Drug Safety Information for DIFICID (Fidaxomicin)

Safety-related Labeling Changes for DIFICID (FIDAXOMICIN) Rx Drug: FDA Link

Adverse Drug Reactions for DIFICID* (Fidaxomicin)

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 DIFICID
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Disease recurrence	162
2	Diarrhoea	140
3	Clostridium difficile colitis	93
4	Drug ineffective	61
5	Off label use	60
6	Nausea	46
7	Abdominal pain	39
8	Treatment failure	31
9	White blood cell count increased	25
10	Pyrexia	21
11	Vomiting	19
12	Abdominal pain upper	18
13	Blood creatinine increased	16
14	Weight decreased	15
15	Death	14
16	Clostridial infection	12
17	Mucous stools	11
18	Constipation	11
19	Abnormal faeces	11
20	Decreased appetite	11

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

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

	Reason	# of FDA Reports
1	Clostridium difficile colitis	793
2	Clostridial infection	514
3	Product used for unknown indication	126
4	Prophylaxis	21
5	Antibiotic prophylaxis	14
6	Diarrhoea	11
7	Clostridium test positive	8
8	Pouchitis	8
9	Infection	7
10	Pseudomembranous colitis	7

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

Types of Adverse Events for DIFICID

Total Reports Filed with FDA: 1581

Number of FDA Adverse Event Reports by Patient Age for DIFICID

Total Reports Filed with FDA: 1581*

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

Charts are based on 1581 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.