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Studies conducted in 421 men, either healthy or with mild ED, have
found no evidence that tadalafil has adverse effects on spermatogenesis.
Tadalafil had no clinically relevant effect on sperm concentration, sperm
count per ejaculate, sperm motility, or sperm morphology. Similarly,
tadalafil has no effect on serum levels of testosterone, luteinizing hormone,
or follicle-stimulating hormone.

Clinical trials conducted with tadalafil show it to be safe and generally
well tolerated. The most common treatment-emergent adverse events
reported in men receiving 20 mg of tadalafil are headache and dyspepsia,
which are mild or moderate in severity and transient in nature (18). Flushing
and myalgia have also been reported to occur with somewhat greater
frequency among men taking tadalafil than among those receiving placebo, but the incidence of flushing and myalgia among 804 men
taking up to 20 mg of tadalafil was 5% or less (Table 2). A similar profile of adverse events was observed in men with comorbid
diabetes. In these men, only dyspepsia occurred with significantly greater
frequency in men taking tadalafil (11%) than in men taking placebo (0%)
(p < 0.005). No clinically significant changes in the electrocardiogram,
vital signs, or blood chemistry have been observed with tadalafil.
Notably, there has been only one report of visual disturbance, consisting of
abnormal color vision, among men receiving tadalafil. As discussed
earlier, tadalafil lacks selectivity for the PDE6 isoenzyme, which may
explain the low incidence of visual disturbances. For this reason, tadalafil
as a therapy for ED has been suggested as an option in patients with retinopathy. In addition, no visual disturbances were reported among men
with comorbid diabetes, including those with diabetic retinopathy.

The recommended starting dose of tadalafil in most patients is 10 mg,
taken before anticipated sexual activity. The dose may be increased to
20 mg or decreased to 5 mg once per day, based on individual efficacy
and tolerability. No dose adjustment of tadalafil is required in patients
older than 65 yr age, in patients with diabetes, or in patients with mild
renal insufficiency.