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Aripiprazole (Abilify®) Approved

By: Sang Hyo Kim, Section Editor

On April 28, 2015, the U.S. Food and Drug Administration approved aripiprazole, the generic of Abilify®.1 Aripiprazole tablets are used to treat patients with schizophrenia and bipolar disorder.1 Although Otsuka Pharmaceuticals, the manufacturer of Abilify®, tried to block generic competition by requesting a temporary restraining order on one of three patents beyond the April 20th expiration deadline, the U.S District Court for the District of New Jersey denied the request.2 Now, pharmaceutical companies can launch the affordable generic for patients.

Aripiprazole is available as a tablet, oral solution, orally disintegrating tablet, and injection.4 The injection comes in prefilled syringes and vials for reconstitution and must be injected via intramuscular route only.4 The prescribed dose varies, depending on various factors such as patient age and symptoms. Aripiprazole is usually taken by mouth once a day with or without food; the drug can control the symptoms of schizophrenia and bipolar disorder, but will not cure it.3 There is no dosage adjustment necessary for renal and hepatic impairment, but the drug requires dosage adjustment with concurrent CYP450 inducer or inhibitor therapy, or based on individual CYP2D6 metabolizer status.4

Some common side effects of aripiprazole include headache, nervousness, weight gain, dizziness, and diarrhea.5 Serious side effects include seizures, chest pain, high fever, or changes in vision, which should immediately be reported to the prescriber.5 Aripiprazole is a Category C drug on the pregnancy safety rating scale, which means that although there is limited human data to show possible risk on the fetus, there have been animal studies to show developmental toxicity and teratogenicity. Continuing therapy during pregnancy is a patient-provider specific decisionl however, administration during the first trimester must be avoided.6

Aripiprazole is not used to treat patients with dementia-related psychosis and contains a boxed warning indicating an increased risk of death in elderly patients with dementia-related psychosis.1 The warning also includes an increase in suicidal thoughts and behaviors in children, adolescents, and young adults taking antidepressants.1 When dispensing aripiprazole, the pharmacist must include a medication guide that explains to the patient the potential risks and factors associated with the drug.


  1. FDA approves first generic Abilify® to treat mental illnesses. FDA. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm444862.html. Updated 4/30/2015. Accessed Aug 10th, 2015.
  2. Teva Launches Generic Abilify® Tablets in the United States. TEVA Pharmaceutical Industries Ltd. Available at: http://www.tevapharm.com/news/?itemid=%7B72A03233-DF38-4F01-8A99-649C0ECC8F1C%7D. Published August 10th, 2015. Accessed June 9th, 2015.
  3. Aripiprazole. U.S National Library of Medicine. Available at: http://www.nlm.nih.gov/medlineplus/druginfo/meds/a603012.html. Last Updated May 16, 2011. Accessed August 10th, 2015.
  4. Lexi-Comp Online™ , Aripiprazole: Lexi-Drugs Online™. Hudson, Ohio: Lexi-Comp, Inc.; June 15th, 2015.
  5. Abilify® (Aripiprazole) [package insert]. North Wales, PA; Teva Pharmaceuticals USA, Inc; Revised 05/2015.
  6. Aripiprazole During Pregnancy. American Pregnancy Association. Available at: http://americanpregnancy.org/medication/aripiprazole-during-pregnancy/. Accessed August 10th, 2015.


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