Skip to content
Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

BENZBROMARONE: 77 Adverse Event Reports & Safety Profile

Boost Your Natural Energy & Metabolism

Mitolyn — 6 exotic plants to unlock your body's fat-burning power. 90-day guarantee.

Try Mitolyn Now
77
Total FAERS Reports
10 (13.0%)
Deaths Reported
49
Hospitalizations
77
As Primary/Secondary Suspect
14
Life-Threatening
4
Disabilities

First Report: 20030828 · Latest Report: 20250101

What Are the Most Common BENZBROMARONE Side Effects?

#1 Most Reported
Acute kidney injury
12 reports (15.6%)
#2 Most Reported
Drug-induced liver injury
11 reports (14.3%)
#3 Most Reported
Nausea
9 reports (11.7%)

All BENZBROMARONE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Acute kidney injury 12 15.6% 4 10
Drug-induced liver injury 11 14.3% 4 10
Nausea 9 11.7% 2 7
Drug ineffective 6 7.8% 0 4
Gout 6 7.8% 0 1
Off label use 6 7.8% 0 3
Pneumonia 6 7.8% 1 6
Renal impairment 6 7.8% 0 5
Vomiting 6 7.8% 1 4
Autoimmune hepatitis 5 6.5% 0 5
Product use in unapproved indication 5 6.5% 0 5
Rash 5 6.5% 0 4
Stevens-johnson syndrome 5 6.5% 0 5

Who Reports BENZBROMARONE Side Effects? Age & Gender Data

Gender: 22.7% female, 77.3% male. Average age: 62.3 years. Most reports from: JP. View detailed demographics →

Is BENZBROMARONE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2003 1 0 1
2007 1 1 1
2009 1 0 1
2011 1 0 1
2012 4 0 3
2013 3 0 2
2014 6 4 3
2015 3 1 1
2016 6 0 3
2017 4 2 2
2018 2 0 1
2019 2 0 0
2020 2 0 2
2021 6 0 5
2022 6 0 3
2024 3 0 3
2025 1 0 0

View full timeline →

What Is BENZBROMARONE Used For?

IndicationReports
Hyperuricaemia 25
Product used for unknown indication 24
Gout 14

Official FDA Label for BENZBROMARONE

Official prescribing information from the FDA-approved drug label.