Skip to main content

What the label lists and what reports show

Dobutamine side effects

Dobutamine's FDA label lists its adverse reactions in its own words. FAERS holds 4,908 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is cardiogenic shock (485 reports).

  • Generic listed
  • In shortage

Check it at the source: the dobutamine FDA label on DailyMed (effective June 3, 2026, Hospira, Inc.); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

Increased Heart Rate, Blood Pressure, and Ventricular Ectopic Activity: A 10- to 20-mm Hg increase in systolic blood pressure and an increase in heart rate of 5 to 15 beats/minute have been noted in most patients (see WARNINGS regarding exaggerated chronotropic and pressor effects). Approximately 5% of adult patients have had increased premature ventricular beats during infusions. These effects are dose related. Hypotension: Precipitous decreases in blood pressure have occasionally been described in association with dobutamine therapy. Decreasing the dose or discontinuing the infusion typically results in rapid return of blood pressure to baseline values. In rare cases, however, intervention may be required and reversibility may not be immediate. Stress Cardiomyopathy: Stress cardiomyopathy has been reported with dobutamine in association with cardiac stress testing. …

Source: FDA drug label, Hospira, Inc., effective June 3, 2026 (SPL set 9943a961-3b50-4847-8a84-d8414ce38daa), via openFDA; the full label on DailyMed

What do FAERS reports show?

4,908 reports list dobutamine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,861 are coded as a death and 2,307 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 20 reactions below, 3 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

  • Drug Ineffective (a use or a product term, not a reaction)891
  • Off Label Use (a use or a product term, not a reaction)634
  • Death (an outcome recorded in the report)494
  • Cardiogenic Shock485
  • Multiple Organ Dysfunction Syndrome449
  • Condition Aggravated (a use or a product term, not a reaction)431
  • Sepsis427
  • General Physical Health Deterioration368
  • Nausea (named in the label)366
  • Stress (named in the label)361
  • Vomiting335
  • Hyponatraemia320
  • Ascites319
  • Abdominal Distension314
  • Abdominal Pain297
  • Ventricular Fibrillation296
  • Constipation294
  • Dyspnoea294
  • Appendicitis289
  • Appendicolith284
  • Hypotension (named in the label)263
  • Anaemia254
  • Somnolence222
  • Product Use In Unapproved Indication (a use or a product term, not a reaction)218
  • Renal Failure217

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Dobutamine: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions