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What are documented cases of ivermectin-induced liver injury and when were they reported?
Executive Summary
Documented instances of ivermectin-associated liver injury are rare but present in the medical literature and pharmacovigilance databases, with clustered reports during the COVID‑19 era tied largely to off‑label use and misuse. Key sources identify a small number of serious hepatic events in VigiBase pharmacovigilance analyses and several individual case reports dating mainly from 2006 through 2024, including cases of cholestatic hepatitis, mixed hepatic failure after self-injection of veterinary formulations, and multiorgan toxicity where liver injury occurred alongside other toxic effects [1] [2] [3] [4]. These reports show temporality with ivermectin exposure and recovery after cessation in many cases, but they are sparse relative to total use and often involve confounding factors such as concurrent substances, COVID‑19 illness, or veterinary product misuse.
1. Small cluster signals in the WHO database that demanded attention
A pharmacovigilance review of VigiBase identified a cluster of serious hepatic disorders linked to ivermectin reported in the context of COVID‑19, noting six hepatic events among reports flagged as serious and 25 serious reports specifically tied to COVID‑19 treatment; the review analyzed 1,393 individual case safety reports and flagged hepatitis, hepatocellular injury, cholestasis and abnormal liver tests as the main presentations [1] [5]. The authors concluded these signals warrant closer monitoring, especially because several reports involved concomitant hepatotoxic drugs or pre‑existing liver disease, which are important confounders. The pharmacovigilance findings date to analyses published between 2022 and 2024 and represent signal detection rather than definitive causation, reflecting spontaneous reporting limitations such as underreporting, variable data quality, and absence of denominator exposure data [1] [6].
2. Individual case reports: concrete examples and varying contexts
Several case reports detail individual patients with temporally associated liver injury after ivermectin exposure. A reported 61‑year‑old man developed acute liver failure after self‑injecting horse ivermectin; his presentation included mixed enzyme elevations, encephalopathy and coagulopathy, with recovery under supportive care, and the authors interpreted ivermectin misuse as the likely driver [2]. A 70‑year‑old woman developed cholestatic hepatitis after prophylactic ivermectin for COVID‑19 and improved with low‑dose corticosteroids, and the report characterized this as one of only a handful of documented human ivermectin‑related hepatotoxic events [3]. Another clinical vignette described a patient with multiorgan failure attributed to combined ivermectin and DEET toxicity, reported in Critical Care Medicine, emphasizing polyexposure as a complicating factor [4].
3. Timeline and provenance: where and when were they reported
The earliest cited clinical report in this assembled material references a 2006 case in a parasitic treatment context, with more concentrated reporting occurring during and after the COVID‑19 pandemic, when off‑label and self‑administered ivermectin use increased; formal pharmacovigilance analyses and case series emerged between 2022 and 2024 documenting the six VigiBase hepatic events and individual case reports published in 2022–2024 [1] [3] [2] [7]. A May 2024 case report of severe drug‑induced liver injury from fenbendazole is unrelated to ivermectin but underscores the broader issue of self‑administration of veterinary antiparasitics, which has been a recurrent theme in reports of severe toxicity during the pandemic era [8].
4. How clinicians and researchers interpret causality and uncertainty
Clinicians and pharmacovigilance researchers treat ivermectin‑linked liver injury as plausible but uncommon, with causality often suggested by temporal association, improvement after withdrawal, and biopsy patterns consistent with drug‑induced liver injury in some reports [3]. However, assessments uniformly note major limitations: small numbers of reports, potential for confounding by COVID‑19 itself (which can cause hepatic abnormalities), concomitant hepatotoxins, and misuse of veterinary formulations with different excipients and doses [5] [6]. These limitations mean the literature supports a signal that warrants caution and monitoring, not a quantified risk estimate applicable to appropriately dosed, medically supervised use.
5. What the pattern tells public health and clinical practice
The pattern of reports points to a risk concentrated where ivermectin was used off‑label, in high doses, or as veterinary formulations, and in settings of polypharmacy or underlying illness, rather than clear evidence of frequent hepatotoxicity in regulated human use. Public‑health implications include the need for clinician awareness to inquire about ivermectin exposure in unexplained liver injury, to document and report suspected cases to pharmacovigilance systems, and to emphasize that rare but serious hepatic events have been observed—most prominently during the COVID‑19 period when off‑label use surged [1] [2] [4]. The assembled evidence supports monitoring and caution without claiming widespread ivermectin hepatotoxicity in medically supervised contexts.