Micardis Adverse Reactions

Summary of the safety profile: In patients treated for hypertension the overall incidence of adverse events reported with telmisartan (41.4%) was usually comparable to those reported with placebo (43.9%) in controlled clinical trials. The incidence of adverse events was not dose related and showed no correlation with gender, age or race of the patients.
The safety profile of MICARDIS in patients treated for reduction of cardiovascular morbidity was consistent with that obtained in hypertensive patients.
Tabulated summary of adverse reactions: The following adverse drug reactions derived from the use of telmisartan as monotherapy in clinical trials in patients treated for hypertension or from post-marketing experience, are shown in the table as follows classified by MedDRA System organ class and MedDRA Preferred terms. The listing also takes into account serious adverse events and adverse events leading to discontinuation reported in three clinical long-term studies including 21642 patients treated with telmisartan for reduction of cardiovascular morbidity for up to six years. (See Table 3.)

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