The table as follows lists the adverse reactions observed from spontaneous reporting and in placebo-controlled clinical trials (comprising a total of 8,022 patients on Tadalafil and 4,422 patients on placebo) for on-demand and once-a-day treatment of ED and the once-a-day treatment of BPH.
Frequency convention: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000) and Not known (cannot be estimated from the available data). (See Table 3.)
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Description of selected adverse reactions: A slightly higher incidence of ECG abnormalities, primarily sinus bradycardia, has been reported in patients treated with tadalafil once a day as compared with placebo. Most of these ECG abnormalities were not associated with adverse reactions.
Other special populations: Data in patients over 65 years of age receiving tadalafil in clinical trials, either for the treatment of ED or BPH, are limited. In clinical trials with tadalafil taken on-demand for the treatment of ED, diarrhoea was reported more frequently in patients over 65 years of age. In clinical trials with tadalafil 5mg taken once a day for the treatment of BPH, dizziness and diarrhoea were reported more frequently in patients over 75 years of age.
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