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
Last updated on MDtodate: 10/03/2022

SIDE EFFECTS

Clinical Trials Experience

The following adverse reactions are discussed in greater detail elsewhere in the labeling:

  • Hypersensitivity
  • 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

EPIDUO FORTE
(N=217)
Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%
(N=217)
Vehicle
(N=69)
Skin irritation 4% <1% 0%
Eczema 1% 0% 0%
Dermatitis atopic 1% 0% 0%
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)
Moderate Severe Moderate Severe
EPIDUO FORTE (N=213)
Erythema 20% 1% 4% <1%
Scaling 17% 1% 1% <1%
Dryness 15% 2% 3% <1%
Stinging/burning 19% 6% 1% 1%
Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% (N=212)
Erythema 15% 1% 2% <1%
Scaling 12% <1% 2% 0%
Dryness 13% 1% 2% 0%
Stinging/burning 14% 9% 3% 0%
Vehicle (N=68)
Erythema 6% 1% 1% 0%
Scaling 6% 0% 1% 0%
Dryness 4% 1% 1% 0%
Stinging/burning 3% 1% 0% 0%

Postmarketing Experience

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 .