Quick answers
- What is Risperidone used for?
- The FDA-approved label (Risperidone, Janssen Pharmaceuticals, Inc., August 20, 2026) says: “Risperidone is an atypical antipsychotic indicated for: Treatment of schizophrenia As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder Treatment of irritability associated with autistic disorder 1.1 Schizophrenia Risperidone is indicated for the treatment of schizophrenia. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Risperidone have a boxed warning?
- Yes. The FDA label for Risperidone has a boxed warning (“WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Risperidone?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Risperidone been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Risperidone?
- 36 companies list prescription products of Risperidone in the FDA NDC Directory, including Janssen Pharmaceuticals, Inc., Jubilant Cadista Pharmacuticals Inc. and Remedyrepack Inc..
What Risperidone is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Risperidone is an atypical antipsychotic indicated for: Treatment of schizophrenia As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder Treatment of irritability associated with autistic disorder 1.1 Schizophrenia Risperidone is indicated for the treatment of schizophrenia. …
— FDA label: Risperidone, Janssen Pharmaceuticals, Inc., effective August 20, 2026. Read the full label on DailyMed →
The FDA has 62 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
. Read it on the full label →
61 of 62 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet · Tablet, film coated · Tablet, orally disintegrating · Solution · Injection, suspension, extended release |
|---|---|
| Route | Oral · Subcutaneous |
| Prescription products | 176 in the FDA NDC Directory |
| Brand names | Uzedy, Risperdal, Risperdal M-Tab |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| risperidone 0.25 mg tablet | Generic | $0.0377 per tablet |
| risperidone 0.25 mg tablet, film coated | Generic | $0.0377 per tablet |
| risperidone 0.25 mg tablet, orally disintegrating | Generic | $2.54 per tablet |
| risperidone 0.5 mg tablet | Generic | $0.0380 per tablet |
| risperidone 0.5 mg tablet | Brand: Risperdal | $4.38 per tablet |
| risperidone 0.5 mg tablet, film coated | Generic | $0.0380 per tablet |
| risperidone 0.5 mg tablet, orally disintegrating | Generic | $0.9944 per tablet |
| risperidone 1 mg tablet | Generic | $0.0388 per tablet |
| risperidone 1 mg tablet | Brand: Risperdal | $4.69 per tablet |
| risperidone 1 mg tablet, film coated | Generic | $0.0388 per tablet |
| risperidone 1 mg tablet, orally disintegrating | Generic | $1.16 per tablet |
| risperidone 1 mg/mL solution | Generic | $0.4699 per mL |
| risperidone 1 mg/mL solution | Brand: Risperdal | $5.28 per mL |
| risperidone 100 mg/0.28 mL injection, suspension, extended release | Brand: Uzedy | $9,371.34 per mL |
| risperidone 125 mg/0.35 mL injection, suspension, extended release | Brand: Uzedy | $9,343.06 per mL |
| risperidone 2 mg tablet | Generic | $0.0541 per tablet |
| risperidone 2 mg tablet | Brand: Risperdal | $7.86 per tablet |
| risperidone 2 mg tablet, film coated | Generic | $0.0541 per tablet |
| risperidone 2 mg tablet, orally disintegrating | Generic | $1.18 per tablet |
| risperidone 200 mg/0.56 mL injection, suspension, extended release | Brand: Uzedy | $9,353.41 per mL |
| risperidone 250 mg/0.7 mL injection, suspension, extended release | Brand: Uzedy | $9,317.55 per mL |
| risperidone 3 mg tablet | Generic | $0.0736 per tablet |
| risperidone 3 mg tablet | Brand: Risperdal | $9.19 per tablet |
| risperidone 3 mg tablet, film coated | Generic | $0.0736 per tablet |
| risperidone 3 mg tablet, orally disintegrating | Generic | $1.74 per tablet |
| risperidone 4 mg tablet | Generic | $0.0843 per tablet |
| risperidone 4 mg tablet | Brand: Risperdal | $12.35 per tablet |
| risperidone 4 mg tablet, film coated | Generic | $0.0843 per tablet |
| risperidone 4 mg tablet, orally disintegrating | Generic | $1.59 per tablet |
| risperidone 50 mg/0.14 mL injection, suspension, extended release | Brand: Uzedy | $9,451.01 per mL |
| risperidone 75 mg/0.21 mL injection, suspension, extended release | Brand: Uzedy | $9,377.80 per mL |
NADAC list of November 4, 2026; these prices took effect between January 1, 2026 and October 28, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Janssen Pharmaceuticals, Inc.12 products
- Jubilant Cadista Pharmacuticals Inc.11 products
- Remedyrepack Inc.11 products
- Teva Pharmaceuticals USA, Inc.7 products
- Chartwell RX, LLC7 products
- Bryant Ranch Prepack7 products
- Torrent Pharmaceuticals Limited6 products
- Ajanta Pharma USA Inc.6 products
- AvKARE6 products
- Zydus Lifesciences Limited6 products
- Zydus Pharmaceuticals USA Inc.6 products
- Amneal Pharmaceuticals NY LLC6 products
- Major Pharmaceuticals6 products
- Solco Healthcare US, LLC6 products
- Par Health USA, LLC6 products
- American Health Packaging6 products
- Westminster Pharmaceuticals, LLC6 products
- Golden State Medical Supply, Inc.6 products
- Proficient Rx LP5 products
- Sun Pharmaceutical Industries, Inc.5 products
- NCS HealthCare of KY, LLC dba Vangard Labs5 products
- Amici Pharma, Inc.5 products
- Amerisyn LLC5 products
- Coupler LLC4 products
- Aphena Pharma Solutions - Tennessee, LLC3 products
- PD-Rx Pharmaceuticals, Inc.3 products
- A-S Medication Solutions3 products
- Cardinal Health 107, LLC2 products
- NuCare Pharmaceuticals, Inc.2 products
- Atlantic Biologicals Corp.1 product
- Amneal Pharmaceuticals LLC1 product
- Aurobindo Pharma Limited1 product
- Cranbury Pharmaceuticals, LLC1 product
- ANI Pharmaceuticals, Inc.1 product
- Apozeal Pharmaceuticals Inc1 product
- Direct_Rx1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA020272 RISPERDAL | Janssen Pharms | December 29, 1993 | 54, latest January 22, 2025 2025: Labeling · 2022: Labeling · 2021: Labeling |
| NDA020588 RISPERDAL | Janssen Pharms | June 10, 1996 | 43, latest January 22, 2025 2025: Labeling · 2022: Labeling · 2021: Labeling |
| NDA021444 RISPERDAL | Janssen Pharms | April 2, 2003 | 33, latest January 22, 2025 2025: Labeling · 2022: Labeling · 2021: Labeling |
| NDA213586 UZEDY | Teva | April 28, 2023 | 4, latest October 10, 2025 2025: Labeling · 2025: Efficacy · 2025: Labeling |
Generic approvals (19)
- ANDA078040Zydus Pharms USA Inc · October 16, 2008
- ANDA079088Torrent Pharms · October 30, 2008
- ANDA078707Renata · December 29, 2008
- ANDA076440Ani Pharms · January 30, 2009
- ANDA077328Pharmazone · February 24, 2009
- ANDA078828Jubilant Cadista · March 23, 2009
- ANDA077494Ph Health · April 30, 2009
- ANDA078071Amneal · June 17, 2009
- ANDA078909Pharmazone · July 29, 2009
- ANDA078452Aurobindo Pharma Ltd · September 4, 2009
- ANDA077542Sun Pharm Inds Ltd · August 6, 2010
- ANDA078474Sun Pharm Inds Ltd · August 6, 2010
- ANDA077543Chartwell Molecular · May 18, 2011
- ANDA091384Amneal Pharms · May 25, 2011
- ANDA201003Ajanta Pharma Ltd · August 24, 2011
- ANDA090839Jubilant Generics · November 4, 2011
- ANDA077493Prinston Inc · November 29, 2011
- ANDA079059Tris Pharma Inc · December 12, 2012
- ANDA202386Chartwell Molecular · January 12, 2015
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Risperidone, Janssen Pharmaceuticals, Inc., effective August 20, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →