Prescription medicine
Isoproterenol First approved as Isuprel
Isoproterenol (Isuprel) is a prescription medicine with an FDA approval on record since 1948. FDA's NDC Directory lists it from 13 generic labelers.
- Generic listed
Check it at the source: the isoproterenol FDA label on DailyMed (effective December 16, 2025, Eugia US LLC); the NDA 6328 record on Drugs@FDA; every isoproterenol label on DailyMed.
Highlights of the record
FDA label of December 16, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageIsoproterenol hydrochloride injection is indicated: To improve hemodynamic status in patients in distributive shock and shock due to reduced cardiac output For bronchospasm occurring during anesthesia Isoproterenol hydrochloride injection is a beta-adrenergic agonist indicated: To improve hemodynamic status in patients in distributive shock and shock due to reduced cardiac output ( 1 ) For treatment of bronchospasm o
Forms and strengths
- 0.2 mg/ml
- 1 mg/5ml
Injection (solution); injection.
On the market
- Earliest approval on file
- February 19, 1948 Isuprel, Sanofi Aventis Us; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 22 first November 15, 1974; 12 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 13 of which 13 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 0 since 2019 0 Class I among all firms' recalls; 1 more by firms not listed as its makers
- FAERS reports
- 422 through July 30, 2026
What is isoproterenol used for?
From the label: indications and usageIsoproterenol hydrochloride injection is indicated: To improve hemodynamic status in patients in distributive shock and shock due to reduced cardiac output For bronchospasm occurring during anesthesia Isoproterenol hydrochloride injection is a beta-adrenergic agonist indicated: To improve hemodynamic status in patients in distributive shock and shock due to reduced cardiac output ( 1 ) For treatment of bronchospasm occurring during anesthesia
FDA pharmacologic class: beta-Adrenergic Agonist.
Source: FDA drug label (Isoproterenol Hydrochloride), Eugia US LLC, effective December 16, 2025 (SPL set 3e4050e8-7d94-4ed7-951d-1ff818ddadf1), via openFDA; the full label on DailyMed
Is there a generic for isoproterenol (Isuprel)?
The FDA approved the first generic isoproterenol on November 15, 1974. 22 generic applications are approved; 12 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 isoproterenol from 13 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1948 earliest approval on file
- 1974 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has isoproterenol been recalled?
The FDA's Enforcement Report lists 1 recall naming isoproterenol since 2019: 0 Class I (the most serious), 1 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 isoproterenol 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 |
|---|---|---|---|
| September 12, 2019 | Class II | KRS Global Biotechnology, Inc not a listed maker | Lack of Assurance of Sterility |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the isoproterenol label say about other medicines?
The isoproterenol label names 3 other medicines in its interaction, contraindication or warning sections. The labels of 17 other medicines name isoproterenol. 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 |
|---|---|---|
| Epinephrine | drug interactions | Intervention; Isoproterenol hydrochloride injection and epinephrine should not be administered simultaneously. |
| Levothyroxine | drug interactions | Clinical Impact; The effects of isoproterenol may be potentiated by tricyclic antidepressants, monoamine oxidase inhibitors, levothyroxine sodium, and certain antihistamines, notablychlorpheniramine, tripelennamine, and diphenhydramine. |
| Propranolol | drug interactions | Clinical Impact; The cardiostimulating and bronchodilating effects of isoproterenol are antagonized by beta-adrenergic blocking drugs, such as propranolol. |
Other labels that name isoproterenol
Source: FDA drug label (Isoproterenol Hydrochloride), Eugia US LLC, effective December 16, 2025 (SPL set 3e4050e8-7d94-4ed7-951d-1ff818ddadf1), via openFDA; the full label on DailyMed
What do FAERS reports show for isoproterenol?
The FDA Adverse Event Reporting System holds 422 reports that list isoproterenol among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 56 are coded as a death and 234 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 next?
- Other beta-adrenergic agonists
- the pharmacologic class, with prices and generics
- Isoproterenol side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other