What are the FDA‑approved human uses and dosages for ivermectin?
Executive summary
Ivermectin is FDA‑approved for specific antiparasitic and dermatologic uses in humans — primarily oral formulations for certain parasitic worm infections and topical formulations for skin conditions — and the agency has explicitly not authorized it for COVID‑19 [1] [2] [3]. Dosages vary by indication and formulation, and off‑label prescribing occurs but must be weighed against safety warnings, especially about using veterinary products or higher-than‑recommended doses [4] [3] [5].
1. What the FDA has approved: parasites and rosacea, not COVID‑19
The FDA recognizes prescription ivermectin tablets for human parasitic infections such as intestinal strongyloidiasis and onchocerciasis (river blindness), and has approved topical ivermectin products for certain dermatologic conditions including rosacea and other mite‑related skin infestations [1] [2]. The agency has been unequivocal that ivermectin is not authorized or approved to prevent or treat COVID‑19 in humans or animals, a point repeated in its public consumer guidance [3].
2. Approved formulations and the clinical rationale
Approved human products come in oral tablets for systemic parasitic disease and topical creams for skin disease; these human formulations differ from veterinary ivermectin in formulation and safety profile, a distinction regulators stress because animal products can contain inactive ingredients or concentrations hazardous to people [1] [3] [5]. Clinically, ivermectin’s antiparasitic effect rests on paralysis and death of worms and mites through action on invertebrate neuronal channels, which explains its approved niche across nematode and ectoparasite indications [6] [7].
3. Dosages by approved indication — what prescribing references say
Authoritative dosing guides used in clinical practice list indication‑specific regimens for the approved human uses of oral and topical ivermectin, and recommend careful dose calculation and follow‑up for parasitic infections [4]. Published prescribing resources enumerate dosing details for scabies, ascariasis, cutaneous larva migrans, onchocerciasis and other parasitic conditions, and describe adjustments for special situations such as renal or hepatic impairment and retreatment needs for some infections [4]. Topical ivermectin formulations are prescribed according to labeled instructions for dermatologic indications such as rosacea [2].
4. Off‑label use, clinical uncertainty, and the COVID‑19 controversy
Although clinicians may legally prescribe approved drugs off‑label, major U.S. health authorities — including the FDA, CDC and professional societies — advise against using ivermectin to prevent or treat COVID‑19 outside of clinical trials because available clinical trial data do not establish safety and efficacy for that indication; meanwhile in vitro studies that showed antiviral activity prompted further research but do not substitute for clinical evidence [3] [8] [6]. Advocacy groups and some researchers continue to argue for benefit based on select trials and meta‑analyses, creating a polarized discourse; regulatory bodies and mainstream medical organizations caution that self‑medication, especially with veterinary products or high doses, has resulted in reported hospitalizations [9] [3] [5].
5. Safety, interactions and practical takeaways for clinicians and patients
Even when used for FDA‑approved indications, ivermectin can interact with other medications and has known adverse reactions that require monitoring; using formulations intended for animals, taking excessive doses, or sidestepping medical supervision can be dangerous and has prompted regulator warnings and clinical reports of harm [3] [5] [7]. For emerging or off‑label uses, clinicians are urged to rely on randomized trial evidence and to enroll patients in trials when uncertainty exists; patients and policymakers should also recognize that some jurisdictions have moved to change access rules, but that manufacturing statements from companies emphasize use within approved FDA frameworks [10] [11] [2].