The side effects that occurred in at least 3% of patients during short-term (12 weeks) studies of tadalafil include headache, dyspepsia, back pain, nasopharyngitis, myalgia, flushing, and nasal congestion [22,23]. A similar profile of adverse events was seen in a long-term study (18 to 24 months) of tadalafil [50]. In most patients, these events are mild or moderate in severity, and they are not persistent. Over the course of the clinical trials, the incidence of new-onset adverse events declined from the initial visits to the last patient visits for the tadalafil-treated subjects.
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