Travocort Adverse Reactions

Summary of the safety profile: In clinical studies, most frequently observed adverse reactions included application site irritation and application site burning.
Tabulated list of adverse reactions: Frequencies of adverse reactions observed in clinical studies and given in the table as follows are defined according to the MedDRA frequency convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to<1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); frequency not known (cannot be estimated from the available data). (See table.)

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Description of selected adverse reactions: As with other glucocorticoids for topical application, the following local adverse reactions may occur (frequency not known): Skin atrophy, application site folliculitis, hypertrichosis, telangiectasia, perioral dermatitis, skin discoloration, acne, and/or allergic skin reactions to any of the ingredients of the formulation. Systemic effects due to absorption may occur when topical preparations containing glucocorticoids are applied.
Adverse reactions cannot be excluded in neonates whose mothers have been treated extensively or for a prolonged period of time during pregnancy or while lactating (for example reduced adrenocortical function, immunosuppression).