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What the FDA labels say about taking them together

Amiodarone and atorvastatin

Amiodarone's FDA label of December 9, 2025 names atorvastatin in its drug interactions section; the atorvastatin labels PlainMeds reads (2) do not name amiodarone. The amiodarone label: “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. …”

Check it at the source: the amiodarone FDA label on DailyMed (effective December 9, 2025, Chartwell RX, LLC); the atorvastatin FDA label on DailyMed (effective April 15, 2024, Viatris Specialty LLC).

What does the amiodarone label say about atorvastatin?

Amiodarone label, drug interactions

Concomitant 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 atorvastatin label say about amiodarone?

Atorvastatin's label (effective April 15, 2024) and its 1 other brand-application label do not name amiodarone in these sections. A label lists what its studies and reports found; it is not a complete list.

Source: FDA drug label (Lipitor), NDA020702 (Upjohn), as published by Viatris Specialty LLC, effective April 15, 2024 (SPL set a60cc18b-0631-4cf0-b021-9f52224ece65), 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

32Amiodarone generic labelers
59Atorvastatin generic labelers
AmiodaroneAtorvastatin
Labeled forn/aHigh cholesterol, Angina, High triglycerides, Heart attack and coronary artery disease
Boxed warningYesNo
Pharmacy cost (NADAC)$0.122 per tablet 200 mg tablet$0.0228 per tablet 10 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?