Dobutamine Recall

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Questions & Answers

Side Effects & Adverse Reactions

1. Increase in Heart Rate or Blood Pressure

Dobutamine may cause a marked increase in heart rate or blood pressure, especially systolic pressure. Dobutamine may cause a marked increase in heart rate or blood pressure, especially systolic pressure. Approximately 10% of patients in clinical studies have had rate increases of 30 beats/minute or more, and about 7.5% have had a 50 mm Hg or greater increase in systolic pressure. Usually, reduction of dosage promptly reverses these effects. Because dobutamine facilitates atrioventricular conduction, patients with atrial fibrillation are at risk  of developing rapid ventricular response. Patients with preexisting hypertension appear to face an increased risk of developing an exaggerated pressor response.

2. Ectopic Activity

Dobutamine may precipitate or exacerbate ventricular ectopic activity, but it rarely has caused ventricular tachycardia.

3. Hypersensitivity

Reactions suggestive of hypersensitivity associated with administration of dobutamine injection, including skin rash, fever, eosinophilia, and bronchospasm, have been reported occasionally.

4. Dobutamine injection contains sodium metabisulfite, a sulfite that may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes, in certain susceptible people. The overall prevalence of sulfit sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.


Dobutamine injection is indicated when parenteral therapy is necessary for inotropic support in the short-term treatment of adults with cardiac decompensation due to depressed contractility resulting either from organic heart disease or from cardiac surgical procedures.

In patients who have atrial fibrillation with rapid ventricular response, a digitalis preparation should be use prior to institution of therapy with dobutamine hydrochloride.


There is currently no drug history available for this drug.

Other Information

Dobutamine Injection, USP is 1,2-benzenediol, 4-[2-[[3-(4-hydro-xphenyl)-1-methylpropyl]amino]ethyl]-hydrochloride, (±). It is a synthetic catecholamine.


The clinical formulation is supplied in a sterile form for intravenous use only. Each mL contains: Dobutamine hydrochloride, equivalent to 12.5 mg (41.5 umol) dobutamine; 0.24 mg sodium metabisulfite (added during manufacture), and water for injection, pH adjusted between 2.5 to 5.5 with hydrochloric acid and/or sodium hydroxide. Dobutamine is oxygen sensitive.

Dobutamine Manufacturers

  • General Injectables And Vaccines, Inc.
    Dobutamine (Dobutamine Hydrochloride Injection) Injection, Solution [General Injectables And Vaccines, Inc.]
  • Physicians Total Care, Inc.
    Dobutamine (Dobutamine Hydrochloride) Injection, Solution [Physicians Total Care, Inc.]
  • Hospira, Inc.
    Dobutamine (Dobutamine Hydrochloride) Injection, Solution [Hospira, Inc.]

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