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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.

GADOVERSETAMIDE: 286 Adverse Event Reports & Safety Profile

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286
Total FAERS Reports
5 (1.7%)
Deaths Reported
11
Hospitalizations
286
As Primary/Secondary Suspect
8
Life-Threatening
29
Disabilities
Dec 8, 1999
FDA Approved
Discontinued
Status

FDA Application: 020937 ·

First Report: 200312 · Latest Report: 20190124

What Are the Most Common GADOVERSETAMIDE Side Effects?

#1 Most Reported
Pain
189 reports (66.1%)
#2 Most Reported
Gadolinium deposition disease
176 reports (61.5%)
#3 Most Reported
Arthralgia
167 reports (58.4%)

All GADOVERSETAMIDE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Pain 189 66.1% 1 0
Gadolinium deposition disease 176 61.5% 0 0
Arthralgia 167 58.4% 0 0
Fatigue 166 58.0% 0 0
Burning sensation 165 57.7% 1 0
Muscle spasms 165 57.7% 0 1
Paraesthesia 163 57.0% 0 1
Rash 163 57.0% 0 0
Hypoaesthesia 162 56.6% 0 1
Injury 162 56.6% 1 1
Asthenia 159 55.6% 0 0
Confusional state 158 55.2% 0 0
Inflammation 155 54.2% 0 0
Mass 150 52.5% 0 0
Anxiety 101 35.3% 1 1
Emotional distress 97 33.9% 1 1
Contrast media deposition 82 28.7% 0 0
Mental impairment 79 27.6% 0 0
Mobility decreased 77 26.9% 0 0
Anhedonia 76 26.6% 0 0

Who Reports GADOVERSETAMIDE Side Effects? Age & Gender Data

Gender: 67.0% female, 33.0% male. Average age: 45.7 years. Most reports from: US. View detailed demographics →

Is GADOVERSETAMIDE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2003 1 0 0
2006 2 1 0
2007 1 1 0
2008 2 0 0
2010 2 0 0
2011 1 0 0
2012 1 0 1
2013 1 1 0
2014 6 1 0
2015 16 0 0
2016 9 0 2
2017 13 0 4
2018 8 0 2
2019 1 0 1

View full timeline →

What Is GADOVERSETAMIDE Used For?

IndicationReports
Nuclear magnetic resonance imaging 131
Angiogram 80
Diagnostic procedure 78
Computerised tomogram 73
Product used for unknown indication 33
Magnetic resonance imaging 13
Nuclear magnetic resonance imaging brain 11

GADOVERSETAMIDE vs Alternatives: Which Is Safer?

GADOVERSETAMIDE vs GADOXETATE GADOVERSETAMIDE vs GALANTAMINE GADOVERSETAMIDE vs GALANTAMINE HYDROBROMIDE GADOVERSETAMIDE vs GALCANEZUMAB GADOVERSETAMIDE vs GALCANEZUMAB-GNLM GADOVERSETAMIDE vs GALLIUM GA-OZETOTIDE GADOVERSETAMIDE vs GALSULFASE GADOVERSETAMIDE vs GAMMAGARD LIQUID GADOVERSETAMIDE vs GANAXOLONE GADOVERSETAMIDE vs GANCICLOVIR

Official FDA Label for GADOVERSETAMIDE

Official prescribing information from the FDA-approved drug label.