budesonide

Inhaled corticosteroids (ICS)

ATC code: R03BA02 (Budesonide)

Brand names

Pulmicort, Rhinocort, 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

First-line controller for asthma in adults and children per 2024. At GINA steps 1–2 in adults, GINA recommends as-needed low-dose budesonide/formoterol (anti-inflammatory reliever). At step 3, regular low- or medium-dose ICS combined with LABA (formoterol, salmeterol). ICS reduce asthma mortality per large meta-analyses. Starting dose 200 mcg twice daily.

Chronic obstructive pulmonary disease

Individual decision

Per 2024, ICS in COPD is not for everyone. Triple therapy (ICS + LABA + LAMA) is indicated with frequent exacerbations or eosinophilia. In patients without these criteria, ICS confer no benefit and increase pneumonia risk — dual bronchodilation (LABA + LAMA) is preferred.

ICS in COPD only with frequent exacerbations (≥ 2/year or 1 with hospitalization) or blood eosinophils ≥ 300/μL.

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.

Common cold

Not recommended

Inhaled budesonide for viral URI in patients without underlying asthma or COPD is not supported by international guidelines. , CDC, BMJ Best Practice, and do not include ICS in cold treatment standards. Self-prescribing Pulmicort «for cough» in adults and children is common in Russia and the CIS and frequently delays correct diagnosis and adds unjustified glucocorticoid exposure.

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 , NIH, 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.

Timing and administration

Use regularly twice daily regardless of symptoms. Effect develops over 1–2 weeks of regular use, peaking at 4–6 weeks. Do not stop controller therapy after improvement — this is the leading cause of exacerbations. Rinse the mouth with water and spit after each inhalation to prevent oral candidiasis and dysphonia.

Device compatibility

Inhaler type matters. Inhaled corticosteroids are delivered via metered-dose inhaler (pMDI), dry powder inhaler (DPI), or jet (compressor) nebulizer. Ultrasonic nebulizers must not be used — ultrasound disrupts the corticosteroid suspension and fails to aerosolize the drug correctly (Boucher RM, Kreuter J. Ann Allergy 1968; manufacturer SmPCs of ICS suspensions). For patients who cannot coordinate inhalation with actuation (children under 5, elderly, severe exacerbations), use a spacer with face mask or a jet nebulizer. With pMDI, a spacer increases lower-airway deposition by 60–80 % and reduces oral candidiasis and dysphonia. After ICS inhalation, rinse the mouth with water and spit — this prevents oral candidiasis.

Safety

Contraindications

Hypersensitivity
Active pulmonary tuberculosis
Systemic fungal infections
Age under 6 months (most formulations)

Serious adverse effects

Adrenal suppression (only at very high doses)
Reduced bone mineral density (only with very long-term high-dose therapy)
Glaucoma and cataract (with long-term high-dose use)

Common adverse effects

Oral candidiasis (up to 5 % when mouth rinsing is omitted)
Dysphonia, hoarseness
Throat irritation
Post-inhalation cough

Uncommon adverse effects

Paradoxical bronchospasm (rare)
Perioral dermatitis (with nebulizer use without face protection)
Slowed linear growth in children at high doses (about 1 cm in the first year)

Pregnancy

FDA categories were retired in 2015. Inhaled budesonide has the largest pregnancy safety dataset among ICS. The Swedish Medical Birth Registry on thousands of pregnancies showed no increased malformation risk. ICS are not withdrawn in pregnant asthma patients — the risk of uncontrolled asthma exceeds the drug risk.

Breastfeeding

Frequently asked

What is budesonide used for?

budesonide 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?

Common side effects of budesonide (≥ 1 in 100): Oral candidiasis (up to 5 % when mouth rinsing is omitted), Dysphonia, hoarseness, Throat irritation, Post-inhalation cough. See the Safety section for uncommon and serious reactions.

Is budesonide safe during pregnancy?

Is budesonide compatible with breastfeeding?

Compatible with breastfeeding. Systemic exposure after inhalation is low and milk concentrations are minimal.

Who should not take budesonide?

budesonide is contraindicated in: Hypersensitivity; Active pulmonary tuberculosis; Systemic fungal infections; Age under 6 months (most formulations). Full list in the Safety section.