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GADOLINIUM

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Gadolinium Adverse Events Reported to the FDA Over Time

How are Gadolinium adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Gadolinium, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Gadolinium is flagged as the suspect drug causing the adverse event.

Most Common Gadolinium Adverse Events Reported to the FDA

What are the most common Gadolinium adverse events reported to the FDA?

Nephrogenic Systemic Fibrosis
784 (6.42%)
Pain
488 (3.99%)
Skin Induration
372 (3.04%)
Skin Tightness
325 (2.66%)
Skin Hypertrophy
324 (2.65%)
Oedema Peripheral
315 (2.58%)
Mobility Decreased
290 (2.37%)
Joint Range Of Motion Decreased
271 (2.22%)
General Physical Health Deteriorati...
221 (1.81%)
Musculoskeletal Stiffness
217 (1.78%)
Scar
207 (1.69%)
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Anxiety
204 (1.67%)
Emotional Distress
197 (1.61%)
Fibrosis
191 (1.56%)
Skin Discolouration
191 (1.56%)
Pain In Extremity
178 (1.46%)
Skin Fibrosis
176 (1.44%)
Deformity
175 (1.43%)
Erythema
167 (1.37%)
Arthralgia
166 (1.36%)
Joint Stiffness
166 (1.36%)
Skin Hyperpigmentation
158 (1.29%)
Pruritus
154 (1.26%)
Joint Contracture
151 (1.24%)
Injury
146 (1.2%)
Muscular Weakness
144 (1.18%)
Gait Disturbance
143 (1.17%)
Rash
135 (1.11%)
Asthenia
127 (1.04%)
Hypoaesthesia
127 (1.04%)
Skin Exfoliation
126 (1.03%)
Dry Skin
121 (.99%)
Extremity Contracture
121 (.99%)
Skin Plaque
120 (.98%)
Oedema
96 (.79%)
Anhedonia
86 (.7%)
Skin Disorder
86 (.7%)
Skin Lesion
79 (.65%)
Abasia
76 (.62%)
Depression
74 (.61%)
Pain Of Skin
74 (.61%)
Paraesthesia
69 (.56%)
Muscle Tightness
60 (.49%)
Pruritus Generalised
58 (.47%)
Skin Ulcer
56 (.46%)
Fatigue
55 (.45%)
Muscle Contracture
54 (.44%)
Burning Sensation
51 (.42%)
Back Pain
48 (.39%)
Rash Papular
43 (.35%)
Myalgia
42 (.34%)
Swelling
41 (.34%)
Motor Dysfunction
40 (.33%)
Dyspnoea
39 (.32%)
Hyperkeratosis
39 (.32%)
Off Label Use
37 (.3%)
Fall
32 (.26%)
Skin Swelling
32 (.26%)
Blister
31 (.25%)
Pneumonia
30 (.25%)
Quality Of Life Decreased
30 (.25%)
Vomiting
30 (.25%)
Bone Pain
29 (.24%)
Musculoskeletal Pain
27 (.22%)
Cardiac Failure Congestive
26 (.21%)
Cellulitis
26 (.21%)
Discomfort
26 (.21%)
Dysstasia
26 (.21%)
Joint Swelling
26 (.21%)
Pigmentation Disorder
26 (.21%)
Rash Macular
26 (.21%)
Nausea
25 (.2%)
Renal Failure Chronic
25 (.2%)
Activities Of Daily Living Impaired
24 (.2%)
Muscle Spasms
24 (.2%)
Chest Pain
23 (.19%)
Insomnia
23 (.19%)
Muscle Rigidity
23 (.19%)
Skin Fissures
23 (.19%)
Rash Pruritic
22 (.18%)
Wheelchair User
22 (.18%)
Skin Burning Sensation
21 (.17%)
Generalised Oedema
20 (.16%)
Myosclerosis
19 (.16%)
Subcutaneous Nodule
19 (.16%)
Urticaria
18 (.15%)
Balance Disorder
17 (.14%)
Diarrhoea
17 (.14%)
Excoriation
17 (.14%)
Hypotension
17 (.14%)
Neuropathy Peripheral
17 (.14%)
Skin Hypopigmentation
17 (.14%)
Abdominal Pain
16 (.13%)
Anaemia
16 (.13%)
Arteriosclerosis
16 (.13%)
Deep Vein Thrombosis
16 (.13%)
Skin Warm
16 (.13%)
Atrial Fibrillation
15 (.12%)
Headache
15 (.12%)
Induration
15 (.12%)
Major Depression
15 (.12%)

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This graph shows the top adverse events submitted to the FDA for Gadolinium, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Gadolinium is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Gadolinium

What are the most common Gadolinium adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Gadolinium, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Gadolinium is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Gadolinium According to Those Reporting Adverse Events

Why are people taking Gadolinium, according to those reporting adverse events to the FDA?

Nuclear Magnetic Resonance Imaging
502
Nuclear Magnetic Resonance Imaging ...
179
Angiogram
154
Nuclear Magnetic Resonance Imaging ...
67
Venogram
26
Scan With Contrast
23
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Fistulogram
22
Product Used For Unknown Indication
20
Imaging Procedure
17
Drug Use For Unknown Indication
16
Angioplasty
12
Scan Brain
10
Dizziness
8
Renal Transplant
8
Arteriogram Coronary
6
Angiogram Peripheral
5
Computerised Tomogram Head
5
Computerised Tomogram
5
Diagnostic Procedure
5
Headache
5
Cerebral Infarction
5
X-ray
4
Endoscopic Retrograde Cholangiopanc...
4
Back Pain
4
Aortogram
4
Multiple Sclerosis
4
Pain In Extremity
4
Submandibular Mass
3
Neck Mass
3
Venogram Renal
3
Arteriogram
3
Renal Failure Chronic
3
Nuclear Magnetic Resonance Imaging ...
3
Angiogram Cerebral
3
Vascular Graft
3
Non-small Cell Lung Cancer
3
Paraesthesia
2
Mental Status Changes
2
Joint Injury
2
Optic Neuritis
2
Vascular Imaging
2
Tinnitus
2
Scan
2
Haemorrhage Intracranial
2
Muscular Weakness
2
Neoplasm
2
Lymphoma
2
Hepatic Cirrhosis
1
Splenic Artery Aneurysm
1
Muscle Necrosis
1
Surgery
1

Gadolinium Case Reports

What Gadolinium safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Gadolinium. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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