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Ciprodex

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Ciprodex




Side Effects
Interactions

SIDE EFFECTS

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.

Adverse Reactions 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 adverse reactions were each reported in a single patient: tympanostomy tube blockage; ear pruritus; tinnitus; oral moniliasis; crying; dizziness; and erythema.

Acute Otitis Externa

The following adverse reactions occurred in 0.4% or more of the patients with intact tympanic Membranes

Adverse Reactions 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 adverse reactions were each reported in a single patient: ear discomfort; decreased hearing; and ear disorder (tingling).

Postmarketing Experience

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

DRUG INTERACTIONS

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

Side Effects
Interactions

Ciprodex - User Reviews

Ciprodex User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Ciprodex sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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