Paliperidone adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Paliperidone
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Generic name
Class: Atypical antipsychotic
Also reported as: Paliperidone Er, Paliperidone Xr

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Drug reports received through 30 Jun 2026. Device reports have a separate cutoff, 30 Sep 2026. Why a report count is not a rate.

Reports on file

From February 2007 to June 2026, FDA received 3,670 adverse event reports that name Paliperidone. In these reports the drug is a suspect or interacting product.

In the same period, 1,516 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 402 reports in the 12 months to June 2026 and 375 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 402 (under 0.1%) name Paliperidone. Reports for patients aged 18 to 44 were 45% of the reports that name Paliperidone and 12.3% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Paliperidone is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

The latest update of the FDA data, recorded on 28 Oct 2026, changed no count of this page.

In April to June 2026, FDA received 86 reports that name Paliperidone.
In January to March 2026, FDA received 79.
In April to June 2025, FDA received 92.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 395 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for 3,636 of the 3,670 reports (99.1%).

The reports of the other years are not in the counts.

So a count in the table can be lower than the count of FDA.

Find a reaction term

The table shows the first 50 of 395 terms.

Reaction terms in the reports that name Paliperidone, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 3,670 reports
Drug ineffectivethe medicine did not work as expected	790	21.5%
Sedationdrowsiness	419	11.4%
Dystoniainvoluntary muscle contractions	405	11%
Dyskinesiainvoluntary movements	401	10.9%
Suicide attempta suicide attempt	378	10.3%
Schizophrenia	346	9.4%
Sexual dysfunctiona sexual problem	326	8.9%
Blood prolactin abnormal	303	8.3%
Blood glucose increasedraised blood sugar reading	296	8.1%
Metabolic disorder	294	8%
Anosognosia	293	8%
Disturbance in social behaviour	287	7.8%
Condition aggravatedthe condition being treated got worse	271	7.4%
Personality change	265	7.2%
Drug interactionan interaction between medicines	192	5.2%
Tremorshaking	167	4.6%
Weight increasedweight gain	162	4.4%
Neuroleptic malignant syndromea rare severe reaction with fever and rigidity	154	4.2%
Off label useused for a purpose or in a way not on the label	154	4.2%
Psychotic disordera loss of contact with reality	154	4.2%
Akathisiainner restlessness and an urge to move	140	3.8%
Extrapyramidal disordermovement problems such as stiffness or tremor	137	3.7%
Toxicity to various agentspoisoning or toxic effect of one or more substances	135	3.7%
Adverse drug reactiona harmful or unpleasant reaction (the term names a medicine)	128	3.5%
Somnolencedrowsiness	124	3.4%
Treatment noncompliancethe treatment was not taken as directed	124	3.4%
Anxiety	121	3.3%
Completed suicidedeath by suicide	116	3.2%
Tachycardiafast heart rate	107	2.9%
Confusional stateconfusion	106	2.9%
Delusiona fixed false belief	105	2.9%
Parkinsonism	104	2.8%
Agitationrestlessness	92	2.5%
Hyperprolactinaemia	89	2.4%
Rhabdomyolysismuscle breakdown	87	2.4%
Constipation	86	2.3%
Insomniadifficulty sleeping	85	2.3%
Tardive dyskinesiainvoluntary repetitive movements	85	2.3%
Hyponatraemialow blood sodium	81	2.2%
Aggressionaggressive behaviour	76	2.1%
Suicidal ideationthoughts of suicide	76	2.1%
Fatiguetiredness	75	2%
Overdosea dose above the recommended amount	73	2%
Hypotensionlow blood pressure	72	2%
Depressionlow mood	66	1.8%
Salivary hypersecretion	66	1.8%
Hallucinationseeing or hearing things that are not there	65	1.8%
Mental impairmentreduced thinking ability	65	1.8%
Hyperhidrosisexcessive sweating	63	1.7%
Neutropenialow neutrophils, a type of white blood cell	62	1.7%

Download all 395 terms of Paliperidone (CSV)

The counts add to more than 3,670 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Same ingredient, other names

Reporters write a brand name or a generic name. Each name has its own page and its own count.

Names of Paliperidone with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Paliperidone (this page)	Generic name	3,670
Invega	Brand name	16,672

Sum of the separately reported names: 20,342. A report that names two of these names is in the sum two times. The sum is not the number of reports for the ingredient.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Paliperidone, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Congenital Anomaly/Birth Defect	Other Serious (Important Medical Events)	Not serious
2007	20	19	4	2	9	0	0	6	1
2008	82	78	7	4	53	2	0	21	4
2009	58	56	1	3	46	2	0	13	2
2010	49	47	4	3	31	1	0	15	2
2011	126	116	8	1	53	1	0	64	10
2012	186	176	18	10	65	1	0	111	10
2013	58	57	7	2	30	0	0	34	1
2014	72	65	2	4	36	1	0	36	7
2015	74	66	14	2	26	1	0	39	8
2016	124	115	17	20	43	1	0	68	9
2017	207	170	42	26	71	3	0	113	37
2018	187	165	21	21	78	3	1	113	22
2019	189	172	16	10	72	8	1	125	17
2020	265	255	11	19	117	21	0	174	10
2021	255	244	14	13	84	6	0	194	11
2022	308	294	22	7	122	5	0	234	14
2023	396	371	40	26	179	11	0	269	25
2024	306	288	20	13	150	12	0	208	18
2025	494	466	24	50	224	49	0	378	28
2026	214	200	20	23	88	31	0	137	14

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Paliperidone, by the year in which FDA received them

The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.

Show the figures of the chart as a table

Reports that name Paliperidone, by the year in which FDA received them
Year	Reports
2007	25
2008	78
2009	57
2010	48
2011	129
2012	197
2013	56
2014	75
2015	79
2016	129
2017	207
2018	193
2019	232
2020	277
2021	286
2022	288
2023	384
2024	328
2025	437
2026	165

Reports that name Paliperidone, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Paliperidone
Age	Reports	Share
Under 2	0	0%
2 to 11	33	0.9%
12 to 17	86	2.3%
18 to 44	1,651	45%
45 to 64	707	19.3%
65 to 74	95	2.6%
75 and over	29	0.8%
Age not given	1,069	29.1%

Sex of the patient in the reports that name Paliperidone
Sex	Reports	Share
Female	1,488	40.5%
Male	1,792	48.8%
Unknown or not given	390	10.6%

Type of reporter in the reports that name Paliperidone
Reporter	Reports	Share
Physician	1,183	32.2%
Pharmacist	308	8.4%
Other health professional	1,517	41.3%
Lawyer	13	0.4%
Consumer or non-health professional	596	16.2%
Not given	53	1.4%

Age and sex are as the report gives them. The reporter is the primary source in the report. 22.5% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Paliperidone record
Indication as recorded (MedDRA)	Reports	Share
Schizophrenia	1,173	32%
Schizoaffective disorder	216	5.9%
Psychotic disorder	172	4.7%
Bipolar disorder	108	2.9%
Schizoaffective disorder bipolar type	41	1.1%
Antipsychotic therapy	40	1.1%

The reporter fills in the indication, and the field is often empty. Each share is of all 3,670 reports.

Drugs in the same reports

Other drugs that the reports of Paliperidone name, in any role, in order of name
Drug	Reports that name the two
Aripiprazole	896
Clozapine	901
Haloperidol	347
Lorazepam	386
Olanzapine	1,173
Quetiapine	620
Quetiapine fumarate	428
Risperdal	354
Risperidone	957
Zuclopenthixol	312

The table has the 10 drug names that these reports name most. Two names in one report says only that the report recorded the two. It says nothing about the part of a product in the event.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Pages near this one

Invega same ingredient
Olanzapine same class
Paliperidone palmitate same class
Nuplazid same class
Quetiapine same class
Lybalvi same class
Quetiapine fumarate same class
Palforzia next in the A to Z list
Palexia next in the A to Z list
Palivizumab next in the A to Z list
Palbociclib next in the A to Z list
Palladone next in the A to Z list

These links are for navigation. No count selected them. The class page lists each drug of the class.

Official pages

DailyMed labels for PaliperidoneThe labels (prescribing information) that have this name, at the National Library of Medicine.
MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Paliperidone: adverse event reports that FDA received. https://reportedreactions.com/drug/paliperidone/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Paliperidone as a suspect or interacting product. The 1,516 reports that name it only as a concomitant medicine are not in the count. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Do these reports show that Paliperidone was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Paliperidone?

No. It is a count of what people reported to FDA: 3,670 reports from February 2007 to June 2026. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Other health professional (41.3%), physician (32.2%) and consumer or non-health professional (16.2%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.

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