Topically Acting Corticosteroid
Pregnancy: Administration during pregnancy should be avoided unless there are compelling reasons for therapy; there are few data on pregnancy outcomes after oral budesonide in humans and glucocorticosteroids have caused abnormalities of fetal development in pregnant animals. Budesonide is excreted in human milk but only minor effects on the breastfed child are anticipated within the therapeutic range - decide whether to discontinue breast-feeding or budesonide, weighing the benefit of each.
This page concerns oral budesonide, a locally-acting corticosteroid, used to induce remission in inflammatory bowel disease, principally mild-to-moderate Crohn's disease affecting the ileum and ascending colon.
Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.
Adult dose
Dose:Crohn's disease, induction of remission: 9 mg budesonide daily - three 3 mg gastro-resistant capsules once daily in the morning, or one 3 mg capsule three times daily (morning, midday and evening)
Route: Oral - capsules taken about half an hour before meals, swallowed whole with plenty of fluid
Frequency: Once daily in the morning, or three times daily
Max: Duration of treatment in active Crohn's disease should be limited to 8 weeks
Source is the eMC SPC for Budenofalk 3 mg gastro-resistant capsules (oral ileal-release budesonide). MICROSCOPIC COLITIS in the same SPC: induction of remission three capsules once daily in the morning (9 mg daily), limited to 8 weeks; maintenance of remission, only in patients with frequently recurring symptoms after successful induction, two capsules once daily in the morning (6 mg) or two capsules once daily alternating with one capsule daily (average 4.5 mg daily), using the lowest effective dose - evaluate the treatment effect regularly and no later than 12 months after starting maintenance, extending beyond 12 months only if benefits outweigh risks. AUTOIMMUNE HEPATITIS (also in this SPC, not an IBD indication): induction 3 mg three times daily (9 mg daily) until remission, then maintenance 3 mg twice daily (6 mg daily), increased back to 9 mg daily if ALAT and/or ASAT rise during maintenance; combined with azathioprine in patients tolerant to it; maintenance continued for at least 24 months. Treatment should not be stopped abruptly but withdrawn gradually with tapering doses - gradual dose reduction over 2 weeks is recommended. This medicine is not appropriate for patients with Crohn's disease of the upper gastrointestinal tract, and because of the preferential local mode of action benefit for extraintestinal symptoms (eyes, skin, joints) cannot be expected. This SPC covers the oral capsule only - it contains no rectal (foam or enema) posology. Paediatric: should not be taken by children younger than 12 years due to insufficient experience and possibly increased risk of adrenal suppression; in adolescents aged 12 to 18 years safety and efficacy have not been established and no posology recommendation can be made - verify against a children's formulary. The US label in this bundle (openFDA) is an over-the-counter budesonide NASAL allergy spray and is not applicable to oral gastrointestinal use.
Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.
Contraindications
Hypersensitivity to budesonide or to any of the excipients
Hepatic cirrhosis
Side effects
Cushing's syndrome features (common) - moon face, truncal obesity, reduced glucose tolerance, diabetes mellitus, hypertension, sodium retention with oedema, inactivity or atrophy of the adrenal cortex, steroid acne, red striae, menstrual disturbance
Increased risk of infection (common)
Dyspepsia and abdominal pain (common); duodenal or gastric ulcer (uncommon); pancreatitis (rare)
Muscle and joint pain, muscle weakness and twitching, osteoporosis (common); headache (common); osteonecrosis (rare)
Depression, irritability, euphoria (common); psychomotor hyperactivity and anxiety (uncommon); glaucoma, cataract and blurred vision (rare); growth retardation in children (very rare)
Clinical monograph
How it works
Budesonide is a potent glucocorticoid with extensive first-pass hepatic metabolism, so modified-release formulations deliver topical anti-inflammatory action at the gut mucosa while limiting systemic corticosteroid exposure.
Prescribing in practice
Despite lower systemic effects than conventional steroids, it can still suppress the adrenal axis, so do not stop abruptly after prolonged courses and provide steroid-sickness advice.
Co-administration with potent CYP3A4 inhibitors substantially raises systemic budesonide exposure and should generally be avoided.
It is for induction rather than long-term maintenance, and watch for systemic corticosteroid effects with extended or repeated use.
Monitoring
Monitor for systemic corticosteroid effects on prolonged use and review disease response to guide tapering within the IBD pathway.
Counselling the patient
Swallow modified-release capsules whole as directed so the medicine releases in the right part of the bowel.
Do not stop suddenly if you have taken it for a while; the dose should be reduced gradually.
Carry a steroid alert card and mention this medicine if you become unwell or need surgery.
Evidence & guidelines
NICE guidance on Crohn's disease supports budesonide to induce remission in mild-to-moderate ileocaecal disease where its more favourable side-effect profile than prednisolone is relevant.
Reference: ECCO IBD Guidelines 2021; NICE NG129 Crohn's Disease; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing.
The structured dose values shown have been reviewed by a clinician.
Monograph status: clinician-reviewed (2026-07-04).
Related
Curated clinical cross-links plus same-class fallbacks.
