Epiduo Gel

Epiduo Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Epiduo (adapalene and benzoyle peroxide) Gel is used to treat acne in people who are at least 12 years old. It is a combination of adapalene, a medication similar to vitamin A, and benzoyl peroxide, and antibacterial medication that also has a mild drying effect. Common side effects include skin redness, dryness, peeling, mild burning, swelling, or worsening of acne during the first 4 weeks of using this product. These effects usually decrease with continued use.

Epiduo is for topical (for the skin) use only. Apply a thin film of Epiduo gel to affected areas once daily after washing. Use a pea-sized dose amount for each area of the face (e.g., forehead, chin, each cheek). Avoid the eyes, lips and mucous membranes. Do not use other medicated skin products unless your doctor has told you to. It is not likely that other drugs you take orally or inject will have an effect on topically applied Epiduo. Many drugs can interact with each other. Tell your doctor all prescription and over-the-counter medications and supplements you use. During pregnancy, Epiduo should be used only when prescribed. It is not known whether this drug passes into breast milk when used on the skin. Consult your doctor before breast-feeding.

Our Epiduo (adapalene and benzoyle peroxide) 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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Epiduo in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

During your first 4 weeks of using adapalene and benzoyl peroxide topical, your skin may be dry, red, or scaly. You may also feel some burning or stinging. Call your doctor if these side effects are severe.

Less serious side effects may include mild itching.

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 (Adapalene and Benzoyl Peroxide Gel) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Epiduo Overview - Patient Information: Side Effects

SIDE EFFECTS: Skin redness, dryness, peeling, mild burning, swelling, or worsening of acne may occur during the first 4 weeks of using this product. These effects usually decrease with continued use. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. Your doctor may want you to use a moisturizer, decrease how often you use the product, or have you stop using it.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Epiduo (Adapalene and Benzoyl Peroxide Gel)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Epiduo FDA Prescribing Information: Side Effects
(Adverse Reactions)

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 clinical trials, 1401 subjects were exposed to EPIDUO gel. A total of 1036 subjects with acne vulgaris, 12 years and older, were treated once daily for 12 weeks to 12 months. Related adverse events reported within 12 weeks of treatment and in at least 1% of subjects treated with EPIDUO gel and those reported in subjects treated with the vehicle gel are presented in Table 1:

Table 1 : Drug Related Adverse Events Reported in Clinical Trials by At Least 1% of Patients Treated For 12 Weeks

System Organ Class/ Preferred Term EPIDUO gel
N = 564
Vehicle gel
N = 489
Subjects with AE (s) 14% 4%
Dry Skin 7% 2%
Contact dermatitis 3% < 1%
Application site burning 2% < 1%
Application site irritation 1% < 1%
Skin irritation 1% 0%

Local tolerability evaluations, presented in Table 2, were conducted at each study visit in clinical trials by assessment of erythema, scaling, dryness, burning, and stinging.

Table 2 : Incidence of Local Cutaneous Irritation in Controlled Clinical Trials (N = 553) Treatment Emergent Signs and Symptoms

  Maximum Severity During Treatment End of Treatment Severity (12 Weeks)
Mild Moderate Severe Mild Moderate Severe
Erythema 27% 13% 1% 8% 2% 1%
Scaling 35% 11% 1% 9% 1% < 1%
Dryness 41% 13% 1% 10% 2% < 1%
Stinging/burning 41% 15% 3% 7% 2% 1%

Analysis over the 12-week period showed that local tolerability scores for erythema, scaling, dryness, and stinging/burning peaked at Week 1 of therapy and decreased thereafter.

During a pediatric clinical trial, 285 children with acne vulgaris, 9 to 11 years of age were treated with EPIDUO gel or with the vehicle gel once daily for 12 weeks. Overall, the safety profile of EPIDUO gel in these subjects is comparable to the safety profile observed in older subjects 12 years of age and above, both in the nature and frequency of the observed events.

Analysis of local tolerability evaluations shows similar incidence of treatment emergent signs and symptoms as in subjects 12 years of age and above, with local tolerability signs and symptoms peaking during the first week and decreasing over time.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of EPIDUO Gel: 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 (Adapalene and Benzoyl Peroxide Gel) »

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Epiduo Gel - User Reviews

Epiduo Gel User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Epiduo Gel sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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