💊 Budesonide (Budesonide)
Budesonide delayed-release capsules are a corticosteroid used to treat mild to moderate Crohn's disease involving the ileum and/or ascending colon. It is taken once daily in the morning; your doctor sets the dose and duration.
In Arabic: بوديزونايد
🏷️ Brand names & manufacturers
Pulmicort Flexhaler🏭 H2-Pharma LLCDailyMed
Uceris🏭 Salix Pharmaceuticals, Inc.DailyMed
Pulmicort Respules🏭 AstraZeneca Pharmaceuticals LPDailyMed
Tarpeyo🏭 Calliditas Therapeutics ABDailyMed
Budesonide Inhalation Suspension🏭 Cipla USA Inc.DailyMed✅ What it is used for
- Treatment of mild to moderate active Crohn's disease involving the ileum and/or ascending colon in patients 8 years and older
- Maintenance of clinical remission of mild to moderate Crohn's disease for up to 3 months in adults
🧪 Active ingredient
Budesonide: an anti-inflammatory corticosteroid with high glucocorticoid and weak mineralocorticoid effect
🌿 Benefits
- Helps treat active mild to moderate Crohn's disease of the ileum and/or ascending colon
- Helps maintain remission for up to 3 months in adults
📝 How to use
- The dose is set by your doctor or pharmacist for your condition; do not change it yourself
- Take once daily in the morning
- Swallow the capsule whole; do not chew or crush
- If you cannot swallow the capsule whole, it can be opened and the granules emptied onto one tablespoonful of soft, not hot, applesauce, mixed, and the entire mixture consumed within 30 minutes without chewing the granules
- Follow immediately with a glass (8 ounces) of cool water; do not save the mixture for later
- Avoid grapefruit juice for the duration of treatment
💊 Dosage forms
- Delayed-release capsules, 3 mg
⚠️ Common side effects
- Headache
- Respiratory infection
- Nausea
- Back pain
- Dyspepsia (indigestion)
- Dizziness
- Abdominal pain
- Flatulence
- Vomiting
- Fatigue
- Pain
🚨 Serious — seek medical help
- Hypercorticism and adrenal axis suppression
- Steroid withdrawal symptoms in patients transferred from other systemic corticosteroids
- Immunosuppression and increased risk of infection (viral, bacterial, fungal, protozoal, helminthic), including potentially fatal varicella and measles
- Kaposi's sarcoma
- Serious hypersensitivity reactions, including anaphylaxis
⛔ Do not use if
- Hypersensitivity to budesonide or any ingredient in the capsules
❗ Warnings & precautions
- Hypercorticism and adrenal axis suppression may occur; monitor for signs and symptoms during treatment
- Pediatric patients and patients with hepatic impairment may be at increased risk; avoid use in severe hepatic impairment (Child-Pugh Class C)
- When transferring from other corticosteroids, taper slowly and monitor for withdrawal symptoms and unmasking of allergies (rhinitis, eczema)
- Increased risk of infection; avoid in patients with fungal infections, Strongyloides infestation, cerebral malaria and ocular herpes simplex; screen for hepatitis B infection
- Monitor patients with conditions such as hypertension and diabetes mellitus where corticosteroids may have unwanted effects
- Corticosteroids may reduce growth velocity in pediatric patients
🔄 Drug interactions
- CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin, cyclosporine) can increase systemic budesonide concentrations; avoid use together
- Ketoconazole, a strong CYP3A4 inhibitor, caused an eight-fold increase in systemic exposure to oral budesonide
- Grapefruit juice increases systemic exposure; avoid during therapy
🤰 Pregnancy
Published data are insufficient to inform the risk of major birth defects or miscarriage. In animal studies, budesonide caused increased fetal loss, decreased pup weights, and skeletal abnormalities. Hypoadrenalism may occur in infants born to mothers receiving corticosteroids and they should be observed. Discuss with your doctor before use.
🍼 Breastfeeding
Lactation studies have not been conducted with oral budesonide. One published study found budesonide in human milk after maternal inhalation. Nursing infant exposure to oral budesonide may be up to 10 times higher than with inhaled budesonide. Your doctor will weigh the benefits of breastfeeding against your clinical need for the drug.
🧒 Children
Safety and effectiveness are established for treating mild to moderate active Crohn's disease in patients 8 to 17 years who weigh more than 25 kg. Not established under 8 years or for maintenance of remission in children. Pediatric patients have about 17% higher mean systemic exposure and cortisol suppression than adults, and growth velocity may be reduced.
👴 Older adults
Studies did not include enough patients aged 65 and over to determine whether they respond differently. Dose selection for elderly patients should be cautious, usually starting at the low end of the range, given the greater frequency of decreased hepatic, renal, or cardiac function and concomitant disease or drug therapy.
🌡️ Storage
Store at 20°C to 25°C (68°F to 77°F). Keep the container tightly closed.
⏰ Missed dose
The label does not give specific instructions for a missed dose; ask your doctor or pharmacist and do not double the dose on your own.
🆘 Overdose
Reports of acute toxicity or death after glucocorticoid overdose are rare. Treatment is immediate gastric lavage or emesis followed by supportive and symptomatic therapy. Seek emergency care if overdose is suspected. Excessive doses for prolonged periods may cause hypercorticism and adrenal axis suppression.
💰 Price & brands in your area
🏛️ Official price in Palestine — Ministry of Health price list:
| Product | Company | Pack | Price |
|---|---|---|---|
| Axivo Nasal Spray with metered dose pump (Suspension) Budesonide | Pharmacare Company | 10 ml (120 doses) | 39 ₪ |
Locally made brands: BUDICORT RESPULES 0.5MG/2ML - 20 UNITS (suspension for inhalation)، BUDICORT RESPULES 1MG/2ML - 20 UNITS (suspension for inhalation)
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Mechanism of action
Anti-inflammatory corticosteroid with high glucocorticoid and weak mineralocorticoid effect; glucocorticoid receptor affinity is about 200-fold that of cortisol and 15-fold that of prednisolone. Budesonide is a CYP3A4 substrate.
Labeled dosing
Adults: 9 mg once daily in the morning for up to 8 weeks for active Crohn's disease; 8-week courses may be repeated for recurrences. Maintenance: 6 mg once daily for up to 3 months, then taper to cessation. Pediatrics 8–17 years (>25 kg): 9 mg once daily for up to 8 weeks, then 6 mg once daily for 2 weeks. Consider 3 mg once daily in adults with moderate hepatic impairment (Child-Pugh B). The dose is set by the physician.
- When switching from oral prednisolone, begin tapering prednisolone concomitantly with starting budesonide
- Treatment beyond 3 months has not been shown to provide substantial clinical benefit
- Avoid in severe hepatic impairment (Child-Pugh C)
- Monitor for hypercorticism and adrenal axis suppression, especially in pediatrics and hepatic impairment
- Screen for hepatitis B infection per warnings
🎓 Key points for students
- Budesonide is a corticosteroid with systemic effects possible despite targeted ileal/ascending colon use
- CYP3A4 substrate: inhibitors (ketoconazole, grapefruit juice) raise systemic exposure
- Can suppress the HPA axis; cortisol AUC0-24 reduction was 45% with budesonide 9 mg vs 78% with prednisolone 20 mg in healthy volunteers
- Contraindication: hypersensitivity to budesonide or its ingredients
- Swallow whole; capsule may be opened and granules sprinkled on applesauce if needed
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What is budesonide delayed-release capsule used for?
It treats mild to moderate Crohn's disease of the ileum and/or ascending colon in patients 8 years and older, and helps maintain remission for up to 3 months in adults.
How should I take it?
Once daily in the morning, swallowed whole without chewing. Your doctor or pharmacist sets the dose. If you cannot swallow it, the capsule can be opened and the granules taken on applesauce within 30 minutes.
Can I drink grapefruit juice?
No. Avoid grapefruit juice during treatment because it increases the body's exposure to the drug.
What are the common side effects?
Headache, respiratory infection, nausea, back pain, indigestion, dizziness, abdominal pain, gas, vomiting and fatigue.
Is it safe in pregnancy or breastfeeding?
Data are insufficient, and animal studies showed fetal harm. Talk to your doctor, who will weigh benefits and risks.
How long is treatment?
Usually up to 8 weeks for active disease and up to 3 months for maintaining remission in adults; your doctor decides the duration.
⚕️ For education only — not a substitute for advice from your doctor or pharmacist. Do not start or stop any medicine without advice. Source: official FDA drug label via openFDA (2025-02), simplified. Updated: 2026-11-10.