Epiduo Forte Adverse Reactions

Summary of safety profile: Approximately 10% of patients can be expected to experience adverse skin reactions. Treatment-related adverse reactions typically associated with use of Epiduo Forte 0.3% / 2.5% gel include mild to moderate application site reactions, such as skin irritation mainly characterized by scaling, dryness, erythema, and burning/stinging. Recommendation is to use moisturiser, temporarily reduce the application frequency to every other day, or temporarily discontinue its use until once daily schedule can be resumed.
These reactions usually occur early in the treatment, and tend to gradually lessen over time.
Tabulated summary of adverse reactions: The adverse reactions are classified by System Organ Class and frequency, using the following 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) and were reported with Epiduo Forte 0.3% / 2.5% gel in vehicle-controlled Phase 3 clinical study (see Table 3).

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Skin-related adverse events were more frequent with Epiduo Forte 0.3% / 2.5% gel than Epiduo gel (Adapalene 0.1% / Benzoyl peroxide 2.5%) as compared to vehicle. In the pivotal study (see Pharmacology: Pharmacodynamics under Actions), 9.2% of subjects in the combined population treated with Epiduo Forte 0.3% / 2.5% gel had skin-related adverse events and 3.7% in the population treated with Epiduo gel compared to Vehicle Gel group (2.9%).
In addition to some of the previously mentioned, other adverse drug reactions were reported with Epiduo gel (Adapalene 0.1% / Benzoyl peroxide 2.5%), the previously approved fixed combination of adapalene and benzoyl peroxide: Clinical trials: Other adverse drug reactions reported in clinical trials with Epiduo gel are irritative contact dermatitis (common) and sunburn (uncommon).
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.