Drug Safety Information for NOROXIN (Norfloxacin)

Safety-related Labeling Changes for NOROXIN (NORFLOXACIN) Rx Drug: FDA Link

Adverse Drug Reactions for NOROXIN* (Norfloxacin)

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 NOROXIN
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Drug interaction93
2Pyrexia81
3Urinary tract infection71
4Confusional state54
5Diarrhoea54
6Renal failure acute53
7Vomiting50
8Nausea49
9Dyspnoea46
10Renal failure44
11Anaemia40
12Asthenia39
13Rhabdomyolysis36
14Fall36
15Hyponatraemia35
16Death33
17Arthralgia33
18General physical health deterioration31
19International normalised ratio increased31
20Fatigue31

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

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

Reason # of FDA Reports
1Urinary tract infection*1134
2Product used for unknown indication481
3Cystitis*226
4Prophylaxis141
5Infection prophylaxis84
6Diarrhoea71
7Pyelonephritis62
8Prostatitis*58
9Infection49
10Prophylaxis urinary tract infection32

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


Types of Adverse Events for NOROXIN

Total Reports Filed with FDA: 5877


Number of FDA Adverse Event Reports by Patient Age for NOROXIN

Total Reports Filed with FDA: 5877*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Norfloxacin (Chibroxin, Noroxin)

Charts are based on 5877 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 NOROXIN Reviews and Review Summary .

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.

Visit   DrugInformer.com more on NOROXIN's side effects.