Safety of low-dose oral minoxidil for

hair loss: A multicenter study of

1404 patients
Sergio Va~ -Galvan, MD, PhD,a,b Rodrigo Pirmez, MD,c Angela Hermosa-Gelbard, MD,a,b
no

Oscar M. Moreno-Arrones, MD, PhD,a,b David Saceda-Corralo, MD, PhD,a,b Rita Rodrigues-Barata, MD,b
Juan Jimenez-Cauhe, MD,a Wei L. Koh, MBBS, MRCP,d,e Janina E. Poa, MD, FPDS,d
Rebekka Jerjen, BMSc (Hons), MChD,d Lara Trindade de Carvalho, MD,d
Jared Marc John, BMSc (Hons), MBBS, MPH,d Corina I. Salas-Callo, MD,c Colombina Vincenzi, MD, PhD,f
Lu Yin, MD,g Kristen Lo-Sicco, MD,g Anna Waskiel-Burnat, MD, PhD,h Michela Starace, MD, PhD,i
Jose Luis Zamorano, MD, PhD,j Pedro Jaen-Olasolo, MD, PhD,a,b Bianca Maria Piraccini, MD, PhD,i
Lidia Rudnicka, MD, PhD,h Jerry Shapiro, MD, PhD,g Antonella Tosti, MD, PhD,k
Rodney Sinclair, MD, FACD,d and Bevin Bhoyrul, MBBS, MRCPd
Madrid, Spain; Rio de Janeiro, Brazil; Melbourne, Australia; Singapore, Singapore; Bologna, Italy; New
York, New York; Warsaw, Poland; and Miami, Florida

Background: The major concern regarding the use of low-dose oral minoxidil (LDOM) for the treatment
of hair loss is the potential risk of systemic adverse effects.
Objective: To describe the safety of LDOM for the treatment of hair loss in a large cohort of patients.
Methods: Retrospective multicenter study of patients treated with LDOM for at least 3 months for any type
of alopecia.
Results: A total of 1404 patients (943 women [67.2%] and 461 men [32.8%]) with a mean age of 43 years
(range 8-86) were included. The dose of LDOM was titrated in 1065 patients, allowing the analysis of 2469
different cases. The most frequent adverse effect was hypertrichosis (15.1%), which led to treatment
withdrawal in 14 patients (0.5%). Systemic adverse effects included lightheadedness (1.7%), fluid retention
(1.3%), tachycardia (0.9%), headache (0.4%), periorbital edema (0.3%), and insomnia (0.2%), leading to
drug discontinuation in 29 patients (1.2%). No life-threatening adverse effects were observed.
Limitations: Retrospective design and lack of a control group.
Conclusion: LDOM has a good safety profile as a treatment for hair loss. Systemic adverse effects were
infrequent and only 1.7% of patients discontinued treatment owing to adverse effects. ( J Am Acad
Dermatol 2021;84:1644-51.)

Key words: alopecia; androgenetic alopecia; arterial hypotension; dizziness; edema; effluvium; fluid
retention; frontal fibrosing alopecia; hair loss; hypertrichosis; lichen planopilaris; lightheadedness; new
treatments; periorbital edema; safety; tachycardia.

From the #TricoHRC Research Group, Trichology Unit, Derma- Alcala, Madridj; and Department of Dermatology and Cuta-
tology Department, Ram on y Cajal University Hospital, Instituto neous Surgery, Miller School of Medicine, University of Miami.k
Ramon y Cajal de Investigaci on Sanitaria, University of Alcala, Funding sources: None.
Madrida; Trichology and Hair Transplantation Unit, Grupo Pedro IRB approval status: Approved.
Jaen Clinic, Madridb; Instituto de Dermatologia Professor Accepted for publication February 18, 2021.
Rubem David Azulay, Santa Casa de Miseric ordia do Rio de Reprints not available from the authors.
Janeiroc; Sinclair Dermatology, Melbourned; Department of Correspondence to: Sergio Va~ -Galvan, MD, PhD, Hospital
no
Dermatology, Changi General Hospital, Singaporee; Nigrisoli Universitario Ram on y Cajal, Ctra. De Colmenar Viejo km.
Hospital, Bolognaf; The Ronald O. Perelman Department of 9100, 28034 Madrid, Spain. E-mail: [email protected].
Dermatology, New York University Grossman School of Medi- Twitter: @SergioVanoG.
cineg; Department of Dermatology, Medical University of Published online February 24, 2021.
Warsawh; Dermatology -IRCCS Policlinico di SantOrsola, Depart- 0190-9622/$36.00
ment of Experimental, Diagnostic and Specialty Medicine Ó 2021 by the American Academy of Dermatology, Inc.
(DIMES) Alma Mater Studiorum University of Bolognai; Depart- https://doi.org/10.1016/j.jaad.2021.02.054
ment of Cardiology, Ram on y Cajal Hospital, University of

1644
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INTRODUCTION Although published studies of LDOM for hair loss

Minoxidil is a potent arteriolar vasodilator that have demonstrated a favorable safety profile,8,9,13,14
was approved by the US Food and Drug the number of patients evaluated in these studies is
Administration for the treatment of severe generally low, and therefore, infrequent adverse
refractory hypertension in 1979.1,2 For patients effects may not have been detected. The objective
aged [12 years, the dosage range is usually be- of this study was to investigate the safety of LDOM
tween 10-40 mg/day, with a maximum recommen- for hair loss in a large cohort of patients.
ded dose of 100 mg.2,3
Minoxidil has a duration of METHODS
action of approximately CAPSULE SUMMARY A retrospective, multi-
24 hours despite having a center, and descriptive study
plasma half-life of d
Low-dose oral minoxidil for hair loss has including 10 centers from 6
4.2 hours,2,3 suggesting a good safety profile. Only 1.7% of different countries was de-
extravascular accumula- patients discontinued the drug owing to signed. Patients treated with
tion.4 Minoxidil sulfate, the adverse effects. LDOM for $3 months for hair
biologically active metabo- d
Although infrequent, dermatologists loss of any cause were
lite of minoxidil, lowers should be aware of the potential included. Epidemiological
blood pressure by opening systemic adverse effects of low-dose oral and safety data were
sarcolemmal adenosine minoxidil, which include collected. In patients who
triphosphate-sensitive po- lightheadedness, fluid retention, developed adverse effects,
tassium channels in vascular tachycardia, headache, periorbital the type and time to devel-
smooth muscle cells.5 edema, and insomnia. opment of the adverse effect,
Oral minoxidil has dose- in addition to the need to
dependent predictable side withdraw or adjust the dose
effects at doses of 10-40 mg, including postural of LDOM, were also recorded. We analyzed the
hypotension, fluid retention, tachycardia, pericar- above parameters for each dose in patients who
ditis, and nausea.2 However, the most common received [1 dose of LDOM.
adverse effect is hypertrichosis, which occurs in Logistic regression was used to identify the vari-
approximately 80% of patients.2 Based on this ables associated with an increased risk of adverse
serendipitous adverse effect, topical minoxidil was effects in a multivariate model adjusted for age,
developed in 1987 for male and female pattern hair weight, and sex.
loss.6,7 The precise mechanism through which
minoxidil promotes hair growth is unclear. RESULTS
Minoxidil shortens the telogen phase of the hair A total of 1404 patients (943 women [67.2%] and
growth cycle, thus causing premature transition to 461 men [32.8%]) with a mean age of 43 years (range
anagen.1 It also prolongs anagen, resulting in 8-86) were included. The most common indication
increased hair length and diameter. The initial hair for LDOM was androgenetic alopecia (82.4%), fol-
growth-promoting effects of minoxidil occur after lowed by telogen effluvium (4.8%), alopecia areata
approximately 2 months, with maximal effects (3.8%), frontal fibrosing alopecia (2.8%), lichen
observed at 4 months.1 planopilaris (2.5%), and fibrosing alopecia in a
Low-dose oral minoxidil (LDOM) (0.25-5 mg/day) pattern distribution (1.8%). LDOM was the only
has been used off label to treat various forms of systemic therapy in 20.8% of patients. Three hundred
alopecia.8-21 The use of LDOM for the treatment of and thirty-nine patients received a fixed dose
hair loss has significantly increased in the last few regimen of LDOM with no increments. The remain-
years for several reasons: (1) many patients find oral ing 1065 patients received LDOM at various incre-
administration more convenient than the topical mental doses as tolerated, resulting in a total of 2469
application of a lotion or foam; (2) topical applica- doses administered to 1404 patients (Table I). The
tion is operator-dependent, ie, some parts of the mean dose used was 1.63 mg (range 0.03-15) and the
scalp may be missed in those with widespread mean duration of treatment was 7.9 months (range
alopecia; and (3) LDOM circumvents the local 3-79). Adverse effects were detected in 509 cases
side effects associated with topical minoxidil such (20.6%), leading to treatment withdrawal in 43
as irritation and allergic contact dermatitis.22 patients (1.7%). The most common adverse effect
Nevertheless, the major concern of oral administra- was hypertrichosis (374 patients, 15.1%), which
tion is the potential risk of systemic adverse effects. resulted in discontinuation in 14 cases (0.5%).
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neither the dose of LDOM nor the other variables

Abbreviations used:
were associated with a higher risk of systemic
EOD: every other day adverse effects.
LDOM: low-dose oral minoxidil

DISCUSSION
Systemic adverse effects (Table II) were observed in To our knowledge, this research represents the
135 patients (5.5%), of whom 29 (1.2%) discontinued largest study on the safety of LDOM for the treatment
treatment, and these adverse effects included light- of patients with hair loss disorders. Since the first
headedness (n = 43), fluid retention/leg edema report of its use in 2 women with monilethrix in
(n = 32), tachycardia (n = 21), headache (n = 9), 2016,19,21 LDOM has been widely used for various
periorbital edema (n = 7), and insomnia (n = 6). types of alopecia,22 especially male10,16 and female
Fourteen patients (0.9%) had [1 adverse effect. Of pattern hair loss.13,14
those, 6 (5 female and 1 male; median dose 1 mg; LDOM was found to be well-tolerated in 2 recent
range 0.25-5 mg) developed hypertrichosis as well as systematic reviews investigating its effectiveness and
lower limb edema (n = 3), lightheadedness (n = 2), or safety in patients with hair loss.15,16 The most
periorbital edema (n = 1). The overall frequency of frequent adverse effect was hypertrichosis (20%-
adverse effects and the proportion of patients 24%), which rarely led to treatment discontinua-
requiring discontinuation did not significantly differ tion.23 Cardiovascular adverse effects, which are
in patients with androgenetic alopecia from those relatively common with antihypertensive doses,
with other types of alopecia. were rare and typically minor. Symptoms of postural
Less common adverse effects included increased hypotension, tachycardia, and lower limb edema
hair shedding (n = 5), nausea (n = 2), mild increase in were reported by 1%-3% of patients, while pedal
liver enzymes (n = 2), menorrhagia (n = 2), self- edema was associated with higher doses (5 mg). No
limiting chest pain (n = 1), and acne (n = 1). serious or life-threatening adverse effects were
All systemic adverse effects improved with dose reported, supporting the good safety profile of
adjustment or withdrawal of LDOM, and no life- LDOM for the treatment of hair loss.
threatening adverse effects were reported. The most The overall frequency of adverse effects in our
common adverse effects that resulted in discontinu- study was 20.6%. Hypertrichosis was by far the most
ation (n = 43, 1.7%; 39 female and 4 male) were common and was associated with a mean dose of
hypertrichosis (n = 14, 0.5%), fluid retention (n = 8, LDOM of 1.4 mg in females and 4.1 mg in males.
0.3%), tachycardia (n = 7, 0.2%), lightheadedness Interestingly, only 3.7% of patients who grew un-
(n = 5, 0.2%), and headaches (n = 4, 0.1%) (Fig 1). wanted hair on the face/body discontinued treat-
Weight was recorded in 342 patients (24.3%; mean ment. Our findings reflect those of Jimenez-Cauhe
67.2 kg; range 42-124). No statistically significant et al23 who found that only 4% of patients who
association was found between weight and any of developed hypertrichosis discontinued LDOM treat-
the adverse effects. Topical minoxidil was used in ment for their hair loss. In our experience, patients
26.1% of patients in combination with LDOM and prefer to manage hypertrichosis with hair removal
was not associated with a higher risk of hyper- methods while continuing therapy, provided that
trichosis or other adverse effects. LDOM was admin- they can appreciate the benefits of LDOM (decreased
istered daily in 95% of patients and every other day hair shedding and increased scalp hair density). We
(EOD) in 5% of patients. Bivariate analysis showed found that EOD administration may be associated
that EOD administration was associated with a lower with a lower risk of hypertrichosis. The reason for
risk of hypertrichosis (15.8% vs 9.8%, P = .04). The this observation is unclear and more studies are
compounded medication was associated with a required to corroborate this finding and to define
higher risk of hypertrichosis, but no other adverse whether EOD administration is better tolerated than
effects, compared with the commercially marketed daily intake. Both scalp hair growth and hyper-
drug (Loniten) (18.7% vs 14.5%, P = .014). trichosis in patients on LDOM therapy are dose-
Multivariate analysis showed that the most impor- dependent. In our experience, the correlation
tant risk factor for hypertrichosis was the dose of between the increase in scalp hair growth and
LDOM (odds ratio 1.26 [95% confidence interval: hypertrichosis is not linear. In fact, the mean dose
1.17-1.35], P \.001), when adjusted for age, weight, of LDOM that resulted in hypertrichosis was 1.77 mg.
sex, and duration of treatment. EOD administration However, improvements in hair density can be
showed a trend toward a protective affect against achieved with doses as low as 0.25-1 mg.11,13,14,18
hypertrichosis [odds ratio 0.55, P = .062]. However, Due to the absence of marketed tablets of oral
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VOLUME 84, NUMBER 6

Table I. Description of the cohort of women and men treated with low-dose oral minoxidil (LDOM) and
frequency of adverse effects (N = 2469, different doses of LDOM)
Women (n = 1612) Men (n = 857) Total (N = 2469)
Mean age in years (range) 47 (8-86) 37 (14-78) 43 (8-86)
Country of origin Australia (n = 528), Australia (n = 323), Australia (n = 851),
Brazil (n = 173), Brazil (n = 129), Brazil (n = 302),
Italy (n = 135), Italy (n = 71), Italy (n = 206),
Poland (n = 51), Poland (n = 0), Poland (n = 51),
Spain (n = 574), and Spain (n = 260), and Spain (n = 834), and
United States (n = 151) United States (n = 74) United States (n = 225)
Median dose in mg (range) 1.11 (0.03-12.5) 2.60 (0.15-15) 1.63 (0.03-15)
Median treatment duration 8 (3-79) 7.8 (3-63) 7.9 (3-79)
in months (range)
Marketed drug 1402 (87%) 542 (63%) 1943 (78.7%)
Concomitant use of topical 442 (27.4%) 184 (21.5%) 626 (25.4%)
minoxidil
Adverse effects (any) 422 (26.1%) 87 (10.1%) 509 (20.6%)
Required discontinuation 39 (2.5%) 4 (0.5%) 43 (1.7%)
Hypertrichosis 324 (20.1%) 50 (5.8%) 374 (15.1%)
Median latency period (in days) 60 (14-450) 60 (21-120) 60 (14-450)
until hypertrichosis (range)
Mean dose in mg (range) that 1.42 (0.25-5) 4.10 (0.5-12.5) 1.77 (0.25-12.5)
produced hypertrichosis
Required dose adjustment 84 (5.2%) 9 (1.1%) 93 (3.8%)
Required discontinuation 14 (0.9%) 0 14 (0.5%)
Mean time (in days) receiving 73 (45-100) - 73 (45-100)
LDOM until discontinuation
(range)
Systemic side effects 98 (6.1%) 37 (4.3%) 135 (5.5%)
Required discontinuation 25 (1.6%) 4 (0.5%) 29 (1.2%)
Mean time (in days) receiving 34 (1-120) 45 (1-60) 36 (1-120)
LDOM until discontinuation
(range)

LDOM, Low-dose oral minoxidil.

minoxidil at low doses, the administration of non- concordance with previous studies,15,16 there were
marketed compounds is necessary in some coun- no serious or life-threatening side effects associated
tries. The use of compounded LDOM capsules was with LDOM therapy. The risk of systemic adverse
associated with a higher risk of hypertrichosis. This effects associated with LDOM was unrelated to dose,
finding may suggest unintended dose variations in age or sex. Despite the relatively high incidence of
compounded capsules. At least 3 patients in the systemic side effects with antihypertensive doses of
current study developed hypertrichosis as a result of minoxidil (10-40 mg),2,3 we found that systemic side
errors in the dosage of the medication by the effects associated with low doses of oral minoxidil
compounding pharmacy, resulting in a higher dose (#5 mg) were uncommon and not dose-dependent.
of LDOM than that prescribed by their dermatologist. We hypothesize that the systemic adverse effects of
This highlights the importance of a carefully LDOM may be influenced by idiosyncratic patient
controlled compounding pharmacy environment, characteristics and individual genetic variations in
which should include handling only by a licensed the activity of the minoxidil sulfotransferase enzyme
compounding pharmacist. (SULT1A1).24,25
Systemic adverse effects of LDOM occurred in Pericardial effusions occur in approximately 3% of
5.5% of patients (Fig 1). In all cases, these were mild patients treated with high-dose oral minoxidil and
and resolved with dose reduction or treatment are most common among patients with advanced
discontinuation. Twenty-nine patients (1.2%) nephropathy or on dialysis.26 In a study of 1869
stopped LDOM therapy owing to systemic adverse patients with severe hypertension treated with
effects, mostly edema (n = 8), tachycardia (n = 7), minoxidil, approximately 5% developed pericardial
lightheadedness (n = 5), and headache (n = 4). In disorders, including pericarditis, pericardial effusion,
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Table II. Description of the systemic side effects associated with the use of low-dose oral minoxidil in men and
women
Women (n = 1612) Men (n = 857) Total (N = 2469)
Systemic side effects 98 (6.1%) 37 (4.3%) 135 (5.5%)
Lightheadedness 33 (2.0%) 10 (1.1%) 43 (1.7%)
Median latency period (in days) until lightheadedness (range) 5 (1-20) 5 (1-20) 5 (1-20)
Mean dose in mg that produced lightheadedness 0.93 3.90 1.62
Required discontinuation 4/33 (12%) 1/10 (10%) 5/44 (11.3%)
Fluid retention (leg edema) 18 (1.1%) 14 (1.6%) 32 (1.3%)
Median latency period (in days) until fluid retention (range) 90 (15-360) 57 (30-90) 60 (15-360)
Mean dose in mg that produced fluid retention 0.97 3.25 1.97
Required discontinuation 6/18 (33%) 2/14 (14%) 8/32 (25%)
Tachycardia 15 (0.9%) 6 (0.7%) 21 (0.9%)
Median latency period (in days) until tachycardia (range) 2 (0-7) 1 (0-2) 1 (0-7)
Mean dose in mg that produced tachycardia 0.73 2.52 1.24
Required discontinuation 7/15 (46%) 0/6 7/21 (33.3%)
Headache 8 (0.5%) 1 (0.1%) 9 (0.4%)
Median latency period (in days) until headache (range) 19 (5-20) 25 (25-25) 20 (5-25)
Mean dose in mg that produced headache 1.28 1.25 1.27
Required discontinuation 4/8 (50%) 0/1 4/9 (44.4%)
Periorbital edema 4 (0.2%) 3 (0.3%) 7 (0.3%)
Median latency period (in days) until periorbital edema 105 (30-210) 60 (30-60) 60 (30-210)
(range)
Mean dose in mg that produced periorbital edema 0.75 5.80 2.92
Required discontinuation 0/4 0/3 0/7
Insomnia 5 (0.3%) 1 (0.1%) 6 (0.2%)
Median latency period (in days) until insomnia (range) 120 (7-180) 7 (7-7) 90 (7-180)
Mean dose in mg that produced insomnia 1 1 1
Required discontinuation 3/5 (60%) 0/1 3/6 (50%)
Others 15 (0.9%) 2 (0.2%) 17 (0.7%)
Required discontinuation 1/15 (7%) 1/2 (50%) 2/17 (11.7%)
(both: intense hair shedding)

Fig 1. Schematic of total number of patients treated with low-dose oral minoxidil (N = 1404),
percentage of patients who developed adverse effects and number of patients requiring
discontinuation owing to adverse effects. The time from starting low-dose oral minoxidil
therapy to the development of adverse effects (median and range, days) is shown at the
bottom. LDOM, Low-dose oral minoxidil.
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Table III. Common adverse effects of low-dose oral minoxidil, mean time to development of adverse effects,
and suggested management strategies
Adverse effect Mean time for adverse
of LDOM effect to develop (days) Management*
Hypertrichosis 60 Hair removal methods (laser, shaving, plucking, bleaching, waxing)
Lightheadedness 5 Taking LDOM at bedtime, getting up slowly from a lying/sitting position,
increasing fluid intake, adjusting doses of antihypertensives (by general
practitioner)
Fluid retention 60 Limiting salt intake; diuretics, eg, furosemide (in males and females) and
Periorbital edema 60 spironolactone (in females)
Tachycardia 1 Beta-blockers; if persistent, refer to cardiologist
Headache 20 Simple analgesics, eg, paracetamol, nonsteroidal anti-inflammatory drugs
Insomnia 90 Sleep strategies/relaxation, pharmacotherapy (by general practitioner)

LDOM, Low-dose oral minoxidil.

*If adverse effects are severe or persist in spite of the above management strategies, consider dose reduction or discontinuation.

and cardiac tamponade.27 Most of the patients who special caution should be exercised in patients with a
developed pericarditis had an underlying systemic history of orthostatic hypotension and syncope and
disorder such as systemic lupus erythematosus, in patients taking calcium channel antagonists
whereas most of those who developed pericardial (which are peripheral vasodilators). Lower extremity
effusion and cardiac tamponade had chronic renal edema is related to sodium and water retention
failure or chronic congestive cardiac failure. It is secondary to renal hemodynamic and/or neurohu-
unclear whether minoxidil was responsible for these moral changes as well as direct tubular effects of oral
pericardial disorders as other risk factors were pre- minoxidil.28 Spironolactone, a potassium-sparing
sent and no baseline echocardiogram was per- diuretic with antiandrogenic properties, may be
formed. Most of the effusions resolved despite used to manage LDOM-induced fluid retention in
continued treatment with minoxidil. Moreover, there women, especially those with female pattern hair
are no reports of pericardial disorders among pa- loss. Tachycardia is the result of reflex sympathetic
tients treated with minoxidil for hair loss. activation in response to the vasodilatory effect of
Fortunately, there were no cases of pericardial oral minoxidil. In most of our 21 cases, the reflex
disorders or ischemic heart disease in our large tachycardia was transient, but in persistent cases, it
cohort. Theoretically, myocardial ischemia can be led to treatment discontinuation. Although tachy-
aggravated by oral minoxidil-induced reflex tachy- cardia can theoretically be managed with beta-
cardia. In fact, minoxidil therapy for hypertension blockers, we argue that a persistently elevated heart
was sometimes administered with a diuretic and a rate may warrant LDOM withdrawal or consultation
beta-blocker to reduce sympathetic tone and sodium with a cardiologist. Interestingly, there were no
retention.26 The absence of severe cardiovascular reports of nausea or vomiting in our study, even
side effects in our cohort may be related to the though nausea is cited as a common side effect of
favorable risk profile of our population, most of high-dose oral minoxidil.2
whom were relatively young and healthy, in addition We found that LDOM-induced adverse effects
to the low doses required for the treatment of hair developed in a time-dependent fashion (Fig 1).
loss. We suggest that a baseline electrocardiogram is While reflex tachycardia and orthostatic hypotension
unnecessary when doses of minoxidil #5 mg are manifested early (median latency periods of 1 and
administered, which most of our patients were on. 5 days, respectively), fluid retention, periorbital
However, this should be assessed on a case-by-case edema, and hypertrichosis had a delayed onset
basis, and we recommend a low threshold for (median latency period of 60 days). These data will
performing an electrocardiogram in patients with help dermatologists counsel their alopecia patients
cardiovascular risk factors such as angina, pericar- on when to anticipate various adverse effects. As
ditis, chronic heart failure, and renal impairment. hypertrichosis usually develops within 3 months of
The management of adverse effects of LDOM initiation or dose escalation, we suggest that the dose
raises an interesting issue for dermatologists. We of LDOM can be uptitrated after 3 months in the
suggest strategies that we have found helpful in absence of undesirable hair growth.23
managing common side effects (Table III). Given We cannot exclude that other drugs used for hair
that lightheadedness can occur with LDOM therapy, loss were responsible for some of the side effects. For
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example, 13 of 43 patients who complained of 6. Olsen EA, DeLong ER, Weiner MS. Dose-response study of
lightheadedness were also taking oral spironolac- topical minoxidil in male pattern baldness. J Am Acad
Dermatol. 1986;15(1):30-37.
tone. However, there was no association between 7. Rietschel RL, Duncan SH. Safety and efficacy of topical
the development of orthostatic hypotension and minoxidil in the management of androgenetic alopecia. J
concomitant use of specific antihypertensive drugs. Am Acad Dermatol. 1987;16(3 Pt 2):677-685.
Further research is required to equip dermatologists 8. Sinclair RD. Female pattern hair loss: a pilot study investigating
with data on the use of LDOM in patients with pre- combination therapy with low-dose oral minoxidil and spi-
ronolactone. Int J Dermatol. 2018;57(1):104-109.
existing cardiovascular diseases or arterial hyperten- 9. Jimenez-Cauhe J, Saceda-Corralo D, Rodrigues-Barata R, et al.
sion, including those on antihypertensives. Effectiveness and safety of low-dose oral minoxidil in male
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following starting doses and titration regimens for 649.
females: starting dose of 0.5 mg/day followed by 10. Pirmez R, Salas-Callo CI. Very-low-dose oral minoxidil in male
androgenetic alopecia: a study with quantitative trichoscopic
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response and tolerability up to a maximum dose of 11. Jha AK, Sonthalia S, Zeeshan MD, Vinay K. Efficacy and safety
2.5 mg; and males: starting dose of 2.5 mg/day of very-low-dose oral minoxidil 1.25 mg in male androgenetic
followed by 1.25 mg increments every 3 months alopecia. J Am Acad Dermatol. 2020;83(5):1491-1493.
depending on response and tolerability up to a 12. Panchaprateep R, Lueangarun S. Efficacy and safety of oral
minoxidil 5 mg once daily in the treatment of male patients
maximum dose of 5 mg/day. We recommend this with androgenetic alopecia: an open-label and global photo-
protocol for patients aged $12 years, although lower graphic assessment. Dermatol Ther (Heidelb). 2020;10(6):1345-
starting doses should be considered in those aged 1357.
12-17 years. Experience with oral minoxidil in 13. Ramos PM, Sinclair RD, Kasprzak M, Miot HA. Minoxidil 1 mg
children under 12 is still limited. In patients with oral versus minoxidil 5% topical solution for the treatment of
female-pattern hair loss: a randomized clinical trial. J Am Acad
chronic hair loss conditions, LDOM may be used Dermatol. 2020;82(1):252-253.
indefinitely, otherwise any improvement in hair 14. Rodrigues-Barata R, Moreno-Arrones OM, Saceda-Corralo D,
density may be lost within a few months of treatment et al. Low-dose oral minoxidil for female pattern hair loss: a
discontinuation. We should emphasize that this is unicenter descriptive study of 148 women. Skin Appendage
strictly an off-label indication and detailed informed Disord. 2020;6(3):175-176.
15. Randolph M, Tosti A. Oral minoxidil treatment for hair loss: a
consent should be obtained. Furthermore, the dose review of efficacy and safety. J Am Acad Dermatol. 2021;84(3):
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on comorbidities. 16. Jimenez-Cauhe J, Saceda-Corralo D, Rodrigues-Barata R, et al.
The limitations of our study were the retrospective Safety of low-dose oral minoxidil treatment for hair loss. A
design, lack of a control group, and lack of recording systematic review and pooled-analysis of individual patient
data. Dermatol Ther. 2020;33(6):e14106.
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et al. Oral minoxidil improves background hair thickness in
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Conflicts of interest
Dermatol. 2016;57(4):e130-e132.
None disclosed. 20. Perera E, Sinclair R. Treatment of chronic telogen effluvium
with oral minoxidil: a retrospective study. F1000Res. 2017;6:
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