Symbicort® and Asthma – Side Effects and Tolerability

Symbicort® Side Effects

The Symbicort® safety profile is well known for both asthma and COPD. Several large, long-term clinical studies have shown that Symbicort Turbuhaler® is well tolerated in the long-term maintenance treatment of asthma in patients aged 6 years and above, at a wide range of doses [1-4].

Studies in over 14,000 patients have also confirmed that Symbicort SMART® is as well tolerated as fixed maintenance dosing with an inhaled corticosteroid (ICS) alone or an ICS/long-acting β2-agonist (LABA) combination plus a short-acting β2-agonist (SABA) as needed [5-10].

Pharmacological predictable budesonide side effects such as tremor and palpitations are the most common drug related adverse events reported with Symbicort. These are generally mild and disappear within a few days of treatment.

For more detailed information about safety of Symbicort, please download pdf copies of the Summary of Product Characteristics (SmPC):

• SmPC 80/4.5 µg/inhalation
• SmPC 160/4.5 µg/inhalation
• SmPC 320/9 µg/inhalation

Formoterol side effects: should I be concerned about LABA safety?

The use of LABAs without concomitant ICS is of concern, as studies have reported an increased risk of asthma-related mortality and serious adverse events with LABA monotherapy [11]. However, adding a LABA to an ICS has been shown to have a favourable safety profile [12-16]. Analysis of a large dataset of > 14,000 asthma patients from Symbicort SMART trials reported that Symbicort SMART was not associated with any increase in common LABA adverse events compared with higher maintenance doses of ICS alone, combinations of higher-dose ICS with a LABA or same-dose ICS with a LABA, all with a SABA as-needed for relief [17].

The use of LABAs in combination with an appropriate dose of ICS is consistent with recommendations by international guidelines [18,19] and the labels approved by most regulatory authorities.

References

1. Jenkins C, Kolarikova R, Kuna P, et al. Efficacy and safety of high-dose budesonide/formoterol (Symbicort) compared with budesonide administered either concomitantly with formoterol or alone in patients with persistent symptomatic asthma. Respirology 2006;11:276-286.
2. Rosenhall L, Elvstrand A, Tilling B, Vinge et al. One-year safety and efficacy of budesonide/formoterol in a single inhaler (Symbicort Turbuhaler) for the treatment of asthma. Respir Med 2003;97:702-708.
3. Stallberg B, Olsson P, Jorgensen LA, et al. Budesonide/formoterol adjustable maintenance dosing reduces asthma exacerbations versus fixed dosing. Int J Clin Pract 2003;57:656-661.
4. Tal A. Symbicort: controlling asthma in children. Respir Med 2002;96 Suppl A:S23-S28.
5. O'Byrne PM, Bisgaard H, Godard PP, et al . Budesonide/formoterol combination therapy as both maintenance and reliever medication in asthma. Am J Respir Crit Care Med 2005;171:129-136.
6. Scicchitano R, Aalbers R, Ukena D, et al. Efficacy and safety of budesonide/formoterol single inhaler therapy versus a higher dose of budesonide in moderate to severe asthma. Curr Med Res Opin 2004;20:1403-1418.
7. Kuna P, Peters MJ, Manjra AI, et al. Effect of budesonide/formoterol maintenance and reliever therapy on asthma exacerbations. Int J Clin Pract 2007;61:725-736.
8. Bousquet J, Boulet LP, Peters MJ, et al. Budesonide/formoterol for maintenance and relief in uncontrolled asthma vs. high-dose salmeterol/fluticasone. Respir Med 2007;101:2437-2446.
9. Rabe KF, Atienza T, Magyar P, et al. Effect of budesonide in combination with formoterol for reliever therapy in asthma exacerbations: a randomised controlled, double-blind study. Lancet 2006;368:744-753.
10. Rabe KF, Pizzichini E, Stallberg B, et al. Budesonide/formoterol in a single inhaler for maintenance and relief in mild-to-moderate asthma: a randomized, double-blind trial. Chest 2006;129:246-256.
11. Salpeter SR, Buckley NS, Ormiston TM, et al. Meta-analysis: effect of long-acting beta-agonists on severe asthma exacerbations and asthma-related deaths. Ann Intern Med 2006;144:904-912.
12. Bateman E, Nelson H, Bousquet J, et al. Meta-analysis: effects of adding salmeterol to inhaled corticosteroids on serious asthma-related events. Ann Intern Med 2008;149:33-42.
13. Jaeschke R, O'Byrne PM, Nair P, et al. The safety of formoterol among patients with asthma using inhaled corticosteroids. Systematic review and meta-analysis. Pol Arch Med Wewn 2008;118:627-635.
14. Ni CM, Greenstone IR, Danish A, et al. Long-acting beta2-agonists versus placebo in addition to inhaled corticosteroids in children and adults with chronic asthma. Cochrane Database Syst Rev 2005;CD005535.
15. Walters EH, Gibson PG, Lasserson TJ, et al. Long-acting beta2-agonists for chronic asthma in adults and children where background therapy contains varied or no inhaled corticosteroid. Cochrane Database Syst Rev 2007;CD001385.
16. Sears MR,.Radner F. Safety of budesonide/formoterol maintenance and reliever therapy in asthma trials. Respir Med 2009;103:1960-1968.
17. Sears MR, Ottosson A, Radner F, et al. Long-acting beta-agonists: A review of formoterol safety data from asthma clinical trials. Eur Respir J 2009;33:21-32.
18. British Thoracic Society and Scottish Intercollegiate Guidelines Network. British Guideline on the Management of Asthma: A National Clinical Guideline. 2009.
19. Global Initiative for Asthma. Global strategy for asthma management and prevention - updated 2008. Available at: www.ginasthma.com. Last accessed 11 December 2009.