Cialis (Long-Term Safety)
The long-term safety of tadalafil has been assessed in 1173 patients
enrolled in an ongoing, international, open-label study. Of the patients
enrolled, most (870) had been exposed to 10 or 20 mg of tadalafil daily
for at least 1 yr, with 991 being exposed to these dosages for more than
6 mo. Adverse events experienced by patients in the long-term study
generally reflected those observed in the shorter-term studies. Headache
and dyspepsia were the most frequently reported treatment-emergent
adverse events, with incidence rates of 15% and 11%, respectively. Other
adverse events reported with a frequency of 6 to 10% included infection,
back pain, rhinitis, flu syndrome, pain, and a need for surgical procedures.
Overall, tadalafil was associated with good safety and tolerability for
the treatment of ED in a broad range of patients using the drug for periods
up to 1 yr. Few subjects in this study discontinued use because of adverse
events.
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