Visipaque Adverse Reactions

Listed as follows are possible side effects in relation with radiographic procedures which include the use of Visipaque.
Undesirable effects associated with VISIPAQUE are usually mild to moderate and transient in nature. Serious reactions as well as fatalities are only seen on very rare occasions, these may include acute-on-chronic renal failure, acute renal failure, anaphylactic or anaphylactoid shock, hypersensitivity reaction followed by cardiac reactions (Kounis' syndrome), cardiac or cardio-respiratory arrest and myocardial infarction. Cardiac reaction may be promoted by the underlying disease or the procedure.
Hypersensitivity reactions may present as respiratory or cutaneous symptoms like dyspnoea, rash, erythema, urticaria, pruritus, severe skin reactions, angioneurotic oedema, hypotension, fever, laryngeal oedema, bronchospasm or pulmonary oedema. In patients with autoimmune diseases cases of vasculitis and SJS-like syndrome were observed.
They may appear either immediately after the injection or up to a few days later. Hypersensitivity reactions may occur irrespectively of the dose and mode of administration and mild symptoms may represent the first signs of a serious anaphylactoid reaction/shock.
Administration of the contrast medium must be discontinued immediately and, if necessary, specific therapy instituted via the vascular access. Patients using beta blockers may present with atypical symptoms of hypersensitivity which may be misinterpreted as a vagal reaction.
A minor transient increase in serum creatinine is common after iodinated contrast media, but is usually of no clinical relevance.
The frequencies of undesirable effects are defined as follows: Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
The listed frequencies are based on internal clinical documentation and published studies, comprising more than 57,705 patients.
The following undesirable effects are recognised for VISIPAQUE: See Tables 5, 6, 7, 8 and 9.

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Description of selected adverse reactions: Transient contrast-induced encephalopathy: In unknown occasions the contrast medium may cross the blood-brain barrier resulting in uptake of contrast medium in the cerebral cortex that may cause contrast-induced encephalopathy. The symptoms may include agitation, transient cortical blindness, amnesia, hallucination, paralysis, paresis, disorientation, transient speech disorder, aphasia, dysarthria.