Prescription medicine
Paliperidone Brand names: Invega, Erzofri
Paliperidone (Invega) is a prescription medicine with an FDA approval on record since 2006. FDA's NDC Directory lists it from 18 generic labelers, and pharmacies paid $0.972 per paliperidone ER 3 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the paliperidone FDA label on DailyMed (effective January 31, 2025, Janssen Pharmaceuticals, Inc.); the NDA 21999 record on Drugs@FDA; every paliperidone label on DailyMed.
Highlights of the record
FDA label of January 31, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS.
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. INVEGA is not approved for the treatment of patients with dementia-related psychosis. [see Warnings and Precautions (5.1) ] WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS See full prescribing information for complete boxed warning. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. INVEGA is not approved for use in patients with dementia-related psychosis.
Used for
From the label: indications and usageINVEGA is an atypical antipsychotic agent indicated for Treatment of schizophrenia ( 1.1 ) Adults: Efficacy was established in three 6-week trials and one maintenance trial.
Forms and strengths
- 1.5 mg
- 3 mg
- 6 mg
- 9 mg
- 39 mg/.25ml
- 78 mg/.5ml
- 117 mg/.75ml
- 156 mg/ml
- 234 mg/1.5ml
- 273 mg/.88ml
- 351 mg/2.25ml
- 410 mg/1.32ml
Extended-release tablet; film-coated extended-release tablet; injection; extended-release injection (suspension).
On the market
- Earliest approval on file
- December 19, 2006 Invega, Janssen Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 15 first August 3, 2015; 11 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 21 of which 18 under generic applications, 3 under brand applications, repackagers included
- Last listed patent
- November 24, 2041 Invega Trinza injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.972 per tablet Paliperidone ER 3 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 5 since 2016 1 Class I among all firms' recalls; latest February 28, 2022
- FAERS reports
- 52,997 through July 30, 2026
What is paliperidone used for?
From the label: indications and usageINVEGA is an atypical antipsychotic agent indicated for Treatment of schizophrenia ( 1.1 ) Adults: Efficacy was established in three 6-week trials and one maintenance trial. ( 14.1 ) Adolescents (ages 12–17): Efficacy was established in one 6-week trial. ( 14.1 ) Treatment of schizoaffective disorder as monotherapy and as an adjunct to mood stabilizers and/or antidepressants. ( 1.2 ) Efficacy was established in two 6-week trials in adult patients. ( 14.2 ) 1.1 Schizophrenia INVEGA (paliperidone) Extended-Release Tablets are indicated for the treatment of schizophrenia [see Clinical Studies (14.1) ]. […]
Conditions named in the indications of paliperidone's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Atypical Antipsychotic.
Source: FDA drug label (INVEGA), Janssen Pharmaceuticals, Inc., effective January 31, 2025 (SPL set 7b8e5b26-b9e4-4704-921b-3c3c0d159916), via openFDA; the full label on DailyMed
What does the patient leaflet for paliperidone say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about ERZOFRI?ERZOFRI may cause serious side effects, including: Increased risk of death in elderly people with dementia-related psychosis. ERZOFRI increases the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). ERZOFRI is not for the treatment of people with dementia-related psychosis.
From the patient leaflet: What should I avoid while receiving ERZOFRI?Do not drive, operate heavy machinery, or do other dangerous activities until you know how ERZOFRI affects you. ERZOFRI may affect your ability to make decisions, think clearly, or react quickly. Avoid getting too hot or becoming dehydrated. Do not exercise too much. In hot weather, stay inside in a cool place if possible. Stay out of the sun. Do not wear too much clothing or heavy clothing. Drink plenty of water. Avoid alcohol during treatment with ERZOFRI.
Source: FDA drug label (Erzofri extended-release), Shandong Luye Pharmaceutical Co., Ltd., effective March 9, 2026 (SPL set 492bf9dd-868e-421a-92db-8cca8973aac1), via openFDA; the full label on DailyMed
Is there a generic for paliperidone (Invega)?
The FDA approved the first generic paliperidone on August 3, 2015. 15 generic applications are approved; 11 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 5 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists paliperidone from 18 labelers under a generic (ANDA) application and from 3 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 5 patents for Invega Trinza injection, the last expiring on November 24, 2041. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2006 earliest approval on file
- 2015 first generic approved
- 2041 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for paliperidone (Invega)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.972 per Paliperidone ER 3 mg tablet, down 23% from $1.27 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Paliperidone ER 3 mg tablet (generic)
- Invega ER 6 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Paliperidone ER 1.5 mg tablet | Generic | $0.820 per tablet | $24.61 | -26% |
| Paliperidone ER 3 mg tablet | Generic | $0.972 per tablet | $29.16 | -23% |
| Paliperidone ER 6 mg tablet | Generic | $1.05 per tablet | $31.38 | -16% |
| Paliperidone ER 9 mg tablet | Generic | $1.06 per tablet | $31.67 | -28% |
| Invega ER 3 mg tablet | Brand | $12.45 per tablet | $373.59 | +3% |
| Invega ER 6 mg tablet | Brand | $12.35 per tablet | $370.46 | +2% |
| Invega ER 9 mg tablet | Brand | $18.64 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $559.24 | +3% |
| Invega hafyera 1,092 mg/3.5 mL | Brand | $4,047.71 per mL | n/a | +3% |
| Invega hafyera 1,560 mg/5 mL | Brand | $4,233.40 per mL | n/a | +2% |
| Invega sustenna 117 mg/0.75 mL | Brand | $2,339.67 per mL | n/a | +2% |
| Invega sustenna 156 mg/mL syrg | Brand | $2,337.71 per mL | n/a | +2% |
| Invega sustenna 234 mg/1.5 mL | Brand | $2,338.47 per mL | n/a | +2% |
| Invega sustenna 39 mg/0.25 mL | Brand | $2,338.75 per mL | n/a | +3% |
| Invega sustenna 78 mg/0.5 mL | Brand | $2,337.05 per mL | n/a | +2% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has paliperidone been recalled?
The FDA's Enforcement Report lists 5 recalls naming paliperidone since 2016: 1 Class I (the most serious), 4 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| February 28, 2022 | Class II | The Harvard Drug Group | Failed Dissolution Specifications |
| August 6, 2018 | Class II | Teva Pharmaceuticals USA | Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release. |
| May 31, 2017 | Class I | Teva Pharmaceuticals | Failed Dissolution Specifications: Drug release test result, obtained during routine 9-month stability testing, which was below specification for one tablet. … |
| February 12, 2016 | Class II | Mylan Pharmaceuticals Inc. | Failed Dissolution Specifications; three month stability time point. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the paliperidone label say about other medicines?
The paliperidone label names 18 other medicines in its interaction, contraindication or warning sections. The labels of 2 other medicines name paliperidone. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Amiodarone | warnings and precautions | The use of paliperidone should be avoided in combination with other drugs that are known to prolong QTc including Class 1A (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmic medications, antipsychotic medications (e.g., chlorpromazine, thioridazine), antibiotics (e.g. … |
| Aripiprazole | warnings and precautions | Patients with Dementia-Related Psychosis In placebo-controlled trials with risperidone, aripiprazole, and olanzapine in elderly subjects with dementia, there was a higher incidence of cerebrovascular adverse reactions (cerebrovascular accidents and transient ischemic attacks) including fatalities compared to … |
| Carbamazepine | drug interactions | It may be necessary to increase the dose of INVEGA when a strong inducer of both CYP3A4 and P-gp (e.g., carbamazepine) is co-administered. |
| Chlorpromazine | warnings and precautions | The use of paliperidone should be avoided in combination with other drugs that are known to prolong QTc including Class 1A (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmic medications, antipsychotic medications (e.g., chlorpromazine, thioridazine), antibiotics (e.g. … |
| Divalproex | drug interactions | Conversely, on discontinuation of the strong inducer, it may be necessary to decrease the dose of INVEGA. ( 7.2 ) Co-administration of divalproex sodium increased C max and AUC of paliperidone by approximately 50%. |
| Gatifloxacin | warnings and precautions | … antiarrhythmic medications, antipsychotic medications (e.g., chlorpromazine, thioridazine), antibiotics (e.g., gatifloxacin, moxifloxacin), or any other class of medications known to prolong the QTc interval. |
| Levodopa | drug interactions | Paliperidone may antagonize the effect of levodopa and other dopamine agonists. |
| Lithium | drug interactions | Dosage reduction for INVEGA should be considered when INVEGA is co-administered with valproate after clinical assessment. Pharmacokinetic interaction between lithium and INVEGA is unlikely. |
| Moxifloxacin | warnings and precautions | … medications, antipsychotic medications (e.g., chlorpromazine, thioridazine), antibiotics (e.g., gatifloxacin, moxifloxacin), or any other class of medications known to prolong the QTc interval. |
| Olanzapine | warnings and precautions | Patients with Dementia-Related Psychosis In placebo-controlled trials with risperidone, aripiprazole, and olanzapine in elderly subjects with dementia, there was a higher incidence of cerebrovascular adverse reactions (cerebrovascular accidents and transient ischemic attacks) including fatalities compared to … |
| Paroxetine | drug interactions | In an interaction study in healthy subjects in which a single 3 mg dose of INVEGA was administered concomitantly with 20 mg per day of paroxetine (a potent CYP2D6 inhibitor), paliperidone exposures were on average 16% (90% CI: |
| Procainamide | warnings and precautions | The use of paliperidone should be avoided in combination with other drugs that are known to prolong QTc including Class 1A (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmic medications, antipsychotic medications (e.g., chlorpromazine, thioridazine), antibiotics (e.g. … |
| Quinidine | warnings and precautions | The use of paliperidone should be avoided in combination with other drugs that are known to prolong QTc including Class 1A (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmic medications, antipsychotic medications (e.g., chlorpromazine, thioridazine), antibiotics (e.g. … |
| Rifampin | drug interactions | Avoid using a strong inducer of CYP3A4 and/or P-gp (e.g., carbamazepine, rifampin, St John's Wort) during a dosing interval for INVEGA SUSTENNA. |
Every other medicine the paliperidone label names
| Medicine named | Section | What the label says |
|---|---|---|
| Risperidone | contraindications | CONTRAINDICATIONS INVEGA is contraindicated in patients with a known hypersensitivity to either paliperidone or risperidone, or to any of the excipients in the INVEGA formulation. |
| Sotalol | warnings and precautions | … 1A (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmic medications, antipsychotic medications (e.g., chlorpromazine, thioridazine), antibiotics (e.g. … |
| Thioridazine | warnings and precautions | … antiarrhythmic medications, antipsychotic medications (e.g., chlorpromazine, thioridazine), antibiotics (e.g., gatifloxacin, moxifloxacin), or any other class of medications known to prolong the QTc … |
| Valproic acid | drug interactions | Conversely, on discontinuation of the strong inducer, it may be necessary to decrease the dose of INVEGA. ( 7.2 ) Co-administration of divalproex sodium increased C max and AUC of paliperidone by … |
Source: FDA drug label (INVEGA), Janssen Pharmaceuticals, Inc., effective January 31, 2025 (SPL set 7b8e5b26-b9e4-4704-921b-3c3c0d159916), via openFDA; the full label on DailyMed
What do FAERS reports show for paliperidone?
The FDA Adverse Event Reporting System holds 52,997 reports that list paliperidone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,941 are coded as a death and 10,748 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as paliperidone?
20 other medicines are given the same way (oral) and in the same FDA class as paliperidone or labeled mainly for the same use (schizophrenia), the same class first. Schizophrenia lists all 24 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Quetiapine | Schizophrenia | 50 labelers | $0.127 per tablet 300 mg tablet | No current entry |
| Aripiprazole | Schizophrenia | 47 labelers | $0.110 per tablet 5 mg tablet | No current entry |
| Olanzapine | Schizophrenia | 33 labelers | $0.147 per tablet 20 mg tablet | No current entry |
| Risperidone | Schizophrenia | 35 labelers | $0.0368 per tablet 0.25 mg tablet | No current entry |
| Lurasidone | Schizophrenia | 29 labelers | $0.142 per tablet 20 mg tablet | No current entry |
| Ziprasidone | Schizophrenia | 16 labelers | $0.269 per capsule 20 mg capsule | No current entry |
| Clozapine | Schizophrenia | 11 labelers | $0.610 per tablet 100 mg tablet | No current entry |
| Iloperidone | Schizophrenia | 1 labeler | $60.01 per tablet 12 mg tablet | No current entry |
Every medicine labeled for the same conditions as paliperidone
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does paliperidone compare with medicines for the same use?
7 side-by-side pages set paliperidone beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to paliperidone
- 20 medicines for the same use
- Other atypical antipsychotics
- the pharmacologic class, with prices and generics
- Paliperidone side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other