For pattern hair loss, the FDA has approved topical minoxidil and oral finasteride (men only). Spironolactone and oral minoxidil are used off-label, and compounded topical blends are not FDA-approved. Here is how the categories differ.
For the most common type of hair loss, pattern hair loss, the FDA has approved two medications: topical minoxidil, sold without a prescription, and oral finasteride, a prescription tablet approved for men only. Several other treatments, including spironolactone and low-dose oral minoxidil, are prescribed off-label, meaning the drug is FDA-approved for a different condition. Compounded formulas, such as topical blends that combine several ingredients, are a third category entirely: they are not FDA-approved at all. Knowing which bucket a treatment falls into helps you ask better questions about the evidence behind it.
These three terms describe regulatory status, not how well a treatment works for you.
| Treatment | Approved for | Notes from the labeling |
|---|---|---|
| Topical minoxidil (2% and 5%) | Hereditary hair loss on the top of the scalp | Available without a prescription; the men's foam is labeled for the crown (vertex), not a receding hairline |
| Oral finasteride (Propecia) | Male pattern hair loss in men only | Not indicated for women; contraindicated in pregnancy |
| Oral baricitinib (Olumiant) | Severe alopecia areata in adults | A JAK inhibitor; carries infection and other warnings |
The AAD describes minoxidil as able to stimulate growth and prevent further loss in early hair loss, while noting it cannot regrow an entire head of hair. The men's 5% foam label states that results may appear at 2 months, that some men need at least 4 months, and that it will not work for everyone. The AAD says most people need about 6 to 12 months to judge results, and that stopping leads to the benefit fading. We cover timelines in more depth in our article on topical hair regrowth treatments.
According to its prescribing information, finasteride blocks the enzyme that converts testosterone to DHT. The label states that daily use for three months or more is generally needed before benefit is seen, and that stopping reverses the effect within 12 months. It also lists sexual side effects and a decrease in PSA test results. Our finasteride explainer walks through the label in detail.
Alopecia areata is a different condition: the immune system attacks hair follicles, often causing patchy hair loss. In its 2022 announcement, the FDA described baricitinib as the first systemic treatment approved for severe alopecia areata. In one of the two pivotal trials, 35 percent of patients on the higher dose and 22 percent on the lower dose reached at least 80 percent scalp coverage at week 36, compared with 5 percent on placebo.
Spironolactone is a diuretic that, according to the AAD, has been prescribed for decades to treat hair loss. The AAD notes it is a common treatment for female pattern hair loss and cites studies suggesting it helps about 40 percent of women; in one study of 166 women, 42 percent reported mild improvement and 31 percent reported increased thickness. The AAD stresses that it can cause birth defects, so pregnancy must be avoided while taking it. Our article on hair thinning in women covers this in more depth.
Minoxidil was first approved by the FDA in 1979 as an oral medication for severe, hard-to-control high blood pressure, so using low doses for hair is off-label. A 2021 study in the Journal of the American Academy of Dermatology reviewed 1,404 patients treated this way. The most common side effect was unwanted hair growth elsewhere on the body (15.1 percent). Systemic effects included lightheadedness (1.7 percent), fluid retention (1.3 percent) and a fast heart rate (0.9 percent), and 1.7 percent stopped because of side effects. The authors note the study was retrospective and had no control group, so it describes safety in practice rather than proving effectiveness.
Some compounded hair products combine several ingredients in one topical solution, for example minoxidil with finasteride and a retinoid. Combination formulas like these are not FDA-approved, and the FDA notes there are no FDA-approved topical products containing finasteride.
In 2025, the FDA issued an alert about compounded topical finasteride after receiving 32 adverse event reports between 2019 and 2024. The reported effects were consistent with those of oral finasteride and included erectile dysfunction, decreased libido, anxiety, depression and suicidal thoughts; most reports said the effects persisted after the product was stopped. The FDA also noted that topical finasteride poses a greater risk of accidental transfer to others, especially to women who are or may become pregnant, because unlike coated tablets, a topical product has no protective coating.
NewDay Wellness offers a compounded, finasteride-free hair regrowth spray (minoxidil 7%, tretinoin, fluocinolone, biotin and melatonin). Like every compounded product, it is not FDA-approved. Finasteride, oral or topical, is not offered through NewDay at this time.
The AAD notes that laser combs, helmets and caps are sold for home use and that a few studies show promise, though not everyone responds and long-term safety is still unknown. It describes platelet-rich plasma (PRP) injections as early-stage, with more research needed, and notes that most supplements studied for hair have not shown an effect.
The AAD notes that prescribing FDA-approved medications for other conditions is common, but it means the specific use has not gone through FDA review for that condition. A prescriber weighs the published evidence and your health history. Ask what studies support the use and what monitoring, if any, is recommended.
Finasteride is not indicated for women, and the label lists pregnancy as a contraindication because of risk to a male fetus. In a study described in the label, it did not improve hair in postmenopausal women. The AAD notes that some dermatologists prescribe it off-label for women with hereditary hair loss who cannot become pregnant.
As the AAD puts it, hair grows slowly, so it takes time to see results. The finasteride label points to three months or more of daily use, the men's minoxidil foam label points to 2 to 4 months, and the AAD suggests 6 to 12 months before judging whether a treatment works for you.
The benefits generally fade. The finasteride label says stopping reverses the effect within 12 months, and the AAD notes that stopping minoxidil leads to more shedding and loss of the hair it helped maintain.
The right option depends on the type of hair loss you have, your sex, your plans for pregnancy, your other medications and how you feel about daily treatment. A licensed provider can confirm the diagnosis, explain the evidence for each category and set dosing if a prescription is appropriate. You can explore options on our Hair & Skin page. This article is educational and does not determine eligibility for any treatment.
Written by the NewDay Wellness editorial team from the sources above and checked against them before publication, and medically reviewed by Dr. Sean Arora and Dr. Shannon Arora of Arora Health & Aesthetics; see our editorial standards. This article is educational and does not diagnose conditions, establish eligibility for any medication, or replace care from a licensed provider. Compounded medications are not FDA-approved.
The most common cause of thinning hair in women is female pattern hair loss, a hereditary condition that often begins in midlife. Shedding after childbirth or illness, thyroid problems and anemia can look similar, so diagnosis comes first.
Read articleTopical minoxidil labels say results may appear at 2 to 4 months for men and 3 to 6 months for women, and the AAD suggests 6 to 12 months to judge. A brief shed early on is common, and benefits last only with continued use.
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