What are the risks of Symbicort (Budesonide and Formoterol)?

From the Guidelines

Symbicort carries potential risks, including increased risk of pneumonia, cardiovascular effects, and adrenal suppression, but its benefits in controlling asthma or COPD typically outweigh these risks for most patients. The main risks associated with Symbicort include:

• Increased risk of pneumonia, with a 4% increased risk compared to long-acting beta-agonist therapy alone 1
• Cardiovascular effects, including increased heart rate and blood pressure
• Adrenal suppression with long-term use
• Potential for growth suppression in children
• Eye problems, such as glaucoma or cataracts with prolonged use
• Bone loss (osteoporosis) with long-term use
• Fungal infections in the mouth and throat
• Weakened immune system, leading to increased susceptibility to infections To minimize risks, use Symbicort exactly as prescribed, rinse your mouth after each use, and attend regular check-ups with your doctor. Report any unusual symptoms promptly. According to the most recent and highest quality study, the combination of inhaled corticosteroid and long-acting beta-agonist therapy, such as Symbicort, reduces the number of exacerbations and improves lung function, health-related quality of life, and dyspnea, but may increase the risk of pneumonia 1.

From the FDA Drug Label

The following adverse reactions have been reported during post-approval use of budesonide inhalation suspension. The incidence and nature of adverse events reported for budesonide inhalation suspension was comparable to that reported for placebo. Formoterol Fumarate Inhalation Solution can cause serious side effects, including: • people with asthma who take long-acting beta2 adrenergic agonist (LABA) medicines, such as Formoterol Fumarate Inhalation Solution, without also using a medicine called an inhaled corticosteroid, have an increased risk of serious problems from asthma, including being hospitalized, needing a tube placed in their airway to help them breathe, or death. • using too much of a LABA medicine may cause: • chest pain • fast and irregular heartbeat • tremor • increased blood pressure • headache • nervousness • sudden shortness of breath immediately after use of Formoterol Fumarate Inhalation Solution Sudden shortness of breath may be life-threatening.

The risks of Symbicort (Budesonide and Formoterol) include:

• Serious asthma problems: People with asthma who take long-acting beta2 adrenergic agonist (LABA) medicines, such as Formoterol Fumarate Inhalation Solution, without also using a medicine called an inhaled corticosteroid, have an increased risk of serious problems from asthma, including being hospitalized, needing a tube placed in their airway to help them breathe, or death.
• Cardiovascular effects: Using too much of a LABA medicine may cause chest pain, fast and irregular heartbeat, tremor, increased blood pressure, headache, and nervousness.
• Respiratory problems: Sudden shortness of breath immediately after use of Formoterol Fumarate Inhalation Solution may be life-threatening.
• Allergic reactions: Serious allergic reactions, including rash, hives, swelling of the face, mouth, and tongue, and breathing problems, have been reported.
• Other side effects: Common side effects of Formoterol Fumarate Inhalation Solution include headache, muscle cramps, dizziness, tremor, nausea, tiredness, nervousness, vomiting, trouble sleeping, dry mouth, and diarrhea.
• Growth suppression: Cases of growth suppression have been reported for inhaled corticosteroids, including post-marketing reports for budesonide inhalation suspension.
• Eye disorders: Cataracts, glaucoma, and increased intraocular pressure have been reported with the use of budesonide inhalation suspension.
• Immune system disorders: Immediate and delayed hypersensitivity reactions, including anaphylaxis, angioedema, bronchospasm, rash, contact dermatitis, and urticaria, have been reported with the use of budesonide inhalation suspension. 2 3

From the Research

Risks of Symbicort (Budesonide and Formoterol)

The provided studies do not directly discuss the risks of Symbicort (Budesonide and Formoterol) in detail. However, some information can be inferred from the studies:

• The studies primarily focus on the efficacy and safety of Symbicort in treating asthma and COPD, with most reporting that it is well-tolerated and effective 4, 5, 6, 7, 8.
• One study mentions that budesonide/formoterol maintenance and reliever therapy was well-tolerated with an incidence of adverse events similar to that with conventional regimens 7.
• Another study reports that budesonide/formoterol pMDI demonstrated a safety profile similar to that of budesonide, with no unexpected pattern of abnormalities in a 52-week tolerability study 6.
• However, the studies do not provide a comprehensive list of potential risks or side effects associated with Symbicort.

Potential Side Effects

Some potential side effects can be inferred from the studies, including:

• Adverse events similar to those experienced with conventional regimens 7
• No unexpected pattern of abnormalities in a 52-week tolerability study 6
• It is essential to note that the provided studies do not offer a detailed analysis of the risks associated with Symbicort, and further research may be necessary to fully understand its potential side effects.