{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,23]],"date-time":"2026-03-23T14:04:35Z","timestamp":1774274675574,"version":"3.50.1"},"reference-count":21,"publisher":"MDPI AG","issue":"3","license":[{"start":{"date-parts":[[2026,3,21]],"date-time":"2026-03-21T00:00:00Z","timestamp":1774051200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Life"],"abstract":"<jats:p>Oral minoxidil, including low-dose regimens, is increasingly used off-label for alopecia, but cardiovascular safety remains a clinical concern. We compared cardiovascular adverse event reporting patterns for oral versus topical minoxidil using a disproportionality analysis of the FDA Adverse Event Reporting System (FAERS). FAERS data (2004Q1\u20132025Q3) were imported and deduplicated; minoxidil reports were restricted to primary\/secondary suspect (PS\/SS) drugs and eligible reports from 2012 to 2025. Exposure was classified as ORAL, TOPICAL, BOTH, or UNKNOWN using a standardized route\/dose-form dictionary. Signals for Core and Expanded cardiovascular MedDRA Preferred Terms (PTs) were assessed using reporting odds ratios (RORs) with 95% confidence intervals; sensitivity analyses included alopecia-restricted cohorts excluding hypertension indications. In the primary ORAL-versus-TOPICAL cohort (559 oral; 56,947 topical), 23 Core-list PTs and 31 Expanded-list PTs met the signal definition. Strongest primary signals included pericardial effusion (ROR 307; 95% CI 158\u2013597), hypertensive crisis (ROR 1037; 95% CI 133\u20138117), pulmonary hypertension (ROR 932; 95% CI 118\u20137368), and pulmonary edema (ROR 1965; 95% CI 114\u201333,813). In an alopecia-restricted sensitivity cohort excluding hypertension\/blood-pressure indications (146 oral; 24,367 topical), hemodynamic and effusion-related PTs (e.g., tachycardia, palpitations, orthostatic hypotension, syncope, and pericardial effusion) remained disproportionately reported, although event counts were smaller and confidence intervals were wider. Oral minoxidil PS\/SS reports in FAERS showed disproportionate reporting of several cardiovascular PTs relative to topical minoxidil reports. However, because FAERS is a spontaneous reporting system without exposed-patient denominators and with important limitations including under-reporting, stimulated reporting, incomplete clinical information, and residual confounding, these findings should be interpreted strictly as hypothesis-generating reporting signals rather than evidence of incidence, relative risk, or definitive comparative clinical safety.<\/jats:p>","DOI":"10.3390\/life16030522","type":"journal-article","created":{"date-parts":[[2026,3,23]],"date-time":"2026-03-23T13:07:06Z","timestamp":1774271226000},"page":"522","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Cardiovascular Safety Signals of Oral Versus Topical Minoxidil in FAERS: A Disproportionality Analysis (Analytic Cohort 2012\u20132025)"],"prefix":"10.3390","volume":"16","author":[{"ORCID":"https:\/\/orcid.org\/0009-0000-5226-1622","authenticated-orcid":false,"given":"Hima Bindu","family":"Makkena","sequence":"first","affiliation":[{"name":"Independent Researcher, McKinney, TX 75071, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vikas","family":"Kasu","sequence":"additional","affiliation":[{"name":"Independent Researcher, McKinney, TX 75071, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2026,3,21]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"737","DOI":"10.1016\/j.jaad.2020.06.1009","article-title":"Oral minoxidil treatment for hair loss: A review of efficacy and safety","volume":"84","author":"Randolph","year":"2021","journal-title":"J. Am. Acad. Dermatol."},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"761","DOI":"10.1016\/j.jaad.2020.10.032","article-title":"Low-dose oral minoxidil for treating alopecia: A 3-year North American retrospective case series","volume":"84","author":"Beach","year":"2021","journal-title":"J. Am. Acad. Dermatol."},{"key":"ref_3","unstructured":"U.S. Food and Drug Administration (2026, March 17). Loniten (minoxidil) Tablets, USP: Prescribing Information. Revised 2015, Available online: https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2015\/018154s026lbl.pdf."},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"e16574","DOI":"10.1111\/jocd.16574","article-title":"Low-dose oral minoxidil and associated adverse events: Analyses of the FDA Adverse Event Reporting System (FAERS) with a focus on pericardial effusions","volume":"24","author":"Gupta","year":"2025","journal-title":"J. Cosmet. 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