What the label lists and what reports show
Sertaconazole side effects
Sertaconazole's FDA label: “Most common adverse reactions observed in clinical trials (incidence >2%) were contact dermatitis, dry skin, burning skin, application site skin tenderness.” FAERS holds 156 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 fatigue (15 reports).
- No generic listed
Check it at the source: the sertaconazole FDA label on DailyMed (effective December 9, 2024, Lacer Pharma, 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 ERTACZO cream?The most common side effects of ERTACZO cream include: redness, itching, dry skin, burning, blistering, swelling, drainage, and skin tenderness at the treated skin areas. Tell your healthcare provider if you have any of these skin reactions. These are not all the possible side effects of ERTACZO 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, Lacer Pharma, LLC, effective December 9, 2024 (SPL set 27d51f01-3282-34ea-e063-6394a90a91ed), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions observed in clinical trials (incidence >2%) were contact dermatitis, dry skin, burning skin, application site skin tenderness.
From the label: adverse reactions, continuedMost common adverse reactions observed in clinical trials (incidence >2%) were contact dermatitis, dry skin, burning skin, application site skin tenderness. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lacer Pharma, LLC at 1-888-403-8874 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 clinical trials, cutaneous adverse events occurred in 7 of 297 (2%) subjects (2 of them severe) receiving ERTACZO cream, 2%, and in 7 of 291 (2%) subjects (2 of them severe) receiving vehicle. These reported cutaneous adverse events included contact dermatitis, dry skin, burning skin, and application site skin tenderness. In a dermal sensitization trial, 8 of 202 evaluable subjects tested with ERTACZO cream, 2%, and 4 of 202 evaluable subjects tested with vehicle exhibited a erythematous reaction in the challenge phase. There was no evidence of cumulative irritation or contact sensitization in a repeated insult patch test involving 202 healthy volunteers. 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of ERTACZO cream, 2%. …
Source: FDA drug label, Lacer Pharma, LLC, effective December 9, 2024 (SPL set 27d51f01-3282-34ea-e063-6394a90a91ed), via openFDA; the full label on DailyMed
What do FAERS reports show?
156 reports list sertaconazole among the medicines taken, each a report of something that happened, not proof the medicine caused it; 21 are coded as a death and 59 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 24 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?
- Sertaconazole: 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