In controlled clinical trials for essential hypertension, dizziness was the only side effect reported as drug-related that occurred with an incidence greater than placebo in ≥1% of patients treated with COZAAR. In addition, dose-related orthostatic effects were seen in <1% of patients. Rarely, rash was reported, although the incidence in controlled clinical trials was less than placebo.
In these double-blind controlled clinical trials for essential hypertension, the following adverse experiences reported with COZAAR occurred in ≥1 percent of patients, regardless of the drug relationship: See table.
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COZAAR was generally well tolerated in a controlled clinical trial in hypertensive patients with left ventricular hypertrophy. The most common drug-related side effects were dizziness, asthenia/fatigue and vertigo.
In the LIFE study, among patients without diabetes at baseline, there was a lower incidence of new onset diabetes mellitus with COZAAR as compared to atenolol (242 patients vs 320 patients, respectively, p<0.001). Because there was no placebo group included in the study, it is not known if this represents a beneficial effect of COZAAR or an adverse effect of atenolol.
COZAAR was generally well tolerated in a controlled clinical trial in type 2 diabetic patients with proteinuria. The most common drug-related side effects were asthenia/fatigue, dizziness, hypotension and hyperkalemia (see Hypotension and Electrolyte/Fluid Imbalance under PRECAUTIONS).
The following additional adverse reactions have been reported in post-marketing experience: Hypersensitivity: Anaphylactic reactions, angioedema including swelling of the larynx and glottis causing airway obstruction and/or swelling of the face, lips, pharynx and/or tongue has been reported rarely in patients treated with losartan; some of these patients previously experienced angioedema with other drugs including ACE inhibitors. Vasculitis, including Henoch-Schoenlein purpura, has been reported rarely.
Gastrointestinal: Hepatitis (reported rarely), liver function abnormalities, vomiting.
General Disorders and Administration Site Conditions: Malaise.
Hematologic: Anemia, thrombocytopenia (reported rarely).
Musculoskeletal: Myalgia, arthralgia.
Nervous System/Psychiatric: Migraine, dysgeusia.
Reproductive System and Breast Disorders: Erectile dysfunction/impotence.
Respiratory: Cough.
Skin: Urticaria, pruritus, erythroderma, photosensitivity.
Laboratory Test Findings: In controlled clinical trials for essential hypertension, clinically important changes in standard laboratory parameters were rarely associated with the administration of COZAAR. Hyperkalemia (serum potassium >5.5 mEq/L) occurred in 1.5% of patients in the hypertension clinical trials. In a clinical study conducted in type 2 diabetic patients with proteinuria, 9.9% of patients treated with COZAAR and 3.4% of patients treated with placebo developed hyperkalemia (see Hypotension and Electrolyte/Fluid Imbalance under PRECAUTIONS). Elevations of ALT occurred rarely and usually resolved upon discontinuation of therapy.