Drug reference

Budesonide

Corticosteroid

Also known as Budesonida, Pulmicort, Rhinocort, Entocort, Budecort, Symbicort (in combination)

START

200-400 µg inhaled BID (or 100-200 µg if ICS-formoterol MART)

TYPICAL MAX

1,600 µg/day (high-dose ICS)

STOP IF

Active untreated oral candidiasis · severe COPD without LABA

WATCH

Oral candidiasis · dysphonia · adrenal suppression with high dose

CDSCO approvedSchedule HJan AushadhiATC R03BA02

Dose laddermg/d

Renal dose adjustmenteGFR mL/min/1.73m²

KDIGO 2024 + manufacturer label

Pharmacokineticsplasma · t hours

ONSET: 1d · anti-inflammatory effect at 1-2 days
PEAK: 1w · max benefit at 1-2 weeks
t½: 3h · plasma t½
DURATION: 12h · BID dosing window

EXCRETION

CYP3A4 hepatic · renal metabolites

route + CYP

INTERACTIONS

12 major

SEVERE in our sources

PREGNANCY

Category B — ICS of choice in pregnancy

FDA category + note

Top interactionssee all 12 →

RifampinSevereTextbookG&G 14e · p1592
AdalimumabSevereDatabaseDDInter
AmprenavirSevereDatabaseDDInter
AtazanavirSevereDatabaseDDInter

Available in India

75 branded formulations. Look up specific brands in the Drugs workspace.

Jan Aushadhi — generic available at GoI pharmacies

Mechanism

Budesonide is a potent synthetic glucocorticoid that exerts its anti-inflammatory effects by binding to intracellular glucocorticoid receptors. This binding leads to the formation of a receptor-steroid complex that translocates to the nucleus, modulating gene expression. It inhibits the release of inflammatory mediators (e.g., cytokines, chemokines, prostaglandins, leukotrienes) and reduces the activity and number of inflammatory cells, such as eosinophils, mast cells, and lymphocytes, thereby suppressing the inflammatory response.

Indications

Asthma (maintenance treatment)Chronic Obstructive Pulmonary Disease (COPD) (maintenance, often in combination)Allergic RhinitisCrohn's Disease (mild to moderate, active)Ulcerative Colitis (mild to moderate, active)Eosinophilic Esophagitis (off-label)Asthma (in combination with LABA)mild-to-moderate colonic or terminal ileal Crohn’s diseasemild-to-moderate ulcerative colitisshort-term maintenance of remission (up to 3 months)AsthmaNasal polyposis

Dosing

Adult: Asthma (Inhalation): 200-800 mcg twice daily. Maintenance: 200-400 mcg twice daily. COPD (Inhalation, nebulized): 1 mg twice daily initially, then 0.5 mg twice daily. Crohn's Disease (Oral): 9 mg once daily in the morning for up to 8 weeks; then taper to 6 mg once daily for 2 weeks if required. Allergic Rhinitis (Nasal): 32 mcg or 64 mcg per nostril once daily.
Pediatric: Asthma (Inhalation): Children > 6 years: 200-400 mcg twice daily. Children 12 months to 8 years (nebulized): 0.25-0.5 mg twice daily. Crohn's Disease (Oral): Children > 8 years and > 25 kg: 9 mg once daily for up to 8 weeks, then taper.
Renal adjustment: No dose adjustment generally required.
Hepatic adjustment: Use with caution and consider dose reduction in severe hepatic impairment due to increased systemic exposure.
Geriatric: Generally same as adult dose. Monitor for increased susceptibility to side effects (e.g., osteoporosis, cataracts, glaucoma).
Max dose: Varies by indication. For asthma, up to 1600 mcg/day is often used. Oral for Crohn's is 9 mg/day for induction.

Pharmacokinetics

Onset

Inhaled (asthma): Within 24 hours, full effect in 1-2 weeks. Oral (Crohn's): Within 2 weeks.

Peak effect

Inhaled: 15-30 minutes for lung levels, clinical effect peaks over several days to weeks. Oral: Approximately 5 hours.

Duration

12-24 hours

Half-life

Approximately 2-3 hours (systemic)

Bioavailability

Oral: Approximately 10-15% (due to extensive first-pass metabolism). Inhaled: Approximately 34% (lung deposition).

Protein binding

85-90%

Metabolism

Extensive first-pass metabolism in the liver by CYP3A4 to inactive metabolites.

Excretion

Primarily renal (approximately 60% as metabolites), fecal (approximately 30-40% as metabolites).

Contraindications

Hypersensitivity to budesonide or any components
Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required
Systemic fungal infections
Active untreated infections (viral, bacterial, fungal, parasitic, or tuberculosis) if not on appropriate therapy
Presence of infection (intranasal)
Nasal ulcers (intranasal)

Side effects

Common

Oral candidiasis (thrush)CoughHoarsenessThroat irritationHeadacheUpper respiratory tract infectionNauseaAbdominal painDyspepsiaFatigueAcneNasal irritationEpistaxisDry nosePharyngitisSimilar profile of adverse events to conventional glucocorticoids, but with lower incidence due to extensive first-pass hepatic metabolism.Nasal irritation (especially in the beginning with nasal spray)Sneezing (especially in the beginning with nasal spray)Crusting (especially in the beginning with nasal spray)Itching of throat (especially in the beginning with nasal spray)Dryness (especially in the beginning with nasal spray)

Serious

Adrenal suppression
Growth retardation in children
Osteoporosis
Cataracts
Glaucoma
Hyperglycemia
Psychiatric disturbances (e.g., mood changes, depression)
Hypersensitivity reactions
Increased susceptibility to infections
Cushing's syndrome (with high systemic absorption)
Add Cataracts and Glaucoma to KDT's list of potential significant systemic side effects, or qualify their prominence for inhaled steroids.
Clarify the type of increased infection susceptibility (e.g., systemic vs. local), or reconcile with KDT's statement regarding lack of increased chest infections.

Pregnancy & lactation

Pregnancy

Category B — ICS of choice in pregnancy

Lactation

Budesonide is excreted into human milk. However, at therapeutic inhaled doses, the systemic exposure to the nursing infant is expected to be low. Oral budesonide may result in slightly higher exposure. Generally considered compatible with breastfeeding, but caution is advised, especially with high doses or prolonged use.