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Dronedarone

  • Prescription medicine
  • Prescription only
  • Identity checked
  • Sources last checked 2026-09-04

This page shows what was measured, who it was measured in, and what that does not settle.

What Dronedarone does in the body

The risk of hospitalization for atrial fibrillation

From the FDA-approved label: The mechanism of action of dronedarone is unknown. Dronedarone has antiarrhythmic properties belonging to all four Vaughan-Williams classes, but the contribution of each of these activities to the clinical effect is unknown.

What happened in people

RNAWiki has not yet published a reviewed conclusion for this use.

A fixed RNAWiki sentence

Where this came from

Wording RNAWiki always uses, not a finding about this substance.

No reviewed claim names a result for any goal on this record.

No source is stored against this line.

The limit that matters most

Not recorded.

Where it acts
Not recorded.
Kind of result
No result is published, so no kind of result applies yet
Supervision
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.

What the registries record it as

  • The substance registry classes this as chemical.

    FDA substance registry · JQZ1L091Y2 · read 2026-08-29

  • Its recorded molecular formula is C31H44N2O5S.

    US prescribing information · 7fa41601-7fb5-4155-8e50-2ae903f0d2d6 · read 2026-08-30

Where each sentence above came from

No recorded sentence describes the change this makes in a way that stands on its own. The page opens with what it is taken for instead, and the recorded explanation follows below.

Shown as the opening line on this page.

No statement of the main limit is recorded.

The four opening statements run to 56 words.

Words this page uses

Four words worth knowing first

Chosen from what this page shows, with each one explained before the word it depends on.

Biomarker

A biomarker is a number from a test that stands in for something about health.

A picture of it, and where the picture fails

A biomarker is like a fuel gauge.

Where that stops being true. A gauge is wired to the tank. Many biomarkers are only loosely tied to health.

What people get wrong. A better number is read as a better life. Several medicines improved a number and helped nobody.

A measurable indicator used as a substitute for a clinical outcome of interest.

Placebo

A placebo is a dummy treatment given so the real one can be compared with it.

A picture of it, and where the picture fails

A placebo is like a blank control in an experiment.

Where that stops being true. A blank does nothing. People given a placebo often do get better.

What people get wrong. A placebo effect is read as imaginary. The improvement is measured and real.

An inactive intervention matched in appearance to the test intervention, used to control for non-specific effects.

Comparator

A comparator is whatever the treatment was measured against.

A picture of it, and where the picture fails

It is like the other runner in a race.

Where that stops being true. A race has one winner. A study can show both arms improved.

What people get wrong. Results are read without asking what the other group got. Beating nothing is not beating a treatment.

The control condition against which the experimental intervention is assessed.

What happened in peopleRead from sources, not yet reviewed

What happened in people

Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.

First Hospitalization for Cardiovascular Reason or Death From Any Cause

The study did not show it

Who was studied
NCT00174785
How many people
4628
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Overview of the Two Co-primary Outcomes

The study did not show it

Who was studied
NCT01151137
How many people
3236
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

A composite of cardiovascular death, stroke and hospitalization due to worsening of heart failure or due to acute coronary syndrome.

The study did not show it

Who was studied
NCT01288352
How many people
2789
Study design
Phase 4
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Composite of Stroke, Systemic Embolism, or Cardiovascular Death

The study did not show it

Who was studied
NCT02618577
How many people
2608
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Number of Participants With Composite of Total Mortality, Disabling Stroke, Serious Bleeding, or Cardiac Arrest in Patients Warranting Therapy for AF.

The study did not show it

Who was studied
NCT00911508
How many people
2204
Study design
Not applicable
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Efficacy : Recurrence of Atrial Fibrillation

The study did not show it

Who was studied
NCT07270848
How many people
1898
Study design
Phase 4
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot
What we know
RNAWiki holds 6 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.

What is missing or unclearRead from sources, not yet reviewed

Were people like you studied?

RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.

Who was studied

People similar to this profile were included.

  • 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) [see Clinical Studies (14) ]. 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 ).

Who is missing from the studies

  • Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

What the label states about particular groups

  • On pediatric, the label states: “Safety and efficacy in children below the age of 18 years have not been established.”

    US prescribing information · 7fa41601-7fb5-4155-8e50-2ae903f0d2d6 · read 2026-08-30

  • On older people, the label states: “More than 4500 patients with AF or AFL aged 65 years or above were included in the MULTAQ clinical program (of whom more than 2000 patients were 75 years or older).”

    US prescribing information · 7fa41601-7fb5-4155-8e50-2ae903f0d2d6 · read 2026-08-30

  • On people who are pregnant, the label states: “Risk Summary MULTAQ may cause fetal harm when administered to a pregnant woman.”

    US prescribing information · 7fa41601-7fb5-4155-8e50-2ae903f0d2d6 · read 2026-08-30

  • On people who are breastfeeding, the label states: “Risk Summary There are no available data on the presence of dronedarone in human milk, the effects on the breastfed infant, or the effect on milk production.”

    US prescribing information · 7fa41601-7fb5-4155-8e50-2ae903f0d2d6 · read 2026-08-30

  • On people with reduced liver function, the label states: “Dronedarone is extensively metabolized by the liver.”

    US prescribing information · 7fa41601-7fb5-4155-8e50-2ae903f0d2d6 · read 2026-08-30

  • On people with reduced kidney function, the label states: “Patients with renal impairment were included in clinical studies.”

    US prescribing information · 7fa41601-7fb5-4155-8e50-2ae903f0d2d6 · read 2026-08-30

Where the result stopped carrying

  • This is a scope explorer, not a diagnosis engine.
  • It shows who was studied so you can see whether people similar to you were included.

RNAWiki cannot tell whether a study fits you. It can show who was in it.

What it would be like to takeRead from sources, not yet reviewed

Why it might seem to do nothing

A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.

It was studied in different people

The people in the studies were not much like the reader.

On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

The evidence may simply be wrong

Small early studies often do not hold up.

On this record: RNAWiki has not yet published a reviewed conclusion for this use.

Other reasons RNAWiki checked and found nothing for (11)
It was studied for a different goal
The studies measured something else entirely. Nothing in this record points to this reason.
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.

None of these is a reason to take more. Taking more is not a step this page ever suggests.

What it would be like to takeRead from sources, not yet reviewed

What taking it involves

The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.

How it is supplied

Prescription only

Quoted from a source

Where this came from

Copied from a source RNAWiki stored, with the source named.

Read from the recorded approval status.

No source is stored against this line.

Form and route

Oral

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The form and route recorded on this substance.

No source is stored against this line.

Who oversees it

Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.

Quoted from a source

Where this came from

Copied from a source RNAWiki stored, with the source named.

Suppression classes recorded: S1, S3, S6.

No source is stored against this line.

What is in the pack

Sold as tablet, tablet, film coated, given by the oral route.

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

Recorded notes on how this is sold and what that means for what is in the pack.

No source is stored against this line.

Where it is registered

Regulatory records are listed in the technical disclosure at the foot of this page.

Counted from records

Where this came from

A count of rows RNAWiki holds. It describes our records, not your body.

Register entries are stored per jurisdiction and shown with their dates.

No source is stored against this line.

Why people stop

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

No record of why people stopped taking it is stored for this substance.

No source is stored against this line.

What it would be like to takeNothing found in the sources checked

What can go wrong

Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.

Nothing found in the sources checked

No harm is recorded against this substance in the sources RNAWiki checked. Finding nothing is not the same as showing there is nothing.

The sources listed were searched and held nothing. That is not the same as nothing existing.

Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.

Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

What is missing or unclearRead from sources, not yet reviewed

Does the exact form matter?

Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.

The form that was studied

Oral

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The form used in the studies cited on this page.

No source is stored against this line.

What is sold

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

Nothing further is recorded about which forms are sold.

No source is stored against this line.

What is recorded as being sold

  • 11 products list this as an active ingredient in the United States drug directory. 11 of them contain it and nothing else.

    FDA National Drug Code directory · 14593-866 · read 2026-08-29

  • They are sold as powder and tablet, film coated, taken oral.

    FDA National Drug Code directory · 14593-866 · read 2026-08-29

  • The regulator's established pharmacologic class for it is antiarrhythmic [epc], cytochrome p450 2d6 inhibitors [moa] and cytochrome p450 3a inhibitors [moa].

    FDA National Drug Code directory · 14593-866 · read 2026-08-29

  • 2 published labels name it as an active ingredient. 2 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · 7fa41601-7fb5-4155-8e50-2ae903f0d2d6 · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · 7fa41601-7fb5-4155-8e50-2ae903f0d2d6 · read 2026-08-29

  • Multaq is oral at 3 DOSAGE FORMS AND STRENGTHS MULTAQ 400 mg tablets are provided as white film-coated tablets for oral administration, oblong-shaped, engraved with a double wave marking on one side and "4142" code on the other side. 400…, recorded as fda label in effect 2025-05-29 in the United States.

    US prescribing information · 7fa41601-7fb5-4155-8e50-2ae903f0d2d6 · read 2026-08-30

Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.

What it would be like to takeRead from sources, not yet reviewed

What you could measure

This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.

Self-experiment planning is not offered for a prescription or clinician-supervised medicine. The questions below are for a clinician or pharmacist.

Questions worth asking

  • Which of the trials of Dronedarone studied people like me?
  • What was measured, and for how long?
  • Was the result a laboratory value or a health outcome?
  • What would we watch for, and when would we stop?

Tracking can show whether something changed for you. It cannot show what caused it.

RNAWiki records evidence. It does not say whether this substance is right for you.

What is missing or unclearRead from sources, not yet reviewed

What nobody knows yet

Open questions, each with why it is open and what would close it.

Missing populations

Which groups were under-represented in the studies has not been recorded.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Missing long-term data

No completed tested study window is recorded.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

No reviewed conclusion

RNAWiki has not yet published a reviewed conclusion for this use.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Missing interaction studies

No interaction was found in the registers checked. Not finding one is not the same as showing there is none.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Formulation uncertainty

Several salts, forms or products of Dronedarone are recorded. Results from one form may not transfer to another.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Mechanism not reviewed

No reviewed mechanism story exists for this substance.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

What happened in peopleRead from sources, not yet reviewed

Check any of this yourself

Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.

How many documents were read

  • 2 documents were read for this substance.

    RNAWiki source record

  • 2 of them state the same halfLife, and they agree.

    RNAWiki source record

  • 2 of them state the same bioavailability, and they agree.

    RNAWiki source record

  • 2 of them state the same proteinBinding, and they agree.

    RNAWiki source record

  • 2 of them state the same volumeOfDistribution, and they agree.

    RNAWiki source record

Where else this substance is registered

FDA substance identifier (UNII)
JQZ1L091Y2
RxNorm concept
854856

Checks this page had to pass

  • Passed

    Identity resolved

    no open identity hold

  • Passed

    No unresolved merge across substance families

    no quarantine open

  • Passed

    Every public sentence names a source

    The opening statement carries the origin: Written into the record, not signed off.

  • Not passed

    Trial roles classified for highlighted evidence

    No registered study is classified as testing this substance.

  • Passed

    No internal keys in reader text

    enforced by the copy-contract test over the rendered page

  • Passed

    Safety mode resolved

    Suppression classes recorded: S1, S3, S6.

  • Passed

    Canonical metadata present

    slug and display name present

What is missing or unclearRead from sources, not yet reviewed

How this medicine reached us

Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.

What the approval register records

  • 8 approved applications cover products containing this substance. The earliest was NDA022425, approved 20090701 to SANOFI AVENTIS US.

    Drugs@FDA application register · NDA022425 · read 2026-08-29

  • Marketing status on the register: discontinued, none (tentative approval) and prescription.

    Drugs@FDA application register · NDA022425 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20090701.

    FDA National Drug Code directory · 14593-866 · read 2026-08-29

What is missing or unclearRead from sources, not yet reviewed

What to learn next

Ordered by what would most change how you read this page, starting with what is easiest to misunderstand.

This order is fixed in code and does not count clicks or time on the page.

What is not here

9 questions this page could not answer

These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.

  • What was measured, goal by goal — found nothing in the sources checked.
  • How close this is to real life — found nothing in the sources checked.
  • The path through the body — found nothing in the sources checked.
  • Felt, measured, or meaningful — found nothing in the sources checked.
  • How long anything takes — found nothing in the sources checked.
  • What it may clash with — found nothing in the sources checked.
  • Other ways to the same goal — found nothing in the sources checked.
  • Claims that go past the evidence — found nothing in the sources checked.
  • What changed on this page — found nothing in the sources checked.

The record as stored

The full record, for auditing

Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.

Recorded evidence blocks (10)

On the Dronedarone label: indicated for what?


"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) [see Clinical Studies (14) ] . MULTAQ is an antiarrhythmic drug indicated to reduce the risk of hospitalization for atrial fibrillation…": indications and usage on Dronedarone's label. DailyMed label · 3bd4006a-8bad-4909-ac6d-b6d84390155c · 2026-01-27

29 registered trials of Dronedarone — at which phases?


Registered studies posting no result
21 of 29

29 registered studies of Dronedarone: 11 phase4, 9 phase3, 6 na, 3 phase2, 1 na or unstated. CLINICALTRIALS_SNAPSHOT · 2026-09-01

49 with a PubMed record

Show the evidence
  • phase4
    11
  • phase3
    9
  • na
    6
  • phase2
    3
  • na or unstated
    1
  • completed
    16
3 more recorded rows
  • terminated
    6
  • unknown
    6
  • not yet recruiting
    1

recorded 2026-09-01 · last checked 2026-09-04

4 of Dronedarone's trials stopped: safety, funding/business, other?


safety (2), funding/business (1) and other (1): Dronedarone's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01

"Terminated as the active treatment was associated with an increased hazard"; 4 of 29 registered studies

Show the evidence

Trial

  • NCT00696631
    terminated; "Terminated as the active treatment was associated with an increased hazard"
  • NCT01026090
    terminated; "'Sponsor decision following recruitment issues, not related to any safety concerns in the study"
  • NCT01151137
    terminated; "The study was stopped because of safety concerns"
  • NCT04704050
    terminated; "Sponsor withdrew funding"

recorded 2026-09-01 · last checked 2026-09-04

Human studies of Dronedarone used dronedarone 400 mg Oral Tablet — over how long?


studies of Dronedarone used the recorded amount. ClinicalTrials.gov · 2026-09-01

1 recorded entry; human; also "dronedarone 400 mg Oral Tablet"

Show the evidence
  • human NCT04704050
    dronedarone 400 mg Oral Tablet

recorded 2026-09-01 · last checked 2026-09-04

Dronedarone's half-life is 13 to 19 hours — which schedules were studied?


13 to 19 hours, the half-life Dronedarone's label states: "Its elimination half-life is 13 to 19 hours." DailyMed label · 3bd4006a-8bad-4909-ac6d-b6d84390155c · 2026-01-27

tmax 3 to 6 hours; bioavailability 4 %.

Show the evidence
  • half life pharmacokinetics
    13 to 19 hours; Its elimination half-life is 13 to 19 hours.
  • tmax pharmacokinetics
    3 to 6 hours; After oral administration in fed conditions, peak plasma concentrations of dronedarone and the main circulating active metabolite (N-debutyl metabolite) are reached within 3 to 6 hours.
  • bioavailability pharmacokinetics
    4 %; Absorption Because of presystemic first pass metabolism the absolute bioavailability of dronedarone without food is low, about 4%.
  • metabolism pharmacokinetics
    Dronedarone is extensively metabolized and has low systemic bioavailability; its bioavailability is increased by meals.

recorded 2026-01-27 · last checked 2026-09-04

Which 12 trials of Dronedarone posted no result?


Posted no result
12 of 12 completed trials
Registrations
NCT00259428, NCT00259376, NCT00697086, NCT01213368, NCT01047566 and NCT01140581, and 6 more
Completion dates
oldest 2003-08; newest 2024-06-30
Show the evidence

Trial

  • NCT00259428
    2003-08
  • NCT00259376
    2003-09
  • NCT00697086
    2004-06
  • NCT01213368
    2011-04
  • NCT01047566
    2011-09
  • NCT01140581
    2011-12
6 further recorded trials
  • NCT01199081
    2012-04
  • NCT01991119
    2013-10
  • NCT05279833
    2022-03-31
  • NCT07396519
    2022-12-07
  • NCT07396506
    2023-07-10
  • NCT05130268
    2024-06-30

At the median, Dronedarone's trials enrolled 174 people — anything larger?


Median enrolment
174
Largest enrolment
87810
Registered trials counted
29

What do 2125 spontaneous reports say about Dronedarone — and not say?


These are reports people sent to a regulator. They do not show the medicine caused the reaction. Nobody counted how many people took the medicine and reported nothing. The same event can be reported more than once, and many reports are incomplete. News coverage, lawsuits and new warnings change how often people report. A count is not a rate and not a risk.

Dronedarone appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 2125 reaction mentions were counted: atrial fibrillation 500; dyspnoea 331; cardiac failure 291; blood creatinine increased 237. FAERS via Open Targets · CHEMBL1201729 · 2026-06-24

Show the evidence
  • atrial fibrillation
    500
  • dyspnoea
    331
  • cardiac failure
    291
  • blood creatinine increased
    237
  • drug interaction
    211
  • international normalised ratio increased
    139
4 more recorded rows
  • cardiac failure congestive
    121
  • alanine aminotransferase increased
    103
  • oedema peripheral
    99
  • bradycardia
    93

recorded 2026-06-24 · last checked 2026-09-04

Which 10 reactions does Dronedarone's label not list?


alanine aminotransferase increased, atrial fibrillation and blood creatinine increased and 7 more reported for Dronedarone, absent from its label. FAERS via Open Targets · CHEMBL1201729 · 2026-06-24

2 label terms; 10 reported and unlisted; 3bd4006a-8bad-4909-ac6d-b6d84390155c

Show the evidence
  • alanine aminotransferase increased
    count not stated
  • atrial fibrillation
    count not stated
  • blood creatinine increased
    count not stated
  • bradycardia
    count not stated
  • cardiac failure
    count not stated
  • cardiac failure congestive
    count not stated
4 more recorded rows
  • drug interaction
    count not stated
  • dyspnoea
    count not stated
  • international normalised ratio increased
    count not stated
  • oedema peripheral
    count not stated

recorded 2026-06-24 · last checked 2026-09-04

Dronedarone and CYP3A, P-GP and CYP2D6: shared by which compounds?


CYP3A, P-GP and CYP2D6 appear in Dronedarone's recorded interaction sentences, 8 in all. DailyMed label · 3bd4006a-8bad-4909-ac6d-b6d84390155c · 2026-01-27

CYP2D6, CYP3A, CYP3A, CYP3A, P-gp; 5 shared nodes; drug_interactions

Show the evidence

Interaction statement

  • drug_interactions
    Dronedarone is metabolized by CYP3A and is a moderate inhibitor of CYP3A and CYP2D6 and has potentially important pharmacodynamic interactions ( 7 ) • Class I or III antiarrhythmics: Contraindicated.
  • drug_interactions
    ( 7.1 , 7.3 ) • CYP3A inducers: Avoid concomitant use.
  • drug_interactions
    Follow label recommendations for concomitant use of other statins with a CYP3A and P-gp inhibitor like dronedarone.
  • drug_interactions
    ( 7.3 ) • CYP3A substrates with a narrow therapeutic index (e.g., sirolimus and tacrolimus): Monitor and adjust dosage of concomitant drug as needed when used with MULTAQ.
  • drug_interactions
    7.2 Effects of Other Drugs on Dronedarone Ketoconazole and Other Potent CYP3A Inhibitors Concomitant use of ketoconazole as well as other potent CYP3A inhibitors such as itraconazole, voriconazole, ritonavir, clarithromycin, and nefazodone is contraindicated because exposure to dronedarone is significantly increased [see Contraindications (4) , Clinical Pharmacology (12.3) ] .
  • drug_interactions
    Rifampin and Other CYP3A Inducers Avoid rifampin or other CYP3A inducers such as phenobarbital, carbamazepine, phenytoin, and St.
2 more recorded rows
  • Interaction statement drug_interactions
    Calcium Channel Blockers Verapamil and diltiazem are moderate CYP3A inhibitors and increase dronedarone exposure.
  • Interaction statement drug_interactions
    Other Statins Because of multiple mechanisms of interaction with statins (CYPs and transporters), follow statin label recommendations for use with CYP3A and P-gp inhibitors such as dronedarone.
  • CYP2D6
    FINGOLIMOD LAURYL SULFATE, Darunavir Propylene Glycolate, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Rasagiline, Sofpironium, Fluoxetine

CYP3A

  • FINGOLIMOD LAURYL SULFATE, Darunavir Propylene Glycolate, Vincristine, Naldemedine, Pemetrexed, Eravacycline, Rasburicase, Repotrectinib
  • FINGOLIMOD LAURYL SULFATE, Darunavir Propylene Glycolate, Vincristine, Naldemedine, Pemetrexed, Eravacycline, Rasburicase, Repotrectinib
  • FINGOLIMOD LAURYL SULFATE, Darunavir Propylene Glycolate, Vincristine, Naldemedine, Pemetrexed, Eravacycline, Rasburicase, Repotrectinib
  • P-gp
    FINGOLIMOD LAURYL SULFATE, ERYTHROMYCIN LACTOBIONATE, Darunavir Propylene Glycolate, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Ceftobiprole Medocaril, Vincristine

recorded 2026-01-27 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL1201729
PubChem CID
219025
CAS number
141625-93-6
RxCUI
736680
InChIKey
ZQTNQVWKHCQYLQ-UHFFFAOYSA-N
Also called
DRONEDARONE HYDROCHLORIDE, Dronedarona, Dronedarone hydrochloride [EP MONOGRAPH], Dronedarone hydrochloride [MART.], Dronedarone hydrochloride [MI], Dronedarone hydrochloride [ORANGE BOOK], Dronedarone hydrochloride [USAN], Dronedarone hydrochloride [USP MONOGRAPH], Dronedarone hydrochloride [USP-RS], Dronedarone hydrochloride [WHO-DD]
Salt form
Dronedarone hcl, dronedarone hydrochloride tablets, Dronedarone Hydrochloride / Multaq
Trade name
Multaq
Development code
SR-33598B, SR33598B, SR-33589, SR33589
Sources (6)

Sources

ChEMBL 37 — CC BY-SA 3.0 Unported · ClinicalTrials.gov — US Government work · Open Targets 26.06 — CC0 · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work

How these records are assembled · Which registers were checked

Index-quality checks
  • identity passed: no open identity hold
  • required summary fields resolved: 4 required field(s) not terminal: Why people use it, Best-supported result, Biggest unanswered question, Human evidence
  • public claims reviewed: 0 reviewed claim(s); drafts are never rendered
  • source coverage passed: 6 source rows
  • no critical contamination: no quarantine open
  • canonical metadata passed: slug and display name present
  • no raw internal fields: enforced by the copy-contract test over the rendered page

This is a record of evidence. It is not medical advice, and it does not say this substance suits you. Nothing here says any substance on RNAWiki is appropriate for a child.