What are the side effects of oral budesonide?

Side Effects of Oral Budesonide

Oral budesonide has a more favorable side effect profile compared to conventional corticosteroids due to its high first-pass hepatic metabolism, but it still carries risks of both local and systemic adverse effects that require monitoring.

Common Side Effects

• Headache is one of the most frequently reported side effects, occurring in approximately 11.4% of patients taking budesonide 9 mg daily 1
• Nausea affects about 5.1% of patients on budesonide 9 mg daily 1
• Decreased blood cortisol levels occur in approximately 4.3% of patients, reflecting the drug's systemic absorption despite its designed first-pass metabolism 1
• Upper abdominal pain (3.9%), fatigue (3.1%), flatulence (2.4%), and abdominal distension (2.4%) are common gastrointestinal side effects 1
• Acne (2.4%), urinary tract infections (2.0%), arthralgia (2.0%), and constipation (2.0%) are also reported in clinical trials 1

Adrenal Suppression and Immunosuppression

• Adrenal suppression can occur with long-term use, causing symptoms such as tiredness, weakness, nausea, vomiting, and low blood pressure 1
• Immunosuppression increases the risk of infections from viruses, bacteria, fungi, and parasites 1
• Budesonide can make current infections worse, increase risk of disseminated infections, reactivate latent infections, and mask signs of infection 1
• Tuberculosis reactivation is possible in patients with latent TB 1
• Patients taking budesonide who haven't had chickenpox or measles should avoid contact with people who have these diseases 1
• Hepatitis B virus reactivation can occur in carriers 1

Special Considerations for Different Conditions

Inflammatory Bowel Disease

• In ulcerative colitis, budesonide MMX 9 mg daily has been shown to be more effective than placebo with fewer side effects than conventional corticosteroids 2
• For Crohn's disease, budesonide 9 mg/day is recommended for mild to moderate ileal and/or right colonic disease with fewer systemic side effects than conventional corticosteroids 2

Autoimmune Hepatitis

• Budesonide may be considered in non-cirrhotic patients with severe steroid-related side effects such as psychosis, poorly controlled diabetes, or osteoporosis 2
• Reduced liver function affects elimination of budesonide and increases systemic availability, potentially leading to more side effects 1

Eosinophilic Esophagitis

• Candida infection may occur in approximately 3.6% of patients treated with orodispersible budesonide tablets but can be managed with topical antifungals while continuing budesonide therapy 2

Pregnancy and Lactation Considerations

• Budesonide is classified as pregnancy category C 2
• It may lower fetal exposure compared to other corticosteroids and is considered compatible with breastfeeding 2
• Although older literature reported increased risk of orofacial clefts with first-trimester corticosteroid exposure, more recent data shows no increased risk 2

Long-term and Serious Side Effects

• Kaposi's sarcoma has been reported in patients receiving corticosteroid therapy, particularly for chronic conditions 1
• Worsening of allergies may occur if switching from other corticosteroids to budesonide 1
• Osteoporosis, hypertension, diabetes mellitus, peptic ulcer, glaucoma, and cataracts are potential concerns with long-term use 1
• In children and adolescents on long-term therapy, monitoring of adrenal gland suppression and bone mineral density is recommended 2

Monitoring Recommendations

• Regular monitoring of cortisol levels is advised for patients on long-term therapy 2
• Patients should be monitored for signs and symptoms of infection while taking budesonide 1
• Patients with reduced liver function require closer monitoring due to increased systemic exposure 1

Contraindications and Cautions

• Budesonide should be avoided in patients with known or suspected Strongyloides infection as it may lead to dissemination with widespread larval migration 1
• It should be avoided in patients with cerebral malaria 1
• Caution is needed in patients with latent amebiasis, especially those who have spent time in the tropics or have unexplained diarrhea 1

Despite these potential side effects, budesonide generally has a more favorable safety profile compared to conventional corticosteroids, making it a valuable option for various inflammatory conditions when systemic steroid effects need to be minimized 3.