Cozaar

[Losartan]

15
4
5

10
3
4 Endocrine

Diabetic neuropathy
Diabetic vascular disease 4 10 3 9
Eyes, Ears, Nose and Throat
Cataract
Sinusitis 7 6 5 5
Hemic
Anemia 14 11
Metabolic and Nutrition
Hyperkalemia
Hypoglycemia
Weight gain

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7
14
4

3
10
3 Musculoskeletal

Back pain
Leg pain
Knee pain
Muscular weakness

12
5
5
7

10
4
4
4 Nervous System

Hypesthesia 5 4
Respiratory
Bronchitis
Cough 10 11 9 10
Skin
Cellulitis 7 6
Urogenital
Urinary tract infection 16 13

Post-Marketing Experience
The following additional adverse reactions have been reported in post-marketing experience: Hypersensitivity: 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-Schönlein purpura, has been reported. Anaphylactic reactions have been reported.
Digestive: Hepatitis (reported rarely).
Respiratory: Dry cough (see above).
Hyperkalemia and hyponatremia have been reported. Laboratory Test Findings

In controlled clinical trials, clinically important changes in standard laboratory parameters were rarely associated with administration of COZAAR.

Creatinine, Blood Urea Nitrogen:

Minor increases in blood urea nitrogen (BUN) or serum creatinine were observed in less than 0.1 percent of patients with essential hypertension treated with COZAAR alone (see PRECAUTIONS, Impaired Renal Function).

Hemoglobin and Hematocrit:

Small decreases in hemoglobin and hematocrit (mean decreases of approximately 0.11 grams percent and 0.09 volume percent, respectively) occurred frequently in patients treated with COZAAR alone, but were rarely of clinical importance. No patients were discontinued due to anemia.

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