Skip to the answer

Brexpiprazole

Brexpiprazole is an atypical antipsychotic used as an add-on treatment for major depressive disorder and to treat schizophrenia, and (for Rexulti) agitation linked to Alzheimer's dementia.

Brand name Rexulti
Drug class Atypical Antipsychotic
Rx Form 1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 4 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 5, 2026
Brexpiprazole at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Brexpiprazole (Rexulti) is an atypical antipsychotic, usually added to an antidepressant that is not doing enough for major depressive disorder, and used for schizophrenia and, as Rexulti, Alzheimer's-related agitation; it partly activates some serotonin and dopamine receptors and blocks others, and has been around since about 2015, now available as a generic. Most people tolerate it fairly well; weight gain, sleepiness and akathisia (an inner restlessness that makes sitting still hard) are what they notice. The boxed warning flags higher death risk in older adults with dementia-related psychosis and suicidal thoughts and behaviors in young people, so report mood changes promptly, plus any uncontrolled face or tongue movements.

Clinical pearls

  • Strong CYP3A4 or CYP2D6 enzyme blockers usually mean a lower dose, but fluoxetine and paroxetine need no change for depression.
  • Expect periodic weight, blood sugar and cholesterol checks, since this antipsychotic can push all three up.
  • Stand up slowly, especially early on, because dizziness on standing plus sleepiness raises fall risk in older adults.
  • Report any new urge to gamble or other compulsive behavior, a listed effect that is easy to overlook.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Older adults with dementia-related psychosis who take antipsychotics have a higher risk of death. Most deaths in studies were from heart problems or infections. Rexulti is not approved for dementia-related psychosis without agitation due to Alzheimer's disease.

Antidepressant-type medicines can also raise the risk of suicidal thoughts and behaviors in children, teens and young adults. Watch closely for worsening mood, new or sudden changes in behavior, or thoughts of self-harm, and call the prescriber right away.

Read the full warning on DailyMed →
How you get itPrescription only
Comes asTablet
Earliest FDA record2015
Companies listing it with the FDA3
FDA label last updatedMay 6, 2026
FDA’s strongest warning (boxed)Yes, read the warning

Patient information guide A plain-language walkthrough of Brexpiprazole, written from its FDA label.

What Brexpiprazole is used for

▾

Brexpiprazole is an atypical antipsychotic with these supported uses:

  • Add-on treatment with an antidepressant for major depressive disorder in adults (Rexulti and Brexpiprazole tablets)
  • Schizophrenia in adults (Rexulti and Brexpiprazole tablets)
  • Schizophrenia in ages 13 and older (Rexulti)
  • Agitation associated with dementia due to Alzheimer's disease (Rexulti, not for as-needed use)

How Brexpiprazole works

▾

The exact way brexpiprazole works is unknown. It may work by partly activating serotonin 5-HT1A and dopamine D2 receptors. It also blocks serotonin 5-HT2A receptors. This helps balance brain chemicals involved in mood and thinking.

Brexpiprazole dosage

▾

Brexpiprazole is a tablet taken by mouth once daily, with or without food. Your prescriber chooses the dose based on your condition, your liver and kidney function, and your other medicines. Follow the label and your prescriber's directions.

Dosing details from the FDA-approved label

From the Brexpiprazole prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • MDD Adults
    • Starting dosage 0.5 mg/day or 1 mg/day
    • Recommended target dosage 2 mg/day
    • Administered orally once daily with or without food
    • Maximum: 3 mg/day
  • Schizophrenia Adults
    • Starting dosage 1 mg/day
    • Recommended target dosage 2 to 4 mg/day
    • Administered orally once daily with or without food
    • Maximum: 4 mg/day
  • Schizophrenia Pediatric (13 - 17 years)
    • Starting dosage 0.5 mg/day
    • Recommended target dosage 2 to 4 mg/day
    • Administered orally once daily with or without food
    • Maximum: 4 mg/day
  • Agitation associated with dementia due to Alzheimer's disease
    • Starting dosage 0.5 mg/day
    • Recommended target dosage 2 mg/day
    • Administered orally once daily with or without food
    • Maximum: 3 mg/day
  • Moderate to Severe Hepatic Impairment (MDD or agitation associated with dementia due to Alzheimer's disease)
    • Maximum recommended dosage is 2 mg once daily
    • Maximum: 2 mg once daily
    • Hepatic impairment adjustment
  • Moderate to Severe Hepatic Impairment (schizophrenia)
    • Maximum recommended dosage is 3 mg once daily
    • Maximum: 3 mg once daily
    • Hepatic impairment adjustment
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION Administer REXULTI orally once daily with or without food. ( 2 , 12.3 ) Indication Starting Dosage Recommended Target Dosage Maximum Dosage MDD Adults ( 2.2 ) 0.5 mg/day or 1 mg/day 2 mg/day 3 mg/day Schizophrenia Adults ( 2.3 ) 1 mg/day 2 to 4 mg/day 4 mg/day Schizophrenia Pediatric (13 - 17 years) ( 2.3 ) 0.5 mg/day 2 to 4 mg/day 4 mg/day Agitation associated with dementia due to Alzheimer's disease ( 2.4 ) 0.5 mg/day 2 mg/day 3 mg/day Moderate to Severe Hepatic Impairment: Maximum recommended dosage is 2 mg once daily for patients with MDD or agitation associated with dementia due to Alzheimer's disease and 3 mg once daily for patients with schizophrenia. ( 2.5 ) CrCl<60 mL/minute: Maximum recommended dosage is 2 mg once daily for patients with MDD or agitation associated with dementia due to Alzheimer's disease and 3 mg once daily for patients with schizophrenia. ( 2.6 ) See Full Prescribing Information for dosage modifications for CYP2D6 poor metabolizers and for concomitant use with CYP inhibitors or inducers. ( 2.7 ) 2.1 Administration Information Administer REXULTI orally, once daily with or without food [see Clinical Pharmacology (12.3) ] 2.2 Recommended Dosage for Adjunctive Treatment of Major Depressive Disorder (Adults) The recommended starting REXULTI dosage for the adjunctive treatment of MDD in adults is 0.5 mg or 1 mg orally once daily . Titrate to 1 mg once daily, then titrate to the target dosage of 2 mg once daily (based on the patient's clinical response and tolerability, increase the dosage at weekly intervals). The maximum recommended daily dosage is 3 mg. Periodically reassess to determine the continued need and appropriate dosage for treatment. 2.3 Recommended Dosage for Schizophrenia (Adults and Pediatric Patients 13 to 17 Years) Adults The recommended starting REXULTI dosage for the treatment of schizophrenia in adults is 1 mg orally once daily on Days 1 to 4. Titrate to 2 mg once daily on Day 5 through Day 7. On Day 8, the dosage can be increased to the maximum recommended daily dosage of 4 mg based on clinical response and tolerability. The recommended target dosage is 2 mg to 4 mg once daily. Pediatric Patients (13 to 17 years of age) The recommended starting REXULTI dosage for the treatment of schizophrenia in pediatric patients 13 to 17 years of age is 0.5 mg orally once daily on Days 1 to 4.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Brexpiprazole side effects

▾

Common side effects seen in studies include:

Common side effects

  • Weight gain
  • Sleepiness (somnolence)
  • Akathisia (inner restlessness and an urge to move)
  • Headache
  • Trouble sleeping (insomnia)
  • Dizziness
  • Tremor
  • Common cold symptoms (nasopharyngitis)

When to get medical help

  • Call your doctor right away for high fever, stiff muscles, confusion, or a fast or uneven heartbeat. These can be signs of neuroleptic malignant syndrome.
  • Tell your doctor about uncontrolled movements of the face, tongue or body. This may be tardive dyskinesia.
  • Get help for new or worsening depression, suicidal thoughts or unusual behavior changes, especially in young people.
  • Get emergency help for stroke signs such as sudden weakness, trouble speaking or confusion, especially in older adults with dementia.
  • Report new urges to gamble or other compulsive behaviors.
  • Tell your doctor about fainting or dizziness when standing up, or about seizures.
  • Report signs of infection such as fever or sore throat, since low white blood cell counts can occur.
  • Seek help for an allergic reaction such as rash, facial swelling, hives or trouble breathing.

Call your doctor promptly for high fever with stiff muscles, uncontrolled movements, fainting, seizures, signs of infection, stroke symptoms or worsening mood.

Brexpiprazole warnings and precautions

▾

The biggest risks are higher death risk in older adults with dementia-related psychosis and suicidal thoughts in young people.

  • Stroke in older adults with dementia
  • Neuroleptic malignant syndrome
  • Tardive dyskinesia
  • High blood sugar, cholesterol changes, weight gain
  • Compulsive behaviors such as gambling
  • Low white blood cell counts
  • Low blood pressure and fainting
  • Seizures, falls, trouble swallowing, body temperature problems

Brexpiprazole interactions

▾

Some medicines change brexpiprazole levels, so doses may be adjusted.

  • Strong CYP3A4 or CYP2D6 inhibitors: raise levels, so the dose is lowered.
  • Both types of inhibitors together: a larger dose reduction.
  • Strong CYP3A4 inducers: lower levels, so the dose may be raised.
  • For MDD, paroxetine and fluoxetine need no dose change.
  • Omeprazole and similar acid reducers need no adjustment.

Interactions listed in the FDA-approved label

From the Brexpiprazole prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Strong CYP3A4 inhibitors: Increased the exposure of brexpiprazole compared to the use of brexpiprazole tablets alone. Reduce the brexpiprazole tablets dosage; administer half of usual dose.
  • Strong CYP2D6 inhibitors: Increased the exposure of brexpiprazole compared to the use of brexpiprazole tablets alone. Reduce the dosage; administer half of usual dose. In patients with MDD, may be administered without dosage adjustment (e.g., paroxetine, fluoxetine).
  • Both CYP3A4 inhibitors and CYP2D6 inhibitors (strong/moderate combinations): Increased the exposure of brexpiprazole compared to the use of brexpiprazole tablets alone. Decrease the dosage; administer a quarter of usual dose.
  • Known CYP2D6 poor metabolizers taking strong/moderate CYP3A4 inhibitors: Label lists a dosage adjustment for this group. Administer a quarter of usual dose.
  • Strong CYP3A4 inducers: Decreased the exposure of brexpiprazole compared to the use of brexpiprazole tablets alone. Increase the dosage; double the usual dose and further adjust based on clinical response.
  • CYP2B6 inhibitors (e.g., ticlopidine) and gastric pH modifiers (e.g., omeprazole): No clinically important interaction based on pharmacokinetic studies. No dosage adjustment of brexpiprazole tablets is required.
  • Substrates of CYP2D6 (e.g., dextromethorphan), CYP3A4 (e.g., lovastatin), CYP2B6 (e.g., bupropion), BCRP (e.g., rosuvastatin), or P-gp (e.g., fexofenadine): No clinically important interaction when administered concomitantly with brexpiprazole tablets. No dosage adjustment for these substrates is required.
Read the label’s full interactions text

7 DRUG INTERACTIONS * Brexpiprazole tablets may be administered without dosage adjustment in patients with MDD when administered with strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine). Factors Dosage Adjustments for brexpiprazole tablets ( 2.5 ) Strong CYP2D6* or CYP3A4 inhibitors Administer half of usual dose. Strong/moderate CYP2D6 with Strong/moderate CYP3A4 inhibitors Administer a quarter of usual dose. Known CYP2D6 poor metabolizers taking strong/moderate CYP3A4 inhibitors Administer a quarter of usual dose. Strong CYP3A4 inducers Double the usual dose and further adjust based on clinical response. 7.1 Drugs Having Clinically Important Interactions with Brexpiprazole Tablets Table 9: Clinically Important Drug Interactions with Brexpiprazole Tablets * In the clinical trials examining the adjunctive use of brexpiprazole tablets in the treatment of MDD, dosage was not adjusted for strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine). Thus, CYP considerations are already factored into general dosing recommendations, and brexpiprazole tablets may be administered without dosage adjustment in patients with MDD. Strong CYP3A4 Inhibitors Clinical Impact: Concomitant use of brexpiprazole tablets with strong CYP3A4 inhibitors increased the exposure of brexpiprazole compared to the use of brexpiprazole tablets alone [see Clinical Pharmacology ( 12.3 )]. Intervention: With concomitant use of brexpiprazole tablets with a strong CYP3A4 inhibitor, reduce the brexpiprazole tablets dosage [see Dosage and Administration ( 2.5 )]. Strong CYP2D6 Inhibitors* Clinical Impact: Concomitant use of brexpiprazole tablets with strong CYP2D6 inhibitors increased the exposure of brexpiprazole compared to the use of brexpiprazole tablets alone [see Clinical Pharmacology ( 12.3 )]. Intervention: With concomitant use of brexpiprazole tablets with a strong CYP2D6 inhibitor, reduce the brexpiprazole tablets dosage [see Dosage and Administration ( 2.5 )].

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

🌿177 supplements and herbs with documented Brexpiprazole interactions, ranked by severity Check Brexpiprazole against a supplement or herb →

Before taking Brexpiprazole

▾
  • Do not use if you are allergic to brexpiprazole.
  • Older adults with dementia-related psychosis face a higher risk of death.
  • Pregnancy: third-trimester exposure can cause movement or withdrawal symptoms in newborns. A pregnancy registry exists.
  • Breastfeeding: effects on the infant are unknown.
  • Children: not established for MDD. Rexulti is established for schizophrenia ages 13 and older.
  • Older adults: dosing is usually cautious.
  • Liver problems, moderate kidney impairment and CYP2D6 poor metabolizers may need adjusted dosing.

Brexpiprazole overdose

▾

Experience with overdose is limited. Call Poison Control at 1-800-222-1222. Treatment focuses on supportive care, including airway and breathing support and symptom management, with close monitoring until recovery. Dialysis is unlikely to help.

What Brexpiprazole does in the body

▾

Brexpiprazole partly activates serotonin 5-HT1A and dopamine D2 and D3 receptors. It blocks several others, including serotonin 5-HT2A and some noradrenaline receptors. It also binds histamine H1 receptors. At higher-than-recommended doses it did not meaningfully lengthen the QTc interval, a heart rhythm measure.

How your body processes Brexpiprazole

▾

Levels peak within about 4 hours, and about 95% is absorbed. Food does not significantly change absorption. Steady levels build up in 10 to 12 days. The liver breaks it down mainly using CYP3A4 and CYP2D6. The half-life is about 91 hours, and most of it leaves through feces and urine as breakdown products.

How to store Brexpiprazole

▾

Store REXULTI tablets at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) .

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

177

Supplements & herbs that interact with Brexpiprazole

177 supplements and herbal products have documented interactions with Brexpiprazole in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 6
  • Moderate · 130
  • Minor · 41
ACTIVATED CHARCOAL Major GRAPEFRUIT Major INDIAN SNAKEROOT Major LITHIUM Major RAUVOLFIA VOMITORIA Major ST. JOHN'S WORT Major 1,3-DMAA Moderate 5-HTP Moderate +169 more
Every supplement checked against Brexpiprazole — ranked by severity The full interaction hub: 6 major · 130 moderate · 41 minor · every one linked to its full report. Check Brexpiprazole against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

Brexpiprazole: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Brexpiprazole — the kind of thing our pharmacy team would talk through with you at the counter.

What is brexpiprazole used for?

▾
It is used along with an antidepressant for major depressive disorder in adults, and to treat schizophrenia. Rexulti is also used for schizophrenia in teens 13 and older and for agitation tied to Alzheimer's dementia.

How do I take it?

▾
Take one tablet by mouth once a day, with or without food. Follow your prescriber's directions and the label closely. Do not change how you take it without asking.

What side effects should I expect?

▾
Weight gain, sleepiness, headache, trouble sleeping and restlessness (akathisia) are common. Tell your doctor if they bother you. Call right away for high fever with stiff muscles, uncontrolled movements, fainting, seizures or thoughts of self-harm.

Are there medicines I should watch out for?

▾
Yes. Some medicines that affect CYP3A4 or CYP2D6 enzymes can raise or lower brexpiprazole levels, so your doses may be adjusted. Always tell me or your doctor about everything you take, including supplements.

Is it safe for older adults with dementia?

▾
Antipsychotics raise the risk of death in older adults with dementia-related psychosis. Rexulti is approved only for agitation due to Alzheimer's dementia, not as an as-needed medicine. Talk with the prescriber about the risks and benefits.

What about pregnancy?

▾
Tell your doctor if you are pregnant or planning to be. Newborns exposed late in pregnancy can have movement or withdrawal symptoms such as agitation, tremor, sleepiness or feeding problems. Your doctor can help you weigh the options.

Is Brexpiprazole available over the counter?

▾
No. Brexpiprazole is a prescription medicine: every Brexpiprazole product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Brexpiprazole first available?

▾
The earliest FDA record we hold for Brexpiprazole is from 2015: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Brexpiprazole was first used.

Who makes Brexpiprazole?

▾
3 companies currently list Brexpiprazole products in the FDA's NDC Directory, including Otsuka America Pharmaceutical, Inc., Ajanta Pharma USA Inc., Remedyrepack Inc.. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Brexpiprazole on HelloPharmacist

📊Brexpiprazole supplement interactions177 checked — ranked by severity 🌿Drug & Supplement CheckerBrexpiprazole vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Brexpiprazole NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Brexpiprazole Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Brexpiprazole forms and strengths (how it comes)

Brexpiprazole is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Brexpiprazole inactive ingredients by manufacturer.

Tablet

By mouth
Brands Rexulti
How this form is used
What it may be used for
  • Rexulti tablets are used as add-on treatment for MDD in adults, for schizophrenia in adults and ages 13 and older, and for agitation associated with dementia due to Alzheimer's disease.
  • Brexpiprazole tablets are used as add-on treatment for MDD in adults and for schizophrenia in adults.
Important instructions
  • Rexulti is taken by mouth once daily, with or without food.
  • Brexpiprazole tablets can be taken with or without food.
  • Rexulti is not meant to be used as an as-needed treatment for Alzheimer's-related agitation.
Available strengths 6 strengths
0.25 mg 0.5 mg 1 mg 2 mg 3 mg 4 mg
40 FDA-listed product records ⓘ

Brexpiprazole on the U.S. market: products, makers and brands

How Brexpiprazole appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

3 companies list 16 Brexpiprazole product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2015. Brand names on the directory include Rexulti; the rest are generics.

1
Dose forms ⓘ
3
Labelers (makers, repackagers, distributors)
2
Brand names
16
FDA-listed product records ⓘ
2015
Earliest FDA record ⓘ

Also listed with the FDA, not a patient dose form: Powder (10) · Kit (4) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Otsuka America Pharmaceutical, Inc.50%
Ajanta Pharma USA Inc.38%
Remedyrepack Inc.13%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Brexpiprazole is used (Medicaid data)

A general measure of how commonly Brexpiprazole is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Brexpiprazole is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

344,798
Medicaid prescriptions filled (Q1–Q4 2025)
$515.6M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Brexpiprazole prescribed? Of the 1,601 medications we measure, Brexpiprazole ranks #305 by Medicaid prescriptions — more than 81% of them.

Where Brexpiprazole ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #305 of 1,601
#300 Aripiprazole Injection 354,838 Rx #301 Emtricitabine and Teno... 354,223 Rx #302 Emtricitabine / Tenofo... 354,223 Rx #303 Vortioxetine 354,075 Rx #304 Azelastine Ophthalmic 347,051 Rx #305 Brexpiprazole 344,798 Rx #306 OnabotulinumtoxinA Inj... 343,452 Rx #307 Diphenhydramine Inject... 342,553 Rx #308 Nitroglycerin Spray 340,741 Rx #309 Nitroglycerin 340,741 Rx #310 Olmesartan 340,022 Rx

Utilization by Brexpiprazole product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 1 mg oral tablet is the most-dispensed Brexpiprazole product — about 31% of these Medicaid prescriptions.

brexpiprazole 1 MG Oral Tablet Most dispensed

108,346 Medicaid prescriptions (Q1–Q4 2025) 31% of Brexpiprazole prescriptions shown $162.6M gross reimbursement (before rebates) ≈ $1,501 per prescription (gross)

Summed across the 1 of 9 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1658331

brexpiprazole 2 MG Oral Tablet

98,542 Medicaid prescriptions (Q1–Q4 2025) 29% of Brexpiprazole prescriptions shown $148.5M gross reimbursement (before rebates) ≈ $1,507 per prescription (gross)

Summed across the 1 of 11 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1658335

brexpiprazole 0.5 MG Oral Tablet

55,840 Medicaid prescriptions (Q1–Q4 2025) 16% of Brexpiprazole prescriptions shown $82.2M gross reimbursement (before rebates) ≈ $1,471 per prescription (gross)

Summed across the 1 of 7 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1658327

brexpiprazole 3 MG Oral Tablet

46,331 Medicaid prescriptions (Q1–Q4 2025) 13% of Brexpiprazole prescriptions shown $69.2M gross reimbursement (before rebates) ≈ $1,495 per prescription (gross)

Summed across the 1 of 7 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1658339

brexpiprazole 4 MG Oral Tablet

26,959 Medicaid prescriptions (Q1–Q4 2025) 8% of Brexpiprazole prescriptions shown $39.9M gross reimbursement (before rebates) ≈ $1,480 per prescription (gross)

Summed across the 1 of 7 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1658343

brexpiprazole 0.25 MG Oral Tablet

8,780 Medicaid prescriptions (Q1–Q4 2025) 3% of Brexpiprazole prescriptions shown $13.3M gross reimbursement (before rebates) ≈ $1,509 per prescription (gross)

Summed across the 1 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1658319

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Brexpiprazole, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 6 of 47 listed Brexpiprazole NDCs with Medicaid activity.

Compare Brexpiprazole products

A representative set of FDA-listed product records for Brexpiprazole — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 16 of 16 products — FDA National Drug Code Directory. See every product, package size and price: browse all 16 Brexpiprazole NDCs →

Brexpiprazole recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list no Brexpiprazole recalls since July 2021.

✅No Brexpiprazole recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Brexpiprazole RxCUI 1658314 1 dose form · 6 strengths
  1. Dose form (SCDF) Oral Tablet RxCUI 1658318 In current FDA listings
    Clinical drug / strength (SCD) 0.25 MG RxCUI 1658319 0.5 MG RxCUI 1658327 1 MG RxCUI 1658331 2 MG RxCUI 1658335 3 MG RxCUI 1658339 4 MG RxCUI 1658343

Look up RxCUI 1658314 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

💵 What Brexpiprazole costs pharmacies (NADAC benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Tablet · Oral 4 mg $49.47 per tablet NDC details & price history
Tablet · Oral 3 mg $49.51 per tablet NDC details & price history
Tablet · Oral 0.5 mg $49.49 per tablet NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Brexpiprazole brand names

Brexpiprazole is sold under one brand name in the FDA directory — Rexulti. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Rexulti

Who makes Brexpiprazole: manufacturers and labelers

3 companies list Brexpiprazole products with the FDA. By number of product records, the largest are Otsuka America Pharmaceutical, Inc., Ajanta Pharma USA Inc., Remedyrepack Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Otsuka America Pharmaceutical, Inc. 8 Ajanta Pharma USA Inc. 6 Remedyrepack Inc. 2

Brexpiprazole drug class (RxNorm)

Brexpiprazole belongs to the Atypical Antipsychotic class.

Pharmacologic class Atypical Antipsychotic
Drug family (ATC) Other antipsychotics

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Brexpiprazole page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective May 6, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Brexpiprazole.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Brexpiprazole after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
4
Finished products in the current FDA directory
16
Companies listing them (makers, repackagers, distributors)
3
FDA labeler codes behind them ⓘ
3
Linked representative label ⓘ
Otsuka America Pharmaceutical, Inc.
Linked label effective
May 6, 2026
Composite sections available
26
Linked SPL Set ID
2d301358-6291-4ec1-bd87-37b4ad9bd850
Linked SPL Document ID
3a208135-0d99-4d6a-b73e-61d63cf48f4f
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Otsuka America Pharmaceutical, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →