Ultravist Side Effects Center
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Ultravist FDA Prescribing Information: Side Effects
The most important adverse drug reactions in patients receiving ULTRAVIST are anaphylactoid shock, contrast induced acute kidney injury, coma, cerebral infarction, stroke, brain edema, convulsion, arrhythmia, cardiac arrest, myocardial ischemia, myocardial infarction, cardiac failure, bradycardia, cyanosis, hypotension, shock, dyspnea, pulmonary edema, respiratory insufficiency and aspiration.
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect or predict the rates observed in practice.
The following table of incidence of reactions is based upon controlled clinical trials in which ULTRAVIST Injection was administered to 1142 patients. This listing includes all reported adverse reactions regardless of attribution. Adverse reactions are listed by System Organ Class and in decreasing order of occurrence for rates greater than 1% in the ULTRAVIST group: see Table 3.
Table 3: ADVERSE REACTIONS REPORTED IN > 1% OF PATIENTS WHO RECEIVED ULTRAVIST INJECTION IN CLINICAL TRIALS
|System Organ Class||Adverse Reaction||ULTRAVIST Injection
|Nervous system disorders||Headache||46 (4)|
|Eye disorders||Abnormal Vision||12 (1.1)|
|Cardiac disorders||Chest pain||18 (1.6)|
|Vascular disorders||Vasodilatation||30 (2.6)|
|Gastrointestinal disorders||Nausea||42 (3.7)|
|Musculoskeletal and connective tissue disorders||Back pain||22 (1.9)|
|Renal and urinary disorders||Urinary urgency||21 (1.8)|
|General disorders and administration site conditions||Injection site and infusion site reactions (hemorrhage, hematoma, pain, edema, erythema, rash)||41 (3.7)|
One or more adverse reactions were recorded in 273 of 1142 (24%) patients during the clinical trials, coincident with the administration of ULTRAVIST Injection or within the defined duration of the study follow-up period (24-72 hours). ULTRAVIST Injection is often associated with sensations of warmth and/or pain.
Serious, life-threatening and fatal reactions have been associated with the administration of iodine-containing contrast media, including ULTRAVIST Injection. In clinical trials 7/1142 patients given ULTRAVIST Injection died 5 days or later after drug administration. Also, 10/1142 patients given ULTRAVIST Injection had serious adverse events.
The following adverse reactions were observed in ≤ 1% of the subjects receiving ULTRAVIST Injection:
Cardiac disorders: atrioventricular block (complete), bradycardia, ventricular extrasystole;
Gastrointestinal disorders: abdominal discomfort, abdominal pain, abdominal pain upper, constipation, diarrhea, dry mouth, dyspepsia, gastrointestinal disorder, gastrointestinal pain, salivation increased, stomach discomfort, rectal tenesmus;
Immune system disorders: asthma, face edema;
Psychiatric disorders: anxiety;
Renal and urinary disorders: dysuria, renal pain, urinary retention;
The following adverse reactions have been identified during post approval use of ULTRAVIST Injection. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Adverse reactions reported in foreign postmarketing surveillance and other trials with the use of ULTRAVIST Injection include:
Endocrine disorders: hyperthyroidism, thyrotoxic crisis, hypothyroidism;
Gastrointestinal disorders: dysphagia, swelling of salivary glands;
Musculoskeletal and connective tissue disorders: compartment syndrome in case of extravasation
Renal and urinary disorders:renal failure, hematuria;
Skin and subcutaneous tissue disorders: Stevens-Johnson Syndrome, skin discoloration;
The overall character, quality, and severity of adverse reactions in pediatric patients are generally similar to those reported in adult patients. Additional adverse reactions reported in pediatric patients from foreign marketing surveillance or other information are: epistaxis, angioedema, migraine, joint disorder (effusion), muscle cramps, mucous membrane disorder (mucosal swelling), conjunctivitis, hypoxia, fixed eruptions, vertigo, diabetes insipidus, and brain edema [see Use in Specific Populations].
Read the entire FDA prescribing information for Ultravist (Iopromide Injection) »
Additional Ultravist Information
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