What are the FDA-approved indications and dosing regimens for ivermectin in humans?
Executive summary
Ivermectin oral tablets (brand Stromectol) are FDA‑approved for certain parasitic worm infections — notably intestinal strongyloidiasis and onchocerciasis — and topical formulations are approved for rosacea and head lice; the FDA explicitly states it has not authorized or approved ivermectin to prevent or treat COVID‑19 [1] [2] [3]. Typical prescribing and dosing guidance in clinical references centers on weight‑based single doses around 150–200 μg/kg for many indications, with higher or repeated regimens used in specific parasitic control programs and trials reporting different schedules [4] [5] [6] [7].
1. FDA‑approved human indications: what regulators say
The FDA’s consumer guidance makes the regulatory baseline simple: oral ivermectin tablets are approved to treat some parasitic worm infections in humans, and topical products are approved for head lice and rosacea; the agency also warns it has not authorized or approved ivermectin to prevent or treat COVID‑19 in people or animals [1]. Drugs.com’s product summary aligns: Stromectol (ivermectin tablets) is FDA‑approved for strongyloidiasis and onchocerciasis, while Soolantra (cream) and Sklice (lotion) are approved for rosacea and head lice respectively [2].
2. Typical dosing used in practice: single weight‑based doses
Clinical dosing references commonly use weight‑based single doses. Mayo Clinic’s summary lists typical regimens of about 150–200 micrograms per kilogram (μg/kg) as a single dose for adults and children ≥15 kg, with the dose sometimes repeated at intervals depending on the parasite and clinical response [4]. Drugs.com and other clinical compendia note 200 μg/kg as a commonly recommended dose for many uses and that repeat doses may be needed in immunocompromised patients or for some parasites [5] [6].
3. Public‑health and mass‑drug regimens differ from individual prescriptions
Mass drug administration (MDA) programs use different regimens for neglected tropical diseases: examples include annual single doses of 0.4 mg/kg (400 μg/kg) given in some filariasis programs, and research explores fixed‑dose tablets for operational simplicity [6] [8]. An individual‑participant meta‑analysis and MDA literature show the standard programmatic dose used historically is often 200 μg/kg, while some campaigns or studies use higher single annual doses like 0.4 mg/kg [5] [6].
4. Experimental and trial dosing: higher or multi‑day regimens appear in research
Clinical trials and protocol papers have tested multi‑day or higher doses for research aims rather than approved indications: for example, malaria transmission studies modeled a 3‑day regimen of 600 μg/kg/day to match the exposure of an 800 μg/kg single dose; other trials have evaluated 3–5 day courses at 300–600 μg/kg/day for antiviral or vector control hypotheses [7] [9]. These are investigational regimens and not FDA approvals [7] [9].
5. Safety framing and regulatory warnings: do not use animal formulations or for COVID‑19
The FDA and major medical bodies have repeatedly warned against self‑medicating with veterinary ivermectin products and against using ivermectin for COVID‑19 because they are not approved for that indication and animal formulations differ in concentration and safety testing [1] [10] [11]. The American Medical Association and FDA consumer updates emphasize potential harm from unapproved uses and the lack of regulatory authorization for COVID‑19 treatment [11] [1].
6. Where sources disagree or leave gaps
Sources converge that oral ivermectin is approved for parasitic infections and topical forms for rosacea and lice, and that COVID‑19 treatment is not FDA‑approved [1] [2] [3]. Variations appear around exact routine dosing: Mayo Clinic lists 150–200 μg/kg as common single doses and notes repetition intervals, while programmatic literature and Drugs.com highlight 200 μg/kg as the commonplace recommendation and MDA uses sometimes 400 μg/kg annually [4] [5] [6]. Available sources do not present the full, official FDA prescribing information label text for every indication and dose in one place; for the precise, legally binding dose and population specifics you should consult the current FDA label or Drugs@FDA — not found in current reporting [12].
7. Practical takeaway for clinicians and the public
The FDA‑approved human uses are narrow and specific: use oral ivermectin for the parasitic indications listed in product labeling and topical ivermectin for rosacea and lice; follow weight‑based dosing (commonly ~150–200 μg/kg single dose) and programmatic guidance where applicable, and do not use veterinary ivermectin or consider ivermectin an FDA‑approved treatment for COVID‑19 [1] [4] [5]. Sources cited: FDA consumer update and clinical compendia [1] [2] [4] [6] [5].