Zuclopenthixol Decanoate adverse event reports that FDA received

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

Name type: Product name as reported

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 March 2005 to June 2026, FDA received 624 adverse event reports that name Zuclopenthixol Decanoate. The name is as reporters wrote it. In these reports the drug is a suspect or interacting product.

In the same period, 247 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 45 reports in the 12 months to June 2026 and 34 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, 45 (under 0.1%) name Zuclopenthixol Decanoate. Reports for patients aged 18 to 44 were 57.7% of the reports that name Zuclopenthixol Decanoate 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 Zuclopenthixol 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 6 reports that name Zuclopenthixol Decanoate.
In January to March 2026, FDA received 8.
In April to June 2025, FDA received 7.

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 119 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 599 of the 624 reports (96%).

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 119 terms.

Reaction terms in the reports that name Zuclopenthixol Decanoate, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 624 reports
Drug ineffectivethe medicine did not work as expected	294	47.1%
Sedationdrowsiness	285	45.7%
Sexual dysfunctiona sexual problem	254	40.7%
Anosognosia	245	39.3%
Blood glucose increasedraised blood sugar reading	245	39.3%
Blood prolactin abnormal	244	39.1%
Disturbance in social behaviour	244	39.1%
Dyskinesiainvoluntary movements	244	39.1%
Metabolic disorder	244	39.1%
Suicide attempta suicide attempt	233	37.3%
Dystoniainvoluntary muscle contractions	229	36.7%
Personality change	224	35.9%
Condition aggravatedthe condition being treated got worse	188	30.1%
Schizophrenia	187	30%
Adverse drug reactiona harmful or unpleasant reaction (the term names a medicine)	106	17%
Insurance issue	59	9.5%
Tardive dyskinesiainvoluntary repetitive movements	59	9.5%
Drug interactionan interaction between medicines	51	8.2%
Completed suicidedeath by suicide	46	7.4%
Orthostatic hypotension	41	6.6%
Obesity	40	6.4%
Aggressionaggressive behaviour	37	5.9%
Intentional product misusedeliberate use not as intended	37	5.9%
Arrhythmia	36	5.8%
Off label useused for a purpose or in a way not on the label	36	5.8%
Agitationrestlessness	35	5.6%
Toxicity to various agentspoisoning or toxic effect of one or more substances	31	5%
Drug level increaseda raised blood level of the medicine	29	4.6%
Extrapyramidal disordermovement problems such as stiffness or tremor	29	4.6%
Irritability	29	4.6%
Akathisiainner restlessness and an urge to move	25	4%
Electrocardiogram QT prolongeda QT prolongation on the ECG	24	3.8%
Deliriumsudden confusion	23	3.7%
Neutropenialow neutrophils, a type of white blood cell	23	3.7%
Leukopenialow white blood cells	22	3.5%
Deaththe patient died; cause not stated by this term	19	3%
Delusiona fixed false belief	18	2.9%
Disorientation	18	2.9%
Mental impairmentreduced thinking ability	18	2.9%
Loss of personal independence in daily activities	17	2.7%
Metabolic syndrome	16	2.6%
Psychotic disordera loss of contact with reality	16	2.6%
Sedation complication	16	2.6%
Antipsychotic drug level increased	15	2.4%
Labelled drug-drug interaction medication error	15	2.4%
Personality change due to a general medical condition	14	2.2%
Personality disorder	14	2.2%
Priapism	14	2.2%
Psychotic symptom	14	2.2%
Treatment noncompliancethe treatment was not taken as directed	14	2.2%

Download all 119 terms of Zuclopenthixol Decanoate (CSV)

The counts add to more than 624 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.

Outcomes by year

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

Outcomes in the reports that name Zuclopenthixol 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
2005	2	2	0	0	2	0	0	0	0
2010	3	3	1	0	1	0	0	1	0
2011	1	1	0	0	1	0	0	0	0
2012	0	0	0	0	0	0	0	0	0
2013	0	0	0	0	0	0	0	0	0
2014	7	7	0	0	5	4	0	6	0
2015	9	9	1	0	1	0	0	8	0
2016	3	3	1	0	1	0	0	3	0
2017	13	12	0	0	7	0	0	7	1
2018	34	33	0	3	9	0	0	29	1
2019	58	57	7	2	11	0	0	50	1
2020	85	85	26	2	8	5	0	66	0
2021	75	74	8	11	11	9	0	60	1
2022	98	98	9	2	22	0	1	91	0
2023	93	93	24	2	32	0	0	80	0
2024	61	60	11	5	34	0	0	54	1
2025	59	59	12	2	34	1	0	42	0
2026	23	22	6	2	7	0	0	18	1

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 Zuclopenthixol 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 Zuclopenthixol Decanoate, by the year in which FDA received them
Year	Reports
2005	2
2010	3
2011	1
2013	1
2014	6
2015	9
2016	3
2017	17
2018	41
2019	95
2020	93
2021	85
2022	88
2023	84
2024	38
2025	44
2026	14

Reports that name Zuclopenthixol 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 Zuclopenthixol Decanoate
Age	Reports	Share
Under 2	1	0.2%
2 to 11	0	0%
12 to 17	1	0.2%
18 to 44	360	57.7%
45 to 64	120	19.2%
65 to 74	3	0.5%
75 and over	10	1.6%
Age not given	129	20.7%

Sex of the patient in the reports that name Zuclopenthixol Decanoate
Sex	Reports	Share
Female	280	44.9%
Male	305	48.9%
Unknown or not given	39	6.3%

Type of reporter in the reports that name Zuclopenthixol Decanoate
Reporter	Reports	Share
Physician	103	16.5%
Pharmacist	22	3.5%
Other health professional	360	57.7%
Lawyer	0	0%
Consumer or non-health professional	133	21.3%
Not given	6	1%

Age and sex are as the report gives them. The reporter is the primary source in the report. 0.6% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Zuclopenthixol Decanoate record
Indication as recorded (MedDRA)	Reports	Share
Schizophrenia	302	48.4%
Psychotic disorder	39	6.3%
Schizoaffective disorder bipolar type	30	4.8%
Schizoaffective disorder	23	3.7%
Aggression	2	0.3%
Behaviour disorder	2	0.3%

The reporter fills in the indication, and the field is often empty. Each share is of all 624 reports.

Drugs in the same reports

Other drugs that the reports of Zuclopenthixol Decanoate name, in any role, in order of name
Drug	Reports that name the two
Aripiprazole	273
Clozapine	356
Latuda	248
Olanzapine	360
Quetiapine fumarate	220
Risperdal	231
Risperidone	276
Saphris	218
Zuclopenthixol Acetate	213
Zyprexa	246

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

Zuclopenthixol Acetate next in the A to Z list
Zuclopenthixol Hydrochloride next in the A to Z list
Zuclopenthixol next in the A to Z list
Zulresso next in the A to Z list
Zubsolv next in the A to Z list
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These links are for navigation. No count selected them.

Official pages

DailyMed labels for Zuclopenthixol 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. Zuclopenthixol Decanoate: adverse event reports that FDA received. https://reportedreactions.com/drug/zuclopenthixol-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 Zuclopenthixol Decanoate as a suspect or interacting product. The 247 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 Zuclopenthixol 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 Zuclopenthixol Decanoate?

No. It is a count of what people reported to FDA: 624 reports from March 2005 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 (57.7%), consumer or non-health professional (21.3%) and physician (16.5%). 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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