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Fact check: What is the FDA-recommended dosage of ivermectin for approved human conditions (e.g., onchocerciasis, strongyloidiasis)?
Executive Summary
The FDA-recommended, product-label dosing for oral ivermectin in approved human parasitic infections is approximately 150 micrograms per kilogram (0.15 mg/kg) as a single dose for onchocerciasis (river blindness) and approximately 200 micrograms per kilogram (0.2 mg/kg) as a single dose for strongyloidiasis; weight-based tablet tables are provided in the approved Stromectol/prescribing information [1] [2]. Several clinical guides and dosing summaries repeat the same figures and add practical weight-band tablet equivalents and repeat-interval guidance for onchocerciasis [3] [4].
1. Key claims pulled straight from the record — what people are asserting and why it matters
The dominant, repeated claim across the provided analyses is that ivermectin dosing for the two FDA-approved human indications uses weight-based single doses: ~150 mcg/kg for onchocerciasis and ~200 mcg/kg for strongyloidiasis. The package insert language and multiple dosing guides restate these numbers and present them as the basis for tablet-count tables and clinical dosing charts [1] [2] [3]. This matters because dose calculation errors can produce under-treatment or safety risks. The materials also highlight that onchocerciasis dosing is often administered once and may be repeated at intervals (commonly 3–12 months in some summaries), which is a critical programmatic distinction from the single-course approach typically used for strongyloidiasis [4] [2].
2. Where the official, regulatory wording sits — label, package insert, and FDA framing
The FDA-approved product information for Stromectol (ivermectin) supplies the formal dosing framework used in practice: single oral doses designed to provide about 150 mcg/kg for onchocerciasis and about 200 mcg/kg for strongyloidiasis, with explicit weight-based tablet equivalents in the prescribing information [1] [2]. The same language appears in contemporary package-insert reproductions and dosing summaries dated in 2025 that clinicians rely on for precise tablet counts by weight band. The package insert is the canonical regulatory source and is cited across clinical references, reinforcing that the label is the anchor for recommended dosing [2] [1].
3. Practical dosing tables and examples clinicians actually use in the clinic
Clinical dosing references translate the mcg/kg directives into practical tablet counts by weight bands so that clinicians can dose without microgram calculations: examples include 3 mg for 15–24 kg, 6 mg for 25–35 kg, 9 mg for 36–50 kg, and larger bands up to 150–200 mcg/kg for adults, matching the label targets [4]. These tables also note the repeat dosing window for onchocerciasis — commonly every 3–12 months in mass treatment contexts — whereas strongyloidiasis is presented as a single-dose regimen [4] [2]. The chart approach reduces calculation error and is how many hospitals and public-health programs operationalize label guidance [4].
4. Differences, omissions, and where guidance diverges between sources
Most sources concordantly state the same mcg/kg numbers, but there are minor divergences in presentation and detail. Some clinical guides summarize the recommendations without reproducing the entire label table, which can omit exact tablet equivalents or repeat-interval nuance [5]. Other summaries explicitly convert mcg/kg to mg/kg nomenclature (0.15 mg/kg and 0.20 mg/kg) for clarity [3]. The main practical gap across the documents is that programmatic repetition intervals for onchocerciasis may be discussed differently depending on public-health context versus individual treatment guidance, and some sources emphasize weight-based tables more than others [4] [2] [3].
5. What dates and sources tell us about the currency and consensus of dosing statements
The analyses include package-insert and clinical-dosing documents from 2024–2025 that restate the same numbers, indicating recent and sustained consensus: prescribing information and clinical guides dated in 2024–2025 repeat 150 mcg/kg for onchocerciasis and 200 mcg/kg for strongyloidiasis [4] [2] [3]. A clinical guide noted in 2025 reiterates the mg/kg expression and underlines label consistency [3]. One reputable clinical resource (Johns Hopkins ABX Guide) acknowledges the indications but in the provided excerpt did not reproduce the exact mcg/kg figures, reflecting a presentation choice rather than a substantive disagreement [5]. Overall, the convergence across recent documents indicates stable regulatory guidance.
6. Bottom line for clinicians and patients — exactly what to use and what to watch for
For dosing decisions, follow the FDA-approved package insert and weight-based tablet table: aim for ~150 mcg/kg (0.15 mg/kg) single dose for onchocerciasis and ~200 mcg/kg (0.2 mg/kg) single dose for strongyloidiasis, using the tablet-count tables provided in the Stromectol/prescribing information; onchocerciasis may be repeated at programmatic intervals such as 3–12 months where indicated [1] [2] [4]. Clinicians should rely on current prescribing information for exact tablet equivalents and patient-specific adjustments, and be aware that some clinical summaries may omit table details even while endorsing the same mg/kg figures [3] [5].