Olmetec Adverse Reactions

Olmesartan medoxomil has been evaluated for safety in more than 3,825 patients/subjects, including more than 3,275 patients treated for hypertension in controlled trials. This experience included about 900 patients treated for at least 6 months and more than 525 for at least 1 year. Treatment with olmesartan medoxomil was well tolerated, with an incidence of adverse events similar to placebo. Events generally were mild, transient and had no relationship to the dose of olmesartan medoxomil.
The overall frequency of adverse events was not dose-related. Analysis of gender, age and race groups demonstrated no differences between olmesartan medoxomil- and placebo-treated patients. The rate of withdrawals due to adverse events in all trials of hypertensive patients was 2.4% (i.e., 79/3,278) of patients treated with olmesartan medoxomil and 2.7% (i.e., 32/1,179) of control patients. In placebo-controlled trials, the only adverse event that occurred in more than 1% of patients treated with olmesartan medoxomil and at a higher incidence versus placebo was dizziness (3% vs 1%).
The following adverse events occurred in placebo-controlled clinical trials at an incidence of more than 1% of patients treated with olmesartan medoxomil, but also occurred at about the same or greater incidence in patients receiving placebo: back pain, bronchitis, creatine phosphokinase increased, diarrhea, headache, hematuria, hyperglycemia, hypertriglyceridemia, influenza-like symptoms, pharyngitis, rhinitis and sinusitis.
The incidence of cough was similar in placebo (0.7%) and olmesartan medoxomil (0.9%) patients. Other (potentially important) adverse events that have been reported with an incidence of greater than 0.5%, whether or not attributed to treatment, in the more than 3,100 hypertensive patients treated with olmesartan medoxomil monotherapy in controlled or open-label trials are listed as follows: Body as a Whole: Chest pain, peripheral edema.
Central and Peripheral Nervous System: Vertigo.
Gastrointestinal: Abdominal pain, dyspepsia, gastroenteritis, nausea.
Heart Rate and Rhythm Disorders: Tachycardia.
Metabolic and Nutritional Disorders: Hypercholesterolemia, hyperlipemia, hyperuricemia.
Musculoskeletal: Arthralgia, arthritis, myalgia.
Skin and Appendages: Rash.
Facial edema was reported in 5 patients receiving olmesartan medoxomil. Angioedema has been reported with other angiotensin II antagonists.
Laboratory Test Findings: In controlled clinical trials, clinically important changes in standard laboratory parameters were rarely associated with administration of olmesartan medoxomil.
Hemoglobin and Hematocrit: Small decreases in hemoglobin and hematocrit (mean decreases of approximately 0.3 g/dL and 0.3 volume percent, respectively) were observed.
Liver Function Tests: Elevations of liver enzymes and/or serum bilirubin were observed infrequently. Five patients (0.1%) assigned to olmesartan medoxomil and one patient (0.2%) assigned to placebo in clinical trials were withdrawn because of abnormal liver chemistries (transaminases or total bilirubin). Of the five olmesartan medoxomil patients, three had elevated transaminases, which were attributed to alcohol use, and one had a single elevated bilirubin value, which normalized while treatment continued.
Clinical Trial Experience: Dizziness has been reported commonly (≥1%, <10% incidence) in clinical trials with olmesartan medoxomil.
Post-launch Experience: In post-launch experience, adverse drug reactions which have been reported very rarely (<0.01% incidence) are: Peripheral edema, headache, cough, abdominal pain, nausea, vomiting, diarrhea, sprue-like enteropathy, anaphylactic reaction, rash, pruritus, angioedema, acute renal failure, hepatic enzymes increased, blood creatinine increased, hyperkalaemia, myalgia and asthenic conditions, such as asthenia, fatigue, lethargy, malaise. Rare cases of rhabdomyolysis have been reported in patients receiving angiotensin II receptor blockers.