Real-world 5-ARI data show increased sexual side effects with finasteride vs dutasteride


Real-world data for patients treated with 5 alpha-reductase inhibitors (5-ARIs) showed that sexual adverse events (AEs) occurred at higher rates in patients receiving finasteride compared with dutasteride, according to a study presented during the 2021 European Association of Urology Annual Congress.1

The risk of ejaculation disorders was 8 times higher with finasteride versus dutasteride, and the risk of erectile dysfunction and decreased libido was 5 times higher (P = .001).

“Clinicians should considerer these data when prescribing 5-ARIs,” said presenting author Antonio Franco, MD, Sant'Andrea Hospital, Sapienza University of Rome, Department of Urology, Rome, Italy.

The urology literature has established an increased risk of sexual AEs in patients with benign prostate hyperplasia (BPH) treated with the 5-ARIs finasteride and dutasteride. The investigators launched this study to compile and compare real-world data for these 5-ARIs. 

For their study, the researchers used data from the Eudra-Vigilance (European Union Drug Regulatory Authorities) database, a system created by the European Medicines Agency to manage and analyze AE information related to medicines approved in or being examined in clinical trials in the European Economic Area (EU countries, Iceland, Liechtenstein, and Norway).

“We recorded the number of sexual AEs for dutasteride and finasteride per category and severity until January 2021. Pooled relative risk was used to compare data between the 2 drugs,” said Franco.

Franco reported that the real-world findings showed an increased risk of sexual AEs in patients treated with 5-ARIs, which is consistent with the literature. Across all patients, there were 2748 sexual AEs reported for dutasteride and 6099 sexual AEs reported for finasteride.

The rates were higher for finasteride for ejaculation disorders, erectile dysfunction, and decreased libido at 6.3% versus <1% (P <.05), 25% versus 4.6% (P >.05), and 12% versus 2.4% (P <.05), respectively.

The rates of gynecomastia and hot flushes were comparable between the 2 arms. Gynecomastia occurred in 5.5% of the dutasteride arm and 7% of the finasteride arm. Hot flushes occurred in <1% of each group.

Franco noted most of the AEs occurred in elderly patients (aged 65-85 years), at 62% in both the finasteride and dutasteride arms (P >.05).

Franco explained that when interpreting the results of the study, limitations of the EudraVigilance databased should be noted, included the number of patients, the indication of the treatment itself, and combination therapy with 5-ARIs that the patient may have received.


1. De Nunzio C, Nacchia A, Lombardo R, et al. Sexual adverse events-related to dutasteride e finasteride: Analysis of real-life data from EudraVigilance database. Presented at 36th Annual EAU Congress (virtual). July 8-12, 2021. P0033.

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