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dobutamine Side Effects

Also known as: Dobutrex

Analysis of 3,554 adverse event reports submitted to the FDA from 2004 to 2025.

Total Reports

3,554

Death-Related

1,361

38.3% of reports

Hospitalizations

1,820

51.2% of reports

Top Indication

Product Used For Unknown Indication

Most Reported Adverse Reactions

DRUG INEFFECTIVE
744
OFF LABEL USE
510
CARDIOGENIC SHOCK
396
MULTIPLE ORGAN DYSFUNCTION SYNDROME
349
SEPSIS
324
CONDITION AGGRAVATED
317
GENERAL PHYSICAL HEALTH DETERIORATION
282
NAUSEA
282
VOMITING
262
ABDOMINAL DISTENSION
248
ASCITES
246
DEATH
241
HYPONATRAEMIA
241
STRESS
237
ABDOMINAL PAIN
234
APPENDICITIS
229
CONSTIPATION
226
APPENDICOLITH
225
VENTRICULAR FIBRILLATION
225
HYPOTENSION
217

Who Reports Side Effects

Gender Distribution

Female 1,387 (44%)
Male 1,772 (56%)
Unknown 22

Age Distribution

0-17 346 (12%)
18-44 583 (20%)
45-64 889 (31%)
65-74 458 (16%)
75+ 625 (22%)

Reporting Trend by Year

2004 2025

Reactions in Death Reports

Top reactions reported in 1,361 reports where death was an outcome. These are voluntarily reported and do not establish causation.

Reaction Reports
MULTIPLE ORGAN DYSFUNCTION SYNDROME 335
OFF LABEL USE 311
DRUG INEFFECTIVE 301
SEPSIS 297
CARDIOGENIC SHOCK 280
GENERAL PHYSICAL HEALTH DETERIORATION 263
DEATH 241
ABDOMINAL DISTENSION 239
ASCITES 236
STRESS 232
APPENDICITIS 229
HYPONATRAEMIA 229
VOMITING 229
NAUSEA 227
APPENDICOLITH 225
ABDOMINAL PAIN 224
CONSTIPATION 216
VENTRICULAR FIBRILLATION 207
CONDITION AGGRAVATED 203
BLOOD PHOSPHORUS INCREASED 146

Reactions in Hospitalization Reports

Top reactions in 1,820 reports where hospitalization was an outcome.

Reaction Reports
DRUG INEFFECTIVE 504
OFF LABEL USE 254
CARDIOGENIC SHOCK 223
CONDITION AGGRAVATED 197
MULTIPLE ORGAN DYSFUNCTION SYNDROME 176
DYSPNOEA 168
SEPSIS 160
NAUSEA 147
ANAEMIA 144
VOMITING 141
HYPOTENSION 137
GENERAL PHYSICAL HEALTH DETERIORATION 133
ABDOMINAL DISTENSION 130
VENTRICULAR FIBRILLATION 122
PULMONARY EMBOLISM 121
SOMNOLENCE 119
ASCITES 117
ABDOMINAL PAIN 116
HYPONATRAEMIA 114
MYASTHENIA GRAVIS 111

Nearby — Related Medications

Compare dobutamine vs adenosine →

What the FAERS Data Reveals About dobutamine Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 3,554 voluntary reports linked to dobutamine and its brand equivalents (Dobutrex), spanning 2004 through 2025. Of those, 1,361 (38.3%) listed death as an outcome and 1,820 (51.2%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.

Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 44% were female and 56% male; age distribution skews toward 45-64, with 889 reports in that bracket. The single most reported reaction is drug ineffective with 744 submissions, followed by off label use and cardiogenic shock.

FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.