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Details

Stereochemistry ACHIRAL
Molecular Formula C31H44N2O5S
Molecular Weight 556.7587
Optical Activity NONE
Defined Stereocenters 0 / 0
E/Z Centers 0
Charge 0

SHOW SMILES / InChI
Structure of DRONEDARONE

SMILES

CCCCc1c(c2cc(ccc2o1)NS(=O)(=O)C)C(=O)c3ccc(cc3)OCCCN(CCCC)CCCC

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

Description
Curator's Comment:: 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

1246406400000
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

1246406400000
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
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
Hemodynamic and antiadrenergic effects of dronedarone and amiodarone in animals with a healed myocardial infarction.
2000 Sep
Mechanisms of action of antiarrhythmic drugs relative to the origin and perpetuation of cardiac arrhythmias.
2001 Jan
Electrophysiological effects of dronedarone (SR 33589), a noniodinated amiodarone derivative in the canine heart: comparison with amiodarone.
2001 Jul
Dronedarone (Sanofi-Synthélabo).
2001 May
New antiarrhythmic drugs for the treatment of atrial fibrillation.
2002 Feb
Old and new antiarrhythmic drugs for converting and maintaining sinus rhythm in atrial fibrillation: comparative efficacy and results of trials.
2003 Mar 20
Acute effects of dronedarone on both components of the cardiac delayed rectifier K+ current, HERG and KvLQT1/minK potassium channels.
2003 Nov
Theoretical possibilities for the development of novel antiarrhythmic drugs.
2004 Jan
[Atrial fibrillation: choice of the method of pharmacological cardioversion].
2005
In vivo and in vitro antiarrhythmic effects of SSR149744C in animal models of atrial fibrillation and ventricular arrhythmias.
2005 Feb
Dronedarone administration prevents body weight gain and increases tolerance of the heart to ischemic stress: a possible involvement of thyroid hormone receptor alpha1.
2005 Jan
[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
Amiodarone inhibits thyroidal iodide transport in vitro by a cyclic adenosine 5'-monophosphate- and iodine-independent mechanism.
2006 Jun
Amiodarone: a multifaceted antiarrhythmic drug.
2006 Sep
Dronedarone: an amiodarone analog for the treatment of atrial fibrillation and atrial flutter.
2007 Apr
Inhibition of the HERG potassium channel by the tricyclic antidepressant doxepin.
2007 Aug 1
Dronedarone in atrial fibrillation.
2007 Dec 6
Dronedarone: in quest of the ideal antiarrhythmic drug.
2007 Fall
Effect of amiodarone and dronedarone administration in rats on thyroid hormone-dependent gene expression in different cardiac components.
2007 Jun
A review of the investigational antiarrhythmic agent dronedarone.
2007 Mar
Acute in vitro effects of dronedarone, an iodine-free derivative, and amiodarone, on the rabbit sinoatrial node automaticity: a comparative study.
2007 Sep
[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
Concurrent Chagas' disease and borderline disseminated cutaneous leishmaniasis: The role of amiodarone as an antitrypanosomatidae drug.
2008 Jun
Anti-arrhythmic drug therapy for atrial fibrillation: current anti-arrhythmic drugs, investigational agents, and innovative approaches.
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
Increased mortality after dronedarone therapy for severe heart failure.
2008 Jun 19
Dronedarone: a new treatment for atrial fibrillation.
2008 Nov
New antiarrhythmic drugs for atrial fibrillation: focus on dronedarone and vernakalant.
2008 Oct
[Current pharmacological management of atrial fibrillation management by practice cardiologists - news from congress in Munich].
2008 Sep
Clinical trials update from Heart Rhythm 2008 and Heart Failure 2008: ATHENA, URGENT, INH study, HEART and CK-1827452.
2008 Sep
Trial watch: novel antiarrhythmic agent shows promise in Phase III trial.
2009 Apr
Alternatives to amiodarone: search for the Holy Grail.
2009 Apr
A preliminary assessment of the effects of ATI-2042 in subjects with paroxysmal atrial fibrillation using implanted pacemaker methodology.
2009 Apr
Dronedarone for atrial fibrillation--an odyssey.
2009 Apr 30
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 Feb
Effect of dronedarone on cardiovascular events in atrial fibrillation.
2009 Feb 12
Atrial-selective pharmacological therapy for atrial fibrillation: hype or hope?
2009 Jan
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
The role of thyroid hormone nuclear receptors in the heart: evidence from pharmacological approaches.
2010 Mar
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).
Name Type Language
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
SR-33589
Code English
DRONEDARONE [VANDF]
Common Name English
N-(2-BUTYL-3-(4-(3-(DIBUTYLAMINO)PROPROXY)BENZOYL)BENZOFURAN-5-YL)METHANESULFONAMIDE
Common Name English
DRONEDARONE [EMA EPAR]
Common Name English
DRONEDARONE [MI]
Common Name English
DRONEDARONE [MART.]
Common Name English
DRONEDARONE [WHO-DD]
Common Name English
Classification Tree Code System Code
WHO-VATC QC01BD07
Created by admin on Fri Jun 25 22:36:14 UTC 2021 , Edited by admin on Fri Jun 25 22:36:14 UTC 2021
LIVERTOX 331
Created by admin on Fri Jun 25 22:36:14 UTC 2021 , Edited by admin on Fri Jun 25 22:36:14 UTC 2021
NDF-RT N0000175426
Created by admin on Fri Jun 25 22:36:14 UTC 2021 , Edited by admin on Fri Jun 25 22:36:14 UTC 2021
WHO-ATC C01BD07
Created by admin on Fri Jun 25 22:36:14 UTC 2021 , Edited by admin on Fri Jun 25 22:36:14 UTC 2021
NCI_THESAURUS C47793
Created by admin on Fri Jun 25 22:36:14 UTC 2021 , Edited by admin on Fri Jun 25 22:36:14 UTC 2021
Code System Code Type Description
WIKIPEDIA
DRONEDARONE
Created by admin on Fri Jun 25 22:36:14 UTC 2021 , Edited by admin on Fri Jun 25 22:36:14 UTC 2021
PRIMARY
DRUG BANK
DB04855
Created by admin on Fri Jun 25 22:36:14 UTC 2021 , Edited by admin on Fri Jun 25 22:36:14 UTC 2021
PRIMARY
NDF-RT
N0000185503
Created by admin on Fri Jun 25 22:36:14 UTC 2021 , Edited by admin on Fri Jun 25 22:36:14 UTC 2021
PRIMARY P-Glycoprotein Inhibitors [MoA]
RXCUI
233698
Created by admin on Fri Jun 25 22:36:14 UTC 2021 , Edited by admin on Fri Jun 25 22:36:14 UTC 2021
PRIMARY RxNorm
PUBCHEM
208898
Created by admin on Fri Jun 25 22:36:14 UTC 2021 , Edited by admin on Fri Jun 25 22:36:14 UTC 2021
PRIMARY
MESH
C118667
Created by admin on Fri Jun 25 22:36:14 UTC 2021 , Edited by admin on Fri Jun 25 22:36:14 UTC 2021
PRIMARY
EPA CompTox
141626-36-0
Created by admin on Fri Jun 25 22:36:14 UTC 2021 , Edited by admin on Fri Jun 25 22:36:14 UTC 2021
PRIMARY
HSDB
7928
Created by admin on Fri Jun 25 22:36:14 UTC 2021 , Edited by admin on Fri Jun 25 22:36:14 UTC 2021
PRIMARY
MERCK INDEX
M4768
Created by admin on Fri Jun 25 22:36:14 UTC 2021 , Edited by admin on Fri Jun 25 22:36:14 UTC 2021
PRIMARY Merck Index
NDF-RT
N0000182137
Created by admin on Fri Jun 25 22:36:14 UTC 2021 , Edited by admin on Fri Jun 25 22:36:14 UTC 2021
PRIMARY Cytochrome P450 2D6 Inhibitors [MoA]
IUPHAR
7465
Created by admin on Fri Jun 25 22:36:14 UTC 2021 , Edited by admin on Fri Jun 25 22:36:14 UTC 2021
PRIMARY
CAS
141626-36-0
Created by admin on Fri Jun 25 22:36:14 UTC 2021 , Edited by admin on Fri Jun 25 22:36:14 UTC 2021
PRIMARY
EVMPD
SUB06408MIG
Created by admin on Fri Jun 25 22:36:14 UTC 2021 , Edited by admin on Fri Jun 25 22:36:14 UTC 2021
PRIMARY
ChEMBL
CHEMBL184412
Created by admin on Fri Jun 25 22:36:14 UTC 2021 , Edited by admin on Fri Jun 25 22:36:14 UTC 2021
PRIMARY
NDF-RT
N0000190114
Created by admin on Fri Jun 25 22:36:14 UTC 2021 , Edited by admin on Fri Jun 25 22:36:14 UTC 2021
PRIMARY Cytochrome P450 3A Inhibitors [MoA]
NCI_THESAURUS
C65485
Created by admin on Fri Jun 25 22:36:14 UTC 2021 , Edited by admin on Fri Jun 25 22:36:14 UTC 2021
PRIMARY
INN
7382
Created by admin on Fri Jun 25 22:36:14 UTC 2021 , Edited by admin on Fri Jun 25 22:36:14 UTC 2021
PRIMARY
FDA UNII
JQZ1L091Y2
Created by admin on Fri Jun 25 22:36:14 UTC 2021 , Edited by admin on Fri Jun 25 22:36:14 UTC 2021
PRIMARY
DRUG CENTRAL
4112
Created by admin on Fri Jun 25 22:36:14 UTC 2021 , Edited by admin on Fri Jun 25 22:36:14 UTC 2021
PRIMARY