Budesonide/formoterol

Budesonide/formoterol
Combination of
BudesonideGlucocorticoids
FormoterolLong-acting beta-adrenoceptor agonist
Clinical data
Trade namesSymbicort, others
AHFS/Drugs.comProfessional Drug Facts
MedlinePlusa623022
License data
Pregnancy
category
Routes of
administration		Inhalation[2]
ATC code
Legal status
Legal status
  • AU: S4 (Prescription only)
  • UK: POM (Prescription only)[3]
  • US: ℞-only[2]
  • EU: Rx-only[4][5]
  • In general: ℞ (Prescription only)
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]

  1. ^ a b "Budesonide / formoterol (Symbicort) Use During Pregnancy". Drugs.com. 28 August 2019. Retrieved 13 April 2020.
  2. ^ a b c d e f g h i "Symbicort- budesonide and formoterol fumarate dihydrate aerosol". DailyMed. 24 July 2019. Retrieved 29 April 2020.
  3. ^ a b "Symbicort Turbohaler 200/6 Inhalation powder - Summary of Product Characteristics (SmPC)". (emc). 30 August 2019. Retrieved 13 April 2020.
  4. ^ Cite error: The named reference BiResp Spiromax EPAR was invoked but never defined (see the help page).
  5. ^ Cite error: The named reference DuoResp Spiromax EPAR was invoked but never defined (see the help page).
  6. ^ 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.
  7. ^ "Symbicort Turbohaler 100/6 Summary of Product Characteristics". Medicines.ie. Irish Pharmaceutical Healthcare Association. 2 February 2021. Retrieved 2 July 2021.
  8. ^ "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.
  9. ^ "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
  10. ^ Cite error: The named reference FDA approval was invoked but never defined (see the help page).
  11. ^ 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.
  12. ^ 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.
  13. ^ "FDA Approves First Generic of Symbicort to Treat Asthma and COPD". U.S. Food and Drug Administration (Press release). 15 March 2022. Retrieved 15 March 2022.
  14. ^ "The Top 300 of 2022". ClinCalc. Archived from the original on 30 August 2024. Retrieved 30 August 2024.
  15. ^ "Budesonide; Formoterol Drug Usage Statistics, United States, 2013 - 2022". ClinCalc. Retrieved 30 August 2024.