Corticosteroid — Locally Acting (GI)
Budesonide (Oral / Rectal)
Brand names: Entocort, Budenofalk, Cortiment
This page covers gastrointestinal budesonide by oral and rectal routes, a locally-acting corticosteroid used in inflammatory bowel disease and related conditions, with the route chosen to target the affected segment of bowel.
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: three capsules (3 mg each) once daily in the morning, or one capsule (3 mg budesonide) three times daily (morning, midday and evening) if more convenient to the patient - corresponding to a total daily dose of 9 mg budesonide. Microscopic colitis, induction of remission: three capsules once daily in the morning (9 mg budesonide daily); maintenance of remission (only in patients with frequently recurring symptoms after successful induction): two capsules once daily in the morning (6 mg budesonide), or two capsules once daily in the morning alternating with one capsule daily in the morning (an average daily dose of 4.5 mg budesonide), according to individual requirements - the lowest effective dose should be used. Autoimmune hepatitis, induction of remission: one capsule (3 mg) three times daily, morning, midday and evening (total 9 mg daily); maintenance of remission: one capsule (3 mg) twice daily, morning and evening (total 6 mg daily), increased back to 3 capsules per day (9 mg daily) if ALAT and/or ASAT rise during maintenance.
Route: Oral - gastro-resistant capsules containing gastro-resistant granules, 'taken about half an hour before meals, swallowed whole with plenty of fluid (e.g. a glass of water)'
Frequency: Crohn's disease and microscopic colitis induction: once daily in the morning (Crohn's may alternatively be given three times daily). Microscopic colitis maintenance: once daily in the morning. Autoimmune hepatitis: three times daily for induction, twice daily for maintenance.
NO NUMERIC CEILING IS STATED. The SPC gives no 'maximum' dose wording for any indication - 9 mg daily is the recommended (not stated maximum) total daily dose for Crohn's induction, microscopic colitis induction and autoimmune hepatitis induction, so maxDose is left empty rather than inferred. The limits the SPC does impose are on DURATION, not dose (below). || DURATION (SPC 4.2, verbatim): 'The duration of treatment in active Crohn's Disease should be limited to 8 weeks.' 'The duration of treatment in active microscopic colitis should be limited to 8 weeks. In maintenance therapy, the treatment effect should be evaluated regularly to assess if continued treatment is necessary, not later than 12 months after the initiation of maintenance treatment. Maintenance treatment should only be extended beyond a duration of 12 months if the benefits for the individual patient are considered to outweigh the risks.' Autoimmune hepatitis: 'For the induction of remission a total daily dose of 9 mg should be given until remission is achieved... Treatment for maintenance of remission in autoimmune hepatitis should be continued at least for 24 months. It might be terminated only if biochemical remission is constantly maintained and if no signs of inflammation are present in a liver biopsy.' 'In patients tolerant to azathioprine, treatment for induction and maintenance of remission with budesonide should be combined with azathioprine.' || STOPPING (SPC 4.2, verbatim): 'The treatment with Budenofalk 3mg should not be stopped abruptly, but withdrawn gradually (tapering doses). Gradual dose reduction over 2 weeks is recommended.' || PAEDIATRIC - paedDose is null because the SPC gives NO paediatric posology for this product. SPC 4.2, verbatim: 'Children under the age of 12: Budenofalk 3mg should not be taken by children younger than 12 years due to insufficient experience and possibly increased risk of adrenal suppression in this age group. Adolescent patients aged 12 to 18 years: The safety and efficacy of Budenofalk 3mg in children aged 12 to 18 years have not yet been established. Currently available data in adolescent patients (12-18 years) with Crohn's disease or autoimmune hepatitis are described in sections 4.8 and 5.1 but no recommendation on a posology can be made.' Any paediatric dose must come from a children's formulary, not from this label. || NOT APPROPRIATE FOR UPPER GI CROHN'S (SPC 4.4, verbatim): 'This medicine is not appropriate for patients suffering from Crohn's disease of the upper gastrointestinal tract. Due to the preferential local mode of action of the compound beneficial effects for patients suffering from extraintestinal symptoms (e.g. of the eyes, skin, joints) cannot be expected.' || 'Treatment with Budenofalk 3mg results in lower systemic steroid levels than conventional oral glucocorticosteroid therapy. Transfer from other glucocorticosteroid therapy may result in symptoms relating to the change in systemic steroid levels' (SPC 4.4).
Dose adjustments
Renal
Not stated - no renal-impairment dosing statement appears in any fetched section (4.2, 4.3, 4.4, 4.6, 4.8) of this SPC.
Hepatic
CONTRAINDICATED IN HEPATIC CIRRHOSIS - SPC 4.3 lists 'hepatic cirrhosis' as an absolute contraindication for Budenofalk 3mg. No dose-reduction schedule for lesser degrees of hepatic impairment is given. SPC 4.4 begins a 'Patients with liver function disorders' paragraph - 'Based on the experience with patients suffering from late stage primary biliary cirrhosis (PBC) with hepatic cirrhosis an increased...' - but that paragraph was TRUNCATED at the source-fetch limit, so its content is not asserted here; verify it against the full SPC.
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 the active substance or to any of the excipients (SPC 4.3)
- Hepatic cirrhosis (SPC 4.3, verbatim: 'Budenofalk 3mg must not be used in patients with: ... hepatic cirrhosis')
- Not a contraindication but a use restriction (SPC 4.2): 'Budenofalk 3mg should not be taken by children younger than 12 years due to insufficient experience and possibly increased risk of adrenal suppression in this age group.'
- Not a contraindication but a use restriction (SPC 4.4): 'This medicine is not appropriate for patients suffering from Crohn's disease of the upper gastrointestinal tract.'
- Not a contraindication but a vaccine rule (SPC 4.4): 'Live vaccines should not be given to individuals with chronic glucocorticosteroid use. The antibody response to other vaccines may be diminished.'
- Not a contraindication but a caution (SPC 4.4): 'Caution is required in patients with tuberculosis, hypertension, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma, cataracts, family history of diabetes, family history of glaucoma, or any other condition in which glucocorticosteroids may have undesirable effects.'
- Not a contraindication but an infection risk (SPC 4.4): suppression of the inflammatory response and immune function increases susceptibility to infections and their severity; chickenpox may be fatal in immunosuppressed patients and non-immune exposed patients need urgent advice and passive immunisation with varicella zoster immunoglobulin within 10 days of exposure; measles contacts should receive normal immunoglobulin as soon as possible
Side effects
- Common (SPC 4.8): Cushing's syndrome features - moon face, truncal obesity, reduced glucose tolerance, diabetes mellitus, hypertension, sodium retention with oedema, increased potassium excretion, inactivity or atrophy of the adrenal cortex, red striae, steroid acne, disturbance of sex hormone secretion (amenorrhoea, hirsutism, impotence)
- Common (SPC 4.8): dyspepsia, abdominal pain; increased risk of infection; muscle and joint pain, muscle weakness and twitching, osteoporosis; headache; depression, irritability, euphoria; allergic exanthema, petechiae, delayed wound healing, contact dermatitis
- Uncommon (SPC 4.8): duodenal or gastric ulcer; psychomotor hyperactivity, anxiety
- Rare (SPC 4.8): glaucoma, cataract, blurred vision; pancreatitis; osteonecrosis; aggression; ecchymosis
- Very rare (SPC 4.8): growth retardation in children; constipation; pseudotumor cerebri including papilloedema in adolescents; increased risk of thrombosis, vasculitis (withdrawal syndrome after long-term therapy); fatigue, malaise
- SPC 4.8: 'Clinical studies showed that the frequency of glucocorticosteroid-associated adverse events is lower with oral Budenofalk than with oral treatment of equivalent dosages of prednisolone.'
- SPC 4.8: 'An exacerbation or the reappearance of extra-intestinal manifestations (especially affecting skin and joints) can occur on switching a patient from systemically acting glucocorticosteroids to the locally acting budesonide.'
- In clinical trials of Budenofalk 3mg capsules in 82 paediatric patients with Crohn's disease, adrenal suppression and headache were the most frequent undesirable effects; other rare reactions reported were dizziness, nausea, vomiting and hyperacusis (SPC 4.8)
- Systemic glucocorticosteroid effects, particularly at high doses and for prolonged periods (SPC 4.4): Cushing's syndrome, adrenal suppression, growth retardation, decreased bone mineral density, cataract, glaucoma and a wide range of psychiatric/behavioural effects
Monitoring
- Response and the need to continue - in microscopic colitis maintenance, 'the treatment effect should be evaluated regularly to assess if continued treatment is necessary, not later than 12 months after the initiation of maintenance treatment' (SPC 4.2)
- ALAT and ASAT during autoimmune hepatitis maintenance - a rise indicates the dose should be increased back to 9 mg daily; termination requires constantly maintained biochemical remission and no signs of inflammation on liver biopsy (SPC 4.2)
- Watch for the systemic glucocorticosteroid effects listed in SPC 4.4 - Cushing's syndrome, adrenal suppression, growth retardation, decreased bone mineral density, cataract, glaucoma and psychiatric/behavioural effects - particularly at high doses and prolonged treatment
- Watch for infection: clinical presentation may be atypical and serious infections such as septicaemia and tuberculosis may be masked and reach an advanced stage before being recognised (SPC 4.4)
- Chickenpox and measles exposure status in non-immune patients (SPC 4.4) - urgent medical attention and passive immunisation if exposed
- Symptoms relating to the change in systemic steroid levels when transferring from another glucocorticosteroid, including reappearance of extra-intestinal manifestations (SPC 4.4, 4.8)
- Monitor during the 2-week taper at the end of treatment - the drug must not be stopped abruptly (SPC 4.2)
Clinical monograph
How it works
Budesonide exerts topical glucocorticoid anti-inflammatory activity at the intestinal mucosa, and because of high first-pass hepatic metabolism it produces less systemic corticosteroid effect than conventional steroids; rectal formulations target distal disease directly.
Prescribing in practice
- Even with predominantly local action, systemic absorption can suppress the adrenal axis, so avoid abrupt cessation after prolonged use and give steroid-sickness advice.
- Rectal preparations are suited to distal colonic or rectal disease, whereas modified-release oral forms target the ileocaecal region, so match the route to disease location.
- Avoid combining with potent CYP3A4 inhibitors, which markedly increase systemic budesonide exposure.
Monitoring
No routine bloods are mandated for short courses, but monitor for systemic steroid effects on prolonged treatment and review the clinical response.
Counselling the patient
- Use the prescribed route exactly as directed; for rectal preparations, follow the administration instructions for best contact with the bowel lining.
- Do not stop abruptly after extended use, and carry a steroid alert card.
- Report signs of infection or feeling unwell, as steroids can mask or worsen them.
Evidence & guidelines
NICE guidance on inflammatory bowel disease supports topical-acting budesonide formulations, with route selected according to the site and extent of disease.
Reference: ECCO Crohn's Disease Guidelines 2023; NICE NG129 (Microscopic Colitis); Manns et al. Gastroenterology 2010 (AIH budesonide trial); MHRA SPC Entocort / Cortiment; 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.
Calculators