Prescription medication · Vasodilator
minoxidil
Also sold as Loniten. This medicine is used to help regrow hair on the top of your head.
Data updated 2026-05-15
- 43,650
- FDA reportsOften reported
- $0.15
- Generic price (NADAC)
minoxidil (Loniten) is a prescription Vasodilator. This medicine is used to help regrow hair on the top of your head.
Minoxidil (Loniten) is a medicine that helps regrow hair. It works by widening blood vessels in the scalp.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Generic Price
$0.15/unit
Generic Available
Yes (18 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
This medicine is used to help regrow hair on the top of your head.
Common side effects
Headache, Itching, Rash
Key warnings
Hair regrowth has not been shown to last longer than 48 weeks when using minoxidil topical solution 5% continuously.
The sections below are summarized in plain English from minoxidil's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Minoxidil is a vasodilator. This means it widens blood vessels in your scalp. This may help more blood flow to the hair follicles, which can help hair grow.
Side Effects (from patient reports)
Based on 43,650 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for minoxidil, by number of reports
- Adverse Drug Reaction
Adverse Drug Reaction
8,511 reports
- Alopecia
Alopecia
3,740 reports
- Application Site Pruritus 2,903
Application Site Pruritus
2,903 reports
- Overdose 1,429
Overdose
1,429 reports
- Application Site Irritation 1,399
Application Site Irritation
1,399 reports
- Hair Texture Abnormal 1,389
Hair Texture Abnormal
1,389 reports
- Application Site Pain 1,388
Application Site Pain
1,388 reports
- Headache 1,299
Headache
1,299 reports
- Incorrect Dose Administered 1,274
Incorrect Dose Administered
1,274 reports
- Inappropriate Schedule Of Product Administration 1,157
Inappropriate Schedule Of Product Administration
1,157 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for minoxidil each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where minoxidil sits
minoxidil has more FDA adverse-event reports than 71% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is minoxidil; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 43,650 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.
Total Reports
43,650
Reports Mentioning Death
443
1.0% of reports — not proof of cause
Hospitalization Reports
2,012
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | ADVERSE DRUG REACTION | 8,511 |
| 3 | ALOPECIA | 3,740 |
| 4 | APPLICATION SITE PRURITUS | 2,903 |
| 6 | OVERDOSE | 1,429 |
| 7 | APPLICATION SITE IRRITATION | 1,399 |
| 8 | HAIR TEXTURE ABNORMAL | 1,389 |
| 9 | APPLICATION SITE PAIN | 1,388 |
| 10 | HEADACHE | 1,299 |
| 11 | INCORRECT DOSE ADMINISTERED | 1,274 |
| 12 | INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION | 1,157 |
| 15 | PRURITUS | 993 |
| 17 | APPLICATION SITE DRYNESS | 811 |
| 18 | RASH | 799 |
| 19 | PRODUCT FORMULATION ISSUE | 790 |
| 20 | DIZZINESS | 784 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Hair regrowth has not been shown to last longer than 48 weeks when using minoxidil topical solution 5% continuously.
Common Questions
How long will it take to see results?
What happens if I stop using minoxidil?
Can I use more than 1 mL at a time?
How often should I use this?
Where should I apply the medicine?
Is this product for everyone?
What strength should I use?
Where can I find more information?
Can women use this product?
What do I do if I get side effects?
What are the common side effects of minoxidil?
What drug class is minoxidil?
What pregnancy or breastfeeding source fields are listed for minoxidil?
Related Medications in Vasodilator
Other drugs grouped near minoxidil - same-class peers and common alternatives.
acebutolol
Sectral
Acebutolol is a medicine that helps lower blood pressure and control irregular heartbeats.
Compare with minoxidil →
aliskiren
Tekturna
Tekturna is a medicine used to treat high blood pressure.
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amiloride
Midamor
Amiloride is a water pill that helps your body hold onto potassium.
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amlodipine
Norvasc
Amlodipine (Norvasc) is a drug that lowers blood pressure and treats chest pain.
Compare with minoxidil →
amlodipine/benazepril
Lotrel
Lotrel is a combination medicine that contains amlodipine and benazepril.
Compare with minoxidil →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for minoxidil: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 43,650.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 1.01%.
- abaloparatide Δ 0.06 pts · 24,667 reports · PTHrP Analog 1.08%death share
- varenicline Δ 0.11 pts · 5,766 reports · Nicotinic Receptor Partial Agonist 1.13%death share
- dexmethylphenidate Δ 0.13 pts · 4,083 reports · CNS Stimulant 0.88%death share
- ertugliflozin Δ 0.14 pts · 1,037 reports · SGLT2 Inhibitor 1.16%death share
Medication Guides
Understanding Drug Interactions
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Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for minoxidil
The FDA label for minoxidil (sold under brand names such as Loniten) classifies it as a prescription-only medication in the Vasodilator class. This medicine is used to help regrow hair on the top of your head. Official labeling lists 4 commonly reported side effects, including Headache, Itching, Rash.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 43,650 voluntary reports. Interaction data is drawn directly from FDA-approved prescribing information. NADAC pricing from CMS shows a generic unit cost of $0.15.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.
Last updated: October 8, 2025
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages