Multaq (dronedarone) adverse event reports that FDA received

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

Name type: Brand name
Generic name: Dronedarone
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 5,773 adverse event reports that name Multaq. In these reports the drug is a suspect or interacting product.

In the same period, 3,353 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 289 reports in the 12 months to June 2026 and 226 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, 289 (under 0.1%) name Multaq. Reports for patients 75 and over were 29.9% of the reports that name Multaq 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 Multaq 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 84 reports that name Multaq.
In January to March 2026, FDA received 77.
In April to June 2025, FDA received 56.

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 354 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 5,773 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 354 terms.

Reaction terms in the reports that name Multaq, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 5,773 reports
Atrial fibrillationan irregular heart rhythm	1,033	17.9%
Dyspnoeashortness of breath	566	9.8%
Off label useused for a purpose or in a way not on the label	411	7.1%
Fatiguetiredness	387	6.7%
Nauseafeeling sick	320	5.5%
Diarrhoealoose or frequent stools	293	5.1%
Dizzinesslight-headedness or unsteadiness	286	5%
Blood creatinine increasedraised creatinine, a kidney test	263	4.6%
Astheniaweakness or lack of energy	249	4.3%
Drug interactionan interaction between medicines	248	4.3%
Drug ineffectivethe medicine did not work as expected	203	3.5%
Cardiac failureheart failure	190	3.3%
Oedema peripheralswelling of the legs, ankles or hands	149	2.6%
Palpitationsawareness of the heartbeat	147	2.5%
Condition aggravatedthe condition being treated got worse	142	2.5%
International normalised ratio increasedblood clotting slower than intended (raised INR)	140	2.4%
Cardiac failure congestivecongestive heart failure	138	2.4%
Malaisegeneral feeling of being unwell	138	2.4%
Weight increasedweight gain	136	2.4%
Cough	127	2.2%
Headachehead pain	125	2.2%
Heart rate increaseda fast heart rate reading	121	2.1%
Arrhythmia	120	2.1%
Heart rate decreased	119	2.1%
Renal failurekidney failure	112	1.9%
Bradycardiaslow heart rate	111	1.9%
Rashskin rash	109	1.9%
Vomitingbeing sick	105	1.8%
Feeling abnormalfeeling odd or not right	104	1.8%
Pruritusitching	103	1.8%
Alanine aminotransferase increasedraised liver enzyme (ALT)	96	1.7%
Hypotensionlow blood pressure	93	1.6%
Ventricular tachycardiaa fast rhythm from the lower heart chambers	89	1.5%
Abdominal discomfortstomach discomfort	88	1.5%
Weight decreasedweight loss	87	1.5%
Renal failure acute	86	1.5%
Abdominal pain upperupper stomach pain	84	1.5%
Decreased appetitereduced appetite	81	1.4%
Aspartate aminotransferase increasedraised liver enzyme (AST)	80	1.4%
Chest pain	79	1.4%
Hepatic enzyme increasedraised liver enzymes	78	1.4%
Abdominal painstomach or belly pain	77	1.3%
Painpain, site not specified	74	1.3%
Gait disturbancedifficulty walking	73	1.3%
Deaththe patient died; cause not stated by this term	72	1.2%
Tremorshaking	66	1.1%
Pneumonialung infection	65	1.1%
Insomniadifficulty sleeping	64	1.1%
Underdoseless than the intended dose	64	1.1%
Electrocardiogram QT prolongeda QT prolongation on the ECG	62	1.1%

Download all 354 terms of Multaq (CSV)

The counts add to more than 5,773 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	Generic name	717
Dronedarone hydrochloride	Generic name	495
Multaq (this page)	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 Multaq, 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	Congenital Anomaly/Birth Defect	Other Serious (Important Medical Events)	Not serious
2009	202	199	13	9	53	1	0	134	3
2010	1,028	992	43	53	315	31	0	662	36
2011	1,075	1,004	85	69	391	32	0	623	71
2012	365	332	26	19	107	16	0	216	33
2013	461	309	17	12	116	8	0	207	152
2014	367	234	17	6	79	5	0	168	133
2015	275	186	18	5	78	6	0	111	89
2016	220	128	3	5	42	2	1	94	92
2017	174	104	6	0	39	2	0	67	70
2018	174	112	5	6	40	10	0	82	62
2019	225	105	11	3	26	3	0	77	120
2020	159	76	5	1	18	0	0	65	83
2021	146	61	6	3	18	3	0	52	85
2022	145	51	7	7	16	1	0	44	94
2023	153	53	5	4	21	10	1	46	100
2024	186	64	0	1	20	6	0	54	122
2025	254	43	2	1	10	1	0	37	211
2026	164	40	2	2	13	4	0	34	124

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 Multaq, 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 Multaq, by the year in which FDA received them
Year	Reports
2009	182
2010	1,017
2011	1,122
2012	406
2013	463
2014	374
2015	257
2016	215
2017	165
2018	177
2019	216
2020	140
2021	144
2022	154
2023	149
2024	185
2025	246
2026	161

Reports that name Multaq, 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 Multaq
Age	Reports	Share
Under 2	0	0%
2 to 11	3	0.1%
12 to 17	3	0.1%
18 to 44	65	1.1%
45 to 64	750	13%
65 to 74	1,436	24.9%
75 and over	1,727	29.9%
Age not given	1,789	31%

Sex of the patient in the reports that name Multaq
Sex	Reports	Share
Female	2,804	48.6%
Male	2,279	39.5%
Unknown or not given	690	12%

Type of reporter in the reports that name Multaq
Reporter	Reports	Share
Physician	2,019	35%
Pharmacist	381	6.6%
Other health professional	755	13.1%
Lawyer	12	0.2%
Consumer or non-health professional	2,538	44%
Not given	68	1.2%

Age and sex are as the report gives them. The reporter is the primary source in the report. 72.7% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Multaq record
Indication as recorded (MedDRA)	Reports	Share
Atrial fibrillation	3,029	52.5%
Atrial flutter	120	2.1%
Arrhythmia	105	1.8%
Supraventricular tachycardia	50	0.9%
Ventricular extrasystoles	22	0.4%
Heart rate irregular	20	0.3%

The reporter fills in the indication, and the field is often empty. Each share is of all 5,773 reports.

Drugs in the same reports

Other drugs that the reports of Multaq name, in any role, in order of name
Drug	Reports that name the two
Aspirin	440
Coumadin	423
Digoxin	170
Eliquis	237
Lasix	187
Lisinopril	160
Metoprolol	275
Simvastatin	262
Warfarin	170
Xarelto	179

The table has the 10 drug names that these reports name most. Two names in one report says only that the report recorded the two. It says nothing about the part of a product in the event.

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.

Pages near this one

Dronedarone same ingredient
Dronedarone hydrochloride same ingredient
Flecainide acetate same class
Nexterone (amiodarone hci) same class
Norpace same class
Dofetilide same class
Nuedexta same class
Mucosta next in the A to Z list
MultiHance next in the A to Z list
Mucomyst next in the A to Z list
Multivitamin next in the A to Z list
Mucodyne 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 MultaqThe 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.

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Reported Reactions. Multaq: adverse event reports that FDA received. https://reportedreactions.com/drug/multaq/ 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 Multaq as a suspect or interacting product. The 3,353 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 Multaq 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 Multaq?

No. It is a count of what people reported to FDA: 5,773 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?

Consumer or non-health professional (44%), physician (35%) and other health professional (13.1%). 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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