Ciprodex Side Effects
Please note - some side effects for Ciprodex may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
Side Effects of Ciprodex - for the Consumer
Ciprodex
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Ciprodex:
Seek medical attention right away if any of these SEVERE side effects occur when using Ciprodex:Discomfort, pain, or itching in the ear.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); decreased hearing.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
TopCiprodex Side Effects - for the Professional
Ciprodex
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 were each reported in a single patient: ear discomfort; decreased hearing; and ear disorder (tingling).
TopSide Effects by Body System - for Healthcare Professionals
Local
Local side effects in patients with intact tympanic membranes have included ear pruritus (1.5%), ear debris (0.6%), superimposed ear infection (0.6%), ear congestion (0.4%), ear pain (0.4%), ear discomfort, decreased hearing, and tingling. Ear discomfort (3%), ear pain (2.3%), and ear residue (0.5%), tube blockage, tinnitus, and ear pruritus have been reported in pediatric patients with tympanostomy tubes.
Gastrointestinal
Gastrointestinal side effects have included taste perversion and oral moniliasis.
Nervous system
Nervous system side effects have included dizziness and irritability.
Dermatologic
Dermatologic side effects have included erythema.
Other
Other side effects in patients with tympanostomy tubes have included crying.
TopMore Ciprodex resources
- Ciprodex Prescribing Information (FDA)
- Ciprodex Advanced Consumer (Micromedex) - Includes Dosage Information
- Ciprodex MedFacts Consumer Leaflet (Wolters Kluwer)
- Ciprodex Consumer Overview
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