Dexmedetomidine hydrochloride adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Dexmedetomidine 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: Dexmedetomidine Hydrochloride Injection, Dexmedetomidine Hcl Injection

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 June 2009 to June 2026, FDA received 1,436 adverse event reports that name Dexmedetomidine hydrochloride. In these reports the drug is a suspect or interacting product.

In the same period, 321 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 134 reports in the 12 months to June 2026 and 150 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, 134 (under 0.1%) name Dexmedetomidine hydrochloride. Reports from consumers or other non-health professionals were 2.6% of the reports that name Dexmedetomidine hydrochloride 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 Dexmedetomidine 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 25 reports that name Dexmedetomidine hydrochloride.
In January to March 2026, FDA received 16.
In April to June 2025, FDA received 39.

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 142 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 1,412 of the 1,436 reports (98.3%).

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 142 terms.

Reaction terms in the reports that name Dexmedetomidine hydrochloride, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 1,436 reports
Bradycardiaslow heart rate	177	12.3%
Off label useused for a purpose or in a way not on the label	132	9.2%
Cardiac arrestthe heart stopped	100	7%
Product use in unapproved indicationused for a purpose not on the label	82	5.7%
Hypotensionlow blood pressure	81	5.6%
Product administered to patient of inappropriate age	72	5%
Product use issuea problem in how the product was used	62	4.3%
Drug interactionan interaction between medicines	61	4.2%
Pyrexiafever	56	3.9%
Diabetes insipidus	53	3.7%
Oxygen saturation decreased	52	3.6%
Arteriospasm coronary	49	3.4%
Drug ineffectivethe medicine did not work as expected	47	3.3%
Agitationrestlessness	43	3%
Drug administered to patient of inappropriate age	36	2.5%
Withdrawal syndrome	36	2.5%
Respiratory depressionslow or shallow breathing	31	2.2%
Overdosea dose above the recommended amount	29	2%
Tachycardiafast heart rate	29	2%
Torsade de pointesa serious irregular heart rhythm	29	2%
Sedation complication	28	1.9%
Accidental overdosean accidental overdose	27	1.9%
Somnolencedrowsiness	27	1.9%
Upper airway obstruction	27	1.9%
Apnoeapauses in breathing	25	1.7%
Drug withdrawal syndromesymptoms on stopping a medicine	25	1.7%
Hyperthermia	25	1.7%
Sinus bradycardia	25	1.7%
Respiratory failurethe lungs could not supply enough oxygen	23	1.6%
Deliriumsudden confusion	22	1.5%
Hypoxialow oxygen	22	1.5%
Toxicity to various agentspoisoning or toxic effect of one or more substances	22	1.5%
Hypocapnia	21	1.5%
Seizure like phenomena	21	1.5%
Sinus arrest	21	1.5%
Ventricular fibrillationa chaotic rhythm from the lower heart chambers	21	1.5%
Floppy iris syndrome	20	1.4%
Loss of consciousnesspassing out	20	1.4%
Drug withdrawal convulsions	19	1.3%
Hypotonia	19	1.3%
Seizurea fit or convulsion	19	1.3%
Wrong product administered	19	1.3%
Anaphylactic shocka severe allergic reaction with collapse	18	1.3%
Blood pressure decreaseda low blood pressure reading	18	1.3%
Dyspnoeashortness of breath	18	1.3%
Generalised tonic-clonic seizure	18	1.3%
Syncopefainting	18	1.3%
Tachypnoea	18	1.3%
Rhabdomyolysismuscle breakdown	17	1.2%
Ventricular tachycardiaa fast rhythm from the lower heart chambers	17	1.2%

Download all 142 terms of Dexmedetomidine hydrochloride (CSV)

The counts add to more than 1,436 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 Dexmedetomidine with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Dexmedetomidine	Generic name	1,653
Dexmedetomidine hydrochloride (this page)	Generic name	1,436
Precedex	Brand name	598

Sum of the separately reported names: 3,687. 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 Dexmedetomidine 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
2009	4	3	1	1	1	0	0	2	1
2010	15	13	2	4	5	0	0	5	2
2011	11	11	0	3	6	0	0	2	0
2012	15	15	0	5	6	0	0	5	0
2013	38	38	12	12	3	1	0	11	0
2014	49	49	11	11	12	0	0	22	0
2015	39	39	2	12	9	1	0	25	0
2016	90	80	5	14	22	3	0	64	10
2017	89	86	8	13	13	0	0	75	3
2018	55	51	4	14	9	0	0	35	4
2019	113	113	4	32	28	1	0	92	0
2020	118	118	5	21	39	2	0	98	0
2021	106	106	4	26	38	1	2	89	0
2022	131	131	9	12	47	0	0	117	0
2023	173	171	10	26	88	0	0	126	2
2024	148	146	5	32	82	1	0	97	2
2025	193	188	3	58	77	1	0	129	5
2026	49	49	1	10	20	0	0	42	0

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 Dexmedetomidine 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 Dexmedetomidine hydrochloride, by the year in which FDA received them
Year	Reports
2009	4
2010	15
2011	12
2012	17
2013	39
2014	53
2015	34
2016	105
2017	79
2018	66
2019	110
2020	128
2021	108
2022	128
2023	173
2024	146
2025	178
2026	41

Reports that name Dexmedetomidine 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 Dexmedetomidine hydrochloride
Age	Reports	Share
Under 2	102	7.1%
2 to 11	131	9.1%
12 to 17	55	3.8%
18 to 44	212	14.8%
45 to 64	278	19.4%
65 to 74	173	12%
75 and over	129	9%
Age not given	356	24.8%

Sex of the patient in the reports that name Dexmedetomidine hydrochloride
Sex	Reports	Share
Female	476	33.1%
Male	696	48.5%
Unknown or not given	264	18.4%

Type of reporter in the reports that name Dexmedetomidine hydrochloride
Reporter	Reports	Share
Physician	422	29.4%
Pharmacist	100	7%
Other health professional	854	59.5%
Lawyer	0	0%
Consumer or non-health professional	37	2.6%
Not given	23	1.6%

Age and sex are as the report gives them. The reporter is the primary source in the report. 31.7% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Dexmedetomidine hydrochloride record
Indication as recorded (MedDRA)	Reports	Share
Sedation	417	29%
Sedative therapy	291	20.3%
Agitation	54	3.8%
Anaesthesia	38	2.6%
General anaesthesia	30	2.1%
Delirium	26	1.8%

The reporter fills in the indication, and the field is often empty. Each share is of all 1,436 reports.

Drugs in the same reports

Other drugs that the reports of Dexmedetomidine hydrochloride name, in any role, in order of name
Drug	Reports that name the two
Acetaminophen	70
Fentanyl	267
Fentanyl citrate	62
Ketamine	95
Lidocaine	67
Lorazepam	67
Midazolam	252
Propofol	375
Remifentanil	89
Sevoflurane	87

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

Dexmedetomidine same ingredient
Precedex same ingredient
Guanfacine same class
Clonidine transdermal system same class
Guanfacine hydrochloride same class
Clonidine hydrochloride same class
Intuniv same class
Dexmethylphenidate next in the A to Z list
Dexlansoprazole next in the A to Z list
Dexmethylphenidate hydrochloride next in the A to Z list
Dexketoprofen next in the A to Z list
Dexpanthenol 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 Dexmedetomidine 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. Dexmedetomidine hydrochloride: adverse event reports that FDA received. https://reportedreactions.com/drug/dexmedetomidine-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 Dexmedetomidine hydrochloride as a suspect or interacting product. The 321 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 Dexmedetomidine 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 Dexmedetomidine hydrochloride?

No. It is a count of what people reported to FDA: 1,436 reports from June 2009 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 (59.5%), physician (29.4%) and pharmacist (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.

To the top of the page