Summary of safety profile: The most commonly reported adverse reactions are hypersensitivity reactions, mainly dermatological, in subjects with a predisposition to allergic and asthmatic reactions and maculopapular rashes.
During clinical trials, hypokalemia (plasma potassium <3.4 mmol/l) was seen in 10% of patients and <3.2 mmol/l in 4 % of patients after 4 to 6 weeks treatment. After 12 weeks treatment, the mean fall in plasma
potassium was 0.23 mmol/l.
The majority of adverse reactions concerning clinical or laboratory parameters are dose-dependent.
Tabulated summary of adverse reactions: The following undesirable effects have been observed with indapamide during treatment ranked under the following frequency: 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 (≥1/100,000 to <1/10,000), not known (cannot be estimated from the available data). See table.
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