Two medicines, side by side
Paliperidone vs risperidone
Paliperidone and risperidone are both labeled for schizophrenia. Drugs@FDA records approvals of paliperidone since 2006 and of risperidone since 1993. Pharmacies paid $0.972 per paliperidone ER 3 mg tablet and $0.0368 per risperidone 0.25 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: Paliperidone, “Paliperidone is the major active metabolite of risperidone.”; 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 paliperidone FDA label on DailyMed (effective January 31, 2025); the risperidone FDA label on DailyMed (effective May 28, 2026).
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
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 (Paliperidone label of January 31, 2025, Risperidone label of May 28, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do paliperidone and risperidone differ on the record?
How each works, in its label's words: Paliperidone, “Paliperidone is the major active metabolite of risperidone.”; 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.
Half-life, in each label's words: Paliperidone, “The terminal elimination half-life of paliperidone is approximately 23 hours.”; Risperidone, “The apparent half-life of risperidone was 3 hours (CV=30%) in extensive metabolizers and 20 hours (CV=40%) in poor …”
Both labels carry a boxed warning; the records quote them.
Generics: paliperidone since 2015; risperidone since 2008 (Drugs@FDA).
| Paliperidone | Risperidone | |
|---|---|---|
| Labeled for | Schizophrenia | Bipolar disorder, Schizophrenia |
| Pharmacologic class | Atypical Antipsychotic | Atypical Antipsychotic |
| How it works (label) | Paliperidone is the major active metabolite of risperidone. The mechanism of action of paliperidone in schizophrenia is unclear. | 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) | The terminal elimination half-life of paliperidone is approximately 23 hours. | 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) | December 19, 2006 | December 29, 1993 |
| First generic approved | August 3, 2015 | June 30, 2008 |
| Generic labelers (NDC) | 18 labelers | 37 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.972 per tablet (Paliperidone ER 3 mg tablet) | $0.0368 per tablet (Risperidone 0.25 mg tablet) |
| 12-month price change | -23% | -13% |
| Boxed warning | Yes | Yes |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 5 | 5 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 52,997 | 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?
Paliperidone label, contraindicationsCONTRAINDICATIONS INVEGA is contraindicated in patients with a known hypersensitivity to either paliperidone or risperidone, or to any of the excipients in the INVEGA formulation.
Paliperidone label, warnings and precautionsPaliperidone has a prolactin-elevating effect similar to that seen with risperidone, a drug that is associated with higher levels of prolactin than other antipsychotic drugs.
Risperidone label, contraindicationsCONTRAINDICATIONS RISPERDAL is contraindicated in patients with a known hypersensitivity to either risperidone or paliperidone, or to any of the excipients in the RISPERDAL formulation.
Risperidone label, contraindicationsCONTRAINDICATIONS RISPERDAL CONSTA is contraindicated in patients with a known hypersensitivity to either risperidone or paliperidone, or to any of the excipients in the RISPERDAL CONSTA formulation.
Source: FDA drug labels via openFDA
What next?
- Alternatives to paliperidone
- every medicine labeled for the same conditions