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Ertaczo

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Ertaczo

Ertaczo

SIDE EFFECTS

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.

Postmarketing Experience

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:

Cutaneous adverse events: erythema, pruritus, vesiculation, desquamation, and hyperpigmentation.

Read the Ertaczo (sertaconazole nitrate) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

No information provided.

Last reviewed on RxList: 2/3/2014
This monograph has been modified to include the generic and brand name in many instances.

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Ertaczo - User Reviews

Ertaczo User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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