Budesonide and formoterol and Ketoconazole interaction
Budesonide and formoterol and Ketoconazole: both prescribing labels flag this combination with the strongest language, such as a contraindication, a boxed warning, or an instruction to avoid it.
Do not combine without a prescriber's guidance. The label language below is the strongest FDA uses.
What the FDA labels say
From the Ketoconazole label · effective 2026-07-07
Fluticasone: Coadministration of fluticasone propionate and ketoconazole is not recommended unless the potential benefit to the patient outweighs the risk of systemic corticosteroid side effects.
Immunosuppressants everolimus, rapamycin (also known as sirolimus), temsirolimus budesonide, ciclesonide, cyclosporine, dexamethasone, fluticasone, methylprednisolone, tacrolimus Rapamycin (sirolimus): Ketoconazole tablets 200 mg daily for 10 days increased the C max and AUC of a single 5 mg dose of sirolimus by 4.3 fold and 10.9 fold, respectively in 23 healthy…
Adrenal Insufficiency Ketoconazole tablets decrease adrenal corticosteroid secretion at doses of 400 mg and higher.
From the Budesonide and formoterol (Budesonide and Formoterol Fumarate Dihydrate) label · effective 2026-04-24
Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir): Risk of increased systemic corticosteroid effects.
Drug Interactions With Strong Cytochrome P450 3A4 Inhibitors Caution should be exercised when considering the coadministration of budesonide and formoterol fumarate dihydrate with ketoconazole, and other known strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin) because…
Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir): Use with caution.
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 budesonide and formoterol fumarate dihydrate 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) ] .
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Open in the checkerNot medical advice. Interaction Checker quotes FDA label text and NIH fact sheets. Whether an interaction matters for you depends on doses, timing, kidney and liver function, and other conditions. Confirm with a pharmacist or prescriber.