Exforge Adverse Reactions

The safety of Exforge has been evaluated in five controlled clinical studies with 5,175 patients, 2,613 of whom received valsartan in combination with amlodipine.
Adverse drug reactions or adverse experiences (Table 1 and Table 2) are ranked under heading of frequency, the most frequent first, using the following convention: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1,000, < 1/100); rare (≥ 1/10,000, < 1/1,000) very rare (< 1/10,000), including isolated reports. Within each frequency grouping, adverse reactions are ranked in order of decreasing seriousness. (See Table 1.)

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Additional information on the combination: In double-blind, active- or placebo-controlled completed clinical trials, the incidence of peripheral edema was statistically lower in patients treated with the combination (5.8%) than in patients treated with amlodipine monotherapy (9%).
Laboratory evaluation: Very few hypertensive patients treated with valsartan/amlodipine showed notable changes in laboratory test results from baseline. There was a slightly higher incidence of notably increased blood urea nitrogen in the amlodipine/valsartan (5.5 %) and valsartan monotherapy (5.5%) groups as compared to the placebo group (4.5%).
Additional information on individual components: Adverse reactions previously reported with one of the individual components may occur with Exforge even if not observed in clinical trials.
Amlodipine: Other additional adverse experiences reported in clinical trials with amlodipine monotherapy, irrespective of their causal association with the study drug, are presented in Table 2: Because amlodipine clinical trials were conducted under widely varying conditions, adverse experience rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. (See Table 2.)

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Valsartan: Other ADRs reported from clinical studies, post-marketing experience and laboratory findings in hypertension indication are presented in Table 3 according to system organ class.
For all the ADRs reported from post-marketing experience and laboratory findings, it is not possible to apply any ADR frequency and therefore they are mentioned with a "not known" frequency. (See Table 3.)

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The following events have also been observed during clinical trials in hypertensive patients irrespective of their causal association with the study drug: Insomnia, libido decrease, pharyngitis, rhinitis, sinusitis, upper respiratory tract infection, viral infections.