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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.

GADOLINIUM: 1,315 Adverse Event Reports & Safety Profile

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1,315
Total FAERS Reports
38 (2.9%)
Deaths Reported
169
Hospitalizations
1,315
As Primary/Secondary Suspect
81
Life-Threatening
376
Disabilities
Hahnemann Laboratories, INC.
Manufacturer

Route: ORAL · Manufacturer: Hahnemann Laboratories, INC. · HUMAN OTC DRUG · FDA Label: Available

First Report: 19721020 · Latest Report: 20250708

What Are the Most Common GADOLINIUM Side Effects?

#1 Most Reported
Nephrogenic systemic fibrosis
370 reports (28.1%)
#2 Most Reported
Pain
310 reports (23.6%)
#3 Most Reported
Gadolinium deposition disease
310 reports (23.6%)

All GADOLINIUM Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Nephrogenic systemic fibrosis 370 28.1% 32 8
Gadolinium deposition disease 310 23.6% 0 11
Pain 310 23.6% 0 19
Arthralgia 303 23.0% 0 26
Fatigue 278 21.1% 0 20
Burning sensation 272 20.7% 1 11
Paraesthesia 264 20.1% 0 13
Hypoaesthesia 260 19.8% 0 19
Asthenia 257 19.5% 0 7
Rash 253 19.2% 0 9
Muscle spasms 250 19.0% 0 9
Confusional state 234 17.8% 0 4
Injury 234 17.8% 0 3
Inflammation 228 17.3% 0 4
Anxiety 172 13.1% 0 10
Emotional distress 161 12.2% 0 2
Mass 152 11.6% 0 0
Contrast media deposition 113 8.6% 1 6
Headache 105 8.0% 0 30
Off label use 95 7.2% 1 5

Who Reports GADOLINIUM Side Effects? Age & Gender Data

Gender: 68.6% female, 31.4% male. Average age: 51.7 years. Most reports from: US. View detailed demographics →

Is GADOLINIUM Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 5 1 1
2001 3 0 0
2002 11 0 1
2003 16 3 0
2004 29 4 0
2005 39 5 0
2006 55 2 3
2007 38 3 1
2008 12 0 1
2009 15 0 4
2010 10 0 0
2011 6 0 1
2012 8 0 1
2013 18 0 5
2014 19 0 9
2015 43 0 14
2016 28 0 9
2017 43 1 12
2018 33 1 9
2019 15 0 5
2020 14 0 11
2021 14 1 6
2022 26 0 16
2023 9 0 2
2024 15 0 6
2025 7 0 4

View full timeline →

What Is GADOLINIUM Used For?

IndicationReports
Product used for unknown indication 526
Nuclear magnetic resonance imaging 261
Diagnostic procedure 193
Angiogram 153
Magnetic resonance imaging 125
Computerised tomogram 73
Scan with contrast 29
Nuclear magnetic resonance imaging brain 15
Back pain 13
Headache 13

GADOLINIUM vs Alternatives: Which Is Safer?

GADOLINIUM vs GADOPENTETATE DIMEGLUMINE GADOLINIUM vs GADOPICLENOL GADOLINIUM vs GADOTERATE MEGLUMINE GADOLINIUM vs GADOTERIDOL GADOLINIUM vs GADOVERSETAMIDE GADOLINIUM vs GADOXETATE GADOLINIUM vs GALANTAMINE GADOLINIUM vs GALANTAMINE HYDROBROMIDE GADOLINIUM vs GALCANEZUMAB GADOLINIUM vs GALCANEZUMAB-GNLM

Official FDA Label for GADOLINIUM

Official prescribing information from the FDA-approved drug label.