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Paliperidone

Paliperidone is an atypical antipsychotic used to treat schizophrenia and, in several products, schizoaffective disorder, available as a daily tablet or a long-acting injection given by a healthcare professional.

Brand names InvegaErzofriInvega SustennaInvega TrinzaErzofri extended-release +1 more
Drug class Atypical Antipsychotic
Rx Forms 3
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 25 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 7, 2026
Other forms & routes:
Injection
Paliperidone 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

Paliperidone (Invega) is an atypical antipsychotic for schizophrenia and, in some products, schizoaffective disorder, working by blocking dopamine and serotonin receptors in the brain; on the market since about 2006 and available generically, it is best known for long-acting injections that can go months between doses. Most people tolerate it reasonably well, and what they notice is sleepiness, weight gain, and stiffness, tremor or akathisia (an inner restlessness that makes sitting still hard). It carries a boxed warning for a higher risk of death in older adults with dementia-related psychosis, a use it is not approved for. Report new uncontrolled movements, fainting, high fever with stiffness, or unusual thirst promptly.

Clinical pearls

  • Paliperidone is the active form of risperidone, so a past allergy to risperidone rules paliperidone out too.
  • Swallow the extended-release tablet whole, never chewed, split or crushed, because it is built to release slowly over the day.
  • Starting or stopping carbamazepine or valproate can shift paliperidone levels, so tell whoever prescribes your seizure or mood medicine.
  • Avoid combining it with heart rhythm-altering drugs such as amiodarone, sotalol or moxifloxacin, which add to its QT prolongation risk.
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 medicines like paliperidone have a higher risk of death. Most deaths in studies appeared to be related to the heart (such as heart failure or sudden death) or infections (such as pneumonia). Paliperidone 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 asExtended-release tablet, Injection, Oral solution
Earliest FDA record2006
Companies listing it with the FDA20
FDA label last updatedJan 31, 2025
FDA’s strongest warning (boxed)Yes, read the warning

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

What Paliperidone is used for

▾

Paliperidone is used for these conditions, depending on the product:

  • Schizophrenia in adults and adolescents ages 12 to 17: Invega and paliperidone extended-release tablets.
  • Schizoaffective disorder in adults, alone or with mood stabilizers or antidepressants: Invega and paliperidone tablets, Invega Sustenna and Erzofri injections.
  • Schizophrenia in adults: Invega Sustenna and Erzofri monthly injections.
  • Schizophrenia after at least four months of Invega Sustenna: Invega Trinza (every 3 months).
  • Schizophrenia in adults after adequate treatment with a monthly or every-three-month injection: Invega Hafyera (every 6 months).

How Paliperidone works

▾

Paliperidone blocks dopamine type 2 and serotonin type 2A receptors in the brain. This combined action may mediate its effect in schizophrenia. The exact mechanism in the listed conditions is unclear.

Paliperidone is the main active breakdown product of risperidone. The injectable form, paliperidone palmitate, is converted to paliperidone in the body.

Paliperidone dosage

▾

The tablets are taken by mouth once daily and swallowed whole. The injections are given into a muscle by a healthcare professional.

  • Invega Sustenna and Erzofri: monthly after starting doses.
  • Invega Trinza: once every 3 months.
  • Invega Hafyera: once every 6 months, into the gluteal muscle.

People new to paliperidone or risperidone may first try an oral form to check tolerability before Erzofri or Invega Sustenna. Follow your prescriber and the product label.

Dosing details from the FDA-approved label

From the Paliperidone 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 (Invega Sustenna)
    • 234 mg on Day 1 and 156 mg on Day 8, both in the deltoid muscle
    • Then monthly maintenance dose of 39–234 mg administered 5 weeks after the first injection (deltoid or gluteal)
    • The recommended maintenance dose is 117 mg
    • Maximum: 234 mg
    • Mild renal impairment: 156 mg on Day 1 and 117 mg on Day 8, then 78 mg monthly; maximum monthly dose 156 mg. Not recommended if creatinine clearance < 50 mL/min
  • Schizoaffective disorder (Invega Sustenna)
    • 234 mg on Day 1 and 156 mg on Day 8, both in the deltoid muscle
    • Then monthly maintenance dose of 78–234 mg administered 5 weeks after the first injection (deltoid or gluteal)
    • Adjust dose based on tolerability and/or efficacy using available strengths
    • Maximum: 234 mg
    • The 39 mg strength was not studied in the long-term schizoaffective disorder study
  • Schizophrenia (Erzofri)
    • Initial dose 351 mg on Day 1 in the deltoid muscle
    • Then monthly dosage of 39 mg to 234 mg administered 4 weeks after the first injection (deltoid or gluteal)
    • Recommended monthly dosage is 117 mg
    • Maximum: 234 mg
    • Mild renal impairment: 234 mg on Day 1 in the deltoid, then 78 mg monthly; maximum monthly dosage 156 mg
  • Schizoaffective disorder (Erzofri)
    • Initial dose 351 mg on Day 1 in the deltoid muscle
    • Then monthly dosage of 78 mg to 234 mg administered 4 weeks after the first injection (deltoid or gluteal)
    • Adjust dose based on tolerability and/or efficacy using available strengths
    • Maximum: 234 mg
    • The 39 mg strength was not studied in the long-term schizoaffective disorder study
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION Initial Dose Recommended Dose Maximum Dose Schizophrenia - adults (2.1) 6 mg/day 3 to 12 mg/day 12 mg/day Schizophrenia-adolescents (2.1) Weight < 51 kg 3 mg/day 3 to 6 mg/day 6 mg/day Weight ≥ 51 kg 3 mg/day 3 to 12 mg/day 12 mg/day Schizoaffective disorder - adults (2.2) 6 mg/day 3 to 12 mg/day 12 mg/day Tablet should be swallowed whole and should not be chewed, divided, or crushed. (2.3) 2.1 Schizophrenia Adults The recommended dose of paliperidone extended-release tablets for the treatment of schizophrenia in adults is 6 mg administered once daily. Initial dose titration is not required. Although it has not been systematically established that doses above 6 mg have additional benefit, there was a general trend for greater effects with higher doses. This must be weighed against the dose-related increase in adverse reactions. Thus, some patients may benefit from higher doses, up to 12 mg/day, and for some patients, a lower dose of 3 mg/day may be sufficient. Dose increases above 6 mg/day should be made only after clinical reassessment and generally should occur at intervals of more than 5 days. When dose increases are indicated, increments of 3 mg/day are recommended. The maximum recommended dose is 12 mg/day. In a longer-term study, paliperidone extended-release tablets have been shown to be effective in delaying time to relapse in patients with schizophrenia who were stabilized on paliperidone extended-release tablets for 6 weeks [see Clinical Studies (14) ]. Paliperidone extended-release tablets should be prescribed at the lowest effective dose for maintaining clinical stability and the physician should periodically reevaluate the long-term usefulness of the drug in individual patients. Adolescents (12 to 17 years of age) The recommended starting dose of paliperidone extended-release tablets for the treatment of schizophrenia in adolescents 12 to 17 years of age is 3 mg administered once daily. Initial dose titration is not required. Dose increases, if considered necessary, should be made only after clinical reassessment and should occur at increments of 3 mg/day at intervals of more than 5 days.

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

Paliperidone side effects

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Common side effects seen in studies include:

Common side effects

  • Movement-related symptoms (extrapyramidal symptoms), such as tremor, stiffness and muscle spasms
  • Fast heartbeat (tachycardia)
  • Akathisia (inner restlessness and trouble sitting still)
  • Sleepiness or drowsiness
  • Weight gain
  • Indigestion and constipation
  • Stuffy nose and sore throat (nasopharyngitis)
  • Anxiety (in adolescents)

When to get medical help

  • Get emergency help for high fever, severe muscle stiffness, confusion, sweating or an irregular pulse or blood pressure. These can be signs of neuroleptic malignant syndrome, a potentially fatal reaction.
  • Tell your doctor if you notice uncontrolled, repetitive movements. This may be tardive dyskinesia, which can be permanent.
  • Seek help for fainting, dizziness on standing, or a racing or irregular heartbeat. Paliperidone can affect heart rhythm (QT prolongation) and blood pressure.
  • Report signs of high blood sugar: unusual thirst, frequent urination, increased hunger or weakness.
  • Call your doctor for signs of infection such as fever or sore throat. Paliperidone can lower white blood cell counts.
  • Seek help for a seizure, trouble swallowing, or a painful erection that will not go away (priapism).
  • Report sudden signs of stroke in older adults with dementia.

Paliperidone warnings and precautions

▾
  • Boxed warning: higher risk of death in older adults with dementia-related psychosis. Not approved for that use.
  • Stroke risk is higher in older adults with dementia.
  • Neuroleptic malignant syndrome is a rare but potentially fatal reaction.
  • Tardive dyskinesia may be permanent.
  • QT prolongation can affect heart rhythm.
  • Metabolic changes include high blood sugar, cholesterol changes and weight gain.
  • Low white blood cell counts can occur.
  • Dizziness on standing, drowsiness, seizures, trouble swallowing and priapism are also possible.

Paliperidone interactions

▾

These can change how paliperidone works or add to its effects:

  • Alcohol and sedating drugs: additive drowsiness.
  • Blood pressure-lowering drugs: additive dizziness on standing.
  • QT-prolonging drugs (such as amiodarone, sotalol, moxifloxacin, thioridazine): avoid combining.
  • Carbamazepine: lowers paliperidone levels.
  • Divalproex sodium: raises paliperidone levels.
  • Levodopa and dopamine agonists: paliperidone may weaken them.

Interactions listed in the FDA-approved label

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

  • Centrally-acting drugs and alcohol: Due to the primary CNS effects of paliperidone, caution is needed in combination. Use caution in combination; avoid alcohol.
  • Drugs that may cause orthostatic hypotension: An additive effect may be observed when co-administered with paliperidone.
  • Levodopa and other dopamine agonists: Paliperidone may antagonize their effect.
  • Strong CYP3A4/P-gp inducers (e.g., carbamazepine): Carbamazepine 200 mg twice daily decreased mean steady-state Cmax and AUC of paliperidone by approximately 37%. On initiation, re-evaluate and increase the paliperidone dose if necessary; on discontinuation, re-evaluate and decrease the dose if necessary.
  • Divalproex sodium (valproate): Increased Cmax and AUC of paliperidone by approximately 50%. Adjust dose of paliperidone if necessary based on clinical assessment; dosage reduction should be considered.
  • Paroxetine (potent CYP2D6 inhibitor): Paliperidone exposures were on average 16% higher in CYP2D6 extensive metabolizers with paroxetine 20 mg per day; clinical relevance is unknown.
  • Lithium: Pharmacokinetic interaction between lithium and paliperidone is unlikely.
  • Drugs metabolized by cytochrome P450 isozymes: Paliperidone is not expected to cause clinically important pharmacokinetic interactions with them.
Read the label’s full interactions text

7 DRUG INTERACTIONS Centrally-acting drugs: Due to CNS effects, use caution in combination. Avoid alcohol. (7.1) Drugs that may cause orthostatic hypotension: An additive effect may be observed when co-administered with paliperidone. (7.1) Strong CYP3A4/P-glycoprotein (P-gp) inducers: It may be necessary to increase the dose of paliperidone when a strong inducer of both CYP3A4 and P-gp (e.g., carbamazepine) is co-administered. Conversely, on discontinuation of the strong inducer, it may be necessary to decrease the dose of paliperidone. (7.2) Co-administration of divalproex sodium increased C max and AUC of paliperidone by approximately 50%. Adjust dose of paliperidone if necessary based on clinical assessment. (7.2) 7.1 Potential for Paliperidone to Affect Other Drugs Given the primary CNS effects of paliperidone [see Adverse Reactions (6.1, 6.2) ] , paliperidone should be used with caution in combination with other centrally acting drugs and alcohol. Paliperidone may antagonize the effect of levodopa and other dopamine agonists. Because of its potential for inducing orthostatic hypotension, an additive effect may be observed when paliperidone is administered with other therapeutic agents that have this potential [see Warnings and Precautions (5.9) ]. Paliperidone is not expected to cause clinically important pharmacokinetic interactions with drugs that are metabolized by cytochrome P450 isozymes. In vitro studies in human liver microsomes showed that paliperidone does not substantially inhibit the metabolism of drugs metabolized by cytochrome P450 isozymes, including CYP1A2, CYP2A6, CYP2C8/9/10, CYP2D6, CYP2E1, CYP3A4, and CYP3A5. Therefore, paliperidone is not expected to inhibit clearance of drugs that are metabolized by these metabolic pathways in a clinically relevant manner. Paliperidone is also not expected to have enzyme inducing properties. Paliperidone is a weak inhibitor of P-glycoprotein (P-gp) at high concentrations.

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.

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

Before taking Paliperidone

▾
  • Do not use it if you are allergic to paliperidone or risperidone.
  • Tell your prescriber about heart rhythm problems, diabetes, seizures or low white blood cell counts.
  • Dosing is individualized in kidney disease.
  • Pregnancy: third-trimester exposure can cause movement or withdrawal symptoms in newborns.
  • Breastfeeding: paliperidone passes into breast milk.
  • Children: not established for schizophrenia under age 12, and not studied for schizoaffective disorder under age 18.
  • Older adults: dosing follows kidney function, like younger adults.

Paliperidone overdose

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Overdose can cause drowsiness, movement symptoms, unsteady walking, fast heartbeat, low blood pressure and QT prolongation. Serious heart rhythm problems have been reported. There is no specific antidote, so treatment is supportive with close medical monitoring. Seek emergency help right away.

What Paliperidone does in the body

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Paliperidone blocks dopamine type 2 and serotonin type 2A receptors. It also blocks alpha-1, alpha-2 and histamine H1 receptors, which may explain some of its other effects. It does not act on muscarinic or beta receptors.

How your body processes Paliperidone

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After an injection, paliperidone palmitate is converted to paliperidone and released slowly. Erzofri levels peak at a median of 16 to 28 days, and its half-life is about 27 days. Paliperidone is not heavily metabolized by the liver. About 59% of an oral dose was excreted unchanged in urine.

How to store Paliperidone

▾

Store up to 25ºC (77ºF); excursions permitted from 15º to 30ºC (59º to 86ºF) . Protect from moisture. Dispense in tight (USP) containers.

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

64

Supplements & herbs that interact with Paliperidone

64 supplements and herbal products have documented interactions with Paliperidone 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 · 9
  • Moderate · 44
  • Minor · 11
ACTIVATED CHARCOAL Major AMERICAN HELLEBORE Major ARSENIC Major CESIUM Major EPHEDRA Major GRAPEFRUIT Major INDIAN SNAKEROOT Major RAUVOLFIA VOMITORIA Major +56 more
Every supplement checked against Paliperidone — ranked by severity The full interaction hub: 9 major · 44 moderate · 11 minor · every one linked to its full report. Check Paliperidone 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.

Paliperidone: pharmacist answers to common questions

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

What is paliperidone used for?

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It treats schizophrenia, and in several products schizoaffective disorder. The tablets are used in adults and, for schizophrenia, in teens 12 to 17. The injections are mostly for adults.

How do I take the tablets?

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Take them by mouth once a day and swallow them whole. Don't chew, split or crush them. Follow your prescriber's directions.

What side effects should I expect?

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Common ones include restlessness, tremor or stiffness, fast heartbeat, sleepiness, and weight gain. Tell your doctor if these bother you. Call right away for high fever with stiffness, fainting, seizures or uncontrolled movements.

Can I drink alcohol with it?

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It's best to avoid alcohol. Paliperidone can cause drowsiness and dizziness, and alcohol can make that worse.

Is it safe for older adults with dementia?

▾
No. It carries a boxed warning for a higher risk of death in older adults with dementia-related psychosis and is not approved for that use. Talk with the prescriber if you have concerns.

What if I'm pregnant or breastfeeding?

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Talk with your doctor before taking it. Newborns exposed late in pregnancy can have movement or withdrawal symptoms, and paliperidone passes into breast milk. Untreated schizophrenia also carries risks, so decisions are made case by case.

Is Paliperidone available over the counter?

▾
No. Paliperidone is a prescription medicine: every Paliperidone 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 Paliperidone first available?

▾
The earliest FDA record we hold for Paliperidone is from 2006: 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 Paliperidone was first used.

Who makes Paliperidone?

▾
20 companies currently list Paliperidone products in the FDA's NDC Directory, including Janssen Pharmaceuticals, Inc., Shandong Luye Pharmaceutical Co., Ltd., ANI Pharmaceuticals, 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 Paliperidone on HelloPharmacist

📊Paliperidone supplement interactions64 checked — ranked by severity 🌿Drug & Supplement CheckerPaliperidone vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Paliperidone NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Paliperidone 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.

Paliperidone forms and strengths (how it comes)

Paliperidone is available in 3 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.

Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Paliperidone inactive ingredients by manufacturer.

Extended-release tablet

By mouth
Brands Invega
How this form is used
What it may be used for
  • Invega and paliperidone extended-release tablets treat schizophrenia in adults and adolescents ages 12 to 17.
  • Invega and paliperidone extended-release tablets treat schizoaffective disorder in adults, alone or with mood stabilizers or antidepressants.
Important instructions
  • Invega and paliperidone tablets are taken once daily.
  • Invega and paliperidone tablets should be swallowed whole, not chewed, divided or crushed.
Available strengths 4 strengths
1.5 mg 3 mg 6 mg 9 mg
128 FDA-listed product records ⓘ

Injection

Into a muscle
Brands Erzofri extended-release Invega Hafyera Invega Sustenna Invega Trinza
How this form is used
What it may be used for
  • Invega Sustenna and Erzofri treat schizophrenia and schizoaffective disorder in adults.
  • Invega Trinza treats schizophrenia after adequate treatment with Invega Sustenna for at least four months.
  • Invega Hafyera treats schizophrenia in adults after adequate treatment with a monthly or every-three-month injection.
Important instructions
  • Invega Sustenna and Invega Trinza are for intramuscular injection only, given by a healthcare professional.
  • Erzofri is given by a healthcare professional, starting in the deltoid muscle, and not by any other route.
  • Invega Trinza is given once every 3 months.
  • Invega Hafyera is given into the gluteal muscle once every 6 months by a healthcare professional.
Available strengths 12 strengths
39 mg/0.25 mL 78 mg/0.5 mL 117 mg/0.75 mL 156 mg/mL 234 mg/1.5 mL 273 mg/0.88 mL
Show 6 more strengths Show fewer strengths
351 mg/2.25 mL 410 mg/1.32 mL 546 mg/1.75 mL 819 mg/2.63 mL 1092 mg/3.5 mL 1560 mg/5 mL
28 FDA-listed product records ⓘ

Oral solution

By mouth
Available strengths 1 strength
1 mg/mg
1 FDA-listed product record ⓘ

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

How Paliperidone 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.

20 companies list 86 Paliperidone product records with the FDA, mostly as extended-release tablet, injection, oral solution; the earliest marketing or approval year on record is 2006. Brand names on the directory include Invega, Erzofri, Invega Sustenna and 3 more; the rest are generics.

3
Dose forms ⓘ
20
Labelers (makers, repackagers, distributors)
6
Brand names
86
FDA-listed product records ⓘ
2006
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: Powder (36) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Janssen Pharmaceuticals, Inc.17%
Shandong Luye Pharmaceutical Co., Ltd.7%
ANI Pharmaceuticals, Inc.5%
Ajanta Pharma USA Inc.5%
Alembic Pharmaceuticals Inc.5%
Alembic Pharmaceuticals Limited5%
Other makers57%

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

How widely Paliperidone is used (Medicaid data)

A general measure of how commonly Paliperidone 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 Paliperidone 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.

1,015,111
Medicaid prescriptions filled (Q1–Q4 2025)
$2.37B gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Paliperidone prescribed? Of the 1,601 medications we measure, Paliperidone ranks #173 by Medicaid prescriptions — more than 89% of them.

Where Paliperidone ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #173 of 1,601
#168 Cyanocobalamin Injecti... 1,087,734 Rx #169 Nifedipine 1,079,242 Rx #170 Cariprazine 1,076,596 Rx #171 Naltrexone 1,052,053 Rx #172 Lurasidone 1,049,340 Rx #173 Paliperidone 1,015,111 Rx #174 Levocetirizine 1,014,061 Rx #175 Ethinyl Estradiol / Fe... 1,010,948 Rx #176 Clotrimazole Topical 1,007,055 Rx #177 Insulin Aspart (rDNA O... 1,003,363 Rx #178 Lisinopril and Hydroch... 999,534 Rx

Utilization by Paliperidone 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 1.5 mL / 156 mg/mL prefilled syringe is the most-dispensed Paliperidone product — about 37% of these Medicaid prescriptions.

1.5 ML paliperidone palmitate 156 MG/ML Prefilled Syringe Most dispensed

374,218 Medicaid prescriptions (Q1–Q4 2025) 37% of Paliperidone prescriptions shown $1.26B gross reimbursement (before rebates) ≈ $3,380 per prescription (gross)

Summed across the 3 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 858052

1 ML paliperidone palmitate 156 MG/ML Prefilled Syringe

193,164 Medicaid prescriptions (Q1–Q4 2025) 19% of Paliperidone prescriptions shown $434.5M gross reimbursement (before rebates) ≈ $2,249 per prescription (gross)

Summed across the 2 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 858054

24 HR paliperidone 6 MG Extended Release Oral Tablet

133,917 Medicaid prescriptions (Q1–Q4 2025) 13% of Paliperidone prescriptions shown $9M gross reimbursement (before rebates) ≈ $67 per prescription (gross)

Summed across the 8 of 38 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 672569

24 HR paliperidone 3 MG Extended Release Oral Tablet

95,438 Medicaid prescriptions (Q1–Q4 2025) 9% of Paliperidone prescriptions shown $5.5M gross reimbursement (before rebates) ≈ $58 per prescription (gross)

Summed across the 9 of 37 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 672567

24 HR paliperidone 9 MG Extended Release Oral Tablet

71,111 Medicaid prescriptions (Q1–Q4 2025) 7% of Paliperidone prescriptions shown $5.2M gross reimbursement (before rebates) ≈ $73 per prescription (gross)

Summed across the 9 of 36 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 672571

0.75 ML paliperidone palmitate 156 MG/ML Prefilled Syringe

48,962 Medicaid prescriptions (Q1–Q4 2025) 5% of Paliperidone prescriptions shown $82.4M gross reimbursement (before rebates) ≈ $1,683 per prescription (gross)

Summed across the 2 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 858056

2.63 ML paliperidone palmitate 311 MG/ML Prefilled Syringe

32,710 Medicaid prescriptions (Q1–Q4 2025) 3% of Paliperidone prescriptions shown $327.8M gross reimbursement (before rebates) ≈ $10,022 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1650975

24 HR paliperidone 1.5 MG Extended Release Oral Tablet

23,437 Medicaid prescriptions (Q1–Q4 2025) 2% of Paliperidone prescriptions shown $1.3M gross reimbursement (before rebates) ≈ $53 per prescription (gross)

Summed across the 6 of 27 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 866103

1.75 ML paliperidone palmitate 312 MG/ML Prefilled Syringe

16,154 Medicaid prescriptions (Q1–Q4 2025) 2% of Paliperidone prescriptions shown $107.6M gross reimbursement (before rebates) ≈ $6,663 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1650973

0.5 ML paliperidone palmitate 156 MG/ML Prefilled Syringe

11,672 Medicaid prescriptions (Q1–Q4 2025) 1% of Paliperidone prescriptions shown $12.4M gross reimbursement (before rebates) ≈ $1,063 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 858048

1.32 ML paliperidone palmitate 311 MG/ML Prefilled Syringe

5,640 Medicaid prescriptions (Q1–Q4 2025) <1% of Paliperidone prescriptions shown $27.9M gross reimbursement (before rebates) ≈ $4,943 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1650971

5 ML paliperidone palmitate 312 MG/ML Prefilled Syringe

3,182 Medicaid prescriptions (Q1–Q4 2025) <1% of Paliperidone prescriptions shown $64.5M gross reimbursement (before rebates) ≈ $20,267 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2570420

0.25 ML paliperidone palmitate 156 MG/ML Prefilled Syringe

2,445 Medicaid prescriptions (Q1–Q4 2025) <1% of Paliperidone prescriptions shown $1.4M gross reimbursement (before rebates) ≈ $576 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 858073

0.88 ML paliperidone palmitate 310 MG/ML Prefilled Syringe

1,628 Medicaid prescriptions (Q1–Q4 2025) <1% of Paliperidone prescriptions shown $5.5M gross reimbursement (before rebates) ≈ $3,354 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1650966

3.5 ML paliperidone palmitate 312 MG/ML Prefilled Syringe

1,433 Medicaid prescriptions (Q1–Q4 2025) <1% of Paliperidone prescriptions shown $19.5M gross reimbursement (before rebates) ≈ $13,589 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2570418

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 Paliperidone, 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 47 of 161 listed Paliperidone NDCs with Medicaid activity.

Compare Paliperidone products

A representative set of FDA-listed product records for Paliperidone — 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 86 of 86 products — FDA National Drug Code Directory. See every product, package size and price: browse all 86 Paliperidone NDCs →

Paliperidone 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 Paliperidone — a signal of what to watch for, not proof the drug caused it.

The effects most often named in FDA reports that mention Paliperidone are injury, gynaecomastia, weight increased; about 45% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.

52,997
Reports mentioning it
45%
Reported as serious
12
Distinct effects shown
Most reported effects
Injury
4,362
Gynaecomastia
4,232
Weight Increased
2,843
Hospitalisation
2,188
Abnormal Weight Gain
1,828
Galactorrhoea
1,657
Schizophrenia
1,608
Hyperprolactinaemia
1,520
Treatment Noncompliance
1,481
Condition Aggravated
1,332
Age groups
Adult · 12,222Elderly · 936Adolescent · 890Child · 672Neonate · 9Infant · 9

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 Paliperidone 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.

Paliperidone FDA approval history

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

Paliperidone was first approved by the FDA in 2006 (Brand: INVEGA · Janssen Pharms); the first generic version was approved in 2015. It remains available in U.S. pharmacies today.

2006
Brand approved
Brand: INVEGA · Janssen Pharms
2015
First generic approved
Lower-cost ANDA competition begins
2026
Available today
Active in U.S. pharmacies

Source: Drugs@FDA.

Paliperidone 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 one Paliperidone recall since July 2021. It is no longer listed as ongoing. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.

Class II Feb 28, 2022 · Terminated · The Harvard Drug Group
Failed Dissolution Specifications
  • PALIPERIDONE EXTENDED-RELEASE TABLETS, 9 mg, 100 Tablets per carton (10 x 10 blister packs), Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191, India. Dis… Lots: Lot #: N00522, Exp. Date 09/2022; N00618, Exp. Date 11/2022 FDA record D-0649-2022 →

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) Paliperidone RxCUI 679314 2 dose forms · 16 strengths
  2. Dose form (SCDF) Prefilled Syringe RxCUI 858047 No current FDA listing
    Clinical drug / strength (SCD) 0.25 ML paliperidone palmitate 156 MG/ML RxCUI 858073 0.5 ML paliperidone palmitate 156 MG/ML RxCUI 858048 0.75 ML paliperidone palmitate 156 MG/ML RxCUI 858056 0.88 ML paliperidone palmitate 310 MG/ML RxCUI 1650966 1 ML paliperidone palmitate 156 MG/ML RxCUI 858054 1.32 ML paliperidone palmitate 311 MG/ML RxCUI 1650971 1.5 ML paliperidone palmitate 156 MG/ML RxCUI 858052 1.75 ML paliperidone palmitate 312 MG/ML RxCUI 1650973 2.25 ML paliperidone palmitate 156 MG/ML RxCUI 2699342 2.63 ML paliperidone palmitate 311 MG/ML RxCUI 1650975 3.5 ML paliperidone palmitate 312 MG/ML RxCUI 2570418 5 ML paliperidone palmitate 312 MG/ML RxCUI 2570420

Look up RxCUI 679314 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 Paliperidone 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, Film Coated, Extended Release · Oral 3 mg $0.972 per tablet NDC details & price history
Tablet, Film Coated, Extended Release · Oral 9 mg $1.06 per tablet NDC details & price history
Tablet, Film Coated, Extended Release · Oral 6 mg $1.05 per tablet NDC details & price history
Tablet, Film Coated, Extended Release · Oral 1.5 mg $0.820 per tablet NDC details & price history
Injection · Intramuscular 234 mg/1.5 mL $2,338.47 per mL NDC details & price history
Injection · Intramuscular 156 mg/mL $2,337.71 per mL NDC details & price history
Injection · Intramuscular 117 mg/0.75 mL $2,339.67 per mL NDC details & price history
Injection · Intramuscular 39 mg/0.25 mL $2,338.75 per mL NDC details & price history
Injection · Intramuscular 78 mg/0.5 mL $2,337.05 per mL NDC details & price history
Injection, Suspension, Extended Release · Intramuscular 819 mg/2.63 mL $3,997.97 per mL 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.

Paliperidone brand names

Paliperidone is sold under 6 brand names in the FDA directory — Invega, Erzofri, Invega Sustenna, Invega Trinza and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Invega Erzofri Invega Sustenna Invega Trinza Erzofri extended-release Invega Hafyera

Who makes Paliperidone: manufacturers and labelers

20 companies list Paliperidone products with the FDA. By number of product records, the largest are Janssen Pharmaceuticals, Inc., Shandong Luye Pharmaceutical Co., Ltd., ANI Pharmaceuticals, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Janssen Pharmaceuticals, Inc. 15 Shandong Luye Pharmaceutical Co., Ltd. 6 ANI Pharmaceuticals, Inc. 4 Ajanta Pharma USA Inc. 4 Alembic Pharmaceuticals Inc. 4 Alembic Pharmaceuticals Limited 4 Amneal Pharmaceuticals LLC 4 AvKARE 4 Bryant Ranch Prepack 4 Camber Pharmaceuticals, Inc 4 Eskayef Pharmaceuticals Limited 4 NorthStar RxLLC 4 Sun Pharmaceutical Industries, Inc. 4 Tris Pharma Inc 4 Westminster Pharmaceuticals, LLC 4 Archis Pharma LLC 3 Major Pharmaceuticals 3 Remedyrepack Inc. 3 American Health Packaging 2 Coupler LLC 2

Sources for this Paliperidone 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 Jan 31, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Paliperidone.
📈
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 Paliperidone after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
25
Finished products in the current FDA directory
86
Companies listing them (makers, repackagers, distributors)
20
FDA labeler codes behind them ⓘ
20
Linked representative label ⓘ
Janssen Pharmaceuticals, Inc.
Linked label effective
Jan 31, 2025
Composite sections available
26
Linked SPL Set ID
7b8e5b26-b9e4-4704-921b-3c3c0d159916
Linked SPL Document ID
3c5e5b30-a841-4dfe-88ce-361806c9275f
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 →