pharmacopeia

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Potassium Channel Interactions.

Indications

Sourced from openFDA
  • Use to regrow hair on the top of the scalp (vertex only, see pictures on side of carton)

Dosage & administration

Sourced from openFDA

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

Warnings & precautions

Sourced from openFDA

For external use only. For use by men only. Flammable: Keep away from fire or flame Do not use if • you are a woman • your amount of hair loss is different than that shown on the side of this carton or your hair loss is on the front of the scalp. Minoxidil topical solution 5% 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. This product will not work for all men. Stop use and ask a doctor if • chest pain, rapid heartbeat, faintness, or dizziness occurs • sudden, unexplained weight gain occurs • your hands or feet swell • scalp irritation or redness occurs • unwanted facial hair growth occurs • you do not see hair regrowth in 4 months May be harmful if used when pregnant or breast-feeding. Keep out of reach of children.

Approval history

Sourced from openFDA
  • Mar 3, 1987ANDAANDA071344Watson Labs
  • Mar 3, 1987ANDAANDA071345Watson Labs
  • Aug 17, 1988NDANDA019501Kenvue Brands
  • Nov 14, 1988ANDAANDA071826Ph Health
  • Nov 14, 1988ANDAANDA071839Ph Health
  • Dec 13, 1995ANDAANDA072709Sun Pharm Industries
  • Nov 14, 1997NDANDA020834Kenvue Brands
  • Jan 20, 2006NDANDA021812Kenvue Brands

FAERS reports

View JSON
Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
44,096 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Adverse Drug Reaction8,51219%
  2. 2Drug Ineffective7,71017%
  3. 3Alopecia3,7688.5%
  4. 4Application Site Pruritus2,9096.6%
  5. 5Off Label Use2,2475.1%
  6. 6Overdose1,4453.3%
  7. 7Application Site Irritation1,4013.2%
  8. 8Hair Texture Abnormal1,3973.2%
  9. 9Application Site Pain1,3943.2%
  10. 10Headache1,3203.0%
  11. 11Incorrect Dose Administered1,2892.9%
  12. 12Product Use In Unapproved Indication1,1732.7%
  13. 13Inappropriate Schedule Of Product Administration1,1672.6%
  14. 14Wrong Technique In Product Usage Process1,1502.6%
  15. 15Pruritus1,0052.3%

Literature

View JSON

Recent PubMed references pinned to Minoxidil as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 106 ClinicalTrials.gov registrations naming Minoxidil as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Minoxidil work?
Mechanism-of-action class: Potassium Channel Interactions.
What is Minoxidil used for?
According to FDA labeling, Minoxidil carries indications including: Use to regrow hair on the top of the scalp (vertex only, see pictures on side of carton). This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Minoxidil?
Minoxidil is classified as Other dermatologicals, Pyrimidine derivatives, Arteriolar Vasodilator, Potassium Channel Interactions, Arteriolar Vasodilation, Cutaneous Arterial Vasodilation, Decreased Blood Pressure.
What are the brand names for Minoxidil?
Minoxidil is marketed under brand names including Regoxidine, Rogaine.
Note. Data for minoxidil is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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