Budesonide and formoterol and Salmeterol interaction

Budesonide and formoterol 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.

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

Major

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) ].

Warnings and precautionsnames SalmeterolView label on DailyMed
Major

…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).

Warnings and precautionsnames SalmeterolView label on DailyMed
Major

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…

Warnings and precautionsnames SalmeterolView label on DailyMed
Major

Use with additional long-acting beta 2 -agonist: Do not use in combination because of risk of overdose.

Warnings and precautionsby drug classView label on DailyMed
Moderate

Excessive Use of Budesonide and Formoterol Fumarate Dihydrate and Use with Other Long-Acting Beta 2 -Agonists As with other inhaled drugs containing beta 2 -adrenergic agents, budesonide and formoterol fumarate dihydrate should not be used more often than recommended, at higher doses than recommended, or in conjunction with other medications containing LABA,…

Warnings and precautionsby drug classView label on DailyMed

From the Salmeterol (SEREVENT DISKUS) label · effective 2022-10-10

Major

WARNING: ASTHMA-RELATED DEATH Long-acting beta 2 -adrenergic agonists (LABA), such as salmeterol, the active ingredient in SEREVENT DISKUS, as monotherapy (without inhaled corticosteroids [ICS]) increase the risk of asthma-related death.

Boxed warningby drug classView label on DailyMed
Major

• Long-acting beta 2 -adrenergic agonists (LABA), such as salmeterol, the active ingredient in SEREVENT DISKUS, as monotherapy (without inhaled corticosteroids [ICS]) increase the risk of asthma - related death.

Boxed warningby drug classView label on DailyMed
Major

Excessive Use of SEREVENT DISKUS and Use with Other Long-acting Beta 2 -agonists SEREVENT DISKUS 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.

Warnings and precautionsby drug classView label on DailyMed
Moderate

In this situation, the patient requires immediate reevaluation with reassessment of the treatment regimen, giving special consideration to the possible need for adding additional ICS or initiating systemic corticosteroids.

Warnings and precautionsby drug classView label on DailyMed
Moderate

When initiating and throughout treatment with SEREVENT DISKUS in patients receiving oral or ICS for treatment of asthma, patients must continue taking a suitable dosage of corticosteroids to maintain clinical stability even if they feel better as a result of initiating SEREVENT DISKUS.

Warnings and precautionsby 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.