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 a controlled clinical trial 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- patients with       Heart       and type 2   marketing left-         Failure     diabetes with experience ventricular                   renal disease hypertrophy
Blood and lymphatic system disorders anaemia                                                                           frequency common not known frequency thrombocytopenia not known
Immune system disorders hypersensitivity reactions,
anaphylactic reactions,                                                                            rare angioedema1,
and vasculitis2


Psychiatric disorders frequency depression not known
Nervous system disorders dizziness               common         common         common         common somnolence              uncommon headache                uncommon                    uncommon sleep disorders         uncommon paraesthesia                                            rare frequency migraine not known frequency dysgeusia not known
Ear and labyrinth disorder vertigo                 common         common frequency tinnitus not known
Cardiac disorders palpitations            uncommon angina pectoris         uncommon syncope                                                 rare atrial fibrillation                                     rare
Adverse reaction             Frequency of adverse reaction by indication          Other Hypertension Hypertensive       Chronic     Hypertension    Post- patients with       Heart       and type 2   marketing left-         Failure     diabetes with experience ventricular                   renal disease hypertrophy cerebrovascular rare accident
Vascular disorders
(orthostatic) hypotension
(including dose-       uncommon                       common         common related orthostatic effects) 3
Respiratory, thoracic and mediastinal disorders dyspnoea                                            uncommon frequency cough                                               uncommon not known
Gastrointestinal disorders abdominal pain         uncommon obstipation            uncommon frequency diarrhoea                                           uncommon not known nausea                                              uncommon vomiting                                            uncommon
Hepatobiliary disorders frequency pancreatitis not known hepatitis                                                                          rare liver function                                                                  frequency abnormalities                                                                   not known Skin and subcutaneous disorders frequency urticaria                                           uncommon not known frequency pruritus                                            uncommon not known frequency rash                   uncommon                     uncommon not known frequency photosensitivity not known
Musculoskeletal and connective tissue disorders frequency myalgia not known frequency arthralgia not known
Adverse reaction              Frequency of adverse reaction by indication                    Other Hypertension Hypertensive            Chronic       Hypertension    Post- patients with            Heart         and type 2   marketing left-              Failure       diabetes with experience ventricular                          renal disease hypertrophy frequency rhabdomyolysis not known
Renal and urinary disorders

 renal impairment                                           common renal failure                                              common
Reproductive system and breast disorders erectile frequency dysfunction / not known impotence
General disorders and administration site conditions asthenia                uncommon          common          uncommon          common fatigue                 uncommon          common          uncommon          common oedema                  uncommon frequency malaise not known
Investigations hyperkalaemia common                          uncommon4          common5
 increased alanine aminotransferase           rare
(ALT) 6 increase in blood urea, serum common creatinine, and serum potassium hyponatraemia                                                                              frequency not known hypoglycaemia                                                                 common 1
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
2
Including Henoch-Schönlein purpura
3
Especially in patients with intravascular depletion, e.g. patients with severe heart failure or under treatment with high dose diuretics
4
Common in patients who received 150 mg losartan instead of 50 mg
5
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
6
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