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In this report, a fatal case is described in which mild initial symptoms rapidly progressed to fulminant hepatocellular injury and acute liver failure within days, underscoring the importance of early recognition of drug\u2010induced liver injury and prompt discontinuation of labetalol. A PRISMA\u2010guided systematic review of MEDLINE, Embase, CINAHL, Cochrane Library, PubMed, and Google Scholar (from inception to December 2025) identified 27 published case reports. Patients were predominantly female (\u224880%), and one\u2010third were pregnant or postpartum. Latency ranged from 7 to 365 days (median \u224860 days). The injury phenotype was consistently hepatocellular, often with autoimmune\u2010like serologic or histologic features. Outcomes included full recovery in most (\u224875%), but also liver transplantation and death. In the FDA Adverse Event Reporting System (2020Q1\u20102025Q1), labetalol showed strong disproportionality signals for DILI (PRR 22.7, 95% CI 15.6\u201033.1; ROR 23.7, 95% CI 16.0\u201035.1; IC025 2.5) and autoimmune hepatitis (PRR 59.8, 95% CI 34.1\u2010104.8; ROR 60.9, 95% CI 34.4\u2010108.1; IC025 2.8), which persisted when restricted to other \u03b2\u2010blockers as comparators. Signals for acute hepatic failure and hyperbilirubinemia were elevated but less statistically robust. The available evidence is consistent with a clinically meaningful and biologically plausible association between labetalol and idiosyncratic hepatotoxicity, supporting heightened clinical awareness and further mechanistic and population\u2010based study.<\/jats:p>","DOI":"10.1002\/jcph.70192","type":"journal-article","created":{"date-parts":[[2026,4,24]],"date-time":"2026-04-24T15:50:08Z","timestamp":1777045808000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Hepatotoxicity Associated with Labetalol Use: A Case Report with Systematic Review and Disproportionality Analysis Using FAERS"],"prefix":"10.1002","volume":"66","author":[{"ORCID":"https:\/\/orcid.org\/0009-0005-0955-7942","authenticated-orcid":false,"given":"Emma D.","family":"Hendriksen","sequence":"first","affiliation":[{"name":"Department of Pharmacology, Schulich School of Medicine and Dentistry University of Western Ontario  London Ontario Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Rieder","sequence":"additional","affiliation":[{"name":"Department of Pharmacology, Schulich School of Medicine and Dentistry University of Western Ontario  London Ontario Canada"},{"name":"Department of Pediatrics and Physiology University of Western Ontario  London Ontario Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elizabeth","family":"Urbantke","sequence":"additional","affiliation":[{"name":"Office of the Chief Coroner of Ontario, Ontario, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,4,24]]},"reference":[{"key":"e_1_2_12_2_1","doi-asserted-by":"publisher","DOI":"10.1097\/AOG.0000000000003891"},{"key":"e_1_2_12_3_1","unstructured":"Hypertension in pregnancy: diagnosis and management (NICE guideline).National Institute for Health and Care Excellence. 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