FDA-Approved Hair Loss Treatments for Androgenic Alopecia

A man's head, bent slightly downward, showing temple and crown hair loss indicative of androgenic alopecia.

Androgenic alopecia, also known as pattern hair loss, affects 50 percent of men and women. In order to treat this common form of hair loss, men and women can go into hair loss clinics for treatments or use various different types of hair loss products at home, some of which are FDA-approved. 

FDA-Approved Hair Growth Products

The three main types of FDA-approved treatments are topical minoxidil, oral finasteride, and low-level laser therapy (LLLT). Both minoxidil and LLLT can be purchased over-the-counter, while finasteride is a prescription-only medication.(1)

What Is Minoxidil?

Minoxidil, more commonly known as Rogaine, was the first FDA-approved hair loss treatment for androgenic alopecia. Minoxidil is a vasodilator that widens your blood vessels. It was originally developed in the 1970’s for those suffering from high blood pressure.(2)

In 1987, a topical version of minoxidil was created as a treatment for pattern hair loss. Rogaine was FDA-approved for androgenic alopecia shortly after. This medication is thought to increase blood flow to the scalp in order to promote hair growth.(2)

These days, minoxidil is FDA-approved in concentrations of 2 percent and 5 percent. It’s sold as either a liquid solution or a foam. The side effects from both products are mild, and limited to issues like:

  • Dermatitis (usually indicating an allergy to an ingredient in the product)
  • Excessive hair growth in undesired places
  • Minoxidil hair shedding
  • Skin irritation and discomfort

For women, the recommended treatment when using minoxidil is one half-capful a day of 5 percent foam to the top of the head. Alternatively, women can also apply the 2 percent liquid twice a day to the top of their scalps.(2)

Men can also use minoxidil 5 percent foam in doses of one half-capful twice a day. Alternatively, the 2 percent or 5 percent liquid solutions can be applied twice a day to the crowns of their heads.(2)

Unapproved Minoxidil Products

Not all minoxidil products are FDA-approved for hair regrowth. Unapproved products include alternative formulations, like sprays and creams, and different concentration items, like extra-strength serums and foams.

Products like these can contain higher concentrations of minoxidil, which tend to cause additional side effects. For example, when 10 percent minoxidil was tested against the FDA-approved 5 percent solution, it caused excess shedding and irritation but performed no better at hair regrowth. (3)

Similarly, products like minoxidil shampoo, minoxidil lotion, and other formulations are also sold in certain countries. However, these alternative formulations haven’t undergone the same amount of testing as the FDA-approved liquid and foam versions of minoxidil, and there is little to no proof they are effective.

Finally, oral minoxidil is FDA-approved, but is still used to reduce blood pressure rather than treat hair loss. Low-dose oral minoxidil is currently being tested in clinical trials. So far, it seems to be effective but is still a while away from being approved by the FDA.(4)

What Is Finasteride?

Finasteride is a FDA-approved hair growth treatment for androgenic alopecia in men. This oral medication works as a dihydrotestosterone (DHT) blocker. DHT is one of the major reasons people with pattern hair loss experience hair thinning and balding. As a DHT blocker, finasteride slows down testosterone’s conversion to dihydrotestosterone to stop this hormone from affecting hair follicles.

Finasteride is usually taken in doses of 1-milligram tablet once daily to help treat androgenic alopecia. Patients typically begin seeing results and an increase in hair growth after 3 to 4 months of use.(5)

While this medication is good at stopping the progression of androgenic alopecia, it has the potential to cause more serious side effects than minoxidil. Some of the side effects associated with finasteride include dizziness, weakness, skin rashes, and erectile dysfunction.(5)

Off-Label Uses of Finasteride

Finasteride is not currently a FDA-approved treatment for female pattern hair loss. However, there have been studies exploring how effective this treatment can be for women. Some studies have shown that finasteride may improve female androgenic alopecia, and may even help with other types of hair loss related to hirsutism and or polycystic ovary syndrome.(6)

Topical finasteride has also been explored as a hair loss treatment for both men and women. Topical finasteride – in various concentrations – has been shown to have success in reducing symptoms of pattern hair loss, and has even been considered comparable to the FDA-approved oral finasteride tablets. Should this version of finasteride ever become FDA-approved, it will likely be very popular as topical finasteride is less likely to cause the systemic side effects that occur after taking the oral medication.(7)

What Is Laser Hair Therapy?

Laser hair therapy, more commonly referred to as low-level laser therapy or LLLT, involves the use of FDA-approved laser hair growth devices. Laser hair therapy devices are available in a variety of shapes and sizes. The FDA has approved laser comb, brush cap, helmet, and a hood-type devices that people can wear or apply to their head.

While the exact way these devices work is still unknown, many scientists suggest that the laser increases stem cell activity, and encourages hair follicles to become more active.(8) FDA-approved laser hair growth studies show these devices ideally need to be used for around 6 to 12 months in order for hair growth to improve. Treatments can be performed daily, but in some cases, may only be needed 3-4 times a week.(8-10)

Laser hair therapy treatments have very few side effects and can be used by both men and women. Side effects include redness, skin hyperpigmentation, and potential hair growth in unwanted areas (particularly when devices are not used carefully).(8-10)

Another downside to laser hair therapy is the cost involved. Treatments at clinics can come at a premium, while the cost of home devices range from hundreds to thousands of dollars. This makes this hair loss treatment much more costly than minoxidil or finasteride.(17)

Is Dutasteride FDA-Approved?

Dutasteride, also known as Avodart or Duagen, is not an FDA-approved hair loss drug. However, this medication is approved to treat prostate issues. It is also approved as a hair loss treatment for men in Japan and Korea. Similar to finasteride, dutasteride is a DHT blocker. However, it’s stronger than finasteride and will also stay in the person’s system for longer durations.(11,12)

Dutasteride is usually taken orally as a 0.5 milligram dose. People taking this medication can expect to see results after 3 or 4 months. Dutasteride has been shown to be an effective hair regrowth medication for people with androgenic alopecia and has long-lasting results, reducing DHT levels in the scalp by up to 51 percent.(11,12)

As a DHT blocker, dutasteride has similar side effects to finasteride. However, since the medication circulates in the body for longer, it can potentially be taken less frequently. (18) This may make it more convenient and tolerable for people using the medication.   

When Will Dutasteride Be FDA-Approved for Hair Loss?

Right now, it’s unknown if or when Avodart will have FDA approval for hair loss. Even though it’s gone through some clinical trials, there is currently no indication as to when the FDA may approve it as a hair loss treatment.

Are There FDA-Approved Hair Growth Vitamins or Supplements?

There currently no FDA-approved hair supplements or vitamins available. Many supplements have been shown to help people with thinning hair and different types of alopecia. However, in most successful studies, hair growth supplements are being used to treat a deficiency. It is not known how much they can help healthy individuals with androgenic alopecia.(19,20)

There are many different supplements commonly sold as hair regrowth products. Among these different supplements, you can find products containing amino acids, anti-oxidants, essential nutrients, nutraceutical DHT-blockers, and many other ingredients. 

As natural products, these ingredients are considered supplements and are not regulated by the FDA in the same way medications are. This means that some of these ingredients, like the vitamin biotin, have very little data showing they can be used effectively for hair loss. Other nutraceutical ingredients have been shown to help with hair loss, but are generally considered to be less effective than FDA-approved hair loss products.(13,14)

Is There an FDA-Approved Shampoo for Hair Loss?

There are currently no FDA-approved hair growth shampoos sold for androgenic alopecia. However, there are other FDA-approved products that can help with hair loss. One of these products, ketoconazole, is not approved as a treatment for pattern hair loss, but it is FDA-approved to treat skin and scalp issues, like dandruff. This product has been shown to help treat androgenic alopecia and can be used alongside FDA-approved hair loss treatments.(15)

Ketoconazole is sold in many different forms. It comes in a shampoo form, cream, jelly, and foam. It’s available in 1 and 2 percent concentrations. The 1 percent formula is available as an over-the-counter medication, while the 2 percent formula is available only as a prescription.(15)

Other shampoo ingredients which may help treat hair loss are caffeine, ginseng, green tea, and licorice.(16) Since many of these are natural products, they’re considered supplements. This means that they aren’t subject to FDA approval, which is also why there isn’t as much research about their effectiveness.(14)

What Is the Best FDA-Approved Hair Loss Treatment?

Minoxidil and laser hair therapy are both FDA-approved for men and women, making them more inclusive than finasteride. Both treatments have minimal side effects localized to the area they have been applied.

Minoxidil has a low up-front cost compared to laser hair therapy devices or laser hair treatment sessions at a clinic. However, LLLT doesn’t need to be applied daily, making it more convenient for people who don’t have the time or are unwilling to incorporate their hair loss treatment into their daily routine.



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Published on February 14, 2023

Last updated February 2023

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