What the label lists and what reports show
Regadenoson side effects
Regadenoson's FDA label: “The most common (incidence ≥ 5%) adverse reactions to LEXISCAN are dyspnea, headache, flushing, chest discomfort, dizziness, angina pectoris, chest pain, and nausea ( 6 ).” FAERS holds 4,755 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is nausea (510 reports).
- Generic listed
Check it at the source: the regadenoson FDA label on DailyMed (effective December 21, 2018, Astellas Pharma US, Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common (incidence ≥ 5%) adverse reactions to LEXISCAN are dyspnea, headache, flushing, chest discomfort, dizziness, angina pectoris, chest pain, and nausea ( 6 ).
Table 1 Adverse Reactions in Studies 1 and 2 Pooled (Frequency ≥ 5%)
| Reaction | LEXISCAN N = 1,337 | ADENOSCAN N = 678 |
|---|---|---|
| Dyspnea | 28% | 26% |
| Headache | 26% | 17% |
| Flushing | 16% | 25% |
| Chest Discomfort | 13% | 18% |
| Angina Pectoris or ST Segment Depression | 12% | 18% |
| Dizziness | 8% | 7% |
| Chest Pain | 7% | 10% |
| Nausea | 6% | 6% |
| Abdominal Discomfort | 5% | 2% |
| Dysgeusia | 5% | 7% |
| Feeling Hot | 5% | 8% |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following adverse reactions are discussed in more detail in other sections of the labeling. • Myocardial Ischemia [ see Warnings and Precautions ( 5.1 ) ] • Sinoatrial and Atrioventricular Nodal Block [ see Warnings and Precautions ( 5.2 ) ] • Atrial Fibrillation/Atrial Flutter [ see Warnings and Precautions ( 5.3 ) ] • Hypersensitivity, Including Anaphylaxis [ see Warnings and Precautions ( 5.4 ) ] • Hypotension [ see Warnings and Precautions ( 5.5 ) ] • Hypertension [ see Warnings and Precautions ( 5.6 ) ] • Bronchoconstriction [ see Warnings and Precautions ( 5.7 ) ] • Seizure [ see Warnings and Precautions ( 5.8 ) ] • Cerebrovascular Accident (Stroke) [ see Warnings and Precautions ( 5.9 ) ] The most common (incidence ≥ 5%) adverse reactions to LEXISCAN are dyspnea, headache, flushing, chest discomfort, dizziness, angina pectoris, chest pain, and nausea ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Astellas Pharma US, Inc. at 1-800-727-7003 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. …
Source: FDA drug label, 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?
4,755 reports list regadenoson among the medicines taken, 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. Of the 25 reactions below, 14 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Regadenoson: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions