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Two medicines, side by side

Brexpiprazole vs cariprazine

Brexpiprazole and cariprazine are both labeled for depression and schizophrenia. Drugs@FDA records approvals of brexpiprazole since 2015 and of cariprazine since 2015. Pharmacies paid $49.50 per Rexulti 0.25 mg tablet and $50.84 per Vraylar 1.5 mg capsule (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. How each works, in its label's words: Brexpiprazole, “The mechanism of action of REXULTI in the adjunctive treatment of major depressive disorder, treatment of agitation associated with dementia due to Alzheimer's disease, or treatment of schizophrenia …”; Cariprazine, “The mechanism of action of cariprazine is unknown.”

Check it at the source: the brexpiprazole FDA label on DailyMed (effective May 6, 2026); the cariprazine FDA label on DailyMed (effective December 18, 2025).

Highlights of the brexpiprazole record

Brexpiprazole (Rexulti) · label of May 6, 2026

Boxed warning

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.

Used for

From the label: indications

REXULTI 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) ]. […]

On the market

Earliest approval on file
July 10, 2015
Generic labelers
1 labeler
Pharmacy cost
$49.50 per tablet

Supply and safety

Shortage
No current entry
Recalls
0

Highlights of the cariprazine record

Cariprazine (Vraylar) · label of December 18, 2025

Boxed warning

INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDAL THOUGHTS AND BEHAVIORS 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. VRAYLAR is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions ( 5.1 )].

Used for

From the label: indications

INDICATIONS AND USAGE VRAYLAR ® is indicated for: • Treatment of schizophrenia in adult and pediatric patients 13 years of age and older [see Clinical Studies ( 14.1 )] • Acute treatment of manic or mixed episodes associated with bipolar I disorder in adult and pediatric patients 10 years of age and older [see Clinical Studies ( 14.2 )] • Treatment of depressive episodes associated with bipolar I disorder (bipolar […]

On the market

Earliest approval on file
September 17, 2015
Generic labelers
none listed
Pharmacy cost
$50.84 per capsule

Supply and safety

Shortage
No current entry
Recalls
0

Source: FDA drug labels via openFDA (Brexpiprazole label of May 6, 2026, Cariprazine label of December 18, 2025); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)

How do brexpiprazole and cariprazine differ on the record?

How each works, in its label's words: Brexpiprazole, “The mechanism of action of REXULTI in the adjunctive treatment of major depressive disorder, treatment of agitation associated with dementia due to Alzheimer's disease, or treatment of schizophrenia …”; Cariprazine, “The mechanism of action of cariprazine is unknown.”

Both are in FDA's class atypical antipsychotics.

Both labels carry a boxed warning; the records quote them.

Generics: brexpiprazole since 2022; cariprazine since 2022 (Drugs@FDA).

BrexpiprazoleCariprazine
Labeled forDepression, SchizophreniaSchizophrenia, Bipolar disorder, Depression
Pharmacologic classAtypical AntipsychoticAtypical Antipsychotic
How it works (label)The mechanism of action of REXULTI in the adjunctive treatment of major depressive disorder, treatment of agitation associated with dementia due to Alzheimer's disease, or treatment of schizophrenia is unknown.The mechanism of action of cariprazine is unknown.
Half-life (label)n/an/a
Earliest approval on file (Drugs@FDA)July 10, 2015September 17, 2015
First generic approvedAugust 11, 2022September 9, 2022
Generic labelers (NDC)1 labelernone listed
Pharmacy cost (NADAC, each one's most listed form; strengths differ)$49.50 per tablet (Rexulti 0.25 mg tablet)$50.84 per capsule (Vraylar 1.5 mg capsule)
12-month price change+3%+5%
Boxed warningYesYes
Shortage nowNo current entryNo current entry
Recalls recorded00
FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used)16,5059,254
DEA schedulenonenone

Source: Drugs@FDA, FDA NDC Directory, CMS NADAC of October 7, 2026, FDA shortages and recalls, FAERS via openFDA (FDA files October 8, 2026)

What next?

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