In clinical studies, most frequently observed side effects included application site burning, application site pruritus, and application site erythema.
Frequencies of side effects 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), not known (cannot be estimated from the available data). (See table.)
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Generally, local skin irritation regresses in the course of treatment.
The following additional adverse reactions have been reported during post-approval use of Skinoren cream (frequency unknown): Angioedema, Dermatitis contact, Eye swelling, Swelling face (which may occur with Hypersensitivity); Rash; Urticaria; Worsening of Asthma.