Skip to main content

What the FDA labels say about taking them together

Sotalol and vardenafil

Vardenafil's FDA label of January 5, 2026 names sotalol in its warnings and precautions section; the sotalol labels PlainMeds reads (3) do not name vardenafil. The vardenafil label: “Patients taking Class 1A or Class III antiarrhythmic medications or those with congenital QT prolongation, should avoid using vardenafil.”

Check it at the source: the sotalol FDA label on DailyMed (effective December 16, 2024, Legacy Pharma USA, Inc.); the vardenafil FDA label on DailyMed (effective January 5, 2026, Zydus Pharmaceuticals USA Inc.).

What does the sotalol label say about vardenafil?

Sotalol's label (effective December 16, 2024) and its 2 other brand-application labels do not name vardenafil 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

What does the vardenafil label say about sotalol?

Vardenafil label, warnings and precautions

Patients taking Class 1A (for example. quinidine, procainamide) or Class III (for example, amiodarone, sotalol) antiarrhythmic medications or those with congenital QT prolongation, should avoid using vardenafil.

Source: FDA drug label (VARDENAFIL), Zydus Pharmaceuticals USA Inc., effective January 5, 2026 (SPL set 5876e062-e604-42a7-99c3-5da30b8dac06), 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

18Sotalol generic labelers
11Vardenafil generic labelers
SotalolVardenafil
Labeled forAtrial fibrillationErectile dysfunction
Boxed warningYesNo
Pharmacy cost (NADAC)$0.0707 per tablet 80 mg tablet$2.79 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?