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dobutamine hydrochloride

Dobutamine Hydrochloride is a medication used to treat Low Cardiac Output.

Generic · by Teva Parenteral

Generic of Dobutrex

⚠ FDA reports a current shortage of the injection form — availability differs between suppliers — see drug shortages →
Not yet rated· sourced from the FDA label
Rated against independent regulatory sources·Last updated June 7, 2026·How we rate
Verified againstopenFDANIH DailyMedRxClass

Key facts

Active ingredient
Dobutamine Hydrochloride
Form
Injectable
Strength
Dobutamine Hydrochloride EQ 12.5MG BASE/ML
Type
Prescription (Rx)
Brand or generic
Generic
Manufacturer
Teva Parenteral
FDA application
ANDA074206
Availability
Discontinued (per FDA)

What is Dobutamine Hydrochloride?

From the FDA label:Dobutamine Hydrochloride in 5% Dextrose Injection is a sterile, nonpyrogenic solution of Dobutamine Hydrochloride, USP and Dextrose, USP in Water for Injection, USP. Dobutamine hydrochloride is chemically designated as (±)-4-[2-[[3-(p-hydroxyphenyl)-1-methylpropyl]amino]ethyl]-pyrocatechol hydrochloride. It is a synthetic catecholamine. Dextrose Hydrous, USP is chemically designated as D-Glucopyranose monohydrate. Structural formulas are shown below: Dobutamine Hydrochloride, USP (D-Glucopyranose monohydrate) Dextrose Hydrous, USP Dobutamine Hydrochloride in 5% Dextrose Injection is intended for intravenous use only. It contains no antimicrobial agents. The pH is adjusted with sodium hydroxide and/or hydrochloric acid. Sodium bisulfite is added as a stabilizer. The solution is intended for single use only. When smaller doses are required, the unused portion should be discarded. Composition, osmolarity, pH and caloric content are given in Table 1. * Approximately 5 mEq/L sodium bisulfite is added as a stabilizer. † Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. Administration of substantially hypertonic solutions (≥ 600 mOsmol/L) may cause vein damage. This VIAFLEX PLUS plastic container is fabricated from a specially formulated polyvinyl chloride (PL 2207 Plastic). VIAFLEX containers, including VIAFLEX PLUS containers, are made of flexible plastic…

How to use

Recommended Dosage Dobutamine Hydrochloride in 5% Dextrose Injection is administered intravenously through a suitable intravenous catheter or needle. A calibrated electronic infusion device is recommended for controlling the rate of flow in mL/hour or drops/minute. Infusion of dobutamine should be started at a low rate (0.5-1.0 mcg/kg/min) and titrated at intervals of a few minutes, guided by the patient’s response, including systemic blood pressure, urine flow, frequency of ectopic activity, heart rate, and (whenever possible) measurements of cardiac output, central venous pressure, and/or pulmonary capillary wedge pressure. In reported trials, the optimal infusion rates have varied from patient to patient, usually 2-20 mcg/kg/min but sometimes slightly outside of this range. On rare occasions, infusion rates up to 40 mcg/kg/min have been required to obtain the desired effect. Rates of infusion in mL/hour for dobutamine hydrochloride concentrations of 1,000, 2,000 and 4,000 mcg/mL are in Table 2. This container system may be inappropriate for the dosage requirements of pediatric patients under 30 kg. Other dosage forms may be more appropriate. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Dobutamine Hydrochloride in 5% Dextrose Injection solutions may exhibit a…

Side effects

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. Reactions at Sites of Intravenous Infusion Phlebitis has occasionally been reported. Local inflammatory changes have been described following inadvertent infiltration. Miscellaneous Uncommon Effects The following adverse effects have been reported in 1% to 3% of adult patients: nausea, headache, anginal pain, nonspecific chest pain, palpitations, and shortness of breath. Administration of dobutamine, like other catecholamines, has been associated with decreases in serum potassium concentrations, rarely to hypokalemic…

Warnings

Important safety information

Increase in Heart Rate or Blood Pressure Dobutamine Hydrochloride in 5% Dextrose Injection may cause a marked increase in heart rate or blood pressure, especially systolic pressure. Approximately 10% of adult 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 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. In patients who have atrial fibrillation with rapid ventricular response, a digitalis preparation should be used prior to institution of therapy with Dobutamine in D5W. Ectopic Activity Dobutamine Hydrochloride in 5% Dextrose Injection may precipitate or exacerbate ventricular ectopic activity, but it rarely has caused ventricular tachycardia. Hypersensitivity Reactions suggestive of hypersensitivity associated with administration of dobutamine including skin rash, fever, eosinophilia, and bronchospasm, have been reported occasionally. Dobutamine Hydrochloride in 5% Dextrose Injection contains sodium bisulfite, 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 sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people. Solutions containing dextrose should not be administered through the same administration set as blood, as this may result in pseudoagglutination or hemolysis. The intravenous administration of solutions may cause fluid overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentrations of the injections. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentration of the injections. Excess administration of potassium-free solutions may result in significant hypokalemia.

Who should not take Dobutamine Hydrochloride

Dobutamine Hydrochloride in 5% Dextrose Injection is contraindicated in patients with idiopathic hypertrophic subaortic stenosis and in patients who have shown previous manifestations of hypersensitivity to dobutamine. Solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products.

Overdose — what happens if you take too much

Overdoses of dobutamine have been reported rarely. The following is provided to serve as a guide if such an overdose is encountered. Signs and Symptoms Toxicity from dobutamine is usually due to excessive cardiac beta-receptor stimulation. The duration of action of dobutamine is generally short (T1/2 = two minutes) because it is rapidly metabolized by catechol-O-methyltransferase. The symptoms of toxicity may include anorexia, nausea, vomiting, tremor, anxiety, palpitations, headache, shortness of breath, and anginal and nonspecific chest pain. The positive inotropic and chronotropic effects of dobutamine on the myocardium may cause hypertension, tachyarrhythmias, myocardial ischemia, and ventricular fibrillation. Hypotension may result from vasodilation. If the product is ingested, unpredictable absorption may occur from the mouth and the gastrointestinal tract. Treatment To obtain up-to-date information about the treatment of overdose, a good resource is your certified Regional Poison Control Center. Telephone numbers of certified poison control centers are listed in the Physicians’ Desk Reference (PDR). In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs, and unusual drug kinetics in your patient. The initial actions to be taken in a dobutamine overdose are discontinuing administration, establishing an airway, and ensuring…

U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.

May treat (source: NIH RxClass)

Dosage forms

Injectable

The forms currently marketed in the U.S., per the FDA National Drug Code Directory.

Ways to save

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Frequently asked questions

What does Dobutamine Hydrochloride treat?
Dobutamine Hydrochloride (Dobutamine Hydrochloride) may be used to treat low cardiac output, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
Is there a coupon or discount for Dobutamine Hydrochloride?
pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Dobutamine Hydrochloride. To pay less, Dobutamine Hydrochloride is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
Who makes Dobutamine Hydrochloride?
Dobutamine Hydrochloride is marketed by Teva Parenteral. You can see Teva Parenteral's full profile, rating, and other products on pharmaranks.
Is Dobutamine Hydrochloride a brand-name or generic drug?
Dobutamine Hydrochloride is a generic medication; its active ingredient is Dobutamine Hydrochloride. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
Is Dobutamine Hydrochloride available over the counter?
No. Dobutamine Hydrochloride is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
What forms does Dobutamine Hydrochloride come in?
Dobutamine Hydrochloride is currently marketed as injectable, per the FDA's National Drug Code Directory.
Is Dobutamine Hydrochloride FDA-registered?
Dobutamine Hydrochloride is on record with the U.S. FDA under application number ANDA074206. You can verify this on its official FDA label.
Is Dobutamine Hydrochloride safe?
There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Dobutamine Hydrochloride. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
What are the side effects of Dobutamine Hydrochloride?
Dobutamine Hydrochloride's side effects are taken directly from its FDA label. From the label: 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).… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.

Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.

What people report to the FDA about Dobutamine Hydrochloride

The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 1,431 reports naming Dobutamine Hydrochloride, and the FDA flagged 96% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:

  • stress168 reports
  • sepsis148 reports
  • multiple organ dysfunction syndrome136 reports
  • general physical health deterioration131 reports
  • cardiogenic shock127 reports
  • ventricular fibrillation121 reports
  • hyponatraemia119 reports
  • nausea117 reports

Read these as a signal, not a rate. A report does not mean Dobutamine Hydrochloride caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label.

Source: openFDA drug/event (FAERS), retrieved September 25, 2026.

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