What the label lists and what reports show
Luliconazole side effects
Luliconazole's FDA label: “The most common adverse reactions observed in clinical trials were application site reactions, which occurred in less than 1% of subjects.” FAERS holds 168 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 hepatic function abnormal (9 reports).
- No generic listed
Check it at the source: the luliconazole FDA label on DailyMed (effective April 1, 2020, Bausch Health US, LLC); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of LUZU Cream?LUZU Cream may cause skin reactions at the treatment site. Skin irritation may happen with LUZU Cream. Tell your doctor if you have any skin reactions on the areas of your skin treated with LUZU Cream. These are not all the possible side effects of LUZU Cream. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Source: FDA drug label, Bausch Health US, LLC, effective April 1, 2020 (SPL set a7016010-ce43-4c09-8d21-aeb697ffed31), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions observed in clinical trials were application site reactions, which occurred in less than 1% of subjects.
From the label: adverse reactions, continuedThe 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 Bausch Health US, LLC 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 LUZU Cream, 1%: 305 with interdigital tinea pedis and 311 subjects with tinea cruris. Subjects with interdigital tinea pedis or tinea cruris applied LUZU Cream, 1% or vehicle cream once daily for 14 days or 7 days, respectively, to affected and adjacent areas. During clinical trials with LUZU Cream, 1%, the most common adverse reactions were application site reactions which occurred in less than 1% of subjects in both the LUZU 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 LUZU Cream, 1% treated population were similar to the vehicle treated population. …
Source: FDA drug label, Bausch Health US, LLC, effective April 1, 2020 (SPL set a7016010-ce43-4c09-8d21-aeb697ffed31), via openFDA; the full label on DailyMed
What do FAERS reports show?
168 reports list luliconazole among the medicines taken, each a report of something that happened, not proof the medicine caused it; 15 are coded as a death and 81 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. Of the 21 reactions below, 2 are 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.
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?
- Luliconazole: 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