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].