What are FDA-approved uses and dosages of ivermectin for humans?

1. What the FDA actually approved — a short inventory

The FDA has approved ivermectin tablets for certain parasitic worm infections — specifically intestinal strongyloidiasis and onchocerciasis (river blindness) — and has cleared topical ivermectin products for dermatologic uses such as rosacea and lice, according to multiple clinical summaries and reporting ^{[1] [2] [3]}. News outlets and drug reference sites repeat that the core human approvals are for antiparasitic indications, not for viral illnesses ^{[6] [1]}.

2. Dosing on the label — the commonly cited numbers

Authoritative summaries and reference pages list typical oral dosing for FDA‑approved parasitic uses in the range of roughly 0.15–0.2 mg per kg body weight — usually given as a single oral dose, with some conditions requiring repeat dosing according to the specific infection and clinical guidance ^{[5] [4] [7]}. Topical products have product‑specific application instructions; labels differ for lotions (lice) and creams (rosacea) and are not interchangeable with oral tablet dosing ^{[1] [3]}.

3. Where confusion and controversy come from

Public debate surged when ivermectin was promoted for COVID‑19 despite no FDA approval for viral infections; the FDA repeatedly warned against using veterinary formulations and noted the drug is not authorized or approved to prevent or treat COVID‑19 ^{[8] [9]}. Scientific papers show in vitro antiviral activity at concentrations far above standard human doses, which fueled off‑label use and misinformation, but clinical reviews and meta‑analyses later found no convincing benefit for COVID‑19 clinical outcomes ^{[10] [11] [12]}.

4. Safety, overdoses, and the veterinary‑product problem

Health agencies emphasized that animal ivermectin products have different formulations and inactive ingredients and should not be used by people; overdoses from inappropriate use produced harms during the pandemic and prompted consumer warnings ^{[9] [4] [8]}. Reviews and reporting note that effective in vitro antiviral concentrations would likely require doses much higher than the FDA‑approved single‑dose range, levels associated with toxicity ^{[4] [10]}.

5. Off‑label use — what the sources show and what they do not

Many clinicians and outlets document that tablets have been used off‑label for conditions such as scabies in selected cases (e.g., crusted scabies), but those are clinical decisions rather than new FDA approvals; DermNet and other clinical sites call most non‑label uses “off‑label” ^[3]. Available sources do not mention any FDA approval of ivermectin for COVID‑19 or for cancer; reporting and reviews explicitly state the FDA has not approved ivermectin for treating or preventing viral infections ^{[8] [2] [11]}.

6. Practical takeaway for patients and prescribers

If you need ivermectin for an FDA‑approved parasitic infection, clinicians prescribe the oral tablet with weight‑based dosing typically around 0.15–0.2 mg/kg and follow product‑specific instructions for repeat doses when indicated; topical products follow their own labeled regimens for lice or rosacea ^{[5] [1] [7]}. For any suspected novel use, the FDA’s stance, summarized in news and agency warnings, is that ivermectin is not authorized for COVID‑19 and veterinary products should never be substituted for human formulations ^{[8] [9]}.

Limitations and conflicts to note: public reporting and review articles reproduce the same core approvals and dosage ranges but vary in emphasis; some advocacy and non‑peer forums promote higher or alternative regimens that are not FDA‑endorsed and are not supported by the clinical reviews cited above ^{[13] [14] [11]}. Always consult product labels or a clinician for exact labeled regimens — available sources provide general dosing ranges but product inserts and FDA documents contain the official, condition‑specific instructions ^{[1] [7]}.