Adverse reactions : תופעות לוואי

4.8   Undesirable effects

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 > 9,000 hypertensive patients 55 to 80 years of age with left ventricular hypertrophy (see LIFE Study, section 5.1)
•     In controlled clinical trials in > 7,700 adult patients with chronic heart failure (see ELITE I, ELITE II, and HEAAL study, section 5.1)
•     In a controlled clinical trial in > 1,500 type 2 diabetic patients 31 years of age and older with proteinuria (see RENAAL study, section 5.1).

In these clinical trials, the most common adverse event was dizziness.

The frequency of adverse reactions listed below 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).

Table 1. The frequency of adverse reactions identified from placebo-controlled clinical studies and post marketing experience

Adverse reaction            Frequency of adverse reaction by indication                     Other 
Hypertension    Hypertensive       Chronic      Hypertension        Post-marketing patients with       Heart        and type 2           experience left-         Failure      diabetes with ventricular                    renal disease hypertrophy

Blood and lymphatic system disorders anaemia                                               common                         frequency not known thrombocytopenia                                                                     frequency not known 
Immune system disorders hypersensitivity reactions,
anaphylactic reactions,                                                                                  Rare angiooedema,
and vasculitis

Psychiatric disorders depression                                                                           frequency not known 
Nervous system disorders dizziness            common            common         common         common somnolence          uncommon headache            uncommon                        uncommon sleep disorders     uncommon paraesthesia                                             rare

Adverse reaction             Frequency of adverse reaction by indication                Other 
Hypertension   Hypertensive     Chronic     Hypertension      Post-marketing patients with     Heart       and type 2         experience left-       Failure     diabetes with ventricular                 renal disease hypertrophy
 migraine                                                                          frequency not known dysgeusia                                                                         frequency not known 
Ear and labyrinth disorders vertigo               common           common tinnitus                                                                          frequency not known 
Cardiac disorders palpitations           uncommon angina pectoris        uncommon syncope                                                  rare atrial fibrillation                                      rare cerebrovascular rare accident

Vascular disorders
(orthostatic) hypotension
(including dose-    uncommon                          common         common related orthostatic effects)║

Respiratory, thoracic and mediastinal disorders dyspnoea                                             uncommon cough                                                uncommon                     frequency not known 
Gastrointestinal disorders abdominal pain       uncommon obstipation          uncommon diarrhoea                                            uncommon                     frequency not known nausea                                               uncommon vomiting                                             uncommon

Hepatobiliary disorders pancreatitis                                                                      frequency not known hepatitis                                                                                 Rare liver function frequency not known abnormalities

Skin and subcutaneous tissue disorders urticaria                                            uncommon                     frequency not known pruritus                                             uncommon                     frequency not known rash               uncommon                          uncommon                     frequency not known photosensitivity                                                                  frequency not known 
Musculoskeletal and connective tissue disorders myalgia                                                                           frequency not known arthralgia                                                                        frequency not known rhabdomyolysis                                                                    frequency not known 
Renal and urinary disorders renal impairment                                      common renal failure                                         common
Adverse reaction                 Frequency of adverse reaction by indication                                   Other 
Hypertension        Hypertensive          Chronic        Hypertension             Post-marketing patients with          Heart          and type 2                experience left-            Failure        diabetes with ventricular                         renal disease hypertrophy


Reproductive system and breast disorders erectile dysfunction /                                                                                         frequency not known impotence

General disorders and administration site conditions asthenia            uncommon         common         uncommon                        common fatigue             uncommon         common         uncommon                        common oedema              uncommon malaise                                                                                               frequency not known 
Investigations hyperkalaemia              common                              uncommon†           common‡ increased alanine aminotransferase             rare
(ALT) § increase in blood urea, serum common creatinine, and serum potassium hyponatraemia                                                                                         frequency not known hypoglycaemia                                                                       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 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 section 4.4).

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form (https://sideeffects.health.gov.il).