Epiduo Side Effects
Please note - some side effects for Epiduo may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
Side Effects of Epiduo - for the Consumer
Epiduo Gel
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Epiduo Gel:
Seek medical attention right away if any of these SEVERE side effects occur when using Epiduo Gel:Dry skin; feeling of warmth; irritation; itching; peeling; redness; scaling; temporary burning and stinging.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blistering; crusting; excessive redness, peeling, or irritation; swelling.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
TopEpiduo Side Effects - for the Professional
Epiduo
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:
| 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.
| 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.
TopSide Effects by Body System - for Healthcare Professionals
Dermatologic
Dermatologic reactions during a clinical study included erythema, scaling, dryness and stinging/burning. These reactions occurred in 27% to 41% of study participants and were mostly mild to moderate, with only 1% to 3% experiencing severe reactions. Analysis of study data during a 12-week period showed that side effects such as erythema, scaling, dryness, and stinging/burning peaked during the first week of therapy and decreased thereafter.
Dermatologic side effects have included dry skin (7%), contact dermatitis (3%), application site burning (2%), application site irritation (1%), and skin irritation (1%).
General
General side effects reported postmarketing have included eyelid edema, sunburn, blister, pain of skin, pruritus, swelling face, conjunctivitis, skin discoloration, rash, eczema, and allergic contact dermatitis.
TopMore Epiduo resources
- Epiduo Prescribing Information (FDA)
- Epiduo Advanced Consumer (Micromedex) - Includes Dosage Information
- Epiduo Gel MedFacts Consumer Leaflet (Wolters Kluwer)
- Epiduo Consumer Overview
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