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What are documented case reports of ivermectin-induced liver injury and their publication dates?
Executive Summary
Two well-documented, peer-reviewed case reports and several pharmacovigilance analyses document rare instances of ivermectin-associated liver injury, with the earliest published case in 2006 and additional clinically serious reports appearing during the COVID-19 era in 2022–2023; multiple pharmacovigilance reviews also flagged hepatic adverse events tied to off-label or self-administered ivermectin. The published case reports and VigiBase analyses vary in clinical severity—from transient transaminase elevations to fulminant liver failure requiring transplantation—and differ in certainty assessments, dosing contexts, and patient comorbidities, underscoring that hepatotoxicity from ivermectin is plausible but uncommon and often linked to misuse or high/extended dosing [1] [2] [3] [4] [5].
1. What proponents and skeptics are claiming — and what the documents actually report
The assembled analyses claim a spectrum of ivermectin-related liver injuries ranging from a single 2006 report of acute hepatocellular necrosis after a single dose to multiple serious hepatic events reported during the COVID-19 period, including one fulminant case requiring liver transplantation and several cases of severe hepatitis and cholestasis. The 2006 case originally published by Veit et al. is cited in LiverTox and described as a 20-year-old woman from Cameroon who developed acute liver injury with onset one month after a single dose; causality was rated possible (score D) and the patient recovered within three months [1]. Later case reports from 2022–2023 describe different clinical patterns and higher severity in the context of self-administration or prolonged off-label use, making the claim that ivermectin can cause liver injury in rare instances consistent across sources [2] [3] [4].
2. Timeline and publication dates — the documented case reports you asked for
The timeline from the provided materials identifies the 2006 case report as the earliest peer-reviewed account (Veit et al., referenced in LiverTox; entry updated April 9, 2021, but original publication 2006) documenting single-dose–associated hepatocellular injury [1]. During the COVID-19 era, case reports and conference/ journal entries emerged: an October 2022 report of acute liver failure after self-injecting veterinary ivermectin is noted in a 2022 American Journal of Gastroenterology poster/abstract [6], a December 2022 liver-failure case requiring transplant appears in the consultation-liaison psychiatry literature [2], and peer-reviewed case reports from mid‑2023 document jaundice, mixed hepatocellular–cholestatic injury, and histologic bile duct changes in patients who took ivermectin for COVID-19 prevention (published June 2023 and May 2023 in journal listings) [3] [4]. Pharmacovigilance reviews covering Jan 2020–Mar 2021 collected additional signal reports [5] [7].
3. The clinical details that matter — patterns, doses, outcomes, and certainty
The 2006 report described hepatocellular necrosis with recovery and a causality rating of possible, suggesting temporal association but uncertainty about other contributors [1]. COVID-era reports show more severe and variable presentations: one 61‑year‑old developed mixed-pattern acute liver failure after self-injecting veterinary ivermectin and recovered with supportive care (poster/abstract, Oct 2022) while another case produced fulminant hepatic failure requiring transplantation following months of escalating daily ivermectin (Dec 2022) [6] [2]. Two 2023 peer-reviewed case reports documented jaundice and biopsy-proven drug-induced injury with cholestatic features treated with corticosteroids and supportive care, and the patients recovered [3] [4]. Across cases, higher cumulative or non-prescribed dosing and off-label use for COVID-19 are common factors linked to more severe outcomes [2] [5].
4. What pharmacovigilance and case-series data add — signal vs. proof
Pharmacovigilance analyses of VigiBase and case‑report aggregations identified multiple serious hepatic events associated temporally with ivermectin between January 2020 and March 2021, including six specifically described serious hepatic disorders and larger counts of serious reports tied to COVID-19 use; these reports show a mean age in the mid‑50s and variable dosing, with most outcomes favorable after drug cessation [5] [7]. Pharmacovigilance cannot by itself establish causality because of reporting biases, co‑medications, and confounders, but it strengthens the signal that rare hepatotoxic reactions have occurred in temporal relation to ivermectin, especially during periods of widespread unsupervised use [5].
5. Limits, alternative explanations, and what’s missing from the record
Available reports vary in methodological strength: the 2006 case was scored only as possible causality, many COVID-era reports involve self-medication, veterinary formulations, or extended dosing, and pharmacovigilance data lack full clinical detail and denominator exposure. Several reports note potential coexisting factors—other hepatotoxins, underlying liver disease, or COVID-19 itself—which complicate attribution. There are no large prospective studies proving a consistent dose–response relationship for standard prescription ivermectin at approved antiparasitic doses. Thus, while the data document rare case reports and adverse‑event signals, definitive quantification of risk for properly dosed, supervised ivermectin remains unestablished [1] [2] [5].
6. Bottom line for clinicians, patients, and policymakers seeking clarity
Documented case reports of ivermectin‑associated liver injury span from 2006 through 2023 and include isolated single‑dose hepatocellular injury, multiple COVID-era instances of severe hepatitis, and a transplant case linked to prolonged misuse; pharmacovigilance datasets consolidate additional serious hepatic reports during 2020–2021 [1] [6] [2] [3] [4] [5]. The consolidated evidence shows that hepatotoxicity is an uncommon but real adverse event, most often reported after nonstandard dosing or self-administration; clinicians should ask about ivermectin use in unexplained liver injury and report suspected cases to pharmacovigilance systems so the signal can be better defined [1] [5].