Summary table of adverse reactions

The most commonly reported side effects in patients taking 시알리스 for the treatment of erectile dysfunction or benign prostatic hyperplasia were:

headache, dyspepsia, back pain, and myalgia, the incidence of which increases with increasing doses of CIALIS.

The adverse effects reported were transient and generally mild or moderate in intensity. The majority of headaches reported with once-daily 시알리스 occur within the first 10 to 30 days of starting treatment.

Summary table of adverse reactions

The table below presents adverse reactions observed from spontaneous reports and in placebo-controlled clinical trials (involving a total of 8022 patients treated with 시알리스 and 4422 patients treated with placebo) for on-demand treatment and once-a-day treatment for erectile dysfunction and once-a-day treatment for benign prostatic hyperplasia.

Frequency convention: very common ( ? 1/10), common ( ? 1/100, ? 1/10), uncommon ( ? 1/1000, ? 1/100), rare ( ? 1/10,000, ? 1/1000), very rare ( ? 1/10,000) and frequency not known (cannot be estimated from the available data).

Most patients had pre-existing cardiovascular risk factors (see section 4.4).

Adverse reactions not observed in placebo-controlled clinical trials have been reported during post-marketing surveillance.

More often reported in patients taking tadalafil and previously treated with antihypertensives.

Description of specific side effects

A slight increase in the incidence of ECG abnormalities, primarily sinus bradycardia, has been reported in patients treated with tadalafil once-a-day compared to placebo. Most of these ECG abnormalities were not associated with adverse effects.

Other special populations

Data from clinical trials in patients over 65 years of age treated with tadalafil for erectile dysfunction or benign prostatic hyperplasia are limited. In clinical trials in patients treated with tadalafil on-demand for erectile dysfunction, diarrhea was reported more frequently in patients over 65 years of age. In clinical trials in patients treated with tadalafil 5 mg once daily for benign prostatic hyperplasia, dizziness and diarrhea were reported more frequently in patients over 75 years of age.

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