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.
How to Take It
Apply 1 mL of the solution with the dropper directly onto your scalp where you are losing hair. Do this 2 times each day. Using more medicine or using it more often will not make it work better. You must keep using it to keep your hair growing.
This is a plain-language summary of minoxidil's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
The safety of this medicine during pregnancy and breastfeeding is not well-studied. Talk to your doctor before using this medicine if you are pregnant or breastfeeding.
This is a plain-language summary of minoxidil's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose, just use your next dose at the regular time. Do not use extra medicine to make up for the missed dose.
This is a plain-language summary of minoxidil's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store at room temperature, between 68° to 77°F (20° to 25°C). Keep the container tightly closed.
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
- Bad reaction to the medicine
Bad reaction to the medicine
8,511 reports
- Hair loss
Hair loss
3,740 reports
- Itching where applied 2,903
Itching where applied
2,903 reports
- Taking too much medicine 1,429
Taking too much medicine
1,429 reports
- Skin irritation where applied 1,399
Skin irritation where applied
1,399 reports
- Hair feels different 1,389
Hair feels different
1,389 reports
- Pain where applied 1,388
Pain where applied
1,388 reports
- Headache 1,299
Headache
1,299 reports
- Wrong dose given 1,274
Wrong dose given
1,274 reports
- Medicine given at the wrong time 1,157
Medicine given at the wrong time
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) 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?
Is minoxidil safe during pregnancy?
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amlodipine
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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 further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
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. Always consult a healthcare professional before making medication decisions.
Last updated: October 8, 2025
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 and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
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