Mediclarum
Medicine guide

Bumetanide

2 mg · Tablet

  • Prescription only
  • Loop Diuretic
Active substance
Bumetanide
Made by
Sandoz Inc

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2023-06-30

What it is

Loop Diuretic

Used for
  • Bumetanide tablets, USP are indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome.
The label’s usual adult dose

Oral Administration The usual total daily dosage of bumetanide tablets is 0.5 mg to 2 mg and in most patients is given as a single dose.

If the diuretic response to an initial dose of bumetanide tablets is not adequate, in view of its rapid onset and short duration of action, a second or third dose may be given at 4- to 5- hour intervals up to a maximum daily dose of 10 mg.

Full directions ↓
Serious warning

Bumetanide is a potent diuretic which, if given in excessive amounts, can lead to a profound diuresis with water and electrolyte depletion.

All warnings ↓
Good to know
  • Prescription only
  • FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
92other products contain Bumetanide — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

  • Bumetanide tablets, USP are indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome.
  • Almost equal diuretic response occurs after oral and parenteral administration of bumetanide.
  • Therefore, if impaired gastrointestinal absorption is suspected or oral administration is not practical, bumetanide should be given by the intramuscular or intravenous route.
  • Successful treatment with bumetanide tablets, USP following instances of allergic reactions to furosemide suggests a lack of cross-sensitivity.

From the official label · 2023-06-30 · DailyMed

How it works

From this product’s own US prescribing label.

Bumetanide is a loop diuretic with a rapid onset and short duration of action.

Pharmacological and clinical studies have shown that 1 mg bumetanide has a diuretic potency equivalent to approximately 40 mg furosemide.

Peak level after15–30 min
How it leaves the body

Oral administration of carbon-14 labeled bumetanide to human volunteers revealed that 81% of the administered radioactivity was excreted in the urine, 45% of it as unchanged drug.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2023-06-30

Serious warning

The strongest warning the FDA requires. It is printed in a box at the top of the label.

  • 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 ) .

Quoted from the official label, section “Boxed Warning”.

Do not take it if

  • Bumetanide is contraindicated in anuria.
  • Although bumetanide can be used to induce diuresis in renal insufficiency, any marked increase in blood urea nitrogen or creatinine, or the development of oliguria during therapy of patients with progressive renal disease, is an indication for discontinuation of treatment with bumetanide.
  • Bumetanide is also contraindicated in patients in hepatic coma or in states of severe electrolyte depletion until the condition is improved or corrected.
  • Bumetanide is contraindicated in patients hypersensitive to this drug.

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

  • Individualize dosage with careful monitoring of patient response.
  • Oral Administration The usual total daily dosage of bumetanide tablets is 0.5 mg to 2 mg and in most patients is given as a single dose.
  • If the diuretic response to an initial dose of bumetanide tablets is not adequate, in view of its rapid onset and short duration of action, a second or third dose may be given at 4- to 5- hour intervals up to a maximum daily dose of 10 mg.
  • An intermittent dose schedule, whereby bumetanide tablets are given on alternate days or for 3 to 4 days with rest periods of 1 to 2 days in between, is recommended as the safest and most effective method for the continued control of edema.
  • In patients with hepatic failure, keep the dosage to a minimum.
  • Because cross-sensitivity with furosemide has rarely been observed, bumetanide can be substituted at approximately a 1:40 ratio of bumetanide in proportion to furosemide in patients allergic to furosemide.
  • Parenteral Administration Bumetanide injection may be administered parenterally (intravenously and intramuscularly) to patients in whom gastrointestinal absorption may be impaired or in whom oral administration is not practical.
  • Terminate parenteral treatment and institute oral treatment as soon as possible.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

  • Volume and Electrolyte Depletion The dose of bumetanide should be adjusted to the patient’s need.
  • Excessive doses or too frequent administration can lead to profound water loss, electrolyte depletion, dehydration, reduction in blood volume and circulatory collapse with the possibility of vascular thrombosis and embolism, particularly in elderly patients.
  • Hypokalemia Hypokalemia can occur as a consequence of bumetanide administration.
  • Prevention of hypokalemia requires particular attention in the following conditions:
  • patients receiving digitalis and diuretics for congestive heart failure, hepatic cirrhosis and ascites, states of aldosterone excess with normal renal function, potassium-losing nephropathy, certain diarrheal states, or other states where hypokalemia is thought to represent particular added risks to the patient, i.e., history of ventricular arrhythmias.
  • In patients with hepatic cirrhosis and ascites, sudden alterations of electrolyte balance may precipitate hepatic encephalopathy and coma.
  • Treatment in such patients is best initiated in the hospital with small doses and careful monitoring of the patient’s clinical status and electrolyte balance.
  • Supplemental potassium and/or spironolactone may prevent hypokalemia and metabolic alkalosis in these patients.
  • Ototoxicity In cats, dogs and guinea pigs, bumetanide has been shown to produce ototoxicity.
  • In these test animals bumetanide was 5 to 6 times more potent than furosemide and, since the diuretic potency of bumetanide is about 40 to 60 times furosemide, it is anticipated that blood levels necessary to produce ototoxicity will rarely be achieved.
  • The potential exists, however, and must be considered a risk of intravenous therapy, especially at high doses, repeated frequently in the face of renal excretory function impairment.
  • Potentiation of aminoglycoside ototoxicity has not been tested for bumetanide.
  • Like other members of this class of diuretics, bumetanide probably shares this risk.
  • Allergy to Sulfonamides Patients allergic to sulfonamides may show hypersensitivity to bumetanide.
  • Thrombocytopenia Since there have been rare spontaneous reports of thrombocytopenia from postmarketing experience, patients should be observed regularly for possible occurrence of thrombocytopenia.
  • General Serum potassium should be measured periodically and potassium supplements or potassium sparing diuretics added if necessary.
  • Periodic determinations of other electrolytes are advised in patients treated with high doses or for prolonged periods, particularly in those on low-salt diets.
  • Hyperuricemia may occur; it has been asymptomatic in cases reported to date.
  • Reversible elevations of the BUN and creatinine may also occur, especially in association with dehydration and particularly in patients with renal insufficiency.
  • Bumetanide may increase urinary calcium excretion with resultant hypocalcemia.
  • Diuretics have been shown to increase the urinary excretion of magnesium; this may result in hypomagnesemia.
  • Laboratory Tests Studies in normal subjects receiving bumetanide revealed no adverse effects on glucose tolerance, plasma insulin, glucagon and growth hormone levels, but the possibility of an effect on glucose metabolism exists.
  • Periodic determinations of blood sugar should be done, particularly in patients with diabetes or suspected latent diabetes.
  • Patients under treatment should be observed regularly for possible occurrence of blood dyscrasias, liver damage or idiosyncratic reactions, which have been reported occasionally in foreign marketing experience.
  • The relationship of these occurrences to bumetanide use is not certain.
  • Drug Interactions Drugs with Ototoxic Potential (see WARNINGS) Especially in the presence of impaired renal function, the use of parenterally administered bumetanide in patients to whom aminoglycoside antibiotics are also being given should be avoided, except in life-threatening conditions.
  • Drugs with Nephrotoxic Potential There has been no experience with the concurrent use of bumetanide with drugs known to have a nephrotoxic potential.
  • Therefore, the simultaneous administration of these drugs should be avoided.
  • Lithium Lithium should generally not be given with diuretics (such as bumetanide) because they reduce its renal clearance and add a high risk of lithium toxicity.
  • Probenecid Pretreatment with probenecid reduces both the natriuresis and hyperreninemia produced by bumetanide.
  • This antagonistic effect of probenecid on bumetanide natriuresis is not due to a direct action on sodium excretion but is probably secondary to its inhibitory effect on renal tubular secretion of bumetanide.
  • Thus, probenecid should not be administered concurrently with bumetanide.
  • Indomethacin Indomethacin blunts the increases in urine volume and sodium excretion seen during bumetanide treatment and inhibits the bumetanide-induced increase in plasma renin activity.
  • Concurrent therapy with bumetanide is thus not recommended.
  • Antihypertensives Bumetanide may potentiate the effect of various antihypertensive drugs, necessitating a reduction in the dosage of these drugs.
  • Digoxin Interaction studies in humans have shown no effect on digoxin blood levels.
  • Anticoagulants Interaction studies in humans have shown bumetanide to have no effect on warfarin metabolism or on plasma prothrombin activity.
  • Carcinogenesis, Mutagenesis and Impairment of Fertility Bumetanide was devoid of mutagenic activity in various strains of Salmonella typhimurium when tested in the presence or absence of an in vitro metabolic activation system.
  • An 18-month study showed an increase in mammary adenomas of questionable significance in female rats receiving oral doses of 60 mg/kg/day (2000 times a 2-mg human dose).
  • A repeat study at the same doses failed to duplicate this finding.
  • Reproduction studies were performed to evaluate general reproductive performance and fertility in rats at oral dose levels of 10, 30, 60 or 100 mg/kg/day.
  • The pregnancy rate was slightly decreased in the treated animals; however, the differences were small and not statistically significant.
  • Pregnancy Teratogenic Effects Bumetanide is neither teratogenic nor embryocidal in mice when given in doses up to 3400 times the maximum human therapeutic dose.
  • Nursing Mothers It is not known whether this drug is excreted in human milk.
  • Pediatric Use Safety and effectiveness in pediatric patients below the age of 18 have not been established.
  • Geriatric Use Clinical studies of bumetanide did not include sufficient numbers of subjects aged 65 and over to determine whether they responded differently from younger subjects.
  • General Serum potassium should be measured periodically and potassium supplements or potassium sparing diuretics added if necessary.
  • Periodic determinations of other electrolytes are advised in patients treated with high doses or for prolonged periods, particularly in those on low-salt diets.
  • Hyperuricemia may occur; it has been asymptomatic in cases reported to date.
  • Reversible elevations of the BUN and creatinine may also occur, especially in association with dehydration and particularly in patients with renal insufficiency.
  • Bumetanide may increase urinary calcium excretion with resultant hypocalcemia.
  • Diuretics have been shown to increase the urinary excretion of magnesium; this may result in hypomagnesemia.

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

  • Teratogenic Effects Bumetanide is neither teratogenic nor embryocidal in mice when given in doses up to 3400 times the maximum human therapeutic dose.
  • Bumetanide has been shown to be nonteratogenic, but it has a slight embryocidal effect in rats when given in doses of 3400 times the maximum human therapeutic dose and in rabbits at doses of 3.4 times the maximum human therapeutic dose.
  • In one study, moderate growth retardation and increased incidence of delayed ossification of sternebrae were observed in rats at oral doses of 100 mg/kg/day, 3400 times the maximum human therapeutic dose.
  • These effects were associated with maternal weight reductions noted during dosing.
  • No such adverse effects were observed at 30 mg/kg/day (1000 times the maximum human therapeutic dose).
  • No fetotoxicity was observed at 1000 to 2000 times the human therapeutic dose.
  • In rabbits, a dose-related decrease in litter size and an increase in resorption rate were noted at oral doses of 0.1 mg/kg/day and 0.3 mg/kg/day (3.4 and 10 times the maximum human therapeutic dose).
  • A slightly increased incidence of delayed ossification of sternebrae occurred at 0.3 mg/kg/day; however, no such adverse effects were observed at the dose of 0.03 mg/kg/day.
  • The sensitivity of the rabbit to bumetanide parallels the marked pharmacologic and toxicologic effects of the drug in this species.
  • Bumetanide was not teratogenic in the hamster at an oral dose of 0.5 mg/kg/day (17 times the maximum human therapeutic dose).
  • Bumetanide was not teratogenic when given intravenously to mice and rats at doses up to 140 times the maximum human therapeutic dose.
  • There are no adequate and well-controlled studies in pregnant women.
  • A small investigational experience in the United States and marketing experience in other countries to date have not indicated any evidence of adverse effects on the fetus, but these data do not rule out the possibility of harmful effects.
  • Bumetanide should be given to a pregnant woman only if the potential benefit justifies the potential risk to the fetus.
  • It is not known whether this drug is excreted in human milk. As a general rule, nursing should not be undertaken while the patient is on bumetanide since it may be excreted in human milk.

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Misuse and dependence

  • Overdosage can lead to acute profound water loss, volume and electrolyte depletion, dehydration, reduction of blood volume and circulatory collapse with a possibility of vascular thrombosis and embolism.
  • Electrolyte depletion may be manifested by weakness, dizziness, mental confusion, anorexia, lethargy, vomiting and cramps.
  • Treatment consists of replacement of fluid and electrolyte losses by careful monitoring of the urine and electrolyte output and serum electrolyte levels.

Quoted from the official label, section “Drug Abuse and Dependence”.

Use in children

  • Safety and effectiveness in pediatric patients below the age of 18 have not been established.
  • In vitro studies using pooled sera from critically ill neonates have shown bumetanide to be a potent displacer of bilirubin (see CLINICAL PHARMACOLOGY:
  • Pediatric Pharmacology ) .
  • The administration of bumetanide could present a particular concern if given to critically ill or jaundiced neonates at risk for kernicterus.

Quoted from the official label, section “Pediatric Use”.

Use in older people

  • Clinical studies of bumetanide did not include sufficient numbers of subjects aged 65 and over to determine whether they responded differently from younger subjects.
  • Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
  • In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.
  • This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function.
  • Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Quoted from the official label, section “Geriatric Use”.

Side effects

  • The most frequent clinical adverse reactions considered probably or possibly related to bumetanide are muscle cramps (seen in 1.1% of treated patients), dizziness (1.1%), hypotension (0.8%), headache (0.6%), nausea (0.6%) and encephalopathy (in patients with pre-existing liver disease) (0.6%).
  • One or more of these adverse reactions have been reported in approximately 4.1% of patients treated with bumetanide.
  • Serious skin reactions (i.e., Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported in association with bumetanide use.
  • Less frequent clinical adverse reactions to bumetanide are impaired hearing (0.5%), pruritus (0.4%), electrocardiogram changes (0.4%), weakness (0.2%), hives (0.2%), abdominal pain (0.2%), arthritic pain (0.2%), musculoskeletal pain (0.2%), rash (0.2%) and vomiting (0.2%).
  • One or more of these adverse reactions have been reported in approximately 2.9% of patients treated with bumetanide.
  • Other clinical adverse reactions, which have each occurred in approximately 0.1% of patients, are vertigo, chest pain, ear discomfort, fatigue, dehydration, sweating, hyperventilation, dry mouth, upset stomach, renal failure, asterixis, itching, nipple tenderness, diarrhea, premature ejaculation and difficulty maintaining an erection.
  • Laboratory abnormalities reported have included hyperuricemia (in 18.4% of patients tested), hypochloremia (14.9%), hypokalemia (14.7%), azotemia (10.6%), hyponatremia (9.2%), increased serum creatinine (7.4%), hyperglycemia (6.6%), and variations in phosphorus (4.5%), CO content (4.3%), bicarbonate (3.1%) and calcium (2.4%).
  • Although manifestations of the pharmacologic action of bumetanide, these conditions may become more pronounced by intensive therapy.
  • Also reported have been thrombocytopenia (0.2%) and deviations in hemoglobin (0.8%), prothrombin time (0.8%), hematocrit (0.6%), WBC (0.3%) and differential counts (0.1%).
  • There have been rare spontaneous reports of thrombocytopenia from postmarketing experience.
  • Diuresis induced by bumetanide may also rarely be accompanied by changes in LDH (1.0%), total serum bilirubin (0.8%), serum proteins (0.7%), SGOT (0.6%), SGPT (0.5%), alkaline phosphatase (0.4%), cholesterol (0.4%) and creatinine clearance (0.3%).
  • Increases in urinary glucose (0.7%) and urinary protein (0.3%) have also been seen.
  • To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Quoted from the official label, section “Adverse Reactions”.

What it looks like and how it is packed

  • Bumetanide Tablets, USP, for oral administration, are available as 0.5 mg Green, round, biconvex, bisected and debossed “E” above and “128” below the bisect on one side and plain on the reverse side and supplied as:
  • NDC 0185-0128-01 bottles of 100 NDC 0185-0128-05 bottles of 500 1 mg Yellow, round, biconvex, bisected and debossed “E” above and “129” below the bisect on one side and plain on the reverse side and supplied as:
  • NDC 0185-0129-01 bottles of 100 NDC 0185-0129-05 bottles of 500 2 mg Beige to light brown, round, biconvex, bisected and debossed “E” above and “130” below the bisect on one side and plain on the reverse side and supplied as:
  • NDC 0185-0130-01 bottles of 100 NDC 0185-0130-05 bottles of 500 Storage
  • Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
  • Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required.
  • KEEP TIGHTLY CLOSED.
  • Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ 08540 Rev.
  • Jun 2023 46326538

Quoted from the official label, section “How Supplied”.

What is in it

  • Bumetanide is a loop diuretic, available as scored tablets.
  • Each tablet for oral administration contains 0.5 mg, 1 mg or 2 mg of bumetanide.
  • In addition, each tablet contains the following inactive ingredients:
  • anhydrous lactose, corn starch, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn), talc, with the following dye systems:
  • 0.5 mg- D&C yellow No. 10 aluminum lake, FD&C blue No. 1 aluminum lake and FD&C red No. 40 aluminum lake; 1 mg- D&C yellow No. 10 aluminum lake; 2 mg- synthetic black iron oxide, synthetic red iron oxide and synthetic yellow iron oxide.
  • Chemically, bumetanide is 3-(butylamino)-4-phenoxy-5-sulfamoylbenzoic acid.
  • It is a practically white powder having a calculated molecular weight of 364.42, and the following structural formula:
  • Chemical-Structure.jpg

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

  • Lactoseanhydrous lactoseMilk sugar: matters with lactose intolerance or a milk allergy.
  • Colour dyeswith the following dye systems: 0.5 mg- D&C yellow No. 10 aluminum lake; FD&C blue No. 1 aluminum lake; FD&C red No. 40 aluminum lake; 1 mg- D&C yellow No. 10 aluminum lakeSome people react to dyes such as tartrazine (Yellow 5) or carmine.

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Every version of this medicine (25)

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Details

Made bySandoz Inc
Active substanceBumetanide
Used inHeart, blood pressure and circulation
Strength2 mg
FormTablet
RouteOral
Packs100 TABLET in 1 BOTTLE · 500 TABLET in 1 BOTTLE
NDC0185-0130
NDC0781-8160

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

89 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

Bumetanide.5 mgPrescription onlyTablet Sandoz Inc · BumetanideBumetanide1 mgPrescription onlyTablet Sandoz Inc · BumetanideBumetanide.5 mgPrescription onlyTablet NCS HealthCare of KY, LLC dba Vangard Labs · BumetanideBumetanide1 mgPrescription onlyTablet NCS HealthCare of KY, LLC dba Vangard Labs · BumetanideBumetanide2 mgPrescription onlyTablet NCS HealthCare of KY, LLC dba Vangard Labs · BumetanideBumetanide.25 mg/mLPrescription onlyInjection, Solution Hikma Pharmaceuticals USA Inc. · Bumetanide

See every product with Bumetanide