Chlorpromazine adverse event reports that FDA received

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

Name type: Generic name
Class: Phenothiazine
Also reported as: Chlorpromazine 25mg, Chlorpromazine /00011902/

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.

Reports on file

From January 2004 to June 2026, FDA received 3,372 adverse event reports that name Chlorpromazine. In these reports the drug is a suspect or interacting product.

In the same period, 2,848 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 225 reports in the 12 months to June 2026 and 235 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

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 Chlorpromazine 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 1 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.

No update is on record for this page. The record starts when FDA adds the reports of July to September 2026.

In April to June 2026, FDA received 40 reports that name Chlorpromazine.
In January to March 2026, FDA received 72.
In April to June 2025, FDA received 45.

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 452 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 3,367 of the 3,372 reports (99.9%).

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 452 terms.

Reaction terms in the reports that name Chlorpromazine, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 3,372 reports
Drug ineffectivethe medicine did not work as expected	354	10.5%
Toxicity to various agentspoisoning or toxic effect of one or more substances	267	7.9%
Off label useused for a purpose or in a way not on the label	240	7.1%
Overdosea dose above the recommended amount	217	6.4%
Neuroleptic malignant syndromea rare severe reaction with fever and rigidity	212	6.3%
Drug interactionan interaction between medicines	211	6.3%
Completed suicidedeath by suicide	154	4.6%
Neutropenialow neutrophils, a type of white blood cell	151	4.5%
Seizurea fit or convulsion	146	4.3%
Suicide attempta suicide attempt	140	4.2%
Drug abusemisuse of a medicine	129	3.8%
Psychotic disordera loss of contact with reality	128	3.8%
Sedationdrowsiness	128	3.8%
Fatiguetiredness	127	3.8%
Extrapyramidal disordermovement problems such as stiffness or tremor	125	3.7%
Somnolencedrowsiness	125	3.7%
Condition aggravatedthe condition being treated got worse	123	3.6%
Schizophrenia	118	3.5%
Insomniadifficulty sleeping	110	3.3%
Nauseafeeling sick	108	3.2%
Foetal exposure during pregnancythe unborn baby was exposed to the medicine	107	3.2%
Intentional overdosea deliberate overdose	107	3.2%
Diarrhoealoose or frequent stools	104	3.1%
Treatment failurethe treatment did not work	101	3%
Hallucination, auditory	94	2.8%
Deaththe patient died; cause not stated by this term	93	2.8%
Coma	92	2.7%
Anxiety	91	2.7%
Leukopenialow white blood cells	89	2.6%
Aggressionaggressive behaviour	88	2.6%
Dyskinesiainvoluntary movements	86	2.6%
Suicidal ideationthoughts of suicide	85	2.5%
Electrocardiogram QT prolongeda QT prolongation on the ECG	84	2.5%
Vomitingbeing sick	84	2.5%
Hypotensionlow blood pressure	83	2.5%
Intentional product misusedeliberate use not as intended	82	2.4%
Catatonia	81	2.4%
Platelet count decreasedlow platelet count	80	2.4%
Tachycardiafast heart rate	80	2.4%
Affective disorder	79	2.3%
Parkinsonism	78	2.3%
Confusional stateconfusion	77	2.3%
Tremorshaking	74	2.2%
Agitationrestlessness	73	2.2%
Product use in unapproved indicationused for a purpose not on the label	73	2.2%
Tardive dyskinesiainvoluntary repetitive movements	73	2.2%
Cellulitisa skin infection	72	2.1%
Covid-19COVID-19 infection	72	2.1%
Incorrect dose administeredthe wrong dose was given	72	2.1%
Lymphocyte count decreased	71	2.1%

Download all 452 terms of Chlorpromazine (CSV)

The counts add to more than 3,372 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 Chlorpromazine with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Chlorpromazine (this page)	Generic name	3,372
Chlorpromazine hydrochloride	Generic name	843

Sum of the separately reported names: 4,215. 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 Chlorpromazine, 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	41	40	15	5	20	1	0	12	1
2005	44	39	16	1	18	0	0	12	5
2006	56	54	7	4	23	5	0	27	2
2007	42	41	6	2	23	2	2	16	1
2008	30	29	5	2	14	1	0	11	1
2009	63	60	21	6	18	1	0	31	3
2010	61	57	21	9	25	6	0	25	4
2011	73	73	31	0	24	2	5	29	0
2012	57	54	12	5	26	0	1	27	3
2013	105	102	28	10	39	3	2	52	3
2014	135	134	38	2	51	7	7	82	1
2015	132	128	65	4	36	0	2	44	4
2016	145	134	34	16	46	3	10	77	11
2017	208	207	69	45	94	0	1	122	1
2018	168	164	29	12	65	2	5	122	4
2019	225	218	40	14	81	2	8	161	7
2020	201	194	42	32	80	10	6	138	7
2021	237	235	21	48	104	7	2	140	2
2022	316	311	54	32	160	9	0	189	5
2023	324	320	46	43	157	11	9	215	4
2024	302	298	61	26	134	2	3	217	4
2025	278	264	35	32	185	4	4	182	14
2026	129	125	30	14	68	3	3	83	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 Chlorpromazine, 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 Chlorpromazine, by the year in which FDA received them
Year	Reports
2004	38
2005	43
2006	45
2007	57
2008	30
2009	62
2010	59
2011	80
2012	68
2013	121
2014	117
2015	137
2016	167
2017	208
2018	183
2019	249
2020	201
2021	261
2022	312
2023	318
2024	270
2025	234
2026	112

Reports that name Chlorpromazine, 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 Chlorpromazine
Age	Reports	Share
Under 2	61	1.8%
2 to 11	81	2.4%
12 to 17	172	5.1%
18 to 44	1,210	35.9%
45 to 64	825	24.5%
65 to 74	250	7.4%
75 and over	118	3.5%
Age not given	655	19.4%

Sex of the patient in the reports that name Chlorpromazine
Sex	Reports	Share
Female	1,305	38.7%
Male	1,644	48.8%
Unknown or not given	423	12.5%

Type of reporter in the reports that name Chlorpromazine
Reporter	Reports	Share
Physician	1,129	33.5%
Pharmacist	443	13.1%
Other health professional	1,314	39%
Lawyer	1	under 0.1%
Consumer or non-health professional	362	10.7%
Not given	123	3.6%

Age and sex are as the report gives them. The reporter is the primary source in the report. 26.2% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Chlorpromazine record
Indication as recorded (MedDRA)	Reports	Share
Schizophrenia	499	14.8%
Psychotic disorder	121	3.6%
Hiccups	102	3%
Bipolar disorder	78	2.3%
Agitation	61	1.8%
Bipolar i disorder	37	1.1%

The reporter fills in the indication, and the field is often empty. Each share is of all 3,372 reports.

Drugs in the same reports

Other drugs that the reports of Chlorpromazine name, in any role, in order of name
Drug	Reports that name the two
Aripiprazole	402
Clozapine	401
Diazepam	351
Haloperidol	747
Lithium	325
Lorazepam	482
Olanzapine	757
Quetiapine	482
Risperidone	603
Valproic acid	285

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

Chlorpromazine hydrochloride same ingredient
Fluphenazine decanoate same class
Perphenazine same class
Chlorpheniramine maleate next in the A to Z list
Chlorpheniramine next in the A to Z list
Chlorprothixene next in the A to Z list
Chlorphenamine next in the A to Z list
Chlorthalidone next in the A to Z list
Chloroquine phosphate next in the A to Z list
Chlorzoxazone next in the A to Z list
Chloroquine next in the A to Z list
Cholbam 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 ChlorpromazineThe 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. Chlorpromazine: adverse event reports that FDA received. https://reportedreactions.com/drug/chlorpromazine/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 1 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 1 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 Oct 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Chlorpromazine as a suspect or interacting product. The 2,848 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 Chlorpromazine 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 Chlorpromazine?

No. It is a count of what people reported to FDA: 3,372 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?

Other health professional (39%), physician (33.5%) and pharmacist (13.1%). 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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