Ciprodex

Last updated on RxList: 9/15/2020
Ciprodex Side Effects Center

What Is Ciprodex?

Ciprodex (ciprofloxacin and dexamethasone) is a combination of a fluoroquinolone antibiotic and a steroid used to treat ear infections.

What Are Side Effects of Ciprodex?

Common side effects of Ciprodex include:

  • discomfort,
  • 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.

Dosage for Ciprodex

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.

What Drugs, Substances, or Supplements Interact with Ciprodex?

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 During Pregnancy and Breastfeeding

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.

Additional Information

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.

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Ciprodex Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: rash, hives, itching; dizziness, fast heartbeats, fluttering in your chest; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have drainage from your ears after you stop using this medicine, especially if it occurs 2 or more times within 6 months after you stop.

Common side effects may include:

  • ear itching or pain, ear discomfort or fullness;
  • unusual taste in your mouth;
  • feeling irritable;
  • rash; or
  • a buildup of debris in the ear canal.

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.

Read the entire detailed patient monograph for Ciprodex (Ciprofloxacin and Dexamethasone )

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Bowel regularity means a bowel movement every day. See Answer
Ciprodex Professional Information

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 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.

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