FDA label
What is paliperidone used for?
The FDA-approved uses of paliperidone, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label for paliperidone lists 2 uses: Schizophrenia; Schizoaffective Disorder.
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Paliperidone, tablet, extended release
Indications and Usage, quoted from the label by Camber Pharmaceuticals, Inc (ANDA216174). Cross-references to other label sections are left out.
Schizophrenia
Paliperidone extended-release tablets are indicated for the treatment of schizophrenia.
The efficacy of paliperidone in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents, as well as one maintenance trial in adults.
Schizoaffective Disorder
Paliperidone extended-release tablets are indicated for the treatment of schizoaffective disorder as monotherapy and an adjunct to mood stabilizers and/or antidepressant therapy.
The efficacy of paliperidone in schizoaffective disorder was established in two 6-week trials in adults.
Source: DailyMed label, set id 1cfcad42-da71-457d-b1e1-aee806642d0c, version 2, effective April 23, 2026. NDC 31722-317, one of 51 listings for this product.
Questions
What is paliperidone used for?
The FDA label for paliperidone lists 2 uses: Schizophrenia; Schizoaffective Disorder.
What drug class is paliperidone?
FDA lists paliperidone in the Atypical Antipsychotic established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.