COZAAR has been found to be generally well tolerated in controlled clinical trials for hypertension; side effects have usually been mild and transient in nature and have not required discontinuation of therapy. The overall incidence of side effects reported with COZAAR was comparable to placebo.
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.
Click on icon to see table/diagram/image
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.
Hepatitis (reported rarely), liver function abnormalities, vomiting.
General Disorders and Administration Site Conditions:
Anemia, thrombocytopenia (reported rarely).
Reproductive System and Breast Disorders:
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.