Epiduo/Epiduo Forte Adverse Reactions

Adverse Reactions-clinical studies: Epiduo: Different degrees of skin irritation appear after application of Epiduo, the intensity is generally mild or moderate, with local tolerability signs and symptoms (erythema, dryness, scaling, burning¹ and pain of skin (stinging pain) peaking during the first week and then subsiding spontaneously.
Epiduo Forte: Treatment-related adverse events or adverse reactions typically associated with use of Adapalene + Benzoyl Peroxide (Epiduo Forte) include mild to moderate application site reactions, such as skin irritation characterized by scaling, dryness, erythema, and burning¹/stinging. These reactions usually occur early in the treatment and tend to gradually lessen and subside spontaneously over time
Tabulated summary of adverse reactions: Epiduo: 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 Adapalene + Benzoyl Peroxide (Epiduo) in clinical studies. (See Table 1.)

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Epiduo Forte: 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 in vehicle-controlled Phase 3 study with Epiduo Forte. (See Table 2.)

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Post Marketing Experience (if any): Epiduo: In addition to some of the previously mentioned, other adverse drug reactions were reported with Adapalene + Benzoyl Peroxide (Epiduo), the previously approved fixed combination of adapalene and benzoyl peroxide: Clinical trials: Other adverse drug reactions reported in clinical trials with Adapalene + Benzoyl Peroxide (Epiduo) gel are irritative contact dermatitis (common) and sunburn (uncommon).
Post-Marketing surveillance data: The following events have been reported since the global launch of Adapalene + Benzoyl Peroxide (Epiduo). These events have been chosen for inclusion due to either their seriousness, causal connection to Adapalene + Benzoyl Peroxide (Epiduo) or frequency of reporting. Post-market adverse events are reported spontaneously from a population of unknown size, thus estimates of frequency cannot be made.
Eye disorders: Eyelid oedema.
Respiratory, thoracic and mediastinal disorders: Throat tightness, dyspnoea².
Skin and subcutaneous tissue disorders: Pain of skin (stinging pain), allergic contact dermatitis, swelling of face, blister (vesicles), skin discolouration, urticaria, anaphylactic reaction².
1 - Most of the cases of "application site burn" were superficial burns but cases with second degree burn or severe burn reactions have been reported.
2 - Anaphylactic reactions include generalised skin eruptions or skin reactions associated with respiratory disorders mainly represented by oedemas, throat tightness, dyspnoea and urticaria.