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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
The role of thyroid hormone nuclear receptors in the heart: evidence from pharmacological approaches.
2010-03
New pharmacological options for patients with atrial fibrillation: the ATHENA trial.
2009-05
Dronedarone for atrial fibrillation--an odyssey.
2009-04-30
Trial watch: novel antiarrhythmic agent shows promise in Phase III trial.
2009-04
Alternatives to amiodarone: search for the Holy Grail.
2009-04
A preliminary assessment of the effects of ATI-2042 in subjects with paroxysmal atrial fibrillation using implanted pacemaker methodology.
2009-04
Major recent trials in cardiovascular diseases.
2009-03
Effect of dronedarone on cardiovascular events in atrial fibrillation.
2009-02-12
Clinical trials update from the Heart Failure Society of America and the American Heart Association meetings in 2008: SADHART-CHF, COMPARE, MOMENTUM, thyroid hormone analogue study, HF-ACTION, I-PRESERVE, beta-interferon study, BACH, and ATHENA.
2009-02
Atrial-selective pharmacological therapy for atrial fibrillation: hype or hope?
2009-01
Benzofuran derivatives and the thyroid.
2009-01
[Amiodaron for treatment of perioperative cardiac arrythmia: a broad spectrum antiarrythmetic agent?].
2008-12
Dronedarone: a new treatment for atrial fibrillation.
2008-11
Amiodarone as paradigm for developing new drugs for atrial fibrillation.
2008-10
New antiarrhythmic drugs for atrial fibrillation: focus on dronedarone and vernakalant.
2008-10
New horizons in antiarrhythmic therapy: will novel agents overcome current deficits?
2008-09-22
[Current pharmacological management of atrial fibrillation management by practice cardiologists - news from congress in Munich].
2008-09
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.
2008-09
Clinical trials update from Heart Rhythm 2008 and Heart Failure 2008: ATHENA, URGENT, INH study, HEART and CK-1827452.
2008-09
Increased mortality after dronedarone therapy for severe heart failure.
2008-06-19
Concurrent Chagas' disease and borderline disseminated cutaneous leishmaniasis: The role of amiodarone as an antitrypanosomatidae drug.
2008-06
Anti-arrhythmic drug therapy for atrial fibrillation: current anti-arrhythmic drugs, investigational agents, and innovative approaches.
2008-06
Pharmacotherapy for atrial arrhythmias: present and future.
2008-06
Acute inhibitory effect of dronedarone, a noniodinated benzofuran analogue of amiodarone, on Na+/Ca2+ exchange current in guinea pig cardiac ventricular myocytes.
2008-06
Update on atrial fibrillation: part II.
2008-03
Is dronedarone effective for the prevention of recurrent atrial fibrillation?
2008-03
Rationale and design of ATHENA: A placebo-controlled, double-blind, parallel arm Trial to assess the efficacy of dronedarone 400 mg bid for the prevention of cardiovascular Hospitalization or death from any cause in patiENts with Atrial fibrillation/atrial flutter.
2008-01
[Efficacy of dronedarone in cardiac failure due to severe left ventricular systolic dysfunction. Results of the ANDROMEDA].
2008
Atrial fibrillation after cardiac surgery: where are we now?
2008
[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
Dronedarone in atrial fibrillation.
2007-12-06
Dronedarone in atrial fibrillation.
2007-12-06
In vitro effects of acute amiodarone and dronedarone on epicardial, endocardial, and M cells of the canine ventricle.
2007-12
Effect of dronedarone on renal function in healthy subjects.
2007-12
New antiarrhythmic drugs for establishing sinus rhythm in atrial fibrillation: what are our therapies likely to be by 2010 and beyond?
2007-11
Antiarrhythmics for maintaining sinus rhythm after cardioversion of atrial fibrillation.
2007-10-17
Maintaining sinus rhythm--making treatment better than the disease.
2007-09-06
Dronedarone for maintenance of sinus rhythm in atrial fibrillation or flutter.
2007-09-06
Na+/Ca2+ exchange inhibitors: a new class of calcium regulators.
2007-09
Acute in vitro effects of dronedarone, an iodine-free derivative, and amiodarone, on the rabbit sinoatrial node automaticity: a comparative study.
2007-09
Inhibition of the HERG potassium channel by the tricyclic antidepressant doxepin.
2007-08-01
New antiarrhythmic treatment of atrial fibrillation.
2007-07
Comparative antiarrhythmic efficacy of amiodarone and dronedarone during acute myocardial infarction in rats.
2007-06-14
Effect of amiodarone and dronedarone administration in rats on thyroid hormone-dependent gene expression in different cardiac components.
2007-06
Dronedarone: an amiodarone analog for the treatment of atrial fibrillation and atrial flutter.
2007-04
A review of the investigational antiarrhythmic agent dronedarone.
2007-03
Dronedarone: in quest of the ideal antiarrhythmic drug.
2007
Dronedarone: drondarone, SR 33589, SR 33589B.
2007
Do we need pharmacological therapy for atrial fibrillation in the ablation era?
2006-12
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