Lipiodol Ultra-Fluide Adverse Reactions

Most of the adverse reactions are dose-related and consequently the dose should be as low as possible. Use of LIPIODOL ULTRA-FLUIDE causes a foreign body reaction, with the formation of macrophages and foreign-body giant cells and the occurrence of sinus catarrh, plasmacytosis and subsequently changes in lymph node connective tissue. Healthy lymph nodes tolerate the resulting decrease in transport capacity. In patients with lymph node lesions or hypoplasia, these changes may exacerbate lymph stasis.
Hypersensitivity reactions are possible. These reactions may involve one or more effects, occurring concomitantly or successively, and usually including cutaneous, respiratory and/or cardiovascular manifestations, each of which can be a warning sign of incipent shock and, in very rare instances, can even prove fatal.
In diagnostic radiology: Lymphography: A large increase in temperature followed by a fever of 38 to 39°C may occur within 24 hours following the examination.
Fat micro-embolisms may occur, with or without symptoms. In very cases, they may resemble embolisms originating in the body, in terms of their appearance and size. They usually appear as punctiform opacities on radiographic images of the lungs. Transient increases in temperature are possible. Fat micro-embolisms usually occur following an overdose of contrast agent or excessively rapid infusion. Anatomic anomalies such as lymphovenous fistulas or a decrease in the capacity of lymph nodes to retain the contrast agent (in elderly patients or after radiotherapy or cystostatic therapy) favour their occurrence. Patients with a right-to-left cardiac shunt and those with a massive pulmonary embolism are particularly at risk for fat micro-embolisms in the brain.
In interventional radiology: In Trans-Arterial Chemo-Embolisation: Most of the adverse reactions are not caused by LIPIODOL ULTRA-FLUIDE itself but are due to anticancer drugs or the embolisation itself.
The most frequent adverse reactions of the TACE treatment are post embolisation syndrome (fever, abdominal pain, nausea, vomiting) and transitory changes in liver function tests.
Adverse Reactions are given in the following table according to system organ class and frequency, using the following classification: Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10 000 to <1/1000), very rare <1/10 000), undetermined frequency (cannot be estimated on the basis of available data). (See Table.)

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Adverse reactions in children: The types of adverse reactions to LIPIODOL ULTRA-FLUIDE are the same as those reported in adults. Their frequency cannot be estimated on the basis of available data.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national declaration system.