Clonidine hydrochloride adverse event reports that FDA received

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

Name type: Generic name
Class: Central alpha-2 adrenergic agonist
Also reported as: Clonidine Hydrochloride Tablets Usp, Clonidine Hcl Injection, Clonidine Hcl Tablets

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 1,842 adverse event reports that name Clonidine hydrochloride. In these reports the drug is a suspect or interacting product.

In the same period, 3,777 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 260 reports in the 12 months to June 2026 and 363 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, 260 (under 0.1%) name Clonidine hydrochloride. Reports from other health professionals were 50.4% of the reports that name Clonidine hydrochloride and 19.7% 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 Clonidine hydrochloride 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 49 reports that name Clonidine hydrochloride.
In January to March 2026, FDA received 63.
In April to June 2025, FDA received 99.

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 328 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 1,691 of the 1,842 reports (91.8%).

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 328 terms.

Reaction terms in the reports that name Clonidine hydrochloride, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 1,842 reports
Hypertensionhigh blood pressure	512	27.8%
Headachehead pain	422	22.9%
Hypersensitivityan allergic-type reaction	409	22.2%
Hepatic enzyme increasedraised liver enzymes	371	20.1%
Infusion related reactiona reaction during or soon after an infusion	370	20.1%
Off label useused for a purpose or in a way not on the label	343	18.6%
Painpain, site not specified	336	18.2%
Joint swellinga swollen joint	328	17.8%
Prescribed overdose	320	17.4%
Fatiguetiredness	283	15.4%
Drug ineffectivethe medicine did not work as expected	272	14.8%
Overdosea dose above the recommended amount	269	14.6%
Upper respiratory tract infectiona cold or similar infection	264	14.3%
Pyrexiafever	249	13.5%
Rashskin rash	249	13.5%
Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease	241	13.1%
Psoriasispsoriasis, a skin condition	240	13%
Hyperhidrosisexcessive sweating	238	12.9%
Product use issuea problem in how the product was used	235	12.8%
Immunodeficiency	229	12.4%
Infectionan infection, type not specified	229	12.4%
Food allergy	222	12.1%
Exposure during pregnancythe medicine was taken during pregnancy	219	11.9%
Asthma	218	11.8%
Intentional product misusedeliberate use not as intended	207	11.2%
Hypoaesthesianumbness	201	10.9%
Drug intolerancethe medicine was not tolerated	194	10.5%
Hypercholesterolaemia	193	10.5%
Nauseafeeling sick	193	10.5%
Impaired healingslow healing	173	9.4%
Dizzinesslight-headedness or unsteadiness	165	9%
Vomitingbeing sick	162	8.8%
Helicobacter infection	161	8.7%
Type 2 diabetes mellitustype 2 diabetes	161	8.7%
Contraindicated product administered	160	8.7%
Joint dislocationa dislocated joint	160	8.7%
Weight increasedweight gain	160	8.7%
Joint stiffnessa stiff joint	158	8.6%
General physical health deteriorationgeneral decline in health	157	8.5%
Irritable bowel syndrome	157	8.5%
Drug hypersensitivityan allergic-type reaction (the term names a medicine)	155	8.4%
Treatment failurethe treatment did not work	155	8.4%
Joint range of motion decreasedreduced movement of a joint	152	8.3%
Osteoarthritis	151	8.2%
Injurya physical injury	149	8.1%
Prescribed underdose	147	8%
Constipation	144	7.8%
Wound infectionan infected wound	144	7.8%
Fluid retentionthe body holding extra fluid	143	7.8%
Wheezing	143	7.8%

Download all 328 terms of Clonidine hydrochloride (CSV)

The counts add to more than 1,842 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 Clonidine with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Clonidine	Generic name	11,712
Clonidine hydrochloride (this page)	Generic name	1,842

Sum of the separately reported names: 13,554. 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 Clonidine hydrochloride, 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	1	1	0	0	1	0
2006	2	2	1	1	2	0	0	0	0
2007	5	4	1	1	2	1	0	1	1
2008	5	4	0	0	2	1	0	2	1
2009	22	4	0	0	4	0	0	0	18
2010	21	9	3	3	2	0	0	4	12
2011	40	21	2	2	9	1	0	16	19
2012	24	21	0	2	12	3	0	14	3
2013	51	29	3	1	8	0	0	19	22
2014	54	28	5	2	8	0	0	18	26
2015	71	35	3	3	21	0	0	22	36
2016	43	26	6	2	9	0	0	13	17
2017	56	38	10	4	21	0	0	25	18
2018	49	38	4	7	18	4	0	25	11
2019	68	43	2	5	29	1	0	26	25
2020	58	38	7	6	25	0	0	21	20
2021	67	47	5	5	28	0	0	30	20
2022	163	115	20	13	72	1	0	72	48
2023	168	138	43	26	58	10	1	114	30
2024	307	262	120	23	46	10	5	224	45
2025	359	338	221	23	57	14	8	298	21
2026	207	191	131	24	33	15	11	169	16

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 Clonidine hydrochloride, 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 Clonidine hydrochloride, by the year in which FDA received them
Year	Reports
2005	2
2006	2
2007	5
2008	5
2009	5
2010	30
2011	42
2012	32
2013	52
2014	57
2015	75
2016	45
2017	51
2018	56
2019	79
2020	78
2021	81
2022	169
2023	197
2024	343
2025	324
2026	112

Reports that name Clonidine hydrochloride, 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 Clonidine hydrochloride
Age	Reports	Share
Under 2	34	1.8%
2 to 11	83	4.5%
12 to 17	46	2.5%
18 to 44	216	11.7%
45 to 64	280	15.2%
65 to 74	114	6.2%
75 and over	141	7.7%
Age not given	928	50.4%

Sex of the patient in the reports that name Clonidine hydrochloride
Sex	Reports	Share
Female	1,102	59.8%
Male	430	23.3%
Unknown or not given	310	16.8%

Type of reporter in the reports that name Clonidine hydrochloride
Reporter	Reports	Share
Physician	234	12.7%
Pharmacist	109	5.9%
Other health professional	929	50.4%
Lawyer	4	0.2%
Consumer or non-health professional	509	27.6%
Not given	57	3.1%

Age and sex are as the report gives them. The reporter is the primary source in the report. 46.4% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Clonidine hydrochloride record
Indication as recorded (MedDRA)	Reports	Share
Hypertension	200	10.9%
Eczema	108	5.9%
Blood pressure increased	40	2.2%
Insomnia	14	0.8%
Attention deficit hyperactivity disorder	12	0.7%
Blood pressure measurement	10	0.5%

The reporter fills in the indication, and the field is often empty. Each share is of all 1,842 reports.

Pages near this one

Clonidine same ingredient
Clonidine transdermal system same class
Catapres-TTS-1 same class
Dexmedetomidine same class
Dexmedetomidine hydrochloride same class
Clonidine hcl next in the A to Z list
Clopidogrel next in the A to Z list
Clonazepam Teva next in the A to Z list
Clopidogrel bisulfate next in the A to Z list
Clonazepam Actavis next in the A to Z list
Clopine next in the A to Z list
Clonazepam Accord 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 Clonidine hydrochlorideThe 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. Clonidine hydrochloride: adverse event reports that FDA received. https://reportedreactions.com/drug/clonidine-hydrochloride/ 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 Clonidine hydrochloride as a suspect or interacting product. The 3,777 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 Clonidine hydrochloride 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 Clonidine hydrochloride?

No. It is a count of what people reported to FDA: 1,842 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 (50.4%), consumer or non-health professional (27.6%) and physician (12.7%). 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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