aripiprazole

Sold as Abilify, Opipza. First FDA approval 11/15/2002: 24 years on the US market.

This grade answers one narrow question: how strong is the public evidence and safety record behind this drug, and how clean is its money trail and court record? It is not a verdict on whether the drug is right for you.

Score breakdown (70/100)

Safety ×35%

Evidence ×25%

Regulatory ×15%

Money & lawsuits ×15%

Options ×10%

Safety: 54

Carries an FDA boxed warning, the strongest warning the FDA issues (-30)
FDA issued 1 Drug Safety Communication(s) naming this drug since 2010, most recently 2016 (-8)
3,786 FDA reports naming it as the suspect drug per million Medicare fills, 1.4x the median drug on this site (-3)
Death share in reports is near or below the FAERS average (0.6x)
Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)

Evidence: 78

314 randomized trials and 92 systematic reviews/meta-analyses indexed in PubMed
On the WHO Model List of Essential Medicines (shown for context; no score effect)
12 independent Cochrane review(s) exist
'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)

Regulatory history: 80

Recalls since 2016: 0 Class I, 13 Class II, 4 Class III across 37 generic makers (-7)
11 label changes approved since 2021: the safety story is still moving (-8)
Label lists recent major changes to warnings or indications (-5)

Money & lawsuits: 85

Maker paid $515 million in 2007 to settle federal allegations naming this drug (Off-label promotion, kickbacks, Medicare fraud) (-15)
Pharma paid doctors $877 tied to this drug last year: negligible
Not named in any pending federal MDL

Options: 70

Generic versions approved (37 applications)
No same-class alternatives found: little leverage to switch (-30)

FDA boxed warning

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDAL THOUGHTS AND BEHAVIORS WITH ANTIDEPRESSANT DRUGS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ABILIFY 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) ] . WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDAL THOUGHTS AND BEHAVIO...

Independent reviews and post-approval warnings

FDA Drug Safety Communications

05/2016 FDA warns about new impulse-control problems associated with mental health drug aripiprazole (Abilify, Abilify Maintena, Aristada)

Warnings the FDA chose to announce publicly after approval, as opposed to quiet label edits. Class-wide items name the drug's class, not this drug specifically.

WHO Essential Medicine

Listed on the WHO Model List of Essential Medicines: a global expert panel judged it among the medicines a health system should always have, on evidence of value, not marketing.

What the FDA label says

Approved uses

(aripiprazole) Tablets are indicated for the treatment of: Schizophrenia Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder Adjunctive Treatment of Major Depressive Disorder Irritability Associated with Autistic Disorder Treatment of Tourette's Disorder ABILIFY is an atypical antipsychotic. ABILIFY is indicated for: Schizophrenia ( 14.1 ) Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder ( 14.2 ) Adjunctive Treatment of Major Depressive Disorder ( 14.3 ) Irritability Associated with Autistic Disorder ( 14.4 ) Treatment of Tourette's Disorder ( 14.5 )

Contraindications

is contraindicated in patients with a history of a hypersensitivity reaction to aripiprazole. Reactions have ranged from pruritus/urticaria to anaphylaxis [see Adverse Reactions (6.2) ] . Known hypersensitivity to ABILIFY ( 4 )

Warnings and precautions

Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis: Increased incidence of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack, including fatalities) ( 5.1 , 5.2 ) Neuroleptic Malignant Syndrome: Manage with immediate discontinuation and close monitoring ( 5.4 ) Tardive Dyskinesia: Discontinue if clinically appropriate ( 5.5 ) Metabolic Changes: Atypical antipsychotic drugs have been associated with metabolic changes that include hyperglycemia/diabetes mellitus, dyslipidemia, and body weight gain ( 5.6 ) Hyperglycemia/Diabetes Mellitus: Monitor glucose regularly in patients with and at risk for diabetes ( 5.6 ) Dyslipidemia: Undesirable alterations in lipid levels have been observed in patients treated with atypical antipsychotics ( 5.6 ) Weight Gain: Weight gain has been observed with atypical antipsychotic use. Monitor weight ( 5.6 ) Pathological Gambling and Other Compulsive Behaviors: Consider dose reduction or discontinuation ( 5.7 ) Orthostatic Hypotension: Monitor heart rate and blood pressure and warn patients with known cardiovascular or cerebrovascular disease, and risk of dehydration or syncope ( 5.8 ) Leukopenia,...

Adverse reactions (label)

The following adverse reactions are discussed in more detail in other sections of the labeling: Increased Mortality in Elderly Patients with Dementia-Related Psychosis [see Boxed Warning and Warnings and Precautions (5.1) ] Cerebrovascular Adverse Events, Including Stroke [see Warnings and Precautions (5.2) ] Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults [see Boxed Warning and Warnings and Precautions (5.3) ] Neuroleptic Malignant Syndrome (NMS) [see Warnings and Precautions (5.4) ] Tardive Dyskinesia [see Warnings and Precautions (5.5) ] Metabolic Changes [see Warnings and Precautions (5.6) ] Pathological Gambling and Other Compulsive Behaviors [see Warnings and Precautions (5.7) ] Orthostatic Hypotension [see Warnings and Precautions (5.8) ] Falls [see Warnings and Precautions (5.9) ] Leukopenia, Neutropenia, and Agranulocytosis [see Warnings and Precautions (5.10) ] Seizures/Convulsions [see Warnings and Precautions (5.11) ] Potential for Cognitive and Motor Impairment [see Warnings and Precautions (5.12) ] Body Temperature Regulation [see Warnings and Precautions (5.13) ] Suicide [see Warnings and Precautions (5.14) ] Dysphagia [see Warnings and Pre...

Recent major label changes

Indications and Usage ( 1 ) 1/2025 Dosage and Administration Agitation Associated with Schizophrenia or Bipolar Mania (Intramuscular Injection) (2.6) Removed 1/2025 Dosing of Oral Solution (2.8) Removed 1/2025 Dosing of Orally Disintegrating Tablet (2.9) Removed 1/2025 Warnings and Precautions Orthostatic Hypotension ( 5.8 ) 1/2025 Seizures/Convulsions ( 5.11 ) 1/2025 Potential for Cognitive and Motor Impairment ( 5.12 ) 1/2025

Source: FDA SPL label for ABILIFY (Otsuka America Pharmaceutical, Inc.), effective 20250129. Full label on DailyMed.

Side-effect reports sent to the FDA

These are counts of reports people filed, not rates of harm. Anyone can file one, and nobody checks whether the drug was the cause. Millions of doses are taken for every report sent, so the useful part is how this drug compares with the average across all drugs.

95,821reports that mention this drug

95,004of those blame this drug, not another one the person was taking

71%of reports describe a serious outcome, such as a hospital stay (average for all drugs: 57%)

5.6%of reports include a death, from any cause (average for all drugs: 9.1%)

Problems reported most often

Drug Ineffective · 7,538Off Label Use · 7,452Weight Increased · 5,780Product Use In Unapproved Indication · 5,393Anxiety · 4,377Fatigue · 3,636Suicidal Ideation · 3,501Nausea · 3,274Suicide Attempt · 3,248Depression · 3,235Drug Interaction · 3,180Condition Aggravated · 3,062Insomnia · 2,970Somnolence · 2,945Tremor · 2,720

Reports per year

2019	2020	2021	2022	2023	2024	2025	2026
6,944	7,018	8,141	6,228	6,583	6,724	5,887	3,308

3,786 reports blaming this drug for every million Medicare prescriptions filled, which is 1.4× the typical drug on this site. (15,568 reports in 2024–2026, against 4,111,568 Medicare fills in one year. This is the one number here that accounts for how many people take the drug.)

Source: the FDA's Adverse Event Reporting System (FAERS). Reports are voluntary and unverified. Drugs that are prescribed a lot, in the news, or in lawsuits attract more reports, so the percentages are compared with the whole database to correct for that partly, not fully.

Recalls and regulatory record

18recall actions on file

9 / 37brand / generic applications

11label changes since 2021

NoREMS program

Date	Class	Firm	Reason
05/2026	Class II	Ajanta Pharma USA Inc	Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg.
08/2025	Class II	Ascend Laboratories, LLC	Superpotent drug
04/2024	Class III	Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.	Cross Contamination with Other Products
04/2024	Class III	Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.	Cross Contamination with Other Products
04/2024	Class III	Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.	Cross Contamination with Other Products
04/2024	Class III	Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.	Cross Contamination with Other Products
03/2023	Class II	Ascend Laboratories, LLC	Out of specification (OOS) for Spectroscopic Identification test by IR.
02/2023	Class II	Accord Healthcare, Inc.	CGMP Deviations: recalling drug products following an FDA inspection.
02/2023	Class II	Accord Healthcare, Inc.	CGMP Deviations: recalling drug products following an FDA inspection.
02/2023	Class II	Accord Healthcare, Inc.	CGMP Deviations: recalling drug products following an FDA inspection.
02/2023	Class II	Accord Healthcare, Inc.	CGMP Deviations: recalling drug products following an FDA inspection.
02/2023	Class II	Accord Healthcare, Inc.	CGMP Deviations: recalling drug products following an FDA inspection.

Class I = reasonable probability of serious harm. Class II = temporary or reversible harm. Class III = unlikely to harm. Most generic recalls are manufacturing or labeling defects for one lot, not a verdict on the molecule.

Evidence base

314randomized trials (PubMed)

92systematic reviews

467registered trials

53%of completed trials posted results

13%terminated or withdrawn

59%industry-funded

Independent Cochrane reviews

Counts measure how much evidence exists and how transparent it is, not how big the benefit is. For that, ask your prescriber: if 100 people like me took this, how many would get better because of it, and how many would be harmed? (Doctors call these the "number needed to treat" and "number needed to harm.") It differs by condition and is the number drug ads leave out. Sources: PubMed, ClinicalTrials.gov.

Money and lawsuits

In 2024, drug companies reported $877 in payments to US physicians and hospitals tied to this drug across 31 transactions (Abilify $877).

No pending federal MDL names this drug or its brands.

Settlements of federal marketing and pricing allegations

2007 · Bristol-Myers Squibb · $515 million
Off-label promotion, kickbacks, Medicare fraud Record

Settlements of $100M+ in which this drug (Abilify) was a named product, as recorded by the Department of Justice. A settlement resolves allegations; civil settlements are not admissions and not findings of wrongdoing. They are shown because off-label promotion cases describe how the evidence many prescribers saw was shaped.

Sources: CMS Open Payments (Sunshine Act); Judicial Panel on Multidistrict Litigation pending docket list; DOJ settlements as tabulated on Wikipedia with links to the primary record. State-court and individual suits are not included.

Who takes it and what it costs

684,239Medicare Part D patients (2024)

4,111,568prescriptions filled

$235average cost per fill

$968Mtotal Medicare spend

Product	Fills	$/fill
Aripiprazole	3,844,727	$64
Abilify Maintena	235,220	$2,739
Aripiprazole ODT	12,808	$637
Abilify Asimtufii	11,621	$5,433
Abilify	7,139	$991
Abilify Mycite	53	$1,704

Same-class alternatives

No same-class alternatives found in RxClass.

Questions to ask your prescriber

In 2016 the FDA issued a safety communication about this drug (FDA warns about new impulse-control problems associated with mental health drug aripiprazole (Abilify, Abilify). Does that risk apply to me?
The maker paid $515 million in 2007 to settle federal allegations about how this drug was marketed. Is my use one of the uses that was promoted improperly?
This drug carries a boxed warning. Which specific risk does it cover, and does it apply to me?
The most-reported problems in FDA's adverse event data are weight increased, product use in unapproved indication. How would we recognize and handle those?
Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?
What result are we expecting, by when, and what is the plan if it does not happen?
If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)