Haloperidol decanoate adverse event reports that FDA received

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

Name type: Generic name
Class: Typical antipsychotic
Also reported as: Haloperidol Decanoate Injection, Haloperidol Decanoate Injection Usp

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 January 2004 to June 2026, FDA received 1,317 adverse event reports that name Haloperidol decanoate. In these reports the drug is a suspect or interacting product.

In the same period, 441 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 93 reports in the 12 months to June 2026 and 101 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, 93 (under 0.1%) name Haloperidol decanoate. Reports from consumers or other non-health professionals were 15% of the reports that name Haloperidol decanoate and 45.8% 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 Haloperidol decanoate 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 18 reports that name Haloperidol decanoate.
In January to March 2026, FDA received 16.
In April to June 2025, FDA received 25.

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 172 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 1,280 of the 1,317 reports (97.2%).

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 172 terms.

Reaction terms in the reports that name Haloperidol decanoate, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 1,317 reports
Weight increasedweight gain	223	16.9%
Drug ineffectivethe medicine did not work as expected	148	11.2%
Extrapyramidal disordermovement problems such as stiffness or tremor	131	9.9%
Akathisiainner restlessness and an urge to move	113	8.6%
Off label useused for a purpose or in a way not on the label	100	7.6%
Suicide attempta suicide attempt	97	7.4%
Neuroleptic malignant syndromea rare severe reaction with fever and rigidity	88	6.7%
Toxicity to various agentspoisoning or toxic effect of one or more substances	88	6.7%
Drug interactionan interaction between medicines	87	6.6%
Product use in unapproved indicationused for a purpose not on the label	74	5.6%
Leukopenialow white blood cells	71	5.4%
Therapeutic product effect incomplete	68	5.2%
Antipsychotic drug level below therapeutic	65	4.9%
Disinhibition	65	4.9%
Euphoric mood	65	4.9%
Increased appetite	65	4.9%
Obsessive-compulsive disorder	65	4.9%
Therapeutic product effect variable	65	4.9%
Hypertensionhigh blood pressure	56	4.3%
Obesity	55	4.2%
Tremorshaking	54	4.1%
Dyslipidaemia	50	3.8%
Treatment noncompliancethe treatment was not taken as directed	50	3.8%
Irritability	44	3.3%
Prescribed overdose	44	3.3%
Sedationdrowsiness	38	2.9%
Tardive dyskinesiainvoluntary repetitive movements	38	2.9%
Parkinsonism	37	2.8%
Anticholinergic syndrome	35	2.7%
Catatonia	35	2.7%
Agitationrestlessness	34	2.6%
Dystoniainvoluntary muscle contractions	33	2.5%
Pyrexiafever	33	2.5%
Somnolencedrowsiness	33	2.5%
Treatment failurethe treatment did not work	33	2.5%
Leukaemia	31	2.4%
General physical health deteriorationgeneral decline in health	30	2.3%
Schizophrenia	29	2.2%
Dyskinesiainvoluntary movements	28	2.1%
Drug resistance	27	2.1%
Aggressionaggressive behaviour	25	1.9%
Schizoaffective disorder	25	1.9%
Dyspnoeashortness of breath	23	1.7%
Emotional poverty	22	1.7%
Pulmonary embolisma blood clot in the lung	21	1.6%
Tachycardiafast heart rate	21	1.6%
Therapy non-responderthe treatment did not work	21	1.6%
Condition aggravatedthe condition being treated got worse	20	1.5%
Hospitalisationadmission to hospital	20	1.5%
Vomitingbeing sick	20	1.5%

Download all 172 terms of Haloperidol decanoate (CSV)

The counts add to more than 1,317 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 Haloperidol decanoate with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Haloperidol decanoate (this page)	Generic name	1,317
Haldol Decanoate	Brand name	813

Sum of the separately reported names: 2,130. 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 Haloperidol decanoate, 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
2004	98	97	1	1	5	0	0	91	1
2005	76	74	2	4	11	2	0	62	2
2006	24	24	1	3	13	0	0	14	0
2007	38	32	6	1	13	2	0	15	6
2008	13	12	1	0	4	0	1	8	1
2009	41	40	4	1	25	0	0	21	1
2010	23	22	4	4	7	0	0	13	1
2011	18	18	1	2	10	0	0	10	0
2012	24	22	3	5	14	0	0	16	2
2013	47	45	12	2	18	0	0	25	2
2014	42	39	4	1	18	0	0	23	3
2015	77	31	0	2	23	0	0	13	46
2016	24	16	0	1	12	0	0	6	8
2017	49	25	1	1	9	0	0	19	24
2018	26	15	1	2	7	2	0	10	11
2019	54	48	1	8	33	3	0	36	6
2020	56	46	6	7	19	3	0	38	10
2021	62	49	4	5	34	3	0	28	13
2022	101	98	6	8	53	4	0	57	3
2023	133	123	8	18	62	6	0	91	10
2024	112	106	7	4	67	5	0	68	6
2025	137	124	12	18	81	2	0	76	13
2026	42	38	7	4	27	1	0	25	4

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 Haloperidol decanoate, 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 Haloperidol decanoate, by the year in which FDA received them
Year	Reports
2004	14
2005	24
2006	24
2007	175
2008	11
2009	43
2010	22
2011	19
2012	27
2013	48
2014	45
2015	77
2016	31
2017	41
2018	35
2019	69
2020	71
2021	80
2022	91
2023	130
2024	90
2025	116
2026	34

Reports that name Haloperidol decanoate, 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 Haloperidol decanoate
Age	Reports	Share
Under 2	0	0%
2 to 11	3	0.2%
12 to 17	29	2.2%
18 to 44	476	36.1%
45 to 64	309	23.5%
65 to 74	88	6.7%
75 and over	32	2.4%
Age not given	380	28.9%

Sex of the patient in the reports that name Haloperidol decanoate
Sex	Reports	Share
Female	432	32.8%
Male	723	54.9%
Unknown or not given	162	12.3%

Type of reporter in the reports that name Haloperidol decanoate
Reporter	Reports	Share
Physician	474	36%
Pharmacist	181	13.7%
Other health professional	428	32.5%
Lawyer	0	0%
Consumer or non-health professional	197	15%
Not given	37	2.8%

Age and sex are as the report gives them. The reporter is the primary source in the report. 35.7% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Haloperidol decanoate record
Indication as recorded (MedDRA)	Reports	Share
Schizophrenia	453	34.4%
Psychotic disorder	91	6.9%
Schizoaffective disorder	54	4.1%
Schizophrenia, paranoid type	50	3.8%
Agitation	29	2.2%
Bipolar disorder	17	1.3%

The reporter fills in the indication, and the field is often empty. Each share is of all 1,317 reports.

Pages near this one

Haldol Decanoate same ingredient
Haloperidol same class
Haloperidol lactate same class
Pimozide same class
Halobetasol propionate next in the A to Z list
Hand sanitizer next in the A to Z list
Harnal next in the A to Z list
Haldol Decanoas next in the A to Z list
Harvoni next in the A to Z list
Haldol next in the A to Z list
Havlane next in the A to Z list
Halcion 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 Haloperidol decanoateThe 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. Haloperidol decanoate: adverse event reports that FDA received. https://reportedreactions.com/drug/haloperidol-decanoate/ 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 Haloperidol decanoate as a suspect or interacting product. The 441 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 Haloperidol decanoate 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 Haloperidol decanoate?

No. It is a count of what people reported to FDA: 1,317 reports from January 2004 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?

Physician (36%), other health professional (32.5%) and consumer or non-health professional (15%). 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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