Two medicines, side by side
Aripiprazole vs paliperidone
Aripiprazole and paliperidone are both labeled for schizophrenia. Drugs@FDA records approvals of aripiprazole since 2002 and of paliperidone since 2006. Pharmacies paid $0.110 per aripiprazole 5 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: Aripiprazole, “The mechanism of action of aripiprazole in schizophrenia or bipolar mania, is unclear.”; Paliperidone, “Paliperidone is the major active metabolite of risperidone.”
Check it at the source: the aripiprazole FDA label on DailyMed (effective January 29, 2025); the paliperidone FDA label on DailyMed (effective January 31, 2025).
Highlights of the aripiprazole record
Aripiprazole (Abilify) · label of January 29, 2025
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDAL THOUGHTS AND BEHAVIORS WITH ANTIDEPRESSANT DRUGS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ABILIFY is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (5.1) ].
Used for
From the label: indicationsABILIFY (aripiprazole) Tablets are indicated for the treatment of: Schizophrenia Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder Adjunctive Treatment of Major Depressive Disorder Irritability Associated with Autistic Disorder Treatment of Tourette's Disorder ABILIFY is an atypical antipsychotic. […]
On the market
- Earliest approval on file
- November 15, 2002
- Generic labelers
- 47 labelers
- Pharmacy cost
- $0.110 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 25
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 (Aripiprazole label of January 29, 2025, Paliperidone label of January 31, 2025); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do aripiprazole and paliperidone differ on the record?
How each works, in its label's words: Aripiprazole, “The mechanism of action of aripiprazole in schizophrenia or bipolar mania, 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: Aripiprazole, “For CYP2D6 poor metabolizers, the mean elimination half-life for aripiprazole is about 146 hours.”; Paliperidone, “The terminal elimination half-life of paliperidone is approximately 23 hours.”
Both labels carry a boxed warning; the records quote them.
Generics: aripiprazole since 2015; paliperidone since 2015 (Drugs@FDA).
| Aripiprazole | Paliperidone | |
|---|---|---|
| Labeled for | Depression, Bipolar disorder, Schizophrenia | Schizophrenia |
| Pharmacologic class | Atypical Antipsychotic | Atypical Antipsychotic |
| How it works (label) | The mechanism of action of aripiprazole in schizophrenia or bipolar mania, is unclear. | Paliperidone is the major active metabolite of risperidone. The mechanism of action of paliperidone in schizophrenia is unclear. |
| Half-life (label) | For CYP2D6 poor metabolizers, the mean elimination half-life for aripiprazole is about 146 hours. | The terminal elimination half-life of paliperidone is approximately 23 hours. |
| Earliest approval on file (Drugs@FDA) | November 15, 2002 | December 19, 2006 |
| First generic approved | April 28, 2015 | August 3, 2015 |
| Generic labelers (NDC) | 47 labelers | 18 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.110 per tablet (Aripiprazole 5 mg tablet) | $0.972 per tablet (Paliperidone ER 3 mg tablet) |
| 12-month price change | +3% | -23% |
| Boxed warning | Yes | Yes |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 25 | 5 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 121,736 | 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 aripiprazole
- every medicine labeled for the same conditions