3.2- Safety data
Azithromycin is considered to be safe, with a low risk for severe adverse effects[26]. The most frequently reported azithromycin’s adverse events were gastrointestinal (diarrhea, nausea, and abdominal pain), central and peripheral nervous system (headache or dizziness), hepatotoxicity and the development of antibacterial resistance[7]. Its use, as occurs with other macrolides, has been related to QTc interval prolongation, torsade de Pointes (TdP), ventricular tachycardia and sudden cardiac death[26]. A study showing an increased risk of cardiovascular death prompted the FDA to introduce a black box warning[7]. However, in a Cochrane review, macrolide use was not associated with a higher risk of cardiac disorders when compared to placebo (OR 0.87 [95% CI 0.54-1.40])[27]. In other systematic review and meta-analysis, macrolide use was not associated neither with an increased risk for short term arrhythmia (OR 1.19 [95% CI 0.89-1.61]) nor 30-day mortality (OR 1.22 [95% CI 0.94-1.60])[26]. The proarrhythmic mechanism of azithromycin is thought to be due to intracellular sodium overload[28].