Dronedarone adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Dronedarone
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Generic name
Class: Antiarrhythmic

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Drug reports received through 30 Jun 2026. Device reports have a separate cutoff, 30 Sep 2026. Why a report count is not a rate.

Reports on file

From August 2009 to June 2026, FDA received 717 adverse event reports that name Dronedarone. In these reports the drug is a suspect or interacting product.

In the same period, 371 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 33 reports in the 12 months to June 2026 and 30 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 33 (under 0.1%) name Dronedarone. Reports for patients 75 and over were 38.8% of the reports that name Dronedarone and 9.5% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Dronedarone is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

The latest update of the FDA data, recorded on 28 Oct 2026, changed no count of this page.

In April to June 2026, FDA received 9 reports that name Dronedarone.
In January to March 2026, FDA received 13.
In April to June 2025, FDA received 7.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 106 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for all 717 reports.

The site keeps a term for a year only if two or more reports of that year record it.

So a count in the table can be lower than the count of FDA.

Find a reaction term

The table shows the first 50 of 106 terms.

Reaction terms in the reports that name Dronedarone, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 717 reports
Drug interactionan interaction between medicines	188	26.2%
Atrial fibrillationan irregular heart rhythm	99	13.8%
Dyspnoeashortness of breath	68	9.5%
Fatiguetiredness	41	5.7%
Dizzinesslight-headedness or unsteadiness	33	4.6%
Acute kidney injurysudden loss of kidney function	31	4.3%
Diarrhoealoose or frequent stools	30	4.2%
Ventricular fibrillationa chaotic rhythm from the lower heart chambers	28	3.9%
Bradycardiaslow heart rate	26	3.6%
Gastrointestinal haemorrhagebleeding in the stomach or bowel	25	3.5%
Blood creatinine increasedraised creatinine, a kidney test	24	3.3%
Cardiac failure congestivecongestive heart failure	24	3.3%
Toxicity to various agentspoisoning or toxic effect of one or more substances	24	3.3%
Palpitationsawareness of the heartbeat	21	2.9%
Tachycardiafast heart rate	19	2.6%
Drug ineffectivethe medicine did not work as expected	18	2.5%
Nauseafeeling sick	18	2.5%
Electrocardiogram QT prolongeda QT prolongation on the ECG	17	2.4%
Hypertensionhigh blood pressure	17	2.4%
International normalised ratio increasedblood clotting slower than intended (raised INR)	17	2.4%
Renal failurekidney failure	17	2.4%
Cardiac failureheart failure	16	2.2%
Cholangitis sclerosing	15	2.1%
Visual impairmentreduced vision	15	2.1%
Arrhythmia	14	2%
Hyperkalaemiahigh blood potassium	14	2%
Hypotensionlow blood pressure	14	2%
Atrioventricular block first degree	13	1.8%
Cardiac disorder	13	1.8%
Torsade de pointesa serious irregular heart rhythm	13	1.8%
Astheniaweakness or lack of energy	12	1.7%
Atrioventricular block	12	1.7%
Drug-induced liver injury	12	1.7%
Melaenablack tarry stools	12	1.7%
Ventricular tachycardiaa fast rhythm from the lower heart chambers	12	1.7%
Atrioventricular block second degree	11	1.5%
Drug hypersensitivityan allergic-type reaction (the term names a medicine)	11	1.5%
Haemorrhagebleeding	11	1.5%
Hyponatraemialow blood sodium	11	1.5%
Oedemaswelling from fluid	11	1.5%
Oedema peripheralswelling of the legs, ankles or hands	11	1.5%
Weight increasedweight gain	11	1.5%
Malaisegeneral feeling of being unwell	10	1.4%
Myalgiamuscle pain	10	1.4%
Abdominal painstomach or belly pain	9	1.3%
Cough	9	1.3%
Gait disturbancedifficulty walking	9	1.3%
Rectal haemorrhage	9	1.3%
Renal failure acute	9	1.3%
Renal impairmentreduced kidney function	9	1.3%

Download all 106 terms of Dronedarone (CSV)

The counts add to more than 717 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Same ingredient, other names

Reporters write a brand name or a generic name. Each name has its own page and its own count.

Names of Dronedarone with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Dronedarone (this page)	Generic name	717
Dronedarone hydrochloride	Generic name	495
Multaq	Brand name	5,773

Sum of the separately reported names: 6,985. A report that names two of these names is in the sum two times. The sum is not the number of reports for the ingredient.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Dronedarone, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Other Serious (Important Medical Events)	Not serious
2009	19	19	0	1	6	0	15	0
2010	23	20	0	2	8	0	13	3
2011	28	25	1	3	15	0	16	3
2012	17	13	1	1	10	1	4	4
2013	46	41	1	1	19	5	25	5
2014	119	115	5	10	79	1	53	4
2015	97	93	14	6	35	3	55	4
2016	14	12	0	0	5	3	8	2
2017	17	16	2	0	7	0	10	1
2018	40	38	1	3	24	1	24	2
2019	71	65	5	0	34	2	38	6
2020	50	46	1	12	39	0	26	4
2021	19	18	1	1	4	0	16	1
2022	27	24	1	0	13	1	15	3
2023	40	38	9	0	19	1	32	2
2024	36	30	6	2	14	0	25	6
2025	32	29	7	0	6	1	27	3
2026	22	22	6	0	2	0	22	0

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Dronedarone, by the year in which FDA received them

The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.

Show the figures of the chart as a table

Reports that name Dronedarone, by the year in which FDA received them
Year	Reports
2009	15
2010	24
2011	33
2012	22
2013	49
2014	120
2015	102
2016	14
2017	14
2018	52
2019	66
2020	48
2021	13
2022	28
2023	36
2024	33
2025	26
2026	22

Reports that name Dronedarone, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Dronedarone
Age	Reports	Share
Under 2	0	0%
2 to 11	0	0%
12 to 17	1	0.1%
18 to 44	11	1.5%
45 to 64	102	14.2%
65 to 74	182	25.4%
75 and over	278	38.8%
Age not given	143	19.9%

Sex of the patient in the reports that name Dronedarone
Sex	Reports	Share
Female	314	43.8%
Male	332	46.3%
Unknown or not given	71	9.9%

Type of reporter in the reports that name Dronedarone
Reporter	Reports	Share
Physician	245	34.2%
Pharmacist	60	8.4%
Other health professional	270	37.7%
Lawyer	0	0%
Consumer or non-health professional	139	19.4%
Not given	3	0.4%

Age and sex are as the report gives them. The reporter is the primary source in the report. 50.9% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Dronedarone record
Indication as recorded (MedDRA)	Reports	Share
Atrial fibrillation	364	50.8%
Arrhythmia	10	1.4%
Arrhythmia supraventricular	5	0.7%
Atrial tachycardia	4	0.6%
Arrhythmia prophylaxis	2	0.3%
Cardiac disorder	2	0.3%

The reporter fills in the indication, and the field is often empty. Each share is of all 717 reports.

Pages near this one

Dronedarone hydrochloride same ingredient
Multaq same ingredient
Dofetilide same class
Flecainide acetate same class
Disopyramide phosphate same class
Betapace same class
Nexterone (amiodarone hci) same class
Dronabinol next in the A to Z list
Droleptan next in the A to Z list
Droperidol next in the A to Z list
Dramamine next in the A to Z list
Drospirenone next in the A to Z list

These links are for navigation. No count selected them. The class page lists each drug of the class.

Official pages

DailyMed labels for DronedaroneThe labels (prescribing information) that have this name, at the National Library of Medicine.
MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Dronedarone: adverse event reports that FDA received. https://reportedreactions.com/drug/dronedarone/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Dronedarone as a suspect or interacting product. The 371 reports that name it only as a concomitant medicine are not in the count. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Do these reports show that Dronedarone was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Dronedarone?

No. It is a count of what people reported to FDA: 717 reports from August 2009 to June 2026. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Other health professional (37.7%), physician (34.2%) and consumer or non-health professional (19.4%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.

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