Budesonide Extended-Release Capsules (Entocort) is a corticosteroid medication primarily indicated for the treatment of mild to moderately active Crohn's disease involving the ileum and/or ascending colon, as well as for the maintenance of clinical remission in adult patients. Despite its significant efficacy in controlling intestinal inflammation, as a corticosteroid, its use is associated with a range of potential adverse reactions and risks.

Adverse Reactions of Budesonide Extended-Release Capsules (Entocort)

Common Adverse Reactions

Nervous system: Headache, dizziness.

Infections: Respiratory tract infections.

Gastrointestinal system: Nausea, dyspepsia, abdominal pain, flatulence, vomiting.

Musculoskeletal system: Back pain, myalgia.

General reactions: Fatigue.

Serious Adverse Reactions

Corticosteroid Excess and Adrenal Axis Suppression

Long-term use or administration of high doses may lead to excessive corticosteroid levels in the body (corticosteroid excess).

Clinical manifestations include: Acne.

Easy bruising.

The medication may suppress the function of the hypothalamic-pituitary-adrenal (HPA) axis, resulting in the inability of the adrenal glands to produce sufficient cortisol during periods of physical stress (e.g., surgery, infection).

The risk may be increased in children and patients with moderate hepatic impairment.

When discontinuing treatment after long-term therapy or switching from systemic corticosteroids with stronger activity to this product, the dosage should be tapered gradually to prevent withdrawal symptoms of adrenal insufficiency.

Immunosuppression and Increased Risk of Infections

Viral infections: Chickenpox and measles may progress to severe and even fatal disease. Non-immune patients should avoid exposure. If exposure occurs, immediate medical attention is required.

Bacterial infections: Latent tuberculosis may be reactivated. Screening should be performed prior to the initiation of treatment, and prophylactic therapy should be administered if necessary.

Fungal infections: May exacerbate systemic fungal infections.

Parasitic infections: May activate latent amebiasis; use in patients with known or suspected strongyloidiasis (nematode infection) may lead to severe infection and sepsis, and is therefore contraindicated.

Other conditions: May worsen cerebral malaria and active ocular herpes simplex; the use of this product is contraindicated in these cases.

Precautions for Budesonide Extended-Release Capsules (Entocort)

Medication Use in Special Populations

Patients with hepatic impairment: For adult patients with moderate hepatic impairment (Child-Pugh Class B), consideration should be given to reducing the dosage to 3 mg once daily. The use of this product is contraindicated in patients with severe hepatic impairment (Child-Pugh Class C).

Pediatric patients: Only indicated for the treatment of active Crohn's disease in children aged 8 years and older with a body weight exceeding 25 kg. The safety and efficacy for maintenance therapy have not been established. Attention should be paid to potential impacts on growth rate.

Pregnant and lactating women: Based on animal data, this medication may cause fetal harm; pregnant women need to weigh the potential benefits against the risks. It is unknown whether the drug is excreted in human breast milk; lactating women should exercise caution.

Elderly patients: Dosage selection should be prudent, usually starting from the lower end of the dosage range.

Drug Interactions

Concomitant use with potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin, etc.) should be avoided.

Otherwise, it will significantly increase the plasma concentration of budesonide and elevate the risk of adverse reactions.

Treatment Monitoring and Patient Counseling

Physicians should regularly monitor patients for signs of corticosteroid excess, infection, blood pressure, blood glucose, etc.

Patients should be informed of and advised to watch for symptoms of serious adverse reactions, such as abnormal bruising, persistent headache, visual changes, and signs of infection (e.g., fever, cough, diarrhea). Immediate medical attention should be sought if any of these symptoms occur.

When switching from other systemic corticosteroids to this medication, the transition should be carried out gradually under the guidance of a physician, and attention should be paid to the possible recurrence of pre-existing allergic symptoms (e.g., rhinitis, eczema).