Skip to the answer

Risperidone

Risperidone is an atypical antipsychotic used to treat schizophrenia, bipolar I disorder (manic or mixed episodes, or maintenance treatment depending on the product), and irritability linked to autistic disorder.

Brand names Risperdal M-TAB Orally Disintegrating TabletsRisperdal Oral SolutionRisperdal TabletsRisperdalPerseris +5 more
Drug class Atypical Antipsychotic
Rx Forms 4
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 73 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 5, 2026
Other forms & routes:
Injection
Risperidone at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Risperidone is an atypical antipsychotic and a common first choice for schizophrenia, bipolar I disorder and irritability linked to autistic disorder, thought to work by blocking dopamine type 2 and serotonin type 2 receptors; it has been on the market since about 1993 and is available generically. Most people tolerate it reasonably well, though sleepiness, weight gain and stiffness or restlessness are what they notice. Its boxed warning is a higher risk of death in older adults with dementia-related psychosis, a use it is not approved for. Expect checks on weight and blood sugar, and report uncontrolled movements of the face or tongue (possible tardive dyskinesia).

Clinical pearls

  • If you take fluoxetine or paroxetine, or start carbamazepine, phenytoin or rifampin, your risperidone dose may need adjusting.
  • Stand up slowly, especially early on, because risperidone can drop your blood pressure when you rise.
  • Risperidone raises prolactin, a hormone that can reduce fertility in women, and this reverses once the drug is stopped.
  • Paliperidone is risperidone’s main active byproduct, so an allergy to either one rules out the other.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Older adults with dementia-related psychosis who take antipsychotic drugs, including risperidone, have a higher risk of death. In trials, deaths were about 4.5% with the drug versus about 2.6% with placebo over roughly 10 weeks. Most deaths appeared to be from heart problems (such as heart failure or sudden death) or infections (such as pneumonia). Risperidone is not approved to treat dementia-related psychosis. If you care for someone with dementia who takes it, talk with their prescriber.

Read the full warning on DailyMed →
How you get itPrescription only
Comes asTablet, Orally disintegrating tablet, Oral solution +1
Earliest FDA record1993
Companies listing it with the FDA41
FDA label last updatedMay 28, 2026
FDA’s strongest warning (boxed)Yes, read the warning

Patient information guide A plain-language walkthrough of Risperidone, written from its FDA label.

What Risperidone is used for

▾

Risperidone is used for several psychiatric conditions, depending on the product.

  • Schizophrenia: oral risperidone (tablets, orally disintegrating tablets, oral solution), Risperdal and Risperdal M-tab. Also the long-acting injections Uzedy, Perseris, Risperdal Consta, Rykindo and generic extended-release injectables.
  • Acute manic or mixed episodes of bipolar I disorder: oral risperidone, alone or added to lithium or valproate.
  • Maintenance treatment of bipolar I disorder: Uzedy, Risperdal Consta, Rykindo and generic extended-release injectables, alone or with lithium or valproate. Not listed for Perseris.
  • Irritability associated with autistic disorder (aggression, self-injury, tantrums, quickly changing moods): oral risperidone in children and adolescents.

How Risperidone works

▾

Risperidone blocks dopamine type 2 and serotonin type 2 receptors in the brain. This is the leading explanation for how it helps in schizophrenia, though the exact mechanism is unknown. Its main active byproduct, 9-hydroxyrisperidone, works much the same way. Together they produce the clinical effect.

Risperidone dosage

▾

Oral risperidone comes as tablets, orally disintegrating tablets and oral solution. It can be taken with or without food. Doctors start low and adjust gradually, and doses differ by condition, age and weight.

  • Uzedy and Perseris are given under the skin by a healthcare professional.
  • Risperdal Consta and Rykindo are given into a muscle by a healthcare professional.
  • Doctors usually confirm you tolerate oral risperidone before starting an injection.

Follow your prescriber's directions and the label.

Dosing details from the FDA-approved label

From the Risperidone prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Schizophrenia (Uzedy) - switching from daily oral risperidone
    • Initiate the day after the last oral dose
    • Once monthly: 2 mg oral = 50 mg
    • 3 mg = 75 mg
    • 4 mg = 100 mg
    • 5 mg = 125 mg
    • Once every 2 months: 2 mg oral = 100 mg
    • 3 mg = 150 mg
    • 4 mg = 200 mg
    • 5 mg = 250 mg
    • Given by subcutaneous injection in the abdomen or upper arm by a healthcare professional
    • Establish tolerability with oral risperidone first; neither a loading dose nor supplemental oral risperidone is recommended
  • Bipolar I disorder maintenance (Uzedy) - switching from daily oral risperidone
    • Once monthly only: 2 mg oral = 50 mg
    • 3 mg = 75 mg
    • 4 mg = 100 mg, as monotherapy or adjunctive therapy to lithium or valproate
    • Uzedy once every 2 months is not recommended for bipolar I disorder
  • Bipolar I disorder (Uzedy) - switching from another risperidone long-acting intramuscular injection given once every 2 weeks
    • Start at least 5 weeks after the last long-acting injection
    • Once monthly: 25 mg = 50 mg
    • 37.5 mg = 75 mg
    • 50 mg = 100 mg
    • Neither a loading dose nor supplemental oral risperidone is recommended
  • Uzedy - renal or hepatic impairment
    • Titrate with oral risperidone to at least 2 mg once daily before starting
    • Then the recommended dosage of Uzedy is 50 mg once monthly
    • Based on clinical response and tolerability after oral titration
  • Perseris - patients switching from oral risperidone
    • Initiate at 90 mg or 120 mg once monthly by subcutaneous injection in the abdomen or back of the upper arm. 3 mg oral per day: 90 mg one day after the last oral dose. 4 mg oral per day: 120 mg one day after the last oral dose
    • Maximum: Do not administer more than one dose (90 mg or 120 mg total) per month
    • Patients on stable oral doses lower than 3 mg per day or higher than 4 mg per day may not be candidates; no loading dose or supplemental oral risperidone
  • Perseris - renal or hepatic impairment
    • Titrate with oral risperidone up to at least 3 mg daily before starting
    • Then the recommended dosage of Perseris is 90 mg once monthly
    • Based on clinical response and tolerability after oral titration
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION Table 1. Recommended Daily Dosage by Indication Initial Dose Titration (Increments) Target Dose Effective Dose Range Schizophrenia: adults (2.1) 2 mg 1 to 2 mg 4 to 8 mg 4 to 16 mg Schizophrenia: adolescents (2.1) 0.5 mg 0.5 to 1 mg 3 mg 1 to 6 mg Bipolar mania: adults (2.2) 2 to 3 mg 1 mg 1 to 6 mg 1 to 6 mg Bipolar mania: children and adolescents (2.2) 0.5 mg 0.5 to 1 mg 1 to 2.5 mg 1 to 6 mg Irritability in autistic disorder (2.3) 0.25 mg Can increase to 0.5 mg by Day 4: (body weight less than 20 kg) 0.5 mg Can increase to 1 mg by Day 4: (body weight greater than or equal to 20 kg) After Day 4, at intervals of > 2 weeks: 0.25 mg (body weight less than 20 kg) 0.5 mg (body weight greater than or equal to 20 kg) 0.5 mg: (body weight less than 20 kg) 1 mg: (body weight greater than or equal to 20 kg) 0.5 to 3 mg Severe Renal and Hepatic Impairment in Adults: use a lower starting dose of 0.5 mg twice daily. May increase to dosages above 1.5 mg twice daily at intervals of one week or longer. Recommended daily dosage: Initial Dose Target Dose Effective Dose Range Schizophrenia: adults ( 2.1 ) 2 mg 4 to 8 mg 4 to 16 mg Schizophrenia: adolescents ( 2.1 ) 0.5 mg 3 mg 1 to 6 mg Bipolar mania: adults ( 2.2 ) 2 to 3 mg 1 to 6 mg 1 to 6 mg Bipolar mania: in children and adolescents ( 2.2 ) 0.5 mg 1 to 2.5 mg 1 to 6 mg Irritability associated with autistic disorder ( 2.3 ) 0.25 mg (Weight < 20 kg) 0.5 mg (Weight ≥20 kg) 0.5 mg (<20 kg) 1 mg (≥20 kg) 0.5 to 3 mg Severe Renal or Hepatic Impairment in Adults: Use a lower starting dose of 0.5 mg twice daily. May increase to dosages above 1.5 mg twice daily at intervals of at least one week. ( 2.4 ) Oral Solution: Can be administered directly from calibrated oral dosing syringe or mixed with beverage (water, coffee, orange juice, or low-fat milk). ( 2.6 ) M-TAB Orally Disintegrating Tablets: Open the blister only when ready to administer, and immediately place tablet on the tongue. Can be swallowed with or without liquid. ( 2.7 ) 2.1 Schizophrenia Adults Usual Initial Dose RISPERDAL can be administered once or twice daily. Initial dosing is 2 mg per day. May increase the dose at intervals of 24 hours or greater, in increments of 1 to 2 mg per day, as tolerated, to a recommended dose of 4 to 8 mg per day. In some patients, slower titration may be appropriate.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Risperidone side effects

▾

Common side effects in trials included:

Common side effects

  • Parkinsonism (stiffness, slowed movement)
  • Akathisia (restlessness)
  • Tremor and muscle spasms (dystonia)
  • Sleepiness, sedation and dizziness
  • Nausea, vomiting and indigestion
  • Constipation and dry mouth
  • Increased appetite and weight gain
  • Fatigue, anxiety and blurred vision
  • Nausea, vomiting, indigestion, diarrhea, constipation, dry mouth
  • Fatigue, rash, nasal congestion and colds

When to get medical help

  • Call your doctor or get emergency help for fever, muscle stiffness, confusion, fast or irregular heartbeat or heavy sweating. These can be signs of neuroleptic malignant syndrome, which can be fatal.
  • Tell your doctor if you notice uncontrolled movements of the face, tongue or body, which may be tardive dyskinesia.
  • Get help right away for stroke symptoms, especially in older adults with dementia.
  • Report excess thirst, frequent urination, increased hunger or weakness, which can signal high blood sugar.
  • Tell your doctor about signs of low white blood cell count, especially if you have had it before.
  • Seek help for a seizure, trouble swallowing, or a painful erection that won't go away (priapism).
  • Report an allergic reaction such as swelling of the face or throat, or trouble breathing.

Risperidone warnings and precautions

▾
  • Dementia-related psychosis: higher risk of death and stroke in older adults. Not approved for this use.
  • Neuroleptic malignant syndrome: a rare, potentially fatal reaction.
  • Tardive dyskinesia: potentially irreversible involuntary movements.
  • Metabolic changes: high blood sugar, cholesterol changes and weight gain.
  • Others: raised prolactin, low blood pressure on standing, low white blood cell counts, seizures, trouble swallowing, priapism and impaired body temperature regulation.

Risperidone interactions

▾

Several drugs change risperidone levels or add to its effects.

  • Carbamazepine and other enzyme inducers lower levels, so a higher dose may be needed.
  • Fluoxetine and paroxetine raise levels, so a lower dose is needed.
  • Alcohol and other brain-acting drugs add to drowsiness.
  • Blood pressure–lowering drugs may have stronger effects.
  • Levodopa and dopamine agonists may be weakened.
  • Methylphenidate may raise the risk of movement symptoms.
  • Clozapine may slow clearance of risperidone.

Interactions listed in the FDA-approved label

From the Risperidone prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Carbamazepine and other enzyme inducers: Decrease plasma concentrations of risperidone. Increase the risperidone dose up to double the patient's usual dose; titrate slowly. Do not exceed twice the patient's usual dose.
  • Fluoxetine, paroxetine, and other CYP 2D6 enzyme inhibitors: Increase plasma concentrations of risperidone. Reduce the initial dose. Do not exceed a final dose of 8 mg per day of risperidone.
  • Ranitidine, cimetidine, amitriptyline, erythromycin: No dose adjustment is needed for risperidone when co-administered. Dose adjustment not needed
  • Lithium: Repeated oral risperidone doses (3 mg twice daily) did not affect lithium exposure (AUC) or peak plasma concentrations (Cmax). Dose adjustment for lithium is not recommended.
  • Valproate: Risperidone did not affect pre-dose or average plasma concentrations or AUC of valproate, but there was a 20% increase in valproate peak plasma concentration (Cmax). Dose adjustment for valproate is not recommended.
  • Digoxin: Risperidone (0.25 mg twice daily) did not show a clinically relevant effect on the pharmacokinetics of digoxin. Dose adjustment for digoxin is not recommended.
  • Centrally acting drugs and alcohol: Given the primary CNS effects of risperidone, caution is needed when taken in combination. Use caution.
  • Drugs with hypotensive effects: Risperidone may enhance the hypotensive effects of other therapeutic agents with this potential.
  • Levodopa and dopamine agonists: Risperidone may antagonize the effects of levodopa and dopamine agonists.
  • Methylphenidate: Concomitant use, when there is a change in dosage of either medication, may increase the risk of extrapyramidal symptoms (EPS). Monitor for symptoms of EPS with concomitant use.
Read the label’s full interactions text

7 DRUG INTERACTIONS • Carbamazepine and other enzyme inducers decrease plasma concentrations of risperidone. Increase the risperidone dose up to double the patient's usual dose. Titrate slowly. ( 7.1 ) • Fluoxetine, paroxetine, and other CYP 2D6 enzyme inhibitors increase plasma concentrations of risperidone. Reduce the initial dose. Do not exceed a final dose of 8 mg per day of risperidone. ( 7.1 ) 7.1 Pharmacokinetic-related Interactions The dose of risperidone should be adjusted when used in combination with CYP2D6 enzyme inhibitors (e.g., fluoxetine, and paroxetine) and enzyme inducers (e.g., carbamazepine) [see Table 18 and Dosage and Administration (2.5) ] . Dose adjustment is not recommended for risperidone when co-administered with ranitidine, cimetidine, amitriptyline, or erythromycin [see Table 18 ]. Table 18. Summary of Effect of Coadministered Drugs on Exposure to Active Moiety (Risperidone + 9-Hydroxy-Risperidone) in Healthy Subjects or Patients with Schizophrenia Coadministered Drug Dosing Schedule Effect on Active Coadministered Drug Dosing Schedule Effect on Active Moiety (Risperidone + 9-Hydroxy Risperidone) (Ratio*) Risperidone Dose Recommendation Coadministered Drug Risperidone AUC C max Enzyme (CYP2D6) Inhibitors Fluoxetine 20 mg/day 2 or 3 mg twice daily 1.4 1.5 Re-evaluate dosing. Do not exceed 8 mg/day Paroxetine 10 mg/day 4 mg/day 1.3 - Re-evaluate dosing. Do not exceed 8 mg/day 20 mg/day 4 mg/day 1.6 - 40 mg/day 4 mg/day 1.8 - Enzyme (CYP3A/PgP inducers) Inducers Carbamazepine 573 ± 168 mg/day 3 mg twice daily 0.51 0.55 Titrate dose upwards.

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

🌿199 supplements and herbs with documented Risperidone interactions, ranked by severity Check Risperidone against a supplement or herb →

Before taking Risperidone

▾
  • Do not use if allergic to risperidone or paliperidone.
  • Tell your doctor about diabetes, seizures or low white blood cell counts.
  • Pregnancy: third-trimester use can cause movement problems or withdrawal symptoms in newborns.
  • Breastfeeding: risperidone passes into breast milk, so watch infants for sedation and jitteriness.
  • Children: oral risperidone is studied in schizophrenia from age 13, bipolar mania from age 10, and autistic irritability from about age 5.
  • Older adults with dementia-related psychosis face higher risks.
  • Severe kidney or liver disease may call for a lower starting dose.

Risperidone overdose

▾

Overdose can cause drowsiness, sedation, fast heartbeat, low blood pressure and movement problems. Seizures and heart rhythm changes have also been reported. There is no specific antidote, so care is supportive. Contact poison control at 1-800-222-1222 or seek emergency help.

What Risperidone does in the body

▾

Risperidone binds strongly to serotonin type 2, dopamine type 2, alpha-1 and alpha-2 adrenergic, and histamine H1 receptors, and blocks them. It has weaker effects at other receptors. It has no affinity for muscarinic or beta adrenergic receptors.

How your body processes Risperidone

▾

Risperidone is well absorbed by mouth. Food does not change absorption. Peak levels occur at about 1 hour. The liver breaks it down, mainly with the CYP2D6 enzyme, into the active 9-hydroxyrisperidone. The combined half-life is about 20 hours. Most of it leaves through the urine, with a smaller amount in the feces.

How to store Risperidone

▾

stored at controlled room temperature 15 °C to 25 °C (59 °F to 77 °F). Protect from light and moisture. Protect from light and freezing.

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

199

Supplements & herbs that interact with Risperidone

199 supplements and herbal products have documented interactions with Risperidone in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 11
  • Moderate · 147
  • Minor · 41
ACTIVATED CHARCOAL Major AMERICAN HELLEBORE Major ARSENIC Major CESIUM Major EPHEDRA Major GRAPEFRUIT Major INDIAN SNAKEROOT Major LITHIUM Major +191 more
Every supplement checked against Risperidone — ranked by severity The full interaction hub: 11 major · 147 moderate · 41 minor · every one linked to its full report. Check Risperidone against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

Risperidone: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Risperidone — the kind of thing our pharmacy team would talk through with you at the counter.

What is risperidone used for?

▾
It treats schizophrenia and bipolar I disorder. The oral forms also treat irritability linked to autistic disorder in children and adolescents. Which condition applies depends on the specific product your prescriber chose.

Should I take it with food?

▾
Oral risperidone can be taken with or without food, because food doesn't change how well it's absorbed. Take it as your prescriber directed. The injections are given by a healthcare professional.

What side effects should I expect?

▾
Common ones include sleepiness, dizziness, restlessness, tremor, stiffness, nausea, constipation, dry mouth and weight gain. Tell your prescriber if they bother you. Don't stop on your own.

When should I call my doctor right away?

▾
Call for fever with muscle stiffness or confusion, uncontrolled movements, stroke symptoms, seizures, signs of high blood sugar like extreme thirst, or a painful erection that won't go away. These can be serious.

Are there medicines I should watch out for?

▾
Yes. Carbamazepine can lower risperidone levels, and fluoxetine and paroxetine can raise them. Alcohol and other sedating drugs add to drowsiness. Tell me about everything you take so I can check.

Is it safe in pregnancy or for older adults?

▾
Taking it in late pregnancy can cause movement problems or withdrawal symptoms in newborns, so talk to your doctor if you're pregnant. Older adults with dementia-related psychosis have a higher risk of death and stroke, and it isn't approved for that use.

Is Risperidone available over the counter?

▾
No. Risperidone is a prescription medicine: every Risperidone product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Risperidone first available?

▾
The earliest FDA record we hold for Risperidone is from 1993: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Risperidone was first used.

Who makes Risperidone?

▾
41 companies currently list Risperidone products in the FDA's NDC Directory, including Janssen Pharmaceuticals, Inc., Jubilant Cadista Pharmacuticals Inc., Remedyrepack Inc.. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Risperidone on HelloPharmacist

📊Risperidone supplement interactions199 checked — ranked by severity 🌿Drug & Supplement CheckerRisperidone vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Risperidone NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Risperidone Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Risperidone forms and strengths (how it comes)

Risperidone is available in 4 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Tablet

By mouth
Brands Risperdal
How this form is used
What it may be used for
  • Risperdal and risperidone tablets are used for schizophrenia.
  • Risperdal and risperidone tablets are used for acute manic or mixed episodes of bipolar I disorder, alone or with lithium or valproate.
  • Risperdal and risperidone tablets are used for irritability associated with autistic disorder.
Important instructions
  • Risperidone tablets can be taken with or without meals.
Available strengths 6 strengths
0.25 mg 0.5 mg 1 mg 2 mg 3 mg 4 mg
254 FDA-listed product records ⓘ

Orally disintegrating tablet

By mouth
Brands Risperdal M-tab
How this form is used
What it may be used for
  • Risperdal M-tab and risperidone orally disintegrating tablets are used for schizophrenia.
  • Risperdal M-tab and risperidone orally disintegrating tablets are used for acute manic or mixed episodes of bipolar I disorder, alone or with lithium or valproate.
  • Risperdal M-tab and risperidone orally disintegrating tablets are used for irritability associated with autistic disorder.
Important instructions
  • Risperidone orally disintegrating tablets are bioequivalent to risperidone tablets.
  • Risperidone can be taken with or without meals.
Available strengths 6 strengths
0.25 mg 0.5 mg 1 mg 2 mg 3 mg 4 mg
80 FDA-listed product records ⓘ

Oral solution

By mouth
Brands Risperdal
How this form is used
What it may be used for
  • Risperidone oral solution is used for schizophrenia.
  • Risperidone oral solution is used for acute manic or mixed episodes of bipolar I disorder, alone or with lithium or valproate.
  • Risperidone oral solution is used for irritability associated with autistic disorder.
Important instructions
  • Risperidone oral solution is bioequivalent to risperidone tablets.
  • Risperidone can be taken with or without meals.
Available strengths 1 strength
1 mg/mL
30 FDA-listed product records ⓘ

Injection

By injection · Under the skin
Brands Uzedy
How this form is used
What it may be used for
  • Uzedy is used for schizophrenia in adults.
  • Uzedy is used for maintenance treatment of bipolar I disorder in adults, alone or with lithium or valproate.
Important instructions
  • Uzedy is given by a healthcare professional as a subcutaneous injection in the abdomen or upper arm.
  • Uzedy should not be given by any other route.
  • Tolerability with oral risperidone should be established before starting Uzedy.
Available strengths 13 strengths
12.5 mg/2 mL 25 mg/2 mL 37.5 mg/2 mL 50 mg/0.14 mL 50 mg/2 mL 75 mg/0.21 mL
Show 7 more strengths Show fewer strengths
90 mg/0.6 mL 100 mg/0.28 mL 120 mg/0.8 mL 125 mg/0.35 mL 150 mg/0.42 mL 200 mg/0.56 mL 250 mg/0.7 mL
29 FDA-listed product records ⓘ

Risperidone on the U.S. market: products, makers and brands

How Risperidone appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

41 companies list 200 Risperidone product records with the FDA, mostly as tablet, orally disintegrating tablet, oral solution; the earliest marketing or approval year on record is 1993. Brand names on the directory include Risperdal M-TAB Orally Disintegrating Tablets, Risperdal Oral Solution, Risperdal Tablets and 7 more; the rest are generics.

4
Dose forms ⓘ
41
Labelers (makers, repackagers, distributors)
7
Brand names
200
FDA-listed product records ⓘ
1993
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Kit (37) · Powder (18) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Janssen Pharmaceuticals, Inc.8%
Jubilant Cadista Pharmacuticals Inc.6%
Remedyrepack Inc.6%
Bryant Ranch Prepack4%
Chartwell RX, LLC4%
Teva Pharmaceuticals USA, Inc.4%
Other makers71%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Risperidone is used (Medicaid data)

A general measure of how commonly Risperidone is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Risperidone is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

3,411,596
Medicaid prescriptions filled (Q1–Q4 2025)
$332.2M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Risperidone prescribed? Of the 1,601 medications we measure, Risperidone ranks #61 by Medicaid prescriptions — more than 96% of them.

Where Risperidone ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #61 of 1,601
#56 Insulin Glargine (rDNA... 3,731,821 Rx #57 Clonazepam 3,602,972 Rx #58 Fluconazole 3,462,620 Rx #59 Polyethylene Glycol 33... 3,441,581 Rx #60 Doxycycline 3,416,939 Rx #61 Risperidone 3,411,596 Rx #62 Lidocaine 3,379,243 Rx #63 Budesonide / Formotero... 3,326,951 Rx #64 Meloxicam 3,321,801 Rx #65 Folic Acid 3,298,551 Rx #66 Metronidazole 3,247,421 Rx

Utilization by Risperidone product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 1 mg oral tablet is the most-dispensed Risperidone product — about 28% of these Medicaid prescriptions.

risperidone 1 MG Oral Tablet Most dispensed

939,462 Medicaid prescriptions (Q1–Q4 2025) 28% of Risperidone prescriptions shown $9.7M gross reimbursement (before rebates) ≈ $10 per prescription (gross)

Summed across the 14 of 98 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 312830

risperidone 0.5 MG Oral Tablet

688,891 Medicaid prescriptions (Q1–Q4 2025) 20% of Risperidone prescriptions shown $6.5M gross reimbursement (before rebates) ≈ $9.46 per prescription (gross)

Summed across the 13 of 75 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 312829

risperidone 2 MG Oral Tablet

618,805 Medicaid prescriptions (Q1–Q4 2025) 18% of Risperidone prescriptions shown $6.8M gross reimbursement (before rebates) ≈ $11 per prescription (gross)

Summed across the 11 of 101 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 312831

risperidone 3 MG Oral Tablet

336,550 Medicaid prescriptions (Q1–Q4 2025) 10% of Risperidone prescriptions shown $3.8M gross reimbursement (before rebates) ≈ $11 per prescription (gross)

Summed across the 10 of 70 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 312832

risperidone 0.25 MG Oral Tablet

268,578 Medicaid prescriptions (Q1–Q4 2025) 8% of Risperidone prescriptions shown $2.5M gross reimbursement (before rebates) ≈ $9.20 per prescription (gross)

Summed across the 9 of 66 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 312828

risperidone 4 MG Oral Tablet

198,553 Medicaid prescriptions (Q1–Q4 2025) 6% of Risperidone prescriptions shown $2.4M gross reimbursement (before rebates) ≈ $12 per prescription (gross)

Summed across the 10 of 72 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 314211

risperidone 1 MG/ML Oral Solution

165,780 Medicaid prescriptions (Q1–Q4 2025) 5% of Risperidone prescriptions shown $7.3M gross reimbursement (before rebates) ≈ $44 per prescription (gross)

Summed across the 5 of 30 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 199387

0.35 ML risperidone 357 MG/ML Prefilled Syringe

24,582 Medicaid prescriptions (Q1–Q4 2025) <1% of Risperidone prescriptions shown $76.3M gross reimbursement (before rebates) ≈ $3,103 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2636041

risperidone 50 MG Injection

24,064 Medicaid prescriptions (Q1–Q4 2025) <1% of Risperidone prescriptions shown $35.8M gross reimbursement (before rebates) ≈ $1,489 per prescription (gross)

Summed across the 2 of 11 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 402012

risperidone 0.5 MG Disintegrating Oral Tablet

22,358 Medicaid prescriptions (Q1–Q4 2025) <1% of Risperidone prescriptions shown $1.1M gross reimbursement (before rebates) ≈ $47 per prescription (gross)

Summed across the 3 of 18 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 403825

risperidone 1 MG Disintegrating Oral Tablet

21,710 Medicaid prescriptions (Q1–Q4 2025) <1% of Risperidone prescriptions shown $1.2M gross reimbursement (before rebates) ≈ $57 per prescription (gross)

Summed across the 3 of 20 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 401953

0.28 ML risperidone 357 MG/ML Prefilled Syringe

19,969 Medicaid prescriptions (Q1–Q4 2025) <1% of Risperidone prescriptions shown $49.9M gross reimbursement (before rebates) ≈ $2,500 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2636033

risperidone 2 MG Disintegrating Oral Tablet

13,489 Medicaid prescriptions (Q1–Q4 2025) <1% of Risperidone prescriptions shown $811,947 gross reimbursement (before rebates) ≈ $60 per prescription (gross)

Summed across the 2 of 18 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 401954

risperidone 25 MG Injection

10,970 Medicaid prescriptions (Q1–Q4 2025) <1% of Risperidone prescriptions shown $8.2M gross reimbursement (before rebates) ≈ $748 per prescription (gross)

Summed across the 2 of 11 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 402010

risperidone 37.5 MG Injection

8,315 Medicaid prescriptions (Q1–Q4 2025) <1% of Risperidone prescriptions shown $9.7M gross reimbursement (before rebates) ≈ $1,170 per prescription (gross)

Summed across the 2 of 11 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 402011

risperidone 3 MG Disintegrating Oral Tablet

6,274 Medicaid prescriptions (Q1–Q4 2025) <1% of Risperidone prescriptions shown $462,581 gross reimbursement (before rebates) ≈ $74 per prescription (gross)

Summed across the 2 of 18 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 616698

0.7 ML risperidone 357 MG/ML Prefilled Syringe

5,965 Medicaid prescriptions (Q1–Q4 2025) <1% of Risperidone prescriptions shown $37.8M gross reimbursement (before rebates) ≈ $6,344 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2636047

risperidone 0.25 MG Disintegrating Oral Tablet

5,589 Medicaid prescriptions (Q1–Q4 2025) <1% of Risperidone prescriptions shown $578,405 gross reimbursement (before rebates) ≈ $103 per prescription (gross)

Summed across the 1 of 7 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 645037

0.8 ML risperidone 150 MG/ML Prefilled Syringe

5,495 Medicaid prescriptions (Q1–Q4 2025) <1% of Risperidone prescriptions shown $14.9M gross reimbursement (before rebates) ≈ $2,714 per prescription (gross)

Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2055667

0.21 ML risperidone 357 MG/ML Prefilled Syringe

5,492 Medicaid prescriptions (Q1–Q4 2025) <1% of Risperidone prescriptions shown $10.4M gross reimbursement (before rebates) ≈ $1,886 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2636051

0.14 ML risperidone 357 MG/ML Prefilled Syringe

5,145 Medicaid prescriptions (Q1–Q4 2025) <1% of Risperidone prescriptions shown $6.6M gross reimbursement (before rebates) ≈ $1,278 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2636049

0.56 ML risperidone 357 MG/ML Prefilled Syringe

4,703 Medicaid prescriptions (Q1–Q4 2025) <1% of Risperidone prescriptions shown $23.6M gross reimbursement (before rebates) ≈ $5,022 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2636045

risperidone 4 MG Disintegrating Oral Tablet

4,671 Medicaid prescriptions (Q1–Q4 2025) <1% of Risperidone prescriptions shown $505,748 gross reimbursement (before rebates) ≈ $108 per prescription (gross)

Summed across the 2 of 16 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 616705

0.42 ML risperidone 357 MG/ML Prefilled Syringe

2,567 Medicaid prescriptions (Q1–Q4 2025) <1% of Risperidone prescriptions shown $9.9M gross reimbursement (before rebates) ≈ $3,861 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2636043

0.6 ML risperidone 150 MG/ML Prefilled Syringe

2,403 Medicaid prescriptions (Q1–Q4 2025) <1% of Risperidone prescriptions shown $5M gross reimbursement (before rebates) ≈ $2,076 per prescription (gross)

Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2055675

risperidone 12.5 MG Injection

1,216 Medicaid prescriptions (Q1–Q4 2025) <1% of Risperidone prescriptions shown $411,733 gross reimbursement (before rebates) ≈ $339 per prescription (gross)

Summed across the 2 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 706822

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Risperidone, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 102 of 670 listed Risperidone NDCs with Medicaid activity.

Compare Risperidone products

A representative set of FDA-listed product records for Risperidone — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 90 of 200 products — FDA National Drug Code Directory. See every product, package size and price: browse all 200 Risperidone NDCs →

Risperidone side effects reported to the FDA (FAERS)

After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Risperidone — a signal of what to watch for, not proof the drug caused it.

The effects most often named in FDA reports that mention Risperidone are gynaecomastia, abnormal weight gain, weight increased; about 67% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.

131,090
Reports mentioning it
67%
Reported as serious
12
Distinct effects shown
Most reported effects
Gynaecomastia
24,647
Abnormal Weight Gain
9,451
Weight Increased
9,190
Emotional Disorder
5,956
Injury
4,631
Drug Interaction
4,549
Hyperprolactinaemia
4,475
Somnolence
4,402
Galactorrhoea
3,758
Obesity
3,717
Age groups
Adult · 18,983Child · 8,557Adolescent · 4,704Elderly · 3,811Neonate · 169Infant · 79

Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Risperidone in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.

Risperidone FDA approval history

How Risperidone went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.

Risperidone was first approved by the FDA in 1993 (Brand: RISPERDAL · Janssen Pharms); the first generic version was approved in 2008. It remains available in U.S. pharmacies today.

1993
Brand approved
Brand: RISPERDAL · Janssen Pharms
2008
First generic approved
Lower-cost ANDA competition begins
2026
Available today
Active in U.S. pharmacies

Source: Drugs@FDA.

Risperidone recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list no Risperidone recalls since July 2021.

✅No Risperidone recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Risperidone RxCUI 35636 5 dose forms · 27 strengths
  1. Dose form (SCDF) Disintegrating Oral Tablet RxCUI 402348 In current FDA listings
    Clinical drug / strength (SCD) 0.25 MG RxCUI 645037 0.5 MG RxCUI 403825 1 MG RxCUI 401953 2 MG RxCUI 401954 3 MG RxCUI 616698 4 MG RxCUI 616705
  2. Dose form (SCDF) Injection RxCUI 1743574 In current FDA listings
    Clinical drug / strength (SCD) 12.5 MG RxCUI 706822 25 MG RxCUI 402010 37.5 MG RxCUI 402011 50 MG RxCUI 402012
  3. Dose form (SCDF) Oral Solution RxCUI 373790 In current FDA listings
    Clinical drug / strength (SCD) 1 MG/ML RxCUI 199387
  4. Dose form (SCDF) Oral Tablet RxCUI 373791 In current FDA listings
    Clinical drug / strength (SCD) 0.25 MG RxCUI 312828 0.5 MG RxCUI 312829 1 MG RxCUI 312830 2 MG RxCUI 312831 3 MG RxCUI 312832 4 MG RxCUI 314211 6 MG RxCUI 153791
  5. Dose form (SCDF) Prefilled Syringe RxCUI 2055666 No current FDA listing
    Clinical drug / strength (SCD) 0.14 ML risperidone 357 MG/ML RxCUI 2636049 0.21 ML risperidone 357 MG/ML RxCUI 2636051 0.28 ML risperidone 357 MG/ML RxCUI 2636033 0.35 ML risperidone 357 MG/ML RxCUI 2636041 0.42 ML risperidone 357 MG/ML RxCUI 2636043 0.56 ML risperidone 357 MG/ML RxCUI 2636045 0.6 ML risperidone 150 MG/ML RxCUI 2055675 0.7 ML risperidone 357 MG/ML RxCUI 2636047 0.8 ML risperidone 150 MG/ML RxCUI 2055667

Look up RxCUI 35636 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

💵 What Risperidone costs pharmacies (NADAC benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Tablet · Oral 4 mg $0.082 per tablet NDC details & price history
Tablet, Orally Disintegrating · Oral 4 mg $1.53 per tablet NDC details & price history
Tablet, Orally Disintegrating · Oral 3 mg $1.32 per tablet NDC details & price history
Tablet, Orally Disintegrating · Oral 2 mg $1.22 per tablet NDC details & price history
Tablet, Orally Disintegrating · Oral 0.5 mg $1.00 per tablet NDC details & price history
Tablet, Orally Disintegrating · Oral 1 mg $1.15 per tablet NDC details & price history
Tablet, Orally Disintegrating · Oral 0.25 mg $2.55 per tablet NDC details & price history
Tablet, Film Coated · Oral 1 mg $0.037 per tablet NDC details & price history
Tablet, Film Coated · Oral 0.25 mg $0.037 per tablet NDC details & price history
Tablet, Film Coated · Oral 0.5 mg $0.036 per tablet NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Risperidone brand names

Risperidone is sold under 10 brand names in the FDA directory — Risperdal M-TAB Orally Disintegrating Tablets, Risperdal Oral Solution, Risperdal Tablets, Risperdal and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Risperdal M-TAB Orally Disintegrating Tablets Risperdal Oral Solution Risperdal Tablets Risperdal Perseris Uzedy Rykindo Risperdal M-tab Risperdal Consta Rykindo extended-release microspheres

Who makes Risperidone: manufacturers and labelers

41 companies list Risperidone products with the FDA. By number of product records, the largest are Janssen Pharmaceuticals, Inc., Jubilant Cadista Pharmacuticals Inc., Remedyrepack Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Janssen Pharmaceuticals, Inc. 15 Jubilant Cadista Pharmacuticals Inc. 11 Remedyrepack Inc. 11 Bryant Ranch Prepack 7 Chartwell RX, LLC 7 Teva Pharmaceuticals USA, Inc. 7 Ajanta Pharma USA Inc. 6 American Health Packaging 6 Amneal Pharmaceuticals NY LLC 6 AvKARE 6 Golden State Medical Supply, Inc. 6 Major Pharmaceuticals 6 Natco Pharma USA LLC 6 Par Health USA, LLC 6 Solco Healthcare US, LLC 6 Torrent Pharmaceuticals Limited 6 Westminster Pharmaceuticals, LLC 6 Zydus Lifesciences Limited 6 Zydus Pharmaceuticals USA Inc. 6 Amerisyn LLC 5 Amici Pharma, Inc. 5 Amneal Pharmaceuticals LLC 5 NCS HealthCare of KY, LLC dba Vangard Labs 5 Proficient Rx LP 5

…and 17 more on the FDA NDC directory.

Risperidone drug class (RxNorm)

Risperidone belongs to the Atypical Antipsychotic class.

Pharmacologic class Atypical Antipsychotic
Drug family (ATC) Other antipsychotics

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Risperidone page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective May 28, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Risperidone.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Risperidone after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
73
Finished products in the current FDA directory
200
Companies listing them (makers, repackagers, distributors)
41
FDA labeler codes behind them ⓘ
44
Linked representative label ⓘ
Janssen Pharmaceuticals, Inc.
Linked label effective
May 28, 2026
Composite sections available
27
Linked SPL Set ID
7e117c7e-02fc-4343-92a1-230061dfc5e0
Linked SPL Document ID
408e48a3-35fc-49e1-8e01-44305d9083a4
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Janssen Pharmaceuticals, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →