“…3 Indeed, the most common adverse events (AEs) associated with sildenafil in clinical trials conducted in the USA, the UK, and Europe were headache, flushing, dyspepsia, and nasal congestion, consistent with PDE5 inhibition in the systemic vasculature, the gastroesophageal sphincter, and the nasal mucosa; and transient visual symptoms, consistent with PDE6 inhibition in the retina. 4 The results of three double-blind, randomized, placebo-controlled, multicenter clinical evaluations of sildenafil in men with ED of various etiologies that were conducted in Brazil=Mexico, 5 and in the northern (Colombia, Ecuador, and Venezuela) 6 and southern regions of South America (Argentina, Peru, Chile, and Uruguay) 7 have been reported. The results of an analysis of the pooled safety data from these three studies are reported in this paper.…”