What the label lists and what reports show
Lotilaner side effects
Lotilaner's FDA label: “The most common adverse reaction was instillation site stinging and burning (10%).” FAERS holds 3,098 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is eye irritation (404 reports).
- No generic listed
Check it at the source: the lotilaner FDA label on DailyMed (effective August 10, 2024, Tarsus Pharmaceuticals, Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common adverse reaction was instillation site stinging and burning (10%).
From the label: adverse reactions, continuedThe 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.
Source: FDA drug label, Tarsus Pharmaceuticals, Inc., effective August 10, 2024 (SPL set ccd9e37c-654e-4e84-8c85-6523457df979), via openFDA; the full label on DailyMed
What do FAERS reports show?
3,098 reports list lotilaner among the medicines taken, each a report of something that happened, not proof the medicine caused it; 27 are coded as a death and 57 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2025 (1,253, against a median of 1 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 18 reactions below, none is named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Lotilaner: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions