Budesonide/Formoterol and Ketoconazole Interaction

Drug interaction information between Budesonide/Formoterol and Ketoconazole.

Budesonide/Formoterol and Ketoconazole have a documented moderate interaction in FDA labeling.

FDA drug labeling documents a moderate-severity interaction between Budesonide/Formoterol 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

Budesonide/Formoterol

Corticosteroid / Long-Acting Beta-2 Agonist Combination

Drug B

Ketoconazole

Azole Antifungal

How They Interact

Ketoconazole blocks the specific liver enzyme that normally breaks down budesonide. This causes the steroid levels in your body to rise higher than intended.

FDA Label Information

After oral administration of ketoconazole, a strong inhibitor of CYP3A4, the mean plasma concentration of orally administered budesonide increased. Caution should be exercised when considering the coadministration of SYMBICORT with long-term ketoconazole and other known strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin) [see Warnings and Precautions (5.9) ] .

Budesonide/Formoterol Also Interacts With

View all Budesonide/Formoterol interactions →

Frequently Asked Questions

What SPL severity band is on file for Budesonide/Formoterol + 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 Budesonide/Formoterol's 5. In the moderate band specifically: Budesonide/Formoterol has 4 (also Clarithromycin, Itraconazole, Formoterol); Ketoconazole has 22 (also Alprazolam, Aprepitant, Dexamethasone, Fesoterodine).

What mechanism field is on file for Budesonide/Formoterol and Ketoconazole?

Ketoconazole blocks the specific liver enzyme that normally breaks down budesonide. This causes the steroid levels in your body to rise higher than intended.

Ketoconazole carries more major-labeled pairs than Budesonide/Formoterol

SPL source-record counts only. This page's band is moderate · classes on file: Budesonide/Formoterol (Corticosteroid / Long-Acting Beta-2 Agonist Combination); Ketoconazole (Azole Antifungal).

Ketoconazole has 6 major-labeled pairs vs Budesonide/Formoterol's 0. This page itself is in the moderate band, not the major band.

Budesonide/Formoterol

0 major · 4 moderate · 1 minor · 5 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.