Invegapaliperidone
According to the FDA label: INVEGA 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.
22,986 adverse event reports submitted to the FDA (2007–2026)
Top Reported Adverse Events
The most frequently reported events in association with Invega in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
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Injury 4,329 reports
A general report of physical harm to the body, used when no more specific type is given.
Full definition in the glossary →- Gynaecomastia 3,665 reports
Drug Ineffective 1,748 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →- Abnormal Weight Gain 1,660 reports
Off Label Use 1,527 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →Weight Increased 1,370 reports
- Hyperprolactinaemia 1,259 reports
- Galactorrhoea 1,051 reports
Sedation 742 reports
A state of calm, drowsiness, or reduced alertness.
Full definition in the glossary →Dystonia 709 reports
Involuntary muscle contractions that cause twisting movements or abnormal postures.
Full definition in the glossary →Dyskinesia 701 reports
Involuntary, uncontrolled movements of the body.
Full definition in the glossary →Suicide Attempt 666 reports
A report that a person attempted suicide. Its presence in reports does not establish that a medication was the cause. If you or someone you know is struggling, the 988 Suicide and Crisis Lifeline (call or text 988 in the US) is available 24 hours a day.
Full definition in the glossary →Treatment Noncompliance 661 reports
A report that a person did not take a treatment as prescribed. This is a reporting category describing what happened, not a judgment about the person.
Full definition in the glossary →Schizophrenia 655 reports
A mental health condition that affects how a person thinks, feels, and perceives reality. It often appears in reports as a condition being treated.
Full definition in the glossary →Product Use in Unapproved Indication 622 reports
Using a medication for a condition it is not officially approved to treat. Like off label use, this is a reporting category and does not by itself mean harm occurred.
Full definition in the glossary →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Male | 13,027 |
| Female | 6,048 |
| Unknown | 95 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 1,512 |
| 18-34 | 3,580 |
| 35-49 | 2,513 |
| 50-64 | 1,630 |
| 65-74 | 390 |
| 75+ | 129 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Invega. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Non-Serious | 11,773 |
| Other Serious | 7,646 |
| Hospitalization | 4,637 |
| Death | 813 |
| Life-Threatening | 615 |
| Disability | 429 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Invega. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2007 | 696 |
| 2008 | 743 |
| 2009 | 650 |
| 2010 | 524 |
| 2011 | 686 |
| 2012 | 783 |
| 2013 | 652 |
| 2014 | 966 |
| 2015 | 2,360 |
| 2016 | 4,208 |
| 2017 | 3,453 |
| 2018 | 910 |
| 2019 | 847 |
| 2020 | 814 |
| 2021 | 812 |
| 2022 | 931 |
| 2023 | 924 |
| 2024 | 801 |
| 2025 | 1,024 |
| 2026 (partial) | 202 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Invega
In FDA adverse event reports that mention Invega, these medications appeared most often in the same report.
- Risperidone (10,506 reports)
- Olanzapine (2,311 reports)
- Quetiapine (2,235 reports)
- Aripiprazole (2,100 reports)
- Clozapine (1,769 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026