Important Safety Information
Indication: Epiduo® Forte (adapalene and benzoyl peroxide) Gel, 0.3%/2.5% is indicated for the topical treatment of acne vulgaris. Adverse Events: In the pivotal study, the most commonly reported adverse reactions (≥1%) in patients treated with Epiduo Forte Gel were skin irritation, eczema, atopic dermatitis and skin burning sensation. Warnings/Precautions: Patients using Epiduo Forte Gel should avoid exposure to sunlight and sunlamps and wear sunscreen when sun exposure cannot be avoided. Erythema, scaling, dryness, stinging/burning, irritant and allergic contact dermatitis may occur with use of Epiduo Forte Gel and may necessitate discontinuation. When applying Epiduo Forte Gel, care should be taken to avoid the eyes, lips and mucous membranes.
Indication: EPIDUO® Gel is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. Adverse Events: In controlled clinical studies, the most commonly reported adverse events (≥1%) in patients treated with EPIDUO® Gel were dry skin, contact dermatitis, application site burning, application site irritation and skin irritation. Warnings/Precautions: Patients taking EPIDUO® Gel should avoid exposure to sunlight and sunlamps and wear sunscreen when sun exposure cannot be avoided. Erythema, scaling, dryness, stinging/ burning, irritant and allergic contact dermatitis may occur with use of EPIDUO® Gel and may necessitate discontinuation.
1. According to data from Symphony Health Solutions, Pharmaceutical Audit Suite, Retail Audit, March 2018. 2. Epiduo® Forte Gel Clinical Study Report (SPR 105061). Data on file. Galderma laboratories, L.P. 3. Tan J, Bourdes V, Bissonnette R, et al. Prospective study of pathogenesis of atrophic acne scars and role of macular erythema. J Drugs Dermatol. 2017;16(6):567-573. 4. Tan J, Sewon K, Leyden J. Prevalence and risk factors of acne scarring among patients consulting dermatologists in the United States. J Drugs Dermatol. 2017;16(2):97-102. 5. Alexis AF, Cook-Bolden FE, York JP. Adapalene/benzoyl peroxide gel in 0.3%/2.5%: a safe and effective acne therapy in all skin prototypes. J Drugs Dermatol. 2017;16(6):574-581. 6. Leyden J, Stein-Gold L, Weiss J. Why topical retinoids are mainstay of therapy for acne. Dermatol Ther. 2017;7(3):293–304. 7. Leyden JJ. Topical treatment of acne vulgaris: retinoids and cutaneous irritation. J Am Acad Dermatol. 998;38(4):S1–S4. 8. Thielitz A, Sidou F, Gollnick H. Control of microcomedone formation throughout a maintenance treatment with adapalene gel, 0.1%. J Eur Acad Dermatol Venereol. 2007;21(6):747-753. 9. Tucker R, Walton S. The role of benzoyl peroxide in the management of acne vulgaris. Pharm J. 2007;279:48-53. 10. Mills OH, Jr, Kligman AM, Pochi P, Comite H. Comparing 2.5%, 5%, and 10% benzoyl peroxide on inflammatory acne vulgaris. Int J Dermatol. 1986;25(10):664-667. 11. Data on file, Galderma Laboratories, L.P. 12. Epiduo® Forte Gel Clinical Study Report (SRE 18240). Data on file. Galderma Laboratories, L.P. 13. Stein Gold L, Weiss J, Rueda MJ, Liu H, Tanghetti E. Moderate and severe inﬂammatory acne vulgaris effectively treated with single-agent therapy by a new fixed-dose combination adapalene 0.3 %/benzoyl peroxide 2.5 % gel: a randomized, double-blind, parallel-group, controlled study. Am J Clin Dermatol. 2016;17:293–303. 14. Acne 2018 Speaker Deck. Data on file. Galderma Laboratories, L.P. 15. Onexton Prescribing Information. Bridgewater, NJ: Valeant Pharmaceuticals North America, LLC; 2016. 16. Aczone Prescribing Information. Irvine, CA: Allergan, Inc; 2016. 17. Clindagel Prescribing Information. Bridgewater, NJ: Valeant Pharmaceuticals North America, LLC; 2017. 18. Epiduo Forte Prescribing Information. Fort Worth, TX: Galderma Laboratories, L.P; 2015. 19. Gollnick H, Cunliffe W, Berson D, et al. Management of acne: a report from a global alliance to improve outcomes in acne. J Am Acad Dermatol. 2003;(49)1:S1-S37.
*Galderma CareConnect is only available for commercially insured or uninsured patients. Patients who are enrolled in a government-run or government-sponsored healthcare plan with a pharmacy benefit are not eligible to use the Galderma CareConnect Patient Savings Card.
†Restrictions apply. Please see Galderma CareConnect Patient Savings Card for details.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‐800‐FDA‐1088.
©2019 Galderma Laboratories, L.P., All Rights Reserved. All trademarks are the property of their respective owners. This site is intended for U.S. audiences only. Information in this website is not intended as medical advice. Talk to your doctor about medical concerns.