LESINURAD: 67 Adverse Event Reports & Safety Profile
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67
Total FAERS Reports
2 (3.0%)
Deaths Reported
18
Hospitalizations
67
As Primary/Secondary Suspect
1
Life-Threatening
Dec 22, 2015
FDA Approved
Discontinued
Status
FDA Application: 207988 ·
Patent Expires: Nov 26, 2028 · First Report: 201208 · Latest Report: 20190601
What Are the Most Common LESINURAD Side Effects?
#1 Most Reported
Acute kidney injury
13 reports (19.4%)
#2 Most Reported
Blood creatinine increased
10 reports (14.9%)
#3 Most Reported
Abdominal pain
10 reports (14.9%)
All LESINURAD Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Acute kidney injury | 13 | 19.4% | 0 | 6 |
| Abdominal pain | 10 | 14.9% | 0 | 0 |
| Blood creatinine increased | 10 | 14.9% | 0 | 1 |
| Malaise | 9 | 13.4% | 0 | 0 |
| Pain | 9 | 13.4% | 0 | 2 |
| Nausea | 8 | 11.9% | 0 | 0 |
| Flank pain | 7 | 10.5% | 0 | 0 |
| Gout | 5 | 7.5% | 0 | 1 |
Who Reports LESINURAD Side Effects? Age & Gender Data
Gender: 13.6% female, 86.4% male. Average age: 53.9 years. Most reports from: US. View detailed demographics →
Is LESINURAD Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2012 | 2 | 0 | 0 |
| 2013 | 3 | 0 | 3 |
| 2014 | 1 | 0 | 1 |
| 2016 | 3 | 0 | 1 |
| 2017 | 7 | 0 | 1 |
| 2018 | 5 | 1 | 2 |
| 2019 | 3 | 0 | 2 |
What Is LESINURAD Used For?
| Indication | Reports |
|---|---|
| Gout | 28 |
| Hyperuricaemia | 18 |
| Gouty arthritis | 7 |
| Product used for unknown indication | 7 |
Official FDA Label for LESINURAD
Official prescribing information from the FDA-approved drug label.