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In Phases II and III clinical trials, a total of 937 patients were treated with CIPRODEX® (ciprofloxacin and dexamethasone ) Otic. This included 400 patients with acute otitis media with tympanostomy tubes and 537 patients with acute otitis externa. The reported treatment-related adverse events are listed below:

Acute Otitis Media in pediatric patients with tympanostomy tubes

The following treatment-related adverse events occurred in 0.5% or more of the patients with non-intact tympanic membranes.

Adverse Event Incidence (N=400)
Ear discomfort 3.0%
Ear pain 2.3%
Ear precipitate (residue) 0.5%
Irritability 0.5%
Taste perversion 0.5%

The following treatment-related adverse events were each reported in a single patient: tympanostomy tube blockage; ear pruritus; tinnitus; oral moniliasis; crying; dizziness; and erythema.

Acute Otitis Externa

The following treatment-related adverse events occurred in 0.4% or more of the patients with intact tympanic membranes.

Adverse Event Incidence (N=537)
Ear pruritus 1.5%
Ear debris 0.6%
Superimposed ear infection 0.6%
Ear congestion 0.4%
Ear pain 0.4%
Erythema 0.4%

The following treatment-related adverse events were each reported in a single patient: ear discomfort; decreased hearing; and ear disorder (tingling).