LOTILANER: 1,622 Adverse Event Reports & Safety Profile
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Drug Class: Ectoparasiticide [EPC] · Route: OPHTHALMIC · Manufacturer: Tarsus Pharmaceuticals, Inc. · FDA Application: 217603 · HUMAN PRESCRIPTION DRUG · FDA Label: Available
Patent Expires: Jan 17, 2030 · First Report: 19461029 · Latest Report: 20250923
What Are the Most Common LOTILANER Side Effects?
All LOTILANER Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Eye irritation | 200 | 12.3% | 0 | 0 |
| Ocular hyperaemia | 135 | 8.3% | 0 | 0 |
| Vision blurred | 134 | 8.3% | 0 | 1 |
| Eye pain | 125 | 7.7% | 0 | 0 |
| Product use issue | 114 | 7.0% | 0 | 0 |
| Condition aggravated | 104 | 6.4% | 0 | 0 |
| Instillation site irritation | 94 | 5.8% | 0 | 1 |
| Off label use | 94 | 5.8% | 0 | 0 |
| Wrong technique in product usage process | 94 | 5.8% | 0 | 2 |
| Therapy interrupted | 91 | 5.6% | 0 | 4 |
| Eye pruritus | 81 | 5.0% | 0 | 1 |
| Eye swelling | 63 | 3.9% | 0 | 1 |
| Lacrimation increased | 62 | 3.8% | 0 | 0 |
| Drug ineffective | 58 | 3.6% | 0 | 1 |
| Headache | 56 | 3.5% | 0 | 2 |
| Eye discharge | 53 | 3.3% | 0 | 0 |
| Drug hypersensitivity | 50 | 3.1% | 0 | 0 |
| Swelling of eyelid | 50 | 3.1% | 0 | 0 |
| Pruritus | 48 | 3.0% | 0 | 3 |
| Product prescribing issue | 45 | 2.8% | 0 | 0 |
Who Reports LOTILANER Side Effects? Age & Gender Data
Gender: 67.8% female, 32.2% male. Average age: 65.2 years. Most reports from: US. View detailed demographics →
Is LOTILANER Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2023 | 54 | 0 | 3 |
| 2024 | 412 | 5 | 7 |
| 2025 | 263 | 4 | 5 |
What Is LOTILANER Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 677 |
| Demodex blepharitis | 432 |
| Blepharitis | 139 |
| Arthropod infestation | 129 |
| Ocular demodicosis | 122 |
| Acariasis | 42 |
| Dry eye | 31 |
| Eyelid margin crusting | 16 |
| Eye disorder | 6 |
LOTILANER vs Alternatives: Which Is Safer?
Official FDA Label for LOTILANER
Official prescribing information from the FDA-approved drug label.
Drug Description
Lotilaner is a member of the isoxazoline family of compounds. Its chemical name is 2-Thiophenecarboxamide, 5-[(5S)-4,5-dihydro-5-(3,4,5-trichlorophenyl)-5-(trifluoromethyl)-3-isoxazolyl]-3-methyl-N-[2-oxo-2-[(2,2,2-trifluoroethyl)amino]ethyl]-2-thiophenecarboxamide. The molecular formula is C 20 H 14 Cl 3 F 6 N 3 O 3 S. The molecular weight is 596.76 g/mol. The chemical structure is: XDEMVY is a sterile, preserved, multi-dose, slightly yellowish, slightly opalescent, topical ophthalmic solution containing lotilaner, 0.25% as the active ingredient. It is preserved with potassium sorbate and contains the following additional inactive ingredients: edetate disodium, hydroxypropyl methylcellulose (HPMC), polyoxyl 35 castor oil, glycerin, dibasic sodium phosphate, monobasic sodium phosphate, and water for injection.
Chemical
Structure
FDA Approved Uses (Indications)
AND USAGE XDEMVY is indicated for the treatment of Demodex blepharitis. XDEMVY is an ectoparasiticide (anti-parasitic) indicated for the treatment of Demodex blepharitis. ( 1 )
Dosage & Administration
AND ADMINISTRATION 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 )
Contraindications
None. None. ( 4 )
Known Adverse Reactions
REACTIONS 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.
Warnings
AND PRECAUTIONS