ADVERSE REACTIONS
In Phases II and III clinical trials, a total of 937 patients were treated with CIPRODEX® 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 occurred in 0.4% or more of the patients with intact tympanic membranes. The following treatment-related adverse events were each reported in a single patient: ear discomfort; decreased hearing; and ear disorder (tingling).
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