Category
Hair loss medications and what the FDA label actually says
5 medications7 FDA labels3 comparisons
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.
FDA approvals and boxed warnings across this category
Built from the 7 labels linked on the pages below, so it cannot drift from them. A boxed warning is the strongest warning the FDA requires, and where several medications carry the same one, it belongs to the class rather than to the product.
| Medication | Class | Approved for hair loss | Boxed warning | Supply |
|---|---|---|---|---|
| FinasteridePropecia, Proscar | Type II 5-alpha reductase inhibitor | Yes | None | Prescription |
| MinoxidilMen's Rogaine Extra Strength, Women's Rogaine | Topical hair regrowth treatment | Yes | None | Over the counter |
| DutasterideAvodart | Type I and type II 5-alpha reductase inhibitor | No | None | Prescription |
| SpironolactoneAldactone | Aldosterone antagonist and potassium-sparing diuretic | No | None | Prescription |
| KetoconazoleNizoral A-D shampoo | Antifungal | No | None | Over the counter |
Two labels, side by side
- PropeciavsMen's Rogaine Extra StrengthFinasteride and topical minoxidil are the only two ingredients approved by the FDA for pattern hair loss. What each label covers, who it covers and how it is used.
- PropeciavsProscarPropecia and Proscar are both finasteride, at 1 mg and 5 mg. One is approved for male pattern hair loss, the other for an enlarged prostate. Compared straight from both FDA labels.
- PropeciavsAvodartFinasteride is FDA-approved for male pattern hair loss. Dutasteride is not approved for hair loss in the United States. What each label covers and how the two differ.
Approved by the FDA for hair loss
Each of these has at least one FDA approval covering this use.
- FinasterideApproved for hair loss
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.
- MinoxidilApproved for hair lossOver 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. Both are 5 percent minoxidil, but they differ in presentation and in how often the label says to apply them.
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. Approvals differ between countries, which is a frequent source of confusion; this page covers the US label, and that label does not mention hair loss.
- 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.