What is the FDA-approved use and dosing of ivermectin in humans?

1. What the FDA has approved: antiparasitic tablets and topical formulations

The federal regulator’s public statements and major reporting make the approval picture clear: ivermectin tablets are approved to treat specific parasitic worm infections in humans, and topical ivermectin products have been authorized for lice and some skin conditions such as rosacea — not for COVID‑19 or other viral diseases ^{[1] [4]}. Independent fact‑checks and news outlets repeat the same point: the drug’s U.S. approvals are for parasitic diseases only ^{[5] [6]}.

2. Standard human dosing used in clinical practice and labels

Authoritative drug references and prescribing information show dosing is weight‑based, typically in the 150–200 mcg/kg (0.15–0.2 mg/kg) range as a single oral dose for many parasitic indications, with repeat dosing schedules that vary by disease — for example, retreatment may be considered every 3–12 months for some infections; some sources cite a usual single dose of 150 mcg/kg while others show 200 mcg/kg for strongyloidiasis or onchocerciasis ^{[2] [3] [7]}. Practical weight‑band tables used by clinicians translate this into fixed tablet counts (e.g., 3 mg tablets) for common weight ranges ^[3].

3. Variations, repeats and dermatology practice

Dermatology and specialist guides report a typical therapeutic window of roughly 150–250 mcg/kg depending on the condition, with repeat doses for scabies or strongyloidiasis sometimes given after 7–14 days or repeated months later for control of onchocerciasis in mass‑treatment programs ^{[8] [7]}. Clinical trial and mass‑drug‑administration literature also uses 200 mcg/kg as a common reference dose in vector‑control or filarial programs ^[9].

4. What the FDA and public health agencies explicitly warn against

The FDA has repeatedly warned it has not authorized or approved ivermectin for COVID‑19 prevention or treatment and has received reports of people harmed after self‑medicating with veterinary formulations — animal products are different formulations and not tested for human safety ^{[4] [10]}. Media fact‑checks that trace social claims about “FDA approval for COVID” conclude those claims are false and reiterate the limited regulatory approvals ^[5].

5. Conflicting dosing figures in secondary sources and why they differ

Different publications quote slightly different “usual” doses (150 mcg/kg vs. 200 mcg/kg) because dosing varies by the specific parasitic disease, by product labeling, and by regional practice guidelines; some sources emphasize 150 mcg/kg as common, others 200 mcg/kg for certain infections or mass‑treatment contexts ^{[2] [7] [9]}. Drug monographs used for prescribing (e.g., Stromectol label) and clinical guides should be consulted for the exact indication and patient weight calculation ^{[11] [12]}.

6. Safety, toxicity and off‑label use context

Pharmacology and safety reporting warn that high doses far above FDA‑approved regimens raise the risk of serious adverse effects and that in vitro antiviral activity occurs at concentrations not achievable safely in humans — reviews and government messaging therefore counsel against off‑label use for COVID‑19 outside clinical trials ^{[4] [13] [14]}. The FDA also notes hospitalizations after misuse of veterinary products ^[4].

7. Policy and access changes outside FDA decisions

Several U.S. states have moved to allow over‑the‑counter access or protect dispensing of ivermectin by state law; those state actions do not equal new FDA approvals and the FDA’s stance on indications remains unchanged ^{[10] [6] [15]}. Reporting frames these state moves as politically driven responses to pandemic-era demand and pharmacist refusals, not new evidence of efficacy for viral illnesses ^{[6] [15]}.

8. How to get the exact FDA‑approved dosing for a patient

For a specific patient or indication, clinicians and patients should consult the official product label or prescribing information and recognized clinical references — the Stromectol (ivermectin) label and drug monographs list weight‑based dosing and safety data (examples cited above) ^{[11] [3]}. Available sources do not mention any FDA approval or an official, safe dosing regimen for COVID‑19; any such claim should be treated as unsupported ^{[4] [5]}.

Limitations: this summary uses the cited news items, FDA consumer guidance, prescribing guides and clinical literature provided in your search set; I do not assert facts beyond those sources ^{[4] [2] [3]}.