|Formoterol||Long-acting beta-adrenoceptor agonist|
|CompTox Dashboard (EPA)|
Budesonide/formoterol, sold under the brand name Symbicort among others, is a combination medication used in the management of asthma or chronic obstructive pulmonary disease (COPD). It contains budesonide, a steroid and formoterol, a long-acting β2-agonist (LABA). It is not recommended for sudden worsening or treatment of active bronchospasm. It is used by breathing in the medication.
Common side effects include throat pain, influenza, runny nose, and a yeast infection of the mouth. 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. It is unclear if use of the combination is 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, the most effective and safe medicines needed in a health system. In the United States, as of 2017, the wholesale cost of an inhaler is about 30 USD. In the United Kingdom the cost as of 2015 was about 35 pounds for a unit with 120 doses. In 2016 it was the 77th most prescribed medication in the United States with more than 10 million prescriptions.
In people with asthma, budesonide/formoterol formulation for both maintenance and as-needed treatment reduces exacerbations better than as-needed formoterol or as-needed terbutaline. Nevertheless, it is unclear as to whether this strategy is better than increasing a maintenance dose of Symbicort or similar combined inhaler.
The combination is approved in the United States only as a maintenance medication in asthma and chronic obstructive pulmonary disease ( COPD).
Symbicort in the United States is a metered-dose inhaler and is available in 160/4.5mcg and 80/4.5mcg per actuation.
In the European Union, Australia, Canada, Israel, Saudi Arabia and elsewhere the combination is available as a dry powder inhaler in the following doses: 50/3 (40/2.25), 100/3 (80/2.25), 100/6 (80/4.5), 200/6 (160/4.5) and 400/12 (320/9), where the larger number is the dose per actuation of budesonide (in micrograms) and the lower number the dose of formoterol (also in micrograms).
Often mild, and usually disappear as the medication continues to be used:
With high doses for a long period of time.
Budesonide/formoterol formulation was introduced in Sweden in 2000. It was approved for use in the United States in July 2006. It is now approved for use in at least 70 countries, yielding global sales in excess of $1 billion in 2005, and now approximately $3.7 billion per annum.