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The most frequently reported (≥10%) adverse reaction was hyperkalaemia. See Description of selected adverse reactions as follows (see Precautions).
Tabulated list of adverse reactions: The adverse reactions reported with KERENDIA are summarised in Table 3 as follows by MedDRA system organ class and by frequency.
Adverse reactions are ranked by system organ class and then by frequency with the most frequent first, using the following convention: 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).
Within each frequency grouping, adverse reactions are ranked in order of decreasing seriousness. (See Tables 3, 4 and 5.)
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Click on icon to see table/diagram/imageDescription of selected adverse reactions: Hyperkalaemia: In the FIDELIO-DKD study, hyperkalaemia events were reported in 18.3% of KERENDIA-treated patients compared with 9.0% of placebo-treated patients. In patients treated with KERENDIA, the majority of hyperkalaemia events were mild to moderate. An increase from baseline in mean serum potassium in the first month of treatment of approximately 0.2 mmol/L was observed in the KERENDIA arm compared to placebo, with a maximum between-group difference of 0.23 mmol/L observed at Month 4, remaining stable thereafter. For specific recommendations, refer to Dosage & Administration and Precautions.
Reporting Suspected Adverse Effects: Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product.
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