Caliberi Adverse Reactions

Summary of the safety profile Caliberi: The most commonly reported adverse reactions in patients taking tadalafil for the treatment of erectile dysfunction or benign prostatic hyperplasia 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.
Tabulated summary of adverse reactions: The table as follows lists the adverse reactions from published data for on-demand and once-a-day treatment of erectile dysfunction and the once-a-day treatment of benign prostatic hyperplasia. (See table.)

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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: Published data showed diarrhoea was reported more frequently in patients over 65 years of age whereas dizziness and diarrhea were reported more frequently in patients over 75 years of age with tadalafil 5mg taken ocnce a day for the treatment of benign prostatic hyperplasia.