Safety of Topical Minoxidil Solution: A One-Year, Prospective, Observational Study


Background: Topical minoxidil solution (TMS) is widely used for androgenetic alopecia (AGA), and this is the first report of a large safety trial. Objectives: The aim of the study was to evaluate the safety profile of TMS by comparing hospitalization and death rates among subjects using TMS with controls. Cardiovascular safety and pregnancy outcomes were evaluated, and usage patterns were described. Methods: All subjects were followed at baseline, 3, 6, 9, and 12 months. Usage patterns, pregnancy status, overnight hospital stays, and cardiovascular risk factors were evaluated. Subjects rated effectiveness of TMS in the treatment of AGA. Statistical analyses were conducted to determine if TMS was associated with an increased risk of death or hospitalization. Results: TMS is a safe and effective treatment for AGA. There were no increases in cardiovascular events and no apparent increased risk for adverse pregnancy outcomes. Conclusions: This large, prospective study demonstrated the overall safety of TMS in the treatment of AGA.


Antécédents: Le minoxidil en solution topique est fréquemment utilisé dans le traitement de la pelade. Nous présentons ici le premier rapport d’innocuité à large échelle. Objectifs: Évaluer le profil d’innocuité du minoxidil en solution topique en comparant les taux d’hospitalisation et de mortalité des sujets qui reçoivent un traitement contrôlé de la solution. L’innocuité cardiovasculaire a été évaluée, les grossesses ont été suivies et les tendances d’utilisation décrites. Méthodes: Tous les sujets ont été suivis dès le début du traitement avec les évaluations ayant lieu aux 3, 6, 9, et 12 mois. Les tendances d’utilisation, le statut des grossesses, les hospitalisations et les facteurs de risques cardiovasculaires ont été évalués. Les sujets ont évalué l’efficacité de la solution de minoxidil dans le traitement de la pelade. Des analyses statistiques ont été effectuées en vue de déterminer si le minoxidil en solution topique était associé à un risque plus élevé de décès ou d’hospitalisation. Résultats: Le traitement au minoxidil en solution topique contre la pelade est sécuritaire et n’augmente pas le risque des accidents cardiovasculaires. Également il n’y a eu aucune augmentation apparente des risques en cas de grossesse. Conclusions: Cette étude prospective à large échelle a démontré l’innocuité générale du traitement au minoxidil en solution topique centre la pelade.

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  1. 1

    VM Meidan E Touitou (2001) ArticleTitleTreatments for androgenetic alopecia and alopecia areata: current options and future prospects. Drugs 61 53–69 Occurrence Handle1:CAS:528:DC%2BD3MXhsVWrsbk%3D Occurrence Handle11217871

    CAS  PubMed  Google Scholar 

  2. 2

    TA Nielsen M Reichel (1995) ArticleTitleAlopecia: diagnosis and management. Am Fam Physician 51 1513–1522 Occurrence Handle7732952

    PubMed  Google Scholar 

  3. 3

    E Olsen (1994) Androgenetic alopecia. E Olsen (Eds) Disorders of hair growth. McGraw-Hill New York 257–283

    Google Scholar 

  4. 4

    AM Kligman B Freeman (1988) ArticleTitleHistory of baldness: from magic to medicine. Clin Dermatol 6 83–88 Occurrence Handle1:STN:280:BiaC3cngsVU%3D

    CAS  Google Scholar 

  5. 5

    TF Cash (1999) ArticleTitleThe psychosocial consequences of androgenetic alopecia: a review of the research literature. Br J Dermatol 141 398–405 Occurrence Handle10.1046/j.1365-2133.1999.03030.x Occurrence Handle1:STN:280:DC%2BD3c%2FltVWhtg%3D%3D Occurrence Handle10583042

    Article  CAS  PubMed  Google Scholar 

  6. 6

    K Davies (1998) ArticleTitleHair apparent. Nature 391 537–539 Occurrence Handle10.1038/35264 Occurrence Handle1:CAS:528:DyaK1cXpvFCktw%3D%3D Occurrence Handle9468131

    Article  CAS  PubMed  Google Scholar 

  7. 7

    RL DeVillez JP Jacobs CA Szpunar et al. (1994) ArticleTitleAndrogenetic alopecia in the female: treatment with 2% topical minoxidil solution. Arch Dermatol 130 303–307 Occurrence Handle10.1001/archderm.130.3.303 Occurrence Handle1:STN:280:ByuC2srlsFA%3D Occurrence Handle8129407

    Article  CAS  PubMed  Google Scholar 

  8. 8

    VH Price E Menefee PC Strauss (1999) ArticleTitleChanges in hair weight and hair count in men with androgenetic alopecia, after application of 5% and 2% topical minoxidil, placebo, or no treatment. J Am Acad Dermatol 41 717–721 Occurrence Handle1:STN:280:DC%2BD3c%2FgsF2msw%3D%3D Occurrence Handle10534633

    CAS  PubMed  Google Scholar 

  9. 9

    CA Chidsey 3rd TB Gottlieb (1974) ArticleTitleThe pharmacologic basis of antihypertensive therapy: the role of vasodilator drugs. Prog Cardiovasc Dis 27 99–113

    Google Scholar 

  10. 10

    Baumgartner MA, Spindler JR. The effects of topical minoxidil in untreated hypertensives (protocol M7410/0084). Study report 7410/85/9157, November 20, 1985.

  11. 11

    JR Spindler (1988) ArticleTitleThe safety of topical minoxidil solution in the treatment of pattern baldness: the results of a 27-center trial. Clin Dermatol 6 200–211 Occurrence Handle1:STN:280:BiaC3cngt1w%3D Occurrence Handle3063372

    CAS  PubMed  Google Scholar 

  12. 12

    Spindler JR, Corak DL, Rohrstaff DM, et al. Topical minoxidil: long-term safety information from studies in males and females with androgenetic alopecia. Upjohn Study Report 9157-93-002. Peapack, NJ: Pharmacia and Upjohn Consumer Healthcare, March 22, 1993.

  13. 13

    CR Herrera RB D’Agostino BB Gerstman et al. (1995) ArticleTitleBaldness and coronary heart disease rates in men from the Framingham Study. Am J Epidemiol 142 828–833 Occurrence Handle1:STN:280:BymD3MjktVI%3D Occurrence Handle7572959

    CAS  PubMed  Google Scholar 

  14. 14

    PA Lotufo CE Chae UA Ajani et al. (2000) ArticleTitleMale pattern baldness and coronary heart disease: the Physicians’ Health Study. Arch Intern Med 160 165–171 Occurrence Handle10.1001/archinte.160.2.165 Occurrence Handle1:STN:280:DC%2BD3c7ht1arsg%3D%3D Occurrence Handle10647754

    Article  CAS  PubMed  Google Scholar 

  15. 15

    VA Matilainen PK Makinen SM Keinanen–Kiukaanniemi (2001) ArticleTitleEarly onset of androgenetic alopecia associated with early severe coronary heart disease: a population-based, case-control study. J Cardiovasc Risk 8 147–151 Occurrence Handle10.1097/00043798-200106000-00005 Occurrence Handle1:STN:280:DC%2BD38%2FitVOksA%3D%3D Occurrence Handle11455846

    Article  CAS  PubMed  Google Scholar 

  16. 16

    B Persson BW Johansson (1984) ArticleTitleThe Kockum study. Twenty-two-year follow-up: coronary heart disease in a population in the south of Sweden. Acta Med Scand 216 485–493 Occurrence Handle1:STN:280:BiqC3MflsVU%3D Occurrence Handle6524453

    CAS  PubMed  Google Scholar 

  17. 17

    S Sasmaz M Senol A Ozcan et al. (1999) ArticleTitleThe risk of coronary heart disease in men with androgenetic alopecia. J Eur Acad Dermatol Venereol 12 123–125 Occurrence Handle10.1016/S0926-9959(98)00145-7 Occurrence Handle1:STN:280:DyaK1M3nsFCjug%3D%3D Occurrence Handle10343940

    Article  CAS  PubMed  Google Scholar 

  18. 18

    M Trevisan E Farinaro V Krogh et al. (1993) ArticleTitleBaldness and coronary heart disease risk factors. J Clin Epidemiol 46 1213–1218 Occurrence Handle1:STN:280:ByuD3MrhvFI%3D Occurrence Handle8410106

    CAS  PubMed  Google Scholar 

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Correspondence to Jerry Shapiro.

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Shapiro, J. Safety of Topical Minoxidil Solution: A One-Year, Prospective, Observational Study . JCMS 7, 322–329 (2003).

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  • Pregnancy Outcome
  • Hair Loss
  • Adverse Pregnancy Outcome
  • Minoxidil
  • Pregnancy Status