Epiduo
- Generic Name: adapalene and benzoyl peroxide gel
- Brand Name: Epiduo Gel
Epiduo Gel (Adapalene and Benzoyl Peroxide Gel) side effects drug center
What is Epiduo?
Epiduo (adapalene and benzoyl peroxide) Gel is a combination of a medication similar to vitamin A and an antibacterial medication that also has a mild drying effect used to treat acne in people who are at least 12 years old.
What Are Side Effects of Epiduo?
Common side effects of Epiduo Gel include:
- skin redness,
- dryness,
- peeling,
- mild burning,
- stinging,
- scaling,
- swelling,
- itching, or
- worsening of acne during the first 4 weeks of using this product.
These side effects usually decrease with continued use of Epiduo Gel. A very serious allergic reaction to Epiduo is rare. Seek immediate medical attention if you have serious symptoms, including:
- rash, itching or swelling (especially of the face/tongue/throat),
- severe dizziness, or
- trouble breathing.
Dosage for Epiduo?
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.
What Drugs, Substances, or Supplements Interact with Epiduo?
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.
Epiduo During Pregnancy and Breastfeeding
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 breastfeeding.
Additional Information
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.
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 (Adapalene and Benzoyl Peroxide Gel)
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)
© Epiduo Patient Information is supplied by Cerner Multum, Inc. and Epiduo Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
