Paliperidone
Paliperidone is an atypical antipsychotic used to treat schizophrenia and schizoaffective disorder, available as oral extended-release tablets and several long-acting injectable formulations.
🧬 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 →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Paliperidone is not approved for elderly patients with dementia-related psychosis, and using it in this group significantly increases the risk of death. Studies of antipsychotic drugs in elderly people with dementia showed the death rate was roughly 1.6 to 1.7 times higher than in those who received a placebo. Deaths were most often related to heart problems (such as heart failure or sudden death) or infections like pneumonia. If you have a loved one with dementia, talk to their doctor — this medication should not be used to treat behavioral symptoms of dementia.
📖 Paliperidone: Patient Information Guide
A plain-language walkthrough of Paliperidone — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Paliperidone is an atypical antipsychotic approved for the following conditions across its various products and formulations:
- Schizophrenia in adults — treated with oral extended-release tablets (Invega, paliperidone), and injectable formulations including Invega Sustenna (monthly), Erzofri extended-release (monthly), Invega Trinza (every 3 months, after stabilization on a monthly injection), and Invega Hafyera (every 6 months, after stabilization on a monthly or 3-month injection)
- Schizophrenia in adolescents ages 12–17 — treated with oral extended-release tablets (Invega, paliperidone) only
- Schizoaffective disorder in adults — treated with oral extended-release tablets (Invega, paliperidone), Invega Sustenna, and Erzofri extended-release; may be used as a standalone treatment or alongside mood stabilizers and/or antidepressants
⚙️How it works▾
Paliperidone is the active form of risperidone in the body. It works mainly by blocking dopamine D2 receptors and serotonin 5HT2A receptors in the brain. Excessive dopamine signaling is linked to psychotic symptoms like hallucinations and delusions, so blocking these receptors helps calm those effects. Paliperidone also blocks certain adrenaline (alpha-adrenergic) and histamine receptors, which may contribute to some of its additional effects such as lowered blood pressure or drowsiness.
💊How it's taken▾
Paliperidone is available as an oral extended-release tablet taken once daily by mouth, or as a long-acting intramuscular injection given by a healthcare professional. The oral tablet should be swallowed whole — never chewed, divided, or crushed. Injectable formulations have different schedules:
- Invega Sustenna and Erzofri extended-release: given once monthly (with a specific loading schedule at the start of treatment)
- Invega Trinza: given once every 3 months, only after stabilization on a monthly injectable
- Invega Hafyera: given once every 6 months, only after stabilization on a monthly or 3-month injectable
Always follow your prescriber's dosing instructions exactly. If you miss a dose of the injectable, contact your healthcare provider right away for guidance — do not try to adjust on your own.
🤒Side effects — in detail▾
The most commonly reported side effects of paliperidone include:
- Extrapyramidal symptoms — movement-related effects like stiffness, tremor, slow movement, or muscle spasms
- Akathisia — a feeling of restlessness or an uncontrollable urge to move
- Tachycardia — a faster-than-normal heartbeat
- Somnolence — drowsiness or feeling unusually sleepy
- Weight gain
- Constipation
- Upset stomach (dyspepsia)
- Stuffy or runny nose (nasopharyngitis)
More serious reactions — including high fever with muscle stiffness (NMS), uncontrolled repetitive movements (tardive dyskinesia), dangerous heart rhythm changes, or significantly high blood sugar — require prompt medical attention. Contact your doctor or seek emergency care right away if these occur.
⚠️Warnings & precautions▾
- Elderly patients with dementia: Paliperidone is not approved for dementia-related psychosis. Antipsychotics significantly raise the risk of death in this group — do not use for this purpose.
- Neuroleptic Malignant Syndrome (NMS): A rare but life-threatening reaction involving high fever, severe muscle rigidity, confusion, and unstable blood pressure or heartbeat. Stop paliperidone immediately and seek emergency care if this occurs.
- Tardive dyskinesia: Long-term use can cause uncontrolled, repetitive muscle movements that may be permanent. Risk increases with higher doses and longer treatment duration.
- QT prolongation: Paliperidone can lengthen the heart's electrical cycle in a way that raises the risk of dangerous arrhythmias. Avoid combining with other QT-prolonging drugs.
- Metabolic changes: Can raise blood sugar, worsen cholesterol, and cause significant weight gain — all of which increase cardiovascular risk over time.
- Orthostatic hypotension: Blood pressure may drop when standing, causing dizziness or fainting. Use caution in people with heart or blood vessel disease.
- Low white blood cell count: Monitor blood counts in patients with a history of low WBC or drug-induced neutropenia.
- Seizures: Use carefully in anyone with a seizure history or conditions that lower the seizure threshold.
🔀What it interacts with▾
Paliperidone can interact with several drugs and substances — tell your prescriber and pharmacist about everything you take:
- Alcohol and CNS depressants — combining with other brain-affecting drugs or alcohol increases drowsiness and impairs coordination
- Blood pressure-lowering drugs — paliperidone can enhance blood-pressure-dropping effects, increasing the risk of dizziness and fainting
- Carbamazepine — this seizure/mood drug can lower paliperidone levels by about 37%, potentially reducing its effectiveness; dose may need to be increased
- Divalproex sodium (valproate) — can raise paliperidone levels by about 50%, increasing the risk of side effects; dose adjustment may be needed
- Paroxetine — this antidepressant may modestly raise paliperidone levels in some people
- QT-prolonging drugs — certain heart rhythm medications (e.g., quinidine, amiodarone, sotalol), some antibiotics, and other antipsychotics can dangerously amplify paliperidone's effect on heart rhythm
- Levodopa and dopamine agonists — paliperidone may reduce the effectiveness of these Parkinson's disease medications
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Do not take paliperidone if you have a known allergy to paliperidone, risperidone, or any ingredient in the specific product formulation
- Pregnancy: Newborns exposed in the third trimester may experience movement problems or withdrawal symptoms after birth. Discuss risks and benefits with your doctor. A pregnancy registry is available at 1-866-961-2388.
- Breastfeeding: Paliperidone passes into breast milk. Breastfed infants should be watched for excess sleepiness, poor feeding, jitteriness, or abnormal movements.
- Kidney problems: Doses must be adjusted based on kidney function — tell your doctor about any kidney disease
- Diabetes or risk of diabetes: Blood sugar monitoring is recommended, as paliperidone can worsen glucose control
- Heart conditions or irregular heartbeat: Use with caution; paliperidone can affect heart rhythm
- History of seizures: Use carefully, as paliperidone may lower the seizure threshold
- Adolescents under 12 / children: Safety and effectiveness for schizophrenia not established under age 12; not studied for schizoaffective disorder under age 18
- Older adults: Dose should be guided by kidney function; paliperidone is not approved for elderly patients with dementia-related psychosis
- Gastrointestinal narrowing: The extended-release tablet may cause problems in people with pre-existing narrowing of the digestive tract
🚑If you take too much▾
Too much paliperidone can cause movement difficulties, unsteady walking, extreme drowsiness, fast heartbeat, low blood pressure, and abnormal heart rhythms — including potentially life-threatening arrhythmias. There is no specific antidote. If an overdose is suspected, seek emergency medical care immediately. Medical teams will focus on supporting breathing and heart function, and will monitor the heart closely with an electrocardiogram (ECG).
📡Pharmacodynamics — effects in the body▾
Paliperidone blocks dopamine D2 receptors and serotonin 5HT2A receptors in the brain, which helps reduce psychotic symptoms. It also blocks alpha-1 and alpha-2 adrenergic receptors (involved in blood pressure regulation) and H1 histamine receptors (which can cause drowsiness). It does not bind to muscarinic cholinergic or beta-adrenergic receptors, which distinguishes its side effect profile from some other antipsychotics.
🔬Pharmacokinetics — how your body processes it▾
After an intramuscular injection, the palmitate form of paliperidone is slowly broken down into active paliperidone and released over an extended period — as long as 176 days with some formulations. The drug is about 74% bound to proteins in the blood. It is not heavily broken down by the liver; roughly 59% of an oral dose is excreted unchanged in the urine. About 80% of a dose leaves the body through urine and 11% through stool. The half-life (how long it takes the body to clear half the drug) after a single injection of Erzofri extended-release is approximately 27 days, reflecting its long-acting nature.
📦How to store it▾
Store up to 25ºC (77ºF); excursions permitted from 15º to 30ºC (59º to 86ºF) . Protect from moisture. Dispense in tight (USP) containers.
📄 Written from Paliperidone’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
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.
- Major · 9
- Moderate · 44
- Minor · 11
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.
🩺 Pharmacist Counseling Corner
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 exactly does paliperidone do — why did my doctor prescribe it? ▾
I've been prescribed the tablet form. Is there anything special about how I take it? ▾
What side effects should I expect, and when should I actually call my doctor? ▾
I'm on valproate (Depakote) for my mood — is it safe to take with paliperidone? ▾
I'm pregnant — is it safe to keep taking paliperidone? ▾
My family member with dementia is having behavioral problems — can paliperidone help? ▾
Is Paliperidone available over the counter? ▾
When was Paliperidone first available? ▾
Who makes Paliperidone? ▾
💬 Answers drafted from Paliperidone’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Paliperidone 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.
Extended-release tablet
How this form is used
- Invega and paliperidone extended-release tablets are used to treat schizophrenia in adults and adolescents ages 12–17
- Invega and paliperidone extended-release tablets are used to treat schizoaffective disorder in adults, either alone or alongside mood stabilizers and/or antidepressants
- Invega and paliperidone extended-release tablets are taken by mouth once daily
- Swallow the tablet whole — do not chew, crush, or divide it
- Follow your prescriber's guidance on timing; the label does not require taking it with food, but follow any specific instructions given to you
Injection
How this form is used
- Invega Sustenna is used to treat schizophrenia and schizoaffective disorder in adults, as monotherapy or with mood stabilizers or antidepressants
- Erzofri extended-release is used to treat schizophrenia and schizoaffective disorder in adults, as monotherapy or with mood stabilizers or antidepressants
- Invega Trinza is used to treat schizophrenia in adults who have already been adequately treated with a once-monthly paliperidone palmitate injection for at least four months
- Invega Hafyera is used to treat schizophrenia in adults after being adequately treated with a once-monthly paliperidone palmitate injection for at least four months, or a every-3-month injection for at least one cycle
- All injections must be administered by a healthcare professional into the muscle — never self-inject
- Invega Sustenna is given as a once-monthly intramuscular injection; the first two doses are given in the deltoid (upper arm) muscle
- Invega Trinza is given once every 3 months into the deltoid or gluteal (buttock) muscle; the prefilled syringe must be shaken vigorously for at least 15 seconds before use
- Invega Hafyera is given once every 6 months by gluteal (buttock) injection only
Show 6 more strengths Show fewer strengths
Oral solution
📊 Paliperidone across the U.S. market
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.
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.
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
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.
How commonly is Paliperidone prescribed? Of the 1,596 medications we measure, Paliperidone ranks #174 by Medicaid prescriptions — more than 89% of them.
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.
1.5 ML paliperidone palmitate 156 MG/ML Prefilled Syringe Most dispensed
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Extended-release tablet | ||||
| 1.5 mg | Oral | Actavis Pharma, Inc. × 2 listings | ANDA | View NDC → |
| 3 mg | Oral | Actavis Pharma, Inc. × 2 listings | ANDA | View NDC → |
| 6 mg | Oral | Actavis Pharma, Inc. × 2 listings | ANDA | View NDC → |
| 9 mg | Oral | Actavis Pharma, Inc. | ANDA | View NDC → |
| 1.5 mg | Oral | Ajanta Pharma USA Inc. | ANDA | View NDC → |
| 3 mg | Oral | Ajanta Pharma USA Inc. | ANDA | View NDC → |
| 6 mg | Oral | Ajanta Pharma USA Inc. | ANDA | View NDC → |
| 9 mg | Oral | Ajanta Pharma USA Inc. | ANDA | View NDC → |
| 1.5 mg | Oral | Alembic Pharmaceuticals Inc. | ANDA | View NDC → |
| 3 mg | Oral | Alembic Pharmaceuticals Inc. | ANDA | View NDC → |
| 6 mg | Oral | Alembic Pharmaceuticals Inc. | ANDA | View NDC → |
| 9 mg | Oral | Alembic Pharmaceuticals Inc. | ANDA | View NDC → |
| 1.5 mg | Oral | Alembic Pharmaceuticals Limited | ANDA | View NDC → |
| 3 mg | Oral | Alembic Pharmaceuticals Limited | ANDA | View NDC → |
| 6 mg | Oral | Alembic Pharmaceuticals Limited | ANDA | View NDC → |
| 9 mg | Oral | Alembic Pharmaceuticals Limited | ANDA | View NDC → |
| 3 mg | Oral | American Health Packaging × 2 listings | ANDA | View NDC → |
| 6 mg | Oral | American Health Packaging × 2 listings | ANDA | View NDC → |
| 1.5 mg | Oral | Amneal Pharmaceuticals LLC × 3 listings | ANDA | View NDC → |
| 3 mg | Oral | Amneal Pharmaceuticals LLC × 3 listings | ANDA | View NDC → |
| 6 mg | Oral | Amneal Pharmaceuticals LLC × 3 listings | ANDA | View NDC → |
| 9 mg | Oral | Amneal Pharmaceuticals LLC × 3 listings | ANDA | View NDC → |
| 1.5 mg | Oral | ANI Pharmaceuticals, Inc. × 4 listings | ANDA | View NDC → |
| 3 mg | Oral | ANI Pharmaceuticals, Inc. × 4 listings | ANDA | View NDC → |
| 6 mg | Oral | ANI Pharmaceuticals, Inc. × 4 listings | ANDA | View NDC → |
| 9 mg | Oral | ANI Pharmaceuticals, Inc. × 4 listings | ANDA | View NDC → |
| 1.5 mg | Oral | Ascent Pharmaceuticals, Inc. | ANDA | View NDC → |
| 3 mg | Oral | Ascent Pharmaceuticals, Inc. | ANDA | View NDC → |
| 6 mg | Oral | Ascent Pharmaceuticals, Inc. | ANDA | View NDC → |
| 9 mg | Oral | Ascent Pharmaceuticals, Inc. | ANDA | View NDC → |
| 1.5 mg | Oral | AvKARE × 2 listings | ANDA | View NDC → |
| 3 mg | Oral | AvKARE × 2 listings | ANDA | View NDC → |
| 6 mg | Oral | AvKARE × 2 listings | ANDA | View NDC → |
| 9 mg | Oral | AvKARE × 2 listings | ANDA | View NDC → |
| 1.5 mg | Oral | Bryant Ranch Prepack | ANDA | View NDC → |
| 3 mg | Oral | Bryant Ranch Prepack | ANDA | View NDC → |
| 6 mg | Oral | Bryant Ranch Prepack | ANDA | View NDC → |
| 9 mg | Oral | Bryant Ranch Prepack | ANDA | View NDC → |
| 1.5 mg | Oral | Camber Pharmaceuticals, Inc | ANDA | View NDC → |
| 3 mg | Oral | Camber Pharmaceuticals, Inc | ANDA | View NDC → |
| 6 mg | Oral | Camber Pharmaceuticals, Inc | ANDA | View NDC → |
| 9 mg | Oral | Camber Pharmaceuticals, Inc | ANDA | View NDC → |
| 3 mg | Oral | Coupler LLC | ANDA | View NDC → |
| 6 mg | Oral | Coupler LLC | ANDA | View NDC → |
| 1.5 mg | Oral | Eskayef Pharmaceuticals Limited | ANDA | View NDC → |
| 3 mg | Oral | Eskayef Pharmaceuticals Limited | ANDA | View NDC → |
| 6 mg | Oral | Eskayef Pharmaceuticals Limited | ANDA | View NDC → |
| 9 mg | Oral | Eskayef Pharmaceuticals Limited | ANDA | View NDC → |
| 1.5 mg | Oral | Janssen Pharmaceuticals, Inc. × 3 listings | NDA | View NDC → |
| 3 mg | Oral | Janssen Pharmaceuticals, Inc. × 3 listings | NDA | View NDC → |
| 6 mg | Oral | Janssen Pharmaceuticals, Inc. × 3 listings | NDA | View NDC → |
| 9 mg | Oral | Janssen Pharmaceuticals, Inc. × 3 listings | NDA | View NDC → |
| 1.5 mg | Oral | Lupin Pharmaceuticals, Inc. × 2 listings | ANDA | View NDC → |
| 3 mg | Oral | Lupin Pharmaceuticals, Inc. × 2 listings | ANDA | View NDC → |
| 6 mg | Oral | Lupin Pharmaceuticals, Inc. × 2 listings | ANDA | View NDC → |
| 9 mg | Oral | Lupin Pharmaceuticals, Inc. × 2 listings | ANDA | View NDC → |
| 3 mg | Oral | Major Pharmaceuticals | ANDA | View NDC → |
| 6 mg | Oral | Major Pharmaceuticals | ANDA | View NDC → |
| 9 mg | Oral | Major Pharmaceuticals | ANDA | View NDC → |
| 1.5 mg | Oral | NorthStar RxLLC | ANDA | View NDC → |
| 3 mg | Oral | NorthStar RxLLC | ANDA | View NDC → |
| 6 mg | Oral | NorthStar RxLLC | ANDA | View NDC → |
| 9 mg | Oral | NorthStar RxLLC | ANDA | View NDC → |
| 1.5 mg | Oral | Patriot Pharmaceuticals, LLC | NDA | View NDC → |
| 1.5 mg | Oral | Patriot Pharmaceuticals, LLC | NDA AUTHORIZED GENERIC | View NDC → |
| 3 mg | Oral | Patriot Pharmaceuticals, LLC | NDA | View NDC → |
| 3 mg | Oral | Patriot Pharmaceuticals, LLC | NDA AUTHORIZED GENERIC | View NDC → |
| 6 mg | Oral | Patriot Pharmaceuticals, LLC | NDA | View NDC → |
| 6 mg | Oral | Patriot Pharmaceuticals, LLC | NDA AUTHORIZED GENERIC | View NDC → |
| 9 mg | Oral | Patriot Pharmaceuticals, LLC | NDA | View NDC → |
| 9 mg | Oral | Patriot Pharmaceuticals, LLC | NDA AUTHORIZED GENERIC | View NDC → |
| 3 mg | Oral | Remedyrepack Inc. | ANDA | View NDC → |
| 6 mg | Oral | Remedyrepack Inc. | ANDA | View NDC → |
| 9 mg | Oral | Remedyrepack Inc. | ANDA | View NDC → |
| 1.5 mg | Oral | Sun Pharmaceutical Industries, Inc. × 2 listings | ANDA | View NDC → |
| 3 mg | Oral | Sun Pharmaceutical Industries, Inc. × 2 listings | ANDA | View NDC → |
| 6 mg | Oral | Sun Pharmaceutical Industries, Inc. × 2 listings | ANDA | View NDC → |
| 9 mg | Oral | Sun Pharmaceutical Industries, Inc. × 2 listings | ANDA | View NDC → |
| 1.5 mg | Oral | Tris Pharma Inc × 2 listings | ANDA | View NDC → |
| 3 mg | Oral | Tris Pharma Inc × 2 listings | ANDA | View NDC → |
| 6 mg | Oral | Tris Pharma Inc × 2 listings | ANDA | View NDC → |
| 9 mg | Oral | Tris Pharma Inc × 2 listings | ANDA | View NDC → |
| 1.5 mg | Oral | Westminster Pharmaceuticals, LLC | ANDA | View NDC → |
| 3 mg | Oral | Westminster Pharmaceuticals, LLC | ANDA | View NDC → |
| 6 mg | Oral | Westminster Pharmaceuticals, LLC | ANDA | View NDC → |
| 9 mg | Oral | Westminster Pharmaceuticals, LLC | ANDA | View NDC → |
| 💊Injection | ||||
| 273 mg/0.88 mL | Intramuscular | Janssen Pharmaceuticals, Inc × 2 listings | NDA | View NDC → |
| 410 mg/1.32 mL | Intramuscular | Janssen Pharmaceuticals, Inc × 2 listings | NDA | View NDC → |
| 546 mg/1.75 mL | Intramuscular | Janssen Pharmaceuticals, Inc × 2 listings | NDA | View NDC → |
| 819 mg/2.63 mL | Intramuscular | Janssen Pharmaceuticals, Inc × 2 listings | NDA | View NDC → |
| 1092 mg/3.5 mL | Intramuscular | Janssen Pharmaceuticals, Inc × 2 listings | NDA | View NDC → |
| 1560 mg/5 mL | Intramuscular | Janssen Pharmaceuticals, Inc × 2 listings | NDA | View NDC → |
| 39 mg/0.25 mL | Intramuscular | Janssen Pharmaceuticals, Inc. × 2 listings | NDA | View NDC → |
| 78 mg/0.5 mL | Intramuscular | Janssen Pharmaceuticals, Inc. × 2 listings | NDA | View NDC → |
| 117 mg/0.75 mL | Intramuscular | Janssen Pharmaceuticals, Inc. × 2 listings | NDA | View NDC → |
| 156 mg/mL | Intramuscular | Janssen Pharmaceuticals, Inc. × 2 listings | NDA | View NDC → |
| 234 mg/1.5 mL | Intramuscular | Janssen Pharmaceuticals, Inc. × 2 listings | NDA | View NDC → |
| 39 mg/0.25 mL | Intramuscular | Shandong Luye Pharmaceutical Co., Ltd. | NDA | View NDC → |
| 78 mg/0.5 mL | Intramuscular | Shandong Luye Pharmaceutical Co., Ltd. | NDA | View NDC → |
| 117 mg/0.75 mL | Intramuscular | Shandong Luye Pharmaceutical Co., Ltd. | NDA | View NDC → |
| 156 mg/mL | Intramuscular | Shandong Luye Pharmaceutical Co., Ltd. | NDA | View NDC → |
| 234 mg/1.5 mL | Intramuscular | Shandong Luye Pharmaceutical Co., Ltd. | NDA | View NDC → |
| 351 mg/2.25 mL | Intramuscular | Shandong Luye Pharmaceutical Co., Ltd. | NDA | View NDC → |
| 💊Oral solution | ||||
| 1 mg/mg | — | Neuland Laboratories Limited | BULK INGREDIENT | View NDC → |
| 💊Bulk drug substance | ||||
| 1 kg/kg | — | Alivus Life Sciences Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Amino Chemicals Ltd | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Apotex Inc. | BULK INGREDIENT | View NDC → |
| 50 kg/50 kg | — | Aurobindo Pharma Limited × 2 listings | BULK INGREDIENT | View NDC → |
| 25 kg/25 kg | — | Cadila Pharmaceuticals Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Curia Spain S.A.U. | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Dr.Reddy's Laboratories Limited × 2 listings | BULK INGREDIENT | View NDC → |
| 5 kg/5 kg | — | Emcure Pharmaceuticals Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Interquim, S.A. × 12 listings | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Janssen Pharmaceutical Sciences Unlimited Company | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Jubilant Biosys limited × 2 listings | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Matrix Pharmacorp Private Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | MSN Laboratories Private Limited × 2 listings | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Neuland Laboratories Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Piramal Pharma Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Sintenovo SA de CV | BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING | View NDC → |
| 1 kg/kg | — | Sun Pharmaceutical Industries, Inc. | BULK INGREDIENT | View NDC → |
| 25 kg/25 kg | — | Sun Pharmaceutical Industries, Inc. | BULK INGREDIENT | View NDC → |
| 100 kg/100 kg | — | TAPI Czech Industries s.r.o. | BULK INGREDIENT | View NDC → |
| 100 kg/100 kg | — | Teva Czech Industries s.r.o | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Unichem Laboratories Limited, India | BULK INGREDIENT | View NDC → |
Showing 200 of 235 products — FDA National Drug Code Directory. See every product, package size and price: browse all 235 Paliperidone NDCs →
📈 What people report — real-world data (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.
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.
🏛️ The road to your pharmacy
How Paliperidone went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 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.
Source: openFDA drug enforcement (recall) reports.
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.
RxCUI 679314 2 dose forms · 16 strengths
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Dose form (SCDF) Extended Release Oral Tablet RxCUI 672566In current FDA listingsClinical drug / strength (SCD) 24 HR paliperidone 1.5 MGRxCUI 86610324 HR paliperidone 3 MGRxCUI 67256724 HR paliperidone 6 MGRxCUI 67256924 HR paliperidone 9 MGRxCUI 672571 -
Dose form (SCDF) Prefilled Syringe RxCUI 858047No current FDA listingClinical drug / strength (SCD) 0.25 ML paliperidone palmitate 156 MG/MLRxCUI 8580730.5 ML paliperidone palmitate 156 MG/MLRxCUI 8580480.75 ML paliperidone palmitate 156 MG/MLRxCUI 8580560.88 ML paliperidone palmitate 310 MG/MLRxCUI 16509661 ML paliperidone palmitate 156 MG/MLRxCUI 8580541.32 ML paliperidone palmitate 311 MG/MLRxCUI 16509711.5 ML paliperidone palmitate 156 MG/MLRxCUI 8580521.75 ML paliperidone palmitate 312 MG/MLRxCUI 16509732.25 ML paliperidone palmitate 156 MG/MLRxCUI 26993422.63 ML paliperidone palmitate 311 MG/MLRxCUI 16509753.5 ML paliperidone palmitate 312 MG/MLRxCUI 25704185 ML paliperidone palmitate 312 MG/MLRxCUI 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.
📦 Supply & shortage status
Whether Paliperidone is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
…and 16 more on the FDA NDC directory.
RxNorm drug class
Paliperidone belongs to the Atypical Antipsychotic class.
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.
🔬 Where this comes from
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.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 25 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Janssen Pharmaceuticals, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.