EPIDUO FORTE SIDE EFFECTS
- Generic Name: adapalene and benzoyl peroxide gel 0.3%/2.5%
- Brand Name: Epiduo Forte
- Drug Class: Acne Agents, Topical Combos, Topical Skin Products
Clinical Trials Experience
The following adverse reactions are discussed in greater detail elsewhere in the labeling:
- Skin Irritation/Contact Dermatitis
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
During the randomized, double-blind, vehicle- and active-controlled clinical trial, 217 subjects were exposed to EPIDUO FORTE. A total of 197 subjects with acne vulgaris, 12 years and older, were treated once daily for 12 weeks. Adverse reactions reported within 12 weeks of treatment in at least 1% of subjects treated with EPIDUO FORTE and for which the rate with EPIDUO FORTE exceeded the rate for the vehicle are presented in Table 1:
Table 1: Adverse Reactions Occurring in ≥1% of Subjects with Acne Vulgaris in a 12-week Clinical Trial
|Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%
|Skin burning sensation||1%||0%||0%|
Local tolerability evaluations presented in Table 2 were conducted at each trial visit in the clinical trial by assessment of erythema, scaling, dryness, and stinging/burning, which peaked at Week 1 of therapy and decreased thereafter.
Table 2: Incidence of Local Cutaneous Irritation in 12-week Clinical Trial in Subjects with Acne Vulgaris
|Maximum Severity During Treatment||End of Treatment Severity (Final Score)|
|EPIDUO FORTE (N=213)|
|Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% (N=212)|
The following adverse reactions have been identified during postapproval use of EPIDUO FORTE. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Skin and subcutaneous tissue disorders: sunburn, blister (including vesicles and bullae), pruritus, hyperpigmentation and hypopigmentation.
SRC: NLM .