Drug · FAERS side-effect profile with label screen
Adenosine side effects: what 1,600 FDA adverse event reports show
Drug class
Adenosine Receptor Agonist
FDA label (Established Pharmacologic Class)
Who reports
1,600 reports · 89% serious · 142 with death outcome · 48% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Adenosine 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 ( 1 )
FDA label, Indications and Usage
What it is
Adenosine is an endogenous nucleoside and is chemically described as 6-amino-9-beta-D-ribofuranosyl-9-H-purine. Adenosine has the following structural formula:
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 10Labeled (related wording) 2Reporting / coding artifact 7Lab value / disease marker 1Not in label — unassessed 20
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.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- 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. 31 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 |
|---|---|---|---|---|---|---|
| Supraventricular tachycardia | 98 | 135.7 111.9–164.6ROR 144.5 · χ² 12,839 / p <1e-300 | 130.9 EB05 110.6 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious PRR 90.4 · 91% clinician | no trial data cached |
| Ventricular fibrillation | 36 | 42.5 30.7–58.7ROR 43.4 · χ² 1,413 / p <1e-300 | 41.5 EB05 31.3 · IC025 +4.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 27.5 · ♀ 24% (drug 48%) · 100% clinician | no trial data cached |
| Ventricular tachycardia | 49 | 38.9 29.5–51.2ROR 40.1 · χ² 1,766 / p <1e-300 | 38.2 EB05 30.1 · IC025 +4.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 25.4 · 100% clinician | no trial data cached |
| Bronchospasm (airway tightening) | 41 | 37.6 27.8–50.9ROR 38.6 · χ² 1,423 / p <1e-300 | 36.9 EB05 28.4 · IC025 +4.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 23.0 · ♀ 23% (drug 48%) · 100% clinician | no trial data cached |
| Cardiogenic shock | 28 | 25.8 17.8–37.2ROR 26.2 · χ² 641 / p 1e-141 | 25.3 EB05 18.4 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 16.6 · 100% clinician | no trial data cached |
| Ventricular extrasystoles | 17 | 21.5 13.4–34.4ROR 21.7 · χ² 311 / p 7e-70 | 20.9 EB05 13.7 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 15.5 | no trial data cached |
| Sinus bradycardia | 14 | 19.0 11.3–32.0ROR 19.1 · χ² 220 / p 4e-50 | 18.2 EB05 11.1 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.6 | no trial data cached |
| Circulatory collapse | 23 | 17.6 11.8–26.5ROR 17.9 · χ² 344 / p 3e-77 | 17.3 EB05 11.9 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 11.5 | no trial data cached |
| Bradycardia (slow heart rate) | 63 | 15.6 12.2–19.8ROR 16.2 · χ² 845 / p 5e-186 | 15.4 EB05 12.4 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.3 · 98% clinician | no trial data cached |
| Anhedonia | 31 | 15.4 10.8–21.8ROR 15.6 · χ² 402 / p 1e-89 | 15.1 EB05 10.9 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 11.0 · ♀ 26% (drug 48%) | no trial data cached |
| Mitral valve incompetence | 12 | 13.9 7.9–24.4ROR 14.0 · χ² 131 / p 1e-30 | 12.5 EB05 6.7 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.3 | no trial data cached |
| Toxic epidermal necrolysis (severe skin peeling reaction) | 15 | 13.0 7.9–21.6ROR 13.2 · χ² 155 / p 7e-36 | 11.9 EB05 7.0 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.5 | no trial data cached |
| Economic problem | 15 | 12.8 7.7–21.1ROR 12.9 · χ² 151 / p 5e-35 | 11.6 EB05 6.8 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 9.0 | no trial data cached |
| Cardiac arrest (heart stopping) | 79 | 12.5 10.1–15.5ROR 13.1 · χ² 827 / p 3e-182 | 12.3 EB05 10.2 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.0 · 90% clinician | no trial data cached |
| Fluid overload | 14 | 12.4 7.4–21.0ROR 12.5 · χ² 136 / p 1e-31 | 11.1 EB05 6.4 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 10.4 | no trial data cached |
| Osteopenia | 14 | 12.0 7.1–20.3ROR 12.1 · χ² 131 / p 1e-30 | 10.7 EB05 6.1 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 9.2 | no trial data cached |
| Pericardial effusion | 21 | 12.0 7.8–18.3ROR 12.1 · χ² 200 / p 9e-46 | 11.1 EB05 7.3 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.5 · ♀ 24% (drug 48%) | no trial data cached |
| Hyperthyroidism | 12 | 10.9 6.2–19.1ROR 11.0 · χ² 98 / p 2e-23 | 9.1 EB05 5.1 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.6 | no trial data cached |
| Liver function test abnormal | 23 | 10.3 6.9–15.5ROR 10.4 · χ² 184 / p 3e-42 | 9.4 EB05 6.3 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 8.3 · ♀ 4% (drug 48%) | no trial data cached |
| Ejection fraction decreased | 11 | 9.3 5.1–16.7ROR 9.3 · χ² 73 / p 6e-18 | 7.4 EB05 4.2 · IC025 +1.7 3/3 methods agree | Lab value / disease marker | serious PRR 6.6 | no trial data cached |
| Tachycardia (fast heart rate) | 62 | 9.2 7.2–11.7ROR 9.5 · χ² 444 / p 9e-99 | 8.8 EB05 7.1 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.1 | no trial data cached |
| Atrial fibrillation | 66 | 8.9 7.0–11.2ROR 9.2 · χ² 455 / p 3e-101 | 8.5 EB05 6.9 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.8 · 90% clinician | no trial data cached |
| Drug ineffective for unapproved indication | 37 | 8.7 6.3–12.0ROR 8.9 · χ² 245 / p 1e-55 | 8.1 EB05 6.1 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 11.9 · 100% clinician | no trial data cached |
| Metabolic acidosis | 21 | 8.7 5.7–13.3ROR 8.8 · χ² 136 / p 1e-31 | 7.7 EB05 5.2 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 · 100% clinician | no trial data cached |
| Premature baby | 20 | 8.7 5.6–13.4ROR 8.8 · χ² 129 / p 4e-30 | 7.7 EB05 5.1 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 · 100% clinician | no trial data cached |
| Premature delivery | 10 | 8.2 4.4–15.2ROR 8.2 · χ² 56 / p 3e-14 | 6.4 EB05 3.6 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Respiratory distress | 17 | 8.1 5.0–13.0ROR 8.1 · χ² 98 / p 2e-23 | 6.9 EB05 4.5 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Cardio-respiratory arrest | 25 | 7.8 5.3–11.5ROR 7.9 · χ² 141 / p 7e-33 | 7.0 EB05 4.9 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 · 95% clinician | no trial data cached |
| Stevens-johnson syndrome (severe blistering skin reaction) | 13 | 7.6 4.5–13.1ROR 7.7 · χ² 69 / p 6e-17 | 6.3 EB05 3.8 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 | no trial data cached |
| Respiratory arrest | 16 | 7.5 4.6–12.3ROR 7.6 · χ² 84 / p 2e-20 | 6.4 EB05 4.1 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.0 | no trial data cached |
| Acute myocardial infarction | 17 | 7.5 4.7–12.1ROR 7.6 · χ² 90 / p 1e-21 | 6.5 EB05 4.2 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.9 | no trial data cached |
| Renal failure acute | 22 | 6.7 4.4–10.1ROR 6.8 · χ² 101 / p 4e-24 | 6.0 EB05 4.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 · ♀ 86% (drug 48%) | no trial data cached |
| Rash maculo-papular | 11 | 6.5 3.6–11.7ROR 6.5 · χ² 46 / p 6e-12 | 5.3 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 | no trial data cached |
| Arrhythmia | 23 | 6.3 4.2–9.5ROR 6.4 · χ² 98 / p 2e-23 | 5.7 EB05 4.0 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.3 | no trial data cached |
| Fear | 13 | 6.3 3.7–10.8ROR 6.3 · χ² 53 / p 2e-13 | 5.2 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | no trial data cached |
| Treatment failure | 34 | 5.4 3.9–7.6ROR 5.5 · χ² 119 / p 5e-28 | 5.1 EB05 3.8 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 6.4 · 94% clinician | no trial data cached |
| Maternal exposure during pregnancy | 35 | 5.2 3.7–7.2ROR 5.3 · χ² 115 / p 4e-27 | 4.9 EB05 3.7 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 4.1 · ♀ 100% (drug 48%) · 94% clinician | no trial data cached |
| Foetal exposure during pregnancy | 32 | 5.2 3.7–7.3ROR 5.2 · χ² 104 / p 1e-24 | 4.8 EB05 3.6 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 3.4 · 100% clinician | no trial data cached |
| Exposure during pregnancy | 23 | 4.8 3.2–7.3ROR 4.9 · χ² 67 / p 2e-16 | 4.4 EB05 3.1 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 4.7 · ♀ 100% (drug 48%) · 91% clinician | no trial data cached |
| Renal injury | 10 | 4.4 2.4–8.1ROR 4.4 · χ² 23 / p 9e-7 | 3.7 EB05 2.2 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 2.8 | 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 |
|---|---|---|---|---|---|---|
| Supraventricular tachycardia | 98 | 135.7 111.9–164.6ROR 144.5 · χ² 12,839 / p <1e-300 | 130.9 EB05 110.6 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious PRR 90.4 · 91% clinician | no trial data cached |
| Cardiac arrest (heart stopping) | 79 | 12.5 10.1–15.5ROR 13.1 · χ² 827 / p 3e-182 | 12.3 EB05 10.2 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.0 · 90% clinician | no trial data cached |
| Atrial fibrillation | 66 | 8.9 7.0–11.2ROR 9.2 · χ² 455 / p 3e-101 | 8.5 EB05 6.9 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.8 · 90% clinician | no trial data cached |
| Bradycardia (slow heart rate) | 63 | 15.6 12.2–19.8ROR 16.2 · χ² 845 / p 5e-186 | 15.4 EB05 12.4 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.3 · 98% clinician | no trial data cached |
| Tachycardia (fast heart rate) | 62 | 9.2 7.2–11.7ROR 9.5 · χ² 444 / p 9e-99 | 8.8 EB05 7.1 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.1 | no trial data cached |
| Ventricular tachycardia | 49 | 38.9 29.5–51.2ROR 40.1 · χ² 1,766 / p <1e-300 | 38.2 EB05 30.1 · IC025 +4.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 25.4 · 100% clinician | no trial data cached |
| Bronchospasm (airway tightening) | 41 | 37.6 27.8–50.9ROR 38.6 · χ² 1,423 / p <1e-300 | 36.9 EB05 28.4 · IC025 +4.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 23.0 · ♀ 23% (drug 48%) · 100% clinician | no trial data cached |
| Emotional distress | 37 | 4.0 2.9–5.5ROR 4.1 · χ² 80 / p 1e-19 | 3.8 EB05 2.9 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 2.9 | no trial data cached |
| Drug ineffective for unapproved indication | 37 | 8.7 6.3–12.0ROR 8.9 · χ² 245 / p 1e-55 | 8.1 EB05 6.1 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 11.9 · 100% clinician | no trial data cached |
| Ventricular fibrillation | 36 | 42.5 30.7–58.7ROR 43.4 · χ² 1,413 / p <1e-300 | 41.5 EB05 31.3 · IC025 +4.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 27.5 · ♀ 24% (drug 48%) · 100% clinician | no trial data cached |
| Maternal exposure during pregnancy | 35 | 5.2 3.7–7.2ROR 5.3 · χ² 115 / p 4e-27 | 4.9 EB05 3.7 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 4.1 · ♀ 100% (drug 48%) · 94% clinician | no trial data cached |
| Treatment failure | 34 | 5.4 3.9–7.6ROR 5.5 · χ² 119 / p 5e-28 | 5.1 EB05 3.8 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 6.4 · 94% clinician | no trial data cached |
| Foetal exposure during pregnancy | 32 | 5.2 3.7–7.3ROR 5.2 · χ² 104 / p 1e-24 | 4.8 EB05 3.6 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 3.4 · 100% clinician | no trial data cached |
| Anhedonia | 31 | 15.4 10.8–21.8ROR 15.6 · χ² 402 / p 1e-89 | 15.1 EB05 10.9 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 11.0 · ♀ 26% (drug 48%) | no trial data cached |
| Cardiogenic shock | 28 | 25.8 17.8–37.2ROR 26.2 · χ² 641 / p 1e-141 | 25.3 EB05 18.4 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 16.6 · 100% clinician | 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.
- Supraventricular tachycardia — n=98, PRR 135.7
- Cardiogenic shock — n=28, PRR 25.8
- Circulatory collapse — n=23, PRR 17.6
- Anhedonia — n=31, PRR 15.4
- Metabolic acidosis — n=21, PRR 8.7
- Premature baby — n=20, PRR 8.7
- Cardio-respiratory arrest — n=25, PRR 7.8
- Renal failure acute — n=22, PRR 6.7
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 Adenosine?
In FDA FAERS, the most frequently co-reported reaction terms for Adenosine are supraventricular tachycardia, cardiac arrest, atrial fibrillation, bradycardia, tachycardia, ventricular tachycardia. 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 Adenosine have an FDA boxed warning?
No. The FDA label retrieved for Adenosine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Adenosine 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 23e5c868-944f-4cc8-887f-9a2dc811af92, effective 20220701; matched on
openfda.generic_name.exact:"ADENOSINE") - 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, 71 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.