Onabet Adverse Reactions

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 Sertaconazole nitrate 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 Sertaconazole nitrate 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.
Post-marketing Experience: The following adverse reactions have been identified during post-approval use of Sertaconazole nitrate 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 Sertaconazole nitrate cream, 2%, the following were reported: Cutaneous adverse events: erythema, pruritus, vesiculation, desquamation, and hyperpigmentation.