Prescription medicine
Adenosine First approved as Adenocard
Adenosine (Adenocard) is a prescription medicine with an FDA approval on record since 1989. FDA's NDC Directory lists it from 13 generic labelers.
- Generic listed
Check it at the source: the adenosine FDA label on DailyMed (effective April 14, 2025, Meitheal Pharmaceuticals Inc.); the NDA 19937 record on Drugs@FDA; every adenosine label on DailyMed.
Highlights of the record
FDA label of April 14, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageAdenosine injection is indicated as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately.
Forms and strengths
- 3 mg/ml
- 60 mg/20ml
- 90 mg/30ml
Injection (solution); injection; solution.
On the market
- Earliest approval on file
- October 30, 1989 Adenocard, Astellas; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 21 first June 16, 2004; 14 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)
- 2 since 2013 1 Class I among all firms' recalls; latest July 29, 2021; 3 more by firms not listed as its makers
- FAERS reports
- 1,600 through July 30, 2026
What is adenosine used for?
From the label: indications and usageAdenosine injection is indicated as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately. Adenosine injection, a pharmacologic stress agent, is indicated as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately
FDA pharmacologic class: Adenosine Receptor Agonist.
Source: FDA drug label (Adenosine), Meitheal Pharmaceuticals Inc., effective April 14, 2025 (SPL set b6851256-6cef-4f23-8129-19bb64380cd5), via openFDA; the full label on DailyMed
Is there a generic for adenosine (Adenocard)?
The FDA approved the first generic adenosine on June 16, 2004. 21 generic applications are approved; 14 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 2 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists adenosine 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.
- 1989 earliest approval on file
- 2004 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has adenosine been recalled?
The FDA's Enforcement Report lists 5 recalls naming adenosine since 2013: 1 Class I (the most serious), 4 Class II, 0 Class III; 0 still ongoing. 3 of them are by firms that FDA's NDC Directory does not list as a maker of adenosine and that hold 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 |
|---|---|---|---|
| July 29, 2021 | Class II | Teva Pharmaceuticals USA | Lack of Assurance of Sterility |
| April 20, 2016 | Class II | Pharmakon Pharmaceuticals, Inc. not a listed maker | Lack of Assurance of Sterility |
| May 28, 2014 | Class I | Central Admixture Pharmacy Services, Inc. not a listed maker | Non Sterility; microbial contamination identified as Aspergillus species |
| May 28, 2013 | Class II | Main Street Family Pharmacy, LLC not a listed maker | The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the adenosine label say about other medicines?
The adenosine label names 4 other medicines in its interaction, contraindication or warning sections. The labels of 6 other medicines name adenosine. 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 | Drugs on Adenosine The vasoactive effects of adenosine are inhibited by adenosine receptor antagonists, (such as methylxanthines (e.g., caffeine, aminophylline, and theophylline). |
| Caffeine | drug interactions | Drugs on Adenosine The vasoactive effects of adenosine are inhibited by adenosine receptor antagonists, (such as methylxanthines (e.g., caffeine, aminophylline, and theophylline). |
| Dipyridamole | drug interactions | DRUG INTERACTIONS Methylxanthines interfere with the activity of adenosine ( 7.1 , 10) Nucleoside transport inhibitors such as dipyridamole can increase the activity of adenosine |
| Theophylline | drug interactions | Drugs on Adenosine The vasoactive effects of adenosine are inhibited by adenosine receptor antagonists, (such as methylxanthines (e.g., caffeine, aminophylline, and theophylline). |
Other labels that name adenosine
Source: FDA drug label (Adenosine), Meitheal Pharmaceuticals Inc., effective April 14, 2025 (SPL set b6851256-6cef-4f23-8129-19bb64380cd5), via openFDA; the full label on DailyMed
What do FAERS reports show for adenosine?
The FDA Adverse Event Reporting System holds 1,600 reports that list adenosine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 142 are coded as a death and 758 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
- Adenosine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other