Furosemide Kabi

Furosemide Kabi Adverse Reactions



Fresenius Kabi


The Glory Medicina
Full Prescribing Info
Adverse Reactions
The evaluation of adverse reactions is based on the following definition of frequency: 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).
As with other diuretics, certain undesirable effects may occur, such as: Investigations: Rare: serum cholesterol and triglyceride levels may rise during furosemide treatment.
Cardiac disorders: In particular, at the initial state of treatment and in elderly, a very intense diuresis may cause a reduction in blood pressure which, if pronounced may cause signs and symptoms such as orthostatic hypotension, acute hypotension, sensations of pressure in the head, dizziness, circulatory collapse, thrombophlebitis or sudden death (with i. m. or i. v. administration).
Blood and lymphatic system disorders: Uncommon: thrombocytopenia; thrombocytopenia may become manifest, especially with an increase of haemorrhage tendency.
Rare: eosinophilia, leukopenia, bone marrow depression; occurrence of this symptom necessitates withdrawal of treatment.
Very rare: haemolytic anaemia, aplastic anaemia, agranulocytosis.
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.
Nervous system disorders: Rare: paraesthesia, vertigo, dizziness, sleepiness, confusion, sensations of pressure in the head.
Not known: Dizziness, fainting and loss of consciousness (caused by symptomatic hypotension).
Eye disorders: Rare: blurred vision; disturbances of vision with hypovolaemia symptoms, which in severe cases may lead to dehydration.
Ear and labyrinth disorders: Uncommon: deafness (sometimes irreversible).
Rare: Dysacusis and/or syrigmus (tinnitus aurium) due to furosemide are rare and usually transitory; incidence is higher in rapid intravenous administration, particularly in patients with renal failure or hypoproteinaemia (e.g. in nephrotic syndrome). Tinnitus may occur (transitory).
Gastrointestinal disorders: Rare: nausea, vomiting and diarrhoea, anorexia, gastric distress, constipation, dry mouth.
Very rare: acute pancreatitis.
Renal and urinary disorders: Diuretics may exacerbate or reveal acute retention of urine symptoms (bladder-emptying disorders, prostatic hyperplasia or narrowing of the urethra), vasculitis, glycosuria, transitorily increase of blood creatinine and urea levels.
Rare: interstitial nephritis.
Skin and subcutaneous tissue disorders: Uncommon: pruritus, dermal and mucosal reactions (e.g. bullous exanthema, rash, urticaria, purpura, erythema multiforme, exfoliative dermatitis, photosensitivity).
Rare: vasculitis, lupus erythematosus exacerbation or activation.
Not known: acute generalised exanthematous pustulosis (AGEP).
Musculoskeletal and connective tissue disorders: Rare: leg muscle cramps, asthenias. Furosemide may decrease calcium serum levels (in very rare cases, tetany has been observed) and chronic arthritis.
Endocrine disorders: Glucose tolerance may decrease with furosemide. In patients with diabetes mellitus this may lead to a deterioration of metabolic control; latent diabetes mellitus may become manifest.
Metabolism and nutrition disorders: Electrolyte and water balance may be disturbed (hypokalaemia, hyponatraemia and metabolic alkalosis), especially after prolonged therapy or when high doses are administered. Regular monitoring of serum electrolytes (especially potassium, sodium and calcium) is therefore indicated. Potassium depletion may occur, especially due to poor potassium diet. Particularly when the supply of potassium is concomitantly reduced and/or extrarenal potassium losses are increased (e.g. in vomiting or chronic diarrhoea) hypokalaemia may occur as a result of increased renal potassium losses. This is manifested as neuromuscular (myasthenia, paraesthesia, pareses), intestinal (vomiting, constipation, meteorism), renal (polyuria, polydipsia) and cardiac (impaired paced setting and conduction disorders) symptoms. Severe potassium losses may lead to paralytic ileus or disturbed consciousness, with coma in extreme cases. Furthermore, underlying disorders (e.g. cirrhotic disease or heart failure), concomitant medication (see Interactions) and nutrition may cause predisposition to potassium deficiency. In such cases, adequate monitoring is necessary as well as therapy substitution.
As a result of increased renal sodium losses, hyponatraemia with corresponding symptoms may occur, particularly if the supply of sodium chloride is restricted. Commonly observed symptoms of sodium deficiency are apathy, systremma, inappetence, asthenia, somnolence, vomiting and confusion.
Increased renal calcium losses can lead to hypocalcaemia, which may induce tetany in rare cases.
In patients with increased renal magnesium losses, tetany or cardiac arrhythmias were observed in rare cases as a consequence of hypomagnesaemia.
Certain patients may present increased uric acid levels and gout attacks may occur.
Metabolic alkalosis may develop, or a pre-existing metabolic alkalosis (for e.g. decompensated hepatic cirrhosis) may become more severe with furosemide.
General disorders and administration site conditions: Rare: febrile conditions; following i. m. injection local reactions such as pain may appear.
Pregnancy, puerperium and perinatal conditions: Premature infants treated with furosemide may develop nephrolithiasis and/or nephrocalcinosis, due to calcium deposit in renal tissue.
In premature infants with respiratory distress syndrome, diuretic treatment in the first weeks of life with furosemide can increase the risk of persistent ductus arteriosus Botalli.
Immune system disorders: Rare: severe anaphylactic and anaphylactoid reactions such as anaphylactic shock (for treatment see Overdosage).
Hepatobiliary disorders: Intrahepatic cholestasis, cholestatic jaundice, hepatic ischaemia, increase in hepatic transaminases.
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. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.
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