Sildenafil and Ketoconazole Interaction

Drug interaction information between Sildenafil and Ketoconazole.

Sildenafil and Ketoconazole have a documented major interaction in FDA labeling.

FDA drug labeling documents a major-severity interaction between Sildenafil and Ketoconazole. This page displays the available source-record category and label text. The category is not an individual risk estimate or medication-combination direction.

Drug A

Sildenafil

PDE5 Inhibitor

Drug B

Ketoconazole

Azole Antifungal

How They Interact

Ketoconazole slows down the breakdown of sildenafil, which can lead to higher levels of the drug in your system.

FDA Label Information

7 DRUG INTERACTIONS Sildenafil can potentiate the hypotensive effects of nitrates, alpha blockers, and anti-hypertensives ( 4.1 , 5.5 , 7.1 , 7.2 , 7.3 , 12.2 ) With concomitant use of alpha blockers, initiate sildenafil at 25 mg dose ( 2.3 ) CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, erythromycin): Increase sildenafil exposure ( 2.4 , 7.4 , 12.3 ) Ritonavir: Do not exceed a maximum single dose of 25 mg in a 48 hour period ( 2.4 , 5.6 ) Erythromycin or strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, saquinavir): Consider a starting dose of 25 mg ( 2.4 , 7.4...

Frequently Asked Questions

What SPL severity band is on file for Sildenafil + Ketoconazole?

Compiled FDA labeling labels this pair major. That is a source-record field, not an individual medication-combination decision.

Which drug in this pair has the larger labeled-interaction portfolio?

Ketoconazole has 113 labeled pairs on file vs Sildenafil's 10. In the major band specifically: Sildenafil has 6 (also Erythromycin, Itraconazole, Darunavir, Hydralazine); Ketoconazole has 6 (also Alfuzosin, Dronedarone, Ranolazine, Saxagliptin).

What mechanism field is on file for Sildenafil and Ketoconazole?

Ketoconazole slows down the breakdown of sildenafil, which can lead to higher levels of the drug in your system.

Ketoconazole's labeled portfolio outnumbers Sildenafil

SPL source-record counts only. This page's band is major · classes on file: Sildenafil (PDE5 Inhibitor); Ketoconazole (Azole Antifungal).

Sildenafil

6 major · 1 moderate · 3 minor · 10 total

Ketoconazole

6 major · 22 moderate · 85 minor · 113 total

Sources: FDA Drug Labels (SPL) via openFDA (2026). This is for informational purposes only and is not medical advice. This registry does not provide individual medication-combination directions.