Adverse reactions : תופעות לוואי

4.8 Undesirable effects

Furosemide 10mg/ml Injection is generally well tolerated.

Metabolism and nutrition disorders: The most common side-effect is fluid and electrolyte imbalance including hyponatraemia, hypokalaemia, hypochloraemic alkalosis, hypotension and increased calcium excretion.

As with other diuretics, electrolytes and water balance may be disturbed as a result of diuresis after prolonged therapy. Furosemide leads to increased excretion of sodium and chloride and consequently water. In addition, excretion of other electrolytes (in particular potassium, calcium and magnesium) is increased. Symptomatic electrolyte disturbances and metabolic alkalosis may develop in the form of a gradually increasing electrolyte deficit or, e.g. where higher furosemide doses are administered to patients with normal renal function, acute severe electrolyte losses.
Warning signs of electrolyte disturbances include increased thirst, dry mouth, headache, hypotension, drowsiness, confusion, muscle cramps, tetany, muscle weakness, disorders of cardiac rhythm and gastrointestinal symptoms.

Increased calcium excretion in infants and new-borns has been associated with reports of decreased bone mineral content, rickets, fractures and renal calcification. Hypocalcaemic tetany has also been reported in hypoparathyroid patients. Nephrocalcinosis / Nephrolithiasis may develop in premature infants.

Pre-existing metabolic alkalosis (e.g. in decompensated cirrhosis of the liver) may be aggravated by furosemide treatment.

Thiamine deficiency with prolonged treatment, particularly in congestive heart failure and the elderly.

Furosemide may cause hyperuricaemia and precipitate attacks of gout in some patients.

Serum cholesterol and triglyceride levels may rise during furosemide treatment. During long term therapy they will usually return to normal within six months.

Nervous system disorders: Syncope, rarely, paraesthesiae may occur.

Ear and labyrinth disorders: tinnitus and deafness, although usually transitory, may occur in rare cases, (usually with large parenteral doses and rapid administration or in patients with hypoproteinaemia or renal impairment). Rarely deafness may be permanent, particularly if furosemide has been given to patients taking other ototoxic drugs.

Eye disorders: Blurred vision, yellow vision.

Vascular disorders: Furosemide may cause a reduction in blood pressure which, if pronounced, may cause signs and symptoms such as impairment of concentration and reactions, light- headedness, sensations of pressure in the head, headache, dizziness, drowsiness, weakness, disorders of vision, dry mouth, orthostatic hypotension. The diuretic action of furosemide may lead to or contribute to hypovolaemia and dehydration, especially in elderly patients. Severe fluid depletion may lead to haemoconcentration with a tendency for thromboses to develop.

Immune system disorders: Hypersensitivity reactions, that may include skin rashes, photosensitivity, vasculitis, fever, urticaria and interstitial nephritis occur rarely but when these occur treatment should be withdrawn. Severe anaphylaxis or anaphylactoid reactions (e.g with shock) may also occur rarely and necessitate immediate withdrawal of furosemide treatment.

Endocrine disorders: Glucose tolerance may decrease with furosemide. In patients with diabetes mellitus this may lead to a deterioration of metabolic control with hyperglycaemia and glycosuria; latent diabetes mellitus may also become manifest.

Gastrointestinal disorders: side-effects of a minor nature such as nausea, or gastric upset (vomiting and diarrhoea) may occur but are not usually severe enough to necessitate withdrawal or treatment. Pancreatitis is more common at high doses.

Blood and lymphatic system disorders: In rare cases, thrombocytopenia, leucopenia, agranulocytosis, eosinophilia, aplastic anaemia or haemolytic anaemia may develop. Bone marrow depression necessitates withdrawal of treatment.

Hepatobiliary disorders: In isolated cases, intrahepatic cholestasis, an increase in liver transaminases, or cholestatic jaundice has been reported. Hepatic encephalopathy in patients with hepatocellular insufficiency may occur.

Pregnancy, puerperium and perinatal conditions: If furosemide is administered to premature infants during the first weeks of life, it may increase the risk of persistence of patent ductus arteriosus.

Renal and urinary disorders: Increased production of urine may provoke or aggravate complaints in patients with an obstruction of urinary outflow. Thus, acute retention of urine with possible secondary complications may occur, for example, in patients with bladder-emptying disorders, prostatic hyperplasia or narrowing of the urethra. As with other diuretics, treatment with furosemide may lead to transitory increases in blood creatinine and urea levels.

Skin and subcutaneous tissue disorders: Skin and mucous membrane reactions may occasionally occur, e.g. itching, urticarial, other rashes or bullous lesions, erythema multiforme, bullous pemphigoid, Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, purpura, AGEP (acute generalized exanthematous pustulosis) and DRESS (Drug rash with eosinophilia and systemic symptoms).

General disorders and administration site conditions: malaise. Following intramuscular injection, local reactions such as pain may occur.


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 http://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectMedic@moh.gov.il