Lifezar Adverse Reactions

Losartan has been evaluated in clinical studies as follows: In a controlled clinical trials in >3,000 adult patients 18 years of age and older for essential hypertension.
In a controlled clinical trial in 177 hypertensive paediatric 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 a controlled clinical trial in >7,700 adult patients with chronic heart failure (see Pharmacology: Pharmacodynamics: ELITE I, ELITE II, and HEAAL study 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: RENAAL study under Actions).
In these clinical trials, the most common adverse reaction was dizziness.
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).
Hypertension: Nervous system disorders: Common: Dizziness.
Uncommon: Somnolence, headache, sleep disorders.
Ear and labyrinth disorders: Common: Vertigo.
Cardiac disorders: Uncommon: Palpitations, angina pectoris.
Vascular disorders: Uncommon: (Orthostatic) hypotension (including dose-related orthostatic effects)II.
Gastrointestinal disorders: Uncommon: Abdominal pain, obstipation.
Skin and subcutaneous disorders: Uncommon: Rash.
General disorders and administration site conditions: Uncommon: Asthenia, fatigue, oedema.
Investigations: Common: Hyperkalaemia.
Rare: Increased alanine aminotransferase (ALT)§.
Hypertensive patients with left ventricular hypertrophy: Nervous system disorders: Common: Dizziness.
Ear and labyrinth disorders: Common: Vertigo.
General disorders and administration site conditions: Common: Asthenia, fatigue.
Chronic heart failure: Blood and lymphatic system disorders: Common: Anaemia.
Nervous system disorders: Common: Dizziness.
Uncommon: Headache.
Rare: Paraesthesia.
Cardiac disorders: Rare: Syncope, atrial fibrillation, cerebrovascular accident.
Vascular disorders: Common: (Orthostatic) hypotension (including dose-related orthostatic effects)II.
Respiratory, thoracic and mediastinal disorders: Uncommon: Dyspnoea, cough.
Gastrointestinal disorders: Uncommon: Diarrhoea, nausea, vomiting.
Skin and subcutaneous tissue disorders: Uncommon: Urticaria, pruritus, rash.
Renal and urinary disorders: Common: Renal impairment, renal failure.
General disorders and administration site conditions: Uncommon: Asthenia, fatigue.
Investigations: Common: Increase in blood urea, serum creatinine and serum potassium.
Uncommon: Hyperkalaemia†.
Hypertension and type 2 diabetes with renal disease: Nervous system disorders: Common: Dizziness.
Vascular disorders: Common: (Orthostatic) hypotension (including dose-related orthostatic effects)II.
General disorders and administration site conditions: Common: Asthenia, fatigue.
Investigations: Common: Hypoglycaemia, hyperkalaemia‡.
Post-marketing experience: Blood and lymphatic system disorders: Not known: Anaemia, thrombocytopenia.
Immune system disorders: Rare: Hypersensitivity reactions, anaphylactic reactions, angioedema*, and vasculitis**.
Psychiatric disorders: Not known: Depression.
Nervous system disorders: Not known: Migraine, dysgeusia.
Ear and labyrinth disorders: Not known: Tinnitus.
Respiratory, thoracic and mediastinal disorders: Not known: Cough.
Gastrointestinal disorders: Not known: Diarrhoea.
Hepatobiliary disorders: Rare: Hepatitis.
Not known: Pancreatitis, liver function abnormalities.
Skin and subcutaneous tissue disorders: Not known: Urticaria, pruritus, rash, photosensitivity.
Musculoskeletal and connective tissue disorders: Not known: Myalgia, arthralgia, rhabdomyolysis.
Reproductive system and breast disorders: Not known: Erectile dysfunction/impotence.
General disorders and administration site conditions: Not known: Malaise.
Investigations: Not known: Hyponatraemia.
*Including swelling of the larynx, glottis, face, lips, pharynx, and/or tongue (causing airway obstruction); in some of these patients angiooedema had been reported in the past in connection with the administration of other medicines, including ACE inhibitors.
**Including Henoch-Schönlein purpura.
II 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 hyperkalaemia >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).
Paediatric population: The adverse reaction profile for paediatric patients appears to be similar to that seen in adult patients. Data in the paediatric population are limited.