Budesonide and formoterol and Darunavir and cobicistat interaction

Budesonide and formoterol and Darunavir and cobicistat: both prescribing labels flag this combination with the strongest language, such as a contraindication, a boxed warning, or an instruction to avoid it.

Major

Do not combine without a prescriber's guidance. The label language below is the strongest FDA uses.

What the FDA labels say

From the Darunavir and cobicistat (PREZCOBIX) label · effective 2026-02-01

Major

Inhaled beta agonist: salmeterol ↑ salmeterol Co-administration with salmeterol is not recommended and may result in increased risk of cardiovascular adverse events associated with salmeterol, including QT prolongation, palpitations, and sinus tachycardia.

Drug interactionsby drug classView label on DailyMed
Moderate

Corticosteroids: dexamethasone (systemic) Corticosteroids primarily metabolized by CYP3A: e.g. betamethasone budesonide ciclesonide fluticasone methylprednisolone mometasone triamcinolone ↓ darunavir ↓ cobicistat ↑ corticosteroids Co-administration with systemic dexamethasone or other systemic corticosteroids that induce CYP3A may result in loss of therapeutic…

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Moderate

Consider alternative corticosteroids.

Drug interactionsby drug classView label on DailyMed
Moderate

Co-administration with corticosteroids (all routes of administration) of which exposures are significantly increased by strong CYP3A inhibitors can increase the risk for Cushing's syndrome and adrenal suppression.

Drug interactionsby drug classView label on DailyMed
Moderate

Alternative corticosteroids including beclomethasone, prednisone and prednisolone (for which PK and/or PD are less affected by strong CYP3A inhibitors relative to other steroids) should be considered, particularly for long-term use.

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From the Budesonide and formoterol (Budesonide and Formoterol Fumarate Dihydrate) label · effective 2026-04-24

Moderate

Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir): Risk of increased systemic corticosteroid effects.

Warnings and precautionsby drug classView label on DailyMed
Moderate

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…

Warnings and precautionsby drug classView label on DailyMed
Moderate

Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir): Use with caution.

Drug interactionsby drug classView label on DailyMed
Moderate

After oral administration of ketoconazole, a strong inhibitor of CYP3A4, the mean plasma concentration of orally administered budesonide increased.

Drug interactionsby drug classView label on DailyMed
Moderate

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) ] .

Drug interactionsby drug classView label on DailyMed

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Not 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.