Bumetanide
.25 mg/mL · Injection, Solution
- Prescription only
- Loop Diuretic
- Active substance
- Bumetanide
- Made by
- Hikma Pharmaceuticals USA Inc.
- Source
- Official label
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 · 2026-07-08
Loop Diuretic
- Bumetanide Injection is indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome.
The usual initial dose is 0.5 to 1 mg intravenously or intramuscularly.
If the response to an initial dose is deemed insufficient, a second or third dose may be given at intervals of 2 to 3 hours, but should not exceed a daily dosage of 10 mg.
Full directions ↓Bumetanide Injection, USP is a potent diuretic which, if given in excessive amounts, can lead to a profound diuresis with water and electrolyte depletion.
All warnings ↓- Prescription only
- FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed
What it is for
- Bumetanide Injection is 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 following instances of allergic reactions to furosemide suggests a lack of cross-sensitivity.
From the official label · 2026-07-08 · 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.
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 · 2026-07-08
Serious warning
The strongest warning the FDA requires. It is printed in a box at the top of the label.
- Bumetanide Injection, USP 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.
- Dosage should be individualized with careful monitoring of patient response.
- Parenteral Administration Bumetanide Injection may be administered parenterally (IV or IM) to patients in whom gastrointestinal absorption may be impaired or in whom oral administration is not practical.
- Parenteral treatment should be terminated and oral treatment instituted as soon as possible.
- The usual initial dose is 0.5 to 1 mg intravenously or intramuscularly.
- Intravenous administration should be given over a period of 1 to 2 minutes.
- If the response to an initial dose is deemed insufficient, a second or third dose may be given at intervals of 2 to 3 hours, but should not exceed a daily dosage of 10 mg.
- Miscibility and Parenteral Solutions The compatibility tests of bumetanide injection with 5% Dextrose Injection in Water, 0.9% Sodium Chloride Injection, and Lactated Ringer’s Injection in both glass and plasticized PVC (Viaflex) containers have shown no significant absorption effect with either containers, nor a measurable loss of potency due to degradation of the drug.
- However, solutions should be freshly prepared and used within 24 hours.
- Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
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.
- Carcinogenesis, Mutagenesis, 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 Pregnancy Category C 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 Pregnancy Category C 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 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”.
Other medicines
- 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.
Quoted from the official label, section “Drug Interactions”.
If you take too much
In an emergency, call your local emergency number or a poison control centre.
- 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 “Overdosage”.
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 preexisting liver disease) (0.6%).
- One or more of these adverse reactions have been reported in approximately 4.1% of bumetanide-treated patients.
- 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 bumetanide-treated patients.
- 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 2 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.
Quoted from the official label, section “Adverse Reactions”.
What it looks like and how it is packed
- Bumetanide Injection, USP, 0.25 mg/mL is a sterile, clear, colorless to slightly yellow solution supplied in amber vials as follows:
- 4 mL Single Dose Vial packaged in 10s (NDC 0641-6008-10) 10 mL Multiple Dose Vial packaged in 10s (NDC 0641-6007-10) This product, including the packaging components, is free of latex.
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30° C (59° to 86°F) [See USP Controlled Room Temperature].
- Protect from light.
- To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
- For Product Inquiry call 1-877-845-0689.
- Manufactured by: Hikma Pharmaceuticals USA Inc.
- Berkeley Heights, NJ 07922 Revised December 2019 462-485-02
Quoted from the official label, section “How Supplied”.
What is in it
- Bumetanide is a loop diuretic, available as 4 mL vials and 10 mL vials (0.25 mg/mL) for intravenous or intramuscular injection as a sterile solution.
- Each mL contains bumetanide 0.25 mg, sodium chloride 8.5 mg and ammonium acetate 4 mg as buffers, edetate disodium 0.1 mg and benzyl alcohol 10 mg as preservative in Water for Injection. pH adjusted to 6.8 – 7.8 with sodium hydroxide.
- Chemically, bumetanide is 3-(butylamino)-4-phenoxy-5-sulfamoylbenzoic acid.
- It is a practically white powder, slightly soluble in water, soluble in alkaline solutions, having the following structural formula:
- C 17 H 20 N 2 O 5 S Molecular weight:
- Structural formula
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.
The stored label for this product has no list of inactive ingredients. The list on the pack is the one to check.
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 (17)
The same active substance, strength and kind of form, from every company that sells it — with what each label lists.
Showing 17 of 17
- BumetanideThis onePrescription onlyHikma Pharmaceuticals USA Inc.No ingredient list on the stored label
- BumetanidePrescription onlyAnthea Pharma Private LimitedNo ingredient list on the stored label
- BumetanidePrescription onlyBryant Ranch PrepackNo ingredient list on the stored label
- BumetanidePrescription onlyCamber Pharmaceuticals, Inc.No ingredient list on the stored label
- BumetanidePrescription onlyCardinal Health 107, LLCNo ingredient list on the stored label
- BumetanidePrescription onlyCivica, Inc.No ingredient list on the stored label
- BumetanidePrescription onlyCivica, Inc.No ingredient list on the stored label
- BumetanidePrescription onlyFresenius Kabi USA, LLCNo ingredient list on the stored label
- BumetanidePrescription onlyGland Pharma LimitedNo ingredient list on the stored label
- BumetanidePrescription onlyGLENMARK PHARMACEUTICALS INC., USANo ingredient list on the stored label
- BumetanidePrescription onlyHF Acquisition Co LLC, DBA HealthFirstNo ingredient list on the stored label
- BumetanidePrescription onlyHikma Pharmaceuticals USA Inc.No ingredient list on the stored label
- BumetanidePrescription onlyLupin Pharmaceuticals, Inc.No ingredient list on the stored label
- BumetanidePrescription onlyMullan Pharmaceutical Inc.No ingredient list on the stored label
- BumetanidePrescription onlyNovadoz Pharmaceuticals LLCNo ingredient list on the stored label
- BumetanidePrescription onlyQilu Pharmaceutical Co., Ltd.No ingredient list on the stored label
- BumetanidePrescription onlySagent PharmaceuticalsNo ingredient list on the stored label
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
CanadaNo exact match for this strength and form
NetherlandsNo exact match for this strength and form
Details
| Made by | Hikma Pharmaceuticals USA Inc. |
|---|---|
| Active substance | Bumetanide |
| Used in | Heart, blood pressure and circulation |
| Strength | .25 mg/mL |
| Form | Injection, Solution |
| Route | Intramuscular; Intravenous |
| Packs | 10 VIAL, MULTI-DOSE in 1 CARTON / 10 mL in 1 VIAL, MULTI-DOSE · 10 VIAL, SINGLE-DOSE in 1 CARTON / 4 mL in 1 VIAL, SINGLE-DOSE |
| NDC | 0641-6007 |
| NDC | 0641-6008 |
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).
Other strengths and forms
89 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
- Tablet72 products
- Injection13 products
- Injection, Solution4 products
.25 mg/mL4
.25 mg/mL · 4 companies
- Anthea Pharma Private Limited
- Civica, Inc.
- Hikma Pharmaceuticals USA Inc. · this page
- Sagent Pharmaceuticals
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.