Budesonid Laboratorios Liconsa
Budesonide 3 mg modified-release hard capsules — oral corticosteroid for inflammatory bowel conditions
Quick Facts About Budesonid Laboratorios Liconsa
Key Takeaways
- Budesonid Laboratorios Liconsa contains budesonide 3 mg in modified-release capsules designed to deliver the drug directly to the ileum and ascending colon, reducing systemic corticosteroid effects.
- It is indicated for mild to moderate Crohn's disease (ileal and/or ascending colon involvement) and for induction and maintenance of remission in collagenous colitis.
- The typical induction dose is 9 mg (three capsules) once daily for up to 8 weeks, followed by a gradual taper over 2–4 weeks.
- Do not stop budesonide abruptly — gradual dose reduction is essential to prevent adrenal insufficiency.
- Avoid grapefruit juice and strong CYP3A4 inhibitors (ketoconazole, itraconazole, ritonavir) as they can significantly increase budesonide blood levels and side effects.
What Is Budesonid Laboratorios Liconsa and What Is It Used For?
Quick Answer: Budesonid Laboratorios Liconsa is an oral corticosteroid containing budesonide 3 mg in modified-release capsules. It is used to treat mild to moderate Crohn's disease of the ileum and ascending colon, and to induce and maintain remission in collagenous colitis.
Budesonide is a potent synthetic glucocorticoid that belongs to the corticosteroid class of anti-inflammatory medicines. Unlike conventional systemic corticosteroids such as prednisolone or prednisone, budesonide in its modified-release formulation has been specifically designed to act locally within the gastrointestinal tract. The capsule contains granules coated with a pH-dependent polymer that dissolves at the slightly alkaline pH found in the terminal ileum and ascending colon, ensuring targeted drug delivery to the sites most commonly affected by Crohn's disease.
One of the key pharmacological advantages of oral budesonide is its extensive first-pass hepatic metabolism. Approximately 90% of the absorbed drug is metabolised by the cytochrome P450 3A4 (CYP3A4) enzyme system during its first passage through the liver, resulting in very low systemic bioavailability (approximately 10–15%). This property significantly reduces the incidence and severity of systemic corticosteroid side effects such as adrenal suppression, bone loss, and metabolic disturbances, making it better tolerated than equivalent doses of prednisolone.
Budesonide has approximately 15 times the glucocorticoid receptor binding affinity of prednisolone and around 200 times that of cortisol. At the cellular level, it suppresses inflammatory gene expression by inhibiting nuclear factor kappa B (NF-κB) and activator protein-1 (AP-1) transcription pathways, thereby reducing the production of pro-inflammatory cytokines, chemokines, and adhesion molecules in the gut mucosa. This results in decreased inflammation, oedema, and immune cell infiltration in affected tissue.
Approved Indications
Budesonid Laboratorios Liconsa is approved for the following conditions:
- Crohn's disease: Induction of remission in patients with mild to moderate active Crohn's disease affecting the ileum and/or ascending colon. Clinical trials (including the landmark studies by Greenberg et al. and Rutgeerts et al.) have demonstrated that budesonide 9 mg daily achieves remission rates of 51–69% at 8 weeks, compared with 20–33% for placebo.
- Collagenous colitis (microscopic colitis): Induction and maintenance of clinical remission. The European Microscopic Colitis Group (EMCG) consensus and the Cochrane systematic review (2017) identify budesonide as the first-line treatment for active collagenous colitis, with clinical response rates exceeding 80%.
Budesonide modified-release capsules are not appropriate for Crohn's disease affecting areas of the gastrointestinal tract other than the ileum and ascending colon, as the drug release site does not reach the stomach, jejunum, or distal colon. For ulcerative colitis or left-sided colonic Crohn's disease, different budesonide formulations (such as budesonide MMX extended-release tablets) or other treatment options may be more suitable.
What Should You Know Before Taking Budesonid Laboratorios Liconsa?
Quick Answer: Before starting budesonide, inform your doctor about all medical conditions, current medications, and any history of infections or liver disease. Budesonide is contraindicated in patients with hypersensitivity to the active substance or excipients and should be used with caution in liver cirrhosis.
Contraindications
Budesonid Laboratorios Liconsa must not be used in patients who have a known hypersensitivity to budesonide or to any of the excipients in the capsule formulation. This includes patients who have experienced allergic reactions to any corticosteroid preparation.
Warnings and Precautions
Several important precautions should be considered before and during treatment with budesonide modified-release capsules:
- Adrenal suppression: Although budesonide has lower systemic bioavailability than conventional corticosteroids, hypothalamic-pituitary-adrenal (HPA) axis suppression can still occur, especially at higher doses or with prolonged use. Patients transferring from systemic corticosteroids (e.g., prednisolone) to budesonide may experience adrenal insufficiency symptoms during the transition period.
- Infections: Corticosteroids suppress immune function. Patients should avoid exposure to chickenpox and measles if they have not had these infections or been vaccinated. Active or latent tuberculosis, fungal infections, and viral infections require careful evaluation before starting treatment.
- Vaccination: Live vaccines should not be administered to patients receiving immunosuppressive doses of corticosteroids. The immune response to inactivated vaccines may also be reduced.
- Ocular effects: Prolonged corticosteroid use can increase the risk of cataracts and glaucoma. Regular ophthalmological monitoring is recommended for patients on long-term therapy.
- Bone health: Although budesonide causes less bone mineral density loss than conventional systemic steroids, some effect on bone metabolism cannot be excluded, particularly with long-term use. Calcium and vitamin D supplementation should be considered.
- Diabetes mellitus: Corticosteroids can raise blood glucose levels. Patients with diabetes or those at risk of diabetes should have their blood glucose monitored more frequently during treatment.
Pregnancy and Breastfeeding
Budesonide should only be used during pregnancy when the potential benefit to the mother outweighs the potential risk to the foetus. Animal reproductive studies have shown adverse effects at high doses, including cleft palate, skeletal abnormalities, and intrauterine growth restriction. Although observational data from inhaled budesonide in pregnancy are generally reassuring (with extensive registry data from over 10,000 pregnancies), the evidence specifically for oral modified-release budesonide in pregnancy is more limited.
Budesonide is excreted in breast milk. Following oral inhalation, the estimated infant exposure is approximately 0.3% of the maternal dose, and systemic exposure in the breastfed infant is expected to be low. For oral modified-release capsules, the amount reaching breast milk may be slightly higher, but is still considered to represent a low risk at therapeutic doses. A clinical decision regarding continuation of breastfeeding should be made in consultation with the prescribing physician, weighing the benefits of breastfeeding against the potential drug exposure to the infant.
How Does Budesonid Laboratorios Liconsa Interact with Other Drugs?
Quick Answer: Budesonide is metabolised by CYP3A4. Strong inhibitors of this enzyme (ketoconazole, itraconazole, ritonavir, cobicistat) can dramatically increase budesonide blood levels, while CYP3A4 inducers (rifampicin, carbamazepine, phenytoin) may reduce its effectiveness. Grapefruit juice should also be avoided.
The most clinically significant drug interactions with budesonide involve the cytochrome P450 3A4 enzyme system. Since budesonide relies heavily on CYP3A4 for its extensive first-pass metabolism, drugs that inhibit or induce this enzyme can have a dramatic impact on budesonide blood levels and clinical effect.
Major Interactions
| Drug | Mechanism | Effect | Clinical Advice |
|---|---|---|---|
| Ketoconazole | Potent CYP3A4 inhibitor | Increases budesonide AUC by ~6-fold | Avoid concomitant use |
| Itraconazole | Potent CYP3A4 inhibitor | Increases budesonide AUC by ~4-fold | Avoid concomitant use |
| Ritonavir | Potent CYP3A4 inhibitor | Markedly increased systemic exposure | Contraindicated |
| Cobicistat | CYP3A4 inhibitor (pharmacokinetic enhancer) | Significantly increased budesonide levels | Avoid concomitant use |
| Grapefruit juice | Intestinal CYP3A4 inhibitor | Increases budesonide AUC by ~2-fold | Avoid during treatment |
Minor Interactions
| Drug | Mechanism | Effect | Clinical Advice |
|---|---|---|---|
| Rifampicin | Potent CYP3A4 inducer | May reduce budesonide levels by up to 60% | May require dose increase; monitor clinical response |
| Carbamazepine | CYP3A4 inducer | Reduced budesonide efficacy | Monitor clinical response; consider dose adjustment |
| Phenytoin | CYP3A4 inducer | Reduced budesonide efficacy | Monitor clinical response |
| Erythromycin | Moderate CYP3A4 inhibitor | Modest increase in budesonide levels | Usually no dose adjustment required |
| Oral contraceptives (oestrogen) | Weak CYP3A4 inhibitor | Slight increase in budesonide plasma concentrations | Usually not clinically significant |
Patients should inform their physician or pharmacist of all medications they are currently taking, including prescription medicines, over-the-counter products, herbal remedies, and dietary supplements. Special attention should be paid to antifungal agents, HIV protease inhibitors, macrolide antibiotics, and enzyme-inducing anticonvulsants.
What Is the Correct Dosage of Budesonid Laboratorios Liconsa?
Quick Answer: The standard adult dose for active Crohn's disease is 9 mg (three 3 mg capsules) once daily in the morning for 8 weeks, followed by a gradual taper. For collagenous colitis, the induction dose is also 9 mg daily for 6–8 weeks. Capsules should be swallowed whole with water, not chewed or crushed.
Adults
Crohn's Disease — Induction of Remission
The recommended dose is 9 mg once daily (three 3 mg capsules taken together) in the morning, approximately 30 minutes before breakfast. Treatment duration is typically 8 weeks. In clinical practice, some patients may show response within 2–4 weeks, but the full 8-week course is generally recommended for optimal remission rates.
Crohn's Disease — Maintenance of Remission
For maintenance of remission, the dose may be reduced to 6 mg once daily (two capsules) or 3 mg once daily (one capsule). Guidelines recommend limiting maintenance therapy to a maximum of 3–6 months and then attempting withdrawal. The European Crohn's and Colitis Organisation (ECCO) does not recommend long-term budesonide maintenance beyond 12 months due to limited evidence of sustained benefit and accumulating risks.
Collagenous Colitis
Induction: 9 mg once daily for 6–8 weeks. Maintenance: 3–6 mg once daily; the lowest effective dose should be used. Relapse is common upon discontinuation (up to 60–80% of patients), so long-term low-dose maintenance may be required in some cases.
Tapering Schedule
After the induction period, the dose should be tapered gradually:
- Week 1–2: Reduce from 9 mg to 6 mg daily
- Week 3–4: Reduce from 6 mg to 3 mg daily
- Week 5: Discontinue or maintain at 3 mg if clinically indicated
The taper may be extended over a longer period in patients who have been on treatment for more than 8 weeks or who have adrenal suppression symptoms.
Children
The safety and efficacy of budesonide modified-release capsules have not been established in children under 18 years of age. Use in the paediatric population should only occur under specialist supervision and on an off-label basis when the potential benefits outweigh the risks. In paediatric Crohn's disease, exclusive enteral nutrition is often the preferred first-line induction therapy, as recommended by ECCO/ESPGHAN guidelines.
Elderly
No specific dose adjustment is required for elderly patients; however, the risks of corticosteroid-related side effects (osteoporosis, diabetes, infections, adrenal suppression) are generally higher in the elderly population. Careful monitoring and the use of the lowest effective dose for the shortest possible duration are recommended. Bone mineral density monitoring and calcium/vitamin D supplementation should be considered.
Missed Dose
If you miss a dose, 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 the next dose at the usual time. Do not take a double dose to make up for a missed one. If you frequently forget doses, consider setting a daily alarm or using a pill organiser.
Overdose
What Are the Side Effects of Budesonid Laboratorios Liconsa?
Quick Answer: The most common side effects include Cushingoid features, headache, nausea, abdominal pain, and insomnia. Budesonide generally causes fewer systemic corticosteroid side effects than prednisolone, but some degree of adrenal suppression and metabolic effects can still occur, especially with higher doses or prolonged use.
Like all medicines, budesonide can cause side effects, although not everybody gets them. The side effect profile of budesonide modified-release capsules is generally more favourable than that of conventional systemic corticosteroids. The Cochrane systematic reviews by Benchimol et al. (2008) and the meta-analysis by Rezaie et al. (2015) confirm that budesonide is associated with significantly fewer steroid-related side effects compared with prednisolone, particularly regarding cosmetic effects, mood disturbances, and adrenal suppression.
Common
May affect up to 1 in 10 people
- Cushingoid features (moon face, truncal obesity)
- Headache
- Nausea
- Abdominal pain and bloating
- Diarrhoea
- Dyspepsia (indigestion)
- Insomnia and nervousness
- Depression and mood swings
- Skin reactions (rash, pruritus, urticaria)
- Muscle cramps and myalgia
- Menstrual irregularities
Uncommon
May affect up to 1 in 100 people
- Tremor and palpitations
- Increased sweating
- Ecchymosis (bruising)
- Oropharyngeal candidiasis (oral thrush)
- Blurred vision
- Increased susceptibility to infections
- Aggression and irritability
- Constipation
- Joint pain
- Fatigue and malaise
Rare
May affect up to 1 in 1,000 people
- Adrenal insufficiency (especially during dose tapering or stress)
- Glaucoma and posterior subcapsular cataracts
- Osteoporosis and increased fracture risk
- Pancreatitis
- Growth retardation in children
- Avascular necrosis of bone
- Anaphylactic reactions
- Psychotic episodes
Seek Immediate Medical Attention
Contact your doctor or emergency services immediately if you experience
- Signs of adrenal crisis: severe fatigue, dizziness, fainting, very low blood pressure, nausea, vomiting
- Signs of severe allergic reaction: facial/throat swelling, difficulty breathing, severe rash
- Signs of serious infection: high fever, severe sore throat, unusual bruising or bleeding
- Sudden vision changes or eye pain (possible glaucoma)
- Severe and persistent abdominal pain (possible pancreatitis)
It is important to remember that the benefits of treating active inflammatory bowel disease generally outweigh the risks of budesonide side effects. Untreated Crohn's disease or collagenous colitis can lead to significant morbidity including malnutrition, bowel obstruction, and impaired quality of life. If you experience any troublesome side effects, consult your doctor before making any changes to your treatment — do not stop the medication abruptly.
How Should You Store Budesonid Laboratorios Liconsa?
Quick Answer: Store below 25°C in the original packaging to protect from moisture and light. Keep out of reach of children. Do not use after the expiry date printed on the package.
Proper storage of medicines is essential to ensure their safety and efficacy throughout the stated shelf life. Budesonide modified-release capsules should be stored under the following conditions:
- Temperature: Store at or below 25°C (77°F). Do not refrigerate or freeze.
- Packaging: Keep the capsules in the original blister packaging or container to protect from moisture and light. The modified-release coating is sensitive to humidity, and exposure to moisture can compromise the drug release mechanism.
- Children: Keep the medicine in a safe place out of the sight and reach of children. Consider using a child-resistant cabinet or storage box.
- Expiry date: Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of that month.
Do not dispose of medicines via household waste or wastewater. Return any unused or expired medicines to your local pharmacy for safe disposal. This helps protect the environment and prevents accidental ingestion by children, pets, or others.
What Does Budesonid Laboratorios Liconsa Contain?
Quick Answer: Each capsule contains 3 mg of budesonide as the active ingredient. Excipients include sugar spheres, povidone, methacrylic acid copolymers (for modified release), triethyl citrate, talc, and anti-caking agents. The capsule shell contains gelatin and titanium dioxide.
Active Ingredient
Each modified-release hard capsule contains 3 mg of budesonide. Budesonide (chemical name: 16α,17α-butylidenedioxy-11β,21-dihydroxypregna-1,4-diene-3,20-dione) is a non-halogenated synthetic glucocorticoid with high topical anti-inflammatory potency and high glucocorticoid receptor binding affinity.
Excipients
The capsule formulation contains the following inactive ingredients, which serve specific pharmaceutical purposes:
- Sugar spheres (sucrose and starch): Provide the core granule onto which the drug and coating layers are applied.
- Povidone: Acts as a binder to ensure the budesonide layer adheres uniformly to the sugar spheres.
- Methacrylic acid copolymer (Eudragit L): pH-dependent polymer coating that dissolves at pH ≥ 5.5, ensuring drug release in the terminal ileum and ascending colon rather than the stomach.
- Triethyl citrate: Plasticiser for the polymer coating, improving flexibility and film quality.
- Talc: Anti-adherent preventing granules from sticking together during manufacturing.
- Capsule shell: Gelatin, titanium dioxide (E171) and, depending on the presentation, may contain iron oxide pigments for colouring.
Frequently Asked Questions About Budesonid Laboratorios Liconsa
Budesonid Laboratorios Liconsa contains budesonide 3 mg in modified-release capsules. It is primarily used to treat mild to moderate Crohn's disease affecting the ileum and/or ascending colon, and collagenous colitis (microscopic colitis). The modified-release formulation delivers the corticosteroid directly to the inflamed areas of the gut, minimising systemic side effects compared with conventional oral corticosteroids.
No. You should never stop taking budesonide suddenly. The dose must be gradually reduced (tapered) over 2–4 weeks to allow your adrenal glands to resume normal cortisol production. Sudden discontinuation can cause adrenal insufficiency, with symptoms such as fatigue, muscle weakness, joint pain, nausea, and low blood pressure. Your doctor will provide a specific tapering schedule.
Common side effects include Cushingoid features (moon face, truncal obesity), headache, nausea, abdominal pain, bloating, diarrhoea, dyspepsia, muscle cramps, skin reactions (rash, itching), and mood changes including insomnia, nervousness, and depression. Most side effects are milder than those seen with conventional systemic corticosteroids like prednisolone.
No. Grapefruit juice inhibits the CYP3A4 enzyme that metabolises budesonide. This can increase blood levels of the drug by approximately two-fold, raising the risk of systemic corticosteroid side effects. You should avoid grapefruit and grapefruit juice throughout your entire course of treatment.
Budesonide should only be used during pregnancy when the potential benefits justify the potential risks to the foetus. Animal studies have shown reproductive toxicity at high doses. While inhaled budesonide has extensive safety data in pregnancy, oral modified-release formulations have less data. Budesonide is excreted in breast milk in small amounts; the risk to the nursing infant is considered low at therapeutic doses, but medical supervision is essential. Discuss the risks and benefits with your doctor.
For active Crohn's disease, the recommended treatment duration is typically 8 weeks at the full dose of 9 mg daily, followed by a 2–4 week taper. For collagenous colitis, initial induction lasts 6–8 weeks, with the possibility of long-term low-dose maintenance therapy if relapse occurs upon discontinuation. Total treatment duration should generally not exceed 9 months without specialist review, due to the cumulative risks of corticosteroid therapy.
References and Medical Sources
All information in this article is based on peer-reviewed medical literature, international guidelines, and official regulatory documents:
- European Medicines Agency (EMA). Budesonide — Summary of Product Characteristics. EMA Product Information Database. Accessed December 2025.
- Greenberg GR, Feagan BG, Hanauer SB, et al. Oral budesonide for active Crohn's disease. N Engl J Med. 1994;331(13):836–841. doi:10.1056/NEJM199409293311303
- 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.
- Benchimol EI, Seow CH, Steinhart AH, Griffiths AM. Budesonide for induction of remission in Crohn's disease. Cochrane Database Syst Rev. 2008;(3):CD000296. doi:10.1002/14651858.CD000296.pub3
- Miehlke S, Aust D, Mihaly E, et al. Efficacy and safety of budesonide in collagenous colitis: A randomized, double-blind, placebo-controlled trial. Gastroenterology. 2014;146(5):1222–1230.e2.
- European Crohn's and Colitis Organisation (ECCO). ECCO Guidelines on Therapeutics in Crohn's Disease: Medical Treatment. J Crohns Colitis. 2020;14(1):4–22.
- Miehlke S, Mäki M, Gonçalves CB, et al. European guidelines on microscopic colitis: United European Gastroenterology and European Microscopic Colitis Group statements and recommendations. United European Gastroenterol J. 2021;9(1):13–37.
- British National Formulary (BNF). Budesonide — Oral. NICE/BNF. Accessed December 2025.
- World Health Organization (WHO). WHO Model List of Essential Medicines — 23rd List, 2023. Geneva: WHO; 2023.
- Rezaie A, Kuenzig ME, Benchimol EI, et al. Budesonide for induction of remission in Crohn's disease. Cochrane Database Syst Rev. 2015;(6):CD000296.
About the Medical Editorial Team
This article has been written and reviewed by the iMedic Medical Editorial Team, comprising licensed specialist physicians with expertise in gastroenterology, clinical pharmacology, and internal medicine.
Content authored by physicians with specialist training in gastroenterology and inflammatory bowel disease. All clinical claims are referenced to peer-reviewed sources and international guidelines (ECCO, EMA, FDA, WHO).
Independently reviewed by the iMedic Medical Review Board. Review process includes verification of clinical accuracy, dosage recommendations, drug interaction data, and alignment with current evidence-based guidelines.
iMedic maintains strict editorial independence. We receive no funding from pharmaceutical companies, and our content is never influenced by commercial interests. For more information, visit our Editorial Standards page.