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The safety profile of MICARDIS in patients treated for prevention of cardiovascular morbidity and mortality 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 prevention of cardiovascular morbidity and mortality for up to six years. (See Table 1.)
Click on icon to see table/diagram/imageMicardis Plus: The overall incidence of adverse events reported with MICARDIS PLUS was comparable to those reported with telmisartan alone in randomised controlled trials involving 1471 patients receiving telmisartan plus hydrochlorothiazide (835) or telmisartan alone (636). There was no dose-relationship to undesirable effects and there was no correlation with gender, age or race of the patients.
Adverse reactions reported in clinical trials with telmisartan plus hydrochlorothiazide are shown as follows according to system organ class.
Adverse reactions not observed in clinical trials with telmisartan plus hydrochlorothiazide but expected during treatment with MICARDIS PLUS based on the experience with telmisartan or hydrochlorothiazide alone are shown in the table as follows classified by MedDRA System organ class and MedDRA Preferred Terms. (See Tables 2a and 2b.)
Click on icon to see table/diagram/image
Click on icon to see table/diagram/image
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