In placebo-controlled trials involving 1041 patients treated with various doses of Telmisartan (20-160 mg) monotherapy for up to 12 weeks, an overall incidence of adverse events similar to that of placebo was observed.
Adverse events occurring at an incidence of 1% or more in patients treated with Telmisartan and at a greater rate than in patients treated with placebo, irrespective of their causal association, are presented in the following table. (See table.)
![](https://mpfshstrg.blob.core.windows.net/mpf-uat-common-resources/Images/monograph/table.gif)
In addition to the adverse events in the table, the following events occurred at rate of 1% but were at least as frequent in the placebo group: influenza-like symptoms, dyspepsia, myalgia, urinary tract infection, abdominal pain, headache, dizziness, pain, fatigue, coughing, hypertension, chest pain, nausea and peripheral edema. Discontinuation of therapy due to adverse events was required in 2.8% of 1455 patients treated with Telmisartan and 6.1% of 380 placebo patients in placebo-controlled clinical trials. The incidence of adverse events was not dose-related and did not correlate with gender, age, or race of patients. The incidence of cough occurring with Telmisartan in six placebo-controlled trials was identical to that noted for placebo-treated patients (1.6%).
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