What are the known risks and side effects of taking ivermectin for COVID-19?
Executive summary
Ivermectin is not authorized or approved to prevent or treat COVID‑19; major regulators say clinical data do not show benefit and report harms from off‑label use, including hospitalizations and deaths (FDA: not authorized; WHO advises against outside trials) [1] [2]. Pharmacovigilance and poison‑center reports list serious adverse events—neurologic effects, liver injury, hypotension, gastrointestinal distress, and overdose symptoms—and databases recorded hundreds to thousands of adverse reactions, including deaths (VigiBase/WHO, NEJM summary; Drugs.com; Wikipedia) [3] [2] [4].
1. Why regulators and major health bodies oppose routine ivermectin use for COVID‑19
The U.S. Food and Drug Administration says it has not authorized or approved ivermectin for COVID‑19 and has determined current clinical‑trial data do not demonstrate effectiveness against SARS‑CoV‑2; the agency warns people against using animal formulations and self‑treating with veterinary products [1]. The World Health Organization and other agencies similarly recommend against routine use outside clinical trials, a position echoed in clinical‑trial assessments summarized by Drugs.com [2] [1].
2. The spectrum of reported side effects from clinical studies and case reports
Safety signals range from common, usually mild effects to severe, sometimes fatal events. Reported reactions include nausea, vomiting, diarrhea, skin rash, hypotension, dizziness, seizures, altered consciousness, and visual disturbances; serious outcomes in pharmacovigilance data include hospitalizations, life‑threatening conditions and deaths (NEJM summary; Wikipedia; Drugs.com) [3] [4] [2].
3. Neurologic harms and genetic susceptibility flagged in trials
Some randomized trials and case series reported delirium‑like behavior, agitation and altered consciousness; investigators in at least one study attributed these to metabolic variants affecting drug transport/metabolism (MDR‑1/ABCB1 or CYP3A4) or to high‑dose exposure (systematic review; PMC) [5]. Poison‑center and WHO reports documented seizures, coma and neurologic toxicity among off‑label users as well [3] [6].
4. Overdose, animal formulations and real‑world poisonings
Public‑facing warnings emphasize that animal ivermectin products are formulated differently and can be dangerous if ingested; regulators and poison centers report many people became very sick or required hospitalization after taking veterinary ivermectin for COVID‑19 (FDA consumer update; Drugs.com; Cleveland Clinic summary) [1] [2] [7]. Overdose symptom lists include hypotension, severe gastrointestinal upset, decreased consciousness, hallucinations, loss of coordination, seizures and death (Wikipedia; Drugs.com) [4] [2].
5. What large safety databases show: numbers and context
Analyses of pharmacovigilance databases show an increase in ivermectin adverse‑event reporting during the pandemic. Between May 2020 and April 2022, one summary counted 2,944 adverse‑drug‑reaction reports with 167 (5.7%) classified as severe and 46 deaths or life‑threatening conditions; authors caution some events may reflect COVID‑19 progression rather than drug toxicity, but the volume signals real harms from off‑label use (NEJM; WHO VigiBase summary) [3] [8].
6. Confounding: ineffective treatment can look harmful
Some reviewers note that poor outcomes reported with ivermectin may partly reflect lack of benefit—i.e., people treated with an ineffective drug can deteriorate from COVID‑19 itself—so causality is not always clear; nevertheless, when toxic dosing, veterinary products or drug‑interaction/genetic vulnerabilities are involved, direct drug harm is documented (systematic review; WHO reports; NEJM) [5] [8] [3].
7. Competing narratives and politicization of ivermectin
Despite regulatory consensus about lack of proven benefit, pockets of advocacy and political moves to expand access persist, and some clinicians and early meta‑analyses argued for efficacy. Major outlets report lawmakers seeking easier access while manufacturers and regulators reiterate the lack of convincing clinical proof and the safety concerns (New York Times; systematic review; Drugs.com) [9] [5] [2].
8. Practical advice and known safer alternatives
Available sources emphasize not self‑medicating: do not use veterinary ivermectin, avoid non‑prescribed dosing, and consult clinicians. Health agencies recommend relying on proven COVID‑19 preventives and treatments (vaccination, approved therapeutics) rather than off‑label ivermectin use; when ivermectin is studied, it should remain in controlled clinical trials [1] [2] [9].
Limitations: available sources summarized here cover regulatory statements, systematic reviews, pharmacovigilance analyses and media reporting; they do not provide an exhaustive list of every reported case or a meta‑analytic pooled risk estimate in a single citation. If you want, I can pull specific trial‑level adverse‑event tables or the NEJM/WHO reports cited above for detailed numbers and case descriptions [3] [8].