Paliperidone is an atypical antipsychotic indicated for Treatment of schizophrenia, among other approved uses. It is available as extended-release tablets for oral use. MedsAcross supplies Paliperidone for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
INVEGA is an atypical antipsychotic agent indicated for Treatment of schizophrenia. Adults: Efficacy was established in three 6-week trials and one maintenance trial. Adolescents (ages 12–17): Efficacy was established in one 6-week trial. Treatment of schizoaffective disorder as monotherapy and as an adjunct to mood stabilizers and/or antidepressants. Efficacy was established in two 6-week trials in adult patients.
Source: US FDA prescribing information
Paliperidone is the major active metabolite of risperidone. The mechanism of action of paliperidone in schizophrenia is unclear. However, the drug's therapeutic effect in schizophrenia could be mediated through a combination of central dopamine Type 2 (D 2 ) and serotonin Type 2 (5HT 2A ) receptor antagonism.
Source: US FDA prescribing information
Initial Dose Recommended Dose Maximum Dose Schizophrenia - adults 6 mg/day 3 – 12 mg/day 12 mg/day Schizophrenia-adolescents. Weight < 51kg 3 mg/day 3 – 6 mg/day 6 mg/day Weight ≥ 51kg 3 mg/day 3 – 12 mg/day 12 mg/day Schizoaffective disorder - adults 6 mg/day 3 – 12 mg/day 12 mg/day Tablet should be swallowed whole and should not be chewed, divided, or crushed.
Source: US FDA prescribing information
INVEGA is contraindicated in patients with a known hypersensitivity to either paliperidone or risperidone, or to any of the excipients in the INVEGA formulation. Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported in patients treated with risperidone and in patients treated with paliperidone. Paliperidone is a metabolite of risperidone. Known hypersensitivity to paliperidone, risperidone, or to any excipients in INVEGA.
Source: US FDA prescribing information
Boxed warning (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. WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS. INVEGA is not approved for use in patients with dementia-related psychosis. Cerebrovascular Adverse Reactions: An increased incidence of cerebrovascular adverse reactions (e.g. stroke, transient ischemic attack, including fatalities) has been seen in elderly patients with dementia- related psychoses treated with atypical antipsychotics. Neuroleptic Malignant Syndrome: Manage with immediate discontinuation of drug and close monitoring.
Source: US FDA prescribing information
The following adverse reactions are discussed in more detail in other sections of the labeling: Increased mortality in elderly patients with dementia-related psychosis Cerebrovascular adverse reactions, including stroke, in elderly patients with dementia-related psychosis Neuroleptic malignant syndrome QT prolongation Tardive dyskinesia Metabolic changes Hyperprolactinemia Potential for gastrointestinal obstruction Orthostatic hypotension and syncope Falls Leukopenia, neutropenia, and agranulocytosis Potential for cognitive and motor impairment Seizures Dysphagia Priapism Disruption of body temperature regulation Commonly observed adverse reactions (incidence ≥ 5% and at least twice that for placebo) were. Adults with schizophrenia: extrapyramidal symptoms, tachycardia, and akathisia.
Source: US FDA prescribing information
Centrally-acting drugs: Due to CNS effects, use caution in combination. Avoid alcohol. Drugs that may cause orthostatic hypotension: An additive effect may be observed when co-administered with INVEGA. Strong CYP3A4/P-glycoprotein (P-gp) inducers: It may be necessary to increase the dose of INVEGA when a strong inducer of both CYP3A4 and P-gp (e.g., carbamazepine) is co-administered. Conversely, on discontinuation of the strong inducer, it may be necessary to decrease the dose of INVEGA. Co-administration of divalproex sodium increased C max and AUC of paliperidone by approximately 50%. Adjust dose of INVEGA if necessary based on clinical assessment.
Source: US FDA prescribing information
Store up to 25 °C (77 °F), excursions permitted to 15 °C to 30 °C (59 °F to 86 °F). Protect from moisture.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
8 presentations of Paliperidone, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Paliperidone 3 mg extended-release tabletOralGeneric name | — | US FDA | Available on request |
| Paliperidone 6 mg extended-release tabletOralGeneric name | — | US FDA | Available on request |
| Paliperidone 9 mg extended-release tabletOralGeneric name | — | US FDA | Available on request |
| Paliperidone 1.5 mg extended-release tabletOralGeneric name | — | US FDA | Available on request |
| Invega 3 mg extended-release tabletOral | Janssen Pharmaceuticals | US FDA | Available on request |
| Invega 6 mg extended-release tabletOral | Janssen Pharmaceuticals | US FDA | Available on request |
| Invega 9 mg extended-release tabletOral | Janssen Pharmaceuticals | US FDA | Available on request |
| Invega 1.5 mg extended-release tabletOral | Janssen Pharmaceuticals | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Conditions linked to Paliperidone in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 8 presentations of Paliperidone and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Paliperidone, including Invega.
Yes. The US FDA first approved Paliperidone on 19 December 2006, according to Drugs@FDA.
Yes. Paliperidone has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Paliperidone is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Paliperidone is classified under ATC code N05AX13 (Paliperidone).
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