Micardis Plus Adverse Reactions

Summary of the safety profile: 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.
Tabulated summary of adverse reactions: The following adverse reactions derived from the use of telmisartan/hydrochlorothiazide combination or the use of monocomponents (telmisartan or hydrochlorothiazide) in clinical trials or from post-marketing experience are shown in the table below classified by MedDRA System organ class and MedDRA Preferred terms. (See table.)

Click on icon to see table/diagram/image


Click on icon to see table/diagram/image

Description of selected adverse reactions: Non-melanoma skin cancer: Based on available data from epidemiological studies, cumulative dose-dependent association between HCTZ and NMSC has been observed (see also Use in Pregnancy & Lactation and Pharmacology: Pharmacodynamics under Actions).