Finasteride: indications and the 2025 AIFA warnings

Different products have different uses

Finasteride formulations for early male androgenetic alopecia must be distinguished from those for benign prostatic hyperplasia. Sharing an active ingredient does not make products interchangeable. The approved information for the actual product determines its indications and warnings.

What the warning says

AIFA’s communication of 16 September 2025 recognises suicidal ideation as an adverse reaction to oral finasteride, with frequency unknown. This means the available data cannot estimate its frequency; it does not mean zero risk or that reports can be counted to calculate your risk.

For people taking oral finasteride for androgenetic alopecia, AIFA advises stopping treatment and contacting a doctor immediately if depressed mood, depression or suicidal thoughts occur.

Contact a doctor about sexual dysfunction too: it can contribute to mood changes. Whether treatment should be stopped needs assessment. Do not wait for a reply from an information website to discuss these symptoms.

Sprays and dutasteride: different conclusions

The review did not establish a causal link between finasteride skin sprays and suicidal ideation. A direct link with dutasteride was not demonstrated, but a precaution was introduced for a possible class effect. AIFA advises contacting a doctor immediately if mood changes occur while taking dutasteride. None of these conclusions means an absence of all risk.

What to clarify before deciding

The European benefit-risk assessment remains favourable for approved uses, with safety measures. Ask your clinician what benefit is realistic, which precautions apply to you and how to report problems. This page summarises a regulatory notice; it does not decide whether you should start treatment or provide dosing schedules. Licensing and product instructions outside Italy must be checked locally.