Two medicines, side by side
Paliperidone vs haloperidol
Paliperidone and haloperidol are both labeled for schizophrenia. Drugs@FDA records approvals of paliperidone since 2006 and of haloperidol since 1967. Pharmacies paid $0.972 per paliperidone ER 3 mg tablet and $15.60 per mL (Haloperidol dec 100 mg/mL vial) (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. In FDA's classes, paliperidone is an atypical antipsychotic and haloperidol a typical antipsychotic.
Check it at the source: the paliperidone FDA label on DailyMed (effective January 31, 2025); the haloperidol FDA label on DailyMed (effective April 23, 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 haloperidol record
Haloperidol (Haldol) · label of April 23, 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: indicationsHaloperidol tablets are indicated for use in the management of manifestations of psychotic disorders. Haloperidol tablets are indicated for the control of tics and vocal utterances of Tourette’s Disorder in children and adults. Haloperidol tablets are effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation). […]
On the market
- Earliest approval on file
- April 12, 1967
- Generic labelers
- 41 labelers
- Pharmacy cost
- $15.60 per mL
Supply and safety
- Shortage
- A presentation being discontinued
- Recalls
- 18
Source: FDA drug labels via openFDA (Paliperidone label of January 31, 2025, Haloperidol label of April 23, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do paliperidone and haloperidol differ on the record?
In FDA's classes, paliperidone is an atypical antipsychotic and haloperidol a typical antipsychotic.
Both labels carry a boxed warning; the records quote them.
Generics: paliperidone since 2015; haloperidol since 1986 (Drugs@FDA).
| Paliperidone | Haloperidol | |
|---|---|---|
| Labeled for | Schizophrenia | Schizophrenia |
| Pharmacologic class | Atypical Antipsychotic | Typical Antipsychotic |
| How it works (label) | Paliperidone is the major active metabolite of risperidone. The mechanism of action of paliperidone in schizophrenia is unclear. | n/a |
| Half-life (label) | The terminal elimination half-life of paliperidone is approximately 23 hours. | n/a |
| Earliest approval on file (Drugs@FDA) | December 19, 2006 | April 12, 1967 |
| First generic approved | August 3, 2015 | June 10, 1986 |
| Generic labelers (NDC) | 18 labelers | 41 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.972 per tablet (Paliperidone ER 3 mg tablet) | $15.60 per mL (Haloperidol dec 100 mg/mL vial) |
| 12-month price change | -23% | no change |
| Boxed warning | Yes | Yes |
| Shortage now | No current entry | A presentation being discontinued |
| Recalls recorded | 5 | 18 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 52,997 | 26,054 |
| 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 paliperidone
- every medicine labeled for the same conditions