This systematic review and meta-analysis evaluated the efficacy and safety of sildenafil citrate in the treatment of male erectile dysfunction. Trials were eligible for this review if they included men with erectile dysfunction, compared sildenafil with control, were randomized, were of at least 7 days' duration, and assessed clinically relevant outcomes. Data sources included multiple electronic databases, bibliographies of retrieved articles and review articles, conference proceedings abstracts, the Food and Drug Administration's Internet Web site, and the manufacturer. Twenty-seven trials (N = 6659 men), published from January 1995 through December 2000, met all criteria for inclusion. Based on parallel-group, flexible dosing, and administration on an as-needed basis trials, sildenafil was significantly more likely than placebo to lead to successful sexual intercourse, with a higher percentage of successful intercourse attempts (57% vs 21%) and a greater percentage of men experiencing at least 1 intercourse success during treatment (83% vs 45%). In data pooled from parallel-group, fixed-dose trials, efficacy appeared slightly greater at higher doses. Treatment response appeared to vary between patient subgroups; however, relative to placebo, sildenafil significantly improved erectile function in all evaluated subgroups. In trials with parallel-group design, flexible dosing, and administration on an as-needed basis, specific adverse events occurring in men who received sildenafil included flushing (12%), headache (11%), dyspepsia (5%), and visual disturbances (3%); all were significantly less likely with placebo. Sildenafil was not significantly associated with serious cardiovascular events or death.