Budesonide and formoterol and Fluticasone and salmeterol interaction
Budesonide and formoterol and Fluticasone and salmeterol: 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 Budesonide and formoterol (Budesonide and Formoterol Fumarate Dihydrate) label · effective 2026-04-24
Serious Asthma-Related Events – Hospitalizations, Intubations and Death Use of LABA as monotherapy (without ICS) for asthma is associated with an increased risk of asthma-related death [see Salmeterol Multicenter Asthma Research Trial (SMART) ].
…intubation (endotracheal) 1 2 Asthma-related hospitalization (≥24-hour stay) 115 105 ICS = Inhaled Corticosteroid, LABA = Long-acting Beta2-adrenergic Agonist The pediatric safety trial included 6208 pediatric patients 4 to 11 years of age who received ICS/LABA (fluticasone propionate /salmeterol inhalation powder) or ICS (fluticasone propionate inhalation powder).
Salmeterol Multicenter Asthma Research Trial (SMART) A 28-week, placebo-controlled U.S. trial that compared the safety of salmeterol with placebo, each added to usual asthma therapy, showed an increase in asthma-related deaths in patients receiving salmeterol (13/13,176 in patients treated with salmeterol vs. 3/13,179 in patients treated with placebo; relative…
Use with additional long-acting beta 2 -agonist: Do not use in combination because of risk of overdose.
In this situation, the patient requires immediate re-evaluation with reassessment of the treatment regimen, giving special consideration to the possible need for replacing the current strength of budesonide and formoterol fumarate dihydrate with a higher strength, adding additional inhaled corticosteroid, or initiating systemic corticosteroids.
From the Fluticasone and salmeterol (Fluticasone Propionate and Salmeterol) label · effective 2025-08-21
Avoid Excessive Use of Fluticasone Propionate/Salmeterol and Avoid Use with Other Long-Acting Beta 2 -Agonists Fluticasone Propionate/Salmeterol MDPI should not be used more often than recommended, at higher doses than recommended, or in conjunction with other medicines containing LABA, as an overdose may result.
In this situation, the patient requires immediate reevaluation with reassessment of the treatment regimen, giving special consideration to the possible need for replacing the current strength of Fluticasone Propionate/Salmeterol MDPI with a higher strength, adding additional inhaled corticosteroid, or initiating systemic corticosteroids.
Three (3) trials included adult and adolescent subjects aged 12 years and older: 1 trial compared budesonide/formoterol to budesonide, 1 trial compared fluticasone propionate/salmeterol inhalation powder to fluticasone propionate inhalation powder, and 1 trial compared mometasone furoate/formoterol to mometasone furoate.
Patients using Fluticasone Propionate/Salmeterol MDPI should not use another medicine containing a LABA (e.g., salmeterol, formoterol fumarate, arformoterol tartrate, indacaterol) for any reason.
Cases of serious eosinophilic conditions have also been reported with other inhaled corticosteroids in this clinical setting.
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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.