Bumetanide
Burinex · ATC code C03CA02
Also known as: Bumetanid
- Key facts
- Active substance
- Bumetanide
- Drug class
- Sulfonamide drug
- ATC code
- C03CA02
- Authorisation
- authorised nationally; no central EU authorisation
- Information as of
- 2026-10-29
Boxed warning
Bumetanide is a potent diuretic which, if given in excessive amounts, can lead to a profound diuresis with water and electrolyte depletion. Therefore, careful medical supervision is required, and dose and dosage schedule have to be adjusted to the individual patient's needs ( see DOSAGE AND ADMINISTRATION ).
Key facts
Bumetanide is a potent loop diuretic. Per the US prescribing information, it is used to treat edema associated with congestive heart failure and hepatic and renal disease, including the nephrotic syndrome.
What it is used for
- Edema associated with congestive heart failure
- Edema associated with hepatic and renal disease, including the nephrotic syndrome
- If gastrointestinal absorption is impaired or oral use is not practical: intramuscular or intravenous route
Dosing
- Individualize dosage with careful monitoring of response
- Oral: usual total daily dose 0.5 mg to 2 mg, in most patients as a single dose
- If response is inadequate, a second or third dose may be given at 4- to 5-hour intervals up to a maximum of 10 mg daily
- For continued control of edema an intermittent schedule is recommended: alternate days, or 3 to 4 days with rest periods of 1 to 2 days
- Hepatic failure: keep the dosage to a minimum
- Switch from parenteral to oral treatment as soon as possible
Contraindications
- Anuria
- Hepatic coma or severe electrolyte depletion until the condition is corrected
- Hypersensitivity to bumetanide
- A marked rise in blood urea nitrogen or creatinine, or oliguria, in progressive renal disease is an indication to stop treatment
Important warnings
- Boxed warning: excessive amounts can cause profound diuresis with water and electrolyte depletion; careful medical supervision and individualized dosing are required
- Volume depletion, dehydration and circulatory collapse with possible vascular thrombosis and embolism, particularly in elderly patients
- Hypokalemia, particularly with digitalis therapy, hepatic cirrhosis with ascites or a history of ventricular arrhythmias
- Hepatic cirrhosis with ascites: sudden electrolyte shifts may precipitate hepatic encephalopathy and coma; best started in hospital
- Ototoxicity is possible, especially with high, frequently repeated intravenous doses and impaired renal function
Side effects
- Most frequent: muscle cramps (1.1%), dizziness (1.1%), hypotension (0.8%), headache (0.6%), nausea (0.6%), encephalopathy in pre-existing liver disease (0.6%)
- Less frequent: impaired hearing (0.5%), pruritus, ECG changes, weakness, hives, abdominal, arthritic and musculoskeletal pain, rash, vomiting
- Serious skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported
Interactions
- Aminoglycosides: avoid parenteral combination, especially with impaired renal function, except in life-threatening conditions
- Nephrotoxic drugs: avoid simultaneous administration
- Lithium: generally do not combine; high risk of lithium toxicity
- Probenecid and indomethacin: blunt the effect; concurrent use not recommended
- Antihypertensives: effect may be potentiated, possibly requiring dose reduction
Pregnancy and breastfeeding
- No adequate studies in pregnant women; use only if the potential benefit justifies the potential risk to the fetus
Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
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For patients
Patient information (US)
This product has no separate US patient information.
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
Austria
- BurinexKaro Pharma Ab · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29
USA
- BumexValidus Pharmaceuticals LLC · 1 register entry
- EnbumystCorstasis USA LLC · 1 register entry
Source: U.S. FDA – Drug labels (openFDA/DailyMed), as of 2026-10-29
Brand names in 11 more European countries
- Belgium
- Burinex
- Denmark
- Burinex
- France
- Burinex
- Greece
- Burinex
- Ireland
- Burinex
- Luxembourg
- Burinex
- Malta
- Burinex
- Netherlands
- Bumetanide Cf, Bumetanide Sandoz, Bumetanide Unichem, Burinex
- Norway
- Burinex
- Spain
- Fordiuran
- Sweden
- Burinex
EMA – Article 57 product data (EU/EEA), 2026-10-29
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
Other substances in the same group
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Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- U.S. Food and Drug Administration. Bumetanide (Sun Pharmaceutical Industries, Inc.) – Prescribing Information, 2026-03-23. DailyMed (NLM), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=5c753aae-77b7-4add-8453-385a8f62d7db
- EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- U.S. FDA – Drug labels (openFDA/DailyMed), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/
- Wikidata (CC0): ATC C03CA.
Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error
Source: U.S. Food and Drug Administration (FDA), prescribing information, via DailyMed (NLM); public domain. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.