Does the drug name Rogaine ring a bell? It is the topical form of an oral medication that was first approved by the FDA in 1979 to treat hypertension. The original brand name was Loniten and the generic formulation was called minoxidil. It never became very popular because of some serious side effects. Now, though, low-dose oral minoxidil is gaining traction for hair loss—male pattern baldness in both men and women. This is definitely “off-label.” The FDA has not approved oral minoxidil at any dose for hair loss!
Minoxidil for Hard-To-Treat Hypertension:
Minoxidil has been around for a very long time! It was originally developed by the Upjohn drug company in the 1950s to help treat stomach ulcers. It didn’t work!
The drug did dilate blood vessels, though. As a result of this discovery, the medicinal chemists at the company created a number of other compounds. One was an N-oxidation product of diallylmelamine dubbed DAMN-O. An analog of this chemical turned into minoxidil (Loniten).
The oral blood pressure medicine eventually ended up with a black box warning, however:
“LONITEN Tablets contain the powerful antihypertensive agent, minoxidil, which may produce serious adverse effects. It can cause pericardial effusion [a buildup of fluid around the heart], occasionally progressing to tamponade [a medical emergency that can lower cardiac output], and angina pectoris [chest pain] may be exacerbated. LONITEN should be reserved for hypertensive patients who do not respond adequately to maximum therapeutic doses of a diuretic and two other antihypertensive agents.
“LONITEN must be administered under close supervision, usually concomitantly with therapeutic doses of a beta-adrenergic blocking agent to prevent tachycardia and increased myocardial workload. It must also usually be given with a diuretic…”
Loniten (Minoxidil): A Big Disappointment
Not surprisingly, the serious warning discouraged many doctors from prescribing oral minoxidil for hypertension. Other side effects included rapid heart rate, fluid retention and swelling of the feet and legs. The official prescribing information recommended the following dose of oral minoxidil for hard-to-treat high blood pressure:
“The effective dosage range is usually 10 to 40 mg per day. The maximum recommended dosage is 100 mg per day.”
Repurposing Minoxidil for Male Pattern Baldness:
One of the unexpected side effects of oral minoxidil was hair growth. Some people were quite distressed to experience this adverse reaction in unwanted places. But others were excited to discover a drug that could actually stimulate the growth of visible hair.
Clinical trials with topical minoxidil eventually led to FDA approval under the name Rogaine. It was somewhat effective, but topical minoxidil never became as successful as many people expected.
Low-Doses Oral Minoxidil Makes a Splash:
Fast Forward more than four decades. We discovered a study in the Archives of Dermatology (Nov. 1987) that tested low-dose oral minoxidil against topical minoxidil in patients with the auto-immune disorder called alopecia areata. The pills were more effective than the lotion, but this kind of hair loss is notoriously difficult to treat and only 18% of the patients achieved a “cosmetic response.”
By 2018 dermatologists were starting to experiment with low-dose oral minoxidil for male-pattern hair loss (Dermatologic Therapy, Nov-Dec, 2018). Over the next few years, lots of studies began popping up, including some in women.
A study from Spain published in Dermatologic Therapy, Nov. 2020) concluded:
“Efficacy of OM [low-dose oral minoxidil] could not be analyzed due to heterogeneous studies. However, four studies using OM for androgenetic alopecia reported a clinical response in 70% to 100% of the patients. Low dose OM is a safe and well-tolerated treatment for hair loss, presenting a lower adverse effect rate than standard doses.”
The New York Times and Low-Dose Oral Minoxidil:
Although there were no really large, well-controlled randomized clinical trial, dermatologists were starting to prescribe low-dose oral minoxidil for male pattern baldness. It was still kind of hush-hush…an insider sort of off-label process.
Then on August 18, 2022 the journalist Gina Kolata blew the lid off this concept in the pages of the New York Times. Her article was titled:
“Dermatologists who specialize in hair loss say that the key ingredient in a topical treatment worked even better when taken orally at a low dose.”
Gina Kolata went on to describe Australian dermatologist Rodney Sinclair. He prescribed low-dose oral minoxidil for a woman who developed an allergic rash to topical minoxidil.
To get the best response, he:
“…tried cutting minoxidil pills into quarters. To his surprise, the lose dose made her hair grow but did not affect her blood pressure, the original purpose of the higher-dose drug.
“He subsequently lowered the dose more and more until he got down to effective doses of one-fortieth of a pill and began routinely prescribing the drug. That first patient still takes it.
“At a meeting in Miami in 2015, Dr. Sinclair reported that low doses of minoxidil prompted hair growth in 100 successive women.”
The Power of the Press:
Not surprisingly, Gina Kolata’s article in the Times set off an avalanche of interest in low-dose oral minoxidil!
A Research Letter published in JAMA Network Open (May 9, 2023) was titled:
“Changes in Minoxidil Prescribing After Media Attention About Oral Use
for Hair Loss.”
The authors note:
“Media coverage of health-related news may be associated with changes in clinician practices and patient behaviors.
“This cross-sectional study found that after a newspaper publication describing use of low-dose oral minoxidil to treat hair loss, there was an immediate increase in prescribing. Importantly, the article did not report new research findings or large-scale randomized evidence. Our findings suggest that media coverage alone, even without new research or with limited evidence, may be associated with immediate changes in prescribing, although they may not be sustained.”
Readers Want to Know About Low-Dose Oral Minoxidil!
Q. What can you tell me about minoxidil pills for hair loss? Some people say that low-dose minoxidil really does increase hair volume. Having thin, “post-menopausal” hair myself, I’m planning to ask my doctor about it sometime soon. First, though, I’d like your opinion.
A. Doctors have long worried about serious side effects from oral minoxidil when it is prescribed for hard-to-treat hypertension. Topical minoxidil was less likely to cause worrisome side effects such as fluid retention (edema), rapid heart rate, headache and weight gain. More serious reactions associated with oral minoxidil include inflammation around the heart, congestive heart failure, worsening angina and severe skin reactions.
Most of those adverse drug reactions have been reported by people taking relatively high oral doses for hard-to-treat hypertension. At the very low doses of oral minoxidil (OM) currently being prescribed off label for hair loss, such problems appear uncommon (Journal of the American Academy of Dermatology, Oct. 14, 2023).
We could find no large, well-controlled trials of low-dose OM for hair loss. A review in the Journal of the American Academy of Dermatology (March 2021) concluded, however:
“Oral minoxidil was found to be an effective and well-tolerated treatment alternative for healthy patients having difficulty with topical formulation.”
A Reader Reports Oral Minoxidil Is Working—Starting Low & Going Slow!
Q. After reading an article in the New York Times, I asked my dermatologist about low-dose oral minoxidil to reverse hair loss. My baby-fine hair has slowly thinned since my 50s.
I started with 1/4 pill (monitoring my blood pressure daily). After four months, I upped it to 1/2 pill. I’ve had no side effects and my hair is somewhat thicker. It’s still not as thick as when I was young, though. After talking to my dermatologist, I’m increasing the dose to 3/4 pill, and I’ll watch for side effects.
Low-dose minoxidil is working for me, but it might not be for everyone. I decided to go slowly, as this is a regimen that you have to continue for life. If you stop, you lose the hair you’ve grown.
A. Minoxidil is better known as a topical medicine under the brand name Rogaine. It was first developed as a pill to treat hypertension. That dose was 10 to 40 mg daily, which unfortunately can produce serious side effects.
Some dermatologists have been experimenting with low-dose oral minoxidil (0.25 mg to 5 mg). As long as your dermatologist is monitoring your progress, this could be an interesting option.
Words of Caution About Low-Dose Oral Minoxidil:
Before people start badgering dermatologists for a prescription for low-dose oral minoxidil, here is a word of caution about this treatment:
An article in JAAD Case Reports (Dec. 2022) provides this alert:
“Since the original introduction of low-dose oral minoxidil for this indication [female androgenetic alopecia], reported adverse effects have been purported to be infrequent and of minor impact, with 15.1% hypertrichosis [hair overgrowth], 1.7% lightheadedness, 1.3% fluid retention, 0.9% tachycardia [rapid heart rate], 0.4% headache, 0.3% periorbital edema [puffy eyes], and 0.2% insomnia reported in the largest retrospective multicenter study so far of 1404 patients, leading to drug discontinuation in 1.2% of patients.
“We also witnessed a young and previously healthy female patient who developed, within weeks of treatment, a pericardial effusion at a dosage of oral minoxidil 1.25 mg for the treatment of female androgenetic alopecia. The patient complained of shortness of breath, discomfort while breathing in the supine position, chest pain, lightheadedness, and swelling in the legs.
“Low-dose oral minoxidil has gained popularity as an off-label pharmacologic treatment for cosmetic conditions. However, as such, it should be prescribed with caution and monitored by physicians experienced and aware of the adverse effects of the drug and potential medicolegal issues.”
We had the opportunity to interview two impressive dermatologists about a variety of skin, hair and nail problems. This nationally syndicated public radio show is available free of charge as a podcast at this link. If you would like to learn more about “How to Have Healthy Hair and Nails” you can stream the audio by clicking on the arrow inside the green circle under the photograph of Dr. Warren R. Heymann.
At that time he was:
“Head of the Division of Dermatology at Cooper Medical School of Rowan University, where he is Professor of Medicine and Pediatrics and Head of the Division of Dermatology. He is also Clinical Professor of Dermatology at the Perelman School of Medicine of the University of Pennsylvania, and serves as a Director of the American Board of Dermatology. Dr. Heymann is the editor of DermWorld Insights & Inquiries.”
Dr. Heyman describes a fascinating condition called green nail syndrome! You won’t want to miss it at this link.
What are your thoughts about low-dose oral minoxidil for hair loss? Have you tried topical Minoxidil (Rogaine)? How well did it work? Please share your experience in the comment section below. If you think friends or family might be interested in this article, please scroll to the top of the page and send it out by clicking on the icons for email or social media. And if you think our newsletter is worthwhile, please encourage your contact to subscribe at this link. It is now working! Thank you for supporting our work.