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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.

GADOPENTETATE DIMEGLUMINE: 751 Adverse Event Reports & Safety Profile

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751
Total FAERS Reports
22 (2.9%)
Deaths Reported
71
Hospitalizations
751
As Primary/Secondary Suspect
50
Life-Threatening
75
Disabilities
Jun 2, 1988
FDA Approved
Discontinued
Status

FDA Application: 019596 ·

First Report: 1994 · Latest Report: 20250704

What Are the Most Common GADOPENTETATE DIMEGLUMINE Side Effects?

#1 Most Reported
Pain
231 reports (30.8%)
#2 Most Reported
Gadolinium deposition disease
209 reports (27.8%)
#3 Most Reported
Paraesthesia
206 reports (27.4%)

All GADOPENTETATE DIMEGLUMINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Pain 231 30.8% 4 8
Gadolinium deposition disease 209 27.8% 0 5
Paraesthesia 206 27.4% 0 11
Arthralgia 204 27.2% 0 9
Hypoaesthesia 193 25.7% 0 17
Burning sensation 190 25.3% 1 6
Fatigue 188 25.0% 0 11
Injury 187 24.9% 2 3
Rash 186 24.8% 1 2
Asthenia 177 23.6% 0 3
Confusional state 175 23.3% 1 5
Muscle spasms 174 23.2% 0 4
Inflammation 159 21.2% 0 1
Mass 155 20.6% 0 0
Anxiety 133 17.7% 2 5
Contrast media deposition 117 15.6% 2 2
Emotional distress 117 15.6% 2 3
Anhedonia 87 11.6% 0 0
Mobility decreased 86 11.5% 0 0
Mental impairment 80 10.7% 0 1

Who Reports GADOPENTETATE DIMEGLUMINE Side Effects? Age & Gender Data

Gender: 68.5% female, 31.5% male. Average age: 46.4 years. Most reports from: US. View detailed demographics →

Is GADOPENTETATE DIMEGLUMINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 1 0 0
2002 4 0 1
2003 2 0 0
2004 8 1 1
2005 8 1 1
2006 15 3 4
2007 10 1 1
2008 7 0 2
2009 3 0 2
2010 7 0 1
2011 5 0 0
2012 2 0 0
2013 8 4 0
2014 67 0 8
2015 83 3 13
2016 61 2 8
2017 57 3 12
2018 23 0 6
2019 18 1 3
2020 1 0 0
2021 1 0 0
2023 1 0 0
2024 1 0 1
2025 1 0 1

View full timeline →

What Is GADOPENTETATE DIMEGLUMINE Used For?

IndicationReports
Nuclear magnetic resonance imaging 244
Angiogram 87
Diagnostic procedure 85
Computerised tomogram 79
Nuclear magnetic resonance imaging brain 73
Product used for unknown indication 54
Magnetic resonance imaging 49
Imaging procedure 18
Scan with contrast 18
Nuclear magnetic resonance imaging abdominal 14

GADOPENTETATE DIMEGLUMINE vs Alternatives: Which Is Safer?

GADOPENTETATE DIMEGLUMINE vs GADOPICLENOL GADOPENTETATE DIMEGLUMINE vs GADOTERATE MEGLUMINE GADOPENTETATE DIMEGLUMINE vs GADOTERIDOL GADOPENTETATE DIMEGLUMINE vs GADOVERSETAMIDE GADOPENTETATE DIMEGLUMINE vs GADOXETATE GADOPENTETATE DIMEGLUMINE vs GALANTAMINE GADOPENTETATE DIMEGLUMINE vs GALANTAMINE HYDROBROMIDE GADOPENTETATE DIMEGLUMINE vs GALCANEZUMAB GADOPENTETATE DIMEGLUMINE vs GALCANEZUMAB-GNLM GADOPENTETATE DIMEGLUMINE vs GALLIUM GA-OZETOTIDE

Official FDA Label for GADOPENTETATE DIMEGLUMINE

Official prescribing information from the FDA-approved drug label.