Prescription medicine
Aripiprazole Brand names: Abilify, Opipza
Aripiprazole (Abilify) is a prescription medicine with an FDA approval on record since 2002. FDA's NDC Directory lists it from 47 generic labelers, and pharmacies paid $0.110 per aripiprazole 5 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the aripiprazole FDA label on DailyMed (effective January 29, 2025, Otsuka America Pharmaceutical, Inc.); the NDA 21436 record on Drugs@FDA; every aripiprazole label on DailyMed.
Highlights of the record
FDA label of January 29, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
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 BEHAVIORS 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. […]
Used for
From the label: indications and usageABILIFY (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.
Forms and strengths
- 2 mg
- 5 mg
- 10 mg
- 15 mg
- 20 mg
- 30 mg
- 1 mg/ml
- 720 mg/2.4ml
- 960 mg/3.2ml
Tablet; orally disintegrating tablet; solution; kit; soluble film.
On the market
- Earliest approval on file
- November 15, 2002 Abilify, Otsuka; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 37 first April 28, 2015; 27 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 50 of which 47 under generic applications, 3 under brand applications, repackagers included
- Last listed patent
- March 2, 2027 Abilify tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.110 per tablet Aripiprazole 5 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 25 since 2012 0 Class I among all firms' recalls; latest May 27, 2026; 2 more by firms not listed as its makers
- FAERS reports
- 121,736 through July 30, 2026
What is aripiprazole used for?
From the label: indications and usageABILIFY (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
Conditions named in the indications of aripiprazole's FDA labels, with every medicine labeled for each:
From other aripiprazole labelsSchizophrenia: OPIPZA is indicated for the: treatment of schizophrenia in patients ages 13 years and older adjunctive treatment of major depressive disorder (MDD) in adults treatment of irritability associated with autistic disorder in pediatric patients …
FDA pharmacologic class: Atypical Antipsychotic.
Source: FDA drug label (ABILIFY), Otsuka America Pharmaceutical, Inc., effective January 29, 2025 (SPL set c040bd1d-45b7-49f2-93ea-aed7220b30ac), via openFDA; the full label on DailyMed
What does the patient leaflet for aripiprazole say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about ABILIFY?(For other side effects, also see " What are the possible side effects of ABILIFY? ") Serious side effects may happen when you take ABILIFY, including: Increased risk of death in elderly patients with dementia-related psychosis: Medicines like ABILIFY can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). ABILIFY is not approved for the treatment of patients with dementia-related psychosis. Risk of suicidal thoughts or actions: Antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions: Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member? Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed. Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings. Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms. […]
From the patient leaflet: What should I avoid while taking ABILIFY?Do not drive, operate heavy machinery, or do other dangerous activities until you know how ABILIFY affects you. ABILIFY may make you drowsy. Avoid getting over-heated or dehydrated. Do not over-exercise. In hot weather, stay inside in a cool place if possible. Stay out of the sun. Do not wear too much or heavy clothing. Drink plenty of water.
From the patient leaflet: How should I store ABILIFY?Store ABILIFY at room temperature, between 68°F to 77°F (20°C to 25°C). Keep ABILIFY and all medicines out of the reach of children.
Source: FDA drug label (ABILIFY), Otsuka America Pharmaceutical, Inc., effective January 29, 2025 (SPL set c040bd1d-45b7-49f2-93ea-aed7220b30ac), via openFDA; the full label on DailyMed
Is there a generic for aripiprazole (Abilify)?
The FDA approved the first generic aripiprazole on April 28, 2015. 37 generic applications are approved; 27 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 5 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists aripiprazole from 47 labelers under a generic (ANDA) application and from 3 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 2 patents for Abilify tablets, the last expiring on March 2, 2027; a patent listed only for Opipza film runs to December 15, 2041. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2002 earliest approval on file
- 2015 first generic approved
- 2027 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for aripiprazole (Abilify)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.110 per Aripiprazole 5 mg tablet, up 3% from $0.106 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Aripiprazole 5 mg tablet (generic)
- Abilify 10 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Aripiprazole 1 mg/mL solution | Generic | $0.331 per mL | n/a | -36% |
| Aripiprazole 10 mg tablet | Generic | $0.112 per tablet | $3.35 | -16% |
| Aripiprazole 15 mg tablet | Generic | $0.131 per tablet | $3.94 | -0.1% |
| Aripiprazole 2 mg tablet | Generic | $0.115 per tablet | $3.44 | -6% |
| Aripiprazole 20 mg tablet | Generic | $0.174 per tablet | $5.23 | +1% |
| Aripiprazole 30 mg tablet | Generic | $0.173 per tablet | $5.20 | +3% |
| Aripiprazole 5 mg tablet | Generic | $0.110 per tablet | $3.29 | +3% |
| Aripiprazole ODT 10 mg tablet | Generic | $2.47 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $74.10 | -29% |
| Aripiprazole ODT 15 mg tablet | Generic | $2.22 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $66.72 | -49% |
| Abilify 10 mg tablet | Brand | $18.62 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $558.47 | -0.5% |
| Abilify 15 mg tablet | Brand | $18.65 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $559.56 | +0.1% |
| Abilify 2 mg tablet | Brand | $18.66 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $559.66 | +0.1% |
| Abilify 20 mg tablet | Brand | $26.25 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $787.51 | -0.3% |
| Abilify 30 mg tablet | Brand | $26.23 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $786.95 | no change |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has aripiprazole been recalled?
The FDA's Enforcement Report lists 27 recalls naming aripiprazole since 2012: 0 Class I (the most serious), 21 Class II, 6 Class III; 7 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of aripiprazole and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| May 27, 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. |
| August 28, 2025 | Class II | Ascend Laboratories, LLC | Superpotent drug |
| April 9, 2024 | Class III | Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. | Cross Contamination with Other Products |
| March 20, 2023 | Class II | RemedyRepack Inc. | cGMP Deviations |
| March 17, 2023 | Class II | Ascend Laboratories, LLC | Out of specification (OOS) for Spectroscopic Identification test by IR. |
| February 7, 2023 | Class II | Accord Healthcare, Inc. | CGMP Deviations: recalling drug products following an FDA inspection. |
| July 7, 2022 | Class II | Apotex Corp. | Failed dissolution specifications: OOS for dissolution at the 12-month stability time point. |
| January 26, 2022 | Class II | CARDINAL HEALTHCARE | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the aripiprazole label say about other medicines?
The aripiprazole label names 18 other medicines in its interaction, contraindication or warning sections. The labels of 14 other medicines name aripiprazole. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Carbamazepine | drug interactions | Concomitant Drug Name or Drug Class: Strong CYP3A4 Inducers (e.g., carbamazepine, rifampin); Clinical Rationale: Concomitant use of ABILIFY and carbamazepine decreased the exposure of aripiprazole compared to the use of ABILIFY alone [see ].; … |
| Clarithromycin | drug interactions | Concomitant Drug Name or Drug Class: Strong CYP3A4 Inhibitors (e.g., itraconazole, clarithromycin) or strong CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine); Clinical Rationale: Concomitant use of ABILIFY with strong CYP3A4 or CYP2D6 inhibitors increased the exposure of aripiprazole compared to the use of … |
| Dextromethorphan | 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 coadministered with ABILIFY. |
| Escitalopram | 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 coadministered with ABILIFY. |
| Famotidine | drug interactions | Interactions with ABILIFY Based on pharmacokinetic studies, no dosage adjustment of ABILIFY is required when administered concomitantly with famotidine, valproate, lithium, and lorazepam. |
| Fluoxetine | drug interactions | Concomitant Drug Name or Drug Class: Strong CYP3A4 Inhibitors (e.g., itraconazole, clarithromycin) or strong CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine); Clinical Rationale: Concomitant use of ABILIFY with strong CYP3A4 or CYP2D6 inhibitors increased the exposure of aripiprazole compared to the use of … |
| Itraconazole | drug interactions | Concomitant Drug Name or Drug Class: Strong CYP3A4 Inhibitors (e.g., itraconazole, clarithromycin) or strong CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine); Clinical Rationale: Concomitant use of ABILIFY with strong CYP3A4 or CYP2D6 inhibitors increased the exposure of aripiprazole compared to the use of … |
| Ketoconazole | drug interactions | Concomitant Drug Name or Drug Class: Strong CYP3A4 Inhibitors (e.g., ketoconazole) or strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine); Clinical Rationale: The concomitant use of oral aripiprazole with strong CYP3A4 or CYP2D6 inhibitors increased the exposure of aripiprazole [see ].; … |
| Lamotrigine | drug interactions | Additionally, no dosage adjustment is necessary for valproate, lithium, lamotrigine, lorazepam, or sertraline when coadministered with ABILIFY [see Clinical Pharmacology (12.3) ]. |
| Lithium | drug interactions | Interactions with ABILIFY Based on pharmacokinetic studies, no dosage adjustment of ABILIFY is required when administered concomitantly with famotidine, valproate, lithium, and lorazepam. |
| Lorazepam | drug interactions | The orthostatic hypotension observed was greater with the combination as compared to that observed with lorazepam alone [see Warnings and Precautions (5.8) ]. Monitor sedation and blood pressure. |
| Omeprazole | 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 coadministered with ABILIFY. |
| Paroxetine | drug interactions | Concomitant Drug Name or Drug Class: Strong CYP3A4 Inhibitors (e.g., itraconazole, clarithromycin) or strong CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine); Clinical Rationale: Concomitant use of ABILIFY with strong CYP3A4 or CYP2D6 inhibitors increased the exposure of aripiprazole compared to the use of … |
| Quinidine | drug interactions | Concomitant Drug Name or Drug Class: Strong CYP3A4 Inhibitors (e.g., itraconazole, clarithromycin) or strong CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine); Clinical Rationale: Concomitant use of ABILIFY with strong CYP3A4 or CYP2D6 inhibitors increased the exposure of aripiprazole compared to the use of … |
Every other medicine the aripiprazole label names
| Medicine named | Section | What the label says |
|---|---|---|
| Rifampin | drug interactions | Concomitant Drug Name or Drug Class: Strong CYP3A4 Inducers (e.g., carbamazepine, rifampin); Clinical Rationale: Concomitant use of ABILIFY and carbamazepine decreased the exposure of aripiprazole … |
| Sertraline | drug interactions | Additionally, no dosage adjustment is necessary for valproate, lithium, lamotrigine, lorazepam, or sertraline when coadministered with ABILIFY [see Clinical Pharmacology (12.3) ]. |
| Venlafaxine | 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 … |
| Warfarin | 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 … |
Other labels that name aripiprazole
Source: FDA drug label (ABILIFY), Otsuka America Pharmaceutical, Inc., effective January 29, 2025 (SPL set c040bd1d-45b7-49f2-93ea-aed7220b30ac), via openFDA; the full label on DailyMed
What do FAERS reports show for aripiprazole?
The FDA Adverse Event Reporting System holds 121,736 reports that list aripiprazole among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 6,758 are coded as a death and 35,939 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as aripiprazole?
40 other medicines are given the same way (oral) and in the same FDA class as aripiprazole or labeled mainly for the same use (depression), the same class first. Depression lists all 37 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Quetiapine | Depression, Bipolar disorder, Schizophrenia | 50 labelers | $0.127 per tablet 300 mg tablet | No current entry |
| Olanzapine | Depression, Bipolar disorder, Schizophrenia | 33 labelers | $0.147 per tablet 20 mg tablet | No current entry |
| Risperidone | Bipolar disorder, Schizophrenia | 35 labelers | $0.0368 per tablet 0.25 mg tablet | No current entry |
| Lurasidone | Depression, Bipolar disorder, Schizophrenia | 29 labelers | $0.142 per tablet 20 mg tablet | No current entry |
| Ziprasidone | Bipolar disorder, Schizophrenia | 16 labelers | $0.269 per capsule 20 mg capsule | No current entry |
| Paliperidone | Schizophrenia | 18 labelers | $0.972 per tablet 3 mg tablet | No current entry |
| Clozapine | Schizophrenia | 11 labelers | $0.610 per tablet 100 mg tablet | No current entry |
| Iloperidone | Bipolar disorder, Schizophrenia | 1 labeler | $60.01 per tablet 12 mg tablet | No current entry |
Every medicine labeled for the same conditions as aripiprazole
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does aripiprazole compare with medicines for the same use?
12 side-by-side pages set aripiprazole beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to aripiprazole
- 40 medicines for the same use
- Other atypical antipsychotics
- the pharmacologic class, with prices and generics
- Aripiprazole side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other