Aprovasc Adverse Reactions

Adverse events: Because clinical trials are conducted under widely varying conditions, the incidence of adverse reaction observed in the clinical trials of one drug cannot be directly compared to that observed in the clinical trials of other drugs and may not reflect that observed in practice.
Irbesartan has been evaluated for safety in approximately 5000 subjects in clinical studies, including 1300 hypertensive patients treated for 6 months and more than 400 patients treated for 1 year or more. Adverse events in patients receiving irbesartan were generally mild and transient with no relationship to the dose administered. The incidence of adverse events was not related to age, gender or race.
In placebo-controlled clinical studies, including 1965 patients treated with irbesartan (usual treatment duration: 1 to 3 months), treatment discontinuation due to any clinical or laboratory adverse event was 3.3 percent for irbesartan-treated patients and 4.5 percent for placebo-treated patients (p=0.029).
Adverse events that have been reported in clinical trials or postmarketing experience with irbesartan are categorized below according to system organ class and frequency (see Table 3).
The frequency of adverse events is defined 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), unknown: no incidence data available.
Frequencies of adverse reactions from postmarketing experience are unknown, as these reactions are reported voluntarily from a population of uncertain size. (See Table 3.)

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For amlodipine: Adverse events that have been reported in amlodipine trials are categorized as follows according to system organ class and frequency (see Table 4).
The frequency of adverse events is defined 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), unknown: no incidence data available. (See Table 4.)

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In the clinical trials comparing the fixed-dose combination irbesartan/amlodipine to either irbesartan or amlodipine monotherapy, the types and incidences of treatment-emergent adverse events (TEAEs) possibly related to study treatment were similar to those observed in earlier monotherapy clinical trials and postmarketing reports. The most frequently reported adverse event was peripheral edema, mainly associated with amlodipine (see Table 5).
The following CIOMS frequency rating is used, when applicable: Very common ≥ 10 %; Common ≥ 1 and <10 %; Uncommon ≥ 0.1 and < 1 %; Rare ≥ 0.01 and < 0.1 %; Very rare < 0.01 %, Unknown (cannot be estimated from available data). (See Table 5.)

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