Prescription medicine
Risperidone Brand names: Risperdal, Uzedy, Rykindo
Risperidone (Risperdal) is a prescription medicine with an FDA approval on record since 1993. FDA's NDC Directory lists it from 37 generic labelers, and pharmacies paid $0.0368 per risperidone 0.25 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the risperidone FDA label on DailyMed (effective May 28, 2026, Janssen Pharmaceuticals, Inc.); the NDA 20272 record on Drugs@FDA; every risperidone label on DailyMed.
Highlights of the record
FDA label of May 28, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
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. RISPERDAL 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. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. RISPERDAL is not approved for use in patients with dementia-related psychosis.
Used for
From the label: indications and usageRISPERDAL is an atypical antipsychotic indicated for: Treatment of schizophrenia ( 1.1 ) As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder ( 1.2 ) Treatment of irritability associated with autistic disorder ( 1.3 ) 1.1 Schizophrenia RISPERDAL (risperidone) is indicated for the treatment of schizophrenia.
Forms and strengths
- 0.25 mg
- 0.5 mg
- 1 mg
- 2 mg
- 3 mg
- 4 mg
- 1 mg/ml
- 50 mg/.14ml
- 75 mg/.21ml
- 100 mg/.28ml
- 125 mg/.35ml
- 150 mg/.42ml
Tablet; film-coated tablet; orally disintegrating tablet; kit; solution.
On the market
- Earliest approval on file
- December 29, 1993 Risperdal, Janssen Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 48 first June 30, 2008; 28 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 40 of which 37 under generic applications, 4 under brand applications, repackagers included
- Last listed patent
- March 17, 2042 Uzedy injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.0368 per tablet Risperidone 0.25 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 5 since 2013 0 Class I among all firms' recalls; latest March 15, 2021
- FAERS reports
- 131,095 through July 30, 2026
What is risperidone used for?
From the label: indications and usageRISPERDAL is an atypical antipsychotic indicated for: Treatment of schizophrenia ( 1.1 ) As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder ( 1.2 ) Treatment of irritability associated with autistic disorder ( 1.3 ) 1.1 Schizophrenia RISPERDAL (risperidone) is indicated for the treatment of schizophrenia. […]
Conditions named in the indications of risperidone's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Atypical Antipsychotic.
Source: FDA drug label (RISPERDAL), Janssen Pharmaceuticals, Inc., effective May 28, 2026 (SPL set 7e117c7e-02fc-4343-92a1-230061dfc5e0), via openFDA; the full label on DailyMed
Is there a generic for risperidone (Risperdal)?
The FDA approved the first generic risperidone on June 30, 2008. 48 generic applications are approved; 28 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists risperidone from 37 labelers under a generic (ANDA) application and from 4 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Risperdal tablets; a patent listed only for Uzedy injection runs to March 17, 2042. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1993 earliest approval on file
- 2008 first generic approved
- 2042 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for risperidone (Risperdal)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0368 per Risperidone 0.25 mg tablet, down 13% from $0.0423 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Risperidone 0.5 mg tablet (generic)
- Risperdal 0.5 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Risperidone 0.25 mg ODT | Generic | $2.55 per unit many times the lowest per-tablet cost; NADAC records the price, not why | n/a | +35% |
| Risperidone 0.25 mg tablet | Generic | $0.0368 per tablet | $1.11 | -13% |
| Risperidone 0.5 mg ODT | Generic | $1.00 per unit many times the lowest per-tablet cost; NADAC records the price, not why | n/a | +19% |
| Risperidone 0.5 mg tablet | Generic | $0.0363 per tablet | $1.09 | -12% |
| Risperidone 1 mg ODT | Generic | $1.15 per unit many times the lowest per-tablet cost; NADAC records the price, not why | n/a | +3% |
| Risperidone 1 mg tablet | Generic | $0.0366 per tablet | $1.10 | -25% |
| Risperidone 1 mg/mL solution | Generic | $0.472 per mL | n/a | -6% |
| Risperidone 2 mg ODT | Generic | $1.22 per unit many times the lowest per-tablet cost; NADAC records the price, not why | n/a | -2% |
| Risperidone 2 mg tablet | Generic | $0.0544 per tablet | $1.63 | -2% |
| Risperidone 3 mg ODT | Generic | $1.32 per unit many times the lowest per-tablet cost; NADAC records the price, not why | n/a | -11% |
| Risperidone 3 mg tablet | Generic | $0.0686 per tablet | $2.06 | +1% |
| Risperidone 4 mg ODT | Generic | $1.53 per unit many times the lowest per-tablet cost; NADAC records the price, not why | n/a | -15% |
| Risperidone 4 mg tablet | Generic | $0.0818 per tablet | $2.45 | -10% |
| Risperidone ER 25 mg vial | Generic | $355.23 per vial many times the lowest per-tablet cost; NADAC records the price, not why | n/a | -25% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has risperidone been recalled?
The FDA's Enforcement Report lists 5 recalls naming risperidone since 2013: 0 Class I (the most serious), 4 Class II, 1 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 15, 2021 | Class II | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. |
| May 21, 2019 | Class II | Torrent Pharma Inc | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). |
| March 20, 2014 | Class III | Apotex Inc. | Failed Impurities/Degradation Specifications: Out of Specification for an impurity at the 18 month stability time point. |
| September 11, 2013 | Class II | Janssen Pharmaceuticals, Inc. | Non-Sterility: Janssen is recalling one lot of Risperdal CONSTA (risperiDONE) due to a sterility failure in a stability sample |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the risperidone label say about other medicines?
The risperidone label names 20 other medicines in its interaction, contraindication or warning sections. The labels of 34 other medicines name risperidone. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Amitriptyline | drug interactions | Dose adjustment is not recommended for RISPERDAL when co-administered with ranitidine, cimetidine, amitriptyline, or erythromycin [see Table 18 ]. |
| Carbamazepine | drug interactions | DRUG INTERACTIONS Carbamazepine and other enzyme inducers decrease plasma concentrations of risperidone. |
| Cimetidine | drug interactions | Dose adjustment is not recommended for RISPERDAL when co-administered with ranitidine, cimetidine, amitriptyline, or erythromycin [see Table 18 ]. |
| Clozapine | drug interactions | Clozapine Chronic administration of clozapine with RISPERDAL may decrease the clearance of risperidone. |
| Digoxin | drug interactions | Digoxin RISPERDAL (0.25 mg twice daily) did not show a clinically relevant effect on the pharmacokinetics of digoxin. Dose adjustment for digoxin is not recommended. |
| Donepezil | drug interactions | In drug interaction studies, oral RISPERDAL did not significantly affect the pharmacokinetics of donepezil and galantamine, which are metabolized by CYP 2D6. |
| Erythromycin | drug interactions | Dose adjustment is not recommended for RISPERDAL when co-administered with ranitidine, cimetidine, amitriptyline, or erythromycin [see Table 18 ]. |
| Fluoxetine | drug interactions | Titrate slowly. ( 7.1 ) Fluoxetine, paroxetine, and other CYP 2D6 enzyme inhibitors increase plasma concentrations of risperidone. |
| Furosemide | warnings and precautions | In two of four placebo-controlled trials in elderly patients with dementia-related psychosis, a higher incidence of mortality was observed in patients treated with furosemide plus RISPERDAL when compared to patients treated with RISPERDAL alone or with placebo plus furosemide. |
| Galantamine | drug interactions | In drug interaction studies, oral RISPERDAL did not significantly affect the pharmacokinetics of donepezil and galantamine, which are metabolized by CYP 2D6. |
| Levodopa | drug interactions | Levodopa and Dopamine Agonists RISPERDAL may antagonize the effects of levodopa and dopamine agonists. |
| Lithium | drug interactions | … 50 mg twice daily 3 mg twice daily 1.2 1.1 Dose adjustment not needed Effect of Risperidone on Other Drugs Lithium Repeated oral doses of RISPERDAL (3 mg twice daily) did not affect the exposure (AUC) or peak plasma concentrations (C max ) of lithium (n=13). Dose adjustment for lithium is not recommended. |
| Methylphenidate | drug interactions | Methylphenidate Concomitant use with methylphenidate, when there is change in dosage of either medication, may increase the risk of extrapyramidal symptoms (EPS). |
| Paliperidone | contraindications | CONTRAINDICATIONS RISPERDAL is contraindicated in patients with a known hypersensitivity to either risperidone or paliperidone, or to any of the excipients in the RISPERDAL formulation. |
Every other medicine the risperidone label names
| Medicine named | Section | What the label says |
|---|---|---|
| Paroxetine | drug interactions | Titrate slowly. ( 7.1 ) Fluoxetine, paroxetine, and other CYP 2D6 enzyme inhibitors increase plasma concentrations of risperidone. |
| Phenobarbital | drug interactions | Co-administration of other known CYP 3A4 enzyme inducers (e.g., phenytoin, rifampin, and phenobarbital) with risperidone may cause similar decreases in the combined plasma concentrations of … |
| Phenytoin | drug interactions | Co-administration of other known CYP 3A4 enzyme inducers (e.g., phenytoin, rifampin, and phenobarbital) with risperidone may cause similar decreases in the combined plasma concentrations of … |
| Ranitidine | drug interactions | Dose adjustment is not recommended for RISPERDAL when co-administered with ranitidine, cimetidine, amitriptyline, or erythromycin [see Table 18 ]. |
| Rifampin | drug interactions | Co-administration of other known CYP 3A4 enzyme inducers (e.g., phenytoin, rifampin, and phenobarbital) with risperidone may cause similar decreases in the combined plasma concentrations of … |
| Topiramate | drug interactions | Topiramate Oral RISPERDAL administered at doses from 1–6 mg/day concomitantly with topiramate 400 mg/day resulted in a 23% decrease in risperidone C max and a 33% decrease in risperidone AUC 0–12 … |
Other labels that name risperidone
Source: FDA drug label (RISPERDAL), Janssen Pharmaceuticals, Inc., effective May 28, 2026 (SPL set 7e117c7e-02fc-4343-92a1-230061dfc5e0), via openFDA; the full label on DailyMed
What do FAERS reports show for risperidone?
The FDA Adverse Event Reporting System holds 131,095 reports that list risperidone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 10,143 are coded as a death and 40,056 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as risperidone?
16 other medicines are given the same way (oral) and in the same FDA class as risperidone or labeled mainly for the same use (bipolar disorder), the same class first. Bipolar disorder lists all 17 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Quetiapine | Bipolar disorder, Schizophrenia | 50 labelers | $0.127 per tablet 300 mg tablet | No current entry |
| Aripiprazole | Bipolar disorder, Schizophrenia | 47 labelers | $0.110 per tablet 5 mg tablet | No current entry |
| Olanzapine | Bipolar disorder, Schizophrenia | 33 labelers | $0.147 per tablet 20 mg tablet | No current entry |
| Lurasidone | Bipolar disorder, Schizophrenia | 29 labelers | $0.142 per tablet 20 mg tablet | No current entry |
| Ziprasidone | Bipolar disorder, Schizophrenia | 16 labelers | $0.269 per capsule 20 mg capsule | No current entry |
| Paliperidone | Schizophrenia | 18 labelers | $0.972 per tablet 3 mg tablet | No current entry |
| Clozapine | Schizophrenia | 11 labelers | $0.610 per tablet 100 mg tablet | No current entry |
| Iloperidone | Bipolar disorder, Schizophrenia | 1 labeler | $60.01 per tablet 12 mg tablet | No current entry |
Every medicine labeled for the same conditions as risperidone
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does risperidone compare with medicines for the same use?
15 side-by-side pages set risperidone beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to risperidone
- 16 medicines for the same use
- Other atypical antipsychotics
- the pharmacologic class, with prices and generics
- Risperidone side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other