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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.

GOLD AU-198: 91 Adverse Event Reports & Safety Profile

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91
Total FAERS Reports
2 (2.2%)
Deaths Reported
14
Hospitalizations
91
As Primary/Secondary Suspect
2
Life-Threatening
27
Disabilities

First Report: 20080101 · Latest Report: 20160101

What Are the Most Common GOLD AU-198 Side Effects?

#1 Most Reported
Treatment failure
69 reports (75.8%)
#2 Most Reported
Rheumatoid arthritis
62 reports (68.1%)
#3 Most Reported
Infection
62 reports (68.1%)

All GOLD AU-198 Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Treatment failure 69 75.8% 1 2
Drug ineffective 62 68.1% 0 2
Infection 62 68.1% 1 3
Rheumatoid arthritis 62 68.1% 1 2
Rash 58 63.7% 1 2
Pain 46 50.6% 1 3
Musculoskeletal stiffness 45 49.5% 1 3
Joint stiffness 43 47.3% 1 2
Sleep disorder 41 45.1% 1 1
Nausea 40 44.0% 1 13
Off label use 37 40.7% 2 12
Contraindicated product administered 34 37.4% 0 1
Pain in extremity 33 36.3% 1 2
Vomiting 33 36.3% 1 13
Decreased appetite 32 35.2% 1 13
Headache 32 35.2% 1 13
Arthralgia 30 33.0% 1 3
Product use issue 30 33.0% 1 2
Anti-cyclic citrullinated peptide antibody positive 27 29.7% 1 3
Asthenia 27 29.7% 1 3

Who Reports GOLD AU-198 Side Effects? Age & Gender Data

Gender: 91.1% female, 8.9% male. Average age: 54.1 years. Most reports from: CA. View detailed demographics →

Is GOLD AU-198 Getting Safer? Reports by Year

YearReportsDeathsHosp.
2008 1 0 1
2015 5 0 0
2016 2 0 0

View full timeline →

What Is GOLD AU-198 Used For?

IndicationReports
Rheumatoid arthritis 55
Product used for unknown indication 34

Official FDA Label for GOLD AU-198

Official prescribing information from the FDA-approved drug label.