What parasitic infections is ivermectin FDA-approved to treat in humans?

1. What the FDA explicitly approves: two worm infections

Ivermectin tablets (Stromectol) are FDA‑approved to treat intestinal strongyloidiasis and onchocerciasis — the two specific human parasitic‑worm conditions consistently cited in U.S. reporting and drug references ^[1][2][3]. Multiple mainstream outlets and drug compendia state the same pair of indications, confirming that the agency’s human approvals focus on these tropical helminth infections ^[2][3].

2. Topical ivermectin: different products, different indications

The molecule ivermectin also exists in topical forms that the FDA has approved — notably a cream for rosacea (Soolantra) and a lotion for head lice (Sklice) — but those approvals are for dermatologic uses, not systemic parasitic‑worm infections ^[3]. Reporting and product summaries distinguish oral tablet approvals for worms from topical approvals for skin conditions ^[3].

3. Common off‑label and international uses — and the limits of FDA approval

Clinicians sometimes prescribe ivermectin off‑label for scabies and other parasitic skin infestations when topical therapy is impractical or has failed; professional guidance and non‑U.S. dermatology sources note this practice while calling such use “off‑label” relative to the FDA’s stated approvals ^[1]. Australian regulators (TGA) and other agencies also restrict its use to approved conditions and warn against unapproved uses such as COVID‑19 treatment, underscoring that national approvals vary and that many uses are not FDA‑authorized ^[4].

4. The COVID‑19 controversy: what the FDA has and hasn’t approved

During the COVID‑19 pandemic ivermectin gained popular attention, but the FDA has not approved (or authorized) ivermectin for prevention or treatment of COVID‑19; multiple outlets and regulatory notices repeat the FDA warning against such use ^[4][2][5]. Reporting documents widespread off‑label demand and harms from inappropriate use of veterinary formulations, and the FDA and public‑health organizations explicitly discourage using animal products or unapproved regimens for humans ^[5][2].

5. Policy and access changes complicate public perception

State laws and policy changes — for example, moves in several U.S. states to make ivermectin available over the counter or more easily dispensed — have muddied public understanding by increasing access while the federal FDA stance on approved indications remains unchanged ^[6][5][7]. News outlets note that these local decisions do not expand FDA‑approved uses and have prompted warnings from clinicians about misuse and toxicity risks ^[7][5].

6. How sources frame certainty and disagreement

Authoritative clinical resources and mainstream news outlets consistently name the same FDA‑approved human indications (strongyloidiasis and onchocerciasis) and add that other uses are off‑label ^[1][2][3]. Some advocacy or alternative medicine commentary promotes experimental uses (cancer, COVID‑19), but mainstream regulatory reporting and drug references emphasize lack of approval and lack of evidence; those divergent viewpoints appear across the provided sources ^[8][9].

7. Practical takeaway and caveats for clinicians and the public

For clinicians: documented FDA approvals are narrow (two intestinal/tissue worm infections) and other prescriptions should be considered off‑label with appropriate clinical justification and informed consent ^[1][3]. For the public: do not assume increased retail availability equals expanded FDA approval; the agency still does not endorse ivermectin for COVID‑19 or many promoted uses, and animal formulations are unsafe for people ^[2][5][4].

Limitations: available sources do not mention every possible off‑label use or the full historic voting record of the FDA on ivermectin; this summary relies on the supplied reporting and drug summaries and cites only those documents ^[1][2][3].