Budaxiro (Budesonide 3mg)
Modified-release capsule for Crohn's disease and autoimmune hepatitis
Quick Facts About Budaxiro
Key Takeaways About Budaxiro
- Locally acting corticosteroid: Budesonide has high topical anti-inflammatory activity with approximately 90% first-pass metabolism, resulting in fewer systemic side effects than prednisolone
- Modified-release formulation: The capsule is designed to release budesonide specifically in the ileum and ascending colon, targeting the most commonly affected areas in Crohn's disease
- Do not stop suddenly: The dose must be tapered gradually to prevent adrenal insufficiency – never discontinue without medical supervision
- Avoid CYP3A4 inhibitors: Ketoconazole, itraconazole, ritonavir, and grapefruit juice can significantly increase budesonide blood levels and side effects
- Swallow whole: Do not chew, crush, or open the capsules as this destroys the modified-release mechanism and prevents proper drug delivery
What Is Budaxiro and What Is It Used For?
Budaxiro is a prescription medicine containing budesonide 3mg in modified-release hard capsules. It is a glucocorticosteroid (corticosteroid) used to reduce inflammation in the gastrointestinal tract, primarily for mild to moderate Crohn's disease and autoimmune hepatitis.
Budesonide, the active substance in Budaxiro, belongs to a group of medicines known as glucocorticosteroids. These medications work by suppressing the immune system's inflammatory response in the lining of the gut. What makes budesonide distinctive from other corticosteroids such as prednisolone or methylprednisolone is its high topical anti-inflammatory potency combined with low systemic bioavailability. Approximately 90% of orally absorbed budesonide is metabolised during its first passage through the liver via the cytochrome P450 enzyme CYP3A4, which means significantly less of the drug reaches the systemic circulation compared to conventional corticosteroids.
The modified-release formulation of Budaxiro is specifically engineered to deliver budesonide to the ileum (the last section of the small intestine) and the ascending colon (the first part of the large intestine). These are the most commonly affected regions in Crohn's disease. The capsule contains granules with a pH-dependent coating that dissolves at pH values above 5.5, which corresponds to the environment found in the terminal ileum and proximal colon. This targeted delivery mechanism ensures maximum local anti-inflammatory effect while minimising systemic exposure and the associated side effects that are commonly seen with conventional corticosteroids.
Approved Indications
Budaxiro is approved for the treatment of the following conditions:
- Mild to moderate active Crohn's disease affecting the ileum and/or ascending colon – used for induction of remission, typically for 8 weeks
- Autoimmune hepatitis – for induction and maintenance of remission in patients who cannot tolerate or do not respond adequately to azathioprine, or as initial treatment in combination with azathioprine
- Microscopic colitis (collagenous colitis) – for induction and maintenance of clinical remission
The European Crohn's and Colitis Organisation (ECCO) recommends oral budesonide as the preferred first-line treatment for mild to moderate ileocaecal Crohn's disease based on evidence from multiple randomised controlled trials demonstrating comparable efficacy to prednisolone with significantly fewer glucocorticoid-related side effects. Studies have shown that 9mg budesonide daily induces remission in approximately 50–60% of patients with active Crohn's disease within 8 weeks, compared to approximately 60–70% with conventional prednisolone, but with a substantially better side-effect profile.
Budesonide binds to glucocorticoid receptors inside cells of the intestinal lining. Once bound, it activates anti-inflammatory genes and suppresses the production of pro-inflammatory cytokines, prostaglandins, and leukotrienes. This reduces the inflammatory cascade responsible for the symptoms of Crohn's disease, including abdominal pain, diarrhoea, and tissue damage. The high first-pass metabolism means that most of the drug is inactivated before reaching the systemic circulation, which is why budesonide causes fewer whole-body side effects than prednisolone.
What Should You Know Before Taking Budaxiro?
Before starting Budaxiro, your doctor needs to know about any infections, liver problems, or other medications you are taking. Budesonide is a corticosteroid that suppresses the immune system, and certain conditions or drug combinations can make treatment unsafe.
Contraindications
You should not take Budaxiro if you have:
- Hypersensitivity to budesonide or any of the excipients in the capsule
- Hepatic cirrhosis – severe liver disease significantly increases systemic exposure to budesonide because the first-pass metabolism is impaired
- Active systemic fungal, bacterial, viral, or parasitic infections that are not adequately treated, as corticosteroids suppress immune function
Warnings and Precautions
Special caution is required in patients with the following conditions, and your doctor will carefully weigh the benefits against the risks:
- Tuberculosis (TB): Latent TB may be reactivated. Patients should be screened for TB before starting long-term corticosteroid therapy
- Hypertension: Corticosteroids can cause sodium and water retention, potentially worsening blood pressure control
- Diabetes mellitus: Budesonide can increase blood glucose levels, and diabetic patients may need dose adjustments of their antidiabetic medications
- Osteoporosis: Long-term corticosteroid use is a known risk factor for bone density loss. Calcium and vitamin D supplementation may be recommended
- Peptic ulcer disease: Corticosteroids may mask symptoms of peptic ulceration and increase the risk of perforation
- Glaucoma or cataracts: Prolonged corticosteroid use can increase intraocular pressure and accelerate cataract formation. Regular eye examinations are recommended during long-term treatment
- Chickenpox or measles exposure: Patients who have not had chickenpox or measles should avoid contact with infected individuals during treatment, as corticosteroids can worsen these infections. If exposed, prophylactic treatment with varicella-zoster immunoglobulin (VZIG) or immunoglobulin may be necessary
- Vaccinations: Live vaccines (such as MMR, varicella, BCG, oral polio, yellow fever) should not be administered during treatment with Budaxiro. Inactivated vaccines may have reduced efficacy due to immunosuppression
Long-term use of corticosteroids, including budesonide, can suppress the hypothalamic-pituitary-adrenal (HPA) axis. Abrupt discontinuation may lead to adrenal insufficiency, which can be life-threatening. Symptoms include severe fatigue, weakness, nausea, vomiting, hypotension, and collapse. Your doctor will always taper the dose gradually when stopping treatment, typically reducing from 9mg to 6mg daily for 2 weeks, then to 3mg daily for 2 weeks before discontinuation.
Pregnancy and Breastfeeding
Budaxiro should only be used during pregnancy when the potential benefit to the mother outweighs the potential risk to the foetus. Animal studies have demonstrated that corticosteroids can cause adverse effects on foetal development, including cleft palate and intrauterine growth restriction. However, epidemiological data from pregnant women using inhaled or oral budesonide have not shown a clear increase in the risk of congenital malformations in humans.
Budesonide is excreted in breast milk, but at therapeutic doses of Budaxiro, the amount reaching the infant is expected to be negligible. The decision to continue or discontinue breastfeeding during treatment should be made in consultation with your doctor, weighing the benefit of breastfeeding for the child against the benefit of therapy for the mother. The British National Formulary (BNF) states that the amount of budesonide reaching the infant via breast milk after oral doses in the mother is likely to be too low to cause adverse effects.
How Does Budaxiro Interact with Other Drugs?
Budaxiro is primarily metabolised by the CYP3A4 enzyme system. Drugs that inhibit CYP3A4 can dramatically increase budesonide blood levels, while CYP3A4 inducers may reduce its effectiveness. Grapefruit juice should be avoided as it also inhibits CYP3A4.
Understanding drug interactions with Budaxiro is crucial for safe and effective treatment. Budesonide is extensively metabolised by cytochrome P450 3A4 (CYP3A4) in the liver and, to a lesser extent, in the gut wall. Any medication or substance that affects CYP3A4 activity can alter the pharmacokinetics of budesonide, potentially increasing the risk of side effects or reducing therapeutic efficacy.
The most clinically significant interactions involve CYP3A4 inhibitors, which prevent the normal breakdown of budesonide and can increase its systemic exposure by several-fold. A well-documented study showed that co-administration of ketoconazole (a potent CYP3A4 inhibitor) with oral budesonide increased budesonide plasma levels approximately 6 to 8 times, dramatically increasing the risk of Cushingoid side effects and adrenal suppression.
Major Interactions
| Drug | Mechanism | Effect | Recommendation |
|---|---|---|---|
| Ketoconazole | Potent CYP3A4 inhibitor | Increases budesonide levels 6–8 fold | Avoid combination |
| Itraconazole | Potent CYP3A4 inhibitor | Significantly increases budesonide levels | Avoid combination |
| Ritonavir | Potent CYP3A4 inhibitor | Markedly increases budesonide exposure | Avoid combination |
| Cobicistat | Potent CYP3A4 inhibitor | Significant increase in budesonide levels | Avoid combination |
| Grapefruit juice | Inhibits intestinal CYP3A4 | Approximately doubles budesonide levels | Avoid during treatment |
Minor Interactions
| Drug | Mechanism | Effect | Recommendation |
|---|---|---|---|
| Carbamazepine | CYP3A4 inducer | Reduces budesonide levels | May need higher budesonide dose |
| Rifampicin | Potent CYP3A4 inducer | Significantly reduces budesonide levels | May need dose adjustment |
| Phenytoin | CYP3A4 inducer | Reduces budesonide levels | Monitor therapeutic response |
| Cardiac glycosides (digoxin) | Corticosteroid-induced hypokalaemia | Enhanced glycoside toxicity risk | Monitor potassium levels |
| Oral contraceptives (oestrogens) | Mild CYP3A4 inhibition | May increase budesonide levels | Monitor for side effects |
Always inform your doctor and pharmacist about all medications you are currently taking, including over-the-counter medicines, herbal products (especially St John's wort, which is a CYP3A4 inducer), and dietary supplements. Keep a list of all your medicines and show it to your healthcare provider at each visit.
What Is the Correct Dosage of Budaxiro?
The standard dose of Budaxiro for active Crohn's disease is 9mg (three capsules) once daily in the morning for up to 8 weeks. The dose is then gradually reduced over 2–4 weeks before stopping. Always follow your doctor's individual dosing instructions.
Budaxiro capsules should be swallowed whole with a glass of water, preferably in the morning before breakfast. Taking the medicine in the morning aligns with the body's natural circadian rhythm of cortisol production. Do not chew, crush, or open the capsules, as this would destroy the modified-release coating and prevent the targeted delivery of budesonide to the ileum and ascending colon.
Adults – Crohn's Disease
Induction of Remission
9 mg once daily (3 capsules taken together) in the morning, for up to 8 weeks. Clinical response is usually observed within 2–4 weeks. If adequate improvement is not achieved after 8 weeks of treatment, the case should be reassessed.
Tapering Phase
When treatment is to be discontinued, the dose should be reduced gradually:
- Reduce from 9 mg to 6 mg daily for 2 weeks
- Then reduce to 3 mg daily for 2 weeks
- Then stop
Adults – Autoimmune Hepatitis
Induction and Maintenance
Induction: 9 mg once daily. Once remission is achieved (usually within 2–3 months), the dose is reduced to 3–6 mg daily as maintenance therapy. The optimal duration of maintenance therapy is determined individually by the treating physician. In autoimmune hepatitis, treatment durations of 12–24 months or longer are common, and the disease may relapse on dose reduction or discontinuation.
Children and Adolescents
The use of Budaxiro in children and adolescents has not been extensively studied. Some clinical data support the use of oral budesonide in paediatric Crohn's disease at doses adjusted for body weight, typically 6–9 mg daily in children over 8 years of age. However, the decision to prescribe Budaxiro to a child must be made by a specialist paediatric gastroenterologist who can closely monitor growth and development, as corticosteroids can affect linear growth in children.
Elderly
No specific dose adjustment is routinely recommended for elderly patients. However, elderly patients may be more susceptible to the side effects of corticosteroids, including osteoporosis, hypertension, and diabetes. Clinical monitoring should be more frequent, and the lowest effective dose should always be used. Bone density assessment may be indicated for elderly patients on prolonged therapy.
Hepatic Impairment
Patients with mild to moderate hepatic impairment may have increased systemic exposure to budesonide due to reduced first-pass metabolism. No formal dose adjustment guidelines exist, but these patients should be monitored more closely for signs of corticosteroid excess. Budaxiro is contraindicated in hepatic cirrhosis, as the impaired liver function can dramatically increase systemic budesonide levels and the risk of serious side effects.
Missed Dose
If you forget to take Budaxiro at the usual time, take it as soon as you remember, unless it is nearly time for your next dose. In that case, skip the missed dose and take your next dose at the usual time. Do not take a double dose to make up for a forgotten dose. Missing occasional doses is unlikely to cause problems, but consistently missing doses can reduce the effectiveness of your treatment and may trigger a disease flare.
Overdose
Acute overdose with budesonide, even in excessive doses, is not expected to cause a clinical emergency. There is no specific antidote for budesonide overdose. In the event of a significant overdose, the patient should be monitored and managed with supportive care. Chronic overdosage over prolonged periods may lead to Cushingoid features (moon face, central obesity, skin thinning, bruising, acne) and adrenal suppression. If you suspect an overdose, contact your doctor or local poison control centre immediately.
| Indication | Induction Dose | Duration | Maintenance |
|---|---|---|---|
| Crohn's disease (active) | 9 mg once daily | Up to 8 weeks | Taper: 6mg → 3mg → stop |
| Autoimmune hepatitis | 9 mg once daily | Until remission (2–3 months) | 3–6 mg daily long-term |
| Microscopic colitis | 9 mg once daily | 6–8 weeks | 3–6 mg daily if needed |
What Are the Side Effects of Budaxiro?
Like all medicines, Budaxiro can cause side effects, although not everybody gets them. The most common side effects are Cushingoid features, headache, nausea, and abdominal discomfort. Most side effects are less severe than with systemic corticosteroids due to budesonide's high first-pass metabolism.
Budesonide has a significantly more favourable side-effect profile compared to conventional systemic corticosteroids such as prednisolone. In clinical trials comparing oral budesonide 9mg daily with prednisolone 40mg daily for Crohn's disease, patients on budesonide experienced approximately 50% fewer glucocorticoid-related adverse effects. This is because approximately 90% of budesonide is inactivated during first-pass metabolism through the liver, resulting in a systemic bioavailability of only about 10–15%.
However, it is important to note that even with reduced systemic exposure, budesonide is still a corticosteroid and can cause corticosteroid-related side effects, especially during prolonged use at higher doses. The likelihood and severity of side effects increase with dose and duration of treatment. Below is a classification of side effects by frequency, based on clinical trial data and post-marketing experience.
Very Common (affects more than 1 in 10 people)
- Cushingoid features (moon face, weight gain around the trunk)
Common (affects 1 to 10 in 100 people)
- Headache
- Dyspepsia (indigestion)
- Nausea
- Abdominal pain
- Bloating and flatulence
- Diarrhoea
- Muscle cramps
- Joint pain (arthralgia)
- Menstrual irregularities
- Skin rash, urticaria, pruritus
- Mood changes (irritability, euphoria, depression)
- Sleep disturbances (insomnia)
- Fatigue and malaise
Uncommon (affects 1 to 10 in 1,000 people)
- Tremor
- Palpitations
- Increased sweating
- Easy bruising (ecchymosis)
- Blurred vision
- Oropharyngeal candidiasis (oral thrush)
- Elevated liver enzymes (ALT, AST)
- Increased blood glucose levels
- Hypertension
Rare (affects fewer than 1 in 1,000 people)
- Adrenal suppression
- Growth retardation in children
- Glaucoma, posterior subcapsular cataracts
- Osteoporosis with long-term use
- Avascular necrosis of bone
- Anaphylactic reactions
- Psychotic reactions (rare, dose-dependent)
Contact your doctor or seek emergency medical help immediately if you experience: signs of severe allergic reaction (difficulty breathing, swelling of face or throat, severe rash), signs of adrenal insufficiency after dose reduction or stopping treatment (severe fatigue, weakness, nausea, dizziness, collapse), severe abdominal pain, or significant mood or behavioural changes.
It is worth noting that the side-effect profile of budesonide is considerably more favourable than that of conventional systemic corticosteroids for the same indications. A landmark randomised controlled trial published in the New England Journal of Medicine demonstrated that budesonide 9mg daily achieved comparable remission rates to prednisolone 40mg daily in active Crohn's disease, while the incidence of corticosteroid-related adverse effects was approximately 33% with budesonide compared to 55% with prednisolone. This more favourable safety profile is one of the primary reasons why international guidelines, including those from ECCO and the American Gastroenterological Association (AGA), recommend budesonide as the preferred first-line corticosteroid for mild to moderate ileocaecal Crohn's disease.
How Should You Store Budaxiro?
Store Budaxiro below 25°C in the original packaging to protect from moisture. Keep out of sight and reach of children. Do not use after the expiry date printed on the carton and blister.
Proper storage of Budaxiro is essential to ensure that the modified-release capsules maintain their integrity and effectiveness throughout the treatment period. The modified-release coating on the granules inside the capsules is sensitive to moisture, and improper storage can compromise the drug delivery mechanism.
- Temperature: Store at or below 25°C (77°F). Do not refrigerate or freeze the capsules
- Moisture protection: Keep the capsules in their original blister packaging until the time of use to protect them from moisture and humidity
- Light exposure: Store the blister packs in the original outer carton to protect from light
- Child safety: Keep this medicine out of the sight and reach of children, preferably in a locked medicine cabinet
- Expiry date: Do not use Budaxiro after the expiry date which is stated on the carton and blister after “EXP”. The expiry date refers to the last day of that month
- Disposal: Do not throw away unused medicines via household waste or wastewater. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment
What Does Budaxiro Contain?
Each Budaxiro modified-release hard capsule contains 3mg of budesonide as the active substance. The capsule also contains various excipients that form the modified-release coating and capsule shell.
The active substance in each Budaxiro capsule is budesonide 3mg. Budesonide is a synthetic glucocorticosteroid with the chemical name 16α,17α-butylidenedioxy-11β,21-dihydroxypregna-1,4-diene-3,20-dione. It is a white to off-white, crystalline powder that is practically insoluble in water.
The capsule contains coated granules with a pH-sensitive coating (typically methacrylic acid copolymer, such as Eudragit L or S) that prevents dissolution in the stomach and releases budesonide at pH values above 5.5, corresponding to the terminal ileum and ascending colon. The capsule shell is made of gelatin and may contain colouring agents such as titanium dioxide (E171) and iron oxide (E172).
Typical excipients include:
- Granule core: Sucrose and maize starch (sugar spheres), budesonide
- Inner coating: Povidone, purified water (removed during manufacturing)
- Enteric coating: Methacrylic acid copolymer (Eudragit L), triethyl citrate, talc
- Capsule shell: Gelatin, titanium dioxide (E171), iron oxide (E172)
Budaxiro capsules contain sucrose (sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should not take this medicine.
Frequently Asked Questions About Budaxiro
Budaxiro contains budesonide 3mg in modified-release capsules and is used to treat mild to moderate active Crohn's disease affecting the ileum and/or ascending colon, autoimmune hepatitis (for induction and maintenance of remission), and microscopic colitis (collagenous colitis). The modified-release formulation ensures budesonide is released directly in the target area of the gut, providing local anti-inflammatory action with fewer systemic side effects than conventional corticosteroids.
No, you should never stop taking Budaxiro suddenly without consulting your doctor. As a corticosteroid, abrupt discontinuation can cause adrenal insufficiency, a potentially life-threatening condition with symptoms such as severe fatigue, weakness, nausea, and low blood pressure. Your doctor will gradually reduce your dose over several weeks, typically stepping down from 9mg to 6mg daily for two weeks, then 3mg daily for another two weeks before stopping completely.
The most common side effect is Cushingoid features (moon face, weight gain around the trunk), which affects more than 1 in 10 patients. Other common side effects include headache, nausea, abdominal pain, bloating, dyspepsia, muscle cramps, mood changes, and sleep disturbances. However, these side effects are generally less frequent and less severe compared to conventional systemic corticosteroids such as prednisolone, because approximately 90% of budesonide is metabolised during first-pass through the liver.
No, you should avoid grapefruit juice while taking Budaxiro. Grapefruit juice inhibits the CYP3A4 enzyme in the gut wall, which can approximately double budesonide levels in your blood and increase the risk of side effects. Similarly, other potent CYP3A4 inhibitors such as ketoconazole, itraconazole, and ritonavir can increase budesonide exposure by 6 to 8 times and should be avoided. Always inform your doctor about all medications and dietary habits.
Budaxiro should only be used during pregnancy when the potential benefit to the mother outweighs the potential risk to the foetus. While animal studies have shown that corticosteroids can cause abnormalities in foetal development, epidemiological data from pregnant women using inhaled or oral budesonide have not demonstrated a clear increase in congenital malformations. Your doctor will carefully assess whether treatment is necessary and will use the lowest effective dose for the shortest possible duration during pregnancy.
Budaxiro capsules should be swallowed whole with a glass of water, preferably in the morning before breakfast. Do not chew, crush, or open the capsules, as this would destroy the modified-release coating that ensures the medicine is delivered to the correct part of your gut. Taking the capsules in the morning aligns with your body's natural cortisol rhythm. If taking 9mg (three capsules), all three can be taken together at the same time.
References and Sources
This article is based on evidence from peer-reviewed medical literature, international guidelines, and official prescribing information. All medical claims are supported by Level 1A evidence where available.
- European Medicines Agency (EMA). Budesonide – Summary of Product Characteristics. EMA/CHMP. Available at: www.ema.europa.eu
- Torres J, Mehandru S, Colombel JF, Peyrin-Biroulet L. Crohn's disease. Lancet. 2017;389(10080):1741–1755. doi:10.1016/S0140-6736(16)31711-1
- Rutgeerts P, Löfberg R, Malchow H, et al. A comparison of budesonide with prednisolone for active Crohn's disease. N Engl J Med. 1994;331(13):842–845. doi:10.1056/NEJM199409293311304
- European Crohn's and Colitis Organisation (ECCO). ECCO Guidelines on Therapeutics in Crohn's Disease. J Crohns Colitis. 2024. Available at: www.ecco-ibd.eu
- British National Formulary (BNF). Budesonide – oral preparations. NICE Evidence Services. Available at: bnf.nice.org.uk
- Manns MP, Woynarowski M, Kreisel W, et al. Budesonide induces remission more effectively than prednisone in a controlled trial of patients with autoimmune hepatitis. Gastroenterology. 2010;139(4):1198–1206. doi:10.1053/j.gastro.2010.06.028
- World Health Organization (WHO). WHO Model List of Essential Medicines, 23rd List. Geneva: WHO; 2023.
- Miehlke S, Aust D, Mihaly E, et al. Efficacy and safety of budesonide, vs mesalazine or placebo, as induction therapy for lymphocytic colitis. Gastroenterology. 2018;155(6):1795–1804. doi:10.1053/j.gastro.2018.08.042
- U.S. Food and Drug Administration (FDA). Budesonide oral capsules – Prescribing Information. Available at: www.fda.gov
- American Gastroenterological Association (AGA). AGA Clinical Practice Guidelines on the Management of Mild-to-Moderate Ulcerative Colitis and Crohn's Disease. Gastroenterology. 2023.
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