Prescription medicine
Brexpiprazole Brand names: Rexulti
Brexpiprazole (Rexulti) is a prescription medicine with an FDA approval on record since 2015. A generic is approved and listed by 1 labeler, but in the October 7, 2026 NADAC survey pharmacies bought only the brand, at $49.50 per Rexulti 0.25 mg tablet.
- Generic approved
- Boxed warning
Check it at the source: the brexpiprazole FDA label on DailyMed (effective May 6, 2026, Otsuka America Pharmaceutical, Inc.); the NDA 205422 record on Drugs@FDA; every brexpiprazole label on DailyMed.
Highlights of the record
FDA label of May 6, 2026; 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 WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at increased risk of death. REXULTI is not approved for the treatment of patients with dementia-related psychosis without agitation associated with dementia due to Alzheimer's disease. ( 5.1 ) Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors. Safety and effectiveness of REXULTI have not been established in pediatric patients with MDD. ( 5.2 , 8.4 ) Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. REXULTI is not approved for the treatment of patients with dementia-related psychosis without agitation associated with dementia due to Alzheimer's disease [see Warnings and Precautions (5.1) ]. […]
Used for
From the label: indications and usageREXULTI is indicated for: Adjunctive treatment to antidepressants for major depressive disorder (MDD) in adults Treatment of schizophrenia in adults and pediatric patients ages 13 years and older Treatment of agitation associated with dementia due to Alzheimer's disease Limitations of Use: REXULTI is not indicated as an as needed ("prn") treatment for agitation associated with dementia due to Alzheimer's disease [see
Forms and strengths
- 0.25 mg
- 0.5 mg
- 1 mg
- 2 mg
- 3 mg
- 4 mg
Tablet; kit.
On the market
- Earliest approval on file
- July 10, 2015 Rexulti, Otsuka; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 12 first August 11, 2022; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 3 of which 1 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- April 12, 2033 Rexulti tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $49.50 per tablet Rexulti 0.25 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 16,505 through July 30, 2026
What is brexpiprazole used for?
From the label: indications and usageREXULTI is indicated for: Adjunctive treatment to antidepressants for major depressive disorder (MDD) in adults Treatment of schizophrenia in adults and pediatric patients ages 13 years and older Treatment of agitation associated with dementia due to Alzheimer's disease Limitations of Use: REXULTI is not indicated as an as needed ("prn") treatment for agitation associated with dementia due to Alzheimer's disease [see Clinical Studies (14.3) ]. […]
Conditions named in the indications of brexpiprazole's FDA labels, with every medicine labeled for each:
From other brexpiprazole labelsDepression: Adjunctive treatment of major depressive disorder (MDD) in adults.
FDA pharmacologic class: Atypical Antipsychotic.
Source: FDA drug label (Rexulti), Otsuka America Pharmaceutical, Inc., effective May 6, 2026 (SPL set 2d301358-6291-4ec1-bd87-37b4ad9bd850), via openFDA; the full label on DailyMed
What does the patient leaflet for brexpiprazole 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 REXULTI?REXULTI may cause serious side effects, including: Increased risk of death in elderly people with dementia-related psychosis. Medicines like REXULTI can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). REXULTI is not approved for the treatment of people with dementia-related psychosis without agitation that may happen with dementia due to Alzheimer's disease. Increased risk of suicidal thoughts and actions. REXULTI and antidepressant medicines may increase the risk of suicidal thoughts and actions in people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed. Depression and other mental illnesses are the most important causes of suicidal thoughts and 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, or if you develop suicidal thoughts or actions. This is very important when REXULTI or the antidepressant medicine is started or when the dose is changed. Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions. Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms. […]
From the patient leaflet: What should I avoid while taking REXULTI?Do not drive a car, operate machinery, or do other dangerous activities until you know how REXULTI affects you. REXULTI may make you feel drowsy. Do not become too hot or dehydrated during treatment with REXULTI. Do not exercise too much. In hot weather, stay inside in a cool place if possible. Stay out of the sun. Do not wear too much clothing or heavy clothing. Drink plenty of water.
From the patient leaflet: How should I store REXULTI?Store REXULTI at room temperature between 68°F to 77°F (20°C to 25°C). Keep REXULTI and all medicines out of the reach of children.
Source: FDA drug label (Rexulti), Otsuka America Pharmaceutical, Inc., effective May 6, 2026 (SPL set 2d301358-6291-4ec1-bd87-37b4ad9bd850), via openFDA; the full label on DailyMed
Is there a generic for brexpiprazole (Rexulti)?
The FDA approved the first generic brexpiprazole on August 11, 2022. 12 generic applications are approved; 1 of them carries a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 4 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists brexpiprazole from 1 labeler under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it. In the latest NADAC survey pharmacies bought only the brand, so a generic may not be on sale yet.
The Orange Book lists 5 patents for Rexulti tablets: the compound patent runs to December 23, 2028 (pediatric exclusivity to June 23, 2029), and the last listed entry to April 12, 2033. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2015 earliest approval on file
- 2022 first generic approved
- 2033 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for brexpiprazole (Rexulti)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $49.50 per Rexulti 0.25 mg tablet, up 3% from $48.24 on October 8, 2025. 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.
- Rexulti 4 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Rexulti 0.25 mg tablet | Brand | $49.50 per tablet | $1,484.91 | +3% |
| Rexulti 0.5 mg tablet | Brand | $49.49 per tablet | $1,484.58 | +2% |
| Rexulti 1 mg tablet | Brand | $49.56 per tablet | $1,486.79 | +2% |
| Rexulti 2 mg tablet | Brand | $49.53 per tablet | $1,485.76 | +2% |
| Rexulti 3 mg tablet | Brand | $49.51 per tablet | $1,485.27 | +2% |
| Rexulti 4 mg tablet | Brand | $49.47 per tablet | $1,484.02 | +2% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the brexpiprazole label say about other medicines?
The brexpiprazole label names 11 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name brexpiprazole. 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 |
|---|---|---|
| Aripiprazole | warnings and precautions | Stroke in Elderly Patients with Dementia-Related Psychosis In placebo-controlled trials in elderly patients with dementia, patients randomized to risperidone, aripiprazole, and olanzapine had a higher incidence of stroke and transient ischemic attack, including fatal stroke. |
| Bupropion | drug interactions | Clinical Impact: Concomitant use of REXULTI and a strong CYP3A4 inducer decreased the exposure of brexpiprazole compared to the use of REXULTI alone. … CYP2D6 (e.g., dextromethorphan), CYP3A4 (e.g., lovastatin), CYP2B6 (e.g., bupropion), BCRP (e.g., rosuvastatin), or P-gp (e.g., fexofenadine) is required when administered concomitantly with REXULTI. |
| Dextromethorphan | drug interactions | Clinical Impact: Concomitant use of REXULTI and a strong CYP3A4 inducer decreased the exposure of brexpiprazole compared to the use of REXULTI alone. … omeprazole). Additionally, no dosage adjustment for substrates of CYP2D6 (e.g., dextromethorphan), CYP3A4 (e.g., lovastatin), CYP2B6 (e.g., bupropion), BCRP (e.g., rosuvastatin), or P-gp (e.g., fexofenadine) is required … |
| Fexofenadine | drug interactions | Clinical Impact: Concomitant use of REXULTI and a strong CYP3A4 inducer decreased the exposure of brexpiprazole compared to the use of REXULTI alone. … lovastatin), CYP2B6 (e.g., bupropion), BCRP (e.g., rosuvastatin), or P-gp (e.g., fexofenadine) is required when administered concomitantly with REXULTI. |
| Fluoxetine | drug interactions | Factors: Strong CYP2D6 REXULTI may be administered without dosage adjustment in patients with MDD when administered with strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine). or CYP3A4 inhibitors; Dosage Adjustments for REXULTI (): Administer half of recommended dosage. |
| Lovastatin | drug interactions | Clinical Impact: Concomitant use of REXULTI and a strong CYP3A4 inducer decreased the exposure of brexpiprazole compared to the use of REXULTI alone. … adjustment for substrates of CYP2D6 (e.g., dextromethorphan), CYP3A4 (e.g., lovastatin), CYP2B6 (e.g., bupropion), BCRP (e.g., rosuvastatin), or P-gp (e.g., fexofenadine) is required when administered concomitantly with … |
| Olanzapine | warnings and precautions | Stroke in Elderly Patients with Dementia-Related Psychosis In placebo-controlled trials in elderly patients with dementia, patients randomized to risperidone, aripiprazole, and olanzapine had a higher incidence of stroke and transient ischemic attack, including fatal stroke. |
| Omeprazole | drug interactions | Clinical Impact: Concomitant use of REXULTI and a strong CYP3A4 inducer decreased the exposure of brexpiprazole compared to the use of REXULTI alone. … with CYP2B6 inhibitors (e.g., ticlopidine) or gastric pH modifiers (e.g., omeprazole). Additionally, no dosage adjustment for substrates of CYP2D6 (e.g., dextromethorphan), CYP3A4 (e.g., lovastatin), CYP2B6 (e.g. … |
| Paroxetine | drug interactions | Factors: Strong CYP2D6 REXULTI may be administered without dosage adjustment in patients with MDD when administered with strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine). or CYP3A4 inhibitors; Dosage Adjustments for REXULTI (): Administer half of recommended dosage. |
| Risperidone | warnings and precautions | Stroke in Elderly Patients with Dementia-Related Psychosis In placebo-controlled trials in elderly patients with dementia, patients randomized to risperidone, aripiprazole, and olanzapine had a higher incidence of stroke and transient ischemic attack, including fatal stroke. |
| Rosuvastatin | drug interactions | Clinical Impact: Concomitant use of REXULTI and a strong CYP3A4 inducer decreased the exposure of brexpiprazole compared to the use of REXULTI alone. … dextromethorphan), CYP3A4 (e.g., lovastatin), CYP2B6 (e.g., bupropion), BCRP (e.g., rosuvastatin), or P-gp (e.g., fexofenadine) is required when administered concomitantly with REXULTI. |
Other labels that name brexpiprazole
Source: FDA drug label (Rexulti), Otsuka America Pharmaceutical, Inc., effective May 6, 2026 (SPL set 2d301358-6291-4ec1-bd87-37b4ad9bd850), via openFDA; the full label on DailyMed
What do FAERS reports show for brexpiprazole?
The FDA Adverse Event Reporting System holds 16,505 reports that list brexpiprazole among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,085 are coded as a death and 2,114 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 brexpiprazole?
40 other medicines are given the same way (oral) and in the same FDA class as brexpiprazole 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, Schizophrenia | 50 labelers | $0.127 per tablet 300 mg tablet | No current entry |
| Aripiprazole | Depression, Schizophrenia | 47 labelers | $0.110 per tablet 5 mg tablet | No current entry |
| Olanzapine | Depression, Schizophrenia | 33 labelers | $0.147 per tablet 20 mg tablet | No current entry |
| Risperidone | Schizophrenia | 35 labelers | $0.0368 per tablet 0.25 mg tablet | No current entry |
| Lurasidone | Depression, Schizophrenia | 29 labelers | $0.142 per tablet 20 mg tablet | No current entry |
| Ziprasidone | 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 |
Every medicine labeled for the same conditions as brexpiprazole
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does brexpiprazole compare with medicines for the same use?
5 side-by-side pages set brexpiprazole beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to brexpiprazole
- 40 medicines for the same use
- Other atypical antipsychotics
- the pharmacologic class, with prices and generics
- Brexpiprazole side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other