U.S. Department of Health & Human Services Divider Arrow National Institutes of Health Divider Arrow NCATS

Details

Stereochemistry ACHIRAL
Molecular Formula C31H44N2O5S.ClH
Molecular Weight 593.217
Optical Activity NONE
Defined Stereocenters 0 / 0
E/Z Centers 0
Charge 0

SHOW SMILES / InChI
Structure of DRONEDARONE HYDROCHLORIDE

SMILES

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

InChI

InChIKey=DWKVCQXJYURSIQ-UHFFFAOYSA-N
InChI=1S/C31H44N2O5S.ClH/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;1H

HIDE SMILES / InChI
Molecular Formula ClH
Molecular Weight 36.461
Charge 0
Count
Stereochemistry ACHIRAL
Additional Stereochemistry No
Defined Stereocenters 0 / 0
E/Z Centers 0
Optical Activity NONE
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.

CNS Activity

Originator

Approval Year

2009
359
Targets

Targets

Primary TargetPharmacologyConditionPotency
Blocker
537
Blocker
537
 1.0 µM [IC50]
Substrate
661
Conditions

Conditions

ConditionModalityTargetsHighest PhaseProduct
Primary
Approved
8429
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
Approved
8429
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
EXPERIMENT
https://onlinelibrary.wiley.com/doi/full/10.1046/j.1472-8206.2003.00216.x
1600 mg single, oral
dose: 1600 mg
route of administration: Oral
experiment type: SINGLE
co-administered: METOPROLOL
METOPROLOL
 DRONEDARONE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: UNKNOWN
food status: UNKNOWN
AUC

AUC

ValueDoseCo-administeredAnalytePopulation
1386 ng × h/mL
EXPERIMENT
https://onlinelibrary.wiley.com/doi/full/10.1046/j.1472-8206.2003.00216.x
1600 mg single, oral
dose: 1600 mg
route of administration: Oral
experiment type: SINGLE
co-administered: METOPROLOL
METOPROLOL
 DRONEDARONE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: UNKNOWN
food status: UNKNOWN
T1/2

T1/2

ValueDoseCo-administeredAnalytePopulation
12 h
EXPERIMENT
https://onlinelibrary.wiley.com/doi/full/10.1046/j.1472-8206.2003.00216.x
1600 mg single, oral
dose: 1600 mg
route of administration: Oral
experiment type: SINGLE
co-administered: METOPROLOL
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:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022425lbl.pdf
unhealthy, 20-97 years
n = 3282
Health Status: unhealthy
Condition: atrial fibrillation | atrial flutter
Age Group: 20-97 years
Sex: M+F
Population Size: 3282
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022425lbl.pdf
Disc. AE: Gastrointestinal disorders, QT interval prolonged...
AEs leading to
discontinuation/dose reduction:
Gastrointestinal disorders (3.2%)
QT interval prolonged (1.5%)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022425lbl.pdf
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:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022425lbl.pdf
https://pubmed.ncbi.nlm.nih.gov/17056831
healthy, 21-40 years
Health Status: healthy
Age Group: 21-40 years
Sex: M
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022425lbl.pdf
https://pubmed.ncbi.nlm.nih.gov/17056831
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022425lbl.pdf
https://pubmed.ncbi.nlm.nih.gov/17056831
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:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
unhealthy, adult
n = 989
Health Status: unhealthy
Condition: atrial fibrillation | atrial flutter
Age Group: adult
Sex: M+F
Population Size: 989
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
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:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
400 mg 2 times / day steady, oral
Dose: 400 mg, 2 times / day
Route: oral
Route: steady
Dose: 400 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022425lbl.pdf
unhealthy, adult
Health Status: unhealthy
Condition: NYHA Class IV heart failure | NYHA Class II - III heart failure
Age Group: adult
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022425lbl.pdf
Other AEs: Heart failure...
Other AEs:
Heart failure (grade 5)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022425lbl.pdf
600 mg 2 times / day multiple, oral
Dose: 600 mg, 2 times / day
Route: oral
Route: multiple
Dose: 600 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
unhealthy, adult
n = 66
Health Status: unhealthy
Condition: atrial fibrillation | atrial flutter
Age Group: adult
Sex: M+F
Population Size: 66
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
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:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
800 mg 2 times / day multiple, oral
Dose: 800 mg, 2 times / day
Route: oral
Route: multiple
Dose: 800 mg, 2 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
unhealthy, adult
n = 62
Health Status: unhealthy
Condition: atrial fibrillation | atrial flutter
Age Group: adult
Sex: M+F
Population Size: 62
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
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:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
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:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022425lbl.pdf
unhealthy, 20-97 years
n = 3282
Health Status: unhealthy
Condition: atrial fibrillation | atrial flutter
Age Group: 20-97 years
Sex: M+F
Population Size: 3282
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022425lbl.pdf
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:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022425lbl.pdf
unhealthy, 20-97 years
n = 3282
Health Status: unhealthy
Condition: atrial fibrillation | atrial flutter
Age Group: 20-97 years
Sex: M+F
Population Size: 3282
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022425lbl.pdf
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:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
unhealthy, adult
n = 989
Health Status: unhealthy
Condition: atrial fibrillation | atrial flutter
Age Group: adult
Sex: M+F
Population Size: 989
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
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:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
unhealthy, adult
n = 989
Health Status: unhealthy
Condition: atrial fibrillation | atrial flutter
Age Group: adult
Sex: M+F
Population Size: 989
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
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:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
unhealthy, adult
n = 989
Health Status: unhealthy
Condition: atrial fibrillation | atrial flutter
Age Group: adult
Sex: M+F
Population Size: 989
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
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:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
unhealthy, adult
n = 989
Health Status: unhealthy
Condition: atrial fibrillation | atrial flutter
Age Group: adult
Sex: M+F
Population Size: 989
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
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:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
unhealthy, adult
n = 989
Health Status: unhealthy
Condition: atrial fibrillation | atrial flutter
Age Group: adult
Sex: M+F
Population Size: 989
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
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:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
unhealthy, adult
n = 989
Health Status: unhealthy
Condition: atrial fibrillation | atrial flutter
Age Group: adult
Sex: M+F
Population Size: 989
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
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:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
unhealthy, adult
n = 989
Health Status: unhealthy
Condition: atrial fibrillation | atrial flutter
Age Group: adult
Sex: M+F
Population Size: 989
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
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:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
unhealthy, adult
n = 989
Health Status: unhealthy
Condition: atrial fibrillation | atrial flutter
Age Group: adult
Sex: M+F
Population Size: 989
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
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:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
unhealthy, adult
n = 989
Health Status: unhealthy
Condition: atrial fibrillation | atrial flutter
Age Group: adult
Sex: M+F
Population Size: 989
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
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:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
unhealthy, adult
n = 989
Health Status: unhealthy
Condition: atrial fibrillation | atrial flutter
Age Group: adult
Sex: M+F
Population Size: 989
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
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:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
unhealthy, adult
n = 989
Health Status: unhealthy
Condition: atrial fibrillation | atrial flutter
Age Group: adult
Sex: M+F
Population Size: 989
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
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:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
unhealthy, adult
n = 989
Health Status: unhealthy
Condition: atrial fibrillation | atrial flutter
Age Group: adult
Sex: M+F
Population Size: 989
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
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:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
unhealthy, adult
n = 989
Health Status: unhealthy
Condition: atrial fibrillation | atrial flutter
Age Group: adult
Sex: M+F
Population Size: 989
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
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:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
unhealthy, adult
n = 989
Health Status: unhealthy
Condition: atrial fibrillation | atrial flutter
Age Group: adult
Sex: M+F
Population Size: 989
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
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:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
unhealthy, adult
n = 989
Health Status: unhealthy
Condition: atrial fibrillation | atrial flutter
Age Group: adult
Sex: M+F
Population Size: 989
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
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:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
unhealthy, adult
n = 989
Health Status: unhealthy
Condition: atrial fibrillation | atrial flutter
Age Group: adult
Sex: M+F
Population Size: 989
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
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:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
unhealthy, adult
n = 989
Health Status: unhealthy
Condition: atrial fibrillation | atrial flutter
Age Group: adult
Sex: M+F
Population Size: 989
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
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:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
unhealthy, adult
n = 989
Health Status: unhealthy
Condition: atrial fibrillation | atrial flutter
Age Group: adult
Sex: M+F
Population Size: 989
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
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:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
unhealthy, adult
n = 989
Health Status: unhealthy
Condition: atrial fibrillation | atrial flutter
Age Group: adult
Sex: M+F
Population Size: 989
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
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:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
unhealthy, adult
n = 989
Health Status: unhealthy
Condition: atrial fibrillation | atrial flutter
Age Group: adult
Sex: M+F
Population Size: 989
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
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:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
unhealthy, adult
n = 989
Health Status: unhealthy
Condition: atrial fibrillation | atrial flutter
Age Group: adult
Sex: M+F
Population Size: 989
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
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:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
unhealthy, adult
n = 989
Health Status: unhealthy
Condition: atrial fibrillation | atrial flutter
Age Group: adult
Sex: M+F
Population Size: 989
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
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:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
unhealthy, adult
n = 989
Health Status: unhealthy
Condition: atrial fibrillation | atrial flutter
Age Group: adult
Sex: M+F
Population Size: 989
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
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:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
unhealthy, adult
n = 989
Health Status: unhealthy
Condition: atrial fibrillation | atrial flutter
Age Group: adult
Sex: M+F
Population Size: 989
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
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:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022425lbl.pdf
unhealthy, adult
Health Status: unhealthy
Condition: NYHA Class IV heart failure | NYHA Class II - III heart failure
Age Group: adult
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022425lbl.pdf
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:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
unhealthy, adult
n = 66
Health Status: unhealthy
Condition: atrial fibrillation | atrial flutter
Age Group: adult
Sex: M+F
Population Size: 66
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
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:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
unhealthy, adult
n = 66
Health Status: unhealthy
Condition: atrial fibrillation | atrial flutter
Age Group: adult
Sex: M+F
Population Size: 66
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
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:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
unhealthy, adult
n = 66
Health Status: unhealthy
Condition: atrial fibrillation | atrial flutter
Age Group: adult
Sex: M+F
Population Size: 66
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
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:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
unhealthy, adult
n = 66
Health Status: unhealthy
Condition: atrial fibrillation | atrial flutter
Age Group: adult
Sex: M+F
Population Size: 66
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
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:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
unhealthy, adult
n = 66
Health Status: unhealthy
Condition: atrial fibrillation | atrial flutter
Age Group: adult
Sex: M+F
Population Size: 66
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
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:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
unhealthy, adult
n = 66
Health Status: unhealthy
Condition: atrial fibrillation | atrial flutter
Age Group: adult
Sex: M+F
Population Size: 66
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
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:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
unhealthy, adult
n = 66
Health Status: unhealthy
Condition: atrial fibrillation | atrial flutter
Age Group: adult
Sex: M+F
Population Size: 66
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
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:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
unhealthy, adult
n = 66
Health Status: unhealthy
Condition: atrial fibrillation | atrial flutter
Age Group: adult
Sex: M+F
Population Size: 66
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
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:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
unhealthy, adult
n = 66
Health Status: unhealthy
Condition: atrial fibrillation | atrial flutter
Age Group: adult
Sex: M+F
Population Size: 66
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
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:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
unhealthy, adult
n = 66
Health Status: unhealthy
Condition: atrial fibrillation | atrial flutter
Age Group: adult
Sex: M+F
Population Size: 66
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
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:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
unhealthy, adult
n = 66
Health Status: unhealthy
Condition: atrial fibrillation | atrial flutter
Age Group: adult
Sex: M+F
Population Size: 66
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
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:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
unhealthy, adult
n = 66
Health Status: unhealthy
Condition: atrial fibrillation | atrial flutter
Age Group: adult
Sex: M+F
Population Size: 66
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
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:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
unhealthy, adult
n = 66
Health Status: unhealthy
Condition: atrial fibrillation | atrial flutter
Age Group: adult
Sex: M+F
Population Size: 66
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
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:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
unhealthy, adult
n = 66
Health Status: unhealthy
Condition: atrial fibrillation | atrial flutter
Age Group: adult
Sex: M+F
Population Size: 66
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
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:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
unhealthy, adult
n = 66
Health Status: unhealthy
Condition: atrial fibrillation | atrial flutter
Age Group: adult
Sex: M+F
Population Size: 66
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
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:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
unhealthy, adult
n = 66
Health Status: unhealthy
Condition: atrial fibrillation | atrial flutter
Age Group: adult
Sex: M+F
Population Size: 66
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
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:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
unhealthy, adult
n = 66
Health Status: unhealthy
Condition: atrial fibrillation | atrial flutter
Age Group: adult
Sex: M+F
Population Size: 66
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
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:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
unhealthy, adult
n = 62
Health Status: unhealthy
Condition: atrial fibrillation | atrial flutter
Age Group: adult
Sex: M+F
Population Size: 62
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
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:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
unhealthy, adult
n = 62
Health Status: unhealthy
Condition: atrial fibrillation | atrial flutter
Age Group: adult
Sex: M+F
Population Size: 62
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
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:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
unhealthy, adult
n = 62
Health Status: unhealthy
Condition: atrial fibrillation | atrial flutter
Age Group: adult
Sex: M+F
Population Size: 62
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
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:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
unhealthy, adult
n = 62
Health Status: unhealthy
Condition: atrial fibrillation | atrial flutter
Age Group: adult
Sex: M+F
Population Size: 62
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
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:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
unhealthy, adult
n = 62
Health Status: unhealthy
Condition: atrial fibrillation | atrial flutter
Age Group: adult
Sex: M+F
Population Size: 62
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
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:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
unhealthy, adult
n = 62
Health Status: unhealthy
Condition: atrial fibrillation | atrial flutter
Age Group: adult
Sex: M+F
Population Size: 62
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
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:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
unhealthy, adult
n = 62
Health Status: unhealthy
Condition: atrial fibrillation | atrial flutter
Age Group: adult
Sex: M+F
Population Size: 62
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
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:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
unhealthy, adult
n = 62
Health Status: unhealthy
Condition: atrial fibrillation | atrial flutter
Age Group: adult
Sex: M+F
Population Size: 62
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
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:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
unhealthy, adult
n = 62
Health Status: unhealthy
Condition: atrial fibrillation | atrial flutter
Age Group: adult
Sex: M+F
Population Size: 62
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
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:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
unhealthy, adult
n = 62
Health Status: unhealthy
Condition: atrial fibrillation | atrial flutter
Age Group: adult
Sex: M+F
Population Size: 62
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
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:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
unhealthy, adult
n = 62
Health Status: unhealthy
Condition: atrial fibrillation | atrial flutter
Age Group: adult
Sex: M+F
Population Size: 62
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
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:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
unhealthy, adult
n = 62
Health Status: unhealthy
Condition: atrial fibrillation | atrial flutter
Age Group: adult
Sex: M+F
Population Size: 62
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
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:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
unhealthy, adult
n = 62
Health Status: unhealthy
Condition: atrial fibrillation | atrial flutter
Age Group: adult
Sex: M+F
Population Size: 62
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
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:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
unhealthy, adult
n = 62
Health Status: unhealthy
Condition: atrial fibrillation | atrial flutter
Age Group: adult
Sex: M+F
Population Size: 62
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
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:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
unhealthy, adult
n = 62
Health Status: unhealthy
Condition: atrial fibrillation | atrial flutter
Age Group: adult
Sex: M+F
Population Size: 62
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
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:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
unhealthy, adult
n = 62
Health Status: unhealthy
Condition: atrial fibrillation | atrial flutter
Age Group: adult
Sex: M+F
Population Size: 62
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
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:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
unhealthy, adult
n = 62
Health Status: unhealthy
Condition: atrial fibrillation | atrial flutter
Age Group: adult
Sex: M+F
Population Size: 62
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
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:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
unhealthy, adult
n = 62
Health Status: unhealthy
Condition: atrial fibrillation | atrial flutter
Age Group: adult
Sex: M+F
Population Size: 62
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
Page: p. 103
Overview

Overview

CYP3A4CYP2C9CYP2D6hERG
inhibitor
1587
inducer
389

inhibitor
1767
substrate
1217

inhibitor
1852
inhibitor
1612

OverviewOther

Other InhibitorOther SubstrateOther Inducer
CYP1A2
1524

CYP2C19
1478

CYP2E1
882

P-gp
1461

OAT1
599

OAT3
642

OCT1
512

OATP1B1
788

OATP1B3
706
CYP3A
191

CYP1A2
1054

P-gp
1537
CYP1A2
701

CYP2A6
79

CYP3A
129

CYP2C8
168

CYP2C19
293
Drug as perpetrator​

Drug as perpetrator​

TargetModalityActivityMetaboliteClinical evidence
OATP1B1
803
 likely
OATP1B3
715
 likely
CYP3A4
1925
 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
CYP1A2
1692
 no
CYP2A6
739
 no
CYP2C19
1553
 no
CYP2C8
965
 no
CYP2C9
1819
 no
CYP3A
298
 no
CYP1A2
1692
 not significant
CYP2C19
1553
 not significant
CYP2E1
970
 not significant
OAT1
603
 not significant
OAT3
644
 not significant
OCT1
543
 not significant
CYP2C9
1819
 not significant
weak (co-administration study)
Comment: dronedarone increased S-warfarin exposure by 1.2- fold
Page: 76.0
P-gp
1650
 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
CYP2D6
1891
 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
CYP3A
191
 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
CYP1A2
1054
 no
CYP2D6
1217
 no
P-gp
1537
 unlikely
Tox targets

Tox targets

TargetModalityActivityMetaboliteClinical evidence
hERG
1647
Sourcing

Sourcing

Vendor/AggregatorIDURL
ChEBI
CHEBI:50659
https://www.ebi.ac.uk/chebi/searchId.do?chebiId=CHEBI:50659
ChemicalBook
CB11117179
https://www.chemicalbook.com/ChemicalProductProperty_EN_CB11117179
MolPort
MolPort-006-170-000
https://www.molport.com/shop/molecule-link/MolPort-006-170-000
ZINC
ZINC000049933061
http://zinc15.docking.org/substances/ZINC000049933061
eMolecules
30152747
https://www.emolecules.com/cgi-bin/more?vid=30152747
PubMed

PubMed

TitleDatePubMed
Effects of amiodarone and dronedarone on voltage-dependent sodium current in human cardiomyocytes.
2003 Aug
Chronic amiodarone-induced inhibition of the Na+-K+ pump in rabbit cardiac myocytes is thyroid-dependent: comparison with dronedarone.
2003 Jan
Theoretical possibilities for the development of novel antiarrhythmic drugs.
2004 Jan
[Safety of new anti-arrhythmic drugs].
2005 Apr
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
Pharmacological treatment of atrial fibrillation: mechanisms of action and efficacy of class III drugs.
2006
Topics on the Na+/Ca2+ exchanger: pharmacological characterization of Na+/Ca2+ exchanger inhibitors.
2006 Sep
Amiodarone: a multifaceted antiarrhythmic drug.
2006 Sep
Medical management of atrial fibrillation: state of the art.
2006 Sep
Dronedarone: an emerging agent with rhythm- and rate-controlling effects.
2006 Sep
Dronedarone in atrial fibrillation.
2007 Dec 6
New antiarrhythmic treatment of atrial fibrillation.
2007 Jul
Na+/Ca2+ exchange inhibitors: a new class of calcium regulators.
2007 Sep
Acute in vitro effects of dronedarone, an iodine-free derivative, and amiodarone, on the rabbit sinoatrial node automaticity: a comparative study.
2007 Sep
[Amiodaron for treatment of perioperative cardiac arrythmia: a broad spectrum antiarrythmetic agent?].
2008 Dec
Anti-arrhythmic drug therapy for atrial fibrillation: current anti-arrhythmic drugs, investigational agents, and innovative approaches.
2008 Jun
Update on atrial fibrillation: part II.
2008 Mar
Is dronedarone effective for the prevention of recurrent atrial fibrillation?
2008 Mar
New antiarrhythmic drugs for atrial fibrillation: focus on dronedarone and vernakalant.
2008 Oct
Patents

Patents

20020150622
2
JP2011529958A
2

Sample Use Guides

In Vivo Use Guide
One tablet of 400 mg twice a day with morning and evening meals.
Route of Administration: Oral
In Vitro Use Guide
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 Fri Dec 15 15:41:28 GMT 2023
Edited
by admin
on Fri Dec 15 15:41:28 GMT 2023
Record UNII
FA36DV299Q
Record Status Validated (UNII)
Record Version
  • Download
Name Type Language
DRONEDARONE HYDROCHLORIDE
DASH   MART.   MI   ORANGE BOOK   USAN   USP-RS   WHO-DD  
USAN  
Official Name English
MULTAQ
Brand Name English
SR33598B
Code English
DRONEDARONE HCL
Common Name English
Methanesulfonamide, N-[2-butyl-3-[4-[3-(dibutylamino)propoxy]benzoyl]-5-benzofuranyl]-, monohydrochloride
Common Name English
DRONEDARONE HYDROCHLORIDE [EP MONOGRAPH]
Common Name English
DRONEDARONE HYDROCHLORIDE [MI]
Common Name English
DRONEDARONE HYDROCHLORIDE [USP-RS]
Common Name English
DRONEDARONE HYDROCHLORIDE [USP MONOGRAPH]
Common Name English
Dronedarone hydrochloride [WHO-DD]
Common Name English
DRONEDARONE HYDROCHLORIDE [MART.]
Common Name English
SR-33598B
Code English
DRONEDARONE HYDROCHLORIDE [USAN]
Common Name English
N-(2-BUTYL-3-(4-(3-(DIBUTYLAMINO)PROPROXY)BENZOYL)BENZOFURAN-5-YL) METHANESULFONAMIDE-, MONOHYDROCHLORIDE
Common Name English
DRONEDARONE HYDROCHLORIDE [ORANGE BOOK]
Common Name English
Classification Tree Code System Code
EMA ASSESSMENT REPORTS MULTAQ (AUTHORIZED ATRIAL FIBRILLATION)
Created by admin on Fri Dec 15 15:41:28 GMT 2023 , Edited by admin on Fri Dec 15 15:41:28 GMT 2023
NCI_THESAURUS C47793
Created by admin on Fri Dec 15 15:41:28 GMT 2023 , Edited by admin on Fri Dec 15 15:41:28 GMT 2023
Code System Code Type Description
PUBCHEM
219025
Created by admin on Fri Dec 15 15:41:28 GMT 2023 , Edited by admin on Fri Dec 15 15:41:28 GMT 2023
PRIMARY
SMS_ID
100000092682
Created by admin on Fri Dec 15 15:41:29 GMT 2023 , Edited by admin on Fri Dec 15 15:41:29 GMT 2023
PRIMARY
FDA UNII
FA36DV299Q
Created by admin on Fri Dec 15 15:41:28 GMT 2023 , Edited by admin on Fri Dec 15 15:41:28 GMT 2023
PRIMARY
USAN
QQ-91
Created by admin on Fri Dec 15 15:41:29 GMT 2023 , Edited by admin on Fri Dec 15 15:41:29 GMT 2023
PRIMARY
RXCUI
736680
Created by admin on Fri Dec 15 15:41:29 GMT 2023 , Edited by admin on Fri Dec 15 15:41:29 GMT 2023
PRIMARY RxNorm
MERCK INDEX
m4768
Created by admin on Fri Dec 15 15:41:28 GMT 2023 , Edited by admin on Fri Dec 15 15:41:28 GMT 2023
PRIMARY Merck Index
EVMPD
SUB28992
Created by admin on Fri Dec 15 15:41:28 GMT 2023 , Edited by admin on Fri Dec 15 15:41:28 GMT 2023
PRIMARY
ChEMBL
CHEMBL184412
Created by admin on Fri Dec 15 15:41:28 GMT 2023 , Edited by admin on Fri Dec 15 15:41:28 GMT 2023
PRIMARY
CHEBI
50659
Created by admin on Fri Dec 15 15:41:28 GMT 2023 , Edited by admin on Fri Dec 15 15:41:28 GMT 2023
PRIMARY
EPA CompTox
DTXSID30161779
Created by admin on Fri Dec 15 15:41:28 GMT 2023 , Edited by admin on Fri Dec 15 15:41:28 GMT 2023
PRIMARY
DRUG BANK
DBSALT000061
Created by admin on Fri Dec 15 15:41:28 GMT 2023 , Edited by admin on Fri Dec 15 15:41:28 GMT 2023
PRIMARY
NCI_THESAURUS
C65486
Created by admin on Fri Dec 15 15:41:28 GMT 2023 , Edited by admin on Fri Dec 15 15:41:28 GMT 2023
PRIMARY
RS_ITEM_NUM
1228530
Created by admin on Fri Dec 15 15:41:29 GMT 2023 , Edited by admin on Fri Dec 15 15:41:29 GMT 2023
PRIMARY
CAS
141625-93-6
Created by admin on Fri Dec 15 15:41:28 GMT 2023 , Edited by admin on Fri Dec 15 15:41:28 GMT 2023
PRIMARY
Related Record Type Details
Structure of DRONEDARONE
PARENT -> SALT/SOLVATE
Related Record Type Details
Structure of DEBUTYLDRONEDARONE
IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
USP
Structure of (5-AMINO-2-BUTYL-3-BENZOFURANYL)(4-(3-(DIBUTYLAMINO)PROPOXY)PHENYL)METHANONE
IMPURITY -> PARENT
Structure of N-Mesyldronedarone
IMPURITY -> PARENT
Related Record Type Details
Structure of DRONEDARONE
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