Vaylen← Back to Vaylen

Safety Information

Last updated: August 13, 2026

Draft for healthcare regulatory counsel review before publication. Placeholder entity details to be confirmed.

Finasteride (and dutasteride)

What it is: Finasteride 1mg is an FDA approved once daily oral treatment for male pattern hair loss. Dutasteride is a related, stronger DHT blocker that clinicians may prescribe off label where appropriate. Both work by lowering DHT, the hormone that shrinks hair follicles.

Who must not take it: Adult men only. Women who are or may become pregnant must not take or handle crushed or broken tablets; it can harm a developing male fetus. Keep away from children.

Reported side effects: In clinical trials of finasteride 1mg, a small minority of men reported sexual side effects (decreased libido, erectile difficulty, decreased ejaculate volume); most cases resolved, including in men who continued treatment. Rarely reported: breast tenderness or enlargement, depression or mood changes, allergic reactions. Some men report sexual side effects persisting after stopping. Finasteride lowers PSA. Tell any physician who tests your PSA that you take it.

Stop and contact a clinician if: you notice breast lumps, pain or nipple discharge, mood changes, or an allergic reaction (rash, swelling of lips/face).

Minoxidil (topical and low dose oral)

What it is: Topical minoxidil is FDA approved for hair regrowth. Low dose oral minoxidil is prescribed off label by clinicians. It supports the growth phase of the hair cycle by improving blood flow to follicles.

Expected early effect: A temporary increase in shedding during the first weeks is a known part of how it works, as resting hairs release before new growth. It settles over subsequent weeks.

Reported side effects: Topical: scalp irritation, itching, dryness, unwanted facial hair with spread of product. Oral: fluid retention or ankle swelling, faster heart rate, dizziness, increased body hair. Men with heart conditions require clinician evaluation before oral minoxidil.

Stop and contact a clinician if: chest pain, rapid heartbeat, faintness, or sudden swelling occurs.

Compounded formulations

Chewable and topical combination products are compounded formulations prepared by a licensed U.S. pharmacy for an individual prescription. Compounded medications are not FDA approved as combination products; the individual active ingredients finasteride and minoxidil are FDA approved for the treatment of male pattern hair loss.

In all cases

This page is a summary, not a complete list of risks. Your clinician screens your full health history before prescribing and remains available for unlimited follow ups. Report side effects to your clinician through your portal, and to FDA MedWatch at 1-800-FDA-1088.