Two medicines, side by side
Olanzapine vs paliperidone
Olanzapine and paliperidone are both labeled for schizophrenia. Drugs@FDA records approvals of olanzapine since 1996 and of paliperidone since 2006. Pharmacies paid $0.147 per olanzapine 20 mg tablet and $0.972 per paliperidone ER 3 mg tablet (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. How each works, in its label's words: Olanzapine, “The mechanism of action of olanzapine, in the listed indications is unclear.”; Paliperidone, “Paliperidone is the major active metabolite of risperidone.”
Check it at the source: the olanzapine FDA label on DailyMed (effective March 5, 2026); the paliperidone FDA label on DailyMed (effective January 31, 2025).
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
Highlights of the paliperidone record
Paliperidone (Invega) · label of January 31, 2025
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. INVEGA 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: indicationsINVEGA is an atypical antipsychotic agent indicated for Treatment of schizophrenia ( 1.1 ) Adults: Efficacy was established in three 6-week trials and one maintenance trial. ( 14.1 ) Adolescents (ages 12–17): Efficacy was established in one 6-week trial. ( 14.1 ) Treatment of schizoaffective disorder as monotherapy and as an adjunct to mood stabilizers and/or antidepressants. […]
On the market
- Earliest approval on file
- December 19, 2006
- Generic labelers
- 18 labelers
- Pharmacy cost
- $0.972 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 5
Source: FDA drug labels via openFDA (Olanzapine label of March 5, 2026, Paliperidone label of January 31, 2025); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do olanzapine and paliperidone differ on the record?
How each works, in its label's words: Olanzapine, “The mechanism of action of olanzapine, in the listed indications is unclear.”; Paliperidone, “Paliperidone is the major active metabolite of risperidone.”
Both are in FDA's class atypical antipsychotics.
Half-life, in each label's words: Olanzapine, “Its half-life ranges from 21 to 54 hours (5th to 95th percentile; mean of 30 hr), and apparent plasma clearance ranges …”; Paliperidone, “The terminal elimination half-life of paliperidone is approximately 23 hours.”
Both labels carry a boxed warning; the records quote them.
Generics: olanzapine since 2011; paliperidone since 2015 (Drugs@FDA).
| Olanzapine | Paliperidone | |
|---|---|---|
| Labeled for | Schizophrenia, Bipolar disorder, Depression | Schizophrenia |
| Pharmacologic class | Atypical Antipsychotic | Atypical Antipsychotic |
| How it works (label) | 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. | Paliperidone is the major active metabolite of risperidone. The mechanism of action of paliperidone in schizophrenia is unclear. |
| Half-life (label) | 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). | The terminal elimination half-life of paliperidone is approximately 23 hours. |
| Earliest approval on file (Drugs@FDA) | September 30, 1996 | December 19, 2006 |
| First generic approved | October 24, 2011 | August 3, 2015 |
| Generic labelers (NDC) | 43 labelers | 18 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.147 per tablet (Olanzapine 20 mg tablet) | $0.972 per tablet (Paliperidone ER 3 mg tablet) |
| 12-month price change | -5% | -23% |
| Boxed warning | Yes | Yes |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 14 | 5 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 107,881 | 52,997 |
| 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?
Paliperidone label, warnings and precautionsPatients with Dementia-Related Psychosis In placebo-controlled trials with risperidone, aripiprazole, and olanzapine in elderly subjects with dementia, there was a higher incidence of cerebrovascular adverse reactions (cerebrovascular accidents and transient ischemic attacks) including fatalities compared to placebo-treated subjects.
Source: FDA drug labels via openFDA
What next?
- Alternatives to olanzapine
- every medicine labeled for the same conditions