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Omniscan Adverse Events Reported to the FDA Over Time

How are Omniscan adverse event reports trending over time?

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

Most Common Omniscan Adverse Events Reported to the FDA

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

Nephrogenic Systemic Fibrosis
3205 (10.31%)
Pain
1759 (5.66%)
Anxiety
964 (3.1%)
Emotional Distress
906 (2.91%)
General Physical Health Deteriorati...
883 (2.84%)
Fibrosis
835 (2.69%)
Mobility Decreased
830 (2.67%)
Scar
757 (2.44%)
Skin Induration
728 (2.34%)
Skin Hypertrophy
720 (2.32%)
Oedema Peripheral
711 (2.29%)
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Skin Tightness
674 (2.17%)
Injury
671 (2.16%)
Skin Fibrosis
598 (1.92%)
Joint Range Of Motion Decreased
575 (1.85%)
Deformity
476 (1.53%)
Pain In Extremity
466 (1.5%)
Musculoskeletal Stiffness
391 (1.26%)
Joint Stiffness
386 (1.24%)
Anhedonia
381 (1.23%)
Joint Contracture
379 (1.22%)
Skin Discolouration
369 (1.19%)
Arthralgia
349 (1.12%)
Pruritus
344 (1.11%)
Erythema
335 (1.08%)
Gait Disturbance
326 (1.05%)
Muscular Weakness
319 (1.03%)
Skin Hyperpigmentation
293 (.94%)
Skin Exfoliation
263 (.85%)
Dry Skin
257 (.83%)
Hypoaesthesia
233 (.75%)
Skin Disorder
222 (.71%)
Extremity Contracture
218 (.7%)
Oedema
204 (.66%)
Pain Of Skin
203 (.65%)
Skin Plaque
200 (.64%)
Rash
196 (.63%)
Asthenia
191 (.61%)
Skin Lesion
166 (.53%)
Muscle Contracture
155 (.5%)
Abasia
142 (.46%)
Fatigue
140 (.45%)
Muscle Tightness
140 (.45%)
Burning Sensation
138 (.44%)
Depression
128 (.41%)
Back Pain
112 (.36%)
Joint Swelling
109 (.35%)
Paraesthesia
109 (.35%)
Myalgia
102 (.33%)
Skin Ulcer
101 (.32%)
Motor Dysfunction
100 (.32%)
Bone Pain
96 (.31%)
Rash Papular
96 (.31%)
Haemodialysis
93 (.3%)
Rash Macular
92 (.3%)
Pruritus Generalised
90 (.29%)
Swelling
90 (.29%)
Quality Of Life Decreased
80 (.26%)
Skin Burning Sensation
71 (.23%)
Dysstasia
69 (.22%)
Skin Swelling
69 (.22%)
Off Label Use
68 (.22%)
Exfoliative Rash
66 (.21%)
Activities Of Daily Living Impaired
65 (.21%)
Skin Fissures
62 (.2%)
Hyperkeratosis
61 (.2%)
Pneumonia
57 (.18%)
Insomnia
56 (.18%)
Dyspnoea
54 (.17%)
Nausea
51 (.16%)
Discomfort
50 (.16%)
Musculoskeletal Pain
49 (.16%)
Ocular Icterus
49 (.16%)
Skin Atrophy
47 (.15%)
Rash Pruritic
44 (.14%)
Dialysis
41 (.13%)
Myosclerosis
41 (.13%)
Renal Failure Chronic
41 (.13%)
Pyrexia
37 (.12%)
Confusional State
36 (.12%)
Scleroderma
36 (.12%)
Sepsis
36 (.12%)
Headache
35 (.11%)
Induration
35 (.11%)
Pigmentation Disorder
35 (.11%)
Arthropathy
34 (.11%)
Vomiting
34 (.11%)
Cellulitis
33 (.11%)
Fall
33 (.11%)
Mental Disorder
33 (.11%)
Renal Failure
33 (.11%)
Anaemia
32 (.1%)
Renal Transplant
32 (.1%)
Convulsion
31 (.1%)
Tremor
31 (.1%)
Balance Disorder
30 (.1%)
Muscle Fibrosis
30 (.1%)
Wheelchair User
30 (.1%)
Cerebrovascular Accident
29 (.09%)
Chest Pain
29 (.09%)
Respiratory Failure
29 (.09%)

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This graph shows the top adverse events submitted to the FDA for Omniscan, 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 Omniscan 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 Omniscan

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

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This graph shows the top categories of adverse events submitted to the FDA for Omniscan, 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 Omniscan 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 Omniscan According to Those Reporting Adverse Events

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

Nuclear Magnetic Resonance Imaging
1689
Drug Use For Unknown Indication
1070
Angiogram
404
Nuclear Magnetic Resonance Imaging ...
229
Product Used For Unknown Indication
184
Imaging Procedure
152
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Renal Transplant
97
Nuclear Magnetic Resonance Imaging ...
82
Diagnostic Procedure
51
Fistulogram
40
Scan With Contrast
30
Venogram
29
Renal Artery Stenosis
20
Arteriogram
18
Headache
18
Back Pain
17
Renal Disorder
16
Venogram Renal
14
Complications Of Transplanted Kidne...
13
Scan
12
Hepatic Neoplasm Malignant
12
Cerebrovascular Accident
11
Angiopathy
11
Ischaemia
10
Renal Cyst
10
Acoustic Neuroma
10
Liver Transplant
10
Peripheral Arterial Occlusive Disea...
10
Transplant Evaluation
10
Arteriogram Carotid
9
Abdominal Pain
9
Preoperative Care
9
Nephrectomy
8
Nuclear Magnetic Resonance Imaging ...
8
Magnetic Resonance Cholangiopancrea...
8
Osteomyelitis
7
Renal Failure
7
Transient Ischaemic Attack
7
Hepatic Cirrhosis
7
Computerised Tomogram
7
Glaucoma
6
Brain Neoplasm
6
Pituitary Tumour Benign
6
Multiple Myeloma
6
Renal Failure Acute
6
Renal Scan
6
Pain In Extremity
6
Arteriogram Coronary
6
Neck Pain
5
Joint Deposit
5
Sepsis
5

Drug Labels

LabelLabelerEffective
OmniscanGE Healthcare Inc.10-MAR-11
OmniscanGE Healthcare Inc.10-MAR-11
OmniscanGE Healthcare Inc.15-FEB-12

Omniscan Case Reports

What Omniscan 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 Omniscan. 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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