Telmez HCT Adverse Reactions

Summary of the safety profile: The most commonly reported adverse reaction is dizziness.
Serious angioedema may occur rarely (≥1/10,000 to <1/1,000).
The overall incidence of adverse reactions reported with Telmisartan and Hydrochlorothiazide was comparable to those reported with telmisartan alone in randomised controlled trials involving 1471 patients randomised to receive telmisartan plus hydrochlorothiazide (835) or telmisartan alone (636). Dose-relationship of adverse reactions was not established and they showed no correlation with gender, age or race of the patients.
Tabulated list of adverse reactions: Adverse reactions reported in all clinical trials and occurring more frequently (p ≤0.05) with telmisartan plus hydrochlorothiazide than with placebo are shown as follows according to system organ class. Adverse reactions known to occur with each component given singly but which have not been seen in clinical trials may occur during treatment with Telmisartan and Hydrochlorothiazide.
Adverse reactions have been ranked under headings of frequency using the following convention: 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).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. (See Table.)

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