Common (≥1/100 to <1/10) side effects includecandidiasis,headache,tremor,palpitations, throat irritation, coughing, anddysphonia.[7] Pneumonia is a common side effect in people with COPD, and other, less common side effects have been documented.[2][3] There were concerns that the LABA component increases the risk of death in children with asthma, however these concerns were removed in 2017.[8] Therefore, this combination is only recommended in those who are not controlled on aninhaled steroid alone.[2] There is tentative evidence that typical doses of inhaled steroids and LABAs are safe in pregnancy.[9] Both formoterol and budesonide are excreted in breast-milk.[1]
Budesonide/formoterol isindicated for the treatment of asthma and for the maintenance treatment of airflow obstruction and reducing exacerbations in people with chronic obstructive pulmonary disease.[2][4][5]
Budesonide/formoterol has shown efficacy to prevent asthma attacks.[6] It is unclear if the efficacy of budesonide/formoterol differs from that offluticasone and salmeterol in chronic asthma.[16]
The combination is approved in the United States only as a maintenance medication in asthma and chronic obstructive pulmonary disease (COPD).[2] However, a 2020 review of the literature does support use as needed during acute worsening in those with mild disease, and as maintenance followed by extra doses during worsening.[6]
Use for both maintenance and as-needed treatment is also known as single maintenance and reliever therapy (SMART) and is a well-established treatment.[17][18] It has been shown to, 1) reduce asthma exacerbations that require oral corticosteroids, 2) reduce hospital visits better than maintenance on inhaled corticosteroids alone at a higher dose, or 3) inhaled corticosteroid at the same or higher dose together with a long-acting bronchodilator (LABA), with a short-acting bronchodilator (SABA) as a reliever.[17][18]
Bronchospasm (tightening of the muscles in the airways causing wheezing immediately after use of the medication, which is possibly sign of an allergic reaction and should be met with immediate medical attention)
Hypokalemia (low levels of potassium in the blood)
Angioedema (swelling of the face, mouth, tongue, and/or throat. Difficulty swallowing. Hives. Difficulty breathing. Feeling of faintness)
Bronchospasm (sudden acute wheezing or shortness of breath immediately after use of medication. The patient should use their reliever medication immediately.)[20]
^World Health Organization (2019).World Health Organization model list of essential medicines: 21st list 2019. Geneva: World Health Organization.hdl:10665/325771. WHO/MVP/EMP/IAU/2019.06. License: CC BY-NC-SA 3.0 IGO.
^World Health Organization (2021).World Health Organization model list of essential medicines: 22nd list (2021). Geneva: World Health Organization.hdl:10665/345533. WHO/MHP/HPS/EML/2021.02.
