Visipaque Adverse Reactions

Description of the Safety Profile: Listed as follows are the possible general side effects in relation with radiographic procedures which include the use of iodixanol (Visipaque).
Undesirable effects associated with the use of iodinated contrast media are usually mild to moderate and transient in nature, and less frequent with non-ionic than with ionic contrast media. Serious reactions as well as fatalities are only seen on very rare occasions. Hypersensitivity reactions occur occasionally and usually present as mild respiratory or cutaneous symptoms like dyspnoea, rash, erythema, urticaria, pruritus and angioedema. Hypersensitivity reactions may appear either immediately after injection or up to 7 days later. Up to 1.3% of subjects in clinical studies have experienced late onset (one hour or more after administration) non-serious hypersensitivity reactions, usually with cutaneous symptoms. Hypotension or fever may occur. Severe and even toxic skin reactions have been reported. Severe manifestations such as laryngeal oedema, bronchospasm, pulmonary oedema and anaphylactic shock are very rare.
Anaphylactoid reactions may occur irrespectively of the dose and mode of administration and mild symptoms of hypersensitivity may represent the first signs of a serious reaction. Administration of the contrast medium must be discontinued immediately and, if necessary, specific therapy instituted via the vascular access.
Post phlebographic thrombophlebitis or thrombosis is very rare. A very few cases of arthralgia have been reported.
Intrathecal Use: Undesirable effects following intrathecal use may be delayed and present some hours or even days after the procedure. The frequency is similar to lumbar puncture alone. Headache, nausea, vomiting or dizziness are common and may largely be attributed to pressure loss in the subarachnoid space resulting from leakage at puncture site. Some of these patients may experience a severe headache lasting for several days. Excessive removal of cerebrospinal fluid should be avoided in order to minimize pressure loss.
Mild local pain and radicular pain at the site of the injection may occur.
Meningeal irritation giving photophobia and meningism and frank chemical meningitis have been observed with other non-ionic iodinated contrast media. The possibility of infective meningitis should also be considered.
Table of Undesirable Effects: Listed as follows are the possible general side effects in relation with radiographic procedures, which include the use of non-ionic dimeric contrast media.
In the tables as follows, 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).
Please first read the "Description of Safety Profile" for more detailed information. (See Tables 5, 6 and 7.)

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