What human conditions is ivermectin FDA-approved to treat and at what doses?
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Executive summary
Ivermectin tablets (Stromectol) and topical formulations are FDA‑approved for specific parasitic or dermatologic conditions: oral ivermectin is approved for intestinal strongyloidiasis and onchocerciasis; topical ivermectin products are approved for rosacea and for head lice in prescribed formulations [1] [2]. The FDA has not approved ivermectin to prevent or treat COVID‑19 and has warned against using animal formulations in people [3] [1] [4].
1. What the FDA has actually approved — narrow, approved indications
The FDA has approved oral ivermectin for two parasitic worm infections in humans — intestinal strongyloidiasis (strongyloides) and onchocerciasis (river blindness) — and it has approved topical ivermectin formulations for certain skin conditions such as rosacea and for head‑lice treatments [1] [2]. Reporting and clinical references repeatedly frame these as the agency’s authorized human uses; other human uses are described as off‑label [5] [2].
2. Doses and formulations in official use — what sources say
Available summaries state that oral tablets (often known commercially as Stromectol) are the human formulations used for the parasitic indications and topical formulations (Soolantra cream, Sklice lotion) are used for rosacea and head lice respectively; these sources identify the approved products but do not enumerate full dose tables in the pulled excerpts [2] [5]. Detailed dosing (mg/kg regimens or pediatric rules) is not provided in the supplied reporting excerpts — available sources do not mention specific numeric dosing schedules in this set of search results.
3. What is off‑label or disapproved by the FDA — COVID‑19 and other claims
The FDA has explicitly not approved ivermectin to prevent or treat COVID‑19; the agency concluded available clinical trial data do not show it is effective for COVID‑19, and it warned against using animal ivermectin formulations in people [1] [3] [4]. Multiple news outlets and public health agencies in the supplied reporting reiterate that ivermectin’s pandemic popularity was not backed by FDA approval for viral infections [3] [6] [1].
4. Policy and access shifts that complicate the message
State legislatures have changed access: several states passed laws to allow over‑the‑counter sale or to expand access, most prominently Texas making human‑dose ivermectin OTC in 2025, which generated local reporting emphasizing that FDA approval for COVID‑19 does not exist [7] [8] [3]. Pharmacy and regulatory observers warn that animal products remain different formulations and untested for human safety, creating a public‑health tension when access expands at the state level [4] [7].
5. Competing perspectives and the evidence landscape
Healthcare authorities and major reviews cited in the supplied material conclude ivermectin is ineffective for COVID‑19 based on randomized trials and systematic reviews; independent advocates and some commentators continue to push broader uses [9]. Sources here present both positions: scientific reviews and FDA public statements rejecting COVID‑19 claims [1] [9], and media/political accounts describing demand and legislative moves that reflect a different, more permissive stance in parts of the U.S. [8] [7].
6. Safety, formulation differences and practical cautions
Authorities stress that animal ivermectin products differ from human formulations and lack human safety testing; misuse or taking higher doses than those approved can be dangerous, and regulators have warned the public repeatedly [4] [3]. The Therapeutic Goods Administration (Australia) and other regulators have limited ivermectin prescribing to approved conditions because doses promoted on social media for COVID‑19 often exceed those found safe for parasitic or scabies treatment [10].
7. Limitations of this report and what to check next
This briefing uses the supplied news and health‑information excerpts, which identify approved human indications and note the FDA’s non‑approval for COVID‑19 [1] [2] [3]. The supplied snippets do not give full, authoritative dosing tables (mg/kg, weight‑based regimens, pediatric limits) for each FDA‑approved use — those specifics are not found in current reporting excerpts and should be checked in FDA labeling or product inserts and professional prescribing references for precise dosing (available sources do not mention numeric dosing schedules here) [2] [5].
Bottom line: FDA approval for ivermectin in humans is limited and specific — parasitic infections and certain topical dermatologic uses — and the FDA has not approved it for COVID‑19; for exact dose regimens consult official FDA product labeling or clinical prescribing references rather than media summaries [1] [2] [4].