Aprovasc Adverse Reactions

Since clinical studies are conducted under broadly variable conditions, the degree of adverse reactions observed in drug clinical studies cannot be directly compared to clinical studies with other medications and may not reflect the rates observed in practice.
For irbesartan: Irbesartan safety has been evaluated in clinical studies with approximately 5000 subjects, including 1300 hypertensive patients treated for 6 months and more than 400 patients treated for a year or more. In general, adverse events in patients receiving Irbesartan were mild and transient and were not related to the dose. The incidence of adverse events was not related to age, gender or race.
In the placebo-controlled clinical trials, including 1965 patients treated with irbesartan (usual treatment duration of 1 to 3 months), the discontinuation of treatment due to some clinical or laboratory adverse event was 3.3% for patients treated with irbesartan and 4.5% for patients treated with placebo (p = 0.029).
Adverse events that have been reported in clinical studies or post-marketing with irbesartan are listed as follows according to the organ system and frequency (see Table 3).
The following CIOMS frequency rating is used, when applicable: 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 data available on its incidence.
The frequencies of adverse reactions from the post-marketing experience are unknown, because these reactions are reported voluntarily for a population of uncertain size. (See Table 3.)

Click on icon to see table/diagram/image

For amlodipine: Adverse events reported in clinical studies with amlodipine are listed as follows according to organ system and frequency. (See Table 4.)
The following CIOMS frequency rating is used, when applicable: 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 data available on its incidence. (See Table 4.)

Click on icon to see table/diagram/image

In clinical studies comparing the combination of irbesartan/amlodipine fixed dose with irbesartan or amlodipine monotherapy, the types and incidences of adverse events arising from treatment (TEAEs) possibly related to study treatment were similar to those observed in the first clinical studies on monotherapy and in post-marketing 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 calculated from the available data). (See Table 5.)

Click on icon to see table/diagram/image