Quick answers
- What is Regadenoson used for?
- The FDA-approved label (Lexiscan, Astellas Pharma US, Inc., December 21, 2018) says: “LEXISCAN ® (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.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Regadenoson have a boxed warning?
- No. None of the 9 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Regadenoson?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Regadenoson been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started October 30, 2024 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Regadenoson?
- 11 companies list prescription products of Regadenoson in the FDA NDC Directory, including Apotex Corp., Eugia US LLC and Gland Pharma Limited.
What Regadenoson is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
LEXISCAN ® (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.
— FDA label: Lexiscan, Astellas Pharma US, Inc., effective December 21, 2018. Read the full label on DailyMed →
The FDA has 9 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 9 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution · Injection |
|---|---|
| Route | Intravenous |
| Prescription products | 12 in the FDA NDC Directory |
| Brand names | Lexiscan |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Apotex Corp.2 products
- Eugia US LLC1 product
- Gland Pharma Limited1 product
- Meitheal Pharmaceuticals Inc.1 product
- Indies Pharma Jamaica Limited1 product
- Astellas Pharma US, Inc.1 product
- Kanchan Healthcare Inc1 product
- HF Acquisition Co LLC, DBA HealthFirst1 product
- Marlex Pharmaceuticals, Inc.1 product
- Accord Healthcare Inc.1 product
- Baxter Healthcare Corporation1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA022161 LEXISCAN | Astellas | April 10, 2008 | 11, latest May 31, 2018 2018: Labeling · 2017: Efficacy · 2014: Labeling |
Generic approvals (7)
- ANDA207604Apotex · April 11, 2022
- ANDA212806Meitheal · April 11, 2022
- ANDA213236Accord Hlthcare · April 11, 2022
- ANDA207320Gland · July 12, 2022
- ANDA216437Eugia Pharma · October 26, 2022
- ANDA217455Baxter Hlthcare Corp · May 23, 2023
- ANDA218054Indies Pharma · August 22, 2024
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
October 30, 2024 · Class II · Ongoing · D-0039-2025
Labeling: Missing Label
Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL), 5mL Single-Dose Pre-filled Syringe, Rx only, Manufactured by: Baxter Pharmaceutical Solutions, LLC, Bloomington, IN 47403; Manufactured for: Baxter Healthcare Corporation, — Baxter Healthcare Corporation
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| SPL set ID of the quoted label | 057289f4-2e18-4c1e-bed4-6c1858e2ef16 |
|---|---|
| FDA labels (SPL) | 9 |
| FDA applications | NDA022161, 7 ANDA |
| Active ingredients (FDA) | REGADENOSON |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Lexiscan, Astellas Pharma US, Inc., effective December 21, 2018; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →