Sodez Adverse Reactions

Summary of the safety profile: The safety of silodosin has been evaluated in four Phase II-III double-blind controlled clinical studies (with 931 patients receiving silodosin 8 mg once daily and 733 patients receiving placebo) and in two-long term open-label extension phase studies. In total, 1,581 patients have received silodosin at a dose of 8 mg once daily, including 961 patients exposed for at least 6 months and 384 patients exposed for 1 year.
The most frequent adverse reactions reported with silodosin in placebo controlled clinical studies and during long term use were ejaculatory disorders such as retrograde ejaculation and anejaculation (ejaculatory volume reduced or absent), with a frequency of 23%. This may temporarily affect male fertility. It is reversible within a few days upon discontinuation of treatment (see Precautions).
Tabulated list of adverse reactions: In the table as follows, adverse reactions reported in all clinical studies and in the worldwide post-marketing experience for which a reasonable causal relationship exists are listed by MedDRA system organ class and frequency very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10000 to <1/1000; very rare (<1/10000), not known (cannot be estimated from available data). Within each frequency grouping the observed adverse reactions are presented in order of decreasing seriousness. (See Table 2.)

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Description of selected adverse reactions: Orthostatic hypotension: The incidence of orthostatic hypotension in placebo controlled clinical studies was 1.2% with silodosin and 1.0% with placebo. Orthostatic hypotension may occasionally lead to syncope (see Precautions).
Intraoperative Floppy Iris Syndrome (IFIS): IFIS has been reported during cataract surgery (see Precautions).
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.