Simvastatin and Ketoconazole Interaction

Drug interaction information between Simvastatin and Ketoconazole.

Simvastatin and Ketoconazole have a documented minor interaction in FDA labeling.

FDA drug labeling documents a minor-severity interaction between Simvastatin 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

Simvastatin

HMG-CoA Reductase Inhibitor (Statin)

Drug B

Ketoconazole

Azole Antifungal

How They Interact

Ketoconazole prevents your body from breaking down simvastatin, which can cause the drug to reach high and potentially harmful levels.

FDA Label Information

Examples: Select azole anti-fungals (e.g., itraconazole, ketoconazole, posaconazole, and voriconazole), select macrolide antibiotics (e.g., erythromycin and clarithromycin, telithromycin), select HIV protease inhibitors (e.g., nelfinavir, ritonavir, and darunavir/ritonavir), select HCV protease inhibitors (e.g., boceprevir and telaprevir), cobicistat-containing products, and nefazodone.

Frequently Asked Questions

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

Compiled FDA labeling labels this pair minor. 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 Simvastatin's 41. In the minor band specifically: Simvastatin has 21 (also Fenofibrate, Erythromycin, Clarithromycin, Darunavir); Ketoconazole has 85 (also Abiraterone, Acetaminophen/Oxycodone, Alosetron, Amphotericin B).

What mechanism field is on file for Simvastatin and Ketoconazole?

Ketoconazole prevents your body from breaking down simvastatin, which can cause the drug to reach high and potentially harmful levels.

Simvastatin carries more major-labeled pairs than Ketoconazole

SPL source-record counts only. This page's band is minor · classes on file: Simvastatin (HMG-CoA Reductase Inhibitor (Statin)); Ketoconazole (Azole Antifungal).

Simvastatin has 11 major-labeled pairs vs Ketoconazole's 6. This page itself is in the minor band, not the major band.

Simvastatin

11 major · 9 moderate · 21 minor · 41 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.