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What the FDA labels say about taking them together

Dronedarone and simvastatin

Dronedarone's FDA label of May 29, 2025 names simvastatin in its drug interactions section, and simvastatin's label names dronedarone too. The simvastatin label: “The risk of myopathy and rhabdomyolysis is increased by concomitant use of amiodarone, dronedarone, ranolazine, or calcium channel blockers with ZOCOR.”

Check it at the source: the dronedarone FDA label on DailyMed (effective May 29, 2025, Sanofi-Aventis U.S. LLC); the simvastatin FDA label on DailyMed (effective March 28, 2025, Organon LLC).

What does the dronedarone label say about simvastatin?

Dronedarone label, drug interactions

Avoid concomitant use. ( 7.2 ) Grapefruit juice: Avoid concomitant use. ( 7.2 ) Statins: Avoid simvastatin doses greater than 10 mg daily.

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

What does the simvastatin label say about dronedarone?

Simvastatin label, drug interactions

Amiodarone, Dronedarone, Ranolazine, or Calcium Channel Blockers Clinical Impact: The risk of myopathy and rhabdomyolysis is increased by concomitant use of amiodarone, dronedarone, ranolazine, or calcium channel blockers with ZOCOR. Intervention: For patients taking verapamil, diltiazem, or dronedarone, do not exceed ZOCOR 10 mg daily. For patients taking amiodarone, amlodipine, or ranolazine, do not exceed ZOCOR 20 mg daily [see ].

Simvastatin label, warnings and precautions

ZOCOR dosage modifications are recommended for patients taking lomitapide, verapamil, diltiazem, dronedarone, amiodarone, amlodipine or ranolazine [see Dosage and Administration (2.5) ].

Source: FDA drug label (ZOCOR), Organon LLC, effective March 28, 2025 (SPL set 8f55d5de-5a4f-4a39-8c84-c53976dd6af9), 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

0Dronedarone generic labelers
27Simvastatin generic labelers
DronedaroneSimvastatin
Labeled forn/aHeart attack and coronary artery disease, High cholesterol, High triglycerides
Boxed warningYesNo
Pharmacy cost (NADAC)$13.19 per tablet 400 mg tablet$0.0321 per tablet 20 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?