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The following serious adverse reactions are described elsewhere in the labeling:
- Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
- Potential for Microbial Overgrowth with Prolonged Use [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In Phases II and III clinical trials, a total of 937 patients were treated with CIPRODEX. This included 400 patients with acute otitis media with tympanostomy tubes and 537 patients with acute otitis externa. The reported adverse reactions are listed below:
Acute Otitis Media In Pediatric Patients With Tympanostomy Tubes
The following adverse reactions occurred in 0.5% or more of the patients with non-intact tympanic membranes.
|Ear precipitate (residue)||0.5%|
Acute Otitis Externa
The following adverse reactions occurred in 0.4% or more of the patients with intact tympanic Membranes
|Superimposed ear infection||0.6%|
The following adverse reactions were each reported in a single patient: ear discomfort; decreased hearing; and ear disorder (tingling).
The following adverse reactions have been identified during post approval use of CIPRODEX. Because these reactions are reported voluntarily from a population of unknown size it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These reactions include: auricular swelling, headache, hypersensitivity, otorrhea, skin exfoliation, rash erythematous, and vomiting.
Read the Ciprodex (ciprofloxacin and dexamethasone) Side Effects Center for a complete guide to possible side effects
No information provided.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 9/21/2016
Additional Ciprodex Information
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