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What the FDA labels say about taking them together

Digoxin and dronedarone

Digoxin's FDA label of December 5, 2024 names dronedarone in its drug interactions section, and dronedarone's label names digoxin too. The dronedarone label: “Contraindicated. Digoxin: Consider discontinuation or halve dose of digoxin before treatment and monitor digoxin levels. Calcium channel blockers (CCB):”

Check it at the source: the digoxin FDA label on DailyMed (effective December 5, 2024, Advanz Pharma (US) Corp.); the dronedarone FDA label on DailyMed (effective May 29, 2025, Sanofi-Aventis U.S. LLC).

What does the digoxin label say about dronedarone?

Digoxin label, drug interactions

Dronedarone; NA; 150%; Measure serum digoxin concentrations before initiating concomitant drugs. Reduce digoxin concentrations by decreasing dose by approximately 30-50% or by modifying the dosing frequency and continue monitoring.

Lanoxin label (Covis Pharma US, Inc, October 17, 2025), drug interactions

Dronedarone; Sudden death was more common in patients receiving digoxin with dronedarone than on either alone; it is not clear whether this represents an interaction or is related to the presence of advanced heart disease, a known risk factor for sudden death in patients receiving digoxin.

Source: FDA drug label (Lanoxin, NDA009330), Covis Pharma US, Inc, effective October 17, 2025 (SPL set 9ec84cac-6ecc-43dc-8006-6ccc029e2707), via openFDA

Source: FDA drug label (LANOXIN), Advanz Pharma (US) Corp., effective December 5, 2024 (SPL set d91e3646-4c63-4512-ab22-db39c085c4dc), via openFDA; the full label on DailyMed

What does the dronedarone label say about digoxin?

Dronedarone label, drug interactions

Contraindicated. ( 4 , 7.1 ) Digoxin: Consider discontinuation or halve dose of digoxin before treatment and monitor digoxin levels. ( 7.1 , 7.3 ) Calcium channel blockers (CCB):

Source: FDA drug label (Multaq), Sanofi-Aventis U.S. LLC, effective May 29, 2025 (SPL set 7fa41601-7fb5-4155-8e50-2ae903f0d2d6), via openFDA; the full label on DailyMed

These are the labels' own sentences. PlainMeds does not grade interactions; a pharmacist or prescriber can say what they mean for one person's medicines.

Both medicines on the record

26Digoxin generic labelers
0Dronedarone generic labelers
DigoxinDronedarone
Labeled forHeart failure, Atrial fibrillationn/a
Boxed warningNoYes
Pharmacy cost (NADAC)$0.133 per tablet 125 mcg tablet$13.19 per tablet 400 mg tablet
Shortage nowNo current entryNo current entry

Source: FDA NDC Directory, CMS NADAC of October 7, 2026 and the FDA Drug Shortage Database (FDA files October 8, 2026)

What next?