Is Finasteride safe?
Finasteride
Finasteride (Propecia for hair loss, Proscar for the prostate) has a very wide overdose margin and almost no interactions. Its risks are sexual side effects in a few percent of men, which some say persist after stopping, and depression and suicidal thoughts, now flagged in EU and UK packs.
- Brands
- Propecia (1 mg, hair loss); Proscar (5 mg, enlarged prostate); generic finasteride
- Hair-loss dose
- 1 mg once a day, men only; 3 months or more before benefit
- Prostate dose
- 5 mg once a day, alone or with doxazosin
- Sexual side effects in trials (1 mg)
- 3.8% vs 2.1% on placebo in the first year
- Boxed warning
- None in the US
- EU and UK action
- Suicidal thoughts confirmed as a side effect (EMA, May 2025); patient card in packs
- Pregnancy
- ContraindicationA situation in which a medicine should not be used, because the risk clearly outweighs any benefit, such as a known allergy to it.More in the glossary; pregnant women should not handle broken or crushed tablets
- On the market
- Proscar US since June 1992; Propecia since December 1997
How the score breaks down
The overall score is the weighted average of these factors. Scoring rules
Serious side effects30% of score
62 out of 100, FairIn 1-year trials of the 1 mg dose, 3.8% of men had sexual side effects vs 2.1% on placebo. Persistent sexual dysfunction after stopping, depression and suicidal thoughts are reported at unknown frequency; at 5 mg, high-grade prostate cancer was 1.8% vs 1.1% (PCPT, label).
Overdose margin20% of score
97 out of 100, ExcellentVery wide. Single doses up to 400 mg and 80 mg a day for three months caused no adverse reactions in studies (Propecia label).
Interactions15% of score
95 out of 100, ExcellentThe label found no clinically important interactions and no effect on liver enzymes. The main practical issue is that it roughly halves PSA test results at 5 mg, which doctors must allow for.
Dependence and misuse15% of score
95 out of 100, ExcellentNot controlled, not misused and no Drug dependenceThe body's adaptation to a drug taken regularly, so that stopping it suddenly causes withdrawal symptoms. It is not the same as addiction.More in the glossary. Hair gained is lost within 12 months of stopping, which is a loss of effect, not dependence.
Regulatory warnings10% of score
50 out of 100, WeakNo US Boxed warningThe strongest safety warning the US FDA puts on a medicine's label, printed inside a black border at the top.More in the glossary, but a 2025 EU referral confirmed suicidal thoughts as a side effect and added a patient card, the MHRA issued alerts in 2024 and 2026, and the FDA warned about compounded topical finasteride on 22 April 2025 after 32 adverse event reports.
Track record10% of score
92 out of 100, ExcellentApproved in the US for the prostate in June 1992 and for hair loss in December 1997, with large long-term trials such as the 18,880-man Prostate Cancer Prevention Trial.
Is finasteride safe?
For most men, yes, but the risks are of a kind that matters to the people who take it. Finasteride blocks the enzyme that turns testosterone into DHT. At 1 mg a day (Propecia) it slows male pattern hair loss; at 5 mg (Proscar) it shrinks an enlarged prostate. Physically it is very forgiving: single doses up to 400 mg caused no harm in studies, and it barely interacts with other drugs.
The catches are sexual and psychiatric. A few percent of men get sexual side effects, some report they persist after stopping, and regulators in Europe and the UK now confirm a link to depression and suicidal thoughts. We score it 81, just above montelukast at 78, which has a similar profile of physical safety and mental health warnings.
What are the sexual side effects of finasteride?
The Propecia trials give the cleanest numbers. In the first year, among 945 men on 1 mg and 934 on placebo:
| Side effect | Finasteride 1 mg | Placebo |
|---|---|---|
| Lower sex drive | 1.8% | 1.3% |
| Erectile dysfunction | 1.3% | 0.7% |
| Less ejaculate | 1.2% | 0.7% |
| Any of these | 3.8% | 2.1% |
In those trials the effects went away in men who stopped and in most who carried on, and by the fifth year each had fallen to 0.3% or less. Since then, the US label has added reports of sexual dysfunction that continued after stopping, male infertility or poor semen quality, and testicular pain. By April 2024 the MHRA had 426 UK reports of sexual dysfunction with finasteride, and in almost half the man had not recovered when the report was made. Reports cannot show how often this happens, and patient groups use the term "post-finasteride syndrome" for persistent symptoms that medicine does not yet explain.
Depression and suicidal thoughts
The US label lists depression and suicidal ideation and behaviour among post-marketing reports. European regulators went further. In May 2025, after an EU-wide review that found 313 reports of suicidal thoughts with finasteride, the EMA's safety committee confirmed suicidal ideation as a side effect of the 1 mg and 5 mg tablets. The frequency is unknown, and the committee judged that benefits still outweigh risks for all approved uses. It found no link for the approved skin spray.
Packs of 1 mg tablets in the EU now carry a patient card. The UK introduced cards for both strengths in 2024 and in May 2026 added a warning that sexual side effects may contribute to low mood. The advice is clear: before starting, tell the prescriber about any history of depression; stop the 1 mg hair-loss tablet at once and contact a doctor if depression or suicidal thoughts appear; men on 5 mg should contact their doctor promptly. Tell people close to you that you take it, because others may notice mood changes first.
Prostate cancer and PSA tests
Finasteride roughly halves PSA results at the 5 mg dose, which can hide a rising PSA. The label says any confirmed increase from your lowest level should be checked, even if it is still "normal".
In the Prostate Cancer Prevention Trial of 18,880 men, finasteride 5 mg cut prostate cancer diagnoses by about a third (10.5% vs 14.9%) but high-grade cancers were slightly more common (3.5% vs 3.0%). After up to 18 years, survival was the same in both groups (15-year survival 78.0% vs 78.2%). The label carries a warning about high-grade cancer; the long-term data are reassuring on deaths.
Pregnancy and handling tablets
Finasteride can cause abnormal genitals in a male fetus. It is ContraindicationA situation in which a medicine should not be used, because the risk clearly outweighs any benefit, such as a known allergy to it.More in the glossary in women who are or may become pregnant, and they should not handle broken or crushed tablets. Intact tablets are coated and safe to touch. It is not approved for women or children.
Topical finasteride and online prescribing
Hair-loss finasteride is now widely sold through telehealth services, often as compounded sprays or minoxidil mixes. On 22 April 2025 the FDA warned that no topical finasteride is approved in the US. It had received 32 reports to its adverse event database from 2019 to 2024 with compounded sprays and solutions, describing erectile dysfunction, low libido, anxiety, depression, suicidal thoughts, brain fog and testicular pain, and in most of them the problems continued after stopping. Finasteride is absorbed through the skin, and a spray or solution also carries a greater risk of transfer to a partner than coated tablets. A topical form is not automatically safer. For hair loss, some people also look at supplements such as biotin, which does not act on DHT and has little evidence outside deficiency.
Who should be careful
Talk to your doctor or pharmacist before starting finasteride if you have had depression, anxiety or suicidal thoughts, have sexual problems already, are trying for a baby, or have regular PSA tests. If you are already taking it and notice mood or sexual changes, contact your prescriber; for the 1 mg dose, UK and EU advice is to stop at once if depression or suicidal thoughts start. A lower score does not mean the drug is wrong for you, especially for prostate symptoms.
How we scored it
Overdose marginHow far a normal dose is from a harmful one. A wide margin means an accidental extra dose is unlikely to cause serious harm.More in the glossary (97), interactions (95) and dependence (95) are excellent. Regulatory warnings (50) reflect the 2025 EU referral, UK alerts and the FDA's warning on compounded products, though there is no US Boxed warningThe strongest safety warning the US FDA puts on a medicine's label, printed inside a black border at the top.More in the glossary. Serious side effects (62) weigh uncommon sexual effects, which can persist, and rare psychiatric harms against a large majority of men who have none.
Questions people ask
Does finasteride cause erectile dysfunction?
In some men. In the Propecia trials, erectile dysfunction affected 1.3% of men on finasteride vs 0.7% on placebo, and lower sex drive 1.8% vs 1.3%. In the trials these effects went away after stopping and in most men who continued, but the label and regulators also list sexual problems that persisted after stopping.
What is post-finasteride syndrome?
It is the name patient groups use for sexual, mental and physical symptoms that some men report continue after stopping finasteride. Regulators accept that sexual dysfunction can persist; how often, and why, is not known. The MHRA had 426 UK reports of sexual dysfunction by April 2024, almost half not recovered at the time of the report.
Can finasteride cause depression or suicidal thoughts?
Yes, rarely. The EMA confirmed suicidal thoughts as a side effect of finasteride tablets in 2025, frequency unknown. UK and EU advice is to stop the 1 mg hair-loss tablet and contact a doctor straight away if depression or suicidal thoughts start; men on the 5 mg prostate dose should contact their doctor promptly.
Can women touch finasteride tablets?
Intact coated tablets are safe to handle. Women who are or may be pregnant should not handle broken or crushed tablets, because finasteride can cause genital abnormalities in a male fetus.
Is topical finasteride safer than tablets?
Not proven. In April 2025 the FDA warned that no topical finasteride is approved in the US and that it had received 32 reports of side effects with compounded sprays and solutions from 2019 to 2024, similar to those seen with tablets. In the EU, the review found no link between the approved spray and suicidal thoughts.
Does finasteride affect PSA tests?
Yes. At 5 mg it lowers PSA by about half, and the label says any confirmed rise while on finasteride should be checked even if it is still in the normal range. Tell whoever orders a PSA test that you take it.
Sources
- 1.PROPECIA (finasteride 1 mg) prescribing information (opens in a new tab) · DailyMed / Organon, 2024
- 2.PROSCAR (finasteride 5 mg) prescribing information (opens in a new tab) · DailyMed / Organon, 2026
- 3.Measures to minimise risk of suicidal thoughts with finasteride and dutasteride medicines (opens in a new tab) · European Medicines Agency, 2025
- 4.Finasteride: reminder of the risk of psychiatric side effects and of sexual side effects (which may persist after discontinuation of treatment) (opens in a new tab) · MHRA Drug Safety Update, 2024
- 5.Finasteride and dutasteride, updated safety warnings for psychiatric side effects and sexual dysfunction (opens in a new tab) · MHRA Drug Safety Update, 2026
- 6.Long-term survival of participants in the Prostate Cancer Prevention Trial (opens in a new tab) · New England Journal of Medicine, 2013
- 7.FDA alerts health care providers, compounders and consumers of potential risks associated with compounded topical finasteride products (opens in a new tab) · US Food and Drug Administration, 2025