Dronedarone side effects: what 10,142 FDA adverse event reports show
Drug class
Antiarrhythmic
Brand names
Multaq
Who reports
10,142 reports · 71% serious · 668 with death outcome · 53% female
Used for
MULTAQ ® is indicated to reduce the risk of hospitalization for atrial fibrillation in patients in sinus rhythm with a history of paroxysmal or persistent atrial fibrillation (AF) . MULTAQ is an antiarrhythmic drug indicated to reduce the risk of hospitalization for atrial fibrillation (AF) in patients in sinus rhythm with a history of paroxysmal or persistent AF ( 1 , 14 ).
What it is
Dronedarone HCl is a benzofuran derivative with the following chemical name: N -{2-butyl-3-[4-(3-dibutylaminopropoxy)benzoyl]benzofuran-5-yl} methanesulfonamide, hydrochloride. Dronedarone HCl is a white fine powder that is practically insoluble in water and freely soluble in methylene chloride and methanol.
Boxed warning
INCREASED RISK OF DEATH, STROKE AND HEART FAILURE IN PATIENTS WITH DECOMPENSATED HEART FAILURE OR PERMANENT ATRIAL FIBRILLATION In patients with symptomatic heart failure and recent decompensation requiring hospitalization or NYHA Class IV heart failure, MULTAQ doubles the risk of death [see Clinical Studies (14.3) ] .
Causality screen of the 40 strongest signals
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- 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.
- 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.
- Outcome field, not a reaction Death is a report outcome, not a reaction term. It is dominated by the underlying illness; see the seriousness profile and the boxed warning instead.
- 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. 976 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Subchondral insufficiency fracture | 11 | 747.7 374.8–1,491.5ROR 748.5 · χ² 5,468 / p <1e-300 | 280.6 EB05 167.2 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Haemorrhagic anaemia | 81 | 38.2 30.7–47.6ROR 38.5 · χ² 2,847 / p <1e-300 | 37.2 EB05 30.9 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=81 · 79% consumer | no trial data cached |
| Haemorrhagic arteriovenous malformation | 16 | 35.6 21.7–58.3ROR 35.6 · χ² 495 / p 6e-110 | 33.7 EB05 22.0 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Cardiac ablation | 27 | 32.0 21.9–46.8ROR 32.1 · χ² 768 / p 2e-169 | 30.9 EB05 22.3 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=24 | no trial data cached |
| Atrial fibrillation | 1,424 | 30.6 29.2–32.1ROR 35.5 · χ² 40,357 / p <1e-300 | 30.2 EB05 28.9 · IC025 +4.8 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 24.8 | no trial data cached |
| Atrial flutter | 105 | 27.4 22.7–33.2ROR 27.7 · χ² 2,614 / p <1e-300 | 27.0 EB05 22.9 · IC025 +4.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 20.7 | no trial data cached |
| Cardioversion | 16 | 23.8 14.5–38.9ROR 23.8 · χ² 323 / p 1e-72 | 22.9 EB05 14.8 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Pericardial haemorrhage | 20 | 19.0 12.3–29.6ROR 19.1 · χ² 321 / p 4e-72 | 18.5 EB05 12.4 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=20 | no trial data cached |
| Torsade de pointes | 67 | 17.8 14.0–22.6ROR 17.9 · χ² 1,034 / p 3e-227 | 17.5 EB05 14.3 · IC025 +3.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 14.2 · 100% clinician | no trial data cached |
| Sinus arrest | 13 | 17.5 10.2–30.2ROR 17.5 · χ² 185 / p 2e-42 | 16.5 EB05 9.5 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Brain natriuretic peptide increased | 25 | 16.9 11.4–25.0ROR 16.9 · χ² 355 / p 2e-79 | 16.4 EB05 11.5 · IC025 +3.0 3/3 methods agree | Lab value / disease marker | serious n=25 | no trial data cached |
| Blood loss anaemia | 18 | 16.8 10.6–26.7ROR 16.8 · χ² 250 / p 1e-56 | 16.1 EB05 10.4 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=18 | no trial data cached |
| Lower gastrointestinal haemorrhage | 59 | 16.6 12.8–21.4ROR 16.6 · χ² 840 / p 4e-185 | 16.3 EB05 13.1 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 13.4 | no trial data cached |
| Diverticulum intestinal haemorrhagic | 18 | 16.5 10.4–26.3ROR 16.6 · χ² 246 / p 1e-55 | 15.9 EB05 10.2 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=18 | no trial data cached |
| Cholangitis sclerosing | 16 | 16.2 9.9–26.4ROR 16.2 · χ² 211 / p 4e-48 | 15.3 EB05 9.4 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Cholestatic liver injury | 16 | 15.5 9.5–25.4ROR 15.6 · χ² 202 / p 4e-46 | 14.7 EB05 9.0 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Renal haemorrhage | 15 | 15.3 9.2–25.4ROR 15.3 · χ² 185 / p 2e-42 | 14.3 EB05 8.5 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Ventricular tachycardia | 118 | 14.8 12.4–17.7ROR 15.0 · χ² 1,497 / p <1e-300 | 14.7 EB05 12.6 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 12.1 · 94% clinician | no trial data cached |
| Supraventricular extrasystoles | 24 | 14.8 9.9–22.1ROR 14.8 · χ² 293 / p 6e-66 | 14.2 EB05 9.7 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=22 | no trial data cached |
| International normalised ratio increased | 191 | 13.8 12.0–15.9ROR 14.0 · χ² 2,243 / p <1e-300 | 13.7 EB05 12.1 · IC025 +3.5 3/3 methods agree | Lab value / disease marker | serious PRR 11.5 | no trial data cached |
| Ventricular fibrillation | 70 | 13.1 10.3–16.5ROR 13.2 · χ² 764 / p 2e-168 | 12.8 EB05 10.4 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.4 · ♀ 30% (drug 53%) · 94% clinician | no trial data cached |
| Pulmonary toxicity | 44 | 13.0 9.7–17.5ROR 13.1 · χ² 474 / p 2e-105 | 12.7 EB05 9.7 · IC025 +3.0 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 10.4 | no trial data cached |
| Bradyarrhythmia | 10 | 12.7 6.8–23.6ROR 12.7 · χ² 96 / p 7e-23 | 10.6 EB05 5.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Glomerular filtration rate decreased | 72 | 12.4 9.8–15.6ROR 12.4 · χ² 736 / p 2e-162 | 12.1 EB05 9.9 · IC025 +3.1 3/3 methods agree | Lab value / disease marker | serious PRR 9.3 | no trial data cached |
| Extrasystoles | 41 | 12.2 8.9–16.5ROR 12.2 · χ² 406 / p 1e-90 | 11.7 EB05 8.8 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=35 | no trial data cached |
| Creatinine renal clearance decreased | 23 | 11.9 7.9–17.9ROR 11.9 · χ² 217 / p 2e-49 | 11.1 EB05 7.4 · IC025 +2.6 3/3 methods agree | Lab value / disease marker | serious n=19 · ♀ 30% (drug 53%) | no trial data cached |
| Orthopnoea | 17 | 11.1 6.9–17.8ROR 11.1 · χ² 145 / p 1e-33 | 9.8 EB05 6.1 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Atrioventricular block second degree | 16 | 10.9 6.7–17.9ROR 10.9 · χ² 134 / p 3e-31 | 9.6 EB05 5.8 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious n=16 | no trial data cached |
| Tachyarrhythmia | 13 | 10.8 6.3–18.6ROR 10.8 · χ² 105 / p 5e-25 | 9.2 EB05 5.2 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Gastrointestinal haemorrhage | 421 | 10.4 9.5–11.4ROR 10.8 · χ² 3,563 / p <1e-300 | 10.3 EB05 9.5 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.5 | no trial data cached |
| Coagulopathy | 81 | 10.1 8.1–12.6ROR 10.2 · χ² 654 / p 1e-144 | 9.8 EB05 8.1 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 · 70% consumer | no trial data cached |
| Upper gastrointestinal haemorrhage | 82 | 10.1 8.1–12.5ROR 10.2 · χ² 660 / p 9e-146 | 9.8 EB05 8.1 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 · 74% consumer | no trial data cached |
| Atrioventricular block first degree | 21 | 10.0 6.5–15.3ROR 10.0 · χ² 160 / p 4e-37 | 9.0 EB05 5.9 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious n=21 | no trial data cached |
| Blood creatinine increased | 311 | 9.9 8.8–11.0ROR 10.2 · χ² 2,466 / p <1e-300 | 9.8 EB05 8.9 · IC025 +3.1 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 6.9 | no trial data cached |
| International normalised ratio decreased | 19 | 9.6 6.2–15.1ROR 9.7 · χ² 138 / p 3e-32 | 8.5 EB05 5.5 · IC025 +2.2 3/3 methods agree | Lab value / disease marker | serious n=13 | no trial data cached |
| Hepatocellular injury | 65 | 9.5 7.4–12.1ROR 9.5 · χ² 483 / p 2e-107 | 9.1 EB05 7.3 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.6 · 94% clinician | no trial data cached |
| Cardiac tamponade | 21 | 9.1 6.0–14.0ROR 9.2 · χ² 144 / p 2e-33 | 8.1 EB05 5.4 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=21 | no trial data cached |
| Sudden cardiac death | 15 | 9.1 5.5–15.1ROR 9.1 · χ² 99 / p 1e-23 | 7.7 EB05 4.7 · IC025 +2.0 3/3 methods agree | Outcome field, not a reaction boxed warning mentions mortality | serious n=15 | no trial data cached |
| Ventricular extrasystoles | 44 | 8.8 6.5–11.8ROR 8.8 · χ² 294 / p 3e-66 | 8.3 EB05 6.3 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.0 | no trial data cached |
| Heart rate decreased | 149 | 8.8 7.5–10.3ROR 8.9 · χ² 1,014 / p 8e-223 | 8.6 EB05 7.5 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.6 · 75% consumer | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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 |
|---|---|---|---|---|---|---|
| Atrial fibrillation | 1,424 | 30.6 29.2–32.1ROR 35.5 · χ² 40,357 / p <1e-300 | 30.2 EB05 28.9 · IC025 +4.8 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 24.8 | no trial data cached |
| Dyspnoea (shortness of breath) | 849 | 3.1 2.9–3.3ROR 3.3 · χ² 1,242 / p 2e-272 | 3.1 EB05 2.9 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.9 | no trial data cached |
| Fatigue (tiredness) | 624 | 1.7 1.5–1.8ROR 1.7 · χ² 170 / p 4e-39 | 1.7 EB05 1.6 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 1.7 | no trial data cached |
| Off label use (used outside approved label) | 537 | 1.3 1.2–1.4ROR 1.3 · χ² 34 / p 3e-9 | 1.3 EB05 1.2 · IC025 +0.2 | Reporting / coding artifact | serious PRR 0.6 | no trial data cached |
| Diarrhoea (diarrhea) | 485 | 1.6 1.4–1.7ROR 1.6 · χ² 100 / p 9e-24 | 1.6 EB05 1.4 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 1.4 | no trial data cached |
| Nausea | 477 | 1.3 1.1–1.4ROR 1.3 · χ² 25 / p 4e-7 | 1.3 EB05 1.2 · IC025 +0.2 | Labeled adverse reaction exact term | serious PRR 1.3 | no trial data cached |
| Drug interaction | 470 | 6.1 5.6–6.7ROR 6.4 · χ² 2,026 / p <1e-300 | 6.1 EB05 5.6 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 5.1 | no trial data cached |
| Dizziness | 453 | 1.9 1.7–2.1ROR 1.9 · χ² 191 / p 1e-43 | 1.9 EB05 1.7 · IC025 +0.8 | Not in label — unassessed | serious PRR 1.9 | no trial data cached |
| Gastrointestinal haemorrhage | 421 | 10.4 9.5–11.4ROR 10.8 · χ² 3,563 / p <1e-300 | 10.3 EB05 9.5 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.5 | no trial data cached |
| Asthenia (weakness) | 384 | 2.1 1.9–2.3ROR 2.2 · χ² 228 / p 1e-51 | 2.1 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 1.8 | no trial data cached |
| Drug ineffective (drug did not work) | 330 | 0.5 0.5–0.6ROR 0.5 · χ² 157 / p 2e-36 | 0.5 EB05 0.5 · IC025 -1.1 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 0.8 | no trial data cached |
| Blood creatinine increased | 311 | 9.9 8.8–11.0ROR 10.2 · χ² 2,466 / p <1e-300 | 9.8 EB05 8.9 · IC025 +3.1 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 6.9 | no trial data cached |
| Headache | 237 | 0.8 0.7–0.9ROR 0.8 · χ² 15 / p 7e-5 | 0.8 EB05 0.7 · IC025 -0.6 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious PRR 0.8 · 75% consumer | no trial data cached |
| Cardiac failure (heart failure) | 224 | 5.8 5.1–6.6ROR 5.9 · χ² 881 / p 7e-194 | 5.7 EB05 5.1 · IC025 +2.3 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 4.7 | no trial data cached |
| Malaise (feeling unwell) | 220 | 1.0 0.9–1.2ROR 1.0 · χ² 0 / p 0.317 | 1.0 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 1.0 | 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.
- Haemorrhagic anaemia — n=81, PRR 38.2
- Cardiac ablation — n=27, PRR 32.0
- Pericardial haemorrhage — n=20, PRR 19.0
- Lower gastrointestinal haemorrhage — n=59, PRR 16.6
- Ventricular tachycardia — n=118, PRR 14.8
- Supraventricular extrasystoles — n=24, PRR 14.8
- Extrasystoles — n=41, PRR 12.2
- Gastrointestinal haemorrhage — n=421, PRR 10.4
- Coagulopathy — n=81, PRR 10.1
- Upper gastrointestinal haemorrhage — n=82, PRR 10.1
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 Dronedarone?
In FDA FAERS, the most frequently co-reported reaction terms for Dronedarone are atrial fibrillation, dyspnoea, fatigue, diarrhoea, nausea, dizziness. 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 Dronedarone have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: INCREASED RISK OF DEATH, STROKE AND HEART FAILURE IN PATIENTS WITH DECOMPENSATED HEART FAILURE OR PERMANENT ATRIAL FIBRILLATION In patients with symptomatic heart failure and recent decompensation requiring hospitalization or NYHA Class IV heart failure, MULTAQ doubles the risk of death [see Clinical Studies (14.3) ] .
Do FAERS signals prove that Dronedarone 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 3bd4006a-8bad-4909-ac6d-b6d84390155c, effective 20260127; matched on
openfda.generic_name.exact:"DRONEDARONE") - 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, 1,016 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.