Prescription medicine
Esmolol Brand names: Brevibloc
Esmolol (Brevibloc) is a prescription medicine with an FDA approval on record since 1986. FDA's NDC Directory lists it from 12 generic labelers.
- Generic listed
Check it at the source: the esmolol FDA label on DailyMed (effective March 14, 2025, Baxter Healthcare Company); the NDA 19386 record on Drugs@FDA; every esmolol label on DailyMed.
Highlights of the record
FDA label of March 14, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageBREVIBLOC injection is a beta adrenergic blocker indicated for the short-term treatment of:
Control of ventricular rate in supraventricular tachycardia including atrial fibrillation and atrial flutter and control of heart rate in noncompensatory sinus tachycardia ( 1.1 )
Control of perioperative tachycardia and hypertension ( 1.2 ) 1.1 Supraventricular Tachycardia or Noncompensatory Sinus Tachycardia BREVIBLOC (E
Forms and strengths
- 10 mg/ml
- 20 mg/ml
- 100 mg/10ml
Injection; injection (solution).
On the market
- Earliest approval on file
- December 31, 1986 Brevibloc, Baxter Hlthcare; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 11 first August 10, 2004; 9 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 15 of which 12 under generic applications, 6 under brand applications, repackagers included
- Last listed patent
- March 15, 2033 Esmolol Hydrochloride In Plastic Container injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 3 since 2014 0 Class I among all firms' recalls; latest March 13, 2019; 1 more by firms not listed as its makers
- FAERS reports
- 265 through July 30, 2026
What is esmolol used for?
From the label: indications and usageBREVIBLOC injection is a beta adrenergic blocker indicated for the short-term treatment of:
Control of ventricular rate in supraventricular tachycardia including atrial fibrillation and atrial flutter and control of heart rate in noncompensatory sinus tachycardia ( 1.1 )
Control of perioperative tachycardia and hypertension ( 1.2 ) 1.1 Supraventricular Tachycardia or Noncompensatory Sinus Tachycardia BREVIBLOC (Esmolol Hydrochloride) injection is indicated for the rapid control of ventricular rate in patients with atrial fibrillation or atrial flutter in perioperative, postoperative, or other emergent circumstances where short term control of ventricular rate with a short-acting agent is desirable. […]
Conditions named in the indications of esmolol's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: beta-Adrenergic Blocker.
Source: FDA drug label (Brevibloc), Baxter Healthcare Company, effective March 14, 2025 (SPL set 595cc3d5-1306-4828-aefa-5595219ffd62), via openFDA; the full label on DailyMed
Is there a generic for esmolol (Brevibloc)?
The FDA approved the first generic esmolol on August 10, 2004. 11 generic applications are approved; 9 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 esmolol from 12 labelers under a generic (ANDA) application and from 6 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Brevibloc injection; a patent listed only for Esmolol Hydrochloride In Plastic Container injection runs to March 15, 2033. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1986 earliest approval on file
- 2004 first generic approved
- 2033 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has esmolol been recalled?
The FDA's Enforcement Report lists 4 recalls naming esmolol since 2014: 0 Class I (the most serious), 4 Class II, 0 Class III; 0 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of esmolol and that holds 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 |
|---|---|---|---|
| December 17, 2020 | Class II | SCA Pharmaceuticals not a listed maker | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit |
| March 13, 2019 | Class II | Advanced Pharma Inc. | Lack of Assurance of Sterility |
| April 12, 2016 | Class II | Baxter Healthcare Corp. | Discoloration: presence of atypical yellow discoloration of the solution . |
| June 16, 2014 | Class II | Baxter Healthcare Corp. | Presence of Particulate Matter: Complaints received of discolored solution identified as subvisible particles of iron oxide that are agglomerating. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the esmolol label say about other medicines?
The esmolol label names 5 other medicines in its interaction, contraindication or warning sections. 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 |
|---|---|---|
| Clonidine | drug interactions | In addition, with some drugs, beta blockade may precipitate increased withdrawal effects. (See clonidine, guanfacine, and moxonidine below.) BREVIBLOC injection should therefore be used only after careful individual assessment of the risks and expected benefits in patients receiving drugs that can cause these types of … |
| Digoxin | drug interactions | Digitalis glycosides: Concomitant administration of digoxin and BREVIBLOC injection leads to an approximate 10% to 20% increase of digoxin blood levels at some time points. |
| Epinephrine | drug interactions | … tachycardia in patients receiving drugs that are vasoconstrictive and have positive inotropic effects, such as epinephrine, norepinephrine, and dopamine. |
| Guanfacine | drug interactions | In addition, with some drugs, beta blockade may precipitate increased withdrawal effects. (See clonidine, guanfacine, and moxonidine below.) BREVIBLOC injection should therefore be used only after careful individual assessment of the risks and expected benefits in patients receiving drugs that can cause these types of … |
| Verapamil | contraindications | IV administration of cardiodepressant calcium-channel antagonists (e.g., verapamil) and BREVIBLOC injection in close proximity (i.e., while cardiac effects from the other are still present); fatal cardiac arrests have occurred in patients receiving BREVIBLOC injection and intravenous verapamil. |
Source: FDA drug label (Brevibloc), Baxter Healthcare Company, effective March 14, 2025 (SPL set 595cc3d5-1306-4828-aefa-5595219ffd62), via openFDA; the full label on DailyMed
What do FAERS reports show for esmolol?
The FDA Adverse Event Reporting System holds 265 reports that list esmolol among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 47 are coded as a death and 93 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.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as esmolol?
4 other medicines are given the same way (intravenous) and in the same FDA class as esmolol or labeled mainly for the same use (high blood pressure), the same class first. High blood pressure lists all 88 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Labetalol | High blood pressure | 15 labelers | $0.185 per mL 100 mg/20 mL vial | No current entry |
| Metoprolol | High blood pressure | 14 labelers | n/a | A presentation being discontinued |
| Nicardipine | High blood pressure | 16 labelers | n/a | No current entry |
| Enalaprilat | High blood pressure | 3 labelers | n/a | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does esmolol compare with medicines for the same use?
4 side-by-side pages set esmolol beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to esmolol
- 4 medicines for the same use
- Other beta blockers
- the pharmacologic class, with prices and generics
- Esmolol side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other