Prescription medicine
Regadenoson Brand names: Lexiscan
Regadenoson (Lexiscan) is a prescription medicine with an FDA approval on record since 2008. FDA's NDC Directory lists it from 13 generic labelers.
- Generic listed
Check it at the source: the regadenoson FDA label on DailyMed (effective December 21, 2018, Astellas Pharma US, Inc.); the NDA 22161 record on Drugs@FDA; every regadenoson label on DailyMed.
Highlights of the record
FDA label of December 21, 2018; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageLEXISCAN ® (regadenoson) injection is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress.
Forms and strengths
- 0.08 mg/ml
Injection (solution); injection.
On the market
- Earliest approval on file
- April 10, 2008 Lexiscan, Astellas; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 13 first April 11, 2022; 11 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 15 of which 13 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- February 2, 2027 Lexiscan 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)
- 1 since 2024 0 Class I among all firms' recalls; latest October 30, 2024
- FAERS reports
- 4,755 through July 30, 2026
What is regadenoson used for?
From the label: indications and usageLEXISCAN ® (regadenoson) injection is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress. LEXISCAN ® is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress ( 1 ).
FDA pharmacologic class: Adenosine Receptor Agonist and Pharmacologic Cardiac Stress Test Agent.
Source: FDA drug label (LEXISCAN), Astellas Pharma US, Inc., effective December 21, 2018 (SPL set 057289f4-2e18-4c1e-bed4-6c1858e2ef16), via openFDA; the full label on DailyMed
Is there a generic for regadenoson (Lexiscan)?
The FDA approved the first generic regadenoson on April 11, 2022. 13 generic applications are approved; 11 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 regadenoson from 13 labelers under a generic (ANDA) application and from 2 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 2 patents for Lexiscan injection: the compound patent runs to February 2, 2027. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2008 earliest approval on file
- 2022 first generic approved
- 2027 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has regadenoson been recalled?
The FDA's Enforcement Report lists 1 recall naming regadenoson since 2024: 0 Class I (the most serious), 1 Class II, 0 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| October 30, 2024 | Class II | Baxter Healthcare Corporation | Labeling: Missing Label |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the regadenoson label say about other medicines?
The regadenoson label names 4 other medicines in its interaction, contraindication or warning sections. The labels of 2 other medicines name regadenoson. 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 |
|---|---|---|
| Aminophylline | drug interactions | Methylxanthines, e.g., caffeine, aminophylline and theophylline, interfere with the activity of LEXISCAN ( 7.1 , 12.2 ). |
| Caffeine | drug interactions | Methylxanthines, e.g., caffeine, aminophylline and theophylline, interfere with the activity of LEXISCAN ( 7.1 , 12.2 ). |
| Dipyridamole | drug interactions | Dipyridamole may increase the activity of LEXISCAN. |
| Theophylline | drug interactions | Methylxanthines, e.g., caffeine, aminophylline and theophylline, interfere with the activity of LEXISCAN ( 7.1 , 12.2 ). |
Source: FDA drug label (LEXISCAN), Astellas Pharma US, Inc., effective December 21, 2018 (SPL set 057289f4-2e18-4c1e-bed4-6c1858e2ef16), via openFDA; the full label on DailyMed
What do FAERS reports show for regadenoson?
The FDA Adverse Event Reporting System holds 4,755 reports that list regadenoson among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 130 are coded as a death and 495 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 adenosine receptor agonists
- the pharmacologic class, with prices and generics
- Regadenoson side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other