Two medicines, side by side
Cariprazine vs paliperidone
Cariprazine and paliperidone are both labeled for schizophrenia. Drugs@FDA records approvals of cariprazine since 2015 and of paliperidone since 2006. Pharmacies paid $50.84 per Vraylar 1.5 mg capsule and $0.972 per paliperidone ER 3 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: Cariprazine, “The mechanism of action of cariprazine is unknown.”; Paliperidone, “Paliperidone is the major active metabolite of risperidone.”
Check it at the source: the cariprazine FDA label on DailyMed (effective December 18, 2025); the paliperidone FDA label on DailyMed (effective January 31, 2025).
Highlights of the cariprazine record
Cariprazine (Vraylar) · label of December 18, 2025
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: indicationsINDICATIONS 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
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 (Cariprazine label of December 18, 2025, Paliperidone label of January 31, 2025); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do cariprazine and paliperidone differ on the record?
How each works, in its label's words: Cariprazine, “The mechanism of action of cariprazine is unknown.”; Paliperidone, “Paliperidone is the major active metabolite of risperidone.”
Both are in FDA's class atypical antipsychotics.
Both labels carry a boxed warning; the records quote them.
Generics: cariprazine since 2022; paliperidone since 2015 (Drugs@FDA).
| Cariprazine | Paliperidone | |
|---|---|---|
| Labeled for | Schizophrenia, Bipolar disorder, Depression | Schizophrenia |
| Pharmacologic class | Atypical Antipsychotic | Atypical Antipsychotic |
| How it works (label) | The mechanism of action of cariprazine is unknown. | Paliperidone is the major active metabolite of risperidone. The mechanism of action of paliperidone in schizophrenia is unclear. |
| Half-life (label) | n/a | The terminal elimination half-life of paliperidone is approximately 23 hours. |
| Earliest approval on file (Drugs@FDA) | September 17, 2015 | December 19, 2006 |
| First generic approved | September 9, 2022 | August 3, 2015 |
| Generic labelers (NDC) | none listed | 18 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $50.84 per capsule (Vraylar 1.5 mg capsule) | $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 | 0 | 5 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 9,254 | 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)
What next?
- Alternatives to cariprazine
- every medicine labeled for the same conditions