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What the FDA labels say about taking them together

Amiodarone and sotalol

Sotalol's FDA label of December 16, 2024 names amiodarone in its drug interactions section; the amiodarone labels PlainMeds reads (2) do not name sotalol. The sotalol label: “Class Ia antiarrhythmic drugs, such as disopyramide, quinidine, and procainamide, and other Class III drugs (for example, amiodarone) are not recommended as concomitant therapy with Betapace/Betapace AF, because of …”

Check it at the source: the amiodarone FDA label on DailyMed (effective December 9, 2025, Chartwell RX, LLC); the sotalol FDA label on DailyMed (effective December 16, 2024, Legacy Pharma USA, Inc.).

What does the amiodarone label say about sotalol?

Amiodarone's label (effective December 9, 2025) and its 1 other brand-application label do not name sotalol in these sections. A label lists what its studies and reports found; it is not a complete list.

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 sotalol label say about amiodarone?

Sotalol label, drug interactions

Class Ia antiarrhythmic drugs, such as disopyramide, quinidine, and procainamide, and other Class III drugs (for example, amiodarone) are not recommended as concomitant therapy with Betapace/Betapace AF, because of their potential to prolong refractoriness [see Warnings and Precautions ( 5.2 )].

Sotalol Hydrochloride label (ALTATHERA Pharmaceuticals, LLC, July 31, 2025), drug interactions

Class Ia antiarrhythmic drugs, such as disopyramide, quinidine, and procainamide, and other Class III drugs (for example, amiodarone) are not recommended as concomitant therapy, because of their potential for additive QTc prolongation [see Warnings and Precautions ( 5.1 )].

Source: FDA drug label (Sotalol Hydrochloride, NDA022306), ALTATHERA Pharmaceuticals, LLC, effective July 31, 2025 (SPL set ff3061ab-d930-4318-a5be-684e38be229e), via openFDA

Source: FDA drug label (Sotylize, NDA205108), Azurity Pharmaceuticals, Inc., effective January 24, 2024 (SPL set 1f33f900-0777-4a92-a7f7-00cf3d57d95c), via openFDA

Source: FDA drug label (BETAPACE), Legacy Pharma USA, Inc., effective December 16, 2024 (SPL set a6a7702f-36c9-45db-b640-453dc324baee), 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
18Sotalol generic labelers
AmiodaroneSotalol
Labeled forn/aAtrial fibrillation
Boxed warningYesYes
Pharmacy cost (NADAC)$0.122 per tablet 200 mg tablet$0.0707 per tablet 80 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)

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