Finasteride and dutasteride may increase the risk of sexual dysfunction

Sexual dysfunction is a known risk included in Canadian product monographs for all finasteride-containing products (Proscar, Propecia, generics) and dutasteride-containing products (Avodart, Jalyn, generics).1 For example, the “Adverse Reactions” section of the Proscar (finasteride tablets) product monograph lists impotence, decreased libido, decreased volume of ejaculate and ejaculation disorder all as occurring more commonly with the drug compared to placebo, particularly during the first year of use. The product monograph notes that the incidence of new drug-related sexual adverse reactions decreases with duration of treatment. However, the monograph also notes that post-market reports indicate sexual dysfunction (erectile dysfunction and ejaculation disorders) may continue after discontinuation of finasteride treatment.2 Following media attention devoted to this issue, Health Canada conducted a safety review to identify and assess newly emerging safety information on the risk of sexual dysfunction with these medications, and to determine whether information currently provided in product monographs is sufficient or requires updating.1Health Canada reviewed Canadian cases of sexual dysfunction in patients taking finasteride (17 cases) or dutasteride (1 case). Of the 18 cases, 17 (16 finasteride and 1 dutasteride) were found to be possibly linked to their use, while the remaining case could not be assessed due to limited clinical information. Health Canada also reviewed published literature, which provided a growing body of evidence supporting a link between the use of finasteride or dutasteride and the risk of sexual dysfunction.1Health Canada concluded that a larger amount of data now exist to support a link between the use of finasteride or dutasteride and the risk of sexual dysfunction. As a result, product safety information in Canadian product monographs for all finasteride- and dutasteride-containing products will be revised to also include a warning about the risk of sexual dysfunction. Health Canada also plans to inform healthcare professionals about the monograph update through a Health Product InfoWatch communication.1References:Health Canada. Summary safety review - finasteride and dutasteride - assessing the potential risk of sexual dysfunction. (accessed June 2, 2026).Organon Canada Inc. Proscar (finasteride tablets) product monograph. Kirkland, QC; November 24, 2023. (accessed June 2, 2026).

Finasteride and dutasteride may increase the risk of sexual dysfunction

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