Medical Editor: John P. Cunha, DO, FACOEP
- pain, or
- itching in the ear, or
- unusual taste in the mouth.
Contact your doctor if you experience serious side effects of Ciprodex including:
- allergic reaction (difficulty breathing, closing of the throat, swelling of the lips/tongue/face),
- skin rash,
- ear drainage,
- ear discharge, or
- worsening pain.
The usual recommended dosage of Ciprodex in patients age 6 months and older is four drops instilled into the affected ear twice daily for seven days. Do not use other ear drops during treatment with Ciprodex without first talking to your doctor. Other drugs may interact with Ciprodex. Talk to your doctor before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products. Ciprodex should be used only when prescribed during pregnancy. This medication passes into breast milk but is unlikely to harm a nursing infant. Consult your doctor before breastfeeding.
Our Ciprodex (ciprofloxacin and dexamethasone) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Stop using ciprofloxacin and dexamethasone otic and seek emergency medical attention or notify your doctor if you experience:
- an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
- skin rash; or
- ear drainage, discharge, or worsening pain.
Other less serious side effects may also occur such as ear discomfort or itching or an unusual taste in the mouth. Continue to use the medication and talk to your doctor if these side effects seem excessive or unusual.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Ciprodex (Ciprofloxacin and Dexamethasone )
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 entire FDA prescribing information for Ciprodex (Ciprofloxacin and Dexamethasone )
© Ciprodex Patient Information is supplied by Cerner Multum, Inc. and Ciprodex Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.