Other treatment-related adverse reactions reported in subjects with non-intact tympanic membranes included: diarrhea (%), nausea (%), vomiting (%), dry mouth (%), headache (%), vertigo (%), otorrhagia (%), tinnitus (%), fever (%). The following treatment-related adverse events were each reported in a single subject: application site reaction, otitis externa, urticaria, abdominal pain, dysaesthesia, hyperkinesia, halitosis, inflammation, pain, insomnia, coughing, pharyngitis, rhinitis, sinusitis, and tachycardia.
The plasma concentrations of ciprofloxacin were not measured following administration of ml Cetraxal % (total dose: mg ciprofloxacin). It is expected that systemic plasma levels will be no detectable or very low, although no significant systemic passage of ciprofloxacin is expected under normal condition of use. Even if the entire amount of ciprofloxacin was absorbed following bilateral ear administration (1mg total dose) it is doubtful that a detectable plasma concentration of this drug would result in a human considering 180L as volume of distribution of ciprofloxacin (EUCAST information) and 5ng/ml as the detection limit.