Normetec Adverse Reactions

Amlodipine/Olmesartan Medoxomil (Normetec): The overall incidence of adverse events on therapy with Amlodipine/Olmesartan Medoxomil (Normetec) was not different from that seen with placebo. Most adverse events were mild.
The most common undesirable effects were dizziness, headache, edema, and fatigue.
Edema is a known dose-dependent undesirable effect of amlodipine. The incidence of edema was significantly lower in patients receiving Amlodipine/Olmesartan Medoxomil (Normetec) than in those who received amlodipine 10 mg alone. Across all treatment groups, the frequency of edema was generally higher in women than in men.
The less common undesirable effects included hypotension, orthostatic hypotension, rash, palpitation, and pollakiuria.
Adverse events previously reported with one of the individual components may be potential adverse events with Amlodipine/Olmesartan Medoxomil (Normetec), even if not observed in clinical trials with this product.
Olmesartan Medoxomil: In clinical trials, treatment with olmesartan medoxomil was well tolerated, with an incidence of adverse events similar to that seen with placebo. Events were generally mild, transient, and without relationship to the dose of olmesartan medoxomil. The overall frequency of adverse events was not dose-related. Analysis of gender, age, and racial groups demonstrated no differences between olmesartan medoxomil and placebo-treated patients. Dizziness has been reported commonly (≥1% to <10% incidence) in clinical trials with olmesartan medoxomil.
In post-launch experience, adverse drug reactions that have been reported very rarely (<0.01% incidence) were peripheral edema, headache, cough, abdominal pain, nausea, vomiting, diarrhea, sprue-like enteropathy, anaphylactic reaction, rash, pruritus, angioedema, acute renal failure, increased hepatic enzymes, increased blood creatinine, hyperkalemia, myalgia and asthenic conditions such as asthenia, fatigue, lethargy, malaise.
Amlodipine (as Besilate): Most adverse reactions reported during therapy with amlodipine were of mild or moderate severity. The most common undesirable effects were headache, edema, dizziness, facial flushing, and palpitation.
In post-launch experience, gynecomastia has been infrequently reported as an adverse reaction where a causal relationship is uncertain. In post-marketing experience, jaundice and hepatic enzyme elevations (mostly consistent with cholestasis or hepatitis), in some cases severe enough to require hospitalization, have been reported in association with use of amlodipine.