Zuclopenthixol adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Zuclopenthixol
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 2004 to June 2026, FDA received 1,665 adverse event reports that name Zuclopenthixol. The name is as reporters wrote it. In these reports the drug is a suspect or interacting product.

In the same period, 755 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 217 reports in the 12 months to June 2026 and 183 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, 217 (under 0.1%) name Zuclopenthixol. Reports for patients aged 18 to 44 were 48.4% of the reports that name Zuclopenthixol 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 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 57 reports that name Zuclopenthixol.
In January to March 2026, FDA received 51.
In April to June 2025, FDA received 46.

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 319 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 1,640 of the 1,665 reports (98.5%).

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 319 terms.

Reaction terms in the reports that name Zuclopenthixol, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 1,665 reports
Drug ineffectivethe medicine did not work as expected	458	27.5%
Schizophrenia	248	14.9%
Sedationdrowsiness	230	13.8%
Dystoniainvoluntary muscle contractions	229	13.8%
Suicide attempta suicide attempt	221	13.3%
Dyskinesiainvoluntary movements	218	13.1%
Sexual dysfunctiona sexual problem	208	12.5%
Blood glucose increasedraised blood sugar reading	203	12.2%
Anosognosia	201	12.1%
Metabolic disorder	200	12%
Blood prolactin abnormal	198	11.9%
Disturbance in social behaviour	198	11.9%
Condition aggravatedthe condition being treated got worse	191	11.5%
Personality change	188	11.3%
Off label useused for a purpose or in a way not on the label	156	9.4%
Drug interactionan interaction between medicines	144	8.6%
Extrapyramidal disordermovement problems such as stiffness or tremor	128	7.7%
Neutropenialow neutrophils, a type of white blood cell	124	7.4%
Psychotic disordera loss of contact with reality	113	6.8%
Leukopenialow white blood cells	106	6.4%
Electrocardiogram QT prolongeda QT prolongation on the ECG	88	5.3%
Fatiguetiredness	88	5.3%
Product use in unapproved indicationused for a purpose not on the label	88	5.3%
Hallucination, auditory	86	5.2%
Seizurea fit or convulsion	85	5.1%
Toxicity to various agentspoisoning or toxic effect of one or more substances	82	4.9%
Overdosea dose above the recommended amount	78	4.7%
Adverse drug reactiona harmful or unpleasant reaction (the term names a medicine)	76	4.6%
Diarrhoealoose or frequent stools	74	4.4%
Delusiona fixed false belief	72	4.3%
Aggressionaggressive behaviour	70	4.2%
Intentional product misusedeliberate use not as intended	68	4.1%
Platelet count decreasedlow platelet count	68	4.1%
Tachycardiafast heart rate	68	4.1%
Neuroleptic malignant syndromea rare severe reaction with fever and rigidity	67	4%
Agitationrestlessness	66	4%
Covid-19COVID-19 infection	64	3.8%
Malaisegeneral feeling of being unwell	64	3.8%
Somnolencedrowsiness	63	3.8%
Neuropathy peripheralnerve damage in hands or feet	61	3.7%
Affective disorder	60	3.6%
Incorrect dose administeredthe wrong dose was given	60	3.6%
Nauseafeeling sick	60	3.6%
Psychotic symptom	60	3.6%
Neutrophil count increased	59	3.5%
Alopeciahair loss	58	3.5%
Delusion of grandeur	58	3.5%
Dyspepsiaindigestion	58	3.5%
Lymphocyte count decreased	58	3.5%
Thrombocytopenialow platelets	58	3.5%

Download all 319 terms of Zuclopenthixol (CSV)

The counts add to more than 1,665 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, 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	3	3	0	0	3	0	0	0	0
2005	7	7	2	0	2	0	0	3	0
2006	2	2	0	0	2	0	0	0	0
2007	4	4	3	2	3	0	0	1	0
2008	5	5	0	0	0	0	0	5	0
2009	4	4	0	0	2	1	0	2	0
2010	14	14	5	1	6	0	0	5	0
2011	12	12	3	0	8	0	0	4	0
2012	28	28	2	4	12	1	0	16	0
2013	14	14	0	4	9	0	0	10	0
2014	19	18	0	0	7	0	0	14	1
2015	31	31	1	1	15	0	1	16	0
2016	25	25	5	0	7	0	0	15	0
2017	38	37	10	7	13	0	0	28	1
2018	49	46	9	6	23	0	0	29	3
2019	115	115	23	5	47	0	1	81	0
2020	117	116	18	4	30	16	0	83	1
2021	141	139	11	7	52	1	0	114	2
2022	237	234	43	20	128	3	5	174	3
2023	202	198	28	13	121	1	0	135	4
2024	207	205	39	16	115	0	0	143	2
2025	243	242	51	13	154	3	5	186	1
2026	148	147	40	14	59	5	0	112	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, 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, by the year in which FDA received them
Year	Reports
2004	3
2005	7
2006	2
2007	2
2008	7
2009	5
2010	14
2011	12
2012	28
2013	14
2014	18
2015	36
2016	24
2017	55
2018	79
2019	144
2020	136
2021	177
2022	199
2023	203
2024	195
2025	197
2026	108

Reports that name Zuclopenthixol, 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
Age	Reports	Share
Under 2	1	0.1%
2 to 11	8	0.5%
12 to 17	39	2.3%
18 to 44	806	48.4%
45 to 64	377	22.6%
65 to 74	58	3.5%
75 and over	58	3.5%
Age not given	318	19.1%

Sex of the patient in the reports that name Zuclopenthixol
Sex	Reports	Share
Female	721	43.3%
Male	777	46.7%
Unknown or not given	167	10%

Type of reporter in the reports that name Zuclopenthixol
Reporter	Reports	Share
Physician	546	32.8%
Pharmacist	160	9.6%
Other health professional	715	42.9%
Lawyer	1	0.1%
Consumer or non-health professional	214	12.9%
Not given	29	1.7%

Age and sex are as the report gives them. The reporter is the primary source in the report. 0.7% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Zuclopenthixol record
Indication as recorded (MedDRA)	Reports	Share
Schizophrenia	468	28.1%
Schizoaffective disorder	87	5.2%
Psychotic disorder	62	3.7%
Bipolar disorder	22	1.3%
Persecutory delusion	21	1.3%
Hallucination, auditory	14	0.8%

The reporter fills in the indication, and the field is often empty. Each share is of all 1,665 reports.

Drugs in the same reports

Other drugs that the reports of Zuclopenthixol name, in any role, in order of name
Drug	Reports that name the two
Aripiprazole	591
Clozapine	511
Haloperidol	309
Lorazepam	248
Olanzapine	783
Paliperidone	296
Quetiapine	379
Quetiapine fumarate	269
Risperdal	296
Risperidone	598

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

Zubsolv next in the A to Z list
Zuclopenthixol Acetate next in the A to Z list
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Zuclopenthixol Decanoate next in the A to Z list
Zovirax next in the A to Z list
Zuclopenthixol Hydrochloride next in the A to Z list
Zotepine next in the A to Z list
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Zosyn next in the A to Z list
Zurzuvae next in the A to Z list
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Zusduri next in the A to Z list

These links are for navigation. No count selected them.

Official pages

DailyMed labels for ZuclopenthixolThe 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: adverse event reports that FDA received. https://reportedreactions.com/drug/zuclopenthixol/ 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 as a suspect or interacting product. The 755 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 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?

No. It is a count of what people reported to FDA: 1,665 reports from March 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?

Other health professional (42.9%), physician (32.8%) and consumer or non-health professional (12.9%). 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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