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Abilify® (aripiprazole)

All FDA warnings are at the end of this fact sheet. Please consult them before taking this medication.

Brand and Generic Names:

Brand name: Abilify®
- Tablets: 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, 30 mg
- Orally disintegrating tablets: 10 mg, 15mg
- Liquid: 1 mg/ml in a 150 ml bottle
- Injection: 9.75 mg/1.3 ml for intramuscular injection
Generic name: aripiprazole

What is Abilify® and what does it treat?

Aripiprazole is a second generation antipsychotic (SGA) medication approved for the treatment of schizophrenia and bipolar disorder. Bipolar disorder involves episodes of depression and/or mania. It is also approved as adjunct treatment of major depressive disorder. Aripiprazole can improve symptoms of schizophrenia such as: hallucinations, delusions, and disorganized thinking; in some people improvement in social isolation, reduced speech productivity and motivation also occur. It can also help control the mood swings of bipolar mania. The remainder of this medication sheet will focus primarily on schizophrenia.

What is the most important information I should know about Abilify®?

Relapse is very common in schizophrenia and the most frequent cause is that patients stop taking their medication. Even when medication is taken exactly as prescribed, relapse may still occur for some people. Therefore it is recommended that you take your medication exactly as prescribed by your healthcare provider as this has been shown to decrease relapse.

Schizophrenia requires long-term treatment. Only your healthcare provider can determine the length of aripiprazole treatment that is right for you.
Do not stop taking aripiprazole or change your dose without talking to your healthcare provider first.
Some people may develop side effects on aripiprazole such as extrapyramidal effects (restlessness, tremor, stiffness) or tardive dyskinesia (slow or jerky movements that one cannot control, often starting in the mouth with tongue rolling or chewing movements). These symptoms are likely to be less severe and occur less often than with the older antipsychotic medications (e.g., Haldol® [haloperidol], Prolixin® [fluphenazine], or Thorazine® [chlorpromazine]). If you develop movements that you cannot control, call your healthcare provider immediately.
Many second generation or atypical antipsychotics may cause an increase in weight, blood sugar levels, or lipid levels. If you gain more than 5% of your original weight during therapy, talk to your healthcare provider about whether switching to another antipsychotic medication should be considered.
Aripiprazole treatment may be associated with strokes and/or transient ischemic attacks (TIAs) in elderly people with dementia and accompanying behavior problems. This safety concern has not been proven confidently, but there is some evidence. Talk with your healthcare provider if you are concerned or have questions.
Both older first and newer second generation antipsychotics have been associated with the risk of sudden cardiac death due to an arrhythmia (irregular conduction of an electrical impulse in the heart). To minimize this possibility, antipsychotic medications should be used in the smallest effective dose in situations where the benefits outweigh the risks, such as schizophrenia or bipolar disorder. Often an EKG tracing may be ordered to monitor for conduction changes.
Aripiprazole treatment must be monitored by a healthcare provider. Be sure to keep all of your scheduled appointments so that you stay healthy while on aripiprazole.
You should not take illegal drugs or drink alcohol while taking aripiprazole.

Are there specific concerns about Abilify®and pregnancy?

If you are planning on becoming pregnant, notify your healthcare provider so that he/she can best manage your medications. People living with schizophrenia who wish to become pregnant face important decisions, each with risks and benefits related to how the illness, medications and the risks to the fetus may interact. This is a complex decision as untreated schizophrenia has risks to the fetus as well as the mother. There are many dimensions to these choices, so be sure to confer with your doctor and caregivers.

Regarding breast-feeding, caution is advised since aripiprazoledoes pass into breast milk.

What should I discuss with my healthcare provider before taking Abilify®?

Symptoms of schizophrenia which are bothersome to you.
If you had any serious side effects to other antipsychotic medications like muscle stiffness, muscle cramping, shaking, tardive dyskinesia, neuroleptic malignant syndrome, weight gain, or diabetes. (See the NAMI Hearts and Minds program.)
If you have had an allergic reaction to aripiprazole or any other medication.
History of heart problems, such as heart rhythm problems, long QT syndrome, or heart attacks. These illnesses may make aripiprazole unsafe for you to take.

How should I take Abilify®?

Aripiprazole can be taken with or without food, but should be taken with a full glass of water.
Aripiprazole orally disintegrating tablets should be opened with dry hands immediately before taking them and should not be split.
Only your doctor can determine the correct dose for you. Typically patients begin at a low dose of medicine and the dose is increased slowly over several weeks.
Use a calendar or pill box to help you remember to take your medication. Or, have a family member or friend remind you to check in with you to be sure you are taking your medication.

What happens if I miss a dose?

If you miss a dose of aripiprazole, take it as soon as you remember it, if it is not too close to when your next dose is due—discuss this with your healthcare provider. Do not double your next dose or take more than what is prescribed.

What should I avoid while taking Abilify®?

Aripiprazole may cause dizziness or drowsiness, especially when first starting the medication. Make sure you know how you react to the medication before you drive, operate machinery, or do other activities that may be dangerous if you are not alert.
Avoid drinking alcohol or using illegal drugs while taking aripiprazole.

What happens if I overdose?

If an overdose occurs, whether intentional or accidental, immediate medical attention is necessary. Call your doctor or emergency medical service (911). You may also contact the poison control center at 1-800-222-1222.

What are the possible side effects of Abilify®?

What are the common side effects seen with aripiprazole?

Aripiprazole has shown a low rate of side effects in clinical trials. The most common side effects were headache, anxiety, and insomnia. Some people also experience a lowering in blood pressure when they get up from lying or sitting, known as "orthostatic hypotension". This can cause dizziness and lightheadedness.

What are the more serious side effects of antipsychotics?

With newer second generation antipsychotics (SGA), more commonly seen are diabetes/weight gain/increased cholesterol and triglycerides as noted in stronger warnings mandated by the FDA in individual drug labeling. For the relative risk of weight gain and diabetes seen with the various drugs, see Table 2 in the Consensus Conference on Antipsychotic Drugs. These guidelines make recommendations for the monitoring of cardiac risk factors while on atypical antipsychotics.

Please also consult the Metabolic and Diabetes tab in the NAMI Hearts and Minds section for the current monitoring information regarding triglycerides, cholesterol, fasting blood glucose, etc. to help plan preventative interventions.
Less commonly seen, but important, is the early death/dementia risk as noted in the FDA boxed warning. In some clinical trials, it was determined that elderly people developed strokes at a higher rate than those on placebo medication (sugar pill). The SGA group has less tardive dyskinesia (TD), neuroleptic malignant syndrome, seizures, and changes in heart rhythm than FGA drugs but not zero.

What do I do about the more serious risks?

Please let your doctors know if you have any of these medical conditions prior to starting aripiprazole.
It is important to be aware of prevention with attention to nutrition, exercise, and reducing your plate size (because the medications may reduce your ability to feel full after eating). For more ideas, see the NAMI Hearts and Minds Program.

Also, obtain Abnormal Involuntary Movement testing (AIMS) to monitor for TD. While it is less common with newer SGA, it has been reported. If you are taking an older FGA, then regular AIMS testing is needed for monitoring, so you can make good choices about the use of the drug when weighing the risks and benefits.

Are there any risks for taking Abilify® for long periods of time?

Tardive dyskinesia (TD) is a side effect that may develop with prolonged use of antipsychotics. Medications such as aripiprazole have been shown to have a much lower risk of TD compared to the older antipsychotics such as Haldol® (haloperidol). Should you develop symptoms of TD, such as grimacing, sucking and smacking of lips, and other movements that you cannot control, contact your healthcare provider immediately.

No one can predict how much weight a person will gain on any medicine, but an approach that includes exercise and diet and monitoring for weight gain and diabetes is recommended.

What other drugs interact with Abilify®?

Some antidepressants, such as Prozac® (fluoxetine), Paxil® (paroxetine) and Luvox® (fluvoxamine) may increase the blood levels of aripiprazole. Ketoconazole, an antifungal medication, may significantly increase the blood levels of aripiprazole. It is possible that patients taking aripiprazole with these agents may experience side effects. Medications with similar effects on aripiprazole blood levels include: Biaxin® (clarithromycin), erythromycin, Cardizem® (diltiazem), Calan® (verapamil), and Accolate® (zafirlukast). Tell your doctor if you begin or discontinue any of these treatments.

Some medications, such as Tegretol® (carbamazepine), Dilantin® (phenytoin), phenobarbital, or Rifadin® (rifampin) may decrease the blood levels of aripiprazole. It is possible that you may experience a decreased effect from aripiprazole if you also take one of these other medications. Medications with similar effects include: Sustiva® (efavirenz), Fulvicin® (griseofulvin), and Mysoline® (primidone). Tell your doctor if you begin or discontinue any of these treatments.

How long does it take for Abilify® to work?

Aripiprazole rebalances dopamine and serotonin to improve thinking, mood, and behavior. Improvement of some symptoms may be noticed in some patients within a few weeks. The full benefit of aripiprazole may not be seen for 6-12 weeks or longer.

FDA ALERT [06/0606]

Both conventional and atypical antipsychotics are associated with an increased risk of mortality in elderly patients treated for dementia-related psychosis.

Antipsychotics are not indicated for the treatment of dementia-related psychosis.

Updated by
Donna Givone, Pharm.D., BCPP.
(November 2010)

NAMI wishes to thank the College of Psychiatric and Neurologic Pharmacists for producing this fact sheet.

Reviewed by Dr. Ken Duckworth, NAMI Medical Director

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