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Abilify

Abilify (aripiprazole) is an antipsychotic drug. The U.S. Food and Drug Administration approved Abilify to treat schizophrenia and other mental health disorders. The FDA also approved the drug to treat major depression in combination with antidepressants. Studies link Abilify use to side effects, including compulsive gambling, weight gain, suicidal thoughts and involuntary movements.

Abilify was once one of the top-grossing and most-prescribed drugs in the U.S.

The Food and Drug Administration first approved Abilify in 2002. Otsuka’s patent on aripiprazole expired in 2014.

The FDA approved the first generic versions in 2015. That same year, Abilify sales fell, in part because of generic competition.

Abilify was also being identified as a possible source of impulse-control problems. These potential Abilify side effects include compulsive gambling, overeating and uncontrollable sexual urges.

What Is Abilify?

Abilify is an atypical antipsychotic medication. It is part of the second generation of antipsychotics. This category also includes Clozaril (clozapine) and Risperdal (risperidone), among others.

Abilify Classification
Abilify is part of a group of drugs called atypical antipsychotics, or second generation antipsychotics.
Source: U.S. Food and Drug Administration

First generation drugs include Haldol (haloperidol) and Thorazine (chlorpromazine). Typical antipsychotics were developed in the 1950s. The second generation was born about 30 years later.

Atypical antipsychotics carry a lower risk of movement disorders, such as Parkinsonism. But they have a higher risk of metabolic side effects. These include weight gain, and increased blood sugar, blood pressure and cholesterol.

What Is Abilify Used for?

The FDA first approved Abilify in 2002 for the treatment of schizophrenia. This is a serious mental illness that causes disordered thoughts, emotions and behavior. The FDA has not approved the drug to treat schizophrenia in children younger than 13.

Doctors prescribe Abilify oral tablets, orally disintegrating tablets and oral solution to treat:
  • Schizophrenia
  • Manic or mixed episodes that happen with bipolar disorder I
  • Major depressive disorder when used with antidepressant medicines
  • Irritability associated with autism
  • Tourette’s disorder

Medical professionals use Abilify injections to treat agitation associated with schizophrenia or bipolar mania.

How Does Abilify Work and What Does Abilify Do in the Brain?

Abilify works by altering the activity of certain natural substances in the brain. Specifically, Abilify interacts with dopamine and serotonin receptors in the brain.

Abilify stabilizes dopamine and serotonin. The two neurotransmitters are responsible for a large portion of psychiatric symptoms and behavior.

Abilify Dosage

Abilify comes in 2 mg, 5 mg, 10 mg, 20mg and 30mg tablets. The actual dose you will take varies based on your condition. Your doctor will determine the amount that’s best for you.

Abilify dosage example
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How to Take Abilify

You can take Abilify with or without food. You should swallow the tablets whole.

If you miss a dose, take the missed dose as soon as you remember. If it’s almost time for your next dose, skip the missed dose and take the next dose at the regular time.

Ask your doctor how you should take Abilify. Do not change how you take the medicine or stop taking it without first talking to your doctor.

Abilify Side Effects

Abilify is linked to several serious side effects. These range from weight gain to compulsive behaviors.

Side effects of Abilify include:
  • Compulsive gambling
  • Compulsive shopping
  • Hypersexual activity
  • Suicidal thoughts
  • Weight gain
  • Tardive dyskinesia (uncontrollable body movements)

Hundreds of patients who developed serious side effects have filed Abilify lawsuits.

Abilify Black Box Warnings

Black box warnings are the most serious drug label warnings required by the FDA. Abilify has two.

The first highlights that the FDA has not approved Abilify for treatment of dementia-related psychosis. Elderly patients who are treated for dementia with Abilify have a higher risk of death.

The second black box warning targets children, adolescents and young adults with major depressive disorder or other psychiatric disorders. These patients experience a higher risk of suicidal thinking when taking Abilify.

Suffering from compulsive behavior after Abilify use? Get a Free Case Review

Abilify Precautions

According to the medication guide, you should not drive or operate heavy machinery until you know how Abilify affects you. The same goes for other dangerous activities. This is because Abilify may make you sleepy. You should also avoid getting overheated or dehydrated.

Abilify and Pregnancy

Researchers don’t know if Abilify will harm your unborn baby. You should talk to your doctor if you are or may become pregnant while taking Abilify. Abilify may pass through breast milk.

Abilify Interactions

Abilify interacts with many other drugs. Make sure your doctor and pharmacist know all the drugs and supplements you are taking.

Some of the drugs and supplements you should avoid while taking Abilify include:
  • Apomorphine
  • Bromocriptine
  • Butalbital
  • Codeine
  • Hydrocodone
  • Kava
  • Promethazine
  • Ropinirole
  • Trimethobenzamide

Abilify and Adderall

Adderall is an amphetamine used to treat attention deficit hyperactivity disorder. The Prescribers’ Digital Reference says the combination of Abilify and Adderall should generally be avoided.

Abilify and Alcohol

You should not drink alcohol while taking Abilify. That’s because alcohol can increase the level of drowsiness that Abilify can create.

On the other hand, a 2008 study in Alcoholism: Clinical and Experimental Research found that Abilify may be useful in treating alcoholism. That’s because it decreased the euphoric effects of alcohol. At the same time, it increased the sedative effects.

Abilify and Antidepressants

One of the approved uses for Abilify is to treat major depression in combination with antidepressants. When the FDA approved this use in 2007, it helped propel Abilify to its blockbuster status.

Combining Abilify with antidepressants can increase the risk of movement disorders such as tardive dyskinesia. It also enhances the risk of weight gain.

Some experts say only a minority of patients respond to the combined treatment. The FDA approval for the combination was based on studies that lasted just six weeks.

Abilify and Antidepressants
Combining Abilify with antidepressants helps a small number of patients with major depression.

The possible benefits may not be more than the risks, according to Consumer Reports. A CR report said Abilify is just as likely to induce a bad side effect as it is to help rid depression.

In one trial, the combination successfully treated depression in 25 percent of patients. That compared with 15 percent given a placebo. But 26 percent of the Abilify group experienced a movement disorder called akathisia. Just 4 percent of those taking the placebo developed that side effect.

Abilify and Zoloft

One of the antidepressants that may be combined with Abilify is Zoloft (sertraline).

A preliminary study in 2011 found that taking low doses of aripiprazole could increase the effectiveness of regular doses of sertraline in treating major depressive disorder.

Abilify and Wellbutrin

Another antidepressant that has been studied with Abilify is Wellbutrin (bupropion).

Preliminary research published in 2008, found that Abilify given in small doses at the same time as bupropion resulted in rapid improvement in depressed patients.

Prozac and Abilify

A 2008 examination of two studies found Abilify combined with an antidepressant, such as Prozac, is an effective strategy for some patients with major depressive disorder. This related to patients who didn’t respond to antidepressants alone. Researchers with Bristol-Myers Squibb and Otsuka America Pharmaceutical Inc. (the companies responsible for Abilify) performed the analysis along with several universities.

Abilify and Lexapro

A seven-week study of aripiprazole combined with Lexapro (escitalopram) concluded the combination seems to be an effective and safe treatment for major depressive disorder. The study, however, included only 16 patients. Just 13 patients completed the study.

Please seek the advice of a medical professional before making health care decisions.

Related Pages

Elaine Silvestrini is an award-winning journalist with 30 years of experience covering state and federal court systems. She joined Drugwatch in 2017. Her coverage for Drugwatch has been cited in the CDC’s Public Health Law News and the USA Today Network. Some of her qualifications include:

  • Centers for Disease Control and Prevention certificates in Health Literacy
  • Experience as an assistant investigator for the Federal Public Defender
  • Loyola Law School Journalist Law School Fellowship
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25 Cited Research Articles

  1. Epocrates. (n.d.). Abilify Black Box Warnings. Retrieved from https://online.epocrates.com/drugs/325811/Abilify/Black-Box-Warnings
  2. Epocrates. (n.d.). Abilify Drug Interactions. Retrieved from https://online.epocrates.com/drugs/325804/Abilify/Drug-Interactions
  3. Reuters. (2008, April 17). Aripiprazole may be effective for alcohol addiction. Retrieved from https://www.reuters.com/article/us-aripiprazole-alcohol-addiction/aripiprazole-may-be-effective-for-alcohol-addiction-idUSTON77742020080417
  4. Everyday Health. (n.d.). What is Abilify? Retrieved from https://www.everydayhealth.com/drugs/abilify/
  5. U.S. Food and Drug Administration. (n.d.). Abilify Medication Guide. Retrieved from https://www.fda.gov/downloads/Drugs/DrugSafety/ucm085804.pdf
  6. Kranzler, H.R., et al. (2008, February 8). Effects of Aripiprazole on Subjective and Physiological Responses to Alcohol. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3159685/
  7. Lin, C.H., et al. (2011, October 31). Adjunctive low-dose aripiprazole with standard-dose sertraline in treating fresh major depressive disorder: a randomized, double-blind, controlled study. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/21869699
  8. Newman, T. (2018, January 3). Aripiprazole (Abilify): What you need to know. Retrieved from https://www.medicalnewstoday.com/articles/248385.php
  9. Sokolski, K.N. (2008, May 20). Adjunctive aripiprazole for bupropion-resistant major depression. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/18492784
  10. Consumer Reports. (2010, July). Best antidepressant for anxiety according to our readers. Retrieved from https://www.consumerreports.org/cro/2013/01/depression-and-anxiety/index.htm
  11. Thase, M.E., et al. (2008). Examining the Efficacy of Adjunctive Aripiprazole in Major Depressive Disorder: A Pooled Analysis of 2 Studies. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2644484/
  12. eHealthMe. (2018, July 15). Abilify and Adderall drug interactions – from FDA reports. Retrieved from https://www.ehealthme.com/drug-interaction/abilify/adderall/
  13. Prescribers’ Digital Reference. (n.d.). amphetamine aspartate monohydrate/amphetamine sulfate/dextroamphetamine saccharate/dextroamphetamine sulfate - Drug Summary. Retrieved from http://www.pdr.net/drug-summary/Adderall-amphetamine-aspartate-monohydrate-amphetamine-sulfate-dextroamphetamine-saccharate-dextroamphetamine-sulfate-1048
  14. Matthews, J.D., et al. (2009, February 29). An open study of aripiprazole and escitalopram for psychotic major depressive disorder. https://www.ncbi.nlm.nih.gov/pubmed/19142112
  15. Encyclopaedia Britannica. (n.d.). Receptor. Retrieved from https://www.britannica.com/science/receptor-nerve-ending
  16. Abilify. (February 2017). Important safety information for Abilify. Retrieved from https://www.abilify.com/
  17. Guzman, Flavio. (2017, July 18). Aripiprazole Indications: FDA-Approved and Off-Label Uses. Psychopharmacology Institute. Retrieved from  http://psychopharmacologyinstitute.com/antipsychotics/aripiprazole/aripiprazole-indications-fda-approved-off-label-uses
  18. Bristol-Myers Squibb (2017, November). U.S. Food and Drug Administration Approves ABILIFY (aripiprazole) as the First Medication for Add-On Treatment of Major Depressive Disorder (MDD). Retrieved from  http://news.bms.com/press-release/us-food-and-drug-administration-approves-abilify-aripiprazole-first-medication-add-tre
  19. Epocrates. (n.d.). Abilify. Retrieved from https://online.epocrates.com/drugs/325806/Abilify/Manufacturer-Pricing
  20. Moore, T., Glenmullen, J., and Mattison, D. (2014, December). Reports of Pathological Gambling, Hypersexuality, and Compulsive Shopping Associated With Dopamine Receptor Agonist Drugs. Retrieved from  https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/1916909
  21. U.S. Food and Drug Administration. (2016, May 3). FDA Drug Safety Communication: FDA warns about new impulse-control problems associated with mental health drug aripiprazole (Abilify, Abilify Maintena, Aristada). Retrieved from https://www.fda.gov/Drugs/DrugSafety/ucm498662.htm
  22. Cohen, B. M. and Carlezon, W.A., Jr., (2007, April 1). Can’t Get Enough of That Dopamine. Retrieved from  http://ajp.psychiatryonline.org/doi/full/10.1176/ajp.2007.164.4.543
  23. Fierce Pharma. (n.d.). Abilify. Retrieved from https://www.fiercepharma.com/special-report/abilify-2
  24. Kohli, S. (2014, November 10). How this antipsychotic became America’s best-selling drug. Retrieved from https://qz.com/293932/how-this-antipsychotic-became-americas-best-selling-drug/
  25. U.S. Food and Drug Administration. (n.d.). Drug Approval Package. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-436_Abilify.cfm
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