Prescription medication · Atypical Antipsychotic

aripiprazole

Also sold as Abilify. Aripiprazole is used to treat schizophrenia in adults and teens.

Data updated 2026-05-15

118,365
FDA reportsOften reported
19
InteractionsSeveral interactions
97% less
Generic vs brandHuge savings
3
Recall records

What the data shows

aripiprazole (Abilify) is a prescription Atypical Antipsychotic, more reported than most tracked drugs (118,365 FDA reports), whose generic costs a fraction of the brand (about 97% less).

Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.

aripiprazole (Abilify) is a prescription Atypical Antipsychotic. Aripiprazole is used to treat schizophrenia in adults and teens.

Aripiprazole (Abilify) is a medicine used to treat certain mental disorders and mood problems. It can help to improve your mood, thinking, and behavior.

Drug Pricing (NADAC)

Brand Price

$18.69/unit

Generic Price

$0.49/unit

Generic Savings

97%

Generic Available

Yes (26 manufacturers)

Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →

View Alternatives → Compare with Another Drug → Full Side Effects Report →

What it does

Aripiprazole is used to treat schizophrenia in adults and teens.

Common side effects

Nausea, Vomiting, Constipation

Key warnings

Aripiprazole may increase the risk of death in elderly patients who have psychosis related to dementia.

The sections below are summarized in plain English from aripiprazole's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.

How It Works

Aripiprazole works by affecting the levels of certain chemicals in the brain. These chemicals, like dopamine and serotonin, can affect mood and behavior. By balancing these chemicals, aripiprazole helps to reduce symptoms of mental health conditions.

Side Effects (from patient reports)

Based on 118,365 FDA adverse event reports.

Most-reported reactions

Adverse reactions in FAERS for aripiprazole, by number of reports

reports

What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.

Source FDA Adverse Event Reporting System (FAERS) As of 2025

Reports over time

Adverse-event reports filed for aripiprazole each year to the FDA Adverse Event Reporting System (FAERS).

05,00010,00015,000 200320062009201220152018202120242025 5,782

Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.

Where aripiprazole sits

aripiprazole has more FDA adverse-event reports than 88% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.

fewest reports most reports

Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is aripiprazole; the line is the median (50th percentile).

FDA Adverse Event Report Analysis

Detailed analysis of 118,365 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2003–2025.

Total Reports

118,365

Reports Mentioning Death

6,577

5.6% of reports — not proof of cause

Hospitalization Reports

34,687

Top Indication

Product Used For Unknown Indication

Gender Distribution

Female 60,556 (59%)
Male 41,802 (41%)

Age Distribution

0–17 11,199
18–44 30,152
45–64 21,738
65–74 5,335
75+ 2,585

Most Reported Adverse Reactions (FAERS)

# Reaction Reports
2 WEIGHT INCREASED 7,698
5 ANXIETY 4,993
6 FATIGUE 4,188
7 SUICIDAL IDEATION 3,991
8 DEPRESSION 3,950
9 NAUSEA 3,904
10 INSOMNIA 3,816
11 TREMOR 3,609
12 DRUG INTERACTION 3,589
13 SUICIDE ATTEMPT 3,504
14 SOMNOLENCE 3,484
15 HEADACHE 3,146
16 DIZZINESS 3,142
17 CONDITION AGGRAVATED 3,129
18 AKATHISIA 2,961

Reactions in Death Reports

DEATH 1,749
COMPLETED SUICIDE 1,282
TOXICITY TO VARIOUS AGENTS 592
CARDIAC ARREST 384
CARDIO-RESPIRATORY ARREST 373
OVERDOSE 277
DRUG INTERACTION 239
SUDDEN DEATH 207
PNEUMONIA 203
NEUROLEPTIC MALIGNANT SYNDROME 185

Reactions in Hospitalization Reports

SUICIDE ATTEMPT 2,001
SUICIDAL IDEATION 1,883
DRUG INTERACTION 1,771
WEIGHT INCREASED 1,718
ANXIETY 1,676
PSYCHOTIC DISORDER 1,536
NAUSEA 1,396
HOSPITALISATION 1,353
DEPRESSION 1,317
SOMNOLENCE 1,223

Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation

Serious Warnings

Aripiprazole may increase the risk of death in elderly patients who have psychosis related to dementia. It is not approved for this use. Antidepressants may increase the risk of suicidal thoughts and behaviors in children, teens, and young adults. Watch closely for worsening mood or suicidal thoughts.

Known Drug Interactions

In addition, no dosage adjustment is necessary for substrates of CYP2D6 (e.g., dextromethorphan, fluoxetine, paroxetine, or venlafaxine), CYP2C9 (e.g., warfarin), CYP2C19 (e.g., omeprazole, warfarin, escitalopram), or CYP3A4 (e.g., dextromethorphan) when co-administered with aripiprazole.

Mechanism: Aripiprazole does not change how your body processes omeprazole, so the levels of the medicine in your blood stay the same.

Additionally, no dosage adjustment is necessary for valproate, lithium, lamotrigine, lorazepam, or sertraline when co-administered with aripiprazole [see Clinical Pharmacology (12.3)] .

Mechanism: Aripiprazole does not interfere with the way your body handles sertraline.

In addition, no dosage adjustment is necessary for substrates of CYP2D6 (e.g., dextromethorphan, fluoxetine, paroxetine, or venlafaxine), CYP2C9 (e.g., warfarin), CYP2C19 (e.g., omeprazole, warfarin, escitalopram), or CYP3A4 (e.g., dextromethorphan) when co-administered with aripiprazole.

Mechanism: Aripiprazole does not affect the levels of escitalopram in your body.

7 DRUG INTERACTIONS Dosage adjustment due to drug interactions (7.1): Factors Dosage Adjustments for Aripiprazole Known CYP2D6 Poor Metabolizers Administer half of usual dose Known CYP2D6 Poor Metabolizers and strong CYP3A4 inhibitors Administer a quarter of usual dose Strong CYP2D6 or CYP3A4 inhibitors Administer half of usual dose Strong CYP2D6 and CYP3A4 inhibitors Administer a quarter of usual dose Strong CYP3A4 inducers Double usual dose over 1 to 2 weeks 7.1 Drugs Having Clinically Important Interactions with Aripiprazole Table 25: Clinically Important Drug Interactions with...

Mechanism: Fluoxetine blocks the enzymes that break down aripiprazole, which can cause the drug to build up to higher levels in your body.

7.2 Drugs Having No Clinically Important Interactions with Aripiprazole Based on pharmacokinetic studies, no dosage adjustment of aripiprazole is required when administered concomitantly with famotidine, valproate, lithium, lorazepam.

Mechanism: These two drugs do not significantly change how the body processes or removes each other.

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This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.

Common Questions

Can I stop taking aripiprazole suddenly?
Do not stop taking aripiprazole without talking to your doctor first. Stopping suddenly can cause withdrawal symptoms.
Will aripiprazole make me gain weight?
Weight gain is a possible side effect. Talk to your doctor about diet and exercise.
Can I drink alcohol while taking aripiprazole?
It is best to avoid alcohol while taking aripiprazole, as it can worsen side effects.
How long does it take for aripiprazole to work?
It may take several weeks for aripiprazole to fully work. Continue taking it as prescribed, even if you don't feel better right away.
What should I do if I experience side effects?
Tell your doctor about any side effects you experience. They may be able to adjust your dose or suggest ways to manage them.
Can I take other medications with aripiprazole?
Tell your doctor about all the medications you take, including over-the-counter drugs and supplements. Some medications can interact with aripiprazole.
Does aripiprazole cause drowsiness?
Aripiprazole can cause drowsiness in some people. Be careful when driving or operating machinery until you know how it affects you.
What if my symptoms get worse?
Contact your doctor immediately if your symptoms worsen or if you have any new or worsening suicidal thoughts or behaviors.
How often will I see my doctor while taking aripiprazole?
Your doctor will want to see you regularly to monitor your progress and check for side effects.
Is aripiprazole addictive?
Aripiprazole is not considered addictive, but it is important to take it as prescribed by your doctor.
What are the common side effects of aripiprazole?
The registry lists Nausea, Vomiting, Constipation, Headache, Dizziness among the most-reported FAERS reaction terms for aripiprazole. The compiled record contains 118,365 FDA adverse-event reports. These counts are not an individual symptom assessment.
Does aripiprazole interact with other medications?
The registry has 19 documented interaction rows for aripiprazole. Notable source-record pairings include omeprazole, sertraline, escitalopram. These rows are not a complete medication review.
What drug class is aripiprazole?
aripiprazole belongs to the Atypical Antipsychotic drug class. It requires a prescription (Rx). Aripiprazole is used to treat schizophrenia in adults and teens.
Is there a generic version of aripiprazole?
Yes, generic aripiprazole is available from 26 manufacturers. The generic costs $0.49 per unit compared to $18.69 for the brand version, saving approximately 97%. Pricing is based on NADAC (National Average Drug Acquisition Cost) data from CMS.
What pregnancy or breastfeeding source fields are listed for aripiprazole?
The FDA label for aripiprazole contains product-specific pregnancy or breastfeeding language. PlainMeds does not apply that source text to an individual.
Has aripiprazole been recalled?
There are 3 recalls associated with aripiprazole products. Cross Contamination with Other Products. Check the recalls section below for full details and affected products.

Active Recalls

Class III April 9, 2024

Cross Contamination with Other Products

Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.

Class III April 9, 2024

Cross Contamination with Other Products

Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.

Class III April 9, 2024

Cross Contamination with Other Products

Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.

Other drugs grouped near aripiprazole - same-class peers and common alternatives.

Compare aripiprazole vs acamprosate side-by-side →

Compare beyond drug class

Nationwide peers by FAERS volume & death-report share

Two PlainMeds-derived comparison paths for aripiprazole: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.

Medication Guides

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What the FDA Data Shows for aripiprazole

The FDA label for aripiprazole (sold under brand names such as Abilify) classifies it as a prescription-only medication in the Atypical Antipsychotic class. Aripiprazole is used to treat schizophrenia in adults and teens. Official labeling lists 8 commonly reported side effects, including Nausea, Vomiting, Constipation.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 118,365 voluntary reports. The database also lists 19 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated minor severity. NADAC pricing from CMS shows a generic unit cost of $0.49 versus $18.69 for the brand - a 97% generic savings.

Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 3 recall records on file), and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.

Data Sources

Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).

FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.

Last updated: February 3, 2025

PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.

Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.

All federal data sources used on this page