Budesonide/formoterol
| Combination of | |
|---|---|
| Budesonide | Glucocorticoids |
| Formoterol | Long-acting beta-adrenoceptor agonist |
| Clinical data | |
| Trade names | Symbicort, others |
| AHFS/Drugs.com | Professional Drug Facts |
| MedlinePlus | a623022 |
| License data | |
| Pregnancy category |
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| Routes of administration | Inhalation[2] |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| KEGG | |
| CompTox Dashboard (EPA) | |
| (verify) | |
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).[2] It contains budesonide, a steroid; and formoterol, a long-acting β2-agonist (LABA).[2] The product monograph does not support its use for sudden worsening or treatment of active bronchospasm.[2] However, a 2020 review of the literature does support such use.[6] It is used by breathing in the medication.[2]
Common (≥1/100 to <1/10) side effects include candidiasis, headache, tremor, palpitations, throat irritation, coughing, and dysphonia.[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 an inhaled 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 was approved for medical use in the United States in 2006.[2][10] It is on the World Health Organization's List of Essential Medicines.[11][12] It is available as a generic medication.[13] In 2022, it was the 83rd most commonly prescribed medication in the United States, with more than 8 million prescriptions.[14][15]
- ^ a b "Budesonide / formoterol (Symbicort) Use During Pregnancy". Drugs.com. 28 August 2019. Retrieved 13 April 2020.
- ^ a b c d e f g h i "Symbicort- budesonide and formoterol fumarate dihydrate aerosol". DailyMed. 24 July 2019. Retrieved 29 April 2020.
- ^ a b "Symbicort Turbohaler 200/6 Inhalation powder - Summary of Product Characteristics (SmPC)". (emc). 30 August 2019. Retrieved 13 April 2020.
- ^ Cite error: The named reference
BiResp Spiromax EPARwas invoked but never defined (see the help page). - ^ Cite error: The named reference
DuoResp Spiromax EPARwas invoked but never defined (see the help page). - ^ Jenkins CR, Bateman ED, Sears MR, O'Byrne PM (August 2020). "What have we learnt about asthma control from trials of budesonide/formoterol as maintenance and reliever?". Respirology. 25 (8): 804–815. doi:10.1111/resp.13804. PMID 32237004.
- ^ "Symbicort Turbohaler 100/6 Summary of Product Characteristics". Medicines.ie. Irish Pharmaceutical Healthcare Association. 2 February 2021. Retrieved 2 July 2021.
- ^ "Safety Alerts for Human Medical Products - Long-Acting Beta agonists (LABAs) and Inhaled Corticosteroids (ICS): Drug Safety Communication - Boxed Warning About Asthma-Related Death Removed". FDA. Retrieved 23 December 2017.
- ^ "Global Strategy for Asthma Management and Prevention" (PDF). Ginasthma.org. 2020. p. 90. Retrieved 9 May 2020.
evidence for safety of usual doses of ICS and LABA
- ^ Cite error: The named reference
FDA approvalwas invoked but never defined (see the help page). - ^ 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.
- ^ "FDA Approves First Generic of Symbicort to Treat Asthma and COPD". U.S. Food and Drug Administration (Press release). 15 March 2022. Archived from the original on 15 March 2022. Retrieved 15 March 2022.
- ^ "The Top 300 of 2022". ClinCalc. Archived from the original on 30 August 2024. Retrieved 30 August 2024.
- ^ "Budesonide; Formoterol Drug Usage Statistics, United States, 2013 - 2022". ClinCalc. Retrieved 30 August 2024.