Prescription medication · Atypical Antipsychotic
paliperidone
Also sold as Invega. This medicine is used to treat schizophrenia in adults and teens (12-17 years old).
Data updated 2026-05-15
- 22,775
- FDA reportsModerately reported
- 5
- InteractionsFew interactions
- $1.17
- Generic price (NADAC)
What the data shows
paliperidone (Invega) is a prescription Atypical Antipsychotic, reported at a middle-of-the-pack volume (22,775 FDA reports), with 5 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
paliperidone (Invega) is a prescription Atypical Antipsychotic. This medicine is used to treat schizophrenia in adults and teens (12-17 years old).
Paliperidone extended-release tablets, also known as Invega, are a type of antipsychotic medicine. It helps manage symptoms of certain mental disorders.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Generic Price
$1.17/unit
Generic Available
Yes (11 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
NADAC price trail: PALIPERIDONE ER 1.5 MG TABLET
Same CMS presentation as the headline generic unit price above (2 effective dates). Adjacent % compares consecutive NADAC releases for this description only, not a patient out-of-pocket quote. Latest step: +10.8% vs prior release.
| Effective | NADAC / unit | vs prior | NDCs |
|---|---|---|---|
| July 17, 2024 | $1.06/EA | - | 1 |
| December 18, 2024 | $1.17/EA | +10.8% | 8 |
What it does
This medicine is used to treat schizophrenia in adults and teens (12-17 years old).
Common side effects
Extrapyramidal symptoms (movement problems), Fast heart rate, Feeling restless and unable to sit still
Key warnings
This medicine has a boxed warning.
The sections below are summarized in plain English from paliperidone's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Paliperidone affects certain chemicals in the brain. These chemicals, like dopamine, can become unbalanced in people with schizophrenia and schizoaffective disorder. By acting on these chemicals, paliperidone helps to reduce symptoms.
Side Effects (from patient reports)
Based on 22,775 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for paliperidone, by number of reports
- Injury
Injury
4,331 reports
- Gynaecomastia
Gynaecomastia
3,664 reports
- Abnormal Weight Gain 1,660
Abnormal Weight Gain
1,660 reports
- Weight Increased 1,361
Weight Increased
1,361 reports
- Hyperprolactinaemia 1,255
Hyperprolactinaemia
1,255 reports
- Galactorrhoea 1,051
Galactorrhoea
1,051 reports
- Sedation 735
Sedation
735 reports
- Dystonia 695
Dystonia
695 reports
- Dyskinesia 686
Dyskinesia
686 reports
- Suicide Attempt 662
Suicide Attempt
662 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for paliperidone each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where paliperidone sits
paliperidone has more FDA adverse-event reports than 58% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is paliperidone; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 22,775 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2007–2025.
Total Reports
22,775
Reports Mentioning Death
801
3.5% of reports — not proof of cause
Hospitalization Reports
4,563
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | INJURY | 4,331 |
| 2 | GYNAECOMASTIA | 3,664 |
| 4 | ABNORMAL WEIGHT GAIN | 1,660 |
| 6 | WEIGHT INCREASED | 1,361 |
| 7 | HYPERPROLACTINAEMIA | 1,255 |
| 8 | GALACTORRHOEA | 1,051 |
| 9 | SEDATION | 735 |
| 10 | DYSTONIA | 695 |
| 11 | DYSKINESIA | 686 |
| 12 | SUICIDE ATTEMPT | 662 |
| 13 | TREATMENT NONCOMPLIANCE | 651 |
| 14 | SCHIZOPHRENIA | 645 |
| 16 | EMOTIONAL DISORDER | 589 |
| 17 | EXTRAPYRAMIDAL DISORDER | 587 |
| 18 | SOMNOLENCE | 575 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
This medicine has a boxed warning. It may increase the risk of death in elderly patients with dementia-related psychosis. Paliperidone is not approved to treat this condition.
Known Drug Interactions
In an interaction study in healthy subjects in which a single 3 mg dose of paliperidone was administered concomitantly with 20 mg per day of paroxetine (a potent CYP2D6 inhibitor), paliperidone exposures were on average 16% (90% CI: 4, 30) higher in CYP2D6 extensive metabolizers. Higher doses of paroxetine have not been studied. In an interaction study in healthy subjects in which a single 3 mg dose of paliperidone was administered concomitantly with 20 mg per day of paroxetine (a potent CYP2D6 inhibitor), paliperidone exposures were on average 16% (90% CI: 4, 30) higher in CYP2D6...
Mechanism: Paroxetine slows down the liver's ability to clear paliperidone from your body. This can cause the levels of paliperidone in your blood to rise slightly.
In a drug interaction study, co-administration of paliperidone (12 mg once daily for 5 days) with divalproex sodium extended-release tablets (500 mg to 2000 mg once daily) did not affect the steady-state pharmacokinetics (AUC 24h and C max,ss ) of valproate in 13 patients stabilized on valproate. In a clinical study, subjects on stable doses of valproate had comparable valproate average plasma concentrations when paliperidone 3 to 15 mg/day was added to their existing valproate treatment. Dosage reduction for paliperidone should be considered when paliperidone is co-administered with...
Mechanism: Taking these drugs together can increase the amount of paliperidone that stays in your blood. It does not seem to change the levels of valproate.
Pharmacokinetic interaction between lithium and paliperidone is unlikely. Pharmacokinetic interaction between lithium and paliperidone is unlikely. Pharmacokinetic interaction between lithium and paliperidone is unlikely.
Mechanism: These two drugs do not interfere with how the body absorbs or breaks down each other. An interaction between them is not expected.
Paliperidone may antagonize the effect of levodopa and other dopamine agonists. Paliperidone may antagonize the effect of levodopa and other dopamine agonists.
Mechanism: Paliperidone blocks the same spots in the body that dopamine tries to reach, which stops dopamine from working correctly.
In addition, carbamazepine causes, or would be expected to cause, decreased levels of the following drugs, for which monitoring of concentrations or dosage adjustment may be necessary: acetaminophen, albendazole, alprazolam, aprepitant, buprenorphone, bupropion, citalopram, clonazepam, clozapine, corticosteroids (e.g., prednisolone, dexamethasone), cyclosporine, dicumarol, dihydropyridine calcium channel blockers (e.g., felodipine), doxycycline, ethosuximide, everolimus, haloperidol, imatinib, itraconazole, lamotrigine, levothyroxine, methadone, methsuximide, mianserin, midazolam,...
Mechanism: Carbamazepine speeds up the removal of paliperidone from your body, which can make the treatment less effective.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
Common Questions
Can I cut the tablet in half?
What should I do if I feel dizzy?
Can I drink alcohol while taking this medicine?
How long will it take for this medicine to work?
Will I gain weight while taking this medicine?
Can I stop taking this medicine suddenly?
What if I have trouble swallowing the tablet?
Does this medicine interact with other medications?
What should I do if I experience side effects?
How often will I see my doctor while taking this medicine?
What are the common side effects of paliperidone?
Does paliperidone interact with other medications?
What drug class is paliperidone?
What pregnancy or breastfeeding source fields are listed for paliperidone?
Related Medications in Atypical Antipsychotic
Other drugs grouped near paliperidone - same-class peers and common alternatives.
acamprosate
Campral
Acamprosate is a medicine that can help you stay away from alcohol if you are alcohol-dependent and have already stopped drinking.
Compare with paliperidone →
alprazolam
Xanax
Alprazolam (Xanax) is a medication that can help you with anxiety and panic disorders.
Compare with paliperidone →
amitriptyline
Elavil
Amitriptyline is a medicine used to treat depression.
Compare with paliperidone →
amphetamine/dextroamphetamine
Adderall, Adderall XR
Adderall XR is a stimulant medicine.
Compare with paliperidone →
aripiprazole
Abilify
Aripiprazole (Abilify) is a medicine used to treat certain mental disorders and mood problems.
Compare with paliperidone →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for paliperidone: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 22,775.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 3.52%.
- lisdexamfetamine Δ 0.04 pts · 5,840 reports · CNS Stimulant 3.56%death share
- permethrin Δ 0.06 pts · 1,707 reports · Topical Antiparasitic 3.46%death share
- acebutolol Δ 0.09 pts · 1,220 reports · Beta-1 Selective Blocker with ISA 3.61%death share
- upadacitinib Δ 0.11 pts · 72,798 reports · JAK Inhibitor 3.63%death share
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for paliperidone
The FDA label for paliperidone (sold under brand names such as Invega) classifies it as a prescription-only medication in the Atypical Antipsychotic class. This medicine is used to treat schizophrenia in adults and teens (12-17 years old). Official labeling lists 11 commonly reported side effects, including Extrapyramidal symptoms (movement problems), Fast heart rate, Feeling restless and unable to sit still.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 22,775 voluntary reports. The database also lists 5 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated minor severity. NADAC pricing from CMS shows a generic unit cost of $1.17.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.
Last updated: January 19, 2026
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages