Brexpiprazole: uses, dosing, side effects & brands
Brexpiprazole is an atypical antipsychotic sold in the U.S. under one brand, for major depressive disorder and schizophrenia. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Atypical Antipsychotic
- Treats (across its forms)
- Major Depressive Disorder and Schizophrenia
- Available as
- Tablet · Kit
- Sold as
- Rexulti
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
- Boxed warning
- Boxed warning
How brexpiprazole is dosed
From the FDA label for Rexulti (application NDA205422). Other brexpiprazole products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
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…
Brexpiprazole side effects
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 , Warnings and Precautions (5.1) ] Suicidal Thoughts and Behaviors in Adolescents and Young Adults [see Boxed Warning , Warnings and Precautions (5.2) ] Cerebrovascular Adverse Reactions Including Stroke in Elderly Patients with Dementia-Related Psychosis [see 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) ] Leukopenia, Neutropenia, and Agranulocytosis [see Warnings and Precautions (5.8) ] Orthostatic Hypotension and Syncope [see Warnings and Precautions (5.9) ] Falls [see Warnings and Precautions (5.10) ] Seizures [see Warnings and Precautions (5.11) ] Body Temperature Dysregulation [see Warnings and Precautions (5.12) ] Dysphagia [see Warnings and Precautions (5.13) ] Potential for Cognitive and Motor Impairment [see Warnings and Precautions (5.14) ] Most common adverse reactions in adults were ( 6.1 ): Adult patients with major depressive disorder (adjunctive treatment to antidepressant therapy): Weight increased, somnolence, and…
Who shouldn’t take brexpiprazole
REXULTI is contraindicated in patients with a known hypersensitivity to brexpiprazole or any of its components. Reactions have included rash, facial swelling, urticaria, and anaphylaxis. Known hypersensitivity to REXULTI or any of its components ( 4 )
Brexpiprazole drug interactions
Factors Dosage Adjustments for REXULTI ( 2.7 ) 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 Administer half of recommended dosage. Strong/moderate CYP2D6 with Strong/moderate CYP3A4 inhibitors Administer a quarter of the recommended dosage. Known CYP2D6 poor metabolizers taking strong/moderate CYP3A4 inhibitors Administer a quarter of the recommended dosage. Strong CYP3A4 inducers Double the recommended dosage and further adjust based on clinical response. 7.1 Drugs Having Clinically Important Interactions with REXULTI See Table 12 for clinically important drug interactions with REXULTI. Table 12 Clinically Important Drug Interactions with REXULTI Strong CYP3A4 Inhibitors Clinical Impact: Concomitant use of REXULTI with strong CYP3A4 inhibitors increased the exposure of brexpiprazole compared to the use of REXULTI alone [see Clinical Pharmacology (12.3) ] . Intervention: With concomitant use of REXULTI with a strong CYP3A4 inhibitor, reduce the REXULTI dosage [see Dosage and Administration (2.7) ] . Strong CYP2D6 Inhibitors In the clinical studies examining the adjunctive use of REXULTI 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 REXULTI may be administered without dosage adjustment in patients with MDD. Clinical Impact: Concomitant use of REXULTI with strong CYP2D6 inhibitors increased the exposure of brexpiprazole compared to the use of REXULTI alone [see Clinical Pharmacology (12.3) ] . Intervention: With concomitant use of REXULTI with a strong CYP2D6 inhibitor, reduce the REXULTI dosage [see Dosage and Administration (2.7) ] . Both CYP3A4 Inhibitors and CYP2D6 Inhibitors Clinical Impact: Concomitant use of REXULTI with 1) a strong CYP3A4 inhibitor and a strong CYP2D6 inhibitor; or 2) a moderate CYP3A4 inhibitor and a strong CYP2D6 inhibitor; or 3) a strong CYP3A4 inhibitor and a moderate CYP2D6 inhibitor; or 4) a moderate CYP3A4 inhibitor and a moderate CYP2D6 inhibitor increased the exposure of brexpiprazole compared to the use of REXULTI alone [see Clinical Pharmacology (12.3) ]. Intervention: With concomitant use of REXULTI with 1) a strong CYP3A4 inhibitor and a strong CYP2D6 inhibitor; or 2) a moderate CYP3A4 inhibitor and a strong CYP2D6 inhibitor; or 3) a strong CYP3A4 inhibitor and a moderate CYP2D6 inhibitor; or 4) a moderate CYP3A4 inhibitor and a moderate CYP2D6 inhibitor, decrease the REXULTI dosage [see Dosage and Administration (2.7) ]. Strong CYP3A4 Inducers Clinical Impact: Concomitant use of REXULTI and a strong CYP3A4 inducer decreased the exposure of brexpiprazole compared to the use of REXULTI alone [see Clinical Pharmacology (12.3) ]. Intervention: With concomitant use of REXULTI with a strong CYP3A4 inducer, increase the REXULTI dosage [see Dosage and Administration (2.7) ]. 7.2 Drugs Having No Clinically Important Interactions with REXULTI Based on pharmacokinetic studies, no dosage adjustment of REXULTI is required when administered concomitantly 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., bupropion), BCRP (e.g., rosuvastatin), or P-gp (e.g., fexofenadine) is required when administered concomitantly with REXULTI.
Every brexpiprazole product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Rexulti.
What brexpiprazole pills look like
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| BRX;and;0;5 | 0.5 mg | orange | round | — |
| BRX;and;1 | 1 mg | yellow | round | — |
| BRX;and;2 | 2 mg | green | round | — |
| BRX;and;3 | 3 mg | purple | round | — |
| BRX;and;4 | 4 mg | white | round | — |
| BRX;and;2 | 2 mg | green | round | — |
| BRX;and;0;25 | 0.25 mg | brown | round | — |
| BX;6 | 0.25 mg | brown | round | — |
| BX;5 | 0.5 mg | orange | round | — |
| BX;1 | 1 mg | yellow | round | — |
| BX;2 | 2 mg | green | round | — |
| BX;3 | 3 mg | pink | round | — |
How long brexpiprazole keeps
No brexpiprazole label we read sets a separate limit for after opening, but they do specify how it must be stored — and the stability behind any date assumes those conditions.
Does brexpiprazole expire? The in-use limits and storage rules from its labelsBrexpiprazole and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for brexpiprazole: levels in milk, effects in breastfed infants, and the drugs it would consider insteadPreliminary information indicates that brexpiprazole in milk does not adversely affect infant growth and development, but that it might decrease the milk supply. Brexpiprazole has been used successfully to counteract galactorrhea and hyperprolactinemia in a woman taking paliperidone. If a mother requires brexpiprazole, it is not a reason to discontinue breastfeeding, but until more data are available, an alternate drug may be preferred. Monitor the infant for adequate weight gain.
National Institute of Child Health and Human Development, record revised July 15, 2026. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about brexpiprazole
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 1,863 reports naming brexpiprazole, and the FDA flagged 86% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- suicidal ideation141 reports
- depression106 reports
- electrocardiogram qt prolonged99 reports
- schizoaffective disorder93 reports
- weight increased86 reports
- insomnia81 reports
- akathisia75 reports
- somnolence75 reports
Read these as a signal, not a rate. A report does not mean brexpiprazole caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
Related calculators
Frequently asked questions
What is brexpiprazole?
Rexulti (Brexpiprazole) is an atypical antipsychotic used to treat Major Depressive Disorder, Schizophrenia.
What kind of drug is brexpiprazole?
The FDA classifies brexpiprazole as an atypical antipsychotic. Atypical antipsychotics block dopamine D2 receptors and serotonin 5-HT2A receptors in the brain, rebalancing these signaling chemicals to reduce hallucinations, delusions, and mood symptoms in conditions like schizophrenia and bipolar disorder. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take brexpiprazole with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run brexpiprazole against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does brexpiprazole come in?
Across the brands we track, brexpiprazole is currently marketed as tablet and kit, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic brexpiprazole?
We do not currently list a generic-labelled brexpiprazole product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Brexpiprazole: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/brexpiprazole
- MLA
- “Brexpiprazole: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/brexpiprazole.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for brexpiprazole on DailyMed (NIH) ↗ — including its boxed warning in full.