Budesonide

ATC code

R03BA02

Therapeutic class

Inhaled corticosteroid · Glucocorticoid

Forms

suspension for nebulization, dry powder inhaler, oral capsule, nasal spray, orodispersible tablet

Brand names

Pulmicort (US) · Budesonida Aldo-Union (ES) · Entocort (Global) · Uceris (US) · Jorveza (EU)

Overall confidence

medium

Regulatory sources consulted

AEMPS-CIMA-FT-66943
PubMed PMID:36375697 ↗
PubMed PMID:34923033 ↗
Clinical Practice Guidelines (GOLD 2023)
AEMPS CIMA · nº registro 66943 ↗
RxNorm rxcui 19831 ↗

Approved indications

Maintenance treatment of persistent asthma in adults and children.
Maintenance treatment of Chronic Obstructive Pulmonary Disease (COPD), usually in combination with a long-acting bronchodilator.
Induction of remission in mild to moderate Crohn's disease with ileal and/or ascending colon involvement (oral formulation).
Treatment of non-cirrhotic autoimmune hepatitis, often in combination with azathioprine (oral formulation).

Contraindications

Absolute

Hypersensitivity to the active substance. Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required.

Clinical warnings

Risk of oropharyngeal candidiasis. Advise patient to rinse mouth with water after inhalation to minimize risk. — AEMPS CIMA
Major warning · An increased incidence of pneumonia, including pneumonia requiring hospitalization, has been observed in patients with COPD receiving inhaled corticosteroids. — Guideline GOLD 2023
Major warning · Long-term use of high doses may cause systemic effects such as adrenal suppression, reduction in bone mineral density, cataracts, and glaucoma. — AEMPS CIMA

Drug interactions

HighStrong CYP3A4 inhibitors (e.g., Ketoconazole, Ritonavir, Itraconazole)J02AB02
Mechanism: Potent inhibition of budesonide metabolism via CYP3A4, resulting in a marked increase in systemic exposure and risk of cushingoid side effects and adrenal suppression.
Recommendation: Avoid concomitant use. If unavoidable, monitor the patient closely for systemic corticosteroid side effects.
AEMPS CIMA

Adverse events

Common (≥1%)

oral candidiasis · dysphonia · cough · throat irritation

Rare but serious

pneumonia · adrenal suppression · paradoxical bronchospasm · hypersensitivity reactions · decreased bone mineral density · glaucoma · cataracts

Pregnancy and lactation

FDA category: N/A

Considered one of the safest inhaled corticosteroids for asthma control during pregnancy. It is excreted in breast milk at low levels and is considered compatible with breastfeeding.

Recent literature (PubMed)

Budesonide in the first line treatment of patients with autoimmune hepatitis.
Olivas I, et al. · Gastroenterol Hepatol · 2022 · Relevance 4/5
Revisión sobre el uso de budesonida como alternativa de primera línea a la prednisona en hepatitis autoinmune no grave. Se discuten sus propiedades farmacológicas de acción local y bajo perfil sistémico, la evidencia disponible y su perfil de seguridad.
Corticosteroids in inflammatory bowel disease: Are they still a therapeutic option?
Quera R, et al. · Gastroenterol Hepatol · 2023 · Relevance 3/5
Artículo de revisión que analiza el papel de los corticosteroides en la inducción de la remisión en la enfermedad inflamatoria intestinal (EII) a pesar de las nuevas terapias. Destaca la importancia del uso correcto y los errores frecuentes en la práctica clínica.