Clariscan Adverse Reactions

Side effects in association with the use of gadoteric acid are usually mild to moderate in intensity and transient in nature.
Injection site reactions, nausea and headache are the most frequently observed reactions.
During clinical trials, nausea, headache, injection site reaction, feeling cold, hypotension, somnolence, dizziness, feeling hot, burning sensation, rash, asthenia, dysgeusia and hypertension and paresthesia were the most frequent, uncommonly observed (≥1/1000 to <1/100), related adverse events.
Since post-marketing, the most commonly reported adverse reactions following administration of gadoteric acid are nausea, vomiting, pruritus and hypersensitivity reactions.
In hypersensitivity reactions, the reactions most frequently observed are skin reactions, which can be localized, extended or generalized.
These reactions occur most often immediately (during the injection or within one hour after the start of injection) or sometimes delayed (one hour to several days after injection), presenting as skin reactions in this case.
Immediate reactions include one or more effects, which appear simultaneously or sequentially, which are most often cutaneous, respiratory and/or cardiovascular reactions. Each sign may be a warning sign of a starting shock and go very rarely to death.
Isolated cases of nephrogenic systemic fibrosis (NSF) have been reported with gadoteric acid, most of which were in patients co-administered other gadolinium-containing contrast agents (see Precautions).
The adverse reactions are listed in the table as follows by SOC (System Organ Class) and by frequency with the following guidelines: 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), not known (cannot be estimated from the available data).
The data presented are from clinical trials involving 2822 patients when available, or from a pool of observational studies involving 185,500 patients. (See Table 3.)

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The following adverse reactions were reported with other intravenous contrast agents for MRI. It is therefore possible that they also occur during examination with Gadoteric Acid (Clariscan). (See Table 4.)

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Adverse reaction in children: Safety of paediatric patients was considered in clinical trials and post marketing studies. As compared to adult, the safety profile of gadoteric acid did not show any specificity in children. Most of reactions are gastrointestinal symptoms or signs of hypersensitivity.
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 reporting system.