Epiduo Forte
- Generic Name: adapalene and benzoyl peroxide gel 0.3%/2.5%
- Brand Name: Epiduo Forte
Epiduo Forte (Adapalene and Benzoyl Peroxide Gel 0.3%/2.5%) side effects drug center
Epiduo Forte Side Effects Center
What Is Epiduo Forte?
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.
What Are Side Effects of Epiduo Forte?
Common side effects of Epiduo Forte include:
Dosage for Epiduo Forte
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).
What Drugs, Substances, or Supplements Interact with Epiduo Forte?
Epiduo Forte may interact with other topical acne therapy used at the same time. Tell your doctor all medications and supplements you use.
Epiduo Forte During Pregnancy or Breastfeeding
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.
Additional Information
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.
Epiduo Forte Consumer Information
Benzoyl peroxide can cause a rare but serious allergic reaction or severe skin irritation. Stop using this medicine and get emergency medical help if you have: hives, itching; difficult breathing, feeling light-headed; or swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- severe redness or swelling of treated skin;
- severe burning or stinging; or
- severe dryness or other skin irritation.
Common side effects (especially during the first 4 weeks of use) may include:
- dry or scaly skin;
- skin redness; or
- mild burning or stinging.
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.
Read the entire detailed patient monograph for Epiduo Forte (Adapalene and Benzoyl Peroxide Gel 0.3%/2.5%)
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%)
&Copy; 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.