Fesoterodine and Ketoconazole Interaction

Drug interaction information between Fesoterodine and Ketoconazole.

Fesoterodine and Ketoconazole have a documented moderate interaction in FDA labeling.

FDA drug labeling documents a moderate-severity interaction between Fesoterodine 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

Fesoterodine

Anticholinergic (Overactive Bladder)

Drug B

Ketoconazole

Azole Antifungal

How They Interact

Ketoconazole stops your body from breaking down fesoterodine properly, which can double the amount of medicine in your blood.

FDA Label Information

7.2 CYP3A4 Inhibitors Doses of fesoterodine fumarate greater than 4 mg are not recommended in adult patients taking strong CYP3A4 inhibitors, such as ketoconazole, itraconazole, and clarithromycin [see Dosage and Administration (2.5) ] . In a study in adults, co-administration of the strong CYP3A4 inhibitor ketoconazole with fesoterodine led to approximately a doubling of the maximum concentration (C max ) and area under the concentration versus time curve (AUC) of 5-hydroxymethyl tolterodine (5-HMT), the active metabolite of fesoterodine. Compared with CYP2D6 extensive metabolizers not...

Frequently Asked Questions

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

Compiled FDA labeling labels this pair moderate. 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 Fesoterodine's 15. In the moderate band specifically: Fesoterodine has 2 (also Clarithromycin); Ketoconazole has 22 (also Alprazolam, Aprepitant, Budesonide/Formoterol, Dexamethasone).

What mechanism field is on file for Fesoterodine and Ketoconazole?

Ketoconazole stops your body from breaking down fesoterodine properly, which can double the amount of medicine in your blood.

Ketoconazole carries more major-labeled pairs than Fesoterodine

SPL source-record counts only. This page's band is moderate · classes on file: Fesoterodine (Anticholinergic (Overactive Bladder)); Ketoconazole (Azole Antifungal).

Ketoconazole has 6 major-labeled pairs vs Fesoterodine's 2. This page itself is in the moderate band, not the major band.

Fesoterodine

2 major · 2 moderate · 11 minor · 15 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.