Hair Loss
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This article summarizes published evidence — FDA-approved drug labeling, FDA safety communications, FDA device guidance, and published randomized trials and meta-analyses, each cited below. It is written by journalists, not clinicians, and has not been reviewed by a physician. Talk to a doctor or a board-certified dermatologist before starting or stopping any treatment. Full medical disclaimer.
Most hair loss coverage online is written by companies that sell hair loss products. This section is not. Every product mentioned across these nine guides carries a badge showing its actual regulatory status — because the difference between FDA-approved and FDA-cleared and compounded is the single most useful thing to know before you spend anything, and it is the thing almost nobody puts on the page.
What the status labels on this page mean
- FDA-approved
- The FDA reviewed the evidence and approved this drug for pattern hair loss.
- FDA-cleared
- Allowed on the market through the 510(k) route because it is judged similar to a device already sold — not the same as the FDA independently approving its effectiveness.
- Off-label
- An FDA-approved drug being prescribed for something other than what it was approved for. Legal and common, but the hair loss use has not been through FDA review.
- Compounded
- Mixed to order by a pharmacy. Not FDA-approved, and not reviewed by the FDA for safety, effectiveness or quality.
- Supplement
- A dietary supplement. The FDA does not approve supplements before they go on sale, and claims about them are not FDA-evaluated.
What this section is built on
- Only two treatments are FDA-approved for pattern hair loss: topical minoxidil[2] and oral finasteride[1]. Everything else is cleared, off-label, compounded or a supplement.
- FDA-cleared devices went through a comparative review against an existing product. FDA-approved drugs went through an independent evaluation of safety and effectiveness. The FDA states this distinction itself.[3]
- There is no FDA-approved topical finasteride. The agency issued a safety alert about compounded versions on 22 April 2025.[4]
- The approved oral drug produced +107 hairs versus placebo at twelve months in a 1,553-man randomized trial[5] — and costs about $117 a year as a generic with a pharmacy coupon.[6]
Start here
Nine guides, ordered by the question they answer rather than by search volume.
| Guide | Answers | Read it if |
|---|---|---|
| What hair loss treatment actually costs per year | Eighteen routes priced over twelve months, including the fees that never appear on a pricing page | You want to know what you are about to spend, and on what regulatory category |
| How finasteride and minoxidil work | The mechanism of both approved drugs, and what the original trials measured | You want to understand what the drugs do before deciding whether to take them |
| The Norwood and Ludwig scales | Every stage described from the original papers, with drawn diagrams | You are not sure how far along you are, or whether treatment still applies |
| Minoxidil: foam, liquid or oral | Why foam versus liquid is the smallest question, and why the tablet is a different category entirely | You are choosing a minoxidil format, or considering the oral form |
| Oral vs topical finasteride | The phase III head-to-head trial, and the FDA alert about compounded topicals | You have been offered a topical spray and want to know what it is |
| Side effects: what the data shows | Rates from the FDA label and a 4,495-man meta-analysis[8], plus what a JAMA Dermatology review said about trial quality | You want the real numbers rather than either reassurance or alarm |
| Female pattern hair loss | The one approved treatment, why finasteride failed its trial in women, and postpartum shedding | You are a woman, or advising one, and the male playbook does not fit |
| Hims vs Keeps vs Ro vs XYON vs Strut | Five subscriptions on price, billing, hidden fees and regulatory status | You are comparing services and want the fees below the headline |
| Laser caps and low-level laser therapy | Two meta-analyses, the cleared-versus-approved distinction, and the refund terms that decide the purchase | You are considering a device costing $499 to $1,799 |
The badge system, and why it exists
Five words get used interchangeably in hair loss marketing, and they mean five different things. We put the right one next to every product, every time it appears.
| Badge | What it means | Example |
|---|---|---|
| FDA-approved | The FDA independently evaluated this product for safety and effectiveness for this use | Topical minoxidil 5%[2]; oral finasteride 1 mg[1] |
| FDA-cleared | A device shown to be substantially equivalent to one already on the market — a comparative standard, not an independent one[3] | Home-use laser caps and combs |
| Off-label | An FDA-approved drug prescribed for a use the FDA did not evaluate. Legal and common; not the same as approved for this | Low-dose oral minoxidil for hair; spironolactone |
| Compounded | Mixed to order by a pharmacy against an individual prescription. No FDA-approved labeling, no agency review of the formulation[4] | Topical finasteride sprays and gels |
| Supplement | Regulated as food. Not evaluated by the FDA for treating any condition | Nutrafol, saw palmetto, biotin |
What we will not do
We will not put an efficacy number next to a product that has not been tested, however plausible the mechanism sounds.
We will not quote a price we have not read on the seller’s own page. Where a company hides its prices behind a quiz or blocks automated access, our articles say so rather than borrowing a figure from a competitor’s blog.
We will not describe a compounded or cleared product with language reserved for approved ones. US advertising rules put responsibility for health claims on affiliates as well as advertisers[7], and the distinction matters to readers more than it matters to regulators anyway.
Where a figure is our own arithmetic on cited numbers rather than a number we read in a source — an annual total built from a monthly price, for example — we label it our calculation rather than dressing it as a citation.
We will not present ourselves as physician-reviewed. These pages are an evidence synthesis with a citation on every figure. Where a question needs clinical judgement about you specifically, we say so and stop.
Almost every route starts with a prescriber
Finasteride is prescription-only. So is oral minoxidil. So is every compounded topical. The cheapest documented route — a generic filled with a pharmacy coupon — needs one too. Sesame Care is a US marketplace that lists consultation prices upfront in cash, including hair loss visits.
Sesame Care is a US telehealth marketplace that lists upfront cash prices for appointments. The link below is an affiliate link: if you book, we may earn a commission at no extra cost to you.
See hair loss consultation prices →Frequently asked questions
What hair loss treatments are actually FDA-approved?
Two: topical minoxidil and oral finasteride. Minoxidil is approved over the counter for both men and women; finasteride is approved for men and its label states it is not indicated for use in women. Everything else sold for hair loss falls into one of three other categories – FDA-cleared devices, approved drugs used off-label, or compounded products and supplements that carry no FDA approval at all.
Where should I start?
With what you are trying to answer. If you want to know what things cost, start with the annual cost breakdown. If you want to know whether the drugs are safe, start with the side effects article. If you are not sure whether what you have is pattern hair loss at all, start with the Norwood and Ludwig scales.
Is this site medically reviewed?
No, and we say so on every article. These pages are an evidence synthesis: they report what FDA-approved labels, published randomized trials and meta-analyses say, with a citation on every figure, and they avoid claims that would require clinical judgement about an individual. They are not a substitute for a clinician who can look at your scalp.
How do you make money?
Some pages carry an affiliate link to a telehealth marketplace, disclosed at the top of each article. We earn nothing from any of the drug brands, subscription services or device manufacturers we write about, which is why our cost article can conclude that the cheapest route is the one none of them sell.
Sources
- U.S. Food and Drug Administration. PROPECIA (finasteride) tablets, prescribing information. 2022. accessdata.fda.gov
- U.S. Food and Drug Administration. Women’s ROGAINE 5% Minoxidil Topical Aerosol, Drug Facts label. 2019. accessdata.fda.gov
- U.S. Food and Drug Administration. Medical device safety and the 510(k) clearance process. fda.gov
- U.S. Food and Drug Administration. FDA alerts health care providers, compounders and consumers of potential risks associated with compounded topical finasteride products. 22 April 2025. fda.gov
- Kaufman KD, Olsen EA, Whiting D, et al. Finasteride in the treatment of men with androgenetic alopecia. J Am Acad Dermatol. 1998;39(4 Pt 1):578-589. PMID 9777765.
- GoodRx. Finasteride prices and coupons. goodrx.com (checked 8 September 2026)
- Federal Trade Commission. Health Products Compliance Guidance. December 2022. ftc.gov
- Lee S, Lee YB, Choe SJ, Lee WS. Adverse sexual effects of treatment with finasteride or dutasteride for male androgenetic alopecia: a systematic review and meta-analysis. Acta Derm Venereol. 2019. medicaljournals.se
Affiliate disclosure: this page contains affiliate links. We may earn a commission when you buy through them, at no additional cost to you. Commissions never determine what we cover or what the evidence sections say. Read our full affiliate disclosure.
How we researched this: every figure on this page is sourced to a numbered reference below. For this article those sources are FDA-approved drug labeling, FDA safety communications, FDA device guidance, published randomized trials and meta-analyses, and FTC advertising guidance. Where a figure could not be verified from a primary source, we say so in the text rather than estimating. Prices were checked on the date shown at the top of this page and change frequently. We do not test products and we do not practice medicine. See our review methodology.