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Minoxidil

Minoxidil is an active ingredient used in oral tablets to treat severe high blood pressure and in topical products to regrow hair on the scalp.

Brand names LonitenRogaineRegoxidinehair regrowth treatmentgood sense hair regrowth treatment +11 more
Drug class Arteriolar Vasodilator
Rx/OTC Forms 6
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 268 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 5, 2026
Other forms & routes:
Minoxidil at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Minoxidil widens blood vessels and does two very different jobs, as a last-resort tablet for severe high blood pressure and as the familiar scalp treatment (Rogaine and many store brands) for hair regrowth, on the market since the late 1980s and available generically. The scalp products are well tolerated and work only with continued twice-daily use, while the tablets commonly cause swelling, a faster heartbeat and unwanted hair on the face and body. The tablets carry a boxed warning for fluid around the heart (pericardial effusion) and worsening chest pain (angina), so they are always paired with a water pill and a beta-blocker under close monitoring.

Clinical pearls

  • Use topical minoxidil on the scalp only, and know that applying more or more often will not speed regrowth.
  • Apply it to a clean, dry scalp and wash your hands afterward.
  • On the tablets, report rapid weight gain, new swelling, chest pressure or shortness of breath right away.
  • Guanethidine plus minoxidil tablets can drop blood pressure sharply on standing, so guanethidine is ideally stopped first.
How you get itPrescription and over the counter
Comes asTopical solution, Inhaler, Tablet +3
Earliest FDA record1979
Companies listing it with the FDA110
FDA label last updatedAug 27, 2021
FDA’s strongest warning (boxed)None on the label

Patient information guide A plain-language walkthrough of Minoxidil, written from its FDA label.

What Minoxidil is used for

▾

Minoxidil is used in two very different ways depending on the form — oral tablets for blood pressure, and topical products for hair regrowth.

  • MINOXIDIL oral tablets treat severe high blood pressure (hypertension) that hasn't responded adequately to other medications
  • Topical solutions, gels, sprays, and foams are used to regrow hair on the top of the scalp (vertex area)
  • Bosley MD Regular Strength for Women topical solution is indicated for hair regrowth in women
  • Bosley MD Extra Strength for Men topical solution is indicated for men's hair regrowth
  • Dizop Minoxidil Topical Gel is a hair regrowth treatment specifically for men
  • RIZE Hair Regrowth Treatment for Men 5% topical spray is used to regrow hair on the top of the scalp in men
  • Axelofein and Azelomax Forte topical solutions are used to regrow hair on the top of the scalp

How Minoxidil works

▾

Oral minoxidil works by directly relaxing the walls of small arteries (peripheral vasodilation), which lowers the resistance blood has to push against and brings blood pressure down. This drop in resistance triggers the body's natural defenses — the heart beats faster, output increases, and the kidneys hold onto salt and water — which is why companion medications like a beta-blocker and a diuretic are almost always needed alongside it.

Minoxidil is absorbed well from the gut, doesn't bind to blood proteins, and doesn't cross into the brain. It's processed mainly by the liver and cleared by the kidneys. The blood pressure–lowering effect can last up to about 75 hours after a single dose.

Minoxidil dosage

▾

Oral minoxidil tablets are taken by mouth once or twice daily, with or without food, always alongside a diuretic and a beta-blocker as prescribed. Topical minoxidil products are applied directly to the scalp — not swallowed. Most topical formulations are used twice a day. Do not use more than directed; more product does not mean better results.

  • Topical solutions and sprays: typically 1 mL applied to the scalp twice daily
  • Using the product more often or in larger amounts will not speed up hair regrowth
  • Hair regrowth requires continued use — stopping will likely cause hair loss to return

Always follow your prescriber's instructions and the specific product labeling for your form of minoxidil.

Dosing details from the FDA-approved label

From the Minoxidil prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Minoxidil Topical Solution 2% (hair loss, scalp)
    • Apply one mL with dropper 2 times a day directly onto the scalp in the hair loss area
    • using more or more often will not improve results; continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again
  • Minoxidil Topical Solution, 5% (hair loss, scalp)
    • Apply one mL with dropper 2 times a day directly onto the scalp in the hair loss area
    • using more or more often will not improve results; continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again
  • Minoxidil spray products (hair loss, scalp)
    • Prime the sprayer by pumping 5 times
    • Apply one mL with spray (6 sprays) 2 times a day directly onto the scalp in the hair loss area
    • do not inhale mist; using more or more often will not improve results; continued use is necessary to keep hair regrowth
Read the label’s full dosing text

Directions • apply one mL with dropper 2 times a day directly onto the scalp in the hair loss area • using more or more often will not improve results • continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again

Read the full Dosage and Administration section on DailyMed →

Minoxidil side effects

▾

Side effects vary significantly depending on whether you're taking oral tablets or using a topical product.

Common side effects

  • Fluid retention or swelling (edema)
  • Increased heart rate
  • Unwanted hair growth on the face, arms, legs, or back (hypertrichosis) — mainly with oral use
  • Worsening or new chest pain (angina)
  • Changes in hair color or texture (topical use)
  • Skin rash
  • Weight gain from fluid retention
  • Skin rash; rarely, serious skin reactions including blistering (toxic epidermal necrolysis) or Stevens-Johnson Syndrome
  • Low platelet or white blood cell counts (thrombocytopenia, leukopenia) — with oral use

When to get medical help

  • Call your doctor right away if you notice rapid weight gain, swelling, or difficulty breathing — these may be signs of fluid buildup or heart failure
  • Get medical help immediately if you have chest pain or worsening angina
  • Seek care urgently if you notice symptoms of pericardial effusion (fluid around the heart): chest pressure, shortness of breath, or irregular heartbeat
  • Tell your doctor immediately if you experience dizziness when standing up, especially if you also take guanethidine
  • Serious skin reactions have rarely occurred — seek care if you develop a severe rash, blistering, or skin peeling
  • Contact your doctor if you notice signs of very low blood pressure: fainting, extreme dizziness, or feeling faint

Minoxidil warnings and precautions

▾
  • Fluid buildup and heart failure risk (oral tablets): Minoxidil causes the body to retain salt and water. Without a diuretic, dangerous fluid accumulation can occur within days. Monitor weight closely and report sudden gains to your doctor.
  • Increased heart rate and angina (oral tablets): Minoxidil speeds up the heart, which can worsen or trigger chest pain. A beta-blocker is almost always required to prevent this.
  • Fluid around the heart (pericardial effusion/tamponade): Occurs in about 3% of patients on oral tablets who are not on dialysis. Can become life-threatening. Report any chest pressure or breathing difficulty immediately.
  • Severe blood pressure drop with guanethidine: Taking oral minoxidil with guanethidine can cause dangerous low blood pressure when standing up (orthostatic hypotension). Guanethidine should be stopped before starting minoxidil if at all possible.
  • Too-rapid blood pressure lowering: In patients with very severe high blood pressure, dropping it too quickly can cause stroke, heart attack, or vision/hearing loss. First doses should be given in a hospital for high-risk patients.
  • Unwanted hair growth (hypertrichosis): About 80% of people on oral minoxidil develop extra hair growth on the body. Women and children should be informed about this before starting treatment.

Minoxidil interactions

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The label specifically identifies one key drug interaction with oral minoxidil tablets, but other blood pressure medications should always be discussed with your prescriber.

  • Guanethidine: Combining oral minoxidil with guanethidine (a blood pressure drug) can cause a severe, dangerous drop in blood pressure when standing up (orthostatic hypotension). Guanethidine should ideally be stopped well before starting minoxidil. If it can't be stopped, treatment must begin in a hospital.

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

Before taking Minoxidil

▾
  • Do not use oral minoxidil tablets if you have pheochromocytoma (an adrenal gland tumor that raises blood pressure) — it is contraindicated
  • Do not use if you have a known allergy to minoxidil or any ingredient in the product
  • Tell your doctor if you have heart disease, heart failure, or kidney disease — close monitoring is essential
  • Patients with malignant (very severe) hypertension must start oral minoxidil in a hospital setting
  • Women and children should be fully informed about the high likelihood of unwanted hair growth (hypertrichosis) with oral minoxidil before starting treatment
  • Tell your doctor about all medications you take — especially guanethidine or other blood pressure drugs
  • For topical products: do not apply to broken or irritated skin, avoid contact with eyes, and do not apply to parts of the body other than the scalp

Minoxidil overdose

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Overdose with oral minoxidil tablets mainly causes severely low blood pressure. If this happens — especially in someone also taking guanethidine or similar drugs — intravenous fluids (normal saline) can help stabilize blood pressure and support kidney function. Stimulant medications like epinephrine or norepinephrine should be avoided in overdose because they overstimulate the heart; other agents such as dopamine or phenylephrine may be used only when a vital organ is not getting enough blood flow.

What Minoxidil does in the body

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Oral minoxidil lowers both systolic and diastolic blood pressure by relaxing the walls of peripheral arteries, reducing the resistance the heart pumps against. Blood pressure typically starts to fall within 30 minutes of an oral dose, reaches its lowest point in 2–3 hours, and the effect can last about 75 hours. The body responds to this drop in pressure by releasing signals that increase heart rate, cardiac output, and salt and water retention — effects that must be managed with companion medications.

How your body processes Minoxidil

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Oral minoxidil is at least 90% absorbed from the gut, with peak blood levels reached within the first hour. Its average half-life in the body is about 4.2 hours. About 90% of the drug is broken down (metabolized) — primarily in the liver — and the byproducts are cleared through the urine. Minoxidil does not bind to blood proteins and does not cross the blood-brain barrier. In people without functioning kidneys, minoxidil and its breakdown products can be removed by hemodialysis.

How to store Minoxidil

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store at 20 ° to 25 ° C (68 ° to 77 ° F).

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

139

Supplements & herbs that interact with Minoxidil

139 supplements and herbal products have documented interactions with Minoxidil in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 4
  • Moderate · 113
  • Minor · 22
Every supplement checked against Minoxidil — ranked by severity The full interaction hub: 4 major · 113 moderate · 22 minor · every one linked to its full report. Check Minoxidil against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

1

Nutrient depletion considerations

Minoxidil has been associated with lower levels of 1 nutrient in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.

See the full Minoxidil nutrient depletion report

Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.

Minoxidil: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Minoxidil — the kind of thing our pharmacy team would talk through with you at the counter.

Can I use the topical minoxidil solution on my beard or other areas, not just my scalp?

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The topical products in the label are specifically approved for hair regrowth on the top of the scalp only — not for use on other parts of the body. Applying it elsewhere isn't recommended based on the product labeling. Stick to the scalp area and follow the directions for your specific product.

How long does it take to see results with topical minoxidil?

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Hair regrowth takes time and patience. Some people start to see results after about 2 months of twice-daily use, but for others it may take 4 months or more. Not everyone responds the same way, and this product won't work for everyone. The key is consistent, continued use — stopping it will likely cause any regrown hair to fall out again.

Why do I need to take a diuretic and a beta-blocker with the oral minoxidil tablet?

▾
Oral minoxidil is very effective at lowering blood pressure, but it causes two significant side effects on its own — it makes your heart beat faster and it causes your body to hold onto salt and water. The beta-blocker controls the heart rate increase, and the diuretic (water pill) flushes out the extra fluid. Without these companion drugs, you'd be at real risk of fluid buildup, swelling, or worsening heart problems. Your doctor will manage all three together.

I heard oral minoxidil can cause extra hair growth on my body — is that true?

▾
Yes, this is a very common side effect with oral minoxidil tablets — about 80% of people who take them notice increased hair growth on the face, arms, back, and legs. It usually appears within 3 to 6 weeks of starting. It's not a hormonal problem, just an effect of the drug. If you stop taking it, the extra hair growth stops and reverses over 1 to 6 months. This effect is particularly worth knowing about upfront if you're a woman or a child.

Is it safe to just stop using topical minoxidil whenever I want?

▾
You can stop using it, but you should know that any hair you've regrown is likely to fall out again once you do. There's no dangerous withdrawal effect from stopping the topical products — it's just that the regrowth depends on continued use. If you're considering stopping, it's worth a conversation with your doctor or pharmacist about what to expect.

What warning signs should make me call my doctor right away while taking oral minoxidil?

▾
Call your doctor immediately if you notice sudden weight gain, swelling in your legs or feet, shortness of breath, or chest pressure — these can be signs of dangerous fluid retention or fluid around the heart. Also call if you develop chest pain (angina) or feel extremely dizzy when you stand up. These are serious warnings on this medication that need prompt attention.

Is Minoxidil available over the counter?

▾
Both. Some Minoxidil products are sold over the counter and others need a prescription. According to their FDA listings, the topical solution, inhaler, topical cream, ointment or gel and topical spray forms are sold over the counter and the tablet form needs a prescription. The package says which kind you have. Your pharmacist can tell you which product is right for you.

When was Minoxidil first available?

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The earliest FDA record we hold for Minoxidil is from 1979: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Minoxidil was first used.

Who makes Minoxidil?

▾
110 companies currently list Minoxidil products in the FDA's NDC Directory, including Bryant Ranch Prepack, Laboratorio Mk Srl, Amazon.com Services LLC. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Minoxidil on HelloPharmacist

Detailed data & references for Minoxidil Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Minoxidil forms and strengths (how it comes)

Minoxidil is available in 6 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Topical solution

On the skin
Brands Basic Care Hair Regrowth Treatment Equate Hair Regrowth Treatment Good Sense Hair Regrowth Treatment Hair regrowth treatment Kirkland Signature Minoxidil Members Mark Hair Regrowth Treatment Minoxidil Hair Regrowth Treatment Womens Rogaine Unscented
How this form is used
What it may be used for
  • Used to regrow hair on the top of the scalp (vertex area only)
  • Bosley MD Regular Strength for Women topical solution is used for hair regrowth in women
  • Bosley MD Extra Strength for Men topical solution is used for hair regrowth in men
  • Axelofein and Azelomax Forte topical solutions are used to regrow hair on the top of the scalp
Important instructions
  • Apply 1 mL with a dropper or sprayer (6 sprays) directly onto the scalp twice a day
  • Do not apply to other parts of the body; avoid contact with eyes
  • Using more or using it more often will not improve results
  • Continued use is necessary — stopping the product will likely cause hair loss to return
Available strengths 18 strengths
Show 12 more strengths Show fewer strengths
180 FDA-listed product records ⓘ

Inhaler

Inhaled · On the skin
Brands Basic Care Hair Regrowth Treatment Equate Hair Regrowth Treatment Good Sense Hair Regrowth Treatment Hair Regrowth Treatment Hers Hair Regrowth Treatment Hims Hair Regrowth Treatment Keeps Minoxidil Topical Kirkland Signature Minoxidil Minoxidil For Women Regoxidine Womens Rogaine Unscented
How this form is used
What it may be used for
  • Used to regrow hair on the top of the scalp (vertex only)
Important instructions
  • Apply directly to the scalp in the hair loss area as directed on the product labeling
  • Continued use is necessary to maintain hair regrowth — stopping will likely result in hair loss returning
Available strengths 5 strengths
116 FDA-listed product records ⓘ

Tablet

By mouth
How this form is used
What it may be used for
  • MINOXIDIL tablets treat severe high blood pressure that hasn't responded to other medications
  • MINOXIDIL tablets are reserved for patients who haven't responded to a diuretic plus two other blood pressure drugs
Important instructions
  • MINOXIDIL tablets are taken by mouth, usually once or twice a day
  • MINOXIDIL tablets must almost always be taken with a diuretic and a beta-blocker as directed by your doctor
  • Monitor your body weight closely while taking MINOXIDIL tablets — report sudden weight gain to your doctor
  • Patients with very severe high blood pressure should begin MINOXIDIL tablet therapy in a hospital
Available strengths 2 strengths
76 FDA-listed product records ⓘ

Topical cream, ointment or gel

On the skin
Brands Dizop Minoxidil Topical Gel Hair Serum
How this form is used
What it may be used for
  • Dizop Minoxidil Topical Gel is a hair regrowth treatment for men, used to regrow hair on the top of the scalp
Important instructions
  • Apply topical gel or cream directly to the scalp in the area of hair loss
  • Wash hands thoroughly after applying
  • Do not apply to areas other than the scalp
Available strengths 5 strengths
7 FDA-listed product records ⓘ

Topical spray

On the skin
Brands KERANIQUE Hair Regrowth Treatment For Women
How this form is used
What it may be used for
  • RIZE Hair Regrowth Treatment for Men 5% is used to regrow hair on the top of the scalp (vertex only)
Important instructions
  • RIZE Hair Regrowth Treatment for Men 5%: prime the sprayer by pumping 5 times before first use
  • Apply 1 mL (6 sprays) twice a day directly onto the scalp in the hair loss area; do not inhale the mist
  • Using more or more often will not improve results
  • Continued use is necessary to maintain hair regrowth
Available strengths 3 strengths
6 FDA-listed product records ⓘ

Oral solution

By mouth
Available strengths 1 strength
1 FDA-listed product record ⓘ

Minoxidil on the U.S. market: products, makers and brands

How Minoxidil appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

110 companies list 247 Minoxidil product records with the FDA, mostly as topical solution, inhaler, tablet; the earliest marketing or approval year on record is 1979. Brand names on the directory include Loniten, Rogaine, Regoxidine and 13 more; the rest are generics.

6
Dose forms ⓘ
110
Labelers (makers, repackagers, distributors)
40
Brand names
247
FDA-listed product records ⓘ
1979
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (38) · Kit (1) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Bryant Ranch Prepack4%
Laboratorio Mk Srl4%
Amazon.com Services LLC3%
Scientific Hair Research, LLC3%
CVS Pharmacy2%
Hims Inc2%
Other makers81%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Minoxidil is used (Medicaid data)

A general measure of how commonly Minoxidil is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Minoxidil is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

241,791
Medicaid prescriptions filled (Q1–Q4 2025)
$3M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Minoxidil prescribed? Of the 1,601 medications we measure, Minoxidil ranks #364 by Medicaid prescriptions — more than 77% of them.

Where Minoxidil ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Minoxidil product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 2.5 mg oral tablet is the most-dispensed Minoxidil product — about 94% of these Medicaid prescriptions.

minoxidil 2.5 MG Oral Tablet Most dispensed

227,590 Medicaid prescriptions (Q1–Q4 2025) 94% of Minoxidil prescriptions shown $2.7M gross reimbursement (before rebates) ≈ $12 per prescription (gross)

Summed across the 4 of 32 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 197987

minoxidil 10 MG Oral Tablet

14,190 Medicaid prescriptions (Q1–Q4 2025) 6% of Minoxidil prescriptions shown $257,625 gross reimbursement (before rebates) ≈ $18 per prescription (gross)

Summed across the 4 of 26 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 197986

minoxidil 50 MG/ML Topical Foam

11 Medicaid prescriptions (Q1–Q4 2025) <1% of Minoxidil prescriptions shown $287 gross reimbursement (before rebates) ≈ $26 per prescription (gross)

Summed across the 1 of 158 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 645146

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Minoxidil, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 9 of 216 listed Minoxidil NDCs with Medicaid activity.

Compare Minoxidil products

A representative set of FDA-listed product records for Minoxidil — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 146 of 247 products — FDA National Drug Code Directory. See every product, package size and price: browse all 247 Minoxidil NDCs →

Minoxidil side effects reported to the FDA (FAERS)

After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Minoxidil — a signal of what to watch for, not proof the drug caused it.

The effects most often named in FDA reports that mention Minoxidil are adverse drug reaction, alopecia, application site pruritus; about 11% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.

44,696
Reports mentioning it
11%
Reported as serious
12
Distinct effects shown
Most reported effects
Adverse Drug Reaction
8,585
Alopecia
3,803
Application Site Pruritus
2,926
Overdose
1,461
Application Site Irritation
1,420
Application Site Pain
1,413
Hair Texture Abnormal
1,409
Headache
1,343
Pruritus
1,018
Rash
824
Age groups
Adult · 4,531Elderly · 2,902Adolescent · 35Child · 18Infant · 14Neonate · 3

Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Minoxidil in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.

Minoxidil FDA approval history

How Minoxidil went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.

Minoxidil was first approved by the FDA in 1979 (Brand: LONITEN · Pfizer); the first generic version was approved in 1987. It remains available in U.S. pharmacies today.

1979
Brand approved
Brand: LONITEN · Pfizer
1987
First generic approved
Lower-cost ANDA competition begins
2026
Available today
Active in U.S. pharmacies

Source: Drugs@FDA.

Minoxidil recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list no Minoxidil recalls since July 2021.

✅No Minoxidil recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Minoxidil RxCUI 6984 5 dose forms · 10 strengths
  1. Dose form (SCDF) Oral Tablet RxCUI 372938 In current FDA listings
    Clinical drug / strength (SCD) 2.5 MG RxCUI 197987 5 MG RxCUI 199776 10 MG RxCUI 197986
  2. Dose form (SCDF) Topical Foam RxCUI 645145 In current FDA listings
    Clinical drug / strength (SCD) 20 MG/ML RxCUI 2637880 50 MG/ML RxCUI 645146
  3. Dose form (SCDF) Topical Gel RxCUI 378054 In current FDA listings
    Clinical drug / strength (SCD) 0.05 MG/MG RxCUI 2668433
  4. Dose form (SCDF) Topical Solution RxCUI 372937 In current FDA listings
    Clinical drug / strength (SCD) 20 MG/ML RxCUI 311723 50 MG/ML RxCUI 311724
  5. Dose form (SCDF) Topical Spray RxCUI 1537946 In current FDA listings
    Clinical drug / strength (SCD) 20 MG/ML RxCUI 1537947 50 MG/ML RxCUI 1537948

Look up RxCUI 6984 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

💵 What Minoxidil costs pharmacies (NADAC benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Tablet · Oral 2.5 mg $0.098 per tablet NDC details & price history
Tablet · Oral 10 mg $0.156 per tablet NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Minoxidil brand names

Minoxidil is sold under 16 brand names in the FDA directory — Loniten, Rogaine, Regoxidine, hair regrowth treatment and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Loniten Rogaine Regoxidine hair regrowth treatment good sense hair regrowth treatment equate hair regrowth treatment basic care hair regrowth treatment kirkland signature minoxidil Womens Rogaine Unscented hims hair regrowth treatment hers hair regrowth treatment keeps minoxidil topical Minoxidil For Women members mark hair regrowth treatment Minoxidil Hair Regrowth Treatment KERANIQUE Hair Regrowth Treatment For Women

Who makes Minoxidil: manufacturers and labelers

110 companies list Minoxidil products with the FDA. By number of product records, the largest are Bryant Ranch Prepack, Laboratorio Mk Srl, Amazon.com Services LLC. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Bryant Ranch Prepack 11 Laboratorio Mk Srl 10 Amazon.com Services LLC 7 Scientific Hair Research, LLC 7 CVS Pharmacy 6 Hims Inc 6 L. Perrigo Company 6 Shenzhen Earth Surface Trading Co., Ltd. 6 Sun Pharmaceutical Industries, Inc. 6 Guangzhou Jianyuan Biological Technology.Co.,Ltd 5 P & L Development, LLC 5 Aurohealth LLC 4 Cardinal Health 110, Llc. Dba Leader 4 Costco Wholesale Company 4 FlexiGo Inc 4 Guangzhou Ariel Medical Technology Co., Ltd. 4 Innovus Pharmaceuticals, Inc. 4 Kenvue Brands LLC 4 Shenzhen Xinxin Yunhai Technology Co., Ltd. 4 TARGET Corporation 4 Thirty Madison Inc 4 Walgreen Company 4 Guangdong Jiaoyu Biotechnology Co., Ltd 3 Guangzhou Binsi Clothing Co.,Ltd. 3

…and 86 more on the FDA NDC directory.

Minoxidil drug class (RxNorm)

Minoxidil belongs to the Arteriolar Vasodilator class.

Pharmacologic class Arteriolar Vasodilator
Drug family (ATC) Pyrimidine derivatives, Other dermatologicals

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Minoxidil page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

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FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Aug 27, 2021
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Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Minoxidil.
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Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
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Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Minoxidil after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
268
Finished products in the current FDA directory
247
Companies listing them (makers, repackagers, distributors)
110
FDA labeler codes behind them ⓘ
113
Linked representative label ⓘ
Amazon.com Services LLC
Linked label effective
Aug 27, 2021
Composite sections available
8
Linked SPL Set ID
89f70638-619f-4bc6-806e-5f685fdcb379
Linked SPL Document ID
ecffad75-d883-4428-843e-e49cd30e35dd
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Amazon.com Services LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →