Drug Safety Information for CIPRODEX (Ciprofloxacin; dexamethasone)

Safety-related Labeling Changes for CIPRODEX (CIPROFLOXACIN; DEXAMETHASONE) Rx Drug: FDA Link

Adverse Drug Reactions for CIPRODEX* (Ciprofloxacin; dexamethasone)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with CIPRODEX
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Pain23
2Nausea21
3Vomiting20
4Dyspnoea20
5Injury15
6Dizziness14
7Anxiety14
8Tympanic membrane perforation14
9Headache14
10Ear pain13
11Diarrhoea13
12Asthenia13
13Fatigue12
14Ear infection12
15Depression11
16Dehydration11
17Chest pain10
18Hypoacusis10
19Abdominal pain10
20Abdominal pain upper9

* This side effect also appears in "Top 10 Side Effects of CIPRODEX " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking CIPRODEX
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Product used for unknown indication169
2Ear infection*89
3Otitis externa34
4Otitis media13
5Corneal abrasion12
6Sinusitis11
7Pneumonia11
8Conjunctivitis10
9Infection prophylaxis9
10Prophylaxis6

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for CIPRODEX

Total Reports Filed with FDA: 1622


Number of FDA Adverse Event Reports by Patient Age for CIPRODEX

Total Reports Filed with FDA: 1622*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Ciprofloxacin; dexamethasone (Ciprodex)

Charts are based on 1622 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and CIPRODEX Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.