Two medicines, side by side
Brexpiprazole vs quetiapine
Brexpiprazole and quetiapine are both labeled for depression and schizophrenia. Drugs@FDA records approvals of brexpiprazole since 2015 and of quetiapine since 1997. Pharmacies paid $49.50 per Rexulti 0.25 mg tablet and $0.127 per quetiapine fumarate 300 mg tablet (NADAC, October 7, 2026); the strengths differ and 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 …”; Quetiapine, “The mechanism of action of quetiapine in the listed indications is unclear.”
Check it at the source: the brexpiprazole FDA label on DailyMed (effective May 6, 2026); the quetiapine FDA label on DailyMed (effective April 10, 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 quetiapine record
Quetiapine (Seroquel) · label of April 10, 2026
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 [see Warnings and Precautions (5.1) ]. SEROQUEL is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (5.1) ].
Used for
From the label: indicationsSEROQUEL is an atypical antipsychotic indicated for the treatment of: • Schizophrenia ( 1.1 ) • Bipolar I disorder manic episodes (1.2) • Bipolar disorder, depressive episodes (1.2) 1.1 Schizophrenia SEROQUEL is indicated for the treatment of schizophrenia. The efficacy of SEROQUEL in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13-17 years). […]
On the market
- Earliest approval on file
- September 26, 1997
- Generic labelers
- 48 labelers
- Pharmacy cost
- $0.127 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 10
Source: FDA drug labels via openFDA (Brexpiprazole label of May 6, 2026, Quetiapine label of April 10, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do brexpiprazole and quetiapine 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 …”; Quetiapine, “The mechanism of action of quetiapine in the listed indications is unclear.”
Both are in FDA's class atypical antipsychotics.
Both labels carry a boxed warning; the records quote them.
Generics: brexpiprazole since 2022; quetiapine since 2012 (Drugs@FDA).
| Brexpiprazole | Quetiapine | |
|---|---|---|
| Labeled for | Depression, Schizophrenia | Schizophrenia, Bipolar disorder, Depression |
| 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 quetiapine in the listed indications is unclear. However, the efficacy of quetiapine in these indications could be mediated through a combination of dopamine type 2 (D 2 ) and serotonin type 2 (5HT 2 ) antagonism. |
| Half-life (label) | n/a | Elimination of quetiapine is mainly via hepatic metabolism with a mean terminal half-life of about 6 hours within the proposed clinical dose range. |
| Earliest approval on file (Drugs@FDA) | July 10, 2015 | September 26, 1997 |
| First generic approved | August 11, 2022 | March 27, 2012 |
| Generic labelers (NDC) | 1 labeler | 48 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $49.50 per tablet (Rexulti 0.25 mg tablet) | $0.127 per tablet (Quetiapine fumarate 300 mg tablet) |
| 12-month price change | +3% | -9% |
| Boxed warning | Yes | Yes |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 0 | 10 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 16,505 | 191,480 |
| 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)
What next?
- Alternatives to brexpiprazole
- every medicine labeled for the same conditions