LULICONAZOLE: 44 Adverse Event Reports & Safety Profile
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Drug Class: Azole Antifungal [EPC] · Route: TOPICAL · Manufacturer: Oceanside Pharmaceuticals · FDA Application: 204153 · HUMAN PRESCRIPTION DRUG · FDA Label: Available
Patent Expires: Sep 6, 2033 · First Report: 201407 · Latest Report: 20250814
What Are the Most Common LULICONAZOLE Side Effects?
All LULICONAZOLE Side Effects by Frequency
Who Reports LULICONAZOLE Side Effects? Age & Gender Data
Gender: 59.1% female, 40.9% male. Average age: 46.3 years. Most reports from: US. View detailed demographics →
Is LULICONAZOLE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2014 | 2 | 0 | 0 |
| 2015 | 4 | 0 | 1 |
| 2016 | 5 | 0 | 0 |
| 2017 | 3 | 0 | 0 |
| 2018 | 1 | 0 | 0 |
| 2019 | 2 | 0 | 0 |
| 2020 | 1 | 0 | 0 |
| 2021 | 2 | 0 | 0 |
| 2023 | 2 | 0 | 0 |
| 2025 | 1 | 0 | 1 |
What Is LULICONAZOLE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 16 |
| Tinea pedis | 6 |
| Fungal infection | 5 |
Other Drugs in Same Class: Azole Antifungal [EPC]
Official FDA Label for LULICONAZOLE
Official prescribing information from the FDA-approved drug label.
Drug Description
Luliconazole Cream, 1% contains 1% luliconazole, an azole antifungal agent, in a white cream for topical application. Luliconazole is (2E)-2-[(4R)-4-(2,4-dichlorophenyl)-1,3-dithiolan-2-ylidene]-2-imidazol-1-ylacetonitrile. Its structural formula is: The molecular formula is C 14 H 9 Cl 2 N 3 S 2 with a molecular weight of 354.28. Luliconazole is the R enantiomer and contains one chiral center. The double bond adjacent to the dithiolane group is in the E configuration.
Luliconazole
Cream, 1% contains 10 mg of luliconazole per gram of cream in a vehicle consisting of benzyl alcohol, butylated hydroxytoluene, cetostearyl alcohol, isopropyl myristate, medium-chain triglycerides, methylparaben, polysorbate 60, propylene glycol, purified water, and sorbitan monostearate.
Luliconazole Chemical
Structure
FDA Approved Uses (Indications)
AND USAGE LUZU (luliconazole) Cream, 1% is indicated for the topical treatment of interdigital tinea pedis, tinea cruris, and tinea corporis caused by the organisms Trichophyton rubrum and Epidermophyton floccosum . LUZU (luliconazole) Cream, 1% is an azole antifungal indicated for the topical treatment of interdigital tinea pedis, tinea cruris, and tinea corporis caused by the organisms Trichophyton rubrum and Epidermophyton floccosum . ( 1 )
Dosage & Administration
AND ADMINISTRATION For topical use only.
Luliconazole
Cream, 1% is not for ophthalmic, oral, or intravaginal use.
- When treating interdigital tinea pedis, a thin layer of Luliconazole Cream, 1% should be applied to the affected area and approximately 1 inch of the immediate surrounding area(s) once daily for 2 weeks.
- When treating tinea cruris or tinea corporis, Luliconazole Cream, 1% should be applied to the affected area and approximately 1 inch of the immediate surrounding area(s) once daily for 1 week.
- For topical use only. Not for ophthalmic, oral, or intravaginal use. ( 2 )
- Interdigital Tinea Pedis: Luliconazole Cream, 1% should be applied to the affected and immediate surrounding area(s) once a day for 2 weeks. ( 2 )
- Tinea Cruris and Tinea Corporis: Luliconazole Cream, 1% should be applied to the affected skin and immediate surrounding area(s) once a day for 1 week. ( 2 )
Contraindications
None. None. ( 4 )
Known Adverse Reactions
REACTIONS The most common adverse reactions observed in clinical trials were application site reactions, which occurred in less than 1% of subjects. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Oceanside Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials 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. In three Phase 3 clinical trials, 616 subjects were exposed to Luliconazole Cream, 1%: 305 with interdigital tinea pedis and 311 subjects with tinea cruris. Subjects with interdigital tinea pedis or tinea cruris applied Luliconazole Cream, 1% or vehicle cream once daily for 14 days or 7 days, respectively, to affected and adjacent areas. During clinical trials with Luliconazole Cream, 1%, the most common adverse reactions were application site reactions which occurred in less than 1% of subjects in both the Luliconazole and vehicle arms. Most adverse reactions were mild in severity. A post-approval clinical trial was conducted in 75 subjects age 2 to <18 years old with tinea corporis. The adverse reactions in the Luliconazole Cream, 1% treated population were similar to the vehicle treated population.
6.2 Postmarketing Experience The following adverse reactions have been identified during postmarketing use of luliconazole cream, 1%: contact dermatitis and cellulitis. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Drug Interactions
INTERACTIONS An in vivo study in adult subjects with moderate to severe interdigital tinea pedis and tinea cruris showed that Luliconazole Cream, 1% is mostly a weak inhibitor of CYP2C19. In a separate trial in adolescent subjects with tinea cruris, in vivo blood levels of Luliconazole Cream, 1%, were seen to approach those levels sufficient to show moderate inhibition of CYP2C19 [see Clinical Pharmacology ( 12.3 )] .