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Regadenoson

Regadenoson is a pharmacologic stress agent given by intravenous injection to help image blood flow in the heart during a nuclear stress test in patients who cannot exercise adequately.

Brand name Lexiscan
Drug class Adenosine Receptor Agonist
Rx Form 1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 11, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 15 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

How we combine label and product data →
✓No current FDA shortage listed · checked Oct 3, 2026 🚨Recall on record
Regadenoson at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Regadenoson (Lexiscan, also available as a generic) is a short-acting medicine injected into a vein that activates adenosine receptors to briefly widen the heart’s arteries, standing in for exercise during a nuclear stress test so the scan can show where narrowed arteries are not keeping up. It is usually the first choice for people who cannot exercise enough on a treadmill. Flushing, headache, shortness of breath and chest discomfort are common, but they usually fade quickly. Serious reactions, including heart attack, dangerous heart rhythms, airway tightening and seizures, are possible, which is why it is only given in a monitored setting with emergency equipment and trained staff ready.

Clinical pearls

  • Avoid coffee, tea, energy drinks and chocolate for at least 12 hours first, since caffeine blocks regadenoson’s effect.
  • Theophylline or aminophylline for lung disease also blocks the drug, so these are usually held for at least 12 hours beforehand.
  • Dipyridamole, a blood-thinning medicine, strengthens regadenoson’s effects, so it is ideally stopped at least 2 days before the test.
  • Tell the stress lab beforehand about asthma, COPD or seizures, since regadenoson can tighten airways and lower the seizure threshold.
How you get itPrescription only
Comes asInjection
Earliest FDA record2008
Companies listing it with the FDA25
FDA label last updatedDec 21, 2018
FDA’s strongest warning (boxed)None on the label

Patient information guide — a plain-language walkthrough of Regadenoson, written from its FDA label.

What Regadenoson is used for

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Regadenoson is used in a single clinical setting as a pharmacologic stress agent — a medication that temporarily mimics the effects of exercise on the heart for imaging purposes.

  • Lexiscan (regadenoson) injection: Indicated for radionuclide myocardial perfusion imaging (MPI) — a nuclear heart scan — in patients who are unable to undergo adequate exercise stress testing.
  • Regadenoson injection (generic): Indicated for the same purpose: radionuclide myocardial perfusion imaging in patients unable to exercise adequately.

How Regadenoson works

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Regadenoson selectively activates the A2A adenosine receptor — a protein found on blood vessel walls in the heart. Activating this receptor causes the coronary arteries to widen (vasodilate), rapidly increasing blood flow through the heart muscle. Because blocked or narrowed coronary arteries cannot dilate as fully as healthy ones, the radioactive imaging agent injected right after regadenoson accumulates more in well-perfused areas, allowing doctors to see where blood flow may be reduced or absent.

Regadenoson has much lower activity at other adenosine receptors (A1, A2B, A3), which helps limit some of the side effects seen with less selective agents.

Regadenoson dosage

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Regadenoson is given only by a healthcare professional as a single rapid intravenous (IV) injection — it is not a medication you take at home or on a schedule. It is administered once per imaging session, followed immediately by a saline flush and then the radioactive imaging agent.

  • Given as a rapid IV injection into a peripheral vein — the whole process takes seconds.
  • Avoid all caffeine, caffeinated beverages, theophylline, and aminophylline for at least 12 hours before your scheduled test.
  • Follow all preparation instructions from your care team exactly — skipping the caffeine restriction can significantly reduce the accuracy of your imaging results.

Dosing details from the FDA-approved label

From the Regadenoson prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Radionuclide myocardial perfusion imaging (MPI) stress agent
    • 5 mL (0.4 mg regadenoson) administered as an intravenous injection within 10 seconds into a peripheral vein using a 22 gauge or larger catheter or needle
    • Followed immediately by a 5 mL saline flush, then the radionuclide myocardial perfusion imaging agent 10–20 seconds after the saline flush
    • Avoid methylxanthine-containing products for at least 12 hours before the scheduled radionuclide MPI
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION The recommended dose of regadenoson injection is 5 mL (0.4 mg regadenoson) administered as an intravenous injection within 10 seconds. • Patients should be instructed to avoid consumption of any products containing methylxanthines, including caffeinated coffee, tea or other caffeinated beverages, caffeine-containing drug products, aminophylline and theophylline for at least 12 hours before a scheduled radionuclide MPI [see Drug Interactions (7.1) and Clinical Pharmacology (12.2) ] . • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer regadenoson injection if it contains particulate matter or is discolored. • Administer regadenoson injection as an intravenous injection within 10 seconds into a peripheral vein using a 22 gauge or larger catheter or needle. • Administer a 5 mL saline flush immediately after the injection of regadenoson injection. • Administer the radionuclide myocardial perfusion imaging agent 10–20 seconds after the saline flush. The radionuclide may be injected directly into the same catheter as regadenoson injection. The recommended dose of regadenoson injection is 5 mL (0.4 mg regadenoson) administered as an intravenous injection within 10 seconds; followed immediately by saline flush and radiopharmaceutical ( 2 ).

Read the full Dosage and Administration section on DailyMed →

Regadenoson side effects

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Common side effects

  • Shortness of breath or difficulty breathing
  • Headache
  • Flushing (feeling of warmth or redness)
  • Chest discomfort or chest pain
  • Dizziness
  • Nausea
  • Abdominal discomfort
  • Altered or unusual taste (dysgeusia)

When to get medical help

  • Call for help immediately if you have severe chest pain, signs of a heart attack, or feel your heart beating very fast or irregularly
  • Seek emergency care if you experience difficulty breathing, wheezing, or throat tightness — these may be signs of a serious allergic reaction (anaphylaxis) or bronchospasm
  • Tell staff right away if you feel faint, lose consciousness, or your blood pressure drops sharply
  • Alert the team immediately if you have a seizure or convulsion during or after the procedure
  • Notify staff at once if you develop symptoms of a stroke, such as sudden weakness, numbness, or trouble speaking
  • Report any severe drop or spike in blood pressure during the procedure

Most side effects start shortly after the injection and resolve within about 15 minutes (headache may last up to 30 minutes). Common reactions include:

  • Shortness of breath or difficulty breathing
  • Headache
  • Flushing or feeling hot
  • Chest discomfort or chest pain
  • Angina (chest pain related to the heart)
  • Dizziness
  • Nausea
  • Abdominal discomfort
  • Altered taste (dysgeusia)

Serious reactions — including heart attack, dangerous heart rhythms, severe allergic reactions (anaphylaxis), bronchospasm, seizures, stroke, and significant blood pressure changes — have occurred and require immediate medical attention. Emergency support is always on hand during administration.

Regadenoson warnings and precautions

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  • Heart attack and cardiac arrest: Fatal and non-fatal heart attacks, ventricular arrhythmias (dangerous irregular heartbeats), and cardiac arrest have occurred. Regadenoson should not be given to patients with active signs of heart ischemia such as unstable angina. Resuscitation equipment and trained staff must be present.
  • Heart block and slow heart rate: Regadenoson can slow electrical conduction through the heart, causing first-, second-, or third-degree heart block, or sinus bradycardia. Third-degree block and asystole (no heartbeat) have been reported after the dose.
  • Atrial fibrillation/flutter: New or recurring rapid, irregular heartbeats have been reported.
  • Severe allergic reactions: Anaphylaxis, angioedema (swelling), respiratory or cardiac arrest, and throat tightness have occurred — emergency treatment may be needed.
  • Low blood pressure (hypotension): Can occur quickly; risk is higher in patients with autonomic dysfunction, low blood volume, valvular heart disease, or carotid artery disease.
  • High blood pressure (hypertension): Significant blood pressure increases have also been reported, particularly in patients with a history of high blood pressure.
  • Bronchospasm (airway tightening): Patients with asthma or COPD are at increased risk of breathing difficulty; bronchodilator therapy should be available.
  • Seizures: Regadenoson may lower the seizure threshold; new or recurrent seizures have occurred, some requiring emergency treatment.
  • Stroke: Both hemorrhagic (bleeding) and ischemic (blockage) strokes have been reported, possibly related to blood pressure changes.

Regadenoson interactions

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Several medications and substances can affect how well regadenoson works or increase the risk of side effects:

  • Caffeine, coffee, tea, energy drinks, chocolate: Caffeine blocks regadenoson's action at the adenosine receptor, reducing imaging accuracy — avoid all sources for at least 12 hours before the test.
  • Theophylline and aminophylline: These drugs also block adenosine receptors and interfere with regadenoson's effect — hold for at least 12 hours before the test. (Aminophylline can be used by medical staff to reverse severe regadenoson side effects if needed.)
  • Dipyridamole: This medication may amplify regadenoson's effects; stop it at least 2 days before the test when possible.
  • Heart medications (beta-blockers, calcium channel blockers, ACE inhibitors, nitrates, digoxin, angiotensin receptor blockers): These were used by patients in clinical studies without reported problems, but always tell your care team about everything you take.

Interactions listed in the FDA-approved label

From the Regadenoson prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Methylxanthines (e.g., caffeine, aminophylline and theophylline): Non-specific adenosine receptor antagonists that interfere with the vasodilation activity of regadenoson. Avoid any products containing methylxanthines as well as any drugs containing theophylline or aminophylline for at least 12 hours before regadenoson administration.
  • Aminophylline: May be used to attenuate severe or persistent adverse reactions to regadenoson. See Overdosage (10) of the label.
  • Dipyridamole: May change the effects of regadenoson (may increase its activity). When possible, withhold dipyridamole for at least two days prior to regadenoson administration.
  • Other cardioactive drugs (β-blockers, calcium channel blockers, ACE inhibitors, nitrates, cardiac glycosides, angiotensin receptor blockers): In clinical studies, regadenoson was given to patients taking these drugs without reported adverse reactions or apparent effects on efficacy.
  • CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP3A4 substrates: Regadenoson does not inhibit their metabolism in human liver microsomes, so it is unlikely to alter the pharmacokinetics of drugs metabolized by these enzymes.
Read the label’s full interactions text

7 DRUG INTERACTIONS No formal pharmacokinetic drug interacion studies have been conducted with regadenoson. Methylxanthines, e.g., caffeine, aminophylline and theophylline, interfere with the activity of regadenoson injection (7.1, 12.2 ). Aminophylline may be used to attenuate severe and/or persistent adverse reactions to regadenoson injection (7.1, 10) . Dipyridamole may increase the activity of regadenoson injection. When possible, withhold dipyridamole for at least two days prior to regadenoson injection administration (7.1) . 7.1 Effects of Other Drugs on Regadenoson • Methylxanthines (e.g., caffeine, aminophylline and theophylline) are non-specific adenosine receptor antagonists that interfere with the vasodilation activity of regadenoson [see Clinical Pharmacology ( 12.2) and Patient Counseling Information ( 17) ]. Patients should avoid consumption of any products containing methylxanthines as well as any drugs containing theophylline or aminophylline for at least 12 hours before regadenoson administration. Aminophylline may be used to attenuate severe or persistent adverse reactions to regadenoson [see Overdosage ( 10 ) ]. • In clinical studies, regadenoson was administered to patients taking other cardioactive drugs (i.e., β- blockers, calcium channel blockers, ACE inhibitors, nitrates, cardiac glycosides, and angiotensin receptor blockers) without reported adverse reactions or apparent effects on efficacy. • Dipyridamole may change the effects of regadenoson. When possible, withhold dipyridamole for at least two days prior to regadenoson administration. 7.2 Effect of Regadenoson on Other Drugs Regadenoson does not inhibit the metabolism of substrates for CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP2D6, or CYP3A4 in human liver microsomes, indicating that it is unlikely to alter the pharmacokinetics of drugs metabolized by these cytochrome P450 enzymes.

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

Before taking Regadenoson

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  • Do not receive regadenoson if you have second- or third-degree AV block (a significant heart conduction problem) without a working artificial pacemaker.
  • Do not receive regadenoson if you have sinus node dysfunction (the heart's natural pacemaker isn't working properly) without a functioning artificial pacemaker.
  • Tell your care team if you have asthma or COPD — breathing problems are more likely and bronchodilator treatment should be available.
  • Tell your team if you have signs or symptoms of an active heart attack or unstable angina — regadenoson should be avoided in this situation.
  • Tell your team about any history of seizures, as regadenoson may lower the threshold for convulsions.
  • Tell your doctor if you are pregnant — there are no human safety data, and animal studies showed potential harm at high doses. Weigh risks carefully.
  • If you are breastfeeding, pump and discard your breast milk for 10 hours after receiving regadenoson.
  • Regadenoson has not been studied in children — safety and effectiveness in pediatric patients are not established.
  • Older adults (especially age 75 and over) may have a slightly higher risk of low blood pressure (hypotension).
  • No dose adjustment is needed for kidney impairment, including patients on dialysis.

Regadenoson overdose

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Too much regadenoson can cause flushing, dizziness, and a rapid increase in heart rate, as well as the serious reactions described in the warnings. If severe or persistent reactions occur, the medical team can give aminophylline — a drug that blocks adenosine receptors and can reverse regadenoson's effects — by slow IV injection. Aminophylline should not be used to reverse effects in patients who experience a seizure related to regadenoson.

What Regadenoson does in the body

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After injection, regadenoson causes a rapid increase in coronary blood flow — reaching more than twice the baseline level within 30 seconds. This increased flow then falls back to less than twice baseline within about 10 minutes. The increase in blood flow is much greater in healthy, open arteries than in narrowed (stenotic) ones, which is what makes the imaging test informative. Most patients also experience a rise in heart rate and a fall in blood pressure within 45 minutes of receiving the drug.

How your body processes Regadenoson

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After IV injection, regadenoson reaches its peak blood concentration within 1 to 4 minutes, which lines up closely with its peak effect on the heart. It moves through the body in three phases: an initial rapid phase (half-life about 2–4 minutes), an intermediate phase (half-life about 30 minutes, when the coronary blood flow effect fades), and a slower terminal phase (half-life about 2 hours). About 57% of the drug is excreted unchanged in the urine, with renal tubular secretion playing an important role in elimination — meaning the kidneys actively pump it out. No dose adjustment is needed in older adults, people with kidney impairment, or (based on the drug's primary renal excretion) in those with liver impairment.

How to store Regadenoson

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Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F).

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

Regadenoson: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Regadenoson — the kind of thing our pharmacy team would talk through with you at the counter.

Why do I need regadenoson if I can't exercise on a treadmill?

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The nuclear heart imaging test — called a myocardial perfusion imaging (MPI) scan — needs your heart to be working hard so the doctor can see how blood flows through it. If you can't exercise enough to get there on your own, regadenoson does that job for you. It briefly widens the coronary arteries (the vessels feeding your heart), increasing blood flow in the same way vigorous exercise would, so the imaging picks up any areas that aren't getting enough blood.

What should I expect to feel during and after the injection?

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Most people feel something within a minute of the injection. Shortness of breath, headache, flushing (warmth or redness), chest discomfort, and dizziness are the most common reactions. They can feel a bit alarming, but they usually pass on their own within about 15 minutes — headache may linger up to 30 minutes. You'll be closely monitored the whole time, and the team has medications ready if anything needs to be treated. Let the staff know right away if anything feels severe or unusual.

Why can't I drink coffee or caffeinated tea before my test?

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Caffeine blocks the same receptor that regadenoson needs to activate to increase blood flow. If you have caffeine in your system, regadenoson won't work as well, and the scan could miss areas of reduced blood flow — giving your doctor an inaccurate picture. You need to avoid all caffeine (coffee, tea, energy drinks, caffeinated sodas) as well as drugs like theophylline or aminophylline for at least 12 full hours before the test. Even decaf can contain small amounts, so it's safest to ask your care team what's allowed.

Is it safe to have this test if I have asthma or COPD?

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Your care team needs to know about your asthma or COPD before the test. Regadenoson can sometimes trigger wheezing or breathing difficulty in people with these conditions. That said, in clinical studies, most breathing reactions resolved on their own or with minimal treatment. The team will have bronchodilator (rescue inhaler-type) treatments and emergency support ready the whole time. Continue taking your regular respiratory medications as prescribed before the test.

Can I have this test if I'm pregnant or breastfeeding?

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If you are pregnant, make sure your doctor knows before scheduling this test. There are no human studies confirming it's safe during pregnancy, and animal studies at high doses showed some harm to developing fetuses. If you are breastfeeding, you can still have the test, but you'll need to pump and discard your breast milk for 10 hours afterward before breastfeeding again, to avoid any potential exposure to your baby.

Are there any heart conditions that mean I shouldn't have this test with regadenoson?

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Yes — if you have a significant heart rhythm problem called second- or third-degree AV block, or a condition called sinus node dysfunction, you should not receive regadenoson unless you already have a working artificial pacemaker. Also, if you're having active chest pain from unstable angina or other signs of a heart attack, this is not the right time for this test. Always give your full medical history to the care team before the procedure so they can confirm it's safe for you.

Is Regadenoson available over the counter?

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No. Regadenoson is a prescription medicine: every Regadenoson product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Regadenoson first available?

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The earliest FDA record we hold for Regadenoson is from 2008: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Regadenoson was first used.

Who makes Regadenoson?

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25 companies list Regadenoson products in the FDA's NDC Directory, including Apotex Corp., Accord Healthcare Inc., Baxter Healthcare Corporation. That count includes repackagers and distributors as well as manufacturers, so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Regadenoson on HelloPharmacist

Detailed data & references for Regadenoson Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Regadenoson forms and strengths (how it comes)

Regadenoson is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Injection

Into a vein
Brands Lexiscan
How this form is used
What it may be used for
  • Lexiscan (regadenoson) injection is indicated as a pharmacologic stress agent for radionuclide myocardial perfusion imaging (MPI) in patients who cannot undergo adequate exercise stress
  • Regadenoson injection is indicated as a pharmacologic stress agent for radionuclide myocardial perfusion imaging (MPI) in patients who cannot undergo adequate exercise stress
Important instructions
  • Lexiscan and regadenoson injection are each given as a single rapid intravenous injection into a peripheral vein, administered within 10 seconds
  • A 5 mL saline flush is given immediately after the injection of Lexiscan or regadenoson injection
  • The radionuclide (imaging agent) is administered 10–20 seconds after the saline flush and may be injected directly into the same catheter
  • Patients must avoid all caffeine, theophylline, and aminophylline-containing products for at least 12 hours before receiving Lexiscan or regadenoson injection
Available strengths 2 strengths
26 FDA-listed product records ⓘ

Regadenoson on the U.S. market: products, makers and brands

How Regadenoson appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

25 companies list 35 Regadenoson product records with the FDA, mostly as injection; the earliest marketing or approval year on record is 2008. Brand names on the directory include Lexiscan; the rest are generics.

1
Dose forms ⓘ
25
Labelers (makers, repackagers, distributors)
2
Brand names
35
FDA-listed product records ⓘ
2008
Earliest FDA record ⓘ

Also listed with the FDA, not a patient dose form: Powder (9) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Apotex Corp.14%
Accord Healthcare Inc.6%
Baxter Healthcare Corporation6%
Mylan Institutional LLC6%
Eugia US LLC6%
Hikma Pharmaceuticals USA Inc.6%
Other makers57%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Regadenoson is used (Medicaid data)

A general measure of how commonly Regadenoson is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Regadenoson is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

141,955
Medicaid prescriptions filled (Q1–Q4 2025)
$12.9M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Regadenoson prescribed? Of the 1,599 medications we measure, Regadenoson ranks #446 by Medicaid prescriptions — more than 72% of them.

Where Regadenoson ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Regadenoson product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

Other Regadenoson products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)

141,955 Medicaid prescriptions (Q1–Q4 2025) 100% of Regadenoson prescriptions shown $12.9M gross reimbursement (before rebates) ≈ $91 per prescription (gross)

Summed across the 12 of 25 listed NDC products with Medicaid activity.

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Regadenoson, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 12 of 25 listed Regadenoson NDCs with Medicaid activity.

Compare Regadenoson products

A representative set of FDA-listed product records for Regadenoson — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 35 of 35 products — FDA National Drug Code Directory. See every product, package size and price: browse all 35 Regadenoson NDCs →

Regadenoson recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list one Regadenoson recall since July 2021. It is still ongoing. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.

Ongoing Class II Oct 30, 2024 · Baxter Healthcare Corporation
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 He… Lots: Lot #: 945169, Exp. Date 9/25/2025; 945170, Exp. Date 10/24/2025 FDA record D-0039-2025 →

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

Regadenoson brand names

Regadenoson is sold under one brand name in the FDA directory — Lexiscan. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Lexiscan

Who makes Regadenoson: manufacturers and labelers

25 companies list Regadenoson products with the FDA. By number of product records, the largest are Apotex Corp., Accord Healthcare Inc., Baxter Healthcare Corporation. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Apotex Corp. 5 Accord Healthcare Inc. 2 Baxter Healthcare Corporation 2 Mylan Institutional LLC 2 Eugia US LLC 2 Hikma Pharmaceuticals USA Inc. 2 Hospira, Inc. 2 USV Private Limited 1 Sun Pharmaceutical Industries, Inc. 1 Sionc Pharmaceutical Private Limited 1 ScinoPharm Taiwan Ltd. 1 MSN Life Sciences Private Limited 1 Meitheal Pharmaceuticals Inc. 1 Marlex Pharmaceuticals, Inc. 1 Kanchan Healthcare Inc 1 International Medication Systems, Limited 1 Indies Pharma Jamaica Limited 1 Gland Pharma Limited 1 Farmak, a,s 1 Dr. Reddy's Laboratories Inc. 1 CZECH-GEN, a.s. 1 Curia Missouri, Inc. 1 Astellas Pharma US, Inc. 1 Apicore Pharmaceuticals Private Limited 1

…and 1 more on the FDA NDC directory.

Regadenoson drug class (RxNorm)

Regadenoson belongs to the Pharmacologic Cardiac Stress Test Agent class.

Pharmacologic class Pharmacologic Cardiac Stress Test Agent
Drug family (ATC) Other cardiac preparations
How it works Adenosine Receptor Agonists

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Regadenoson page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Dec 21, 2018
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Regadenoson.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Regadenoson after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
15
NDC products indexed
35
Distinct labelers/manufacturers represented
25
Linked representative label ⓘ
Astellas Pharma US, Inc.
Linked label effective
Dec 21, 2018
Composite sections available
23
Linked SPL Set ID
057289f4-2e18-4c1e-bed4-6c1858e2ef16
Linked SPL Document ID
8fb5b92b-3654-43ff-98d3-3ac23c9a0b10
Open the linked representative label on DailyMed ↗
NDC package records associated with this linked SPL 1

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Astellas Pharma US, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →