Oxymetazolineside effects

Most common adverse reactions (incidence ≥ 1%) are application site dermatitis, worsening inflammatory lesions of rosacea, application site pruritis, application site erythema, and application site pain. To report SUSPECTED ADVERSE REACTIONS, contact Mayne Pharma at 1-844-825-8500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical

Studies Experience Because clinical trials are conducted under varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. A total of 489 subjects with persistent facial erythema associated with rosacea were treated with Oxymetazoline Hydrochloride Cream once daily for 4 weeks in 3 controlled clinical trials. An additional 440 subjects with persistent facial erythema associated with rosacea were also treated with Oxymetazoline Hydrochloride Cream once daily for up to one year in a long-term (open- label) clinical trial. Adverse reactions that occurred in at least 1% of subjects treated with Oxymetazoline Hydrochloride Cream through 4 weeks of treatment are presented in Table 1 below.

Table 1: Adverse Reactions Reported by ≥ 1% of Subjects through 4 Weeks of Treatment in Controlled Clinical Trials Adverse Reaction Pooled Controlled Clinical Trials Oxymetazoline HCl Cream (N = 489) Vehicle Cream (N = 483) Application site dermatitis 9 (2%) 0 Worsening inflammatory lesions of rosacea 7 (1%) 1 (<1%) Application site pruritus 5 (1%) 4 (1%) Application site erythema 5 (1%) 2 (<1%) Application site pain 4 (1%) 1 (<1%) In the long-term (open-label) clinical trial, the rates of adverse reactions over a one-year treatment period were as follows: worsening inflammatory lesions of rosacea (3%), application site dermatitis (3%), application site pruritis (2%), application site pain (2%), and application site erythema (2%). Subjects with persistent erythema along with inflammatory lesions were allowed to use additional therapy for the inflammatory lesions of rosacea.