Adverse reactions : תופעות לוואי

4.8. Undesirable effects
Here below are the possible side effects of furosemide. The frequency of side effects is reported a ordi g to hat follo s: Ver o        o : ≥ / ; Co       o :≥ /     to < / ; U o        o :≥ / , to < /   ; Rare: ≥ / ,      to < / ,    ; Ver rare: < / ,     ; U known (frequency cannot be estimated from the available data).

System/Organ Classification      Frequency                        Side effects Cardiac disorders                uncommon                         Cardiac arrhythmias Blood and lymphatic system       common                           Haemoconcentration disorders                        uncommon                         Thrombocytopenia rare                             Leukopenia, eosinophilia very rare                        Aplastic anemia, agranulocytosis,
haemolytic anaemia
Nervous system disorders      common              Hepatic encephalopathy in patients with hepatocellular insufficiency uncommon            Drowsiness, headache, dizziness,
confusion rare                Paraesthesia unknown             Dizziness, fainting and loss of consciousness (due to symptomatic hypotension)
Eye disorders                 uncommon            Visual disorders
Ear and labyrinth disorders   uncommon            Usually transient hearing disorders, especially in patients with renal failure,
hypoproteinemia (e.g. in the nephrotic syndrome) and / or in the event of too rapid intravenous administration. Deafness
(sometimes irreversible) very rare           Tinnitus
Gastrointestinal disorders    uncommon            Dry mouth, nausea, intestinal motility disorders uncommon            Vomiting, diarrhoea very rare           Acute pancreatitis
Renal and urinary disorders   common              Polyuria rare                Interstitial nephritis unknown             Increased sodium in the urine,
increased chlorine in the urine,
urinary retention (in patients with prostatic hypertrophy, urethral stricture or difficulty in emptying the bladder), nephrocalcinosis / nephrolithiasis (in preterm infants treated with furosemide); kidney failure
Skin and subcutaneous         rare or very rare   Urticaria, pruritus, purpura, tissue disorders                                  bullous dermatitis, erythema multiforme, pemphigoid,
exfoliative dermatitis,
photosensitivity reactions unknown             Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis (AGEP), drug rash with eosinophilia and systemic symptoms (DRESS syndrome)
Metabolism and nutrition      very common         Electrolyte disorders (including disorders                                         symptomatic ones); dehydration and hypovolemia, especially in elderly patients, increased creatinine and triglycerides in the blood common              Hyponatremia, hypochloraemia,
hypokalemia, increased cholesterol, hyperuricaemia and gout
uncommon                        Impaired glucose tolerance.
Clinical manifestations of latent diabetes mellitus unknown                         Hypocalcaemia,
hypomagnesaemia, metabolic alkalosis, increased urea. Pseudo-
Bartter syndrome in the context of abuse and / or a long-term use of furosemide
Vascular disorders               very common (for i.v.           Reduction in blood pressure, infusion)                       including orthostatic hypotension rare                            Vasculitis unknown                         Hypovolaemia, thrombosis
Musculoskeletal and              uncommon                        Muscle cramps, tetany, connective tissue disorders                                      myasthenia 
General disorders and            uncommon                        Fatigue administration site              rare                            Fever conditions                       unknown                         Local reactions Hepato-biliary disorders         very rare                       Intrahepatic cholestasis, increased liver transaminase
Congenital, familial and         unknown                         Increased risk of persistence of genetic diseases                                                 patent ductus arteriosus when furosemide is administered to premature infants during the first weeks of life
Immune system disorders          rare                            Severe anaphylactic or anaphylactoid reactions (e.g. with shock)

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 a d e ailed to the Registratio Holder’s Patie t Safety Unit at: drugsafety@neopharmgroup.com