Medical Editor: John P. Cunha, DO, FACOEP
Ertaczo (sertaconazole nitrate) Cream is an antifungal medication used to treat fungal infections of the skin such as athlete's foot. Serious side effects are not expected to occur with the use of Ertaczo Cream topical. Side effects of Ertaczo Cream include burning, swelling, irritation, tenderness, discoloration, or dry skin.
The recommended dose to treat interdigital tinea pedis is to apply Ertazco cream twice daily for 4 weeks. Sufficient cream should be applied to cover both the affected areas between the toes and the immediately surrounding healthy skin. Do not use other topical products on the treated area, unless otherwise directed by your doctor. Other topical products may affect the absorption or effectiveness of Ertaczo topical. Although unlikely, other medications may interact with Ertazco topical. Tell your doctor all medications and supplements you use. Ertaczo should be used only when prescribed during pregnancy. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.
Our Ertaczo (sertaconazole nitrate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Serious side effects are not expected to occur with the use of sertaconazole topical. Stop using sertaconazole topical and contact your doctor if you experience unusual or severe itching, redness, burning, blistering, swelling, oozing, or irritation of the skin.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Ertaczo (Sertaconazole Nitrate)
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, 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 slight 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.
The following adverse reactions have been identified during post-approval use of ERTACZO cream, 2%. 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.
In post-marketing surveillance for ERTACZO cream, 2%, the following were reported:
Read the entire FDA prescribing information for Ertaczo (Sertaconazole Nitrate)
© Ertaczo Patient Information is supplied by Cerner Multum, Inc. and Ertaczo Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.