Azoren Adverse Reactions

Azoren: The most commonly reported adverse reactions during treatment with Azoren are peripheral oedema (11.3%), headache (5.3%) and dizziness (4.5%).
Adverse reactions from Azoren in clinical trials, post-authorisation safety studies and spontaneous reporting are summarised in the table as follows as well as adverse reactions from the individual components olmesartan medoxomil and amlodipine based on the known safety profile of these substances.
The following terminologies have been used in order to classify the occurrence of adverse reactions: 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); Not known (cannot be estimated from the available data). (See table.)

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Single cases of rhabdomyolysis have been reported in temporal association with the intake of angiotensin II receptor blockers. Single cases of extrapyramidal syndrome have been reported in patients treated with amlodipine.