Drug Safety Information for CIPRO XR (Ciprofloxacin; ciprofloxacin hydrochloride)

Safety-related Labeling Changes for CIPRO XR (CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE) Rx Drug: FDA Link

Safety-related Labeling Changes for CIPRO XR (CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE) Rx Drug: FDA Link

Risk of mitral and aortic regurgitation Evaluating

Adverse Drug Reactions for CIPRO XR* (Ciprofloxacin; ciprofloxacin hydrochloride)

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 CIPRO XR
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Arthralgia19
2Myalgia18
3Nausea16
4Dizziness16
5Asthenia16
6Pain15
7Gait disturbance14
8Insomnia14
9Pyrexia14
10Tendon rupture13
11Diarrhoea13
12Vision blurred13
13Headache13
14Paraesthesia12
15Pruritus12
16Tendonitis11
17Anxiety11
18Vomiting11
19Pain in extremity11
20Hypoaesthesia10

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

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

Reason # of FDA Reports
1Urinary tract infection324
2Cystitis149
3Product used for unknown indication105
4Upper respiratory tract infection32
5Prostatitis31
6Nail infection24
7Skin ulcer22
8Bronchitis22
9Prophylaxis17
10Exposure during breast feeding14

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


Types of Adverse Events for CIPRO XR

Total Reports Filed with FDA: 1319


Number of FDA Adverse Event Reports by Patient Age for CIPRO XR

Total Reports Filed with FDA: 1319*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Ciprofloxacin; ciprofloxacin hydrochloride (Cipro xr)

Charts are based on 1319 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 CIPRO XR 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.