What are the approved human dosages and indications for ivermectin by regulatory agencies (FDA, EMA)?

1. FDA’s explicit, limited human indications — parasitic worms and selected topical uses

The U.S. Food and Drug Administration has authorized human ivermectin products at specific doses for treatment of certain parasitic worm infections — notably intestinal strongyloidiasis and onchocerciasis — and has approved topical formulations for dermatologic uses such as rosacea and head lice; the agency also emphasizes it has not authorized or approved ivermectin for prevention or treatment of COVID‑19 and warns against using veterinary formulations in people ^{[1] [4] [5]}.

2. EMA’s recent action: combination product opinion, but not a COVID endorsement

The European Medicines Agency’s scientific committee (CHMP) in January 2025 adopted a positive opinion for a fixed‑dose ivermectin/albendazole product aimed at treating various worm parasite infections — including neglected tropical diseases such as lymphatic filariasis — which signals expanded regulatory support in the EU for antiparasitic indications rather than any endorsement for antiviral use in COVID‑19 ^[3].

3. Dosage context cited by public sources — weight‑based single dosing for parasitic disease

Publicly available clinical and reference summaries state the typical FDA‑approved human dosing for antiparasitic use is a single oral dose in the range of about 0.15–0.20 mg/kg for the approved indications (the Wikipedia summary cites that single‑dose range as FDA‑approved for specific parasitic infections), and product labeling and dosing guidance depend on infection type and patient weight ^{[3] [6]}. Available sources do not provide full, line‑by‑line FDA label text here; consult official FDA labeling for precise regimen and adjustments (not found in current reporting).

4. What regulators say about COVID‑19 and off‑label use

The FDA, WHO, NIH and EMA reviewed clinical trial data and do not recommend ivermectin for COVID‑19; the FDA reiterated it has not authorized or approved ivermectin for COVID‑19 and has issued consumer warnings after reports of people harmed by self‑medicating with animal formulations ^{[1] [2] [5]}. Some clinical trials and small studies exist (for example, early trial reports and case series), but major regulators concluded available evidence does not support efficacy for COVID‑19 ^{[7] [2]}.

5. Safety and dosing limits: why antiviral dosing claims are controversial

Laboratory (in vitro) data showed antiviral activity only at concentrations corresponding to oral doses far above approved human regimens — one estimate suggested ~7.0 mg/kg would be needed to reach 50% inhibition in vitro, roughly 35 times the standard single approved dose — raising toxicity concerns; CDC and regulators warned about overdose symptoms seen with large doses ^[3]. This is why regulators stress approved human doses are narrow and tied to parasitic indications, and why using much higher doses for unapproved uses is dangerous ^{[3] [1]}.

6. Policy and access changes in the U.S.: over‑the‑counter laws vs federal approvals

Some U.S. states passed laws permitting over‑the‑counter (OTC) distribution of ivermectin at the state level, a move reported in 2025; the CNN columnist Leana Wen and Pharmacy Times pieces note this is a departure from usual federal-determination of OTC status and underscore the FDA’s continued position that animal products are not safe substitutes for human‑approved formulations ^{[4] [5]}. This highlights a policy tension between state action and federal regulatory determinations ^[4].

7. Limitations, open questions and where reporting is thin

Available reporting in this dataset gives high‑level FDA and EMA positions and cites typical approved dosing ranges, but does not contain the full current FDA product labels, the complete EMA approval documents, nor detailed, step‑by‑step dosing tables for every indication and patient subgroup; for exact, legally authoritative dosing and contraindications, the official FDA label/EMA product information should be consulted (not found in current reporting) ^{[1] [3]}.

Bottom line: regulators approve ivermectin for specific parasitic and topical indications at defined human doses and explicitly do not approve it for COVID‑19; claims that alternative, much higher dosing regimens are safe or supported by regulators are contradicted by the agencies’ statements and toxicology context ^{[1] [3] [2]}.