Atypical Antipsychotic · Brand: Abilify Maintena, Abilify Maintena Kit + 3 more

Aripiprazole Side Effects: Common, Serious & FDA Warnings

Creator: MedivaScan
Published: 2026-05-28T04:28:23.034875+00:00

Verified from FDA on May 28, 2026Refreshes every 6 hoursFDA-Sourced

FDA-Approved For

Quick answer

Based on 123,000+ FDA adverse event reports, the most-reported aripiprazole reactions include weight increased, product use in unapproved indication, and anxiety. FDA reports 6 active Class II recalls of aripiprazole, primarily for failed dissolution specifications. The FDA-approved label carries a boxed warning.

For information only. MedivaScan summarizes public FDA data and is not medical advice. Consult a healthcare professional before changing any medication. If you experience a serious reaction, contact your doctor or call 911.

FDA Boxed Warning

WARNINGS: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS AND SUICIDAL THOUGHTS AND BEHAVIOURS WITH ANTIDEPRESSANT DRUGS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Aripiprazole is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (5.1)]. Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24 years; there was a reduction in risk with antidepressant use in patients aged 65 years and older [see Warnings and Precautions (5.3)]. In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [see Warnings and Precautions (5.3)]. WARNINGS: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; AND SUICIDAL THOUGHTS AND BEHAVIOURS WITH ANTIDEPRESSANT DRUGS See full prescribing information for complete boxed warning. • Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Aripiprazole is not approved for the treatment of patients with dementia-related psychosis. (5.1) • Increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants. Monitor for worsening and emergence of suicidal thoughts and behaviors. (5.3)

Common Side Effects of Aripiprazole

The most-reported reactions in the FDA Adverse Event Reporting System (FAERS) for aripiprazole. Percentages reflect the share of reports mentioning each reaction; a single report may include multiple reactions. Reports indicate co-occurrence, not causation.

Reaction	Reports	% of total
Weight Increased	7,929	6.4%
Product Use In Unapproved Indication	5,301	4.3%
Anxiety	5,176	4.2%
Fatigue	4,366	3.5%
Depression	4,092	3.3%
Nausea	4,034	3.3%
Suicidal Ideation	4,083	3.3%
Insomnia	3,929	3.2%
Drug Interaction	3,651	3.0%
Tremor	3,739	3.0%

Source: FDA FAERS·Updated May 28, 2026·n=123,730+·verify on FDA →·Methodology

Serious Outcomes and FDA Warnings

FAERS reports flagged with a serious outcome (death, hospitalization, life-threatening, disability, or congenital anomaly), plus reactions surfaced in the FDA-approved label's Warnings section. Reports indicate co-occurrence, not causation.

Outcome flag	Reports	% of total
Serious reports (any flag)	—	—
Hospitalization	—	—

From the FDA-approved label, Section 5.1: Increased Mortality in Elderly Patients with Dementia-Related Psychosis

Increased Mortality Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Aripiprazole is not approved for the treatment of patients with dementia-related psychosis [see Boxed Warning]. Safety Experience in Elderly Patients with Psychosis Associated with Alzheimer’s Disease In three, 10 week, placebo-controlled studies of aripiprazole in elderly patients with psychosis associated with Alzheimer’s disease (n=938; mean age: 82.4 years; range: 56 to 99 years), the adverse reactions that were reported at an incidence of ≥3% and aripiprazole incidence at least twice that for placebo were lethargy [placebo 2%, aripiprazole 5%], somnolence (including sedation) [placebo 3%, aripiprazole 8%], and incontinence (primarily, urinary incontinence) [placebo 1%, aripiprazole 5%], excessive salivation [placebo 0%, aripiprazole 4%], and lightheadedness [placebo 1%, aripiprazole 4%].
Show full Section 5.1See less
The safety and efficacy of aripiprazole in the treatment of patients with psychosis associated with dementia have not been established. If the prescriber elects to treat such patients with aripiprazole, assess for the emergence of difficulty swallowing or excessive somnolence, which could predispose to accidental injury or aspiration [see Boxed Warning].

From the FDA-approved label, Section 5.4: Neuroleptic Malignant

Syndrome (NMS) A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) may occur with administration of antipsychotic drugs, including aripiprazole. Rare cases of NMS occurred during aripiprazole treatment in the worldwide clinical database. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia).
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Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a diagnosis, it is important to exclude cases where the clinical presentation includes both serious medical illness (e.g., pneumonia, systemic infection) and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever, and primary central nervous system pathology. The management of NMS should include: 1) immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent therapy; 2) intensive symptomatic treatment and medical monitoring; and 3) treatment of any concomitant serious medical problems for which specific treatments are available. There is no general agreement about specific pharmacological treatment regimens for uncomplicated NMS. If a patient requires antipsychotic drug treatment after recovery from NMS, the potential reintroduction of drug therapy should be carefully considered. The patient should be carefully monitored since recurrences of NMS have been reported.

Source: DailyMed (aripiprazole label)·Updated May 28, 2026

Aripiprazole Recalls

FDA enforcement actions matched to aripiprazole via openFDA's structured generic_name field and the NDC bridge. Ongoing recalls are listed below (verify on FDA →); closed recalls are grouped in the disclosure that follows.

Date	Reason	Class	Quantity	Status
2025-09-24	Superpotent drug Ascend Laboratories, LLC	Class II	2,256 bottles	Ongoing
2024-05-01	Cross Contamination with Other Products Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.	Class III	N/A	Ongoing
2024-05-01	Cross Contamination with Other Products Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.	Class III	N/A	Ongoing
2024-05-01	Cross Contamination with Other Products Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.	Class III	108,192/30 count bottles or 7 count blister packs	Ongoing
2024-05-01	Cross Contamination with Other Products Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.	Class III	N/A	Ongoing
2023-04-26	Out of specification (OOS) for Spectroscopic Identification test by IR. Ascend Laboratories, LLC	Class II	135 bottles	Ongoing

Source: FDA Drug Enforcement Reports·Updated May 28, 2026·Refreshes every 6 hours·verify on FDA →

Show 11 closed recalls (2013 to 2024)

Includes resolved and terminated recalls matched to aripiprazole. Most recent first.

Date	Reason	Class	Quantity	Status
2024-01-03	CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. CARDINAL HEALTHCARE	Class II	2 units	Terminated
2023-03-08	CGMP Deviations: recalling drug products following an FDA inspection. Accord Healthcare, Inc.	Class II	747,464 bottles	Terminated
2023-03-08	CGMP Deviations: recalling drug products following an FDA inspection. Accord Healthcare, Inc.	Class II	539,004 bottles	Terminated
2023-03-08	CGMP Deviations: recalling drug products following an FDA inspection. Accord Healthcare, Inc.	Class II	1,109,904 bottles	Terminated
2023-03-08	CGMP Deviations: recalling drug products following an FDA inspection. Accord Healthcare, Inc.	Class II	88,728 bottles	Terminated
2023-03-08	CGMP Deviations: recalling drug products following an FDA inspection. Accord Healthcare, Inc.	Class II	312,864 bottles	Terminated
2023-03-08	CGMP Deviations: recalling drug products following an FDA inspection. Accord Healthcare, Inc.	Class II	170,448 bottles	Terminated
2020-07-01	Labeling: Label mix up: Bottles labeled as aripiprazole 2 mg, 30 count had aripiprazole 5 mg tablets, 100 count. Alembic Pharmaceuticals Limited	Class II	19,153 bottles	Terminated
2018-02-21	CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications. AMERICAN HEALTH PACKAGING	Class II	270 cartons	Terminated
2018-02-14	CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications. Hetero Labs, Ltd. - Unit III	Class II	3000 bottles	Terminated
2013-03-13	CGMP Deviations: A drum of Abilify 30 mg Tablets rejected during the compression stage was not segregated from the other portion of the lot and was inadvertently shipped, packaged and distributed. Bristol Myers Squibb Manufacturing Company	Class II	21 blister packs	Terminated

Aripiprazole Shortages

FDA-listed shortages of aripiprazole products. Strength and dosage-form level detail.

No active or recent shortages of aripiprazole are listed. We refresh this view daily.

Source: FDA Drug Shortages·Updated May 28, 2026

Is Aripiprazole Safe?

Aripiprazole is FDA-approved. The label's Warnings and Precautions section covers increased mortality in elderly patients with dementia-related psychosis (Section 5.1), cerebrovascular adverse events, including (Section 5.2), suicidal thoughts and behaviors in children, adolescents, and young adults (Section 5.3), neuroleptic malignant (Section 5.4), tardive (Section 5.5), metabolic changes (Section 5.6), normal to (Section 5.3), pathological gambling and other compulsive behaviors (Section 5.7), orthostatic hypotension (Section 5.8), falls (Section 5.9), leukopenia, neutropenia, and (Section 5.10), seizures/convulsions (Section 5.11), potential for cognitive and motor impairment (Section 5.12), body temperature regulation (Section 5.13), suicide (Section 5.14), dysphagia (Section 5.15).

As with any prescription, the assessment of safety is individual; consult a clinician about your own risk profile.

Source: DailyMed (aripiprazole label)·Updated May 28, 2026

FDA-Approved Indications

Aripiprazole is FDA-approved for use in the condition categories below. The FDA-approved label’s Indications and Usage section is shown verbatim.

Aripiprazole is indicated for the treatment of: • Schizophrenia • Irritability Associated with Autistic Disorder • Treatment of Tourette’s Disorder Aripiprazole is an atypical antipsychotic. The oral formulations are indicated for: • Schizophrenia (14.1) • Irritability Associated with Autistic Disorder (14.4) • Treatment of Tourette’s disorder (14.5)

Source: DailyMed (aripiprazole label)·Updated May 28, 2026·Section 1 (Indications and Usage)

Frequently Asked Questions

What are the most-reported side effects of aripiprazole?

Weight increased, product use in unapproved indication, and anxiety are among the most-reported reactions in FDA FAERS data for aripiprazole. The full ranking, with reaction counts and the share of total reports, is in the Common Side Effects table above. Reports indicate co-occurrence, not causation; consult a clinician about your specific case.

Is aripiprazole the same as Abilify Maintena?

Aripiprazole is the generic name; Abilify Maintena is a brand name for the same active ingredient. Other brand names include Abilify Maintena Kit, Opipza, Abilify Asimtufii, and Abilify. The active ingredient is identical; formulation and inactive ingredients may vary by manufacturer.

Has aripiprazole been recalled?

Yes. Aripiprazole has active and closed recalls on record in the FDA enforcement database. Reasons are dominated by CGMP deviations, contamination or foreign material, and mislabeling. See the recalls table on this page for current counts, firm names, dates, and lot quantities.

What are aripiprazole's current ongoing recalls about?

Active aripiprazole recalls are listed in the recalls table above with their class, reason, firm, and affected lots. The dominant reasons across these recalls are contamination or foreign material and subpotent or out-of-spec content. For lot numbers, distribution patterns, and the FDA enforcement record for any individual recall, follow the verify-on-FDA link from each row.

What do FDA recall classes mean?

Class I means a reasonable probability of serious adverse health consequences or death. Class II means temporary or medically reversible adverse health consequences with remote probability of serious harm. Class III means use of the product is unlikely to cause adverse health consequences. The class assignment is the FDA's, not the manufacturer's.

Does aripiprazole have an FDA boxed warning?

Yes. The FDA-approved label for aripiprazole carries a boxed warning. Boxed warnings are the FDA's strongest cautions. See the "FDA Boxed Warning" section above for the verbatim warning text.

Data Sources & Methodology

How each section of this page is sourced, and how often the data is refreshed.

Source	Endpoint	Refresh
FAERS reactions	openFDA `/drug/event.json` count API. Aggregated per drug per reaction term; we do not store individual reports.	Daily
Recalls	openFDA `/drug/enforcement.json`. Drugs matched via three confidence-tracked strategies: structured generic name (HIGH), NDC code bridge (MEDIUM), text token parse (LOW). Only HIGH and MEDIUM matches surface here.	6 hours
Shortages	FDA Drug Shortages list.	Daily
Boxed warnings & label sections	openFDA `/drug/label.json`. Labels are stable; monthly cadence is sufficient.	Monthly
Condition categories	Synonym-mapped from drug_labels.indications. Methodology at /methodology/.	Per-drug

What we do not do. We do not invent, paraphrase, or extrapolate drug claims. Every figure on this page comes from a query against an openFDA endpoint. If the data is unavailable, the section gracefully omits rather than filling the space with editorial guesswork.