Cognitive dysfunction following finasteride use: a disproportionality analysis of the global pharmacovigilance database

ABSTRACT

Background

Finasteride is commonly prescribed for androgenic alopecia and benign prostatic hyperplasia. However, concerns regarding its safety have been growing as cases of cognitive dysfunction have been reported.

Methods

A disproportionality analysis was conducted on data collected between 1967 and 2022 to explore the potential association. Cases of cognitive dysfunction associated with finasteride use were identified, and the reporting odds ratio (rOR) was calculated with 95% confidence intervals to determine the strength of the association between the two variables. Sensitivity analyses were conducted to account for confounding by indication.

Results

Among the 54,766 cases of adverse events reported for finasteride use, 1,624 (2.97%) were associated with cognitive dysfunction. The study found a significant disproportionality for cognitive dysfunction related to finasteride use (rOR 5.43, 95% CI 5.17–5.71). Most cases were considered serious (65.83%), with no signs of recovery (58.37%). Sensitivity analyses showed that patients younger than 45 years (rOR 7.30, 95% CI 6.39–8.35) and those with alopecia (rOR 5.52, 95% CI 5.15–5.91) reported more cognitive dysfunctions than their counterparts.

Conclusion

This study showed an increased reporting of cognitive dysfunction associated with finasteride use, especially among younger alopecia patients. Finasteride should be prescribed with caution, especially to younger alopecia patients.

KEYWORDS:

• Alopecia
• cognitive dysfunction
• disproportionality analysis
• finasteride
• pharmacovigilance

Declaration of interests

Dr. Shin received grants from the Ministry of Food and Drug Safety, the National Research Foundation of Korea, and pharmaceutical companies, including Pfizer, Celltrion, and SK Bioscience. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosure

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contributions

All authors contributed to the study conception and design. Material preparation, data collection were performed by JHB, YC, and SB. Data analysis was performed by JHB and YC. YC and SB wrote the first draft of the manuscript and all authors commented on previous versions of the manuscript. All authors contributed to the interpretation of the data and approved the final manuscript. YC and SB equally contributed to the work.

Data availability statement

Data used in this study are obtainable by services provided by the Uppsala Monitoring Centre, but restrictions may apply to the availability of these data, which were used under the license for the current study, and so are not publicly available. However, data are available from the authors upon reasonable request and with permission of Uppsala Monitoring Centre.

Ethics approval

This study was approved by the Institutional Review Board of Sungkyunkwan University, South Korea (No. 2022-08-015).

Supplementary material

Supplemental data for this article can be accessed online at https://doi.org/10.1080/14740338.2023.2294926

Additional information

Funding

This study was supported by a grant (No. 21153MFDS607) from the Ministry of Food and Drug Safety of South Korea in 2021-2025. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.