Drug · FAERS side-effect profile with label screen
Regadenoson side effects: what 4,754 FDA adverse event reports show
Drug class
Pharmacologic Cardiac Stress Test Agent
FDA label (Established Pharmacologic Class)
Who reports
4,754 reports · 56% serious · 130 with death outcome · 60% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Regadenoson injection is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress. Regadenoson injection is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress ( 1 ).
FDA label, Indications and Usage
What it is
Regadenoson is an A 2A adenosine receptor agonist that is a coronary vasodilator [see Clinical Pharmacology (12.1) ] . Regadenoson is chemically described as adenosine, 2- [ 4- [ (methylamino)carbonyl ] -1 H -pyrazol-1-yl ] . Its structural formula is:
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled adverse reaction 14Labeled (related wording) 8Reporting / coding artifact 3Not in label — unassessed 15
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 67 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Injection site extravasation | 361 | 131.4 118.8–145.3ROR 142.1 · χ² 45,232 / p <1e-300 | 126.7 EB05 116.1 · IC025 +6.6 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Unresponsive to stimuli | 164 | 28.3 24.3–32.9ROR 29.3 · χ² 4,267 / p <1e-300 | 28.0 EB05 24.6 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 28.7 | no trial data cached |
| Incorrect product administration duration | 80 | 17.4 14.0–21.7ROR 17.7 · χ² 1,220 / p 1e-267 | 17.3 EB05 14.3 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious n=48 | no trial data cached |
| Bradycardia (slow heart rate) | 196 | 16.3 14.2–18.7ROR 17.0 · χ² 2,801 / p <1e-300 | 16.2 EB05 14.4 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 16.7 | no trial data cached |
| Cardiac arrest (heart stopping) | 284 | 15.2 13.5–17.0ROR 16.1 · χ² 3,745 / p <1e-300 | 15.1 EB05 13.7 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 15.6 | no trial data cached |
| Blood pressure decreased | 208 | 13.9 12.1–15.8ROR 14.5 · χ² 2,471 / p <1e-300 | 13.8 EB05 12.3 · IC025 +3.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 15.6 | no trial data cached |
| Presyncope (near-fainting) | 70 | 12.8 10.1–16.1ROR 13.0 · χ² 748 / p 6e-165 | 12.6 EB05 10.2 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 13.6 | no trial data cached |
| Heart rate decreased | 100 | 12.5 10.3–15.2ROR 12.8 · χ² 1,048 / p 3e-230 | 12.4 EB05 10.4 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 14.2 · ♀ 36% (drug 60%) | no trial data cached |
| Ventricular extrasystoles | 29 | 12.3 8.6–17.7ROR 12.4 · χ² 290 / p 3e-65 | 11.8 EB05 8.3 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 13.7 | no trial data cached |
| Supraventricular tachycardia | 25 | 11.6 7.8–17.1ROR 11.6 · χ² 230 / p 3e-52 | 10.8 EB05 7.4 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 11.5 | no trial data cached |
| Bronchospasm (airway tightening) | 32 | 9.9 7.0–14.0ROR 9.9 · χ² 246 / p 9e-56 | 9.2 EB05 6.7 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 10.6 | no trial data cached |
| Seizure | 256 | 9.9 8.7–11.1ROR 10.4 · χ² 2,035 / p <1e-300 | 9.8 EB05 8.8 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.6 | no trial data cached |
| Ventricular fibrillation | 23 | 9.1 6.1–13.7ROR 9.2 · χ² 158 / p 1e-36 | 8.2 EB05 5.6 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.5 · ♀ 35% (drug 60%) | no trial data cached |
| Sinus bradycardia | 19 | 8.7 5.5–13.6ROR 8.7 · χ² 121 / p 2e-28 | 7.6 EB05 5.0 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.3 | no trial data cached |
| Infusion site pain | 24 | 8.3 5.6–12.4ROR 8.3 · χ² 147 / p 5e-34 | 7.4 EB05 5.2 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious n=2 | no trial data cached |
| Incorrect drug administration duration | 52 | 8.1 6.1–10.6ROR 8.1 · χ² 314 / p 2e-70 | 7.6 EB05 6.0 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 14.9 | no trial data cached |
| Retching | 35 | 7.3 5.2–10.1ROR 7.3 · χ² 183 / p 6e-42 | 6.7 EB05 5.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 | no trial data cached |
| Hypotension (low blood pressure) | 315 | 6.9 6.2–7.7ROR 7.4 · χ² 1,610 / p <1e-300 | 6.9 EB05 6.3 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.3 | no trial data cached |
| Ventricular tachycardia | 25 | 6.7 4.5–9.9ROR 6.7 · χ² 115 / p 5e-27 | 6.0 EB05 4.3 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.7 | no trial data cached |
| Loss of consciousness | 183 | 6.3 5.5–7.3ROR 6.5 · χ² 815 / p 2e-179 | 6.2 EB05 5.5 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.6 | no trial data cached |
| Myocardial ischaemia | 16 | 6.2 3.8–10.0ROR 6.2 · χ² 64 / p 6e-16 | 5.3 EB05 3.5 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.4 | no trial data cached |
| Acute myocardial infarction | 41 | 6.1 4.5–8.3ROR 6.2 · χ² 170 / p 3e-39 | 5.7 EB05 4.4 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.3 · ♀ 34% (drug 60%) | no trial data cached |
| Syringe issue | 23 | 5.8 3.9–8.7ROR 5.8 · χ² 86 / p 7e-21 | 5.2 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Heart rate increased | 129 | 5.8 4.9–6.8ROR 5.9 · χ² 503 / p 9e-112 | 5.6 EB05 4.9 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.9 | no trial data cached |
| Respiratory arrest | 36 | 5.7 4.1–7.9ROR 5.8 · χ² 135 / p 1e-31 | 5.3 EB05 4.0 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.8 | no trial data cached |
| Product packaging quantity issue | 14 | 5.7 3.4–9.6ROR 5.7 · χ² 49 / p 1e-12 | 4.8 EB05 3.1 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Chest pain | 232 | 5.5 4.9–6.3ROR 5.8 · χ² 860 / p 2e-189 | 5.5 EB05 4.9 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.1 | no trial data cached |
| Tremor (shaking) | 188 | 5.0 4.3–5.7ROR 5.2 · χ² 600 / p 8e-133 | 4.9 EB05 4.4 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.2 | no trial data cached |
| Aphasia (loss of speech) | 34 | 5.0 3.5–6.9ROR 5.0 · χ² 103 / p 1e-24 | 4.7 EB05 3.5 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 | no trial data cached |
| Pallor | 30 | 4.9 3.4–6.9ROR 4.9 · χ² 88 / p 3e-21 | 4.5 EB05 3.3 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Syncope (fainting) | 108 | 4.8 4.0–5.7ROR 4.8 · χ² 318 / p 2e-71 | 4.7 EB05 4.0 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.7 | no trial data cached |
| Cold sweat | 19 | 4.8 3.0–7.4ROR 4.8 · χ² 53 / p 2e-13 | 4.3 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 | no trial data cached |
| Chest discomfort | 108 | 4.7 3.9–5.6ROR 4.8 · χ² 309 / p 1e-69 | 4.6 EB05 3.9 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.6 | no trial data cached |
| Generalised tonic-clonic seizure | 16 | 4.3 2.6–7.0ROR 4.3 · χ² 37 / p 5e-10 | 3.9 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 | no trial data cached |
| Mental status changes | 27 | 4.3 2.9–6.2ROR 4.3 · χ² 65 / p 4e-16 | 4.0 EB05 2.9 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Convulsion (seizure) | 56 | 4.3 3.3–5.5ROR 4.3 · χ² 137 / p 7e-32 | 4.1 EB05 3.3 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.3 | no trial data cached |
| Throat tightness | 25 | 4.1 2.8–6.0ROR 4.1 · χ² 55 / p 5e-14 | 3.8 EB05 2.7 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.9 | no trial data cached |
| Micturition urgency | 10 | 3.9 2.1–7.2ROR 3.9 · χ² 19 / p 8e-6 | 3.4 EB05 2.0 · IC025 +0.7 | Not in label — unassessed | serious PRR 3.3 | no trial data cached |
| Hemiparesis | 15 | 3.9 2.3–6.4ROR 3.9 · χ² 29 / p 3e-8 | 3.5 EB05 2.3 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Cardio-respiratory arrest | 36 | 3.8 2.7–5.2ROR 3.8 · χ² 71 / p 2e-17 | 3.6 EB05 2.7 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Nausea | 510 | 2.9 2.6–3.1ROR 3.1 · χ² 635 / p 2e-140 | 2.8 EB05 2.6 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.7 | no trial data cached |
| Dyspnoea (shortness of breath) | 409 | 3.2 2.9–3.5ROR 3.4 · χ² 629 / p 3e-139 | 3.2 EB05 2.9 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.9 | no trial data cached |
| Injection site extravasation | 361 | 131.4 118.8–145.3ROR 142.1 · χ² 45,232 / p <1e-300 | 126.7 EB05 116.1 · IC025 +6.6 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Vomiting | 358 | 3.4 3.0–3.7ROR 3.6 · χ² 607 / p 2e-134 | 3.4 EB05 3.1 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.0 | no trial data cached |
| Headache | 327 | 2.3 2.1–2.6ROR 2.4 · χ² 247 / p 5e-56 | 2.3 EB05 2.1 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.9 · ♀ 80% (drug 60%) | no trial data cached |
| Hypotension (low blood pressure) | 315 | 6.9 6.2–7.7ROR 7.4 · χ² 1,610 / p <1e-300 | 6.9 EB05 6.3 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.3 | no trial data cached |
| Cardiac arrest (heart stopping) | 284 | 15.2 13.5–17.0ROR 16.1 · χ² 3,745 / p <1e-300 | 15.1 EB05 13.7 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 15.6 | no trial data cached |
| Dizziness | 274 | 2.4 2.2–2.7ROR 2.5 · χ² 234 / p 4e-53 | 2.4 EB05 2.2 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.0 | no trial data cached |
| Seizure | 256 | 9.9 8.7–11.1ROR 10.4 · χ² 2,035 / p <1e-300 | 9.8 EB05 8.8 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.6 | no trial data cached |
| Chest pain | 232 | 5.5 4.9–6.3ROR 5.8 · χ² 860 / p 2e-189 | 5.5 EB05 4.9 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.1 | no trial data cached |
| Blood pressure decreased | 208 | 13.9 12.1–15.8ROR 14.5 · χ² 2,471 / p <1e-300 | 13.8 EB05 12.3 · IC025 +3.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 15.6 | no trial data cached |
| Bradycardia (slow heart rate) | 196 | 16.3 14.2–18.7ROR 17.0 · χ² 2,801 / p <1e-300 | 16.2 EB05 14.4 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 16.7 | no trial data cached |
| Tremor (shaking) | 188 | 5.0 4.3–5.7ROR 5.2 · χ² 600 / p 8e-133 | 4.9 EB05 4.4 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.2 | no trial data cached |
| Loss of consciousness | 183 | 6.3 5.5–7.3ROR 6.5 · χ² 815 / p 2e-179 | 6.2 EB05 5.5 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.6 | no trial data cached |
| Unresponsive to stimuli | 164 | 28.3 24.3–32.9ROR 29.3 · χ² 4,267 / p <1e-300 | 28.0 EB05 24.6 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 28.7 | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Injection site extravasation — n=361, PRR 131.4
- Unresponsive to stimuli — n=164, PRR 28.3
- Presyncope — n=70, PRR 12.8
- Ventricular extrasystoles — n=29, PRR 12.3
- Bronchospasm — n=32, PRR 9.9
- Retching — n=35, PRR 7.3
- Syringe issue — n=23, PRR 5.8
- Aphasia — n=34, PRR 5.0
- Pallor — n=30, PRR 4.9
- Mental status changes — n=27, PRR 4.3
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Regadenoson?
In FDA FAERS, the most frequently co-reported reaction terms for Regadenoson are nausea, dyspnoea, injection site extravasation, vomiting, headache, hypotension. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Regadenoson have an FDA boxed warning?
No. The FDA label retrieved for Regadenoson has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Regadenoson causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 0e3f080d-b1fb-47ed-8cd3-90a4206fa704, effective 20251208; matched on
openfda.generic_name.exact:"REGADENOSON") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 107 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.