MHRA Strengthens Safety Warnings for Finasteride and Dutasteride Over Psychiatric and Sexual Side Effects
Key Insights
The UK MHRA has strengthened product information for finasteride and dutasteride following a detailed review linking finasteride to depression (search), suicidal thoughts, and sexual dysfunction.
Finasteride is significantly associated with low mood, depression (search), suicidal thoughts, and sexual dysfunction including decreased libido, erectile dysfunction, and ejaculation disorders.
Dutasteride product information is being updated as a precautionary measure due to limited data, noting that mood alterations have been reported with finasteride, a medicine in the same class.
The UK Medicines and Healthcare products Regulatory Agency (search) (MHRA) has issued strengthened safety warnings for medicines containing finasteride and, as a precaution, dutasteride, following a detailed review of evidence linking these drugs to psychiatric side-effects and sexual dysfunction.
Dr Alison Cave, MHRA Chief Safety Officer, stated: "The MHRA has taken significant action to raise awareness of the risks of sexual dysfunction, depression (search) and suicidal thoughts associated with finasteride, including issuing a Drug Safety Update and introducing patient alert cards in 2024."
She added: "Following an additional detailed review of the evidence, we have now strengthened product information for both finasteride 1mg and dutasteride to provide clearer guidance on these potential risks and to support informed discussions between healthcare professionals and patients."
Evidence Behind the Decision
Based on scientific literature included in the European referral, Yellow Card reports, and actions taken by other international regulators, the MHRA now concludes that finasteride is significantly associated with low mood, depression (search), suicidal thoughts, and sexual dysfunction — including decreased sex drive, erectile dysfunction, and ejaculation disorders.
The data for dutasteride were very limited. Consequently, the Pharmacovigilance Expert Advisory Group of the Commission on Human Medicines recommended updating the dutasteride product information as a precautionary measure.
Clinical Indications and Prescribing Landscape
Finasteride is used to treat male pattern hair loss (androgenetic alopecia (search)) at a dose of 1 mg, and benign prostatic hyperplasia (search) at a dose of 5 mg. Dutasteride at a dose of 0.5 mg is indicated for benign prostatic hyperplasia and reduction in the risk of acute urinary retention.
Prescribing data indicates that more than 400,000 prescriptions per month are issued for finasteride 5mg and dutasteride-containing medicines. Accurate prescription numbers for finasteride 1mg are not available, as it is not prescribed on the NHS and is only available by private prescription.
Updated Product Information
The strengthened warnings in the product information for finasteride 1mg for androgenetic alopecia (search) now clarify that sexual dysfunction may contribute to mood disorders, and that sexual dysfunction has been reported both with and without mood alterations.
For dutasteride, a precautionary warning is being added to note that mood alterations have been reported with a medicine in the same class — finasteride.
Patient Alert Cards and Reporting
Existing UK patient alert cards for finasteride, introduced in 2024, remain in place. These cards highlight the risks of sexual dysfunction, depression (search), and suicidal thoughts, and advise patients on what action to take if side effects occur.
Healthcare professionals are advised to inform patients of these risks at the point of prescribing and to advise patients to read the finasteride patient cards and the patient leaflet, both of which are supplied in the 1 mg and 5 mg packs.
Patients prescribed finasteride or dutasteride should contact their healthcare professional if they experience sexual dysfunction and report suspected adverse drug reactions using the Yellow Card scheme.