Skinoren Gel Adverse Reactions

Summary of the safety profile: Only cutaneous treatment-related adverse events were reported in clinical studies. In the great majority of cases the symptoms were mild or moderate; the frequency of irritative symptoms gradually decreased during the course of therapy.
In clinical studies, most frequently observed side effects included application site pruritus, application site burning, and application site pain.
Tabulated list of adverse reactions: Frequencies of side effects observed in clinical studies and given in the tables 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).
Acne: See Table 1.

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Rosacea: See Table 2.

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Description of selected adverse reactions: The following additional adverse reactions have been reported during post-approval use of Azelaic acid (Skinoren) gel (frequency unknown): Hypersensitivity, which may occur with one or more of the following adverse reactions: Angioedema, Eye swelling, Swelling face, Dyspnoea; Skin irritation; Urticaria; Worsening of asthma.
Additional information on special populations: Pediatric patients: Treatment of acne vulgaris in adolescents 12-18 years of age: In 4 clinical phase II and II/III studies involving adolescents 12-17 years of age (120/383; 31%), the overall incidence of adverse events for Azelaic acid (Skinoren) gel was similar for the groups aged 12-17 years (40%), aged ≥18 years (37%) and for the entire patient population (38%). This similarity also applied to the group aged 12-20 years (40%).