Is the Safety of Finasteride Correlated With Its Route of Administration: Topical Versus Oral? A Pharmacovigilance Study With Data From the United States Food and Drug Administration Adverse Event Reporting System

July 2025 in “ International Journal of Dermatology ”

Aditya K. Gupta, Mesbah Talukder, Sharon A. Keene, Mary A. Bamimore

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From the encyclopedia

Finasteride →

Frontline, gold standard treatment for combatting androgenic alopecia

Dutasteride →

Heavy duty finasteride that comes with higher risks

Studysummary In this study, analysis of FDA adverse event reports revealed that topical finasteride was associated with fewer post-finasteride syndrome-like adverse events than oral finasteride, but many reports lack critical data, suggesting caution in attributing causality.

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Randomized Controlled Trial on the Efficacy and Safety of the Combination Therapy of Topical 0.1% Finasteride and 5% Minoxidil in Male Androgenetic Alopecia

research Randomized Controlled Trial on the Efficacy and Safety of the Combination Therapy of Topical 0.1% Finasteride and 5% Minoxidil in Male Androgenetic Alopecia

April 2025 in “Archives of Dermatological Research”

The combination of finasteride and minoxidil is as safe and effective as minoxidil alone for improving hair growth in men.

Efficacy and Safety of Topical Finasteride Spray Solution in the Treatment of Chinese Men with Androgenetic Alopecia: A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study

research Efficacy and Safety of Topical Finasteride Spray Solution in the Treatment of Chinese Men with Androgenetic Alopecia: A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study

March 2025 in “Chinese Medical Journal”

This randomized, double-blind, placebo-controlled phase III trial found that a 24-week treatment with topical finasteride significantly increased hair growth and was well-tolerated in Chinese men with androgenetic alopecia compared to placebo.

research The Pharmacokinetics of Topical Finasteride 0.25% Spray in Chinese Adult Male Volunteers with Androgenic Alopecia: A Phase I Study

February 2025 in “Advances in Therapy”

The topical finasteride spray was safe and well-tolerated with stable effects.

research Painful Bilateral Gynecomastia Secondary to Topical Finasteride

December 2024 in “Australasian Journal of Dermatology”

In this report, a rare case of gynecomastia was observed in a 76-year-old man using 0.25% topical finasteride for hair loss, with breast tenderness resolving after stopping treatment but persistent enlargement.

Patient-Reported Outcomes of Topical Finasteride/Minoxidil Treatment for Male Androgenetic Alopecia: A Retrospective Study Using Telemedical Data

research Patient-Reported Outcomes of Topical Finasteride/Minoxidil Treatment for Male Androgenetic Alopecia: A Retrospective Study Using Telemedical Data

May 2024 in “Journal of cosmetic dermatology”

This study found that topical finasteride mixed with minoxidil improved hair appearance and self-esteem in men with androgenetic alopecia, but it was not superior to oral finasteride and had lower treatment adherence.

research Factors Associated With Early-Onset Androgenetic Alopecia: A Scoping Review

March 2024 in “PLOS ONE”

This review explores the risk factors, associated comorbidities, and psychological impacts of early-onset androgenetic alopecia, highlighting its complexity and potential implications for treatment response and overall health.

research The Role of Topical Finasteride in Hair Loss Management: Current Evidence and Future Perspectives

December 2023 in “International Journal of Biomedicine”

In this review, researchers explored the potential of topical finasteride as an innovative treatment for male pattern hair loss, addressing the limitations of oral finasteride, such as side effects and inconsistent effectiveness.

research Comparison of Oral Minoxidil, Finasteride, and Dutasteride for Treating Androgenetic Alopecia

1 citations , August 2022 in “Journal of Dermatological Treatment”

In this study, the authors reported that oral dutasteride at 0.5 mg/day showed a probable greater efficacy in treating male androgenetic alopecia compared to finasteride and minoxidil, but it may cause sexual dysfunction and neuropsychiatric side effects.

research Mesotherapy With Dutasteride for Androgenetic Alopecia: A Retrospective Study in Real Clinical Practice

July 2022 in “PubMed”

This study evaluated the use of dutasteride mesotherapy for treating androgenetic alopecia in real clinical practice, finding it effective in improving hair loss for both men and women with mild side effects, primarily pain.

research Topical Finasteride for Male and Female Pattern Hair Loss: Is It a Safe and Effective Alternative?

2 citations , March 2022 in “Journal of Cosmetic Dermatology”

This review found that topical finasteride has similar efficacy to oral finasteride in treating male and female pattern hair loss, with fewer systemic side effects, mainly causing localized scalp reactions like irritation and erythema.

research Association Between Psychosocial Distress, Sexual Disorders, Self-Esteem, and Quality of Life With Male Androgenetic Alopecia: A Population-Based Study With Men at Age 46

December 2021 in “BMJ Open”

This study found no significant association between androgenetic alopecia and psychosocial well-being among middle-aged men in the Northern Finland Birth Cohort.

research How Routine Pharmacovigilance Failed to Identify Finasteride’s Persistent Sexual Side Effects

October 2021 in “International Journal of Andrology”

This paper reports on the controversy surrounding post-finasteride syndrome and questions Merck and the FDA's handling of associated sexual side effects. Despite significant adverse event reports, both entities failed to conduct further studies or enhance patient safety warnings about finasteride's long-term effects.

research Efficacy and Safety of Topical Finasteride Spray Solution for Male Androgenetic Alopecia: A Phase III, Randomized, Controlled Clinical Trial

11 citations , October 2021 in “Journal of The European Academy of Dermatology and Venereology”

This study found that topical finasteride significantly increased hair count in men with androgenetic alopecia compared to placebo while maintaining similar efficacy to oral finasteride but with lower systemic exposure and a reduced impact on serum DHT levels, potentially minimizing sexual side effects.

Effects of a Novel Finasteride 0.25% Topical Solution on Scalp and Serum Dihydrotestosterone in Healthy Men with Androgenetic Alopecia

research Effects of a Novel Finasteride 0.25% Topical Solution on Scalp and Serum Dihydrotestosterone in Healthy Men with Androgenetic Alopecia

42 citations , December 2015 in “International Journal of Clinical Pharmacology and Therapeutics”

This study found that applying a novel 0.25% finasteride solution to the scalp can effectively reduce scalp DHT levels in men with androgenetic alopecia, potentially reducing systemic side-effects.

research Finasteride 5mg and Sexual Side Effects: How Many Are Related to a Nocebo Phenomenon?

225 citations , July 2007 in “The Journal of Sexual Medicine”

In this study, patients informed about finasteride's potential sexual side effects reported a significantly higher occurrence of these side effects, suggesting a nocebo effect.

research Finasteride in the Treatment of Androgenetic Alopecia

62 citations , April 2004 in “Expert Opinion on Pharmacotherapy”

This article reviews the use of finasteride for treating male pattern hair loss, highlighting its mechanism of action in reducing DHT and noting its safety profile with some common adverse effects.