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Details

Stereochemistry ACHIRAL
Molecular Formula C31H44N2O5S
Molecular Weight 556.756
Optical Activity NONE
Defined Stereocenters 0 / 0
E/Z Centers 0
Charge 0

SHOW SMILES / InChI
Structure of Dronedarone

SMILES

CCCCN(CCCC)CCCOC1=CC=C(C=C1)C(=O)C2=C(CCCC)OC3=C2C=C(NS(C)(=O)=O)C=C3

InChI

InChIKey=ZQTNQVWKHCQYLQ-UHFFFAOYSA-N
InChI=1S/C31H44N2O5S/c1-5-8-12-29-30(27-23-25(32-39(4,35)36)15-18-28(27)38-29)31(34)24-13-16-26(17-14-24)37-22-11-21-33(19-9-6-2)20-10-7-3/h13-18,23,32H,5-12,19-22H2,1-4H3

HIDE SMILES / InChI

Molecular Formula C31H44N2O5S
Molecular Weight 556.756
Charge 0
Count
Stereochemistry ACHIRAL
Additional Stereochemistry No
Defined Stereocenters 0 / 0
E/Z Centers 0
Optical Activity NONE

Description
Curator's Comment: description was created based on several sources, including: https://www.drugs.com/ppa/dronedarone.html | https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7fa41601-7fb5-4155-8e50-2ae903f0d2d6 | http://www.rxlist.com/multaq-drug.htm

Dronedarone is an antiarrhythmic that is FDA approved for the treatment of atrial fibrillation in patients in sinus rhythm with a history of paroxysmal or persistent atrial fibrillation (AF). Dronedarone is multichannel blocker. Common adverse reactions include abdominal pain, diarrhea, indigestion, nausea, vomiting, asthenia and raised serum creatinine. Dronedarone has potentially important pharmacodynamics interactions: Digoxin: Consider discontinuation or halve dose of digoxin before treatment and monitor; Calcium channel blockers (CCB): Initiate CCB with low dose and increase after ECG verification of tolerability; Beta-blockers: May provoke excessive bradycardia, Initiate with low dose and increase after ECG verification of tolerability.

Approval Year

TargetsConditions

Conditions

ConditionModalityTargetsHighest PhaseProduct
Primary
MULTAQ

Approved Use

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)

Launch Date

2009
Primary
MULTAQ

Approved Use

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)

Launch Date

2009
Cmax

Cmax

ValueDoseCo-administeredAnalytePopulation
96.2 ng/mL
1600 mg single, oral
dose: 1600 mg
route of administration: Oral
experiment type: SINGLE
co-administered: METOPROLOL
DRONEDARONE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: UNKNOWN
food status: UNKNOWN
AUC

AUC

ValueDoseCo-administeredAnalytePopulation
1386 ng × h/mL
1600 mg single, oral
dose: 1600 mg
route of administration: Oral
experiment type: SINGLE
co-administered: METOPROLOL
DRONEDARONE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: UNKNOWN
food status: UNKNOWN
T1/2

T1/2

ValueDoseCo-administeredAnalytePopulation
12 h
1600 mg single, oral
dose: 1600 mg
route of administration: Oral
experiment type: SINGLE
co-administered: METOPROLOL
DRONEDARONE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: UNKNOWN
food status: UNKNOWN
Doses

Doses

DosePopulationAdverse events​
400 mg 2 times / day steady, oral
Recommended
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
unhealthy, 20-97 years
Health Status: unhealthy
Age Group: 20-97 years
Sex: M+F
Sources:
Disc. AE: Gastrointestinal disorders, QT interval prolonged...
AEs leading to
discontinuation/dose reduction:
Gastrointestinal disorders (3.2%)
QT interval prolonged (1.5%)
Sources:
1600 mg 2 times / day multiple, oral
Highest studied dose
Dose: 1600 mg, 2 times / day
Route: oral
Route: multiple
Dose: 1600 mg, 2 times / day
Sources:
healthy, 21-40 years
400 mg 2 times / day steady, oral
Recommended
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
Disc. AE: Diarrhea, Nausea...
AEs leading to
discontinuation/dose reduction:
Diarrhea (6.7%)
Nausea (3.9%)
Abdominal pain upper (2%)
Abdominal pain (1.9%)
Vomiting (1.7%)
Dyspepsia (1.3%)
Nasopharyngitis (3.7%)
Upper respiratory tract infection (2.9%)
Dizziness (3.4%)
Blood creatinine increased (2.5%)
Hepatic enzyme increased (1.2%)
Blood urea increased (0.4%)
Bradycardia (2.6%)
Palpitations (1.1%)
Cardiac failure congestive (1.3%)
Cardiac failure (0.8%)
Fatigue (2.7%)
Oedema peripheral (4.2%)
Back pain (3.3%)
Arthralgia (3.1%)
Pain in extremity (2.1%)
Cough (2.2%)
Dyspnoea (2.3%)
Vertigo (1.3%)
Sources:
400 mg 2 times / day steady, oral
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sources:
Other AEs: Heart failure...
600 mg 2 times / day multiple, oral
Dose: 600 mg, 2 times / day
Route: oral
Route: multiple
Dose: 600 mg, 2 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
Disc. AE: Diarrhea, Vomiting...
AEs leading to
discontinuation/dose reduction:
Diarrhea (7.6%)
Vomiting (1.5%)
Dyspepsia (3%)
Abdominal pain (1.5%)
Nasopharyngitis (4.5%)
Electrocardiogram QT prolonged (1.5%)
Blood creatinine increased (1.5%)
Hepatic enzyme increased (4.5%)
Blood urea increased (3%)
Bradycardia (1.5%)
Palpitations (6.1%)
Cardiac failure congestive (4.5%)
Cardiac failure (4.5%)
Fatigue (4.5%)
Cough (1.5%)
Hypokalemia (3%)
Vertigo (4.5%)
Sources:
800 mg 2 times / day multiple, oral
Dose: 800 mg, 2 times / day
Route: oral
Route: multiple
Dose: 800 mg, 2 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
Disc. AE: Diarrhea, Nausea...
AEs leading to
discontinuation/dose reduction:
Diarrhea (29%)
Nausea (8.1%)
Vomiting (3.2%)
Abdominal pain (3.2%)
Influenza (3.2%)
Upper respiratory tract infection (1.6%)
Dizziness (4.8%)
Electrocardiogram QT prolonged (3.2%)
Hepatic enzyme increased (1.6%)
Blood urea increased (3.2%)
Bradycardia (6.5%)
Palpitations (4.8%)
Cardiac failure congestive (1.6%)
Cardiac failure (1.6%)
Fatigue (3.2%)
Atrial tachycardia (4.8%)
Cough (4.8%)
Vertigo (3.2%)
Sources:
AEs

AEs

AESignificanceDosePopulation
QT interval prolonged 1.5%
Disc. AE
400 mg 2 times / day steady, oral
Recommended
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
unhealthy, 20-97 years
Health Status: unhealthy
Age Group: 20-97 years
Sex: M+F
Sources:
Gastrointestinal disorders 3.2%
Disc. AE
400 mg 2 times / day steady, oral
Recommended
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
unhealthy, 20-97 years
Health Status: unhealthy
Age Group: 20-97 years
Sex: M+F
Sources:
Blood urea increased 0.4%
Disc. AE
400 mg 2 times / day steady, oral
Recommended
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
Cardiac failure 0.8%
Disc. AE
400 mg 2 times / day steady, oral
Recommended
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
Palpitations 1.1%
Disc. AE
400 mg 2 times / day steady, oral
Recommended
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
Hepatic enzyme increased 1.2%
Disc. AE
400 mg 2 times / day steady, oral
Recommended
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
Cardiac failure congestive 1.3%
Disc. AE
400 mg 2 times / day steady, oral
Recommended
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
Dyspepsia 1.3%
Disc. AE
400 mg 2 times / day steady, oral
Recommended
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
Vertigo 1.3%
Disc. AE
400 mg 2 times / day steady, oral
Recommended
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
Vomiting 1.7%
Disc. AE
400 mg 2 times / day steady, oral
Recommended
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
Abdominal pain 1.9%
Disc. AE
400 mg 2 times / day steady, oral
Recommended
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
Abdominal pain upper 2%
Disc. AE
400 mg 2 times / day steady, oral
Recommended
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
Pain in extremity 2.1%
Disc. AE
400 mg 2 times / day steady, oral
Recommended
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
Cough 2.2%
Disc. AE
400 mg 2 times / day steady, oral
Recommended
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
Dyspnoea 2.3%
Disc. AE
400 mg 2 times / day steady, oral
Recommended
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
Blood creatinine increased 2.5%
Disc. AE
400 mg 2 times / day steady, oral
Recommended
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
Bradycardia 2.6%
Disc. AE
400 mg 2 times / day steady, oral
Recommended
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
Fatigue 2.7%
Disc. AE
400 mg 2 times / day steady, oral
Recommended
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
Upper respiratory tract infection 2.9%
Disc. AE
400 mg 2 times / day steady, oral
Recommended
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
Arthralgia 3.1%
Disc. AE
400 mg 2 times / day steady, oral
Recommended
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
Back pain 3.3%
Disc. AE
400 mg 2 times / day steady, oral
Recommended
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
Dizziness 3.4%
Disc. AE
400 mg 2 times / day steady, oral
Recommended
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
Nasopharyngitis 3.7%
Disc. AE
400 mg 2 times / day steady, oral
Recommended
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
Nausea 3.9%
Disc. AE
400 mg 2 times / day steady, oral
Recommended
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
Oedema peripheral 4.2%
Disc. AE
400 mg 2 times / day steady, oral
Recommended
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
Diarrhea 6.7%
Disc. AE
400 mg 2 times / day steady, oral
Recommended
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
Heart failure grade 5
400 mg 2 times / day steady, oral
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sources:
Abdominal pain 1.5%
Disc. AE
600 mg 2 times / day multiple, oral
Dose: 600 mg, 2 times / day
Route: oral
Route: multiple
Dose: 600 mg, 2 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
Blood creatinine increased 1.5%
Disc. AE
600 mg 2 times / day multiple, oral
Dose: 600 mg, 2 times / day
Route: oral
Route: multiple
Dose: 600 mg, 2 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
Bradycardia 1.5%
Disc. AE
600 mg 2 times / day multiple, oral
Dose: 600 mg, 2 times / day
Route: oral
Route: multiple
Dose: 600 mg, 2 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
Cough 1.5%
Disc. AE
600 mg 2 times / day multiple, oral
Dose: 600 mg, 2 times / day
Route: oral
Route: multiple
Dose: 600 mg, 2 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
Electrocardiogram QT prolonged 1.5%
Disc. AE
600 mg 2 times / day multiple, oral
Dose: 600 mg, 2 times / day
Route: oral
Route: multiple
Dose: 600 mg, 2 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
Vomiting 1.5%
Disc. AE
600 mg 2 times / day multiple, oral
Dose: 600 mg, 2 times / day
Route: oral
Route: multiple
Dose: 600 mg, 2 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
Blood urea increased 3%
Disc. AE
600 mg 2 times / day multiple, oral
Dose: 600 mg, 2 times / day
Route: oral
Route: multiple
Dose: 600 mg, 2 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
Dyspepsia 3%
Disc. AE
600 mg 2 times / day multiple, oral
Dose: 600 mg, 2 times / day
Route: oral
Route: multiple
Dose: 600 mg, 2 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
Hypokalemia 3%
Disc. AE
600 mg 2 times / day multiple, oral
Dose: 600 mg, 2 times / day
Route: oral
Route: multiple
Dose: 600 mg, 2 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
Cardiac failure congestive 4.5%
Disc. AE
600 mg 2 times / day multiple, oral
Dose: 600 mg, 2 times / day
Route: oral
Route: multiple
Dose: 600 mg, 2 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
Cardiac failure 4.5%
Disc. AE
600 mg 2 times / day multiple, oral
Dose: 600 mg, 2 times / day
Route: oral
Route: multiple
Dose: 600 mg, 2 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
Fatigue 4.5%
Disc. AE
600 mg 2 times / day multiple, oral
Dose: 600 mg, 2 times / day
Route: oral
Route: multiple
Dose: 600 mg, 2 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
Hepatic enzyme increased 4.5%
Disc. AE
600 mg 2 times / day multiple, oral
Dose: 600 mg, 2 times / day
Route: oral
Route: multiple
Dose: 600 mg, 2 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
Nasopharyngitis 4.5%
Disc. AE
600 mg 2 times / day multiple, oral
Dose: 600 mg, 2 times / day
Route: oral
Route: multiple
Dose: 600 mg, 2 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
Vertigo 4.5%
Disc. AE
600 mg 2 times / day multiple, oral
Dose: 600 mg, 2 times / day
Route: oral
Route: multiple
Dose: 600 mg, 2 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
Palpitations 6.1%
Disc. AE
600 mg 2 times / day multiple, oral
Dose: 600 mg, 2 times / day
Route: oral
Route: multiple
Dose: 600 mg, 2 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
Diarrhea 7.6%
Disc. AE
600 mg 2 times / day multiple, oral
Dose: 600 mg, 2 times / day
Route: oral
Route: multiple
Dose: 600 mg, 2 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
Cardiac failure congestive 1.6%
Disc. AE
800 mg 2 times / day multiple, oral
Dose: 800 mg, 2 times / day
Route: oral
Route: multiple
Dose: 800 mg, 2 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
Cardiac failure 1.6%
Disc. AE
800 mg 2 times / day multiple, oral
Dose: 800 mg, 2 times / day
Route: oral
Route: multiple
Dose: 800 mg, 2 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
Hepatic enzyme increased 1.6%
Disc. AE
800 mg 2 times / day multiple, oral
Dose: 800 mg, 2 times / day
Route: oral
Route: multiple
Dose: 800 mg, 2 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
Upper respiratory tract infection 1.6%
Disc. AE
800 mg 2 times / day multiple, oral
Dose: 800 mg, 2 times / day
Route: oral
Route: multiple
Dose: 800 mg, 2 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
Diarrhea 29%
Disc. AE
800 mg 2 times / day multiple, oral
Dose: 800 mg, 2 times / day
Route: oral
Route: multiple
Dose: 800 mg, 2 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
Abdominal pain 3.2%
Disc. AE
800 mg 2 times / day multiple, oral
Dose: 800 mg, 2 times / day
Route: oral
Route: multiple
Dose: 800 mg, 2 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
Blood urea increased 3.2%
Disc. AE
800 mg 2 times / day multiple, oral
Dose: 800 mg, 2 times / day
Route: oral
Route: multiple
Dose: 800 mg, 2 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
Electrocardiogram QT prolonged 3.2%
Disc. AE
800 mg 2 times / day multiple, oral
Dose: 800 mg, 2 times / day
Route: oral
Route: multiple
Dose: 800 mg, 2 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
Fatigue 3.2%
Disc. AE
800 mg 2 times / day multiple, oral
Dose: 800 mg, 2 times / day
Route: oral
Route: multiple
Dose: 800 mg, 2 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
Influenza 3.2%
Disc. AE
800 mg 2 times / day multiple, oral
Dose: 800 mg, 2 times / day
Route: oral
Route: multiple
Dose: 800 mg, 2 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
Vertigo 3.2%
Disc. AE
800 mg 2 times / day multiple, oral
Dose: 800 mg, 2 times / day
Route: oral
Route: multiple
Dose: 800 mg, 2 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
Vomiting 3.2%
Disc. AE
800 mg 2 times / day multiple, oral
Dose: 800 mg, 2 times / day
Route: oral
Route: multiple
Dose: 800 mg, 2 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
Atrial tachycardia 4.8%
Disc. AE
800 mg 2 times / day multiple, oral
Dose: 800 mg, 2 times / day
Route: oral
Route: multiple
Dose: 800 mg, 2 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
Cough 4.8%
Disc. AE
800 mg 2 times / day multiple, oral
Dose: 800 mg, 2 times / day
Route: oral
Route: multiple
Dose: 800 mg, 2 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
Dizziness 4.8%
Disc. AE
800 mg 2 times / day multiple, oral
Dose: 800 mg, 2 times / day
Route: oral
Route: multiple
Dose: 800 mg, 2 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
Palpitations 4.8%
Disc. AE
800 mg 2 times / day multiple, oral
Dose: 800 mg, 2 times / day
Route: oral
Route: multiple
Dose: 800 mg, 2 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
Bradycardia 6.5%
Disc. AE
800 mg 2 times / day multiple, oral
Dose: 800 mg, 2 times / day
Route: oral
Route: multiple
Dose: 800 mg, 2 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
Nausea 8.1%
Disc. AE
800 mg 2 times / day multiple, oral
Dose: 800 mg, 2 times / day
Route: oral
Route: multiple
Dose: 800 mg, 2 times / day
Sources:
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
OverviewDrug as perpetrator​

Drug as perpetrator​

TargetModalityActivityMetaboliteClinical evidence
likely
likely
moderate [Ki 8.12 uM]
yes (co-administration study)
Comment: dronedarone increased verapamil exposure by 1.4- fold, and nisoldipine exposure by 1.5- fold; dronedarone increased simvastatin, a sensitive CYP3A substrate, and simvastatin acid exposure by 4- fold and 2- fold, respectively;
Page: 76,89,194
no
no
no
no
no
no
not significant
not significant
not significant
not significant
not significant
not significant
not significant
weak (co-administration study)
Comment: dronedarone increased S-warfarin exposure by 1.2- fold
Page: 76.0
strong [IC50 0.97 uM]
yes (co-administration study)
Comment: IC50 value obtained using vincristine as substrate; increased S-warfarin exposure by 1.2- fold
Page: 76,90
weak [Ki 4.37 uM]
yes (co-administration study)
Comment: dronedarone increased metoprolol exposure by 1.6- and 2.3- fold, respectively; increased propranolol exposure by 1.3- fold;
Page: 76,89,194
Drug as victim

Drug as victim

TargetModalityActivityMetaboliteClinical evidence
major
yes (co-administration study)
Comment: administration of ketoconazole resulted in a 17- to 25- fold increase in dronedarone exposure; administration with rifampicin decreased dronedarone exposure by 80%
Page: 76,89
no
no
unlikely
Tox targets

Tox targets

TargetModalityActivityMetaboliteClinical evidence
PubMed

PubMed

TitleDatePubMed
Newer antiarrhythmic drugs.
2001 May-Jun
Chronic and acute effects of dronedarone on the action potential of rabbit atrial muscle preparations: comparison with amiodarone.
2002 May
Effects of amiodarone and dronedarone on voltage-dependent sodium current in human cardiomyocytes.
2003 Aug
Electrophysiologic characterization of dronedarone in guinea pig ventricular cells.
2003 Feb
Trials of new antiarrhythmic drugs for maintenance of sinus rhythm in patients with atrial fibrillation.
2004
Oral class III antiarrhythmics: what is new?
2004 Jan
The novel antiarrhythmic drug dronedarone: comparison with amiodarone.
2005 Fall
Pharmacological treatment of atrial fibrillation: mechanisms of action and efficacy of class III drugs.
2006
[Dronedarone--a new therapeutic option for controlling atrial rhythm and ventricular frequency].
2006 Aug 25
Do we need pharmacological therapy for atrial fibrillation in the ablation era?
2006 Dec
Dronedarone: a new antiarrhythmic agent.
2006 Feb
Dose-dependent effects of oral dronedarone on the circadian variation of RR and QT intervals in healthy subjects: implications for antiarrhythmic actions.
2006 Sep
Drug evaluation: dronedarone, a novel non-iodinated anti-arrhythmic agent.
2006 Sep
Topics on the Na+/Ca2+ exchanger: pharmacological characterization of Na+/Ca2+ exchanger inhibitors.
2006 Sep
Dronedarone: an emerging agent with rhythm- and rate-controlling effects.
2006 Sep
Dronedarone: an amiodarone analog for the treatment of atrial fibrillation and atrial flutter.
2007 Apr
Maintaining sinus rhythm--making treatment better than the disease.
2007 Sep 6
Dronedarone for maintenance of sinus rhythm in atrial fibrillation or flutter.
2007 Sep 6
[Efficacy of dronedarone for maintenance of sinus rhythm in atrial fibrillation or flutter. Results of the EURIDIS and ADONIS].
2008
Relationship among amiodarone, new class III antiarrhythmics, miscellaneous agents and acquired long QT syndrome.
2008
[Amiodaron for treatment of perioperative cardiac arrythmia: a broad spectrum antiarrythmetic agent?].
2008 Dec
Pharmacotherapy for atrial arrhythmias: present and future.
2008 Jun
Acute inhibitory effect of dronedarone, a noniodinated benzofuran analogue of amiodarone, on Na+/Ca2+ exchange current in guinea pig cardiac ventricular myocytes.
2008 Jun
Dronedarone: a new treatment for atrial fibrillation.
2008 Nov
Dronedarone for the control of ventricular rate in permanent atrial fibrillation: the Efficacy and safety of dRonedArone for the cOntrol of ventricular rate during atrial fibrillation (ERATO) study.
2008 Sep
New horizons in antiarrhythmic therapy: will novel agents overcome current deficits?
2008 Sep 22
Trial watch: novel antiarrhythmic agent shows promise in Phase III trial.
2009 Apr
Alternatives to amiodarone: search for the Holy Grail.
2009 Apr
Dronedarone for atrial fibrillation--an odyssey.
2009 Apr 30
Effect of dronedarone on cardiovascular events in atrial fibrillation.
2009 Feb 12
Benzofuran derivatives and the thyroid.
2009 Jan
Major recent trials in cardiovascular diseases.
2009 Mar
New pharmacological options for patients with atrial fibrillation: the ATHENA trial.
2009 May
Patents

Sample Use Guides

One tablet of 400 mg twice a day with morning and evening meals.
Route of Administration: Oral
In isolated ventricular myocytes, dronedarone inhibited rapidly activating delayed-rectifier K+ current (I(Kr)) (median inhibitory concentration [IC50] /= 30 uM).
Substance Class Chemical
Created
by admin
on Mon Mar 31 18:24:49 GMT 2025
Edited
by admin
on Mon Mar 31 18:24:49 GMT 2025
Record UNII
JQZ1L091Y2
Record Status Validated (UNII)
Record Version
  • Download
Name Type Language
SR-33589
Preferred Name English
Dronedarone
EMA EPAR   INN   MART.   MI   VANDF   WHO-DD  
INN  
Official Name English
Dronedarone [INN]
Common Name English
Methanesulfonamide, N-[2-butyl-3-[4-[3-(dibutylamino)propoxy]benzoyl]-5-benzofuranyl]-
Systematic Name English
SR33589
Code English
Dronedarone [VANDF]
Common Name English
N-[2-Butyl-3-[4-[3-(dibutylamino)propoxy]benzoyl]benzofuran-5-yl]methanesulfonamide
Systematic Name English
Dronedarone [EMA EPAR]
Common Name English
Dronedarone [WHO-DD]
Common Name English
N-[2-Butyl-3-[4-[3-(dibutylamino)propoxy]benzoyl]-5-benzofuranyl]methanesulfonamide
Systematic Name English
Dronedarone [MI]
Common Name English
Dronedarone [MART.]
Common Name English
Classification Tree Code System Code
WHO-VATC QC01BD07
Created by admin on Mon Mar 31 18:24:49 GMT 2025 , Edited by admin on Mon Mar 31 18:24:49 GMT 2025
LIVERTOX NBK548208
Created by admin on Mon Mar 31 18:24:49 GMT 2025 , Edited by admin on Mon Mar 31 18:24:49 GMT 2025
NDF-RT N0000175426
Created by admin on Mon Mar 31 18:24:49 GMT 2025 , Edited by admin on Mon Mar 31 18:24:49 GMT 2025
WHO-ATC C01BD07
Created by admin on Mon Mar 31 18:24:49 GMT 2025 , Edited by admin on Mon Mar 31 18:24:49 GMT 2025
NCI_THESAURUS C47793
Created by admin on Mon Mar 31 18:24:49 GMT 2025 , Edited by admin on Mon Mar 31 18:24:49 GMT 2025
Code System Code Type Description
WIKIPEDIA
DRONEDARONE
Created by admin on Mon Mar 31 18:24:49 GMT 2025 , Edited by admin on Mon Mar 31 18:24:49 GMT 2025
PRIMARY
DRUG BANK
DB04855
Created by admin on Mon Mar 31 18:24:49 GMT 2025 , Edited by admin on Mon Mar 31 18:24:49 GMT 2025
PRIMARY
NDF-RT
N0000185503
Created by admin on Mon Mar 31 18:24:49 GMT 2025 , Edited by admin on Mon Mar 31 18:24:49 GMT 2025
PRIMARY P-Glycoprotein Inhibitors [MoA]
RXCUI
233698
Created by admin on Mon Mar 31 18:24:49 GMT 2025 , Edited by admin on Mon Mar 31 18:24:49 GMT 2025
PRIMARY RxNorm
SMS_ID
100000081006
Created by admin on Mon Mar 31 18:24:49 GMT 2025 , Edited by admin on Mon Mar 31 18:24:49 GMT 2025
PRIMARY
PUBCHEM
208898
Created by admin on Mon Mar 31 18:24:49 GMT 2025 , Edited by admin on Mon Mar 31 18:24:49 GMT 2025
PRIMARY
MESH
C118667
Created by admin on Mon Mar 31 18:24:49 GMT 2025 , Edited by admin on Mon Mar 31 18:24:49 GMT 2025
PRIMARY
EPA CompTox
DTXSID3048653
Created by admin on Mon Mar 31 18:24:49 GMT 2025 , Edited by admin on Mon Mar 31 18:24:49 GMT 2025
PRIMARY
HSDB
7928
Created by admin on Mon Mar 31 18:24:49 GMT 2025 , Edited by admin on Mon Mar 31 18:24:49 GMT 2025
PRIMARY
MERCK INDEX
m4768
Created by admin on Mon Mar 31 18:24:49 GMT 2025 , Edited by admin on Mon Mar 31 18:24:49 GMT 2025
PRIMARY Merck Index
NDF-RT
N0000182137
Created by admin on Mon Mar 31 18:24:49 GMT 2025 , Edited by admin on Mon Mar 31 18:24:49 GMT 2025
PRIMARY Cytochrome P450 2D6 Inhibitors [MoA]
IUPHAR
7465
Created by admin on Mon Mar 31 18:24:49 GMT 2025 , Edited by admin on Mon Mar 31 18:24:49 GMT 2025
PRIMARY
CAS
141626-36-0
Created by admin on Mon Mar 31 18:24:49 GMT 2025 , Edited by admin on Mon Mar 31 18:24:49 GMT 2025
PRIMARY
EVMPD
SUB06408MIG
Created by admin on Mon Mar 31 18:24:49 GMT 2025 , Edited by admin on Mon Mar 31 18:24:49 GMT 2025
PRIMARY
DAILYMED
JQZ1L091Y2
Created by admin on Mon Mar 31 18:24:49 GMT 2025 , Edited by admin on Mon Mar 31 18:24:49 GMT 2025
PRIMARY
ChEMBL
CHEMBL184412
Created by admin on Mon Mar 31 18:24:49 GMT 2025 , Edited by admin on Mon Mar 31 18:24:49 GMT 2025
PRIMARY
NDF-RT
N0000190114
Created by admin on Mon Mar 31 18:24:49 GMT 2025 , Edited by admin on Mon Mar 31 18:24:49 GMT 2025
PRIMARY Cytochrome P450 3A Inhibitors [MoA]
CHEBI
50659
Created by admin on Mon Mar 31 18:24:49 GMT 2025 , Edited by admin on Mon Mar 31 18:24:49 GMT 2025
PRIMARY
NCI_THESAURUS
C65485
Created by admin on Mon Mar 31 18:24:49 GMT 2025 , Edited by admin on Mon Mar 31 18:24:49 GMT 2025
PRIMARY
INN
7382
Created by admin on Mon Mar 31 18:24:49 GMT 2025 , Edited by admin on Mon Mar 31 18:24:49 GMT 2025
PRIMARY
FDA UNII
JQZ1L091Y2
Created by admin on Mon Mar 31 18:24:49 GMT 2025 , Edited by admin on Mon Mar 31 18:24:49 GMT 2025
PRIMARY
DRUG CENTRAL
4112
Created by admin on Mon Mar 31 18:24:49 GMT 2025 , Edited by admin on Mon Mar 31 18:24:49 GMT 2025
PRIMARY
Related Record Type Details
METABOLIC ENZYME -> SUBSTRATE
MINOR
EXCRETED UNCHANGED
Mass balance indicates that orally administered dronedarone is ultimately excreted in the urine (6 %) and feces (84 %) primarily as metabolites. Dronedarone was extensively metabolized; only low amounts of dronedarone were detected in feces and dronedarone was non-existent in urine.
AMOUNT EXCRETED
URINE
SALT/SOLVATE -> PARENT
BINDER->LIGAND
BINDING
METABOLIC ENZYME -> INHIBITOR
LOW
Ki
METABOLIC ENZYME -> INHIBITOR
LOW
Ki
METABOLIC ENZYME -> SUBSTRATE
MAJOR
TRANSPORTER -> INHIBITOR
Related Record Type Details
METABOLITE -> PARENT
FECAL; URINE
METABOLITE -> PARENT
MAJOR
PLASMA
METABOLITE -> PARENT
FECAL; URINE
METABOLITE -> PARENT
METABOLITE -> PARENT
FECAL; URINE
METABOLITE LESS ACTIVE -> PARENT
Dronedarone is extensively metabolized, mainly by CYP 3A
MAJOR
PLASMA
Related Record Type Details
ACTIVE MOIETY
Name Property Type Amount Referenced Substance Defining Parameters References
Volume of Distribution PHARMACOKINETIC
Tmax PHARMACOKINETIC IN HEPATICALLY IMPAIRED PATIENTS

DOSE

Biological Half-life PHARMACOKINETIC
Tmax PHARMACOKINETIC IN HEALTHY SUBJECTS

DOSE