Palset Adverse Reactions

In clinical studies in adults at a dose of 250 micrograms (total 633 patients) the most frequently observed adverse reactions, at least possibly related to palonosetron, were headache (9%) and constipation (5%).
In the clinical studies the following adverse reactions (ARs) were observed as possibly or probably related to palonosetron. These were classified as common (≥1/100 to <1/10) or uncommon (≥1/1,000 to <1/100). Very rare (<1/10,000) adverse reactions were reported post-marketing.
Within each frequency grouping, adverse reactions are presented as follows in order of decreasing seriousness. (See Table 5.)

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Paediatric population: In paediatric clinical trials for the prevention of nausea and vomiting induced by moderately or highly emetogenic chemotherapy, 402 patients received a single dose of palonosetron (3, 10 or 20 mcg/kg). The following common or uncommon adverse reactions were reported for palonosetron, none were reported at a frequency of >1%. (See Table 6.)

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Adverse reactions were evaluated in paediatric patients receiving palonosetron for up to 4 chemotherapy cycles.