What are the FDA-approved uses and recommended dosages of ivermectin for humans?
Executive summary
The FDA has approved human ivermectin products only for specific parasitic infections and certain topical uses; it has not authorized or approved ivermectin to prevent or treat COVID‑19 [1]. Typical FDA‑referenced oral dosing for approved systemic uses is about 150–200 micrograms per kilogram (mcg/kg) as a single dose for conditions like strongyloidiasis and onchocerciasis; topical formulations exist for head lice and rosacea [2] [3] [4].
1. What the FDA explicitly approves — narrow, parasitic indications
The FDA’s public guidance emphasizes that ivermectin is approved for human use to treat particular parasitic worm infections and that it is not authorized for COVID‑19 [1]. Reporting and medical summaries reiterate the same: oral ivermectin tablets are approved to treat intestinal strongyloidiasis and onchocerciasis (river blindness), while topical ivermectin formulations are used for head lice and some skin conditions such as rosacea [4] [5].
2. Standard approved dosages reported in prescribing information
Authoritative drug references and the product label describe weight‑based oral dosing approximately 150–200 mcg/kg (often rounded to 0.15–0.20 mg/kg) as a single dose for the systemic parasitic indications; tablets commonly contain 3 mg each and dosing tables convert weight to tablet counts [2] [3]. Clinical practice guides and drug databases echo 150–250 mcg/kg ranges used clinically for parasitic infestations and repeat dosing schedules for scabies or strongyloidiasis when needed [6] [7].
3. What the FDA warns against — COVID‑19 and animal products
The FDA explicitly warns that it has not authorized or approved ivermectin for prevention or treatment of COVID‑19 in humans or animals and cautions against using veterinary formulations in people because those products are different and untested in humans [1]. The FDA also notes that taking large or inappropriate doses can be dangerous, and that clinicians may prescribe approved human drugs off‑label only when medically appropriate [1].
4. How other medical bodies and sources frame dosing and limits
Clinical resources (Mayo Clinic, Drugs.com, DailyMed) align with the 200 mcg/kg single‑dose standard for many systemic indications and document safety considerations such as potential neurotoxicity and hepatic metabolism issues; product labeling warns that neurotoxic events have been reported even with recommended doses [2] [8] [3]. WHO and CDC positions on ivermectin and COVID‑19 (cited in some summaries) state that data do not support its routine use for COVID‑19 outside trials [8].
5. Evidence and controversy around higher or repeated dosing
Research efforts and trials have explored higher or repeated ivermectin regimens (for example, malaria control or investigational COVID‑19 protocols), and academic trials sometimes tested multi‑day or higher microgram/kg regimens; however, achieving the in vitro antiviral concentrations reported in some lab studies would require doses far above FDA‑approved ranges and could risk toxicity [9] [10] [11]. Sources note that high doses have been associated with overdose symptoms and that achieving antiviral concentrations seen in vitro is not realistic with approved oral dosing [9] [11].
6. Real‑world use, policy shifts, and confusion
Use of ivermectin surged during the COVID‑19 pandemic despite FDA warnings; outpatient prescriptions rose sharply in 2020–2021 and later declined after authorized COVID treatments became available [12]. State‑level policy moves (some states authorizing OTC access) and advocacy for broader access have created tension between public‑health authorities urging caution and political or patient groups seeking easier access [13] [14]. Reporting highlights pharmacists’ concerns about inappropriate use and supply preservation for approved indications [14] [13].
7. Limitations of current reporting and what is not in these sources
Available sources do not provide a comprehensive, single FDA page listing every approved label dose for each rare indication, nor do they include the most recent state law texts or every clinical trial’s dosing arms; therefore readers should consult the specific FDA product labeling (DailyMed) or a treating clinician for exact tablet counts and schedules in a given case [3] [2]. Sources here also do not present a finalized, FDA‑approved change for OTC status at the federal level — reporting is largely state‑by‑state and contested [13] [14].
Bottom line: FDA approval for humans is limited to antiparasitic and topical dermatologic uses with weight‑based dosing typically around 150–200 mcg/kg for systemic infections; the FDA has not approved ivermectin for COVID‑19 and warns against using animal formulations or excessive doses [1] [2] [3].