Symbicort® Side Effects and Tolerability

Is treatment with Symbicort® well tolerated?

Symbicort® is well tolerated in patients with COPD and asthma (read more about this on the Symbicort and asthma side effects page), and shows a similar frequency of adverse events compared with other treatments [1-3]. In the study by Calverley et al., fewer patients receiving Symbicort withdrew from the study than those receiving (budesonide) alone, formoterol alone or placebo [1].

Budesonide and formoterol side effects

As with any medicine, treatment with budesonide and formoterol may cause potential side effects. There is no increased incidence of adverse reactions seen when these two compounds are administered together in the Symbicort Turbuhaler®. Common drug related adverse reactions are generally due to pharmacologically predictable formoterol side effects such as tremor and palpitations. These are usually mild and disappear within a couple of days of treatment. 

For more detailed information about the safety profile of Symbicort, please refer to the Symbicort Summary of Product Characteristics (SmPC) 160/4.5 µg/inhalation and SmPC 320/9 µg/inhalation. 

Is pneumonia a budesonide side effect?

Concern has previously been raised regarding an increased risk of pneumonia with use of inhaled corticosteroids (ICSs) in patients with COPD [4,5]. However, a meta-analysis by Sin et al. [6] reported that 12 months treatment with the ICS budesonide, with or without formoterol, was not associated with an increased risk of pneumonia adverse events in patients with COPD. Over 12 months’ treatment, in all treatment groups, the risk of the budesonide adverse event pneumonia was low (approximately 3%). Therefore budesonide, when used at its recommended dose as combination therapy in Symbicort, is well tolerated and has a favourable safety profile for clinical use in COPD patients.

References

1. Calverley PM, Boonsawat W, Cseke Z, et al. Maintenance therapy with budesonide and formoterol in chronic obstructive pulmonary disease. Eur Respir J 2003;22:912-919.
2. Szafranski W, Cukier A, Ramirez A, et al. Efficacy and safety of budesonide/formoterol in the management of chronic obstructive pulmonary disease. Eur Respir J 2003;21:74-81.
3. Welte T, Miravitlles M, Peterson S, et al. Budesonide/formoterol added to tiotropium improves the management of COPD patients. Am J Resp Crit Care Med 2009;180:741-750.
4. Calverley PMA, Anderson JA, Celli B, et al for the TORCH investigators. Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease. N Engl J Med 2007;356:775-789.
5. Ernst P, Gonzalez AV, Brassard P, et al. Inhaled corticosteroid use in chronic obstructive pulmonary disease and the risk of hospitalization for pneumonia. Am J Respir Crit Care Med 2007;176:162-166.
6. Sin DD, Tashkin D, Zhang X, et al. Budesonide and the risk of pneumonia: a meta-analysis of individual patient data. Lancet 2009;374:712-719.