Abilify (aripiprazole)

FDA ALERT [04/2005]    Abilify is a type of medicine called an atypical antipsychotic. FDA has found that older patients treated with atypical antipsychotics for dementia had a higher chance for death than patients who did not take the medicine. This is not an approved use.

Brand and Generic Names:

Available forms…

• Abilify® tablets, orally disintegrating tablets, liquid, or injection.
  • Tablets: 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, 30 mg
  • Orally disintegrating tablets: 10 mg, 15mg
  • Liquid: 1 mg/ml liquid in a 150 ml bottle (5 mg dose in one teaspoon)
  • Injection: 7.5 mg/ml for intramuscular injection
• Generic name = aripiprazole

What is Abilify?

Aripiprazole is an antipsychotic medication approved to treat schizophrenia, acute manic and mixed episodes of bipolar disorder, and agitation associated with schizophrenia or bipolar disorder.  It is also approved to prevent relapse in bipolar disorder and schizophrenia.

Aripiprazole can improve positive symptoms of schizophrenia (e.g., hallucinations, delusions, and thought disturbances) as well as negative symptoms (e.g., social withdrawal, inability to experience pleasure, and blunted affect).  Aripiprazole can also improve symptoms of bipolar disorder (e.g., racing thoughts, inflated self-esteem, impulsivity, irritability, and decreased need for sleep).  Aripiprazole can decrease symptoms of agitation which is excessive motor activity associated with inner tension. Some examples are threatening, distressing, or self-exhausting behaviors that may interfere with self-care.

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

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

• Symptoms of schizophrenia and/or bipolar disorder that you find bothersome.
• Medications you have taken in the past for schizophrenia or bipolar disorder.  It would be helpful for your provider to know which medications were effective and which were not.
• 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, tell your healthcare provider.
• All other medications you are currently taking.
• If you smoke cigarettes, use illegal drugs, or drink alcohol.
• Any medication allergies you have.
• If you are pregnant, plan to get pregnant, or are breast-feeding.
• What medical problems you have, especially diabetes, high cholesterol or triglycerides, increased body weight, irregular heartbeats, or seizures.
• Tell your doctor if you have thoughts of suicide.

How should I take Abilify®?

• Aripiprazole is usually taken once daily. The usual oral dose is between 15 mg and 30 mg.  The dose may be adjusted for each individual patient slowly over time.
• Aripiprazole can be taken with or without food.
• Use a calendar or pill-box to help you remember to take your medication. Or, have a family member or friend check in with you to be sure you are taking your medication.
• The dose that is right for you will be determined by you and your healthcare provider. 
• Aripiprazole orally disintegrating tablets should be opened with dry hands immediately before taking them and should not be split.
• Aripiprazole solution is flavored with natural orange cream and other flavorings.  It contains sugar, so use with caution if you have diabetes.  It may be stored for up to 6 months after opening.

What happens if I miss a dose?

What should I avoid while taking Abilify®?

What happens if I overdose?

• 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.
• In short-term trials lasting four to six weeks, the incidence of extrapyramidal side effects (abnormal movements, muscle stiffness/shaking, or an uncomfortable restless feeling) from aripiprazole was low and there was no weight gain. Long–term data suggests that weight gain is similar to placebo after 52 weeks of treatment with aripiprazole.
• More serious side effects may include diabetes, high cholesterol and triglycerides, or neuroleptic malignant syndrome (NMS). NMS is a rare condition in which people may experience extreme muscle rigidity, high body temperatures, confusion, and cardiovascular difficulties. The important concern about NMS is that it is a potentially fatal condition.

Are there any risks for taking this medication for long periods of time?

• Tardive dyskinesia (TD) is an adverse effect that may develop with prolonged use of antipsychotics. People with TD may experience slow or jerky movements that they cannot control, often in the mouth, the tongue or the jaw.  TD may be irreversible.  Medications such as aripiprazole have been shown to have a much lower risk of TD compared to older antipsychotics, such as Haldol® (haloperidol). If you should develop movements that you cannot control, call your healthcare provider immediately.
• Aripiprazole is thought to have a much lower risk of weight gain than some of the other atypical antipsychotics.  No one can predict how much weight a person will gain on any medicine, but a good lifestyle approach should include exercise, diet, and monitoring for weight gain and diabetes.

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 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), 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, like some of the other newer antipsychotics, effects the neurotransmitters dopamine and serotonin. Older antipsychotics seem to primarily affect only dopamine without significant impact on serotonin.

Improvement of some symptoms may be noticed in some patients within a few weeks. The full benefit of aripiprazole may not be seen for 4-6 weeks.

Updated by Heather Brandt, Pharm.D.
(July 2007)

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

Free or low-cost medications provided by pharmaceutical companies

Some pharmaceutical companies offer medication assistance programs to low-income individuals and families. These programs typically require a doctor’s consent and proof of financial status. They may also require that you have either no health insurance, or no prescription drug benefit through your health insurance. Please contact the pharmaceutical company directly for specific eligibility requirements and application information.

Abilify Rx Assistance Program: 1-800-332-2056

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