Dobutamine hydrochloride adverse event reports that FDA received

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

Name type: Generic name
Class: beta-Adrenergic agonist
Also reported as: Dobutamine Hcl

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 January 2004 to June 2026, FDA received 839 adverse event reports that name Dobutamine hydrochloride. In these reports the drug is a suspect or interacting product.

In the same period, 1,058 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 66 reports in the 12 months to June 2026 and 23 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, 66 (under 0.1%) name Dobutamine hydrochloride. Reports from consumers or other non-health professionals were 8.2% of the reports that name Dobutamine 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 Dobutamine 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 15 reports that name Dobutamine hydrochloride.
In January to March 2026, FDA received 9.
In April to June 2025, FDA received 4.

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 757 of the 839 reports (90.2%).

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 Dobutamine hydrochloride, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 839 reports
Drug ineffectivethe medicine did not work as expected	111	13.2%
Off label useused for a purpose or in a way not on the label	103	12.3%
Condition aggravatedthe condition being treated got worse	92	11%
Drug hypersensitivityan allergic-type reaction (the term names a medicine)	87	10.4%
Multiple organ dysfunction syndromeseveral organs failing	86	10.3%
Cardiogenic shockshock from the heart failing to pump	85	10.1%
Nauseafeeling sick	82	9.8%
Stress	82	9.8%
General physical health deteriorationgeneral decline in health	79	9.4%
Hyponatraemialow blood sodium	79	9.4%
Sepsisa severe body-wide response to infection	79	9.4%
Ventricular fibrillationa chaotic rhythm from the lower heart chambers	78	9.3%
Abdominal distensiona bloated abdomen	74	8.8%
Ascitesfluid in the abdomen	73	8.7%
Abdominal painstomach or belly pain	72	8.6%
Somnolencedrowsiness	72	8.6%
Vomitingbeing sick	72	8.6%
Appendicitis	71	8.5%
Appendicolith	69	8.2%
Constipation	69	8.2%
Myasthenia gravis	68	8.1%
Blood phosphorus increased	63	7.5%
Anaemialow red blood cells	62	7.4%
Diabetes mellitusdiabetes	62	7.4%
Swelling	62	7.4%
Thrombosis	62	7.4%
Chronic obstructive pulmonary diseaseCOPD, a long-term lung disease	61	7.3%
Dyspnoeashortness of breath	61	7.3%
Intentional product misusedeliberate use not as intended	61	7.3%
Neuralgia	61	7.3%
Bacterial infectiona bacterial infection	60	7.2%
Drug intolerancethe medicine was not tolerated	60	7.2%
Dry mouth	60	7.2%
Pulmonary embolisma blood clot in the lung	59	7%
Hypertensionhigh blood pressure	58	6.9%
Blood uric acid increasedraised uric acid	56	6.7%
Blood cholesterol increasedraised cholesterol	55	6.6%
Hyperphosphataemia	54	6.4%
Incorrect route of product administrationthe product was given by the wrong route	54	6.4%
Hypophosphataemia	53	6.3%
Product use in unapproved indicationused for a purpose not on the label	51	6.1%
Sleep disordera sleep problem	50	6%
Analgesic therapy	49	5.8%
Drug therapy	49	5.8%
Sleep disorder therapy	47	5.6%
Stress cardiomyopathy	47	5.6%
Ventricular tachycardiaa fast rhythm from the lower heart chambers	46	5.5%
Iron deficiency	44	5.2%
Activated partial thromboplastin time prolonged	43	5.1%
Ulcer	42	5%

Download all 142 terms of Dobutamine hydrochloride (CSV)

The counts add to more than 839 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 Dobutamine with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Dobutamine	Generic name	1,714
Dobutamine hydrochloride (this page)	Generic name	839
Dobutamine Hydrochloride in Dextrose	Brand name	387

Sum of the separately reported names: 2,940. 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 Dobutamine 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
2004	88	12	2	6	3	2	0	2	76
2005	16	11	3	4	4	0	0	3	5
2006	47	36	4	8	5	0	0	20	11
2007	24	20	3	1	12	1	0	9	4
2008	36	32	3	3	10	0	0	19	4
2009	38	38	6	3	10	0	0	27	0
2010	25	24	7	4	8	0	0	10	1
2011	32	31	6	6	13	1	0	18	1
2012	24	21	0	5	11	0	0	14	3
2013	21	20	1	2	5	0	0	19	1
2014	10	10	2	2	4	0	0	4	0
2015	17	11	0	0	1	0	0	10	6
2016	20	9	1	1	3	0	0	7	11
2017	22	18	3	1	4	0	0	13	4
2018	30	25	2	5	2	2	0	22	5
2019	42	20	3	5	6	0	0	17	22
2020	28	26	9	9	9	0	0	20	2
2021	55	49	12	7	16	0	0	34	6
2022	50	48	14	12	18	7	0	39	2
2023	91	89	42	44	57	28	0	63	2
2024	36	31	18	20	19	15	2	25	5
2025	54	49	19	25	21	17	13	43	5
2026	33	33	26	15	22	20	20	28	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 Dobutamine 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 Dobutamine hydrochloride, by the year in which FDA received them
Year	Reports
2004	84
2005	19
2006	44
2007	28
2008	36
2009	36
2010	30
2011	30
2012	28
2013	20
2014	9
2015	17
2016	24
2017	25
2018	29
2019	38
2020	33
2021	62
2022	47
2023	93
2024	30
2025	53
2026	24

Reports that name Dobutamine 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 Dobutamine hydrochloride
Age	Reports	Share
Under 2	7	0.8%
2 to 11	5	0.6%
12 to 17	5	0.6%
18 to 44	93	11.1%
45 to 64	198	23.6%
65 to 74	117	13.9%
75 and over	174	20.7%
Age not given	240	28.6%

Sex of the patient in the reports that name Dobutamine hydrochloride
Sex	Reports	Share
Female	295	35.2%
Male	340	40.5%
Unknown or not given	204	24.3%

Type of reporter in the reports that name Dobutamine hydrochloride
Reporter	Reports	Share
Physician	257	30.6%
Pharmacist	80	9.5%
Other health professional	387	46.1%
Lawyer	3	0.4%
Consumer or non-health professional	69	8.2%
Not given	43	5.1%

Age and sex are as the report gives them. The reporter is the primary source in the report. 49.6% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Dobutamine hydrochloride record
Indication as recorded (MedDRA)	Reports	Share
Stress echocardiogram	127	15.1%
Cardiogenic shock	95	11.3%
Cardiac stress test	70	8.3%
Coronary artery disease	14	1.7%
Cardiac disorder	10	1.2%
Cardiac failure	9	1.1%

The reporter fills in the indication, and the field is often empty. Each share is of all 839 reports.

Pages near this one

Dobutamine same ingredient
Dobutamine Hydrochloride in Dextrose same ingredient
Doans Extra Strength next in the A to Z list
Docefrez next in the A to Z list
Divigel next in the A to Z list
Docetaxel next in the A to Z list
Divalproex sodium er next in the A to Z list
Docetaxel Accord next in the A to Z list
Divalproex sodium next in the A to Z list
Docetaxel Actavis next in the A to Z list
Divalproex next in the A to Z list
Docetaxel Hospira 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 Dobutamine 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. Dobutamine hydrochloride: adverse event reports that FDA received. https://reportedreactions.com/drug/dobutamine-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 Dobutamine hydrochloride as a suspect or interacting product. The 1,058 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 Dobutamine 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 Dobutamine hydrochloride?

No. It is a count of what people reported to FDA: 839 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 (46.1%), physician (30.6%) and pharmacist (9.5%). 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.

To the top of the page