What are the FDA-approved uses and recommended human dosages of ivermectin?
Executive summary
The FDA has approved ivermectin for specific parasitic infections in humans—primarily intestinal strongyloidiasis and onchocerciasis—and for topical uses like head lice and rosacea; typical oral dosing for those systemic indications is about 200 micrograms (0.20 mg) per kilogram as a single dose, with some approved and guideline regimens at 150–200 mcg/kg and repeat dosing in certain conditions [1] [2] [3]. The FDA emphatically has not authorized or approved ivermectin to prevent or treat COVID‑19 and warns against using veterinary formulations for people [4] [5].
1. What the FDA actually approves: antiparasitic and topical indications
The FDA’s approvals for human ivermectin are for parasitic worm infections and some topical skin conditions; the agency states the drug is not approved to prevent or treat COVID‑19 and cautions people not to use animal ivermectin products on themselves [4] [1]. Reporting and fact‑checks repeatedly note that ivermectin’s FDA‑authorized human uses date back decades and are limited to specific parasitic indications, not viral illnesses [6] [5].
2. Standard, FDA‑referenced dosages for human use
Authoritative drug references list the commonly used systemic dose as roughly 200 micrograms per kilogram (200 mcg/kg, i.e., 0.20 mg/kg) taken orally as a single weight‑based dose for many parasitic infections; some guidance and sources cite a 150–250 mcg/kg range depending on condition, with repeat doses sometimes recommended for scabies or heavy infections [2] [3] [7]. The FDA label and Dailymed specify a single oral dose designed to provide approximately 200 mcg/kg for strongyloidiasis and provide tablet strength/dosing tables tied to body weight [8] [2].
3. Variability by condition and need for clinician oversight
Dosage and retreatment intervals vary by parasite: mass‑administration programs and onchocerciasis use annual doses (0.15 mg/kg cited in some program guidance), scabies may use single 150–250 mcg/kg doses with repeats at day 7 or 14, and crusted scabies can require multiple doses spaced weekly [3] [7]. Sources emphasize that ivermectin is prescription‑only for most human formulations and should be used under clinician supervision due to liver metabolism, potential interactions, and rare neurotoxic effects [3] [8].
4. What the FDA and public health agencies warn about — COVID‑19 and veterinary products
The FDA has repeatedly warned the public that it has not authorized ivermectin for COVID‑19 and that animal ivermectin products are different formulations whose safety in people is unknown; taking large or inappropriate doses can be dangerous [4] [5]. Fact‑checks and news outlets corroborate that clinical trials did not support ivermectin for COVID‑19 and that using veterinary products led to reported poisonings and adverse events during the pandemic [5] [1].
5. Higher‑dose research and off‑label use: what sources say and what they don’t
Researchers have studied higher ivermectin doses for novel uses (e.g., malaria transmission reduction or cancer research), and some trials tested doses above standard 200 mcg/kg; however, the FDA’s approvals remain tied to parasitic indications, and clinical evidence did not establish safe, effective COVID‑19 dosing [9] [10]. Popular or political movements pushing over‑the‑counter access or alternative uses exist, but the FDA and manufacturers continue to advise use only within approved frameworks [11] [12].
6. Safety profile and toxicity thresholds referenced in reporting
Drug‑label and review sources note that recommended doses can still produce adverse effects in rare cases (including neurotoxicity), and toxicology context from reporting cites much higher doses required for in‑vitro antiviral inhibition than approved human doses—underscoring that proposing such doses would exceed known safe ranges [8] [10]. Available sources do not mention a comprehensive list of every possible adverse event beyond those summarized in labeling and public health warnings; consult the FDA label for full safety details [8].
7. Bottom line for clinicians and the public
Ivermectin is FDA‑approved for specific parasitic infections in humans with typical oral dosing around 150–200 mcg/kg (single dose, weight‑based), and topical formulations exist for lice and some dermatologic uses; it is not FDA‑approved for COVID‑19 or other viral diseases, and people must not use animal formulations or self‑prescribe higher doses without medical guidance [2] [3] [4]. Sources disagree on broader policy and political pushes to expand access, but the medical and regulatory record remains clear about approved indications and recommended weight‑based dosing [11] [6].