Two medicines, side by side
Paliperidone vs clozapine
Paliperidone and clozapine are both labeled for schizophrenia. Drugs@FDA records approvals of paliperidone since 2006 and of clozapine since 1989. Pharmacies paid $0.972 per paliperidone ER 3 mg tablet and $0.610 per clozapine 100 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.”; Clozapine, “The mechanism of action of clozapine is unknown.”
Check it at the source: the paliperidone FDA label on DailyMed (effective January 31, 2025); the clozapine FDA label on DailyMed (effective June 6, 2025).
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 clozapine record
Clozapine (Clozaril) · label of June 6, 2025
SEVERE NEUTROPENIA; ORTHOSTATIC HYPOTENSION, BRADYCARDIA, AND SYNCOPE; SEIZURE; MYOCARDITIS, PERICARDITIS AND CARDIOMYOPATHY; INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Severe Neutropenia CLOZARIL has caused severe neutropenia which is associated with an increased risk of serious and potentially fatal infections. Prior to initiating CLOZARIL treatment, obtain baseline ANC(s).
Used for
From the label: indicationsCLOZARIL is an atypical antipsychotic indicated for: • Treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. […]
On the market
- Earliest approval on file
- September 26, 1989
- Generic labelers
- 11 labelers
- Pharmacy cost
- $0.610 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 4
Source: FDA drug labels via openFDA (Paliperidone label of January 31, 2025, Clozapine label of June 6, 2025); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do paliperidone and clozapine differ on the record?
How each works, in its label's words: Paliperidone, “Paliperidone is the major active metabolite of risperidone.”; Clozapine, “The mechanism of action of clozapine is unknown.”
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.”; Clozapine, “The mean elimination half-life of clozapine after a single 75 mg dose was 8 hours (range: 4 to 12 hours), compared to a …”
Both labels carry a boxed warning; the records quote them.
Generics: paliperidone since 2015; clozapine since 1996 (Drugs@FDA).
| Paliperidone | Clozapine | |
|---|---|---|
| Labeled for | Schizophrenia | 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 clozapine is unknown. |
| Half-life (label) | The terminal elimination half-life of paliperidone is approximately 23 hours. | The mean elimination half-life of clozapine after a single 75 mg dose was 8 hours (range: 4 to 12 hours), compared to a mean elimination half-life of 12 hours (range: 4 to 66 hours), after achieving steady state with … |
| Earliest approval on file (Drugs@FDA) | December 19, 2006 | September 26, 1989 |
| First generic approved | August 3, 2015 | August 30, 1996 |
| Generic labelers (NDC) | 18 labelers | 11 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.972 per tablet (Paliperidone ER 3 mg tablet) | $0.610 per tablet (Clozapine 100 mg tablet) |
| 12-month price change | -23% | +5% |
| Boxed warning | Yes | Yes |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 5 | 4 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 52,997 | 124,829 |
| 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 do the labels say about using others of their kind?
Clozapine label, warnings and precautionsWhen possible, avoid use with other anticholinergic drugs and use with caution in patients with a current diagnosis or prior history of constipation, urinary retention, clinically significant prostatic hypertrophy, or other conditions in which anticholinergic effects can lead to significant adverse reactions.
Source: FDA drug labels via openFDA
What next?
- Alternatives to paliperidone
- every medicine labeled for the same conditions