Drugs › beta-Adrenergic agonist
Generic name
Dobutamine hydrochloride: adverse event reports filed with FDA
839 reports list it as a suspect or interacting product, 2004–2026. Class: beta-Adrenergic agonist. Also reported as Dobutamine Hcl.
- 839
- reports as suspect product
- 0% of all reports · about 37 a year
- 66
- reports, 12 months to June 2026
- 23 in the 12 months before
- 79%
- marked serious by the reporter
- 88.7% across the class
- 22.2%
- record death among outcomes, as reported
- 186 reports · not verified by FDA
839 adverse event reports received by FDA list dobutamine hydrochloride, a generic name as a suspect or interacting product, from January 2004 to June 2026. A further 1,058 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 66 reports listed it, up 187% from 23 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 37 reports a year and 0% of the 20,646,523 reports in the database, and 32.9% of the reports for the beta-Adrenergic agonist class. How many people take it is not in the data, so a count is not a rate of occurrence.
The MedDRA terms listed most often are drug ineffective (13.2%), off label use (12.3%) and condition aggravated (11%). A report can list several reactions, so shares add to more than 100%; 288 different terms appear across these reports. Drug ineffective is recorded in 13.2% of these reports, a smaller share than in the median beta-Adrenergic agonist drug (22.8%).
79% of the reports are marked serious by the reporter (88.7% across the class); 22.2% record death among the outcomes and 31.3% record hospitalisation, as reported. 46.1% of the reports came from other health professionals, and the largest patient age group is 45 to 64 (23.6%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Dobutamine hydrochloride reports recording the termmedian drug in beta-adrenergic agonist
- Drug ineffectivethe medicine did not work as expected13.2%111
- Off label useused for a purpose or in a way not on the label12.3%103
- Condition aggravatedthe condition being treated got worse11%92
- Drug hypersensitivityan allergic-type reaction to a medicine10.4%87
- Multiple organ dysfunction syndromeseveral organs failing10.3%86
- Cardiogenic shockshock from the heart failing to pump10.1%85
- Nauseafeeling sick9.8%82
- Stressstress9.8%82
- General physical health deteriorationgeneral decline in health9.4%79
- Hyponatraemialow blood sodium9.4%79
- Sepsisa severe body-wide response to infection9.4%79
- Ventricular fibrillationa chaotic rhythm from the lower heart chambers9.3%78
- Abdominal distensiona bloated abdomen8.8%74
- Ascitesfluid in the abdomen8.7%73
- Abdominal painstomach or belly pain8.6%72
- Somnolencedrowsiness8.6%72
- Vomitingbeing sick8.6%72
- Appendicitis8.5%71
- Appendicolith8.2%69
- Constipationconstipation8.2%69
- Myasthenia gravis8.1%68
- Blood phosphorus increased7.5%63
- Anaemialow red blood cells7.4%62
- Diabetes mellitusdiabetes7.4%62
- Swellingswelling7.4%62
- Thrombosis7.4%62
- Chronic obstructive pulmonary diseaseCOPD, a long-term lung disease7.3%61
- Dyspnoeashortness of breath7.3%61
- Intentional product misusedeliberate use not as intended7.3%61
- Neuralgia7.3%61
Top 30 of 288 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 2 drugs in the beta-adrenergic agonist class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 2,553 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 49.6% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| 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 indication field is filled in by the reporter and is often blank; shares are of all 839 reports.
In context
| Measure | Dobutamine hydrochloride | beta-Adrenergic agonist | All reports |
|---|---|---|---|
| Reports as suspect product | 839 | 2,553 | 20,646,523 |
| Share of that pool | — | 32.9% | 0% |
| Reports, latest 12 months | 66 | — | 1,332,454 |
| Marked serious | 79% | 88.7% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 222 | 354 | 91 |
| Hospitalisation recorded, per 1,000 reports | 313 | 448 | 213 |
| Consumer-filed share | 8.2% | 7% | 45.8% |
| Top term, share of reports | Drug ineffective 13.2% | median 22.8% | 6.3% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Other drugs in the beta-adrenergic agonist class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Dobutamine | generic | 1,714 | 168 | 93.4% |
Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.
Questions about Dobutamine hydrochloride reports
How many adverse event reports has FDA received for Dobutamine hydrochloride?
839 reports list Dobutamine hydrochloride as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 66 of them arrived in the latest 12 months. Another 1,058 list it only as a concomitant medication.
What reactions are recorded in Dobutamine hydrochloride reports?
drug ineffective (13.2%), off label use (12.3%), condition aggravated (11%), drug hypersensitivity (10.4%) and multiple organ dysfunction syndrome (10.3%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Dobutamine hydrochloride was responsible.
How serious are the reports?
79% are marked serious by the reporter. Among the outcomes recorded, 22.2% of reports include death and 31.3% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
other health professional (46.1%), physician (30.6%) and pharmacist (9.5%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Dobutamine hydrochloride rising?
66 reports in the 12 months to June 2026, up 187% from 23 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Dobutamine hydrochloride was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Dobutamine hydrochloride?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Dobutamine hydrochloride as a suspect or interacting product; reports listing it only as a concomitant medication (1,058) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.