Adverse events (in most cases headache and flushing) are generally mild in nature, self-limited by continuous use and the drop-out rate due to adverse events is similar to placebo.
A recent post-hoc anlysis of 13 studies1 with Levitra in 4326 men including patients with ED and diabetes, hypertension, dyslipidemia or metabolic syndrome investigated additional safety aspects. Across all subgroups, the number and type of treatment-emergent adverse events were consistent with results from previous studies of phosphodiesterase type 5 inhibitors in men with ED and underlying conditions. Levitra demonstrated favourable tolerability in this large pool of patients with ED and underlying conditions. Importantly, the use of concomitant medications was not associated with any noteworthy changes in the efficacy or safety profile of vardenafil.
1. Eardley I. et al. JSM 2009 accepted for publication