Dronedarone

Antiarrhythmic — CARDIOVASCULAR SYSTEM

Key facts

Dronedarone is an ofp drug in the Antiarrhythmic class catalogued in DrugCentral. It was first approved by the FDA in 2009. DrugCentral lists 11 molecular targets, including KCNQ2, CACNG1 and KCNH2. Recorded indications include Atrial fibrillation and Paroxysmal atrial fibrillation.

• Approval status: ofp (first approved 2009 by the FDA).
• Drug class: Antiarrhythmic.
• Molecular targets: KCNQ2, CACNG1, KCNH2 and KCNA5 (11 listed in DrugCentral).
• Indications: Atrial fibrillation and Paroxysmal atrial fibrillation.
• ATC code: C01BD07 (Antiarrhythmics, class III).
• Molecular formula: C31H44N2O5S; molecular weight 556.77 g/mol.

Indications & contraindications

Drug–disease relationships curated by DrugCentral (OMOP / SNOMED concepts).

Indications (2)

• Atrial fibrillation
• Paroxysmal atrial fibrillation

Contraindications (17)

• Bradycardia
• Breastfeeding (mother)
• Cardiovascular event risk
• Chronic heart failure
• Complete atrioventricular block
• Congenital long QT syndrome
• Decompensated cardiac failure
• Hepatic failure
• Hypokalemia
• Hypomagnesemia
• Liver function tests abnormal
• Pregnancy, function
• Prolonged QT interval
• Second degree atrioventricular block
• Sick sinus syndrome
• Torsades de pointes
• Worsening of Chronic Heart Failure

Mechanism & targets

• Established pharmacologic class: Antiarrhythmic

Molecular targets (11)

Target	Gene	Action	Activity
Potassium voltage-gated channel subfamily KQT member 2	KCNQ2	blocker	IC50 8.00
Voltage-dependent calcium channel gamma-1 subunit	CACNG1	unknown	IC50 6.70
Potassium voltage-gated channel subfamily H member 2	KCNH2	unknown	IC50 6.50
Potassium voltage-gated channel subfamily A member 5	KCNA5	unknown	IC50 5.63
NACHT, LRR and PYD domains-containing protein 3	Nlrp3	unknown	IC50 5.17
Thyroid hormone receptor alpha	THRA	unknown	IC50 4.23
THAP domain-containing protein 1	THAP1	unknown	IC50 4.23
Potassium/sodium hyperpolarization-activated cyclic nucleotide-gated channel 4	HCN4	blocker	—
Potassium/sodium hyperpolarization-activated cyclic nucleotide-gated channel 1	HCN1	blocker	—
Potassium/sodium hyperpolarization-activated cyclic nucleotide-gated channel 2	HCN2	blocker	—
Potassium/sodium hyperpolarization-activated cyclic nucleotide-gated channel 3	HCN3	blocker	—

Regulatory approvals (1)

Date	Agency	Marketed as	Applicant	Orphan
2009-07-01	FDA	—	SANOFI AVENTIS US

ATC classification

ATC code	Therapeutic hierarchy
C01BD07	CARDIOVASCULAR SYSTEM › CARDIAC THERAPY › ANTIARRHYTHMICS, CLASS I AND III › Antiarrhythmics, class III

Pharmacogenomics

Drug-label and guideline annotations from PharmGKB and CPIC.

• EMA label: CYP2D6, CYP3A4 · Informative PGx

Reported adverse-event signals

Strongest FDA FAERS disproportionality signals (log-likelihood ratio). A signal is a statistical association in spontaneous reports, not proof that the drug causes the event.

MedDRA term	LLR
Atrial fibrillation	435.4
Blood creatinine increased	402.3
Drug interaction	364.1
International normalised ratio increased	269.9
Cardiac failure	243.5
Dyspnoea	242.8
Ventricular tachycardia	200.5
Cardiac failure congestive	187.4
Gastrointestinal haemorrhage	164.5
Torsade de pointes	156.0
Atrial flutter	122.1
Glomerular filtration rate decreased	112.2

Chemical structure

• Molecular formula: C₃₁H₄₄N₂O₅S
• Molecular weight: 556.77 g/mol
• CAS number: —
• InChIKey: ZQTNQVWKHCQYLQ-UHFFFAOYSA-N
• PubChem CID: 208898

CCCCN(CCCC)CCCOC1=CC=C(C=C1)C(=O)C1=C(CCCC)OC2=C1C=C(NS(C)(=O)=O)C=C2

Frequently asked questions

Answers are generated from the structured data on this page, not written by hand.

What is Dronedarone used for?

DrugCentral lists the following indications for Dronedarone: Atrial fibrillation and Paroxysmal atrial fibrillation.

How does Dronedarone work?

Its molecular targets in DrugCentral include KCNQ2 (blocker), CACNG1, KCNH2 and KCNA5.

When was Dronedarone first approved?

Dronedarone was first approved by the FDA in 2009.

What drug class does Dronedarone belong to?

Dronedarone is in the Antiarrhythmic class.

What is the chemical formula of Dronedarone?

Dronedarone has the molecular formula C31H44N2O5S and a molecular weight of 556.77 g/mol.

Sources

• DrugCentral drug card 4112 — structure, indications, targets, approvals, pharmacologic classes (CC BY-SA 4.0)
• ChEMBL CHEMBL1201729 — compound record and bioactivity
• PubChem CID 208898 — chemical identifiers
• DrugBank DB04855 — drug record
• FDA UNII JQZ1L091Y2 — substance identity
• DailyMed: FDA labels for Dronedarone — current prescribing information (label search)
• UniProt O43526 (KCNQ2) — target protein
• UniProt Q06432 (CACNG1) — target protein
• UniProt Q12809 (KCNH2) — target protein
• UniProt P22460 (KCNA5) — target protein
• UniProt P10827 (THRA) — target protein
• UniProt Q9NVV9 (THAP1) — target protein
• FDA Adverse Event Reporting System (openFDA FAERS) — adverse-event signals, as aggregated by DrugCentral
• PharmGKB / CPIC — pharmacogenomic label annotations

How this page is built: methodology · editorial policy & corrections.