Skip to main content

What the FDA labels say about taking them together

Azithromycin and sotalol

Azithromycin's FDA label of December 4, 2025 names sotalol in its warnings and precautions section; the sotalol labels PlainMeds reads (3) do not name azithromycin. The azithromycin label: “Providers should consider the risk of QT prolongation which can be fatal when weighing the risks and benefits of azithromycin for at-risk groups including: patients with known prolongation of the QT interval, a history …”

Check it at the source: the azithromycin FDA label on DailyMed (effective December 4, 2025, Bionpharma Inc.); the sotalol FDA label on DailyMed (effective December 16, 2024, Legacy Pharma USA, Inc.).

What does the azithromycin label say about sotalol?

Azithromycin label, warnings and precautions

Providers should consider the risk of QT prolongation which can be fatal when weighing the risks and benefits of azithromycin for at-risk groups including: patients with known prolongation of the QT interval, a history of torsades de pointes, congenital long QT syndrome, bradyarrhythmias or uncompensated heart failure patients on drugs known to prolong the QT interval patients with ongoing proarrhythmic conditions such as uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia, and in patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.

Zithromax label (Pfizer Laboratories Div Pfizer Inc, July 24, 2026), warnings and precautions

patients with ongoing proarrhythmic conditions such as uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia, and in patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.

Source: FDA drug label (Zithromax, NDA050711), Pfizer Laboratories Div Pfizer Inc, effective July 24, 2026 (SPL set db52b91e-79f7-4cc1-9564-f2eee8e31c45), via openFDA

Source: FDA drug label (Azithromycin), Bionpharma Inc., effective December 4, 2025 (SPL set 859bb02c-a4bc-46fa-9fc9-def1219b5dfb), via openFDA; the full label on DailyMed

What does the sotalol label say about azithromycin?

Sotalol's label (effective December 16, 2024) and its 2 other brand-application labels do not name azithromycin in these sections. A label lists what its studies and reports found; it is not a complete list.

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

55Azithromycin generic labelers
18Sotalol generic labelers
AzithromycinSotalol
Labeled forBacterial infectionsAtrial fibrillation
Boxed warningNoYes
Pharmacy cost (NADAC)$0.266 per tablet 250 mg tablet$0.0707 per tablet 80 mg tablet
Shortage nowA presentation being discontinuedNo 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?