In clinical trials, cutaneous adverse events occurred in 7 of 297 (2%) patients (2 of them severe) receiving ERTACZO™ Cream, 2%, and in 7 of 291 (2%) patients (2 of them severe) receiving vehicle. These reported cutaneous adverse events included contact dermatitis, dry skin, burning skin, application site reaction and skin tenderness.

In a dermal sensitization study, 8 of 202 evaluable patients tested with ERTACZO™ Cream, 2%, and 4 of 202 evaluable patients 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. In non-US post-marketing surveillance for ERTACZO™ Cream, 2%, the following cutaneous adverse events were reported: contact dermatitis, erythema, pruritus, vesiculation, desquamation, and hyperpigmentation.

Drug/Laboratory Test Interactions: Potential interactions between ERTACZO™ Cream, 2%, and other drugs or laboratory tests have not been systematically evaluated.

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