Oral finasteride (licensed under the brand name Propecia) is used to treat conditions like male pattern baldness and benign prostatic hyperplasia. However, serious concerns have emerged about the potentially serious and long-term side effects of finasteride in men and women. This has triggered a review by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), as well as other medical regulators. These concerns centre around a set of serious side effects, including mental health issues and sexual health risks. They also include a set of persistent symptoms collectively known as Post-Finasteride Syndrome (PFS). Beyond the sensationalist headline, it can be hard to understand what has triggered this review and the current guidance. We’ll explore these risks, why the MHRA is conducting a review, whether there’s a finasteride ban and the updated guidance. We’ll also review whether this affects topical finasteride and what it potentially means for similar medications such as dutasteride.
What are the Mental Health Risks & Sexual Side Effects of Finasteride?
Finasteride is facing a review due to a number of studies highlighting alarming mental health and sexual side effects. Men taking finasteride have reported increased symptoms of anxiety, depression and even suicidal thoughts. We do not fully understand the mechanism behind these mental health effects. However, the suspicion is that it relates to finasteride’s influence on neurosteroids. These are chemicals in the brain that help regulate mood, and finasteride can reduce their levels. For some individuals, this reduction has led to severe psychological side effects, ranging from mood disturbances to profound depression. In fact, there have been reports of individuals experiencing suicidal ideation after starting finasteride. This alarming side effect is what has garnered much-needed attention from health authorities.
Sexual health risks are among the most significant concerns for those taking finasteride. Men using the drug have reported a range of sexual side effects. These include decreased libido, erectile dysfunction and reduced semen volume. These issues can have a profound impact on quality of life, affecting both physical health and emotional well-being. The sexual side effects are not always temporary. For some individuals, these issues persist even after discontinuation of the drug. This is a core component of Post-Finasteride Syndrome (PFS), where men continue to experience sexual dysfunction long after stopping finasteride.
Women, although less frequently prescribed finasteride, are also at risk of side effects, including changes in mood and sexual function. In general, finasteride should not be given to pregnant women or those who may become pregnant. In fact, they should also receive explicit advice against handling crushed or broken finasteride tablets. This is because the drug can cause birth defects.
Post-Finasteride Syndrome & Long-Term Side Effects
One of the most debated consequences of finasteride use is Post-Finasteride Syndrome (PFS). This is a condition whereby side effects continue to affect some men long after they stop taking finasteride. PFS is characterised by a range of persistent symptoms, including sexual dysfunction, cognitive impairment and emotional instability. These symptoms can persist for months or even years after discontinuation. Although there is a lot of debate around the nature of this condition, the potential permanence of side effects has raised serious concerns. As such, there is discussion about whether finasteride should carry more severe warnings and whether its use requires greater restriction.
What Triggered the MHRA Review into Finasteride?
In early 2024, the MHRA decided to conduct a review of finasteride following an increase in reported adverse events. There was particular concern regarding the effects on mental health. Reports submitted to regulatory bodies have highlighted numerous instances of severe psychological distress and prolonged physical symptoms following finasteride use. The MHRA sought to assess whether patients get adequate safety information and whether finasteride labelling needs an update. This review also focuses on whether healthcare professionals have sufficient information about the potential risks. Mainly, whether it allows them to provide better guidance to patients before prescribing the drug. This is especially relevant as many individuals turn to finasteride for cosmetic reasons, such as to prevent hair loss. The MHRA’s review underscores the importance of weighing these potential risks against the benefits of treating a non-life-threatening condition.
What was the Outcome of the MHRA Review and Will There Be a Ban?
In April 2024, in response to growing concerns, the MHRA issued updated guidance on finasteride for both prescribers and patients. There is now emphasis on healthcare professionals discussing the full spectrum of potential side effects with patients before prescribing finasteride. This includes highlighting the risk of persistent sexual dysfunction and mental health problems even after discontinuation (Post-Finasteride Syndrome).
The advice for patients currently taking finasteride is to be vigilant about any changes in mood or sexual health. If they notice symptoms such as increased anxiety, depression or difficulty with sexual function, they should consult their healthcare provider immediately. Discontinuing finasteride may help alleviate some side effects, but for others the symptoms persist, underscoring the importance of early intervention.
The MHRA review is still ongoing, so there has been no decision yet on whether to ban finasteride for men or women. The review aims to determine whether additional safety measures are necessary, but there is no explicit mention of a ban at this stage. Other regulators were also monitoring the safety of finasteride. These include the Food & Drug Administration (FDA) in the US and the European Medicines Agency (EMA) in Europe. Following the MHRA’s review, the EMA announced a review of both finasteride and dutasteride and possible links to mental health risks. The FDA issued an additional warning to prescribers in 2017 about the risk of suicidal ideation with both drugs, but has not banned their use.
What About Topical Finasteride?
As the reviews and studies largely relate to oral finasteride, there’s a debate about whether topical finasteride might be safer. Topical finasteride is an unlicensed hair loss treatment applied directly to the scalp. This theoretically reduces the drug’s systemic absorption, minimising the risk of side effects like sexual dysfunction and mental health issues. Some studies have shown that topical finasteride can reduce hair loss with fewer systemic side effects compared with oral. However, the evidence is still emerging, and it is not yet clear whether topical finasteride is entirely free of the risks found in the oral version. As such, it is best to proceed with caution and assume that the risks apply to all forms of finasteride. Your provider should look for any factors that could increase your risk of side effects. They should also provide careful monitoring if you start either oral or topical treatment.
Where Does This Leave Dutasteride?
Dutasteride, another 5-alpha-reductase inhibitor, is sometimes used off-licence for hair loss. It is more potent than finasteride, but there are fewer studies on its safety and efficacy because it is less commonly used. It is probably safest to assume at least a similar risk of side effects unless future evidence proves otherwise. Given the MHRA’s review of finasteride, it is possible that they will also scrutinise dutasteride. This is especially the case if reports of adverse long-term side effects continue to emerge. This is why anyone considering dutasteride as an alternative should be aware of the similar risk profile and discuss it thoroughly with their healthcare provider.
Finasteride is a powerful drug, but the possible risks and long-term side effects on men and women need careful consideration. Whilst the drug can be effective for hair loss and BPH, there are some serious side effects. These include mental health problems, sexual dysfunction and the potentially permanent impact of Post-Finasteride Syndrome. As the MHRA continues its review, it is likely that they will implement new safety measures to better protect patients. This may include stronger warnings on packaging, stricter guidelines for prescribers, or even a re-evaluation of who should be eligible for finasteride. If you take finasteride or are considering it, have an open discussion with your provider to weigh up the benefits against the risks.
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This article is intended for general informational purposes only and is not a substitute for medical advice, diagnosis or treatment. Always consult a qualified medical provider for any health concerns or questions you might have.
