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Lotilaner: uses, dosing, side effects & brands

Lotilaner is an ectoparasiticide sold in the U.S. under one brand. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.

By the pharmaranks editorial teamReviewed against the FDA (openFDA label, NDC Directory & Enforcement) sourcesUpdated Jul 24, 2026How we research

Key facts

Drug class
Ectoparasiticide
Available as
Drops
Sold as
Xdemvy
Prescription?
Prescription only
Generic available?
Not in our catalog

How lotilaner is dosed

From the FDA label for Xdemvy (application NDA217603). Other lotilaner products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.

Instill one drop of XDEMVY in each eye twice daily (approximately 12 hours apart) for 6 weeks. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes apart. If one dose is missed, treatment should continue with the next scheduled dose. Instill one drop of XDEMVY in each eye twice daily (approximately 12 hours apart) for 6 weeks. ( 2 )

Lotilaner side effects

The most common adverse reaction was instillation site stinging and burning (10%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Tarsus Pharmaceuticals at 1-888-421-4002 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. XDEMVY was evaluated in 833 patients with Demodex blepharitis in two randomized, double-masked, vehicle-controlled studies (Saturn-1 and Saturn-2) with 42 days of treatment. The most common ocular adverse reaction observed in controlled clinical studies with XDEMVY was instillation site stinging and burning which was reported in 10% of patients. Other ocular adverse reactions reported in less than 2% of patients were chalazion/hordeolum and punctate keratitis.

Who shouldn’t take lotilaner

None. None. ( 4 )

Every lotilaner product we track (1)

Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.

Only one: Xdemvy.

What people report to the FDA about lotilaner

The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 1 reports naming lotilaner. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:

  • eye pain1 reports
  • eye pruritus1 reports
  • eye swelling1 reports
  • ocular hyperaemia1 reports

Read these as a signal, not a rate. A report does not mean lotilaner caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.

Source: openFDA drug/event (FAERS), retrieved August 4, 2026.

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Frequently asked questions

What is lotilaner?

Lotilaner is a member of the isoxazoline family of compounds.

What kind of drug is lotilaner?

The FDA classifies lotilaner as an ectoparasiticide. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.

Can you take lotilaner with other medicines?

It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run lotilaner against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.

What forms does lotilaner come in?

Across the brands we track, lotilaner is currently marketed as drops, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.

Is there a generic lotilaner?

We do not currently list a generic-labelled lotilaner product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.

Cite this page
APA
pharmaranks. (2026, July 24). Lotilaner: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/lotilaner
MLA
“Lotilaner: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/lotilaner.

We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.

Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.

Read the full FDA label for lotilaner on DailyMed (NIH) ↗.