Tadafil Adverse Reactions

The most commonly reported adverse reactions in patients taking Tadalafil for the treatment of ED or BPH were headache, dyspepsia, back pain and myalgia, in which the incidences increase with increasing dose of Tadalafil. The adverse reactions reported were transient and generally mild or moderate. The majority of headaches reported with Tadalafil once-a-day dosing are experienced within the first 10 to 30 days of starting treatment.
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).

Click on icon to see table/diagram/image

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 5 mg taken once a day for the treatment of BPH, dizziness and diarrhoea were reported more frequently in patients over 75 years of age.