HealthyStudy

Hair loss medications and what the FDA label actually says

Two active ingredients are approved by the FDA for pattern hair loss: finasteride and topical minoxidil. Several others are used for hair loss without an approval for that use, and their labels cover something else entirely.

Each page here is built from the prescribing information or Drug Facts label filed with the FDA. Where a medication is used for hair loss without an approval for it, the page says so at the top rather than in a footnote.

Nothing here is a recommendation. This is a reference to what the regulator approved and what the label states.

Comparisons

Approved by the FDA for hair loss

Each of these has at least one FDA approval covering this use.

  • FinasterideFDA approved for this use

    Type II 5-alpha reductase inhibitor. Sold as Propecia, Proscar.

    Finasteride is one of two ingredients approved by the FDA for pattern hair loss. It is approved in men only, at 1 mg, under the name Propecia. The same ingredient at 5 mg is approved as Proscar for an entirely different condition, benign prostatic hyperplasia.

  • MinoxidilFDA approved for this useOver the counter

    Topical hair regrowth treatment. Sold as Men's Rogaine Extra Strength, Women's Rogaine.

    Topical minoxidil is the only hair loss treatment in this category available without a prescription. It is sold under a Drug Facts label, in separate products for men and for women, and those labels differ in formulation and in the directions for use.

Discussed for this, but not approved for it

These medications are approved for something else. They are listed because people look for them here, and the honest answer is what the label covers.

  • DutasterideNot approved for this use

    Type I and type II 5-alpha reductase inhibitor. Sold as Avodart.

    Dutasteride belongs to the same class as finasteride but blocks both type I and type II 5-alpha reductase rather than type II alone. In the United States it is approved only for benign prostatic hyperplasia. It is approved for hair loss in some other countries, which is a frequent source of confusion.

  • SpironolactoneNot approved for this use

    Aldosterone antagonist and potassium-sparing diuretic. Sold as Aldactone.

    Spironolactone is a diuretic with anti-androgen activity, approved for cardiovascular and endocrine conditions. It is discussed in connection with female pattern hair loss because of that anti-androgen effect, but no such indication appears in its FDA label.

  • KetoconazoleNot approved for this useOver the counter

    Antifungal. Sold as Nizoral A-D shampoo.

    Ketoconazole shampoo is an antifungal product sold over the counter for dandruff. It is often mentioned as part of a hair care routine alongside treatments that are approved for hair loss, but its own label makes no claim about hair regrowth.