Drug Safety Information for XIFAXAN (Rifaximin)

FDA Safety-related Labeling Changes for XIFAXAN (RIFAXIMIN) Rx Drug: Safety Information Link

Adverse Drug Reactions for XIFAXAN* (Rifaximin)

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 XIFAXAN
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Diarrhoea	131
2	Nausea	107
3	Abdominal pain	89
4	Hepatic encephalopathy	88
5	Fatigue	75
6	Headache	74
7	Vomiting	70
8	Drug ineffective*	65
9	Dyspnoea	62
10	Anaemia	60
11	Pain	57
12	Ascites	55
13	Dehydration	54
14	Abdominal distension*	52
15	Death	52
16	Asthenia	49
17	Hepatic failure	48
18	Encephalopathy	48
19	Condition aggravated	46
20	Dizziness	45

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

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

	Reason	# of FDA Reports
1	Product used for unknown indication	962
2	Hepatic encephalopathy	504
3	Crohn's disease	249
4	Encephalopathy	128
5	Diarrhoea	124
6	Irritable bowel syndrome	111
7	Overgrowth bacterial	106
8	Hepatic cirrhosis	72
9	Gastrointestinal bacterial infection	60
10	Colitis ulcerative	49

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

Types of Adverse Events for XIFAXAN

Total Reports Filed with FDA: 6648

Number of FDA Adverse Event Reports by Patient Age for XIFAXAN

Total Reports Filed with FDA: 6648*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Rifaximin (Xifaxan)

Charts are based on 6648 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.