What are FDA and WHO official recommendations for human ivermectin dosing by indication?
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Executive summary
The FDA authorizes ivermectin for a small set of parasitic indications and warns it is not approved for COVID‑19; human oral tablets (now available in 3 mg and 6 mg strengths) are dosed by weight for parasitic infections, while animal formulations are explicitly unsafe for people [1] [2]. WHO recommends ivermectin for its established parasitic uses but advises that ivermectin be used to treat COVID‑19 only inside clinical trials because evidence is inconclusive [3] [4].
1. FDA: approved human uses, dosing format, and safety warning
The FDA has approved oral ivermectin products for specific parasitic infections and topical ivermectin for certain dermatologic uses; it has not authorized or approved ivermectin to prevent or treat COVID‑19 and warns people not to use animal formulations or very large doses because they can be dangerous [1]. The agency’s recent documents on approved tablet products list human tablet strengths (3 mg and 6 mg) and regulatory letters tied to those formulations, indicating continued formalization of human oral products rather than approval for new disease indications [2].
2. What the FDA says about COVID‑19 use
The FDA’s public guidance is categorical: ivermectin is not authorized or approved for COVID‑19, the agency has not determined it is safe or effective for that purpose, and people should not take large or animal doses to treat or prevent SARS‑CoV‑2 infection [1]. Clinical trial evidence cited in U.S. guideline summaries shows no consistent benefit in key trials (e.g., adaptive platform trials reported no difference in hospital visits or mortality) and pharmacokinetic analyses indicate in‑vitro antiviral activity would require plasma levels far above those achieved with approved human doses [5].
3. WHO: endorsed parasitic indications, limited COVID‑19 role
WHO continues to list ivermectin among essential medicines for parasitic diseases (onchocerciasis, strongyloidiasis and other helminthiases) and supports its use in those contexts; however, WHO’s living COVID‑19 guidance states current evidence for ivermectin in COVID‑19 is inconclusive and recommends its use for COVID‑19 only within clinical trials [3] [4].
4. Typical dosing used in parasitic disease programs (what reporting shows)
Clinical guidance and drug references used in practice report weight‑based oral regimens for parasitic indications, commonly in the range of about 0.15–0.4 mg/kg depending on disease and programmatic goals (mass drug administration vs individual therapy). Public dosage guides and reviews describing onchocerciasis or mass administration note single‑dose or annual/periodic dosing strategies such as 0.15 mg/kg to 0.4 mg/kg in various programs [6] [7] [8]. Peer‑reviewed reviews summarize conventional ranges of 0.2–0.4 mg/kg for many antiparasitic uses [7] [4].
5. Major professional bodies and guideline groups — position on off‑label/COVID use
U.S. and international guideline panels have advised against routine off‑label ivermectin use for COVID‑19 outside trials: NIH/IDSA and WHO all declined to recommend ivermectin for COVID‑19 in routine care, instead encouraging enrollment in clinical trials where appropriate [5] [9] [3]. Systematic reviews and living meta‑analyses have generally found at best low to moderate certainty evidence for clinical benefit in COVID‑19 and many guideline groups have concluded evidence is insufficient to recommend routine use [10] [7].
6. Areas of disagreement, uncertainty, and misuse risks
Some meta‑analyses and authors have reported possible benefit signals; other high‑quality randomized platform trials and living guideline processes report no convincing benefit, creating persistent controversy in the literature and public debate [7] [10]. The FDA and major clinical societies explicitly warn of harm from self‑medication, including hospitalizations after people take veterinary ivermectin, and note pharmacokinetic barriers to achieving the antiviral concentrations seen in cell culture [1] [5].
7. What sources do not settle and next steps for clinicians and patients
Available sources do not provide an FDA‑endorsed dosing schedule for COVID‑19 because the FDA has not approved ivermectin for that indication; WHO also limits COVID‑19 use to clinical trials and does not give an approved therapeutic dosing schedule for COVID‑19 outside research settings [1] [3]. For parasitic diseases, dosing is weight‑based and described in clinical references and mass‑drug administration literature (0.15–0.4 mg/kg ranges), but prescribing should follow product labeling, national NTD programs, or specialist guidance [6] [8] [4].
Limitations: This summary relies only on the supplied documents; it does not include FDA or WHO materials published outside those sources and does not substitute for checking current product labels, national formularies, or trial protocols before prescribing [2] [3].