What are the side effects of Pulmicort (budesonide) respules (inhaled corticosteroid)?

Side Effects of Pulmicort Respules (Budesonide Inhalation Suspension)

Pulmicort Respules can cause both local oral side effects (primarily oral thrush and throat irritation) and systemic effects (including growth suppression, adrenal insufficiency, and increased infection risk), though local effects are most common and can be minimized with proper mouth rinsing after each treatment. 1

Common Local Side Effects

Oral and Throat Effects

• Oral candidiasis (thrush) is the most significant local side effect, presenting as white patches in the mouth and throat that cause pain and discomfort 2, 3
• The incidence of oral candidiasis increases significantly with inhaled corticosteroid use, with approximately 1 case occurring for every 21 patients treated 2
• Throat irritation and soreness are common, manifesting as pharyngeal irritation and discomfort 2, 4
• Dysphonia (voice changes) and hoarseness can occur 4, 5
• Cough may be triggered immediately upon administration 4

Respiratory Infections

• Respiratory infections including stuffy nose, sore throat, and runny nose are among the most commonly reported side effects 1
• Upper respiratory tract symptoms such as sinusitis and pharyngitis occur frequently 6

Systemic Side Effects

Growth and Development (Pediatric Patients)

• Growth suppression in children has been observed with inhaled corticosteroids, though this effect may be transient 4
• Healthcare providers should monitor growth regularly in children using budesonide inhalation suspension 1

Adrenal Function

• Adrenal insufficiency can develop, particularly at higher doses or with prolonged use 4, 1
• Symptoms include tiredness, weakness, nausea, vomiting, and low blood pressure 1
• Patients transitioning from long-term systemic corticosteroids should carry a warning card indicating potential need for corticosteroids during stress or severe asthma attacks 1
• Studies have shown no evidence of basal or cosyntropin-stimulated hypothalamic-pituitary-adrenal axis suppression in long-term use at appropriate doses 6

Bone Health

• Decreased bone mineral density can occur with long-term use at higher doses 4, 1
• Healthcare providers may monitor bone density during treatment 1

Immune System Effects

• Increased susceptibility to infections due to immune system suppression 1
• Symptoms of infection (fever, pain, chills, fatigue, nausea, vomiting) should prompt immediate medical evaluation 1

Ocular Effects

• Glaucoma and cataracts are potential complications with long-term use 4, 1
• Eye examinations may be recommended during treatment 1

Dermatologic Effects

• Skin thinning and easy bruising can occur with long-term use at higher doses 4

Other Common Side Effects

• Viral infections and viral gastroenteritis (with symptoms of stomach pain, diarrhea, nausea, vomiting, loss of appetite) 1
• Ear infections 1
• Nosebleed 1
• Pink eye (conjunctivitis) 1
• Rash 1

Serious but Rare Adverse Reactions

Allergic Reactions

• Severe allergic reactions can occur, manifesting as skin rash, severe itching, facial/mouth/tongue swelling, difficulty breathing or swallowing, chest pain, and anxiety 1
• Rare cases of severe type IV contact allergy restricted to budesonide have been reported, presenting as angioedema and dysphagia 7

Paradoxical Bronchospasm

• Increased wheezing immediately after administration can occur 1
• Patients should always have a fast-acting bronchodilator available 1

Worsening Asthma

• Sudden asthma attacks or worsening of asthma symptoms require immediate medical attention 1

Risk Mitigation Strategies

Preventing Local Side Effects

• Rinse mouth with water and spit out (do not swallow) after each treatment to reduce the risk of oral candidiasis 1
• This simple measure significantly decreases the likelihood of fungal infections 2

Minimizing Systemic Effects

• Use the lowest effective dose to maintain asthma control 4
• Budesonide has a more favorable systemic safety profile compared to fluticasone 8
• Regular monitoring for systemic effects is recommended in patients on long-term therapy 4

Drug Interactions

• CYP3A4 inhibitors (such as ketoconazole and ritonavir) can increase systemic budesonide concentrations and risk of Cushing syndrome or secondary adrenal insufficiency 4, 1
• Inform healthcare providers of all medications, particularly antiseizure medicines, immunosuppressants, and ketoconazole 1

Important Clinical Considerations

• Budesonide inhalation suspension is well-tolerated overall, with adverse event incidences similar to placebo and conventional asthma therapy groups in clinical trials 9
• Long-term studies (52 weeks) demonstrated good tolerability with the most common events being respiratory infections, sinusitis, and pharyngitis 6
• Improvement in asthma control can occur within 2-8 days, with maximum benefit seen at 4-6 weeks 1
• The medication must be used regularly as prescribed, not just for acute symptoms 1