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minoxidil

Sold as Regoxidine, Rogaine. Class: Pyrimidine derivatives. First FDA approval 10/18/1979: 47 years on the US market.

This grade answers one narrow question: how strong is the public evidence and safety record behind this drug, and how clean is its money trail and court record? It is not a verdict on whether the drug is right for you.

B

Score breakdown (76/100)

Safety ×35%
B
Evidence ×25%
F
Regulatory ×15%
A
Money & lawsuits ×15%
A
Options ×10%
C

Safety: 80

Evidence: 46

Regulatory history: 96

Money & lawsuits: 100

Options: 70

What the FDA label says

Approved uses

Use to regrow hair on the top of the scalp (vertex only, see pictures on side of this carton)

Contraindications

None listed.

Warnings and precautions

Warnings For external use only. For use by men only. Extremely Flammable Avoid fire, flame, or smoking during and immediately following application. Do not Use if you are a woman your amount of hair loss is different than that shown on side of this carton or your hair loss is on the front of the scalp. 5% minoxidil topical foam is not intended for frontal baldness or receding hairline. you have no family history of hair loss your hair loss is sudden and/or patchy you do not know the reason for your hair loss you are under 18 years of age. Do not use on babies and children. your scalp is red, inflamed, infected, irritated, or painful you use other medicines on the scalp Ask a doctor before use if you have heart disease When using this product do not apply on other parts of the body avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water. some people have experienced changes in hair color and/or texture it takes time to regrow hair. Results may occur at 2 months with twice a day usage. For some men, you may need to use this product for at least 4 months before you see results. the amount of hair regrowth is different for each person...

Adverse reactions (label)

Not available.

Source: FDA SPL label for Mens rogaine Minoxidil Unscented Formula (Kenvue Brands LLC), effective 20241111. Full label on DailyMed.

Side-effect reports sent to the FDA

These are counts of reports people filed, not rates of harm. Anyone can file one, and nobody checks whether the drug was the cause. Millions of doses are taken for every report sent, so the useful part is how this drug compares with the average across all drugs.

66,040reports that mention this drug
66,025of those blame this drug, not another one the person was taking
7%of reports describe a serious outcome, such as a hospital stay (average for all drugs: 57%)
0.5%of reports include a death, from any cause (average for all drugs: 9.1%)

Problems reported most often

Drug Ineffective · 10,687Adverse Drug Reaction · 8,614Alopecia · 7,594Product Use Issue · 5,463Off Label Use · 5,232Application Site Pruritus · 3,809Product Use In Unapproved Indication · 2,684Intentional Product Misuse · 2,583Pruritus · 2,545Overdose · 2,435Hair Texture Abnormal · 2,375Incorrect Dose Administered · 2,279Inappropriate Schedule Of Drug Administration · 2,135Wrong Technique In Product Usage Process · 2,080Inappropriate Schedule Of Product Administration · 1,996

Reports per year

20192020202120222023202420252026
4,4345,0077,2999,5257,1944,8643,7281,325

16,423 reports blaming this drug for every million Medicare prescriptions filled, which is 5.9× the typical drug on this site. (9,913 reports in 2024–2026, against 603,619 Medicare fills in one year. This is the one number here that accounts for how many people take the drug.)

Source: the FDA's Adverse Event Reporting System (FAERS). Reports are voluntary and unverified. Drugs that are prescribed a lot, in the news, or in lawsuits attract more reports, so the percentages are compared with the whole database to correct for that partly, not fully.

Recalls and regulatory record

0recall actions on file
4 / 28brand / generic applications
3label changes since 2021
NoREMS program

Evidence base

151randomized trials (PubMed)
35systematic reviews
111registered trials
22%of completed trials posted results
5%terminated or withdrawn
37%industry-funded

Counts measure how much evidence exists and how transparent it is, not how big the benefit is. For that, ask your prescriber: if 100 people like me took this, how many would get better because of it, and how many would be harmed? (Doctors call these the "number needed to treat" and "number needed to harm.") It differs by condition and is the number drug ads leave out. Sources: PubMed, ClinicalTrials.gov.

Money and lawsuits

In 2024, drug companies reported $0 in payments to US physicians and hospitals tied to this drug across 0 transactions.

No pending federal MDL names this drug or its brands.

Not named in any federal pharmaceutical settlement of $100M or more on record.

Sources: CMS Open Payments (Sunshine Act); Judicial Panel on Multidistrict Litigation pending docket list; DOJ settlements as tabulated on Wikipedia with links to the primary record. State-court and individual suits are not included.

Who takes it and what it costs

178,019Medicare Part D patients (2024)
603,619prescriptions filled
$15average cost per fill
$9Mtotal Medicare spend

Same-class alternatives

No same-class alternatives found in RxClass.

Questions to ask your prescriber

  1. The most-reported problems in FDA's adverse event data are adverse drug reaction, alopecia, product use issue. How would we recognize and handle those?
  2. Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?
  3. What result are we expecting, by when, and what is the plan if it does not happen?
  4. If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)