What the FDA labels say about taking them together
Amiodarone and simvastatin
Amiodarone's FDA label of December 9, 2025 names simvastatin in its drug interactions section, and simvastatin's label names amiodarone 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 amiodarone FDA label on DailyMed (effective December 9, 2025, Chartwell RX, LLC); the simvastatin FDA label on DailyMed (effective March 28, 2025, Organon LLC).
What does the amiodarone label say about simvastatin?
Amiodarone label, drug interactionsConcomitant Drug/Class/Name: HMG-CoA Reductase Inhibitors; Examples: simvastatin, lovastatin, atorvastatin; Clinical Comment: Increased plasma concentration of HMG- CoA reductase inhibitor. Limit the dose of lovastatin to 40 mg. Limit the coadministered dose of simvastatin to 20 mg. Lower starting dose of other CYP3A4 substrates may be required.
Source: FDA drug label (Amiodarone Hydrochloride), Chartwell RX, LLC, effective December 9, 2025 (SPL set 5520f11d-968d-4f4f-bf57-d14369c0d746), via openFDA; the full label on DailyMed
What does the simvastatin label say about amiodarone?
Simvastatin label, drug interactionsAmiodarone, 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 precautionsZOCOR 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
| Amiodarone | Simvastatin | |
|---|---|---|
| Labeled for | n/a | Heart attack and coronary artery disease, High cholesterol, High triglycerides |
| Boxed warning | Yes | No |
| Pharmacy cost (NADAC) | $0.122 per tablet 200 mg tablet | $0.0321 per tablet 20 mg tablet |
| Shortage now | No current entry | No 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?
- Check more medicines together
- up to five at once