Prescription medicine
Dobutamine First approved as Dobutrex
Dobutamine (Dobutrex) is a prescription medicine with an FDA approval on record since 1978. FDA's NDC Directory lists it from 4 generic labelers.
- Generic listed
- In shortage
Check it at the source: the dobutamine FDA label on DailyMed (effective June 3, 2026, Hospira, Inc.); the NDA 17820 record on Drugs@FDA; every dobutamine label on DailyMed.
Highlights of the record
FDA label of June 3, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageDobutamine in 5% Dextrose Injection is indicated when parenteral therapy is necessary for inotropic support in the short-term treatment of patients with cardiac decompensation due to depressed contractility resulting either from organic heart disease or from cardiac surgical procedures.
Forms and strengths
- 12.5 mg/ml
- 100 mg/100ml
- 200 mg/100ml
- 250 mg/20ml
- 400 mg/100ml
Injection (solution); injection; injection (solution) (concentrate).
On the market
- Earliest approval on file
- July 18, 1978 Dobutrex, Lilly; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 12 first October 19, 1993; 3 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 6 of which 4 under generic applications, 4 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- 1 of 10 presentations limited or unavailable updated October 2, 2026
- Recalls by its makers (FDA)
- 4 since 2013 1 Class I among all firms' recalls; latest May 28, 2025; 2 more by firms not listed as its makers
- FAERS reports
- 4,908 through July 30, 2026
What is dobutamine used for?
From the label: indications and usageDobutamine in 5% Dextrose Injection is indicated when parenteral therapy is necessary for inotropic support in the short-term treatment of patients with cardiac decompensation due to depressed contractility resulting either from organic heart disease or from cardiac surgical procedures. Experience with intravenous dobutamine in controlled trials does not extend beyond 48 hours of repeated boluses and/or continuous infusions. Whether given orally, continuously intravenously, or intermittently intravenously, neither dobutamine nor any other cyclic-AMP-dependent inotrope has been shown in controlled trials to be safe or effective in the long-term treatment of congestive heart failure. […]
FDA pharmacologic class: beta-Adrenergic Agonist.
Source: FDA drug label (Dobutamine in Dextrose), Hospira, Inc., effective June 3, 2026 (SPL set 9943a961-3b50-4847-8a84-d8414ce38daa), via openFDA; the full label on DailyMed
Is there a generic for dobutamine (Dobutrex)?
The FDA approved the first generic dobutamine on October 19, 1993. 12 generic applications are approved; 3 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists dobutamine from 4 labelers under a generic (ANDA) application and from 4 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1978 earliest approval on file
- 1993 first generic approved
- 2017 to now in shortage
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Is dobutamine in shortage?
The FDA Drug Shortage Database lists 1 of 10 dobutamine presentations as limited or unavailable (updated October 2, 2026); the first entry was posted on November 6, 2017. 9 more presentations are on the list as available.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Dobutamine Hydrochloride In Dextrose 5% In Plastic Container, Injection, 1,000 mg/250mL (4 mg/mL) (NDC 0409-1100-10) | Hospira, Inc., a Pfizer Company | Current | September 22, 2026 |
| Dobutamine Hydrochloride In Dextrose 5% In Plastic Container, Injection, 100 mg/100 mL (NDC 0338-1073-02) | Baxter Healthcare | Current | October 2, 2026 |
| Dobutamine Hydrochloride In Dextrose 5% In Plastic Container, Injection, 200 mg/100 mL (NDC 0338-1075-02) | Baxter Healthcare | Current | October 2, 2026 |
| Dobutamine Hydrochloride In Dextrose 5% In Plastic Container, Injection, 250 mg/250mL (1 mg/mL) (NDC 0409-0025-10) | Hospira, Inc., a Pfizer Company | Current | September 22, 2026 |
| Dobutamine Hydrochloride In Dextrose 5% In Plastic Container, Injection, 400 mg/100 mL (NDC 0338-1077-02) | Baxter Healthcare | Current | October 2, 2026 |
| Dobutamine Hydrochloride In Dextrose 5% In Plastic Container, Injection, 500 mg/250mL (2 mg/mL) (NDC 0409-0151-10) | Hospira, Inc., a Pfizer Company | Current | September 22, 2026 |
| Dobutamine Hydrochloride, Injection, 250 mg/20 mL (NDC 70436-203-80) | Hainan Poly Pharm. Co., Ltd. | Current | September 16, 2026 |
| Dobutamine Hydrochloride, Injection, 250 mg/20mL (12.5 mg/1 mL) (NDC 0409-2344-01) | Hospira, Inc., a Pfizer Company | Current | September 22, 2026 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has dobutamine been recalled?
The FDA's Enforcement Report lists 6 recalls naming dobutamine since 2013: 1 Class I (the most serious), 5 Class II, 0 Class III; 1 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of dobutamine and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| May 28, 2025 | Class II | Pfizer Inc. | Discoloration; discolored solution from cracked vials |
| December 27, 2022 | Class II | Sentara Infusion Services not a listed maker | Lack of sterility assurance |
| August 15, 2016 | Class II | Hospira Inc. | Discoloration: Firm received complaints of product discoloration and particulates. |
| April 18, 2016 | Class II | Baptist Health Medical Towers Pharmacy and Infusion Services not a listed maker | Lack of Sterility Assurance. |
| January 10, 2014 | Class I | Hospira Inc. | Presence of Particulate Matter: Discolored solution due to a chip in the glass at the neck of the vial, also glass particulate was found within the solution. |
| April 30, 2013 | Class II | Hospira Inc. | Lack of Assurance of Sterility: Confirmed report of leaking in the primary container. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the dobutamine label say about other medicines?
The dobutamine label names 10 other medicines in its interaction, contraindication or warning sections. The labels of 11 other medicines name dobutamine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Acetaminophen | drug interactions | … trinitrate, isosorbide dinitrate, morphine, atropine, heparin, protamine, potassium chloride, folic acid, and acetaminophen. |
| Atropine | drug interactions | … preparations, furosemide, spironolactone, lidocaine, glyceryl trinitrate, isosorbide dinitrate, morphine, atropine, heparin, protamine, potassium chloride, folic acid, and acetaminophen. |
| Entacapone | drug interactions | Concomitant use of dobutamine and catechol- O -methyltranferase (COMT) inhibitors (e.g., entacapone) may result in increased heart rate, arrhythmias, and changes in blood pressure. |
| Furosemide | drug interactions | Drug Interactions There was no evidence of drug interactions in clinical studies in which dobutamine hydrochloride was administered concurrently with other drugs, including digitalis preparations, furosemide, spironolactone, lidocaine, glyceryl trinitrate, isosorbide dinitrate, morphine, atropine, heparin, protamine … |
| Heparin | drug interactions | … preparations, furosemide, spironolactone, lidocaine, glyceryl trinitrate, isosorbide dinitrate, morphine, atropine, heparin, protamine, potassium chloride, folic acid, and acetaminophen. |
| Isosorbide dinitrate | drug interactions | Drug Interactions There was no evidence of drug interactions in clinical studies in which dobutamine hydrochloride was administered concurrently with other drugs, including digitalis preparations, furosemide, spironolactone, lidocaine, glyceryl trinitrate, isosorbide dinitrate, morphine, atropine, heparin, protamine … |
| Lidocaine | drug interactions | Drug Interactions There was no evidence of drug interactions in clinical studies in which dobutamine hydrochloride was administered concurrently with other drugs, including digitalis preparations, furosemide, spironolactone, lidocaine, glyceryl trinitrate, isosorbide dinitrate, morphine, atropine, heparin, protamine … |
| Morphine | drug interactions | … digitalis preparations, furosemide, spironolactone, lidocaine, glyceryl trinitrate, isosorbide dinitrate, morphine, atropine, heparin, protamine, potassium chloride, folic acid, and acetaminophen. |
| Protamine | drug interactions | … furosemide, spironolactone, lidocaine, glyceryl trinitrate, isosorbide dinitrate, morphine, atropine, heparin, protamine, potassium chloride, folic acid, and acetaminophen. |
| Spironolactone | drug interactions | Drug Interactions There was no evidence of drug interactions in clinical studies in which dobutamine hydrochloride was administered concurrently with other drugs, including digitalis preparations, furosemide, spironolactone, lidocaine, glyceryl trinitrate, isosorbide dinitrate, morphine, atropine, heparin, protamine … |
Other labels that name dobutamine
Source: FDA drug label (Dobutamine in Dextrose), 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 for dobutamine?
The FDA Adverse Event Reporting System holds 4,908 reports that list dobutamine among the medicines taken, through July 30, 2026, 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.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other beta-adrenergic agonists
- the pharmacologic class, with prices and generics
- Dobutamine side effects
- the label's list beside FAERS reports
- Dobutamine shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other