Budesonide/formoterol, sold under the brand name Symbicort among others, is a fixed-dose combination medication used in the management of asthma or chronic obstructive pulmonary disease (COPD). It contains budesonide, a steroid; and formoterol, a long-acting β 2 -agonist (LABA). The product monograph does not support its use for sudden worsening or treatment of active bronchospasm. However, a 2020 review of the literature does support such use. It is used by breathing in the medication. Common (≥1/100 to <1/10) side effects include candidiasis, headache, tremor, palpitations, throat irritation, coughing, and dysphonia. Pneumonia is a common side effect in people with COPD, and other, less common side effects have been documented. There were concerns that the LABA component increases the risk of death in children with asthma, however these concerns were removed in 2017. Therefore, this combination is only recommended in those who are not controlled on an inhaled steroid alone. There is tentative evidence that typical doses of inhaled steroids and LABAs are safe in pregnancy. Both formoterol and budesonide are excreted in breast-milk. Budesonide/formoterol was approved for medical use in the United States in 2006. It is on the World Health Organization's List of Essential Medicines. It is available as a generic medication. In 2022, it was the 83rd most commonly prescribed medication in the United States, with more than 8million prescriptions.

Medical uses

Budesonide/formoterol is indicated for the treatment of asthma and for the maintenance treatment of airflow obstruction and reducing exacerbations in people with chronic obstructive pulmonary disease.

Maintenance

Budesonide/formoterol has shown efficacy to prevent asthma attacks. It is unclear if the efficacy of budesonide/formoterol differs from that of fluticasone and salmeterol in chronic asthma.

Exacerbation

The combination is approved in the United States only as a maintenance medication in asthma and chronic obstructive pulmonary disease (COPD). 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. Use for both maintenance and as-needed treatment is also known as single maintenance and reliever therapy (SMART) and is a well-established treatment. 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.

Side effects

Common (up to 1 in 10 people)

Often mild, and usually disappear as the medication continues to be used:

Uncommon (up to 1 in 100 people)

Rare (up to 1 in 1,000 people)

Very rare (up to 1 in 10,000 people)

Other

With high doses for a long period of time.

Allergic reaction

Society and culture

Legal status

Budesonide/formoterol was approved for use in the United States in July 2006. Budesonide/formoterol was approved for use in the European Union in April 2014. There are several patents related to the drug; some of which have expired. It was initially marketed by AstraZeneca.

Brand names

It is sold under various brand names including Symbicort, BiResp Spiromax, and DuoResp Spiromax.