Budesonide (inhaled)

Inhaled corticosteroids (ICS)

ATC code: R03BA02 (Budesonide)

Brand names

Pulmicort, Pulmicort Flexhaler, Symbicort

Mechanism of action

A glucocorticoid with high topical anti-inflammatory activity and low systemic bioavailability. Suppresses pro-inflammatory gene transcription via genomic and non-genomic mechanisms. Reduces the number and activity of mast cells, eosinophils, and lymphocytes in airway mucosa. In inhaled form, effect begins within hours and peaks after 1-2 weeks of regular use. Addresses the underlying airway inflammation in asthma, unlike bronchodilators, which only relieve bronchospasm.

Indications

Asthma

First line

Inhaled corticosteroids are the backbone of asthma maintenance therapy. Since 2019, GINA has completely abandoned SABA-only monotherapy and recommends ICS (or ICS+formoterol) for all patients, including mild asthma. Preferred regimen for adults and adolescents aged 12+ is low-dose budesonide+formoterol as needed (MART / AIR). In persistent asthma, daily ICS therapy is used, with formoterol added if needed. Proven to reduce exacerbations, hospitalisations, and asthma mortality.

In children aged 1-5 years with suspected asthma and frequent exacerbations, budesonide is given via nebuliser. In older children and adolescents – via pMDI with spacer or Turbuhaler from age 6.

Chronic obstructive pulmonary disease

Adjunct

In COPD, GOLD 2024 adds an inhaled corticosteroid to bronchodilators (LABA+LAMA) in patients with frequent exacerbations (≥ 2 moderate or ≥ 1 hospitalisation per year) and blood eosinophils > 300 cells/μL. In patients with low eosinophils (< 100), adding ICS is not recommended due to weak effect and increased pneumonia risk. ICS monotherapy is not used in COPD.

Acute bronchospasm

Not recommended

Inhaled corticosteroids are not a rescue medication for acute bronchospasm. The effect develops over hours to days, not minutes. During an attack, short-acting beta-2 agonists (salbutamol) are used and systemic corticosteroids added if needed. Nebulised budesonide in severe paediatric exacerbations can be considered as an adjunct but not a replacement for systemic corticosteroids.

COVID-19

Not recommended

In 2020-2021, after the STOIC and PRINCIPLE trials, inhaled budesonide received attention as an outpatient COVID-19 treatment. Subsequent meta-analyses and WHO, NIH, IDSA guidelines did not include it as standard therapy. Effects on recovery time were modest, effects on serious outcomes were not significant. Routine use of budesonide for COVID-19 is currently not recommended.

Practical notes

technique

Rinse the mouth with water and spit after every corticosteroid inhalation, and use a spacer with pMDI. This reduces the risk of oral candidiasis and hoarseness – the most common local adverse effects. In young children, pMDI with spacer and mask is preferred over a nebuliser for daily therapy: same efficacy with a procedure that takes minutes.

Common myths

Myth: 'A hormonal inhaler is dangerous, I'm afraid to start'. Fact: with inhalation delivery, systemic bioavailability of budesonide is less than 10%. Most of the drug deposits in the airways. Proven adverse effects are local (candidiasis, hoarseness); systemic effects at standard doses are clinically insignificant. Fear of ICS leads to refusal of maintenance therapy and SABA overuse, which genuinely increases the risk of severe exacerbation and asthma death.

Safety

Contraindications

Hypersensitivity to budesonide or excipients
Caution – active pulmonary tuberculosis, fungal or bacterial respiratory infections

Serious adverse effects

Increased pneumonia risk in COPD patients on high doses
Systemic effects at very high doses (> 1000 mcg budesonide daily): reduced bone density, adrenal insufficiency, cataracts
Growth reduction in children at high doses (clinically insignificant at standard doses)

Common adverse effects

Oral and pharyngeal candidiasis
Hoarseness, dysphonia
Airway irritation
Cough after inhalation

Pregnancy

A large body of data shows no increased fetal risk. Budesonide is the ICS of choice in pregnancy. Poorly controlled asthma in pregnancy is more dangerous than ICS therapy.

Breastfeeding

Compatible with breastfeeding. Penetration into breast milk is minimal.

Frequently asked

What is Budesonide (inhaled) used for?

Budesonide (inhaled) is evaluated for the following indications with varying evidence strength: Asthma (evidence tier A), Chronic obstructive pulmonary disease (evidence tier B), Acute bronchospasm (evidence tier C). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Budesonide (inhaled)?

Common side effects of Budesonide (inhaled) (≥ 1 in 100): Oral and pharyngeal candidiasis, Hoarseness, dysphonia, Airway irritation, Cough after inhalation. See the Safety section for uncommon and serious reactions.

Is Budesonide (inhaled) safe during pregnancy?

A large body of data shows no increased fetal risk. Budesonide is the ICS of choice in pregnancy. Poorly controlled asthma in pregnancy is more dangerous than ICS therapy.

Is Budesonide (inhaled) compatible with breastfeeding?

Compatible with breastfeeding. Penetration into breast milk is minimal.

Who should not take Budesonide (inhaled)?

Budesonide (inhaled) is contraindicated in: Hypersensitivity to budesonide or excipients; Caution – active pulmonary tuberculosis, fungal or bacterial respiratory infections. Full list in the Safety section.

A hormonal inhaler is dangerous, I'm afraid to start

with inhalation delivery, systemic bioavailability of budesonide is less than 10%. Most of the drug deposits in the airways. Proven adverse effects are local (candidiasis, hoarseness); systemic effects at standard doses are clinically insignificant. Fear of ICS leads to refusal of maintenance therapy and SABA overuse, which genuinely increases the risk of severe exacerbation and asthma death.