Lostad T50 Adverse Reactions

In clinical trials, the most common adverse event 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).
The following adverse reactions are listed based on indication: 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) (Especially in patients with intravascular depletion, e.g. patients with severe heart failure or under treatment with high dose diuretics).
Gastrointestinal disorders: Uncommon: Abdominal pain, obstipation.
Skin and subcutaneous tissue disorders: Uncommon: Rash.
General disorders and administration site conditions: Uncommon: Asthenia, fatigue, oedema.
Investigations: Common: Hyperkalaemia.
Rare: Increased alanine aminotransferase (ALT) (Usually resolved upon discontinuation).
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) (Especially in patients with intravascular depletion, e.g. patients with severe heart failure or under treatment with high dose diuretics).
Respiratory, thoracic and mediastinal disorders: Uncommon: Dyspnea, 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 (Common in patients who received 150 mg losartan instead of 50 mg).
Hypertension and type 2 diabetes with renal disease: Nervous system disorders: Common: Dizziness.
Vascular disorders: Common: (Orthostatic) hypotension (including dose-related orthostatic effects) (Especially in patients with intravascular depletion, e.g. patients with severe heart failure or under treatment with high dose diuretics).
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, angiooedema (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), and vasculitis (Including Henoch-Schönlein purpura).
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.
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.
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.