Besartan Adverse Reactions

Losartan has been evaluated in clinical studies as follows: In a controlled clinical trial in >3,000 adult patients 18 years of age and older for essential hypertension.
In a controlled clinical trial in 177 hypertensive pediatric patients 6 to 16 years of age.
In a controlled clinical trial in >9,000 hypertensive patients 55 to 80 years of age with left ventricular hypertrophy (see Pharmacology: Pharmacodynamics: LIFE-Study under Actions).
In controlled clinical trials in >7,700 adult patients with chronic heart failure (see Pharmacology: Pharmacodynamics: ELITE I and ELITE II under Actions).
In a controlled clinical trial in >1,500 type 2 diabetic patients 31 years of age and older with proteinuria (see Pharmacology: Pharmacodynamics: REENAL Study under Actions).
In the clinical studies performed for losartan potassium, dizziness was the most common reported adverse event.
The frequency of adverse reactions listed as follows is defined using the following convention: very common (≥1/10); common (≥1/100, to <1/10); uncommon (≥1/1,000, to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
The frequency of adverse reactions identified from placebo-controlled clinical studies and post marketing experience.
Blood and lymphatic system disorders: Anemia: Chronic Heart Failure (common); Post-marketing experience (frequency not known).
Thrombocytopenia: Post-marketing experience (frequency not known).
Immune System Disorders: Hypersensitivity reactions, anaphylactic reactions, angioedema*, and vasculitis**: Post-marketing experience (rare).
Nervous System Disorders: Dizziness: Hypertension (common); Hypertensive patients with left ventricular hypertrophy (common); Chronic heart failure (common); Hypertension and type 2 diabetes with renal disease (common).
Somnolence: Hypertension (uncommon).
Headache: Hypertension (uncommon); Chronic heart failure (uncommon).
Sleep Disorders: Hypertension (uncommon).
Migraine: Post-marketing experience (frequency not known).
Dysgeusia: Post-marketing experience (frequency not known).
Ear and Labyrinth Disorders: Vertigo: Hypertension (common); Hypertensive patients with left ventricular hypertrophy (common).
Cardiac Disorders: Palpitations: Hypertension (uncommon).
Angina Pectoris: Hypertension (uncommon).
Syncope: Chronic heart failure (rare).
Atrial Fibrillation: Chronic heart failure (rare).
Cerebrovascular Accident: Chronic heart failure (rare).
Vascular Disorders: (Orthostatic) hypotension (including dose-related orthostatic effects)^║: Hypertension (uncommon); Chronic heart failure (common); Hypertension and type 2 diabetes with renal disease (common).
Respiratory, Thoracic and Mediastinal Disorders: Dyspnoea: Chronic heart failure (uncommon).
Cough: Chronic heart failure (uncommon); Post-marketing experience (frequency not known).
Gastrointestinal Disorders: Abdominal Pain: Hypertension (uncommon).
Diarrhoea: Chronic heart failure (uncommon).
Nausea: Chronic heart failure (uncommon).
Vomiting: Chronic heart failure (uncommon).
Hepatobiliary Disorders: Hepatitis: Post-marketing experience (frequency not known).
Liver Function Abnormalities: Post-marketing experience (frequency not known).
Skin and Subcutaneous Tissue Disorders: Urticaria: Chronic heart failure (uncommon); Post-marketing experience (frequency not known).
Pruritus: Chronic heart failure (uncommon); Post-marketing experience (frequency not known).
Rash: Hypertension (uncommon); Post-marketing experience (frequency not known).
Photosensitivity: Post-marketing experience (frequency not known).
Musculoskeletal and Connective Tissue Disorders: Myalgia: Post-marketing experience (frequency not known).
Arthralgia: Post-marketing experience (frequency not known).
Renal and Urinary Disorders: Renal Impairment: Chronic heart failure (common).
Renal Failure: Chronic heart failure (common).
Reproductive System and Breast Disorders: Erectile Dysfunction/Impotence: Post-marketing experience (frequency not known).
General Disorders and Administration Site Conditions: Asthenia: Hypertension (uncommon); Hypertensive patients with left ventricular hypertrophy (common); Chronic heart failure (uncommon); Hypertension and type 2 diabetes with renal disease (common).
Fatigue: Hypertension (uncommon); Hypertensive patients with left ventricular hypertrophy (common); Chronic heart failure (uncommon); Hypertension and type 2 diabetes with renal disease (common).
Edema: Hypertension (uncommon).
Malaise: Post-marketing experience (frequency not known).
Investigations: Hyperkalemia: Hypertension (common); Chronic heart failure (uncommon^†); Hypertension and type 2 diabetes with renal disease (common^‡).
Increased Alanine aminotransferase (ALT)^§: Hypertension (rare).
Increased in blood urea, serum creatinine, and serum potassium: Chronic heart failure (common).
Hyponatremia: Post-marketing experience (frequency not known).
Hypoglycemia: Hypertension and type 2 diabetes with renal disease (common).
*Including swelling of the larynx, glottis, face, lips, pharynx, and/or tongue (causing airway obstruction); in some of these patients, angioedema had been reported in the past in connection with the administration of other medicines, including ACE inhibitors.
**Including Henoch-Schönlein purpura.
^║Especially in patients with intravascular depletion, e.g. patients with severe heart failure or under treatment with high dose diuretics.
^†Common in patients who received 150 mg losartan instead of 50 mg.
^‡ In a clinical study conducted in type 2 diabetic patients with nephropathy, 9.9% of patients treated with Losartan tablets developed hyperkalemia >5.5 mmol/L and 3.4% of patients treated with placebo.
^§Usually resolved upon discontinuation.
The following additional adverse reactions occurred more frequently in patients who received losartan than placebo (frequencies not known): back pain, urinary tract infection, and flu-like symptoms.
Renal and urinary disorders: As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function including renal failure have been reported in patients at risk; these changes in renal function may be reversible upon discontinuation of therapy (see Precautions).
Pediatric population: The adverse reaction profile for pediatric patients appears to be similar to that seen in adult patients. Data in the pediatric population are limited.