Drug Safety Information for NOROXIN (Norfloxacin)

FDA Safety-related Labeling Changes for NOROXIN (NORFLOXACIN) Rx Drug: Safety Information 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
1	Drug interaction	93
2	Pyrexia	81
3	Urinary tract infection	71
4	Confusional state	54
5	Diarrhoea	54
6	Renal failure acute	53
7	Vomiting	50
8	Nausea	49
9	Dyspnoea	46
10	Renal failure	44
11	Anaemia	40
12	Asthenia	39
13	Rhabdomyolysis	36
14	Fall	36
15	Hyponatraemia	35
16	Death	33
17	Arthralgia	33
18	General physical health deterioration	31
19	International normalised ratio increased	31
20	Fatigue	31

* 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
1	Urinary tract infection*	1134
2	Product used for unknown indication	481
3	Cystitis*	226
4	Prophylaxis	141
5	Infection prophylaxis	84
6	Diarrhoea	71
7	Pyelonephritis	62
8	Prostatitis*	58
9	Infection	49
10	Prophylaxis urinary tract infection	32

*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.

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.