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Epiduo Forte

Last reviewed on RxList: 1/24/2017
Epiduo Forte Side Effects Center

Last reviewed on RxList 8/6/2015

Epiduo Forte (adapalene and benzoyl peroxide) Gel is a combination of a synthetic retinoid and an antibacterial and keratolytic agent indicated for the topical treatment of acne vulgaris. Common side effects of Epiduo Forte include skin irritation, eczema, skin burning sensation, redness, scaling, and dryness.

Apply a thin layer of Epiduo Forte gel to affected areas of the face and/or trunk once daily after washing. Use a pea-sized dose amount for each area of the face (e.g., forehead, chin, each cheek). Epiduo Forte may interact with other topical acne therapy used at the same time. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using Epiduo Forte. It is unknown if the components of Epiduo Forte pass into breast milk. Consult your doctor before breastfeeding.

Our Epiduo Forte (adapalene and benzoyl peroxide) Gel Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

Acne is the result of an allergy. See Answer
Epiduo Forte Professional Information

SIDE EFFECTS

Clinical Studies Experience

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 Phase 3 clinical trial, 217 subjects were exposed to EPIDUO FORTE gel. 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 gel and for which the rate with EPIDUO FORTE gel exceeded the rate for the vehicle gel are presented inTable 1:

Table 1: ¬†Adverse Reactions Occurring in ≥ 1% of Subjects with Acne Vulgaris in a 12-week Clinical Trial

  EPIDUO FORTE Gel
(N=217)
Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5%
(N=217)
Vehicle Gel
(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 study 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 Gel (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 Gel (N=68)
Erythema 6% 1% 1% 0%
Scaling 6% 0% 1% 0%
Dryness 4% 1% 1% 0%
Stinging/burning 3% 1% 0% 0%

Post-Marketing Experience

There is no post-marketing experience with EPIDUO FORTE gel.

The following adverse reactions have been identified during post-approval use of EPIDUO gel, a similar drug containing 0.1% adapalene and 2.5% benzoyl peroxide as the active ingredients: eyelid edema, sunburn, blister, pain of skin, pruritus, swelling face, conjunctivitis, skin discoloration, rash, eczema, throat tightness and allergic contact dermatitis. 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.

Read the entire FDA prescribing information for Epiduo Forte (Adapalene and Benzoyl Peroxide Gel 0.3%/2.5%)

SLIDESHOW

Skin Health: 15 Tips for Clear Skin See Slideshow
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© Epiduo Forte Patient Information is supplied by Cerner Multum, Inc. and Epiduo Forte Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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