MHRA updates safety warnings for finasteride and dutasteride, highlighting risks of depression, suicidal thoughts, and sexual dysfunction. Read the latest guidance for patients and prescribers.
Written By: Dr. Preethi Putti, PharmD
Reviewed By: Pharmacally Editorial Team
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has updated safety warnings for finasteride and dutasteride, medicines commonly prescribed for male pattern hair loss and benign prostatic hyperplasia (BPH). The revised guidance is intended to strengthen awareness among patients and healthcare professionals about potential psychiatric and sexual side effects associated with these 5‑alpha‑reductase inhibitors.
Background and indications
Finasteride is licensed at 1 mg for androgenetic alopecia (male pattern hair loss) and at 5 mg for BPH, while dutasteride is used at 0.5 mg for BPH. Both agents reduce dihydrotestosterone (DHT) levels, but growing concern has emerged from reports of depression, suicidal thoughts, and sexual dysfunction, including cases that persist after treatment discontinuation.
Key updates to product information
Following an additional review of evidence, the MHRA has strengthened the SmPC (Summary of Product Characteristics) and PIL (Patient Information Leaflet) wording for finasteride 1 mg and dutasteride 0.5 mg. For finasteride 1 mg, the updated information clarifies that sexual dysfunction may contribute to mood changes and that sexual dysfunction has been reported both with and without associated psychiatric symptoms. For dutasteride 0.5 mg, the MHRA has added a precautionary warning that mood alterations (including depressed mood, depression, and suicidal ideation) have been reported with another medicine in the same class, finasteride.
Patient alert cards and prescribing context
Existing UK patient alert cards for finasteride, introduced in 2024, remain in place and will now align with the revised warnings. These cards highlight the risks of sexual dysfunction, depression, and suicidal ideation, and advise patients to stop finasteride 1 mg immediately and seek urgent medical advice if depression or suicidal thoughts occur; for finasteride 5 mg or dutasteride, patients are advised to contact their healthcare professional promptly in such cases. The MHRA notes that more than 400,000 prescriptions for finasteride 5 mg and dutasteride‑containing products are issued monthly in the UK, underscoring the importance of clear risk communication.
Regulatory process and next steps
The updated measures follow consideration of a European regulatory review under Article 31 and advice from the Commission on Human Medicines.
Dr Alison Cave, MHRA Chief Safety Officer, stated that the agency had already introduced a Drug Safety Update and patient alert cards in 2024 to raise awareness of the risks with finasteride; the latest changes further strengthen prescribing information for finasteride 1 mg and dutasteride to support informed discussions between clinicians and patients.
The MHRA continues to encourage reporting of suspected adverse reactions through the Yellow Card scheme and to emphasise early recognition of depressive symptoms and sexual side effects.
References
MHRA strengthens safety warnings for finasteride and dutasteride – GOV.UK
About the Writer
Dr.Preethi Putti, PharmD (LinkedIn) is a pharmaceutical researcher with experience in healthcare and pharmaceutical market research and competitive intelligence. She specializes in analyzing drug pipelines, clinical data, and industry trends and translating complex scientific data into clear and structured medical content. Strong foundation in clinical research, data interpretation, and evidence-based healthcare analysis. Committed to advancing a global career in clinical research and healthcare innovation.
