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Prescription medicine

Bumetanide Brand names: Bumex, Enbumyst

Bumetanide (Bumex) is a prescription medicine with an FDA approval on record since 1983. FDA's NDC Directory lists it from 36 generic labelers, and pharmacies paid $0.108 per bumetanide 1 mg tablet in the October 7, 2026 NADAC survey.

  • Generic listed
  • Boxed warning

Check it at the source: the bumetanide FDA label on DailyMed (effective September 8, 2025, Validus Pharmaceuticals LLC); the NDA 18225 record on Drugs@FDA; every bumetanide label on DailyMed.

Highlights of the record

FDA label of September 8, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026

Boxed warning

Bumex ® (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 ).

Used for

From the label: indications and usage

Bumex tablets are indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome.

Forms and strengths

  • 0.5 mg
  • 1 mg
  • 2 mg
  • 0.25 mg/ml
  • 0.5 mg/.1ml

Tablet; injection; injection (solution); spray.

On the market

Earliest approval on file
February 28, 1983 Bumex, Validus Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals
23 first October 31, 1994; 20 with a marketed status in Drugs@FDA
Labelers listed (NDC)
40 of which 36 under generic applications, 2 under brand applications, repackagers included
Last listed patent
May 14, 2045 Enbumyst spray; not a generic launch date

Supply and safety

Pharmacy cost (NADAC)
$0.108 per tablet Bumetanide 1 mg tablet
Shortage (FDA)
None current 12 past records
Recalls by its makers (FDA)
4 since 2013 0 Class I among all firms' recalls; latest January 26, 2022; 2 more by firms not listed as its makers
FAERS reports
26,259 through July 30, 2026

What is bumetanide used for?

From the label: indications and usage

Bumex tablets 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 Bumex tablets following instances of allergic reactions to furosemide suggests a lack of cross-sensitivity.

Conditions named in the indications of bumetanide's FDA labels, with every medicine labeled for each:

From other bumetanide labels

Heart failure: INDICATIONS AND USAGE Bumex tablets are indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome.

FDA pharmacologic class: Loop Diuretic.

Source: FDA drug label (Bumex), Validus Pharmaceuticals LLC, effective September 8, 2025 (SPL set 32dfbea3-eb2b-4070-8605-57ce3e6d5a2f), via openFDA; the full label on DailyMed

What does the patient leaflet for bumetanide say first?

The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.

From the patient leaflet: What is the most important information I should know about ENBUMYST?

ENBUMYST is a diuretic that causes fluid loss and may lead to abnormalities with blood electrolytes and body energy systems (metabolic). Too much fluid loss can lead to dehydration and decreased blood volume and increase your risk of blood clots. Blood abnormalities may include decreased salts (electrolytes), and increased nitrogen, glucose and uric acid. The chance of getting these abnormalities is higher in people who are elderly, use higher doses, or who do not get enough electrolytes by mouth. Your healthcare provider should do blood tests to check for these abnormalities during treatment with ENBUMYST. You should not use ENBUMYST if you have severe electrolyte loss until it gets better. Tell your healthcare provider if you get any of the following signs or symptoms: unusual thirst dizziness or lightheadedness weakness or tiredness fast heart rate dry mouth or tongue sudden pain, redness or swelling in your joints, especially your big toe (gout) pain, swelling, redness, or warmth in your leg shortness of breath fast breathing high blood sugar dark urine skin is pale, tight, cool or clammy muscle cramps confusion See " What are the possible side effects of ENBUMYST? " for more information about side effects.

From the patient leaflet: How should I store ENBUMYST?

Store ENBUMYST at room temperature between 59°F to 77°F (15°C to 25°C). Do not freeze. Keep ENBUMYST and all medicines out of the reach of children.

Source: FDA drug label (Enbumyst), Corstasis USA LLC, effective August 27, 2026 (SPL set d6f752c5-d2bd-4f77-9611-ca2110066d1f), via openFDA; the full label on DailyMed

Is there a generic for bumetanide (Bumex)?

The FDA approved the first generic bumetanide on October 31, 1994. 23 generic applications are approved; 20 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.

FDA's NDC Directory lists bumetanide from 36 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.

The Orange Book lists no patent for Bumex tablets; a patent listed only for Enbumyst spray runs to May 14, 2045. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

  • 1983 earliest approval on file
  • 1994 first generic approved
  • 2045 last listed patent
  • red ticks recalls

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What do pharmacies pay for bumetanide (Bumex)?

In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.108 per Bumetanide 1 mg tablet, down 25% from $0.145 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.

  • Bumetanide 1 mg tablet (generic)
$0.250
$0.108
January 2024October 2026
NADAC per unit, October 7, 2026
Strength and formBrand or genericPharmacy cost30 tablets, or one pen or vial12-month change
Bumetanide 0.5 mg tabletGeneric$0.129 per tablet$3.86-9%
Bumetanide 1 mg tabletGeneric$0.108 per tablet$3.24-25%
Bumetanide 2 mg tabletGeneric$0.182 per tablet$5.46-24%

Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price

Is bumetanide in shortage?

No bumetanide presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 12 records are all resolved, the latest updated September 30, 2026. ASHP keeps a separate shortage list, which can differ.

PresentationCompanyStatusUpdated
Bumetanide, Injection, .25 mg/1 mL (NDC 0641-6007-10)Hikma Pharmaceuticals USA, Inc.ResolvedSeptember 30, 2026
Bumetanide, Injection, .25 mg/1 mL (NDC 0641-6008-10)Hikma Pharmaceuticals USA, Inc.ResolvedSeptember 30, 2026
Bumetanide, Injection, .25 mg/1 mL (NDC 25021-321-04)Sagent PharmaceuticalsResolvedSeptember 30, 2026
Bumetanide, Injection, .25 mg/1 mL (NDC 25021-321-10)Sagent PharmaceuticalsResolvedSeptember 30, 2026
Bumetanide, Injection, .25 mg/1 mL (NDC 65219-570-04)Fresenius Kabi USA, LLCResolvedSeptember 30, 2026
Bumetanide, Injection, .25 mg/1 mL (NDC 65219-572-10)Fresenius Kabi USA, LLCResolvedSeptember 30, 2026
Bumetanide, Injection, 0.25 mg/1 mL (NDC 72205-101-07)MSN Laboratories Private LimitedResolvedSeptember 30, 2026
Bumetanide, Injection, 0.25 mg/1 mL (NDC 72205-102-07)MSN Laboratories Private LimitedResolvedSeptember 30, 2026

Every bumetanide presentation in the FDA shortage database

Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026

Has bumetanide been recalled?

The FDA's Enforcement Report lists 6 recalls naming bumetanide since 2013: 0 Class I (the most serious), 5 Class II, 1 Class III; 0 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of bumetanide and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.

StartedClassCompanyReason
January 26, 2022Class IICARDINAL HEALTHCARECGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
September 19, 2018Class IIUpsher Smith Laboratories, Inc.Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.
November 6, 2013Class IIISandoz IncFailed Moisture Limit; Out of Specification (OOS) results were obtained for moisture content during stability testing at the 12 month time point, controlled …
July 2, 2013Class IIAidapak Services, LLC not a listed makerLabeling: Label Mixup: BUMETANIDE, Tablet, 0.5 mg, Rx only may have potentially been mislabeled as the following drug: ERYTHROMYCIN DR EC, Tablet, 250 mg, NDC …
July 2, 2013Class IIAidapak Services, LLC not a listed makerLabeling: Label Mixup: BUMETANIDE, Tablet, 1 mg may have potentially been mislabeled as the following drug: guaiFENesin ER, Tablet, 600 mg, NDC 63824000815 …

Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026

What does the bumetanide label say about other medicines?

The bumetanide label names 7 other medicines in its interaction, contraindication or warning sections. The labels of 3 other medicines name bumetanide. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Medicine namedSectionWhat the label says
Digoxindrug interactionsDigoxin Interaction studies in humans have shown no effect on digoxin blood levels.
Ethacrynic acidwarnings and precautionsReports indicate that ototoxicity is associated with rapid injection, severe renal impairment, the use of higher than recommended doses, hypoproteinemia or concomitant therapy with aminoglycoside antibiotics, ethacrynic acid, or other ototoxic drugs.
FurosemidewarningsIn 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.
Indomethacindrug interactionsIndomethacin Indomethacin blunts the increases in urine volume and sodium excretion seen during Bumex treatment and inhibits the bumetanide-induced increase in plasma renin activity.
Lithiumdrug interactionsLithium Lithium should generally not be given with diuretics (such as Bumex) because they reduce its renal clearance and add a high risk of lithium toxicity.
Probeneciddrug interactionsProbenecid Pretreatment with probenecid reduces both the natriuresis and hyperreninemia produced by Bumex.
SpironolactonewarningsSupplemental potassium and/or spironolactone may prevent hypokalemia and metabolic alkalosis in these patients.

Other labels that name bumetanide

Check bumetanide against other medicines

Source: FDA drug label (Bumex), Validus Pharmaceuticals LLC, effective September 8, 2025 (SPL set 32dfbea3-eb2b-4070-8605-57ce3e6d5a2f), via openFDA; the full label on DailyMed

What do FAERS reports show for bumetanide?

The FDA Adverse Event Reporting System holds 26,259 reports that list bumetanide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 4,122 are coded as a death and 12,607 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

Reports received each year

The most reported reactions

  • Dyspnoea2,649
  • Fatigue (named in the label)1,734
  • Death (an outcome recorded in the report)1,695
  • Acute Kidney Injury1,692
  • Diarrhoea (named in the label)1,577
  • Nausea (named in the label)1,545
  • Dizziness (named in the label)1,295
  • Headache (named in the label)1,245

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What else is labeled for the same conditions as bumetanide?

18 other medicines are given the same way (oral) and in the same FDA class as bumetanide or labeled mainly for the same use (heart failure), the same class first. Heart failure lists all 37 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.

MedicineShared indicationGeneric labelers (oral)Pharmacy costShortage
FurosemideHeart failure33 labelers$0.026 per tablet 20 mg tabletIn shortage
TorsemideHeart failure20 labelers$0.0636 per tablet 20 mg tabletNo current entry
Ethacrynic acidHeart failure8 labelers$0.807 per tablet 25 mg tabletNo current entry
CarvedilolHeart failure41 labelers$0.0179 per tablet 6.25 mg tabletNo current entry
SpironolactoneHeart failure38 labelers$0.0426 per tablet 25 mg tabletA presentation being discontinued
HydrochlorothiazideHeart failure44 labelers$0.0115 per tablet 25 mg tabletA presentation being discontinued
Sacubitril and valsartanHeart failure27 labelers$0.533 per unit 49-51 mgNo current entry
DigoxinHeart failure21 labelers$0.133 per tablet 125 mcg tabletNo current entry

Every medicine labeled for the same conditions as bumetanide

Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)

How does bumetanide compare with medicines for the same use?

5 side-by-side pages set bumetanide beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.

What next?

Alternatives to bumetanide
18 medicines for the same use
Other loop diuretics
the pharmacologic class, with prices and generics
Bumetanide side effects
the label's list beside FAERS reports
Bumetanide shortage record
every presentation, company and date
Check an interaction
what two or more labels say about each other