Drug Safety Information for ULORIC (Febuxostat)

FDA Safety-related Labeling Changes for ULORIC (FEBUXOSTAT) Rx Drug: Safety Information Link

Adverse Drug Reactions for ULORIC* (Febuxostat)

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 ULORIC
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Gout*	413
2	Rash	275
3	Nausea	180
4	Diarrhoea	154
5	Arthralgia	128
6	Drug ineffective	123
7	Dizziness	106
8	Condition aggravated	100
9	Fatigue	98
10	Blood creatinine increased	93
11	Dyspnoea	88
12	Oedema peripheral	82
13	Pain in extremity	76
14	Pruritus	76
15	Headache	73
16	Renal failure	71
17	Asthenia	71
18	Renal failure acute	67
19	Vomiting	66
20	Blood uric acid increased	57

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

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

	Reason	# of FDA Reports
1	Gout*	3723
2	Product used for unknown indication	834
3	Hyperuricaemia	307
4	Blood uric acid increased	206
5	Gouty tophus	104
6	Nephrolithiasis	39
7	Tumour lysis syndrome	31
8	Gouty arthritis	30
9	Prophylaxis	13
10	Blood uric acid	12

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

Types of Adverse Events for ULORIC

Total Reports Filed with FDA: 8316

Number of FDA Adverse Event Reports by Patient Age for ULORIC

Total Reports Filed with FDA: 8316*

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

Charts are based on 8316 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.