Two medicines, side by side
Brexpiprazole vs olanzapine
Brexpiprazole and olanzapine are both labeled for depression and schizophrenia. Drugs@FDA records approvals of brexpiprazole since 2015 and of olanzapine since 1996. Pharmacies paid $49.50 per Rexulti 0.25 mg tablet and $0.147 per olanzapine 20 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 …”; Olanzapine, “The mechanism of action of olanzapine, in the listed indications is unclear.”
Check it at the source: the brexpiprazole FDA label on DailyMed (effective May 6, 2026); the olanzapine FDA label on DailyMed (effective March 5, 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 olanzapine record
Olanzapine (Zyprexa) · label of March 5, 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. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients.
Used for
From the label: indicationsOlanzapine is an atypical antipsychotic indicated: As oral formulation for the: · Treatment of schizophrenia. ( 1.1 ) · Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. ( 14.1 ) · Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia ( 14.1 ). […]
On the market
- Earliest approval on file
- September 30, 1996
- Generic labelers
- 43 labelers
- Pharmacy cost
- $0.147 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 14
Source: FDA drug labels via openFDA (Brexpiprazole label of May 6, 2026, Olanzapine label of March 5, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do brexpiprazole and olanzapine 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 …”; Olanzapine, “The mechanism of action of olanzapine, 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; olanzapine since 2011 (Drugs@FDA).
| Brexpiprazole | Olanzapine | |
|---|---|---|
| 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 olanzapine, in the listed indications is unclear. However, the efficacy of olanzapine in schizophrenia could be mediated through a combination of dopamine and serotonin type 2 (5HT 2 ) antagonism. |
| Half-life (label) | n/a | Its half-life ranges from 21 to 54 hours (5th to 95th percentile; mean of 30 hr), and apparent plasma clearance ranges from 12 to 47 L/hr (5th to 95th percentile; mean of 25 L/hr). |
| Earliest approval on file (Drugs@FDA) | July 10, 2015 | September 30, 1996 |
| First generic approved | August 11, 2022 | October 24, 2011 |
| Generic labelers (NDC) | 1 labeler | 43 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $49.50 per tablet (Rexulti 0.25 mg tablet) | $0.147 per tablet (Olanzapine 20 mg tablet) |
| 12-month price change | +3% | -5% |
| Boxed warning | Yes | Yes |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 0 | 14 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 16,505 | 107,881 |
| 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