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Limited Use
[what does this mean?]
Generic drug name:
aripiprazole
(ar ee PIP ra zole)
Brand name(s):
ABILIFY,
ABILIFY MAINTENA KIT,
ABILIFY MYCITE KIT,
ARISTADA,
ARISTADA INITIO KIT
GENERIC:
not available
FAMILY:
Atypical Antipsychotics
Find the drug label by
searching at DailyMed.
Pregnancy and Breast-feeding Warnings [top]
Pregnancy Warning
Aripiprazole (ABILIFY) was found to harm to developing fetuses in animal studies. It caused undescended testicles, delayed bone formation, decreased weight and survival, and increased stillbirths. You should not use this drug during pregnancy. Tell your doctor if you are pregnant or thinking of becoming pregnant before you take this drug.
The FDA updated the information for this entire class of antipsychotic drugs (called atypical antipsychotics) relating to the potential risk to newborns when the medications are used during pregnancy. The drug’s product label has been updated to include information stating that when mothers are treated with these drugs during the third trimester of pregnancy, there is a potential risk of abnormal muscle movements (extrapyramidal signs or EPS) and withdrawal symptoms in their newborns.
Breast-feeding Warning
Aripiprazole is excreted in human breast milk. Women and their health care providers should decide whether to stop nursing or stop taking the drug, depending on the importance of the drug to the mother.[1]
Safety Warnings For This Drug [top]
FDA BLACK BOX WARNING
Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared with those who received a placebo. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks) in these patients revealed a risk of death in the drug-treated patients of between 1.6 to 1.7 times that seen in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared with a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Abilify is not approved for the treatment of patients with dementia-related psychosis.
Product Warnings
Ask a doctor or pharmacist before use if you are taking antibiotics.
When using this product, tiredness, drowsiness or dizziness may occur. Be careful driving or operating machinery.
Stop using and ask a doctor if symptoms get worse, diarrhea lasts more than two days or you get abdominal swelling or bulging. These may be signs of a serious condition.
If pregnant or breast-feeding, ask a health care professional before use.
Older adults are especially sensitive to the harmful anticholinergic effects of this drug. Drugs in this family should not be used unless absolutely necessary.
Mental Effects: confusion, delirium, short-term memory problems, disorientation and impaired attention.
Physical Effects: dry mouth, constipation, difficulty urinating (especially for a man with an enlarged prostate), blurred vision, decreased sweating with increased body temperature, sexual dysfunction and worsening of glaucoma.
Blood Sugar Elevation and Diabetes Mellitus
Elevations in blood sugar (glucose),[2],[3],[4] in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, have been reported in patients treated with atypical antipsychotics that include aripiprazole (ABILIFY), clozapine (CLOZARIL), olanzapine (ZYPREXA), quetiapine (SEROQUEL), risperidone (RISPERDAL) and ziprasidone (GEODON).
The relationship between atypical antipsychotic use and glucose abnormalities is complicated by the possibility of an increased background risk of diabetes mellitus in patients with schizophrenia and the increasing incidence of diabetes mellitus in the general population. Given these confounders, the relationship between atypical antipsychotic use and hyperglycemia-related adverse events is not completely understood. Precise risk estimates for hyperglycemia-related adverse events in patients treated with atypical antipsychotics are not available.
Patients with an established diagnosis of diabetes mellitus who are started on atypical antipsychotics should be monitored regularly for worsening of glucose control. Patients with risk factors for diabetes mellitus (e.g., obesity, family history of diabetes) who are starting treatment with atypical antipsychotics should undergo fasting blood glucose testing at the beginning of treatment and periodically during treatment. Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia, including polydipsia (excessive thirst/drinking of liquids), polyuria (excessive urination), polyphagia (excessive eating) and weakness. Patients who develop symptoms of hyperglycemia during treatment with atypical antipsychotics should undergo fasting blood glucose testing. In some cases, hyperglycemia resolved when the atypical antipsychotic was discontinued; however, some patients required continuation of antidiabetic treatment despite discontinuation of the suspect drug.
Cerebrovascular Adverse Events, Including Stroke, in Elderly Patients with Dementia
Cerebrovascular adverse events (e.g., stroke, transient ischemic attack), including fatalities, were reported in clinical trials of the atypical antipsychotics in elderly patients with dementia-related psychosis.[5] In placebo-controlled trials, there was a significantly higher incidence of cerebrovascular adverse events in patients treated with these drugs than in patients treated with placebo. The atypical antipsychotics are not approved for the treatment of patients with dementia-related psychosis.
Facts About This Drug [top]
Aripiprazole was approved by the Food and Drug Administration (FDA) in 2002 for the treatment of schizophrenia in adults. In 2005, it was also approved as a maintenance therapy for bipolar disorder. In 2007, it was approved for the treatment of schizophrenia in adolescents aged 13 to 17.[6] Refer to the drug product label for additional approved uses of aripiprazole. Aripiprazole is not approved for the treatment of patients with dementia-related psychosis.
Aripiprazole is a member of a...
Aripiprazole was approved by the Food and Drug Administration (FDA) in 2002 for the treatment of schizophrenia in adults. In 2005, it was also approved as a maintenance therapy for bipolar disorder. In 2007, it was approved for the treatment of schizophrenia in adolescents aged 13 to 17.[6] Refer to the drug product label for additional approved uses of aripiprazole. Aripiprazole is not approved for the treatment of patients with dementia-related psychosis.
Aripiprazole is a member of a relatively new family of drugs known as atypical antipsychotics. All antipsychotic drugs usually improve symptoms such as agitation, delusions, hallucinations and suspiciousness. Atypical antipsychotics, more than older antipsychotics, additionally tend to improve "negative" symptoms such as apathy, disorientation, emotional withdrawal and lack of pleasure. However, there is no clear evidence that atypical antipsychotics are more effective or better tolerated than older, conventional antipsychotics such as haloperidol (HALDOL).[7]
Public Citizen lists aripiprazole as a Limited Use drug.
Adverse effects
Weight gain has been a problem with antipsychotic drugs, particularly with atypical antipsychotics. In short-term trials, there was a small difference in average weight gain between aripiprazole and placebo patients. The patients given aripiprazole gained, on average, 1.5 pounds, whereas the placebo patients lost 0.1 pounds on average. About 8% of patients taking aripiprazole gained more than 7% of their body weight, whereas 3% of the patients receiving a placebo gained this much weight.[8]
The possibility of eye toxicity is also a concern with the use of aripiprazole. Preapproval studies conducted on rats clearly showed degeneration of the retina in those receiving aripiprazole. Studies done in mice and monkeys found no retinal degeneration, but the studies were invalid. Bristol Myers Squibb, the manufacturer of aripiprazole, committed to conducting additional post-marketing research on retinal degeneration in animals as a condition of aripiprazole's approval. However, these studies should have been completed before the drug was approved.[8]
There were important findings in the FDA’s safety review of aripiprazole. An alteration in the electrical conduction of the heart known as QT prolongation is an important safety issue with both old and new antipsychotic drugs. QT prolongation can lead to life-threatening heart rhythm disturbances.
There was no evidence of QT prolongation with aripiprazole at dosages of up to 30 milligrams (mg) per day. However, in a special study exploring higher dosages of the drug, there was substantial prolongation of the QT interval at dosages of 75 mg and 90 mg per day.[8]
Neuroleptic malignant syndrome (NMS) is a rare yet severe adverse effect of antipsychotic drugs. The symptoms of NMS can include fever; confusion; disorientation or other cognitive function changes; muscle rigidity; profuse sweating; and unstable blood pressure, heart rate and gastrointestinal function. NMS can be life-threatening. Rapid recognition and treatment are important.[9]
Studies show ...
Three of the five short-term trials submitted to the FDA for aripiprazole’s initial approval showed the efficacy of the drug in dosages ranging from 10 mg to 30 mg per day. The 30-mg dose did not seem to be more effective than the lower doses. The FDA-approved dosage for the drug ranges from 10 mg to 15 mg per day. In one of the two remaining studies, aripiprazole therapy could not be differentiated from treatment with a placebo; the fifth trial failed.[8] One of our reviewers suggests starting with the 5-mg dose to minimize the risk of adverse effects.
These five trials were conducted in a way that did not allow for comparisons between aripiprazole and haloperidol or risperidone (RISPERDAL), which were used as comparator drugs. There is nothing in these five trials suggesting that aripiprazole is a meaningful advancement in the treatment of schizophrenia.
In their evaluation of aripiprazole, the editors of The Medical Letter on Drugs and Therapeutics concluded that “published comparisons with other atypical antipsychotics are needed to determine its relative efficacy and safety.”[10]
In April 2011, the Office of Inspector General of the Department of Health and Human Services released a study, “Medicare Atypical Antipsychotic Drug Claims for Elderly Nursing Home Residents,” with dismal results. The study was conducted at the request of Sen. Charles Grassley (R-Iowa) and evaluated the extent to which elderly nursing home residents receive newer, more expensive atypical antipsychotic drugs and the associated cost to the Medicare system. It also assessed the extent to which dangerous off-label prescribing of these drugs was occurring.
The study found that inappropriate prescribing of antipsychotics to elderly patients cost the Medicare system more than $200 million in the first six months of 2007 alone. Although the labels of antipsychotics carry a boxed warning of an increased risk of death for elderly patients treated with these drugs, 91% of 2007 Medicare claims for atypical antipsychotics were associated specifically with this off-label use. (Read the Worst Pills, Best Pills News article here.)
On May 24, 2013, the Centers for Medicare & Medicaid Services, as part of the National Partnership to Improve Dementia Care in Nursing Homes, issued new guidelines discouraging the use of antipsychotic drugs to treat dementia in nursing-home patients. The recommendations belatedly follow the May 2011 report by the Inspector General of the Department of Health and Human Services, which found that 14% of nursing-home residents had Medicare claims filed on their behalf for atypical antipsychotic medications, which have never been approved by the Food and Drug Association (FDA) for managing dementia.
A study published in the British Medical Journal evaluated the risk of death associated with specific antipsychotic medications used in elderly residents in nursing homes. The study reviewed information relating to the risk of death when using different drug therapies and found that the risk of death varied according to the specific drug used. The authors of the study concluded:
“The evidence accumulated so far implies that use of haloperidol in this vulnerable population cannot be justified because of the excess harm. Quetiapine might be somewhat safer than other atypical drugs, but these findings will require replication in other studies.”[11]
In 2015, JAMA Internal Medicine published an article showing that use of atypical antipsychotic drugs was associated with an increased risk of falls and fractures in patients 65 and older.[12]
In 2015, a study published in the Journal of Clinical Psychiatry showed that aripiprazole, olanzapine (ZYPREXA), quetiapine (SEROQUEL) and risperidone had a high risk of adverse effects and a low rate of effectiveness when used in patients older than 40.[13]
In 2015, an article published in Prescrire International reported that the European Medicines Agency, an agency similar to the FDA, had found that aripiprazole use was associated with violent behavior.[14]
This is one of a limited number of drugs for which the FDA requires an FDA-approved Medication Guide to be dispensed when the prescription is filled. (See the Medication Guide for ABILIFY and ABILIFY MAINTENA.)
Regulatory actions surrounding aripiprazole
2003: In September, the FDA ordered that the product label for this drug warn that patients should be monitored for symptoms of diabetes mellitus. The other drugs requiring the warning are clozapine, olanzapine, quetiapine, risperidone and ziprasidone (GEODON). [15]
2005: In February, France's drug regulatory agency warned of a risk of stroke associated with the use of aripiprazole. In three 10-week placebo-controlled trials of aripiprazole, strokes and transient ischemic attacks (small strokes caused by a temporary blockage of blood flow to part of the brain) were twice as frequent among patients taking aripiprazole. Two of the patients who had strokes died.[16]
In March, the FDA revised the product label of aripiprazole to address an increased incidence of cerebrovascular adverse effects (stroke and transient ischemic attacks), including deaths, in aripiprazole-treated patients.[5]
The FDA issued a public health advisory on April 11 to warn that atypical antipsychotics are associated with an increased risk of death when used to treat dementia in elderly patients.
The atypical antipsychotics affected by the FDA advisory include aripiprazole, clozapine, olanzapine, quetiapine, risperidone and ziprasidone. None of these drugs are approved for the treatment of behavioral disorders in patients with dementia.[17]
2009: The FDA updated the product label of aripiprazole after receiving reports of leukopenia/neutropenia (low white blood cell count). These reports were received in clinical trial and postmarketing reports, and the FDA called them short-term events “related to antipsychotic agents.” The agency said that agranulocytosis (failure of the bone marrow to make enough white blood cells) also had been reported.[18]
2011: The FDA updated the information for all antipsychotic drugs, noting the potential risk to newborns when the medications are used during pregnancy. The drugs’ product labels were updated to include information stating that when mothers are treated with these drugs during the third trimester of pregnancy, there is a potential risk of abnormal muscle movements (extrapyramidal signs, or EPS) and withdrawal symptoms in their newborns.[19]
2015: Health Canada, an agency similar to the FDA, updated the label of aripiprazole to warn that the drug is associated with an increased risk of hypersexuality and uncontrollable gambling.
2016: The FDA issued a safety warning that compulsive gambling, binge eating, compulsive shopping and hypersexuality have been reported with use of aripiprazole.[20]
Health Canada updated the product label of atypical antipsychotics to warn that the drugs are associated with an increased risk of sleep apnea (a disorder that causes breaks in breathing or very shallow breathing during sleep).[21]
2017: The FDA approved a new warning in the product label of aripiprazole that stated that the drug may cause excessive sleepiness, low blood pressure upon sitting up or standing (postural hypotension) and problems with balance, all of which may increase the risk of falls and fractures in patients taking the drug.[22]
2023: In December, the Medicines and Healthcare products Regulatory Agency (agency in the United Kingdom similar to the FDA) issued an advisory on the risk of addictive gambling and impulse-control behaviors reported with aripiprazole. Reports of impulse-control behaviors included excessive eating or spending, or an abnormally high sex drive.[23]
Before You Use This Drug [top]
Tell your doctor if you have or have had:
Tell your doctor about any other drugs you take, including aspirin, blood pressure pills, other drugs for schizophrenia, herbs, vitamins, and other nonprescription products.
When You Use This Drug [top]
How to Use This Drug [top]
Interactions with Other Drugs [top]
The following drugs, biologics (e.g., vaccines, therapeutic antibodies), or foods are listed in Evaluations of Drug Interactions 2003 as causing “highly clinically significant” or “clinically significant” interactions when used together with any of the drugs in this section. In some sections with multiple drugs, the interaction may have been reported for one but not all drugs in this section, but we include the interaction because the drugs in this section are similar to one another. We have also included potentially serious interactions listed in the drug’s FDA-approved professional package insert or in published medical journal articles. There may be other drugs, especially those in the families of drugs listed below, that also will react with this drug to cause severe adverse effects. Make sure to tell your doctor and pharmacist the drugs you are taking and tell them if you are taking any of these interacting drugs:
Interactions with aripiprazole depend on the enzyme system that breaks down both drugs.
The dose of aripiprazole should be half the normal dose when also taking: amiodarone, CARDIOQUIN, CORDARONE, DIFLUCAN, fluconazole, fluoxetine, itraconazole, ketoconazole, NIZORAL, paroxetine, PAXIL, propafenone, PROZAC, QUINAGLUTE, QUINIDEX, quinidine, QUIN-RELEASE, RYTHMOL, SPORANOX.
The dose of aripiprazole should be doubled up to 30 milligrams if taken with these drugs: carbamazepine, TEGRETOL.
The dose of aripiprazole should be lowered to 10 or 15 milligrams if this drug is stopped: carbamazpeine, TEGRETOL.
When aripiprazole is taken with drugs that have anticholinergic effects, risk of dehydration and disruption of temperature control increases. A partial list includes: amitriptyline, ARTANE, atropine, belladonna, benztropine, COGENTIN, cyclobenzaprine, desipramine, ELAVIL, FLEXERIL, hyoscyamine, meclizine, NORPRAMIN, ORAP, oxybutin, pimozide, scopolamine, TRANS-DERM SCOP, tricyclic antidepressants, trihexyphenidyl.
An article published in the September 2018 issue of Worst Pills, Best Pills News (see here) provides an updated discussion of prescription medications that interact with aripiprazole. Refer to the article for a list of medications that interact with aripiprazole.
Adverse Effects [top]
Call your doctor immediately if you experience:
Call your doctor if you continue to experience:
Other adverse effects are possible. Check with your doctor about any concerns.
Signs of overdose:
If you suspect an overdose, call this number to contact your poison control center: (800) 222-1222.
Periodic Tests[top]
Ask your doctor which of these tests should be done periodically while you are taking this drug:
last reviewed January 1, 2024
Worst Pills, Best Pills is a project of Public Citizen's Health Research Group Group. As an independent, nonprofit organization, we take no corporate or government contributions and accept no advertising. Copyright © 2024 Public Citizen's Health Research Group. All rights reserved.
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