Drug Safety Information for ULORIC (Febuxostat)

Safety-related Labeling Changes for ULORIC (FEBUXOSTAT) Rx Drug: FDA 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
1Gout*413
2Rash275
3Nausea180
4Diarrhoea154
5Arthralgia128
6Drug ineffective123
7Dizziness106
8Condition aggravated100
9Fatigue98
10Blood creatinine increased93
11Dyspnoea88
12Oedema peripheral82
13Pain in extremity76
14Pruritus76
15Headache73
16Renal failure71
17Asthenia71
18Renal failure acute67
19Vomiting66
20Blood uric acid increased57

* 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
1Gout*3723
2Product used for unknown indication834
3Hyperuricaemia307
4Blood uric acid increased206
5Gouty tophus104
6Nephrolithiasis39
7Tumour lysis syndrome31
8Gouty arthritis30
9Prophylaxis13
10Blood uric acid12

*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.

Click to go back to search results and ULORIC 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 ULORIC's side effects.