Because clinical studies are conducted under widely varying
conditions, adverse drug 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 clinical practice.
In a randomized, active-controlled clinical trial,
approximately 300 patients with clinical signs and symptoms of otitis externa
were treated with CETRAXAL (ciprofloxacin otic solution) . The most frequently reported adverse reactions were
application site pain, ear pruritus, fungal ear superinfection, and headache,
each reported in approximately 2-3% of patients.