What are FDA-approved indications and dosing regimens for ivermectin in adults?

1. What the FDA’s approvals actually cover — and what they don’t

The FDA has approved oral ivermectin tablets for treatment of certain parasitic worm infections — specifically strongyloidiasis of the intestinal tract and onchocerciasis — and separate topical ivermectin formulations are approved for rosacea and for head lice; the agency has not approved ivermectin for prevention or treatment of COVID‑19 ^{[1] [2] [4]}.

2. Dosing regimens cited in prescribing information — the core human doses

Available reporting and prescribing summaries indicate human ivermectin tablets are approved at “specific doses” for parasitic infections; drugs reference sites list Stromectol dosing tied to body weight for strongyloidiasis and onchocerciasis, but the exact milligram-per‑kilogram regimens are given in product labeling rather than the FDA consumer summaries cited here ^{[2] [1]}. Available sources do not mention the precise mg/kg numbers in this search set; consult the official Prescribing Information (Drugs@FDA) for exact dosing ^[5].

3. Off‑label prescribing and physician authority

Physicians may legally prescribe approved drugs for off‑label uses, and courts and commentators have noted that doctors can prescribe ivermectin off‑label (for example, for COVID‑19), but off‑label use is not the same as FDA approval and typically rests on weaker evidence; the FDA continues to state it has not authorized ivermectin for COVID‑19 ^{[4] [2]}.

4. Safety warnings, veterinary products, and real‑world harms

The FDA warns that veterinary ivermectin formulations differ from human products, are more concentrated, and can cause harm when self‑treated by people; the agency has received reports of hospitalization after people used animal ivermectin intended for livestock ^{[2] [6]}. Independent outlets and fact‑checks stress that using animal formulations in humans is dangerous ^{[3] [7]}.

5. State policy shifts do not equal federal approval

Several U.S. states have passed laws expanding access or allowing over‑the‑counter distribution of ivermectin in certain circumstances, but those state actions change retail availability, not FDA indications or safety determinations; the FDA still controls approved indications while state laws affect dispensing, sometimes via standing orders for pharmacists ^[6].

6. Why dosing detail matters and where to find it

Journalists and clinicians cite “specific doses” for human ivermectin use, but the search results here do not reproduce the product label’s mg/kg regimens; the FDA’s Drugs@FDA database and the official Stromectol Prescribing Information contain the legally authoritative dosing instructions and contraindications that clinicians must follow ^{[5] [1]}. Available sources do not mention the exact numerical dosing in this set.

7. Competing perspectives: efficacy discussions vs. regulatory posture

Public debate has featured claims that ivermectin is effective against COVID‑19; professional societies and the FDA counter that evidence is insufficient and the agency has not approved it for that purpose. Fact‑checkers and mainstream outlets reiterate the FDA’s position and caution about harms from misuse ^{[4] [3] [7]}.

8. Bottom line for clinicians and patients

For treating human parasitic infections, use FDA‑approved human ivermectin products following the official label; do not substitute veterinary formulations for people, and recognize that neither the FDA nor major medical bodies have approved ivermectin for COVID‑19 — off‑label prescriptions are legally possible but not FDA endorsement ^{[2] [4] [1]}.

Limitations: this briefing relies on consumer and secondary summaries in the provided sources; the precise mg/kg dosing regimens and full contraindication lists are found in the official Prescribing Information (Drugs@FDA) and were not reproduced in these search snippets ^{[5] [1]}.