Budesonide/formoterol

Overview

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 β₂-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.[1][2] WP

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.[1][3–7] WP

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 2023, it was the 74th most commonly prescribed medication in the United States, with more than 9 million prescriptions.[1][8–13] WP

Uses, dosage and effects

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.[1][14][15] WP

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.[2][16] WP

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.[1][2] WP

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.[17][18] WP

Risks and side effects

Common (up to 1 in 10 people)

• Mild throat irritation WP
• Coughing WP
• Hoarseness WP
• Oral candidiasis (thrush. significantly less likely if the patient rinses their mouth out with water after inhalations) WP
• Headache WP

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

• Heart palpitations WP
• Trembling WP

Uncommon (up to 1 in 100 people)

• Feeling restlessness, nervous, or agitated WP
• Disturbed sleep WP
• Feeling dizzy WP
• Nausea WP
• Tachycardia (fast heart rate) WP
• Bruising of the skin WP
• Muscle cramps WP

Rare (up to 1 in 1,000 people)

• Rash WP
• Itchiness WP
• 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) WP
• Hypokalemia (low levels of potassium in the blood) WP
• Heart arrhythmia WP

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

• Depression WP
• Changes in behaviour, especially in children WP
• Chest pain or tightness in chest WP
• Increase in blood glucose levels WP
• Taste changes, such as an unpleasant taste in the mouth WP
• Changes in blood pressure WP

Other

With high doses for a long period of time. WP

• Reduced bone mineral density, causing osteoporosis WP
• Cataracts WP
• Glaucoma WP
• Slowed rate of growth in children and adolescents WP
• Dysfunction of the adrenal gland, which affects the production of various hormones WP

Allergic reaction

• Angioedema (swelling of the face, mouth, tongue, and/or throat. Difficulty swallowing. Hives. Difficulty breathing. Feeling of faintness) WP
• Bronchospasm (sudden acute wheezing or shortness of breath immediately after use of medication. The patient should use their reliever medication immediately.)[19] WP

Legal status

Legal status

Budesonide/formoterol was approved for use in the United States in July 2006.[1][8][20] WP

There are several patents related to the drug; some of which have expired. It was initially marketed by AstraZeneca.[21] WP

Chemistry

Harm reduction information

No harm reduction data is on file for this compound yet. That means no dose, timing or combination data from PsychonautWiki or TripSit. Please don't guess a dose from similar compounds. If you have taken it and feel unwell, contact emergency services or a poison control center.

User reports

Pop culture

No references added yet.

Sources

1. Journal / agency Symbicort- budesonide and formoterol fumarate dihydrate aerosol. 24 July 2019
2. Journal / agency Jenkins CR, Bateman ED, Sears MR, O'Byrne PM. What have we learnt about asthma control from trials of budesonide/formoterol as maintenance and reliever?. Respirology. August 2020. doi:10.1111/resp.13804 · PMID 32237004
3. Other Symbicort Turbohaler 100/6 Summary of Product Characteristics. 2 February 2021
4. Other Symbicort Turbohaler 200/6 Inhalation powder - Summary of Product Characteristics (SmPC). 30 August 2019
5. Journal / agency 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
6. Other Global Strategy for Asthma Management and Prevention. 2020
7. Other Budesonide / formoterol (Symbicort) Use During Pregnancy. 28 August 2019
8. Journal / agency Drug Approval Package: Symbicort (budesonide/formoterol fumarate dihydrate) NDA #021929. 30 October 2008
9. Other World Health Organization model list of essential medicines: 21st list 2019. 2019
10. Other World Health Organization model list of essential medicines: 22nd list (2021). 2021
11. Journal / agency FDA Approves First Generic of Symbicort to Treat Asthma and COPD. 15 March 2022
12. Other Top 300 of 2023
13. Other Budesonide; Formoterol Drug Usage Statistics, United States, 2014 - 2023
14. Journal / agency BiResp Spiromax EPAR. 17 September 2018
15. Journal / agency DuoResp Spiromax EPAR. 17 September 2018
16. Journal / agency Lasserson TJ, Ferrara G, Casali L. Combination fluticasone and salmeterol versus fixed dose combination budesonide and formoterol for chronic asthma in adults and children. The Cochrane Database of Systematic Reviews. December 2011. doi:10.1002/14651858.CD004106.pub4 · PMID 22161385 · PMC11437353
17. Journal / agency Kew KM, Karner C, Mindus SM, Ferrara G. Combination formoterol and budesonide as maintenance and reliever therapy versus combination inhaler maintenance for chronic asthma in adults and children. The Cochrane Database of Systematic Reviews. December 2013. doi:10.1002/14651858.CD009019.pub2 · PMID 24343671 · PMC8949777
18. Journal / agency Sobieraj DM, Weeda ER, Nguyen E, Coleman CI, White CM, Lazarus SC, Blake KV, Lang JE, Baker WL. Association of Inhaled Corticosteroids and Long-Acting β-Agonists as Controller and Quick Relief Therapy With Exacerbations and Symptom Control in Persistent Asthma: A Systematic Review and Meta-analysis. JAMA. April 2018. doi:10.1001/jama.2018.2769 · PMID 29554195 · PMC5876810
19. Other PACKAGE LEAFLET:INFORMATION FOR THE USER Symbicort® Turbohaler® 200 micrograms/6 micrograms/inhalation, inhalation powder budesonide, formoterol fumarate dihydrate. July 2015
20. Other Haber G. AstraZeneca banking on asthma inhaler. 19 November 2006
21. Other Has a generic version of Symbicort been approved?

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