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
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 .