Two medicines, side by side
Brexpiprazole vs risperidone
Brexpiprazole and risperidone are both labeled for schizophrenia. Drugs@FDA records approvals of brexpiprazole since 2015 and of risperidone since 1993. Pharmacies paid $49.50 per Rexulti 0.25 mg tablet and $0.0368 per risperidone 0.25 mg tablet (NADAC, October 7, 2026); one is a brand and one a generic, 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 …”; Risperidone, “The drug's therapeutic activity in schizophrenia could be mediated through a combination of dopamine Type 2 (D 2 ) and serotonin Type 2 (5HT 2 ) receptor antagonism.”
Check it at the source: the brexpiprazole FDA label on DailyMed (effective May 6, 2026); the risperidone FDA label on DailyMed (effective May 28, 2026).
Highlights of the brexpiprazole record
Brexpiprazole (Rexulti) · label of May 6, 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.
Used for
From the label: indicationsREXULTI 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 risperidone record
Risperidone (Risperdal) · label of May 28, 2026
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. RISPERDAL is not approved for the treatment of patients with dementia-related psychosis. [see Warnings and Precautions (5.1) ] WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS See full prescribing information for complete boxed warning.
Used for
From the label: indicationsRISPERDAL is an atypical antipsychotic indicated for: Treatment of schizophrenia ( 1.1 ) As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder ( 1.2 ) Treatment of irritability associated with autistic disorder ( 1.3 ) 1.1 Schizophrenia RISPERDAL (risperidone) is indicated for the treatment of schizophrenia. […]
On the market
- Earliest approval on file
- December 29, 1993
- Generic labelers
- 37 labelers
- Pharmacy cost
- $0.0368 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 5
Source: FDA drug labels via openFDA (Brexpiprazole label of May 6, 2026, Risperidone label of May 28, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do brexpiprazole and risperidone 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 …”; Risperidone, “The drug's therapeutic activity in schizophrenia could be mediated through a combination of dopamine Type 2 (D 2 ) and serotonin Type 2 (5HT 2 ) receptor antagonism.”
Both are in FDA's class atypical antipsychotics.
Both labels carry a boxed warning; the records quote them.
Generics: brexpiprazole since 2022; risperidone since 2008 (Drugs@FDA).
| Brexpiprazole | Risperidone | |
|---|---|---|
| Labeled for | Depression, Schizophrenia | Bipolar disorder, Schizophrenia |
| Pharmacologic class | Atypical Antipsychotic | Atypical 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 risperidone in schizophrenia is unclear. The drug's therapeutic activity in schizophrenia could be mediated through a combination of dopamine Type 2 (D 2 ) and serotonin Type 2 (5HT 2 ) receptor antagonism. |
| Half-life (label) | n/a | The apparent half-life of risperidone was 3 hours (CV=30%) in extensive metabolizers and 20 hours (CV=40%) in poor metabolizers. |
| Earliest approval on file (Drugs@FDA) | July 10, 2015 | December 29, 1993 |
| First generic approved | August 11, 2022 | June 30, 2008 |
| Generic labelers (NDC) | 1 labeler | 37 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $49.50 per tablet (Rexulti 0.25 mg tablet) | $0.0368 per tablet (Risperidone 0.25 mg tablet) |
| 12-month price change | +3% | -13% |
| Boxed warning | Yes | Yes |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 0 | 5 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 16,505 | 131,095 |
| DEA schedule | none | none |
Source: Drugs@FDA, FDA NDC Directory, CMS NADAC of October 7, 2026, FDA shortages and recalls, FAERS via openFDA (FDA files October 8, 2026)
Do their labels mention each other?
Brexpiprazole label, warnings and precautionsStroke 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.
Source: FDA drug labels via openFDA
What next?
- Alternatives to brexpiprazole
- every medicine labeled for the same conditions