Ozenoxacin cream has the potential to cause rosacea and seborrheic dermatitis when administered topically on a patient. In clinical trials, only one adult patient treated with ozenoxacin cream reported such adverse reactions FDA Label.

Much like other topical antibiotics, the prolonged use of ozenoxacin cream can result in the overgrowth of nonsusceptible bacteria and fungi. If such overgrowths develop into infections during therapy, discontinue use of the ozenoxacin cream and institue appropriate therapy for the infections FDA Label.

Although clinical studies demonstrate negligible systemic absorption after topical administration of ozenoxacin, there are no formal available data on the use of ozenoxacin in pregnant women to inform any professional drug associated risk for use in pregnancy FDA Label.

Although breastfeeding is not expected to result in exposure of the child to ozenoxacin owing to the negligible systemic absorption of ozenoxacin in humans following topical administration, no formal data are available regarding the presence of ozenoxacin in human milk and the effects of ozenoxacin on breasfed infants or on milk production FDA Label.

Clinical experience with ozenoxacin cream has not identified differences in responses between elderly and younger patients FDA Label.

The safety and effectiveness of ozenoxacin cream in pediatric patients 2 months and older is similar to that of adults, but the safety and effectiveness of ozenoxacin in pediatric patients younger than 2 months of age has not been formally establlished FDA Label.

Long-term studies in animals to evaluate carcinogenic potential have not been conducted with ozenoxacin FDA Label.

Ozenoxacin demonstrated no genotoxicity when evaluated in vitro for gene mutation and/or chromosomal effects in the Ames test, mouse lymphoma cell assay, or when evaluated in vivo in a rat micronucleus test with demonstrated systemic exposure FDA Label.

Oral doses of ozenoxacin did not affect mating and fertility in male and female rats treated up to 500 mg/kg/day (about 8500 and 16,000 times respectively, the maximum human plasma concentration seen with dermal application of ozenoxacin 1% cream) FDA Label.