Adverse Reactions of Budesonide/Formoterol

Common Local Adverse Reactions

• Oropharyngeal effects, including oral thrush (candidiasis), dysphonia (voice changes), pharyngeal irritation, and throat irritation, are common local side effects of the inhaled corticosteroid component (budesonide) 1, 2
• Cough can be caused by inhaled corticosteroids upon administration 1

Common Systemic Adverse Reactions - Budesonide Component

• Adrenal suppression can occur at higher doses of inhaled corticosteroids 1, 2
• Growth suppression in children has been observed, though this effect may be transient 1
• Skin thinning and bruising can occur with long-term use at higher doses 1
• Bone effects, including a potential risk of osteoporosis, can occur with long-term use at higher doses 1

Serious Adverse Reactions

• Inhaled corticosteroids are associated with an increased risk of pneumonia in COPD patients 3, 4, 5
• Cushing syndrome and secondary adrenal insufficiency have been reported, particularly when used with potent CYP3A4 inhibitors like ritonavir and ketoconazole 1

Risk Factors for Adverse Effects

• Drug interactions, such as CYP3A4 inhibitors, can increase systemic concentrations of budesonide 1

Minimizing Adverse Effects

• Proper inhaler technique, including the use of a spacer or valved holding chamber with MDIs, can minimize adverse effects 1
• Mouth rinsing after inhalation can decrease local side effects 1, 6
• Dose optimization, using the lowest effective dose to maintain control, can minimize adverse effects 1
• Regular monitoring for systemic effects in patients on long-term therapy is recommended 1

Special Populations

• Budesonide is the only ICS with FDA-approved labeling for children <4 years of age, but requires special considerations for administration 1
• COPD patients have an increased risk of pneumonia compared to patients using long-acting beta-agonists alone 3, 5