What are the FDA-approved ivermectin doses for common parasitic infections in humans?
Executive summary
The FDA has approved oral ivermectin tablets (Stromectol/generic) for two human parasitic conditions: intestinal strongyloidiasis and onchocerciasis; topical ivermectin formulations are authorized for lice and rosacea [1] [2]. The FDA explicitly has not approved ivermectin for COVID‑19 and warns that animal formulations differ from human products and can be dangerous at high doses [3] [4].
1. What the FDA has actually approved — a short list
Ivermectin tablets are FDA‑approved to treat strongyloidiasis (an intestinal infection) and onchocerciasis (river blindness); separate topical ivermectin products are approved for head lice and certain skin conditions such as rosacea, according to clinical summaries and recent reporting [1] [2]. Available sources do not provide the precise milligram‑per‑kilogram FDA label dosing in a single table but indicate the drug is approved at “specific doses” for these parasitic indications [3] [1].
2. Typical dosing guidance reported by clinical references
Clinical and drug‑information sites state that oral ivermectin dosing depends on the infection and body weight, is often given as a single dose (sometimes repeated), and is weight‑based — but those sources (e.g., Drugs.com, Medical News Today) are secondary summaries rather than the original FDA label [5] [6]. For example, Drugs.com and Medical News Today describe ivermectin as dosed by weight for the listed parasitic infections and note repeat dosing may be needed in some cases [5] [6]. The FDA consumer guidance also affirms that human tablets are approved “at specific doses” for some parasitic worms [3].
3. What the FDA and public‑health outlets explicitly deny
The FDA and multiple public health sources have stated plainly that ivermectin is not authorized or approved to prevent or treat COVID‑19; the agency warns that using large or animal doses can be dangerous and that animal products are different formulations not tested in humans [3] [4]. State and hospital reports from the pandemic documented spikes in poison‑center calls and harms tied to misuse of veterinary ivermectin [7] [8].
4. Why people ask about dosing beyond the label
Scientific interest and media coverage during the COVID‑19 pandemic — including in vitro studies suggesting antiviral activity at concentrations far above those achieved with approved doses — drove public demand for alternative dosing, but those lab concentrations exceed the FDA‑approved dosing by large margins, creating safety and efficacy concerns [9]. Independent reporting emphasizes that ivermectin is widely effective against parasites at approved doses but that higher or prolonged doses raise toxicity risks, especially neurologic effects [2] [9].
5. Regulatory and marketplace shifts that affect access
Several states have moved to make ivermectin easier to obtain without a prescription, a trend noted in national reporting; those changes do not alter the FDA’s approved uses or dosing and prompted warnings from regulators and the drug’s manufacturer that use should remain within the FDA‑approved framework [7] [10]. Pharmacy and state actions expanding over‑the‑counter access have increased concerns among clinicians about unsupervised use and possible adverse events [4] [7].
6. Conflicting guidance and where to find definitive dosing
Authoritative outlets (Drugs.com, FDA consumer pages, and drug‑label repositories) provide dosing information, but the primary source for legal, exact label doses is the FDA prescribing information (the Stromectol label) and the product’s official drug‑label documents; secondary summaries reiterate that dosing is weight‑based and indication‑specific [1] [5] [3]. If you need the exact mg/kg numbers for a clinical decision, consult the FDA‑approved prescribing information or your pharmacy’s verified labeling — those specific milligram‑per‑kilogram figures are not consolidated in the cited consumer‑news pieces [1] [5].
7. Practical takeaway and safety context
Ivermectin is an effective, FDA‑approved antiparasitic at labeled doses for strongyloidiasis, onchocerciasis and certain topical skin uses; it is not approved for COVID‑19 and taking higher or veterinary doses risks serious toxicity, as the FDA has warned repeatedly [1] [3]. Clinicians and pharmacists quoted in reporting urge that use remain within approved indications and dosing, and that anyone needing treatment consult a health professional rather than self‑medicate with animal products or unverified regimens [4] [2].
Limitations: available sources used here are news and drug‑information summaries and FDA consumer guidance; they refer to approved uses and say dosing is “specific” and weight‑based but do not present a single definitive mg/kg table in these excerpts — consult FDA prescribing information or official product labels for exact numeric dosing [3] [5].