What are current medical guidelines for human use of ivermectin and approved indications as of 2025?
Executive summary
Ivermectin is an approved antiparasitic medicine for specified human parasitic infections (scabies, strongyloidiasis, onchocerciasis and related intestinal worms) and dosing guidance is weight‑based — commonly 0.15 mg/kg as a single oral dose for many indications with repeat dosing schedules for some diseases (sources: Drugs.com, Medical News Today) [1] [2]. Major regulators and guideline bodies (FDA, TGA, WHO/Cochrane referenced in reporting) explicitly do not approve ivermectin for COVID‑19 and warn against use of veterinary formulations in people [3] [4] [5].
1. Approved human indications and routine dosing: where the drug is actually authorized
Ivermectin is an FDA‑approved antiparasitic used in humans for infestations including onchocerciasis (river blindness), strongyloidiasis (threadworm), scabies and several intestinal helminthiases; standard human dosing is weight‑based—for example many references list about 0.15 mg/kg orally (single dose) with retreatment intervals that depend on the condition (sometimes every 3–12 months for certain parasitic diseases) [6] [1] [2].
2. Regulatory warnings and what ivermectin is not approved for: the COVID lesson
Regulators have repeatedly said ivermectin is not authorized for prevention or treatment of COVID‑19 and have warned about harms from using animal formulations. The U.S. FDA has not approved ivermectin for COVID‑19 and has documented cases of harm after people self‑medicated with veterinary products; Australia’s TGA restricted prescribing to approved indications and discouraged importation for COVID‑19 [3] [4] [5].
3. Clinical evidence and guideline stances: mixed studies but authoritative rejections for viral disease
Some small trials and in‑vitro studies examined antiviral activity of ivermectin against SARS‑CoV‑2 and a handful of randomized trials reported modest signals, prompting calls for larger trials; however major reviews and public‑health bodies concluded evidence does not support routine use for COVID‑19 and guideline groups advise against it outside trials [7] [6] [5]. Reporting notes that substantial research has shown ivermectin does not treat COVID‑19 in practice and major health organizations advise against it [6] [8].
4. Evolving policy: states, prescribing limits, and access changes
In 2022–2025 some national regulators tightened prescribing (e.g., Australia’s TGA limited who may prescribe oral ivermectin beyond approved indications) while U.S. state legislatures have moved to expand over‑the‑counter access in some states, creating tensions between public‑health authorities and local policy makers; Pharmacy Times and The New York Times reported both legal changes and clinicians’ alarm at expanded OTC availability [4] [9] [8].
5. Safety profile and risks from non‑approved use
Ivermectin has established side effects in appropriate parasitic use and regulators warn that formulations for animals differ and can cause serious toxicity when used by people; the FDA received reports of hospitalizations after self‑medication with animal ivermectin [3] [1]. Dosing recommendations emphasize single, weight‑based oral doses taken fasting for human products; higher or repeated dosing and use of veterinary products carry documented risks [1] [2].
6. Off‑label interest and contested claims (cancer, other repurposing)
Interest in repurposing ivermectin—for cancer or other conditions—persists in some clinical and media circles. Investigational studies and early phase trials exist, but mainstream reporting and reviews emphasize there is no robust evidence to support ivermectin for cancer or COVID‑19 and caution patients [10] [8] [6]. Alternative media and opinion pieces promote broader uses; authoritative outlets flag these as unsupported by current clinical evidence [11] [12].
7. What clinicians and patients should know now
If treating parasitic infections, clinicians follow established, weight‑based dosing and approved indications; authoritative sources and regulators discourage ivermectin for viral illnesses and urge against using animal formulations [1] [3] [5]. Available sources do not mention any FDA approval expanding ivermectin’s indications beyond antiparasitic uses as of the provided reporting (available sources do not mention FDA approvals for new non‑parasitic indications) [3] [6].
Limitations and competing views: reporting shows small clinical trials that investigated ivermectin for COVID‑19 (some with favorable signals), but multiple major regulators and reviews have judged evidence insufficient and issued warnings; policy moves to deregulate access in some U.S. states reflect political and advocacy pressures that conflict with public‑health guidance [7] [3] [9] [8].
If you want, I can pull the specific dosing schedules per approved condition (scabies, strongyloidiasis, onchocerciasis) as listed in Drugs.com and Medical News Today and provide full citation lines from those pages.