|The frequencies are derived from literature data referring to studies where furosemide is used in a total of 1387 patients, at any dose and in any indication. When the frequency category for the same ADR was different, the highest frequency category was selected.The following CIOMS frequency rating is used, when applicable:Very common ≥10%; Common ≥1 and <10%; Uncommon ≥0.1 and <1%; Rare ≥0.01 and <0.1%; Very rare <0.01%, Unknown (cannot be estimated from available data).|
Metabolism and nutrition disordersVery Common: electrolyte disturbances (including symptomatic) dehydration and hypovolaemia, especially in elderly patients. Blood creatinine increased, blood triglyceride increased.Common :hyponatremia, hypochloremia, hypokalaemia, blood cholesterol increased. Blood uric acid increased and attacks of gout, urine volume increasedUncommon: glucose tolerance impaired.Not known :hypocalcemia, hypomagnesemia, blood urea increased , metabolic alkalosis, Pseudo-Bartter syndrome.
Vascular DisordersVery Common:Hypotension including orthostatic hypotension.Rare: vasculitis.Not known: thrombosis
Renal and urinary disordersCommon : urine volume increasedRare : tubulointerstitial nephritisNot known: -urine sodium increased, urine chloride increase, urine retention (in patients with a partial obstruction of urinary outflow, see section 4.4)-nephrocalcinosis/nephrolithiasis in premature infants (see section 4.4)-renal failure (see section 4.5)
Gastrointestinal disordersUncommon: nausea, Rare: vomiting, diarrhoea.Very Rare: pancreatitis acuteHepatobiliary disordersVery Rare: cholestasis, transaminases increased
Ear and labyrinth disordersUncommon: hearing disorders. Cases of deafness, sometimes irreversible have been reported after oral or IV administration of furosemide. Very Rare: tinnitus.
Skin and subcutaneous tissue disordersUncommon: pruritus, urticaria, rashes, dermatitis bullous, erythema multiforme, pemphigoid, dermatitis exfoliative, purpura, photosensitivity reactionNot known: Stevens-Johnson syndrome, toxic epidermal necrolysis, AGEP (acute generalized exanthematous pustulosis) and DRESS (Drug Rash with Eosinophilia and Systemic Symptoms).
Immune system disordersRare: severe anaphylactic or anaphylactoid reactions.Unknown: exacerbation or activation of systemic lupus erythematosus
Nervous system disordersRare: paraesthesiae.Common: hepatic encephalopathy in patients with hepatocellular insufficiency. (see section 4.3)
Blood and the lymphatic system disordersCommon: haemoconcentration.Uncommon: thrombocytopeniaRare: leucopoenia, eosinophiliaVery rare: agranulocytosis, aplastic anaemia, haemolytic anaemia.
Congenital and familiar/genetic disordersNot known: increased risk of persistence of patent ductus arteriosus when furosemide is administered to premature infants during the first weeks of life.
General disorders and administration site conditionsNot known: following intramuscular injection, local reactions such as pain.Rare: fever.
Reporting of suspected adverse reactionsReporting 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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: firstname.lastname@example.org.