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minoxidil

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Brand names: Loniten

Vasodilator Rx

Minoxidil (Loniten) is a medicine that helps regrow hair. It works by widening blood vessels in the scalp.

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.

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.

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.

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.

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 31,952 FDA adverse event reports.

Bad reaction to the medicine
8,511
Medicine not working
7,671
Hair loss
3,740
Itching where applied
2,903
Using the medicine for something not approved
2,223
Taking too much medicine
1,429
Skin irritation where applied
1,399
Hair feels different
1,389
Pain where applied
1,388
Headache
1,299

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

Death-Related Reports

443

Hospitalization Reports

2,012

Top Indication

Product Used For Unknown Indication

Gender Distribution

Female 16,687 (41%)
Male 23,805 (59%)

Age Distribution

0–17 769
18–44 2,447
45–64 4,172
65–74 3,030
75+ 1,829

Most Reported Adverse Reactions (FAERS)

# Reaction Reports
1 ADVERSE DRUG REACTION 8,511
2 DRUG INEFFECTIVE 7,671
3 ALOPECIA 3,740
4 APPLICATION SITE PRURITUS 2,903
5 OFF LABEL USE 2,223
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
13 PRODUCT USE IN UNAPPROVED INDICATION 1,155
14 WRONG TECHNIQUE IN PRODUCT USAGE PROCESS 1,133
15 PRURITUS 993

Reactions in Death Reports

DEATH 111
RENAL FAILURE 56
CHRONIC KIDNEY DISEASE 50
COMPLETED SUICIDE 48
END STAGE RENAL DISEASE 45
CARDIO-RESPIRATORY ARREST 40
HYPERTENSION 29
GENERAL PHYSICAL HEALTH DETERIORATION 26
PNEUMONIA 26
CARDIAC ARREST 25

Reactions in Hospitalization Reports

DYSPNOEA 171
HYPERTENSION 159
NAUSEA 117
CARDIAC FAILURE CONGESTIVE 112
HYPOTENSION 110
RENAL FAILURE 108
VOMITING 107
DIZZINESS 105
HEADACHE 102
ACUTE KIDNEY INJURY 98

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?
It takes time to regrow hair. Hair regrowth has not been shown to last longer than 48 weeks in studies.
What happens if I stop using minoxidil?
If you stop using it, your hair loss will begin again.
Can I use more than 1 mL at a time?
No, using more medicine will not improve results.
How often should I use this?
Apply one mL 2 times a day.
Where should I apply the medicine?
Apply it directly onto the scalp in the hair loss area.
Is this product for everyone?
In studies, this product was tested on mostly white men aged 18-49 years with moderate hair loss.
What strength should I use?
Minoxidil topical solution 5% provided more hair regrowth than minoxidil topical solution 2% in studies.
Where can I find more information?
Read all the information on the carton and the leaflet inside. Keep the carton as it has important information.
Can women use this product?
The provided information does not specify if this product is for women. Talk to your doctor.
What do I do if I get side effects?
Talk to your doctor if you experience side effects.
What are the common side effects of minoxidil?
The most commonly reported side effects of minoxidil include Headache, Itching, Rash, Dizziness. Based on 31,952 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
What drug class is minoxidil?
minoxidil belongs to the Vasodilator drug class. It requires a prescription (Rx). This medicine is used to help regrow hair on the top of your head.
Is minoxidil safe during pregnancy?
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. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.

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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 31,952 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

All federal data sources used on this page