic symptoms while potentially causing fewer side effects than traditional antipsychotics. Some key points to consider when prescribing aripiprazole include:

  • Dosing varies by indication, with typical starting doses of 10-15 mg daily for adults with schizophrenia or bipolar disorder, often titrated based on response.
  • Common side effects include akathisia (restlessness), weight gain (though less than some other antipsychotics), nausea, vomiting, constipation, headache, dizziness, and insomnia.
  • The medication is available in oral tablets, orally disintegrating tablets, oral solution, and long-acting injectable formulations. Aripiprazole has been studied in various populations, including adults and pediatric patients, and has been found to be effective in treating a range of psychiatric conditions, including bipolar I disorder in adults and pediatric patients (10 and older) 1. It is essential to carefully evaluate the potential benefits and risks of aripiprazole in individual patients, taking into account factors such as age, diagnosis, and medical history. In clinical practice, aripiprazole may be used as a first-line treatment for certain conditions, such as schizophrenia or bipolar I disorder, or as an adjunctive treatment for major depressive disorder. Overall, aripiprazole is a valuable treatment option for patients with various psychiatric conditions, offering a unique mechanism of action and a relatively favorable side effect profile.

From the FDA Drug Label

Aripiprazole oral tablets are indicated for the treatment of: • Schizophrenia [see Clinical Studies ( 14.1)] 2 Aripiprazole is approved for the treatment of schizophrenia.

  • The FDA label does not provide a comprehensive list of all approved indications for aripiprazole.
  • However, based on the available information, schizophrenia is a confirmed approved indication.
  • Other potential indications may be approved, but they are not explicitly stated in the provided drug label.

From the Research

Aripiprazole Approval

Aripiprazole is approved for the treatment of various conditions, including:

  • Schizophrenia in adult patients 3, 4, 5, 6
  • Bipolar disorder as adjunctive therapy or monotherapy (manic or mixed episodes) 7
  • Major depressive disorder (MDD) as an augmentation therapy 7
  • Severe manic episodes in bipolar I disorder 6

Approved Dosages

The approved dosages of aripiprazole vary depending on the condition being treated:

  • Schizophrenia: 10 or 15 mg once daily 3
  • Bipolar disorder: dosages may vary, but aripiprazole has been shown to be effective as adjunctive therapy or monotherapy 7
  • Major depressive disorder: dosages may vary, but aripiprazole has been shown to be effective as an augmentation therapy 7

Regulatory Approvals

Aripiprazole has received regulatory approvals from various agencies, including:

  • US FDA: approved in 2002 for the treatment of schizophrenia 6
  • European Commission: approved in 2013 for the treatment of severe manic episodes in bipolar I disorder 6
  • Japan: approved in 2006 6
  • Canada: approved in 2014 6

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Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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