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FDA-Approved Hair Loss Treatments: An Overview for Men and Women

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There are a few hair loss medications on the market, both over-the-counter and prescription. 

But, not all medications that you might commonly see or hear about for hair loss are FDA-approved. This doesn’t necessarily mean that non-FDA-approved medications used (off-label) do not work or are dangerous, it just means that they are not currently approved for use as a hair loss treatment agent.

As always, when you are considering looking into hair loss treatment options, it is best to start by talking to a doctor in person or via an online telemedicine consultation to help decide on the best route for you.

Below, we will discuss the medications which are FDA-approved for hair loss in men, the medications FDA-approved for hair loss in women, which medications you may see used off-label for hair loss, and where you can have an online consultation to see if FDA-approved or off-label hair loss measures are a good fit for you.

Which hair loss medications are FDA-approved for use in men?

In the U.S. there are currently 2 medications that are FDA-approved for use in men experiencing male pattern hair loss, also known as androgenetic alopecia -- the most common form of hair loss in both genders.

There is one that is prescription-only, and one that can be found over-the-counter.


Minoxidil is FDA-approved for male pattern hair loss treatment, and it can be found over-the-counter in grocery stores or pharmacies. Minoxidil is used The exact mechanism for how Minoxidil helps with hair loss is not completely known, but it may have to do with the increased blood flow to the scalp to enhance growth. Minoxidil is used as a topical formulation that is applied to the scalp once or twice daily for hair loss treatment. Minoxidil may also help extend the growth phase of the hair growth cycle. Minoxidil is the active ingredient found in the brand name medication Rogaine, but it works just as well if you can find it in its generic form, labeled as Minoxidil.


The only FDA-approved prescription medication for male pattern hair loss is Finasteride. This is the active ingredient found in the medication Propecia. For hair loss, Finasteride is taken as an oral tablet in the 1mg strength once daily. Finasteride has been found to help with male pattern hair loss by helping to reduce the levels of the hormone, DHT, in the body and scalp. DHT is a culprit in androgenetic alopecia which causes damage to and the potential loss of hair follicles over time. So, by helping to reduce the amount of this hormone around, Finasteride can help men lose less hair and may potentially help regrow some hair (in some users).

For both of these medications, if you stop using them, any hair improvements or results that you have gained will likely revert back to how your hair was before treatment.

Which hair loss medications are FDA-approved for use in women?

There is only one medication that is FDA-approved for use in women experiencing female pattern hair loss, which is also known as androgenetic alopecia.


Minoxidil is the only medication that is FDA-approved for hair loss in women. This is available over-the-counter in the brand name medication, Rogaine, or you can find generic versions listed as just Minoxidil. The 2% minoxidil strength is commonly advertised as the women’s version. In both men and women, part of the functionality for hair growth improvements is by increased blood flow to the scalp, although the full mechanism behind how Minoxidil works for hair loss is not fully known. This is a topical application that can be applied once or twice daily.

For women using Minoxidil, if you stop using the medication, your hair will likely return to how it was before you starting using the product.

There is currently no FDA-approved prescription medication for female pattern hair loss.

Which medications might be used off-label for hair loss?

As you can see above, there are a lot fewer FDA-approved hair loss medications than you might expect for such a common issue. For this reason, many doctors who specialize in hair loss may reach outside the “FDA-approved box” to come up with other treatment options if these have not given patients the results they were hoping for. 

When doctors prescribe medications for indications that they are not approved for, or the medication is approved for hair loss but not with the same application or strength, this is considered off-label use and it is up to the doctor’s discretion to prescribe this for their patient.

For men experiencing male pattern hair loss, you may see off-label uses often. Instead of oral Finasteride tablets, doctors may prescribe topical Finasteride formulations. You may even commonly see Dutasteride prescribed orally or topically for male pattern hair loss. Dutasteride is in the same class as Finasteride, and also helps to reduce the DHT exposure to the hair follicles. These uses may be chosen for men who didn’t respond well to the FDA-approved treatments, or just prefer a topical DHT reducing agent over an oral one.

For women, you may see the off-label use of a medication called Spironolactone, which can help reduce DHT and androgens in women experiencing female pattern hair loss. Spironolactone is FDA-approved for use as a diuretic agent for blood pressure, but is not approved for hair loss treatment. Regardless, it may help some women deal with the root cause of their hair loss if it stems from an androgen-related cause. Other off-label medications sometimes seen used in women may include cimetidine, ketoconazole, estrogen and/or progesterone hormone replacement therapy after menopause, low androgen oral contraceptives, or Finasteride for post-menopausal women.

Finasteride is not FDA-approved for women due to the risk of fetal deformities in women who are pregnant. For this reason, you rarely see this used in women even off-label. If it is used, the woman is usually post-menopausal.

Strut Health FDA-approved and off-label treatments for hair loss online

Here at Strut, our doctors are well-versed in the FDA-approved agents as well as some off-label medications for hair loss treatment in men and women.

For men, we carry oral Finasteride tablets, as well as topical Finasteride combined with Minoxidil, and oral or topical Dutasteride options. For women, we offer an off-label formulation that extends beyond what is available for female hair loss at your local drugstore. Our women’s hair growth formulation combines off-label Spironolactone with Minoxidil and a little Tretinoin to help boost hair growth while helping to retain your current hair by reducing excess androgens.

If you are interested in seeing if a hair loss medication is a good option for you, you can have a free online telemedicine consultation with our U.S. licensed doctors today.

If you are a good candidate for treatment, your medication can be shipped to your front door with our free shipping.

If you have any questions during your treatment, our team and doctors are available for free unlimited follow-ups.

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