What is the FDA's stance on using ivermectin for COVID-19 treatment?
Executive summary
The FDA does not endorse ivermectin as a treatment or prevention for COVID‑19 and has warned the public against using veterinary formulations or self‑medicating with it; the agency has stated that available clinical trial data do not demonstrate ivermectin’s effectiveness against COVID‑19 in humans [1] [2]. News outlets and public health reporting note repeated FDA warnings that people have been hospitalized after using ivermectin intended for animals and that ivermectin is approved only for certain parasitic conditions, not viral infections [3] [4] [5].
1. FDA’s core position: “Do not use ivermectin for COVID‑19”
The FDA’s public guidance has consistently warned Americans not to take ivermectin as a treatment or preventive for COVID‑19, emphasizing that ivermectin formulations for animals are not intended for humans and that some people have been harmed or hospitalized after using them [1] [3] [5]. Multiple mainstream outlets and state summaries quote the FDA language that clinical trial evidence does not show ivermectin is effective against COVID‑19 in humans [2] [5].
2. What the FDA has approved ivermectin to treat — and what it has not
Ivermectin is an FDA‑approved drug for specific parasitic infections in humans (intestinal strongyloidiasis and onchocerciasis) and for topical uses for some external parasites, but it is not approved for any viral infection, including COVID‑19 [4] [1]. The agency’s warnings repeatedly cite that the drug’s human approvals are for parasitic diseases, not SARS‑CoV‑2.
3. Evidence and trials: why the FDA declines to endorse it
Independent reviews and randomized clinical trials through 2023–2025 found ivermectin largely ineffective for COVID‑19; a 2025 review of trials concluded ivermectin is ineffective both for treatment and prophylaxis, and reporting in major outlets states that initial lab findings did not translate into reliable clinical benefit [6] [7] [8]. The FDA’s stance—that currently available trial data do not demonstrate effectiveness—tracks this scientific literature and is cited by local reporting when describing state policy changes [2] [8].
4. Safety concerns that underpin FDA warnings
The FDA warned particularly about people taking veterinary ivermectin formulations or self‑medicating without medical supervision; harms reported include hospitalizations after misuse and potential drug interactions or adverse effects at high doses [3] [5] [9]. Safety messaging stresses that livestock doses are far higher than human prescriptions and that unsupervised use can cause serious adverse events [3] [5].
5. Political and social context around ivermectin use
Ivermectin became highly politicized during the pandemic, adopted by some as a symbol of medical dissent; outlets report that even after clinical trials failed to show benefit, its use persisted among certain groups and influenced state policies expanding access [7] [9]. Several states considered or passed laws to make ivermectin available without prescription, a shift that federal authorities like the FDA have said should not replace clinical oversight [9] [2].
6. How regulators and media have framed conflicting claims
Pro‑ivermectin advocates point to early lab studies and some small trials; critics and regulators point to larger, better‑controlled trials and systematic reviews that show no meaningful benefit. Major media and expert summaries state that early in‑vitro antiviral effects did not equate to clinical efficacy and that many suggestive studies were flawed [8] [6] [7]. The FDA’s public messaging aligns with the latter body of evidence in advising against use for COVID‑19 [1] [2].
7. Limitations and what the sources do not say
Available sources do not mention any recent FDA re‑approval or emergency use authorization for ivermectin as a COVID‑19 therapy; they also do not describe the FDA conducting a new randomized trial that found clinical benefit (not found in current reporting). The sources provided do not include the FDA’s original full text press release here, though multiple outlets and summaries quote FDA warnings and conclusions [1] [5] [2].
8. Practical takeaway for clinicians and the public
The FDA’s position is clear: do not use ivermectin to prevent or treat COVID‑19 outside clinical trials, and avoid veterinary products; seek treatments and vaccines that regulators and high‑quality trials have shown to be effective and consult a clinician before taking antiparasitic drugs for off‑label purposes [1] [4] [5].
Sources quoted in this report include FDA‑referencing summaries and mainstream reporting that cite FDA statements [1] [5] [2], peer‑review overviews and trials analyzed in 2025 [8] [6], and commentary on safety and politicization [3] [7].