DISCLAIMER: This publication is aimed at health professionals. The information is meant to provide updates on medication safety issues, and not as a substitute for clinical judgement. While reasonable care has been taken to verify the accuracy of the information at the time of publication, NPRA shall not be held liable for any loss whatsoever arising from the use of or reliance on this publication.

 

Overview of Product(s)

Finasteride and dutasteride are 5α-reductase inhibitors that block the conversion of testosterone to dihydrotestosterone (DHT), a key hormone involved in both androgenetic alopecia (AGA) and benign prostatic hyperplasia (BPH).¹ Finasteride selectively inhibits the type 2 isozyme, reducing serum DHT by approximately 70%, while dutasteride inhibits both type 1 and type 2, lowering DHT levels by more than 90%. By decreasing DHT levels, these medicines help slow hair loss, promote hair regrowth, and reduce prostate size.

In Malaysia, finasteride is approved for the treatment of male pattern hair loss (AGA), with both the oral 1 mg formulation and topical spray indicated to promote hair growth and prevent further hair loss.^2,3 The 5 mg oral formulation of finasteride and dutasteride are indicated for the treatment and management of BPH.^4,5 There are a total of 8 finasteride-containing products are registered with the Drug Control Authority (DCA), comprising 7 in tablet form and 1 in spray form.⁶ For dutasteride, 13 products are registered, all in oral dosage form.

 

Overview of Safety Concern

Suicidal ideation, depression and sexual dysfunction (e.g., decreased libido, erectile dysfunction) have been linked to the use of 5α-reductase inhibitors in some men.^7-10 A pharmacovigilance case series of six suicide cases in men treated with finasteride for AGA found persistent sexual dysfunction and insomnia were commonly reported, with no pre-existing medical or psychiatric conditions.¹⁰

 

Source of Safety Concern

The National Pharmaceutical Regulatory Agency (NPRA) received information from the European Medicines Agency (EMA) following its review of finasteride and dutasteride in relation to the risk of suicidal ideation.¹¹ The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) confirmed that suicidal ideation is an adverse effect associated with both the 1 mg and 5 mg oral formulations of finasteride, although its frequency is unknown. Nevertheless, the committee maintained that the overall benefit–risk balance of both finasteride and dutasteride remains positive.

The EMA’s assessment was based on multiple sources, including data from clinical trials, EudraVigilance case reports, published literature, and input from patients, caregivers, healthcare professionals, academics, and consumer organisations. The review identified 325 cases of suicidal ideation in the EudraVigilance database: 312 involving finasteride, 12 involving dutasteride, and 1 case involving both. Most cases were assessed as probably or possibly related to treatment, primarily in patients treated for alopecia with finasteride 1 mg. These findings were considered in the context of estimated exposures: 270 million patient-years for finasteride and 82 million for dutasteride (1 patient-year equals one patient treated for one year).

Although no causal link was established between dutasteride and suicidal ideation, the PRAC noted that dutasteride has a similar mechanism of action to finasteride. As a precautionary measure, product information for dutasteride will be updated to include information on mood-related changes. Meanwhile, the review found no evidence of a similar risk associated with finasteride spray formulations, and no changes will be made to their product information.

 

Background of the Safety Issue

The psychiatric effects associated with 5α-reductase inhibitors may be related to disrupted neurosteroid production, particularly allopregnanolone, a key modulator of mood and stress.^7-10,12 Finasteride crosses the blood–brain barrier and directly alters neurosteroid levels in the brain, whereas the extent of dutasteride’s central nervous system penetration remains less clear, potentially explaining their differing psychiatric profiles.¹²

A global analysis of safety reports in VigiBase, the WHO global database of individual case safety reports, covering the period 1967 to 2019 identified a significant disproportionality signal for suicidality and psychological adverse events associated with finasteride, particularly in younger patients treated for alopecia.⁷ No such signal was observed for dutasteride. This may reflect greater psychological vulnerability among younger individuals, potentially due to the emotional impact of hair loss or treatment-related side effects such as sexual dysfunction.

In contrast to findings in younger individuals, a large cohort study of older men (>50 years) using 5α-reductase inhibitors for BPH found no overall increased risk of suicide or self-harm.¹² However, among those with a prior history of mood disorders such as depression, finasteride was associated with a higher risk of suicide and severe self-harm compared to dutasteride (HR = 1.64; 95% CI 1.00–2.68). This risk appeared to be more pronounced within the first 90 days of exposure.

 

Local Adverse Drug Reaction Reports¹³

To date, the NPRA has received 164 reports involving 240 adverse events suspected to be associated with finasteride-containing products, and 80 reports involving 122 adverse events related to dutasteride. No cases of suicidal ideation or depression have been reported for either product. However, there have been 14 reports of sexual dysfunction associated with finasteride and 13 reports with dutasteride.

 

Advice for Health Care Professionals

• While NPRA is still reviewing this safety issue, be vigilant of the risk of suicidal ideation associated with the use of both 1 mg and 5 mg finasteride. A potential risk has also been reported with dutasteride use.
• Be aware of the risk of sexual dysfunction associated with both finasteride and dutasteride, which may contribute to psychiatric adverse events. Ask patients whether they are experiencing related symptoms (e.g., decreased libido, erectile dysfunction), including those that persist after discontinuation of treatment.
• For patients prescribed 1 mg finasteride for androgenetic alopecia (AGA): Advise patients to discontinue treatment and seek medical attention promptly if they develop psychiatric symptoms such as depressed mood, depression, or suicidal ideation.
• For patients prescribed 5 mg finasteride for benign prostatic hyperplasia (BPH): Educate patients to seek medical advice as soon as possible if they experience psychiatric symptoms, including depressed mood, depression, or suicidal ideation.
• For patients prescribed dutasteride: Inform patients of the potential risk of psychiatric adverse events and advise them to report any mood changes or suicidal thoughts immediately.
• Monitor patients with a history of psychiatric disorders closely when prescribing finasteride or dutasteride.
• Report all suspected adverse events related to the use of finasteride- or dutasteride-containing products to the NPRA.

 

References:

1. Garcia-Argibay M, Hiyoshi A, Fall K, Montgomery S. Association of 5α-Reductase Inhibitors With Dementia, Depression, and Suicide. JAMA Netw Open. 2022;5(12):e2248135. Available from: https://doi.org/10.1001/jamanetworkopen.2022.48135
2. National Pharmaceutical Regulatory Agency (NPRA). PROPECIA (finasteride) [Package Insert]. QUEST3+ Product Search. 2025 Jul [cited 2025 Jul 18].Available from: https://www.npra.gov.my
3. National Pharmaceutical Regulatory Agency (NPRA). FINJUVE (finasteride) [Package Insert]. QUEST3+ Product Search. 2025 Jul [cited 2025 Jul 18].Available from: https://www.npra.gov.my
4. National Pharmaceutical Regulatory Agency (NPRA). PROSCAR (finasteride) [Package Insert]. QUEST3+ Product Search. 2025 Jul [cited 2025 Jul 18].Available from: https://www.npra.gov.my
5. National Pharmaceutical Regulatory Agency (NPRA). AVODART (dutasteride) [Package Insert]. QUEST3+ Product Search. 2025 Jul [cited 2025 Jul 18].Available from: https://www.npra.gov.my
6. National Pharmaceutical Regulatory Agency (NPRA). QUEST3+ Product Search [Internet]. 2025 [cited 2025 Jul 18]. Available from: https://www.npra.gov.my
7. Nguyen DD, Marchese M, Cone EB, Paciotti M, Basaria S, Bhojani N, et al. Investigation of suicidality and psychological adverse events in patients treated with finasteride. JAMA Dermatol. 2020;156(11):1361-1369. Available from: https://doi.org/10.1001/jamadermatol.2020.3385
8. Diviccaro, S., Melcangi, R.C., & Giatti, S. (2023). Post-Finasteride Syndrome: An Emerging Clinical Problem. Frontiers in Endocrinology, 14, 123456.Available from: https://doi.org/10.1016/j.ynstr.2019.100209
9. Fertig RM, Gamret AC, Darwin E, et al. Sexual side effects of 5-α-reductase inhibitors finasteride and dutasteride: A comprehensive review. Dermatol Online J. 2017;23(11). Available from: https://doi.org/10.5070/D32311037240
10. Irwig MS. Finasteride and Suicide: A Postmarketing Case Series. Dermatol. 2020; 6: . Available from: https://doi.org/10.1159/000505151
11. European Medicines Agency (EMA). Measures to minimise risk of suicidal thoughts with finasteride and dutasteride medicines. [Internet] 2025 May 8 [cited 2025 Jul 18]. Available from: https://www.ema.europa.eu/en/news/measures-minimise-risk-suicidal-thoughts-finasteride-dutasteride-medicines
12. Laanani M, Weill A, Jollant F, Zureik M, Dray‑Spira R. Suicidal risk associated with finasteride versus dutasteride among men treated for benign prostatic hyperplasia: nationwide cohort study. Sci Rep. 2023;13:5308. Available from: https://doi.org/10.1038/s41598-023-32356-3.
13. National Pharmaceutical Regulatory Agency (NPRA). The Malaysian National ADR Database (QUEST) [Internet]. 2025 [cited 2025 Apr 7]. Available from: https://www.npra.gov.my (access restricted)

 

Written by: Noor'ain Shamsuddin
Reviewed/Edited by: Dr Rema Panickar, Norleen Mohamed Ali