These treatments typically contain minoxidil, and they may be more broadly referred to as topical minoxidil.
Minoxidil is an ingredient that has been used for decades and is generally considered safe and well tolerated. But its effectiveness is variable, says Sandeep Sattur, MD, a hair restoration surgeon at the HairRevive Center for Hair Restoration and Skin Rejuvenation in Mumbai, India. Additionally, this form of minoxidil can cause unpleasant side effects, among other drawbacks.
Now, for potentially better treatment, some dermatologists are now prescribing oral minoxidil to combat hair loss. Although the U.S. Food and Drug Administration (FDA) has not approved these hair loss pills, doctors are free to prescribe oral minoxidil for this off-label use. Here’s what you need to know if you or a loved one is dealing with hair loss and are curious if minoxidil might be an option.
1. Topical minoxidil can help maintain and grow hair, but it’s not perfect
The FDA cleared the first topical version of minoxidil to treat male pattern baldness in the late 1980s. Since then, the FDA has also approved minoxidil for female pattern hair loss, allowed its manufacture in higher concentrations and licensed it for over-the-counter sale without a prescription.
In a nutshell, topical minoxidil helps stimulate hair growth or slow baldness when applied to the scalp once or twice a day.
These scalp treatments usually contain 2 or 5% minoxidil as the active ingredient. They’re available without a prescription and work best for recent hair loss in people under 40, according to MedlinePlus.
Several clinical trials of topical minoxidil in both men and women have shown it helps increase hair thickness in areas where hair loss has been observed, according to data from the Center for Drug Evaluation and Research (PDF ). Some studies suggest that the extra strength version (which uses a 5% concentration of the drug) is more effective than the original formula (which uses a 2% concentration).
But as mentioned, topical minoxidil has its drawbacks. For example, results can take months to see and any new hair growth disappears when you stop treatment. Also, topical minoxidil doesn’t work for all types of hair loss – for example, it’s unlikely to help patients with pattern baldness, especially if they’ve lived with the condition for some time before. to start treatment. And it can have side effects ranging from unpleasant scalp stickiness to itching, rashes and inflammation, according to the Mayo Clinic.
2. Oral minoxidil was originally used to treat high blood pressure
Oral minoxidil actually predates topical minoxidil and was originally approved as a prescription drug for severe hypertension, or high blood pressure, by the Mayo Clinic. Originally approved by the FDA in the late 1970s as a pill to treat severe high blood pressure, minoxidil pills often had an unexpected side effect: excessive hair growth. Drug developers quickly saw the potential for this side effect and reformulated minoxidil into a topical treatment for hair loss, as noted by the American Academy of Dermatology Association (AAD).
“Nowadays it’s rather rare to treat hypertension with minoxidil,” says Juan Jimenez Cauhe, MD, dermatologist at the Ramon y Cajal University Hospital and trichologist at the Grupo Pedro Jaen Clinic, both in Madrid. . According to the American Heart Association, it is only recommended for severe high blood pressure when patients do not respond to other medications or when people have kidney failure.
“Over the past seven years, it has been increasingly used off-label for different types of low-dose hair loss,” he adds. More on that next.
3. Oral minoxidil is an “off-label” treatment for hair loss
The term “off-label” or “unapproved” can mean different things, according to the FDA. This could mean that providers prescribe a drug in a different form (eg, oral or topical), or in a different dosage, or to treat a disease or condition for which it is not FDA-approved.
Minoxidil is currently approved by the FDA as an oral medication to treat high blood pressure and as a topical medication to treat hair loss. But the drug is currently not FDA-approved to treat hair loss when taken orally – and so any prescription for this purpose is considered “off-label”.
4. Research on taking minoxidil by mouth for hair loss is lacking
So far there is not enough high quality research to support oral minoxidil for hair loss. But a handful of small studies suggest that oral minoxidil can help treat hair loss and may be more effective for some patients than topical treatments, Dr. Sattur says.
For example, a small observational study in 100 women with female pattern hair loss suggested that a daily pill containing 0.25 milligrams (mg) of minoxidil and 25 mg of spironolactone was safe and effective in treating the condition. But the study didn’t use a control group, so it’s unclear whether these results are due to the drug.
A later review, published in the Journal of the American Academy of Dermatology in July 2020 reviewed 17 studies involving 634 patients. The review suggested that oral minoxidil was a generally effective and well-tolerated alternative to topical minoxidil, although the researchers add that larger controlled studies are needed.
5. There is no standard dosage for oral minoxidil
Sattur points out that most of these studies involved doses ranging from 0.25mg to 5mg – less than the doses used for hypertension. (Doses for hypertension generally range from 5 to 40 mg for adults and children over 12.)
“Whatever limited small-sample studies have been published, there is no consensus on the optimal dose,” says Sattur – a common drawback of all off-label drugs. The lack of a standard dose means it’s unclear how much minoxidil (if any) is safe when taken for off-label purposes.
6. Minoxidil pills can have serious side effects
Side effects are generally less of a concern with topical treatments, because they target a single area of the body, than with systemic medications like pills, which work beyond just one part of the body.
Common side effects of topical minoxidil can include itching or rash on the scalp, while rarer side effects can include acne, inflammation, swelling, blurred vision or chest pain, according to the Mayo Clinic.
But the safety picture of oral minoxidil for hair loss is much less clear, because it hasn’t been tested in the kind of rigorous clinical trials required for FDA approval. For example, it’s unclear whether low-dose oral minoxidil for hair loss can negatively impact blood pressure in people who don’t have hypertension, says Sattur: “It will need to be individualized for each patient. depending on changes in blood pressure and cardiovascular system.”
What we do know is that minoxidil pills carry an FDA black box warning (PDF) because they may increase your risk of pericardial effusion, which is the clinical name for excessive fluid buildup around heart, by Mayo Clinic.
Other side effects seen in some patients taking low doses of minoxidil by mouth for hair loss include dizziness, heart palpitations and fluid retention, adds Dr. Jiménez Cauhé. Although these side effects should go away when patients stop taking the pills, the potential for these problems is one of the reasons why patients should have them prescribed by a doctor who has a full picture of the current medical conditions and history. patient care, Jiminez-Cauhe adds.
7. Minoxidil is not safe to use during pregnancy
Pregnant or breastfeeding women should not use minoxidil, the DAA warns, because traces of the drug can pass into breast milk. Several other hair loss medications, including finasteride, are not FDA-approved for hair loss in women, but can be used for this purpose as long as patients are not pregnant or planning to have hair loss. become pregnant, according to the AAD.
8. Minoxidil Isn’t Your Only Hair Loss Treatment Option
Patients have a wide variety of treatment options for hair loss besides minoxidil, according to the AAD. Treatment options differ for men and women, in part because some procedures can cause facial hair and others are not recommended for pregnant or breastfeeding women.
Options for treating baldness in addition to minoxidil may include, according to the AAD:
- Finasteride A prescription pill that can slow hair loss in most men who take it
- Hair transplants A procedure that moves hair clogs from one part of the scalp to another
- platelet-rich plasma A procedure that separates plasma from patients’ blood for injection into the scalp, and can be performed alone or combined with hair transplants
9. Topical minoxidil remains the gold standard for treating hair loss
Anyone considering hair loss treatment for the first time should start with FDA-approved options before considering minoxidil pills, dermatologists say. This includes topical minoxidil, which is sold as brand name Rogaine products and in a variety of generic versions.
“The first step for a patient considering low dose oral minoxidil should be to seek out a dermatologist experienced in diagnosing hair disorders,” says Dmitri Wall, MD, consultant dermatologist and hair transplant surgeon at St. James of Dublin.
“In my view, the risk-benefit ratio of oral minoxidil versus topical minoxidil – and the fact that the available evidence for oral minoxidil is not of very high quality – does not support the routine use of oral minoxidil in the hair loss management.” Satur says. “Topical minoxidil is always the first-line treatment.”