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ULTRAVIST

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Ultravist Adverse Events Reported to the FDA Over Time

How are Ultravist adverse event reports trending over time?

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

Most Common Ultravist Adverse Events Reported to the FDA

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

Urticaria
1980 (11.88%)
Pruritus
936 (5.61%)
Dyspnoea
743 (4.46%)
Sneezing
473 (2.84%)
Erythema
459 (2.75%)
Nausea
457 (2.74%)
Vomiting
412 (2.47%)
Nasal Congestion
267 (1.6%)
Loss Of Consciousness
220 (1.32%)
Contrast Media Reaction
219 (1.31%)
Cough
217 (1.3%)
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Rash
215 (1.29%)
Throat Irritation
202 (1.21%)
Anaphylactic Shock
200 (1.2%)
Blood Pressure Decreased
196 (1.18%)
Swelling Face
181 (1.09%)
Throat Tightness
181 (1.09%)
Chest Discomfort
179 (1.07%)
Hypotension
161 (.97%)
Flushing
160 (.96%)
Cardiac Arrest
136 (.82%)
Hyperhidrosis
129 (.77%)
Dizziness
128 (.77%)
Eye Pruritus
127 (.76%)
Feeling Hot
127 (.76%)
Cyanosis
118 (.71%)
Hypersensitivity
112 (.67%)
Anaphylactic Reaction
110 (.66%)
Eye Swelling
110 (.66%)
Laryngeal Oedema
106 (.64%)
Respiratory Arrest
106 (.64%)
Adverse Event
105 (.63%)
Cardio-respiratory Arrest
101 (.61%)
Convulsion
99 (.59%)
Chest Pain
97 (.58%)
Dysphagia
93 (.56%)
Coma
91 (.55%)
Lip Swelling
87 (.52%)
Chills
85 (.51%)
Headache
85 (.51%)
Ocular Hyperaemia
84 (.5%)
Tremor
76 (.46%)
Hypoaesthesia
74 (.44%)
Pharyngeal Oedema
74 (.44%)
Malaise
73 (.44%)
Shock
71 (.43%)
Circulatory Collapse
70 (.42%)
Face Oedema
69 (.41%)
Tachycardia
69 (.41%)
Paraesthesia
65 (.39%)
Pruritus Generalised
65 (.39%)
Depressed Level Of Consciousness
64 (.38%)
Swollen Tongue
63 (.38%)
Wheezing
61 (.37%)
Pallor
58 (.35%)
Lacrimation Increased
55 (.33%)
Bronchospasm
54 (.32%)
Bradycardia
52 (.31%)
Swelling
51 (.31%)
Burning Sensation
50 (.3%)
Urinary Incontinence
49 (.29%)
Blood Pressure Increased
48 (.29%)
Procedural Complication
48 (.29%)
Death
46 (.28%)
Heart Rate Increased
46 (.28%)
Dysphonia
45 (.27%)
Oropharyngeal Discomfort
45 (.27%)
Ear Pruritus
44 (.26%)
Angioedema
43 (.26%)
Asthenia
43 (.26%)
Hypoaesthesia Oral
43 (.26%)
Anxiety
42 (.25%)
Arteriospasm Coronary
41 (.25%)
Eyelid Oedema
41 (.25%)
Pulse Absent
41 (.25%)
Respiratory Distress
41 (.25%)
Confusional State
40 (.24%)
Generalised Erythema
40 (.24%)
Oedema Peripheral
40 (.24%)
Rash Erythematous
39 (.23%)
Syncope
39 (.23%)
Oral Pruritus
38 (.23%)
Oxygen Saturation Decreased
38 (.23%)
Extravasation
37 (.22%)
Renal Failure Acute
37 (.22%)
Back Pain
36 (.22%)
Blood Pressure Immeasurable
35 (.21%)
Palpitations
35 (.21%)
Post Procedural Complication
35 (.21%)
Myocardial Infarction
34 (.2%)
Speech Disorder
34 (.2%)
Muscle Spasms
33 (.2%)
Pulmonary Oedema
33 (.2%)
Agitation
32 (.19%)
Hypertension
32 (.19%)
Unevaluable Event
31 (.19%)
Paraesthesia Oral
30 (.18%)
Rash Macular
30 (.18%)
Heart Rate Decreased
29 (.17%)
Anaphylactoid Reaction
28 (.17%)
Blister
28 (.17%)

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

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

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

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

Computerised Tomogram
1519
Computerised Tomogram Abdomen
1501
Drug Use For Unknown Indication
492
Computerised Tomogram Thorax
331
Angiogram
206
Product Used For Unknown Indication
193
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Arteriogram Coronary
160
Urogram
66
Computerised Tomogram Head
56
Scan Brain
52
Abdominal Pain
39
Scan With Contrast
33
Urography
33
Diagnostic Procedure
29
Haematuria
29
Catheterisation Cardiac
28
Scan
20
Abdominal Pain Lower
18
Angiogram Cerebral
17
Computerised Tomogram Kidney
16
Abdomen Scan
16
Nuclear Magnetic Resonance Imaging
15
Fistulogram
15
Percutaneous Coronary Intervention
14
Arteriogram
13
Positron Emission Tomogram
12
Arthrogram
11
Pulmonary Embolism
11
Spinal Myelogram
11
Abdominal Pain Upper
10
Coronary Angioplasty
8
Acute Myocardial Infarction
8
Venogram
8
Computerised Tomogram Coronary Arte...
8
Unevaluable Event
8
Renal Neoplasm
7
X-ray
7
Renal Cyst
7
Chest Pain
6
Angiogram Pulmonary
6
Cough
6
Neck Mass
6
Flank Pain
5
Central Venous Catheterisation
5
Lung Neoplasm Malignant
5
Myocardial Ischaemia
5
Imaging Procedure
5
Lung Neoplasm
5
Urinary Tract Infection
5
Liver Scan
4
Diarrhoea
4

Drug Labels

LabelLabelerEffective
UltravistBayer HealthCare Pharmaceuticals Inc.30-DEC-09
UltravistBayer HealthCare Pharmaceuticals Inc.28-MAR-12

Ultravist Case Reports

What Ultravist 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 Ultravist. 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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