Adverse-Event Reports in Over-the-Counter Topical Acne Drug Products Containing Benzoyl Peroxide from a Specific Pharmaceutical Company in the USA

Benzoyl peroxide (BPO) has been used extensively in dermatology, often for the treatment of acne vulgaris. In a 20-year period, dermatologists in the United States used over-the-counter BPO more than 13 million times. However, skin irritation and other adverse events (AEs) are associated with the use of BPO. AEs associated with BPO were identified using the Galderma pharmacovigilance system, which collects AE reports from multiple sources. Over approximately 20 years, 558 AE reports were collected from the database, ranging from application site reactions to systemic hypersensitivity reactions, resulting in a reporting rate of under 1%. These data show that the risk of OTC topical acne drug products containing BPO is low.