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What the FDA labels say about taking them together

Ketoconazole and vardenafil

Vardenafil's FDA label of January 5, 2026 names ketoconazole in its drug interactions section; the ketoconazole label PlainMeds reads does not name vardenafil. The vardenafil label: “Interactions with Strong or Moderate CYP3A4 Inhibitors Concomitant administration with strong CYP3A4 inhibitors or moderate CYP3A4 inhibitors (such as erythromycin) increases plasma concentrations of vardenafil.”

Check it at the source: the ketoconazole FDA label on DailyMed (effective January 28, 2026, E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC); the vardenafil FDA label on DailyMed (effective January 5, 2026, Zydus Pharmaceuticals USA Inc.).

What does the ketoconazole label say about vardenafil?

Ketoconazole's label (effective January 28, 2026) does 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 (ketoconazole), E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC, effective January 28, 2026 (SPL set cad7c647-34a9-4e4e-83b3-8d78e58f588f), via openFDA; the full label on DailyMed

What does the vardenafil label say about ketoconazole?

Vardenafil label, drug interactions

In vivo studies Strong CYP3A4 inhibitors Ketoconazole (200 mg once daily) produced a 10-fold increase in vardenafil AUC and a 4-fold increase in maximum concentration (C max ) when co-administered with vardenafil (5 mg) in healthy volunteers.

Vardenafil label, warnings and precautions

Interactions with Strong or Moderate CYP3A4 Inhibitors Concomitant administration with strong CYP3A4 inhibitors (such as ritonavir, indinavir, cobicistat, ketoconazole) or moderate CYP3A4 inhibitors (such as erythromycin) increases plasma concentrations of 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

30Ketoconazole generic labelers
11Vardenafil generic labelers
KetoconazoleVardenafil
Labeled forFungal infectionsErectile dysfunction
Boxed warningNoNo
Pharmacy cost (NADAC)$0.249 per gram 2% cream$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)

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