Valgen-AM Adverse Reactions

The safety of VALGEN-AM has been evaluated in five controlled clinical studies with patients 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 VALGEN-AM 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.