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Treats schizophrenia As monotherapy or adjunctive therapy with lithium or valproate. Sold as Risperdal, Risperdal Consta, Perseris, Rykindo, Uzedy and 1 more. Every FDA application for this active ingredient: 8 branded and 49 generic.
As of Nov 13, 2026, FDA lists 57 applications for Risperidone (sold as Risperdal, Risperdal Consta, Perseris and others), first approved Dec 29, 1993, with 31 new uses approved and 6 published complete response letters.
First approved: Dec 29, 1993
Applications: 57
New uses approved: 31
Complete response letters: 6
Medicare spending, 2025: $236M
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
RisperdalDrugs with a new additional indication and a new dosage for the treatment of irritability associated with autism spectrum disorder in children and adolescents. · Janssen Pharmaceutical K.K. · Feb 29, 2016 · Review report
Risperdal Consta, new approvalDrugs with a new route of administration indicated for the treatment of schizophrenia. · Janssen Pharmaceutical K.K. · Apr 22, 2009
Clinical Trials
29 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all
RisperidoneOphthalmology, Human Factors, Product Quality
Approved
Jan 28, 2020
Rykindo (risperidone)Clinical And Clinical Pharmacology, Product Quality, Use-Related Risk Analysis
Approved
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA
Novitium Pharma
Zydus Pharms USA Inc
Hikma
Sandoz
Sun Pharm Inds Ltd
Teva