Medicines Healthcare Products Regulatory Agency
Advice for healthcare professionals:
- finasteride has been associated with depression, suicidal thoughts and sexual dysfunction
- patients have reported that sexual dysfunction (including decreased libido and erectile dysfunction) has persisted even after treatment was stopped
- before prescribing finasteride, ask patients if they have a history of depression or suicidal ideation
- advise patients to stop finasteride 1mg (Propecia) for male pattern hair loss immediately if they develop depression or suicidal thoughts and to contact their doctor as soon as possible
- advise patients prescribed finasteride 5mg (Proscar) for benign prostatic hyperplasia to consult their doctor for further medical advice as soon as possible if they develop depression or suicidal thoughts
- monitor patients for psychiatric and sexual side effects
- a patient card will be introduced in all finasteride packs, which will highlight the risk of sexual side effects and psychiatric side effects reported with finasteride to increase awareness among patients and prescribers
- report suspected adverse drug reactions associated with finasteride via the Yellow Card scheme
Advice for healthcare professionals to give to patients and caregivers:
- finasteride is a medicine that helps with the management of male pattern hair loss (androgenic alopecia; 1 milligram (mg) formulation) and benign (non-cancerous) enlargement of the prostate (benign prostatic hyperplasia; 5mg formulation)
- finasteride has been associated with depressed mood, depression, suicidal thoughts and sexual dysfunction (including decreased sex drive and erectile dysfunction)
- in some cases sexual dysfunction has persisted in patients even after they have stopped taking finasteride
- before taking finasteride, inform your doctor if you have any personal history of depression or suicidal thoughts
- stop finasteride 1mg (Propecia) immediately if you develop depression or suicidal thoughts and contact your doctor as soon as possible
- if you are prescribed finasteride 5mg (Proscar) and you develop depression or suicidal thoughts, you should inform your doctor for further medical advice as soon as possible
- if you experience any problems with sexual function such as inability to get and maintain an erection or decrease in sex drive, please discuss this with your prescriber or doctor
- you may not notice some changes in your mood and behaviour so it is very important to tell your friends and family that you are taking this medicine and that it can have effects on psychological well-being. Others may notice changes and help you quickly identify any symptoms that you need to talk to your doctor about
- always read the leaflet that is provided alongside your medicine, which contains information about taking finasteride and a full list of known possible side effects.
Review of persistent sexual dysfunction and psychiatric side effects with finasteride
Finasteride is a 5 alpha-reductase-type-2 inhibitor. The 1mg dose (Propecia) is indicated in men 18 to 41 years of age for the treatment of male pattern hair loss (androgenetic alopecia). The 5mg dose (Proscar) is indicated for the treatment and control of benign prostatic hyperplasia in adults.
The MHRA completed a safety review into finasteride following concerns from patients regarding a lack of awareness of these side effects amongst patients and healthcare professionals. We issued a previous Drug Safety Update for finasteride in 2017, however at the time the potential for persistence of some of the side effects were not widely known.
The MHRA recently reviewed the available evidence, including Yellow Card reports, published scientific literature and actions by other regulators, and this was considered by the Pharmacovigilance Expert Advisory Group (PEAG) of the Commission on Human Medicines (CHM). The PEAG noted that the product information for finasteride contains information regarding the potential for persistent sexual side effects after discontinuation with finasteride and depression and suicidal ideation. However, these side effects are not well known by prescribers and patients and therefore a Drug Safety Update article was recommended.
The PEAG also recommended inclusion of a patient card inside the pack. The card aims to increase awareness of the side effects including depression, suicidal thoughts and sexual dysfunction, and to advise patients on what to do if they experience these adverse effects. The patient card will be introduced this year.
A Public Assessment Report has been published on the risks associated with finasteride.
UK reports of persistent sexual dysfunction after discontinuation of finasteride
Since the first report was received in November 1992, the MHRA has received 426 Yellow Card reports up until 5 April 2024 of finasteride (both 1mg and 5mg formulations) and sexual dysfunction, including reports of erectile dysfunction (inability to get and maintain an erection) and decreased sex drive. In almost half of these reports, the outcome was recorded as not recovered or not resolved.
UK reports of psychiatric dysfunction with finasteride
Since the first report was received in February 1993, the MHRA has received 281 reports of finasteride and depressed mood disorders and suicidal and self-injurious behaviours, up until 5 April 2024.
Report suspected reactions on a Yellow Card
Please continue to report suspected adverse drug reactions to finasteride via the Yellow Card scheme. Your report will help us safeguard public health. Healthcare professionals, patients, and caregivers are asked to submit reports using the Yellow Scheme electronically using:
- the Yellow Card website
- the Yellow Card app; download from the Apple App Store or Google Play Store
- some clinical IT systems for healthcare professionals (EMIS, SystmOne, Vision, MiDatabank, and Ulysses)?
When reporting, please provide as much information as possible, including information about medical history, any concomitant medication, onset timing, treatment dates and particularly if a side effect continued or started after treatment was stopped.
Article citation: Drug Safety Update volume 17, issue 9: April 2024: 1