Finasteride and Dutasteride Safety Alerts Issued by Drug Regulatory Authority of Pakistan (DRAP)

Safety Alert on the Potential Risk of Suicidal Thoughts with Finasteride and Dutasteride Containing Medicines

DRAP Safety Alert No. 63

Date: 3 February 2026

Finasteride is a selective type II 5-α-reductase inhibitor that reduces type II–mediated dihydrotestosterone (DHT) production and is used in androgenetic alopecia and benign prostatic hyperplasia.

Dutasteride is a dual type I and type II 5-α-reductase inhibitor that markedly suppresses both type I– and type II–mediated DHT production and is used for the treatment of benign prostatic hyperplasia.

Target Audience

• Provincial Health Departments and Provincial Pharmacovigilance (PV) Centres

• Manufacturers and importers of finasteride- and dutasteride-containing medicines

• Healthcare professionals

• Patients

Background

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA), during its meeting held from 5–8 May 2025, concluded a safety review initiated following a referral from France. This review assessed available evidence regarding suicidal ideation and suicidal behaviours associated with finasteride- and dutasteride-containing medicinal products.

The assessment included written responses from marketing authorisation holders (MAHs), data from clinical trials, spontaneous adverse event reports, published literature, non-clinical data, and submissions from third parties. Based on evaluated cases, PRAC confirmed a causal association between oral finasteride use and suicidal ideation.

As a result, PRAC recommended that suicidal ideation be listed as an adverse drug reaction with a frequency of “not known” in the product information for all oral finasteride products (1 mg and 5 mg). While warnings regarding mood alterations, including suicidal ideation, were already present, PRAC further concluded that sexual dysfunction—an established adverse effect of finasteride—may contribute to suicidal ideation in some patients, particularly those using finasteride 1 mg. Accordingly, enhanced warnings were recommended.

To improve patient awareness, the product information for finasteride 1 mg will now advise patients to seek medical attention if they experience sexual dysfunction, as this may contribute to mood changes and suicidal thoughts. Additionally, a patient alert card will be included in finasteride 1 mg packaging to reinforce these risks and guide appropriate action.

For finasteride products intended for cutaneous use, PRAC did not identify sufficient evidence to support a causal association with suicidal ideation. Therefore, the existing warnings remain unchanged, and the benefit-risk balance for these products continues to be favourable.

PRAC also confirmed that although a direct association between dutasteride and suicidal ideation was not established, dutasteride has a similar mechanism of action to finasteride. As a precautionary measure, information regarding mood alterations observed with finasteride will also be included in the product information for dutasteride.

Overall, PRAC concluded that the benefit-risk balance of finasteride and dutasteride remains positive for all approved indications.

DRAP’s Regulatory Action in Pakistan:

This safety issue was initially discussed during the 2nd meeting of the Pharmacovigilance Risk Assessment Expert Committee (PRAEC-DRAP) held on 7 March 2023, in light of regulatory decisions from the Health Sciences Authority (Singapore) and Health Canada. At that time, PRAEC recommended strengthening warning statements related to suicidal ideation and self-injury, and advised screening patients for psychiatric risk factors prior to initiating finasteride therapy.

The matter was subsequently re-reviewed during the 6th PRAEC meeting held on 31 December 2025. In line with Rule 10(1)(h)(iv) of the Pharmacovigilance Rules, 2022, PRAEC decided that registration holders must update the product information for oral finasteride- and dutasteride-containing medicines registered in Pakistan to include suicidal ideation as an adverse drug reaction with a frequency of “unknown,” consistent with EMA-PRAC recommendations.

Therapeutic Goods Affected

• Finasteride 1 mg (oral tablets): Indicated for the treatment of early-stage androgenetic alopecia in men aged 18–41 years

• Finasteride 5 mg (oral tablets): Indicated for the treatment of benign prostatic hyperplasia (BPH)

• Dutasteride 0.5 mg (capsules): Indicated for the treatment of benign prostatic hyperplasia (BPH)

Advice for Healthcare Professionals

Healthcare professionals are advised that mood alterations, including depressed mood, depression, and less frequently suicidal ideation, have been reported in patients treated with finasteride, with a frequency classified as “unknown.” Most reported cases of suicidal ideation have occurred in patients using finasteride 1 mg for androgenetic alopecia.

When prescribing finasteride, healthcare professionals should carefully assess the benefit-risk balance, particularly in patients with a history of psychiatric illness. Patients should be counselled on the potential psychological adverse effects and advised to seek medical attention promptly if mood changes or suicidal thoughts occur.

Advice for Patients

Patients taking finasteride or dutasteride are advised to contact their healthcare provider immediately if they experience mood changes such as depression or suicidal thoughts during treatment. Early reporting of symptoms is essential to allow timely evaluation and appropriate management.

Reporting of Adverse Drug Reactions

Healthcare professionals and patients are encouraged to report any suspected adverse drug reactions associated with finasteride- or dutasteride-containing medicines through the Med Vigilance E-Reporting System (E-forms) available on the DRAP website, or via the VigiMobile application.