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
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 usageBumex 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- February 28, 1983 Bumex, Validus Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing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 usageBumex 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 labelsHeart 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)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Bumetanide 0.5 mg tablet | Generic | $0.129 per tablet | $3.86 | -9% |
| Bumetanide 1 mg tablet | Generic | $0.108 per tablet | $3.24 | -25% |
| Bumetanide 2 mg tablet | Generic | $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.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Bumetanide, Injection, .25 mg/1 mL (NDC 0641-6007-10) | Hikma Pharmaceuticals USA, Inc. | Resolved | September 30, 2026 |
| Bumetanide, Injection, .25 mg/1 mL (NDC 0641-6008-10) | Hikma Pharmaceuticals USA, Inc. | Resolved | September 30, 2026 |
| Bumetanide, Injection, .25 mg/1 mL (NDC 25021-321-04) | Sagent Pharmaceuticals | Resolved | September 30, 2026 |
| Bumetanide, Injection, .25 mg/1 mL (NDC 25021-321-10) | Sagent Pharmaceuticals | Resolved | September 30, 2026 |
| Bumetanide, Injection, .25 mg/1 mL (NDC 65219-570-04) | Fresenius Kabi USA, LLC | Resolved | September 30, 2026 |
| Bumetanide, Injection, .25 mg/1 mL (NDC 65219-572-10) | Fresenius Kabi USA, LLC | Resolved | September 30, 2026 |
| Bumetanide, Injection, 0.25 mg/1 mL (NDC 72205-101-07) | MSN Laboratories Private Limited | Resolved | September 30, 2026 |
| Bumetanide, Injection, 0.25 mg/1 mL (NDC 72205-102-07) | MSN Laboratories Private Limited | Resolved | September 30, 2026 |
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.
| Started | Class | Company | Reason |
|---|---|---|---|
| January 26, 2022 | Class II | CARDINAL HEALTHCARE | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. |
| September 19, 2018 | Class II | Upsher Smith Laboratories, Inc. | Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product. |
| November 6, 2013 | Class III | Sandoz Inc | Failed Moisture Limit; Out of Specification (OOS) results were obtained for moisture content during stability testing at the 12 month time point, controlled … |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: 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, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: 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 named | Section | What the label says |
|---|---|---|
| Digoxin | drug interactions | Digoxin Interaction studies in humans have shown no effect on digoxin blood levels. |
| Ethacrynic acid | warnings and precautions | Reports 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. |
| Furosemide | warnings | 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. |
| Indomethacin | drug interactions | Indomethacin Indomethacin blunts the increases in urine volume and sodium excretion seen during Bumex treatment and inhibits the bumetanide-induced increase in plasma renin activity. |
| Lithium | drug interactions | Lithium 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. |
| Probenecid | drug interactions | Probenecid Pretreatment with probenecid reduces both the natriuresis and hyperreninemia produced by Bumex. |
| Spironolactone | warnings | Supplemental potassium and/or spironolactone may prevent hypokalemia and metabolic alkalosis in these patients. |
Other labels that name bumetanide
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
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.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Furosemide | Heart failure | 33 labelers | $0.026 per tablet 20 mg tablet | In shortage |
| Torsemide | Heart failure | 20 labelers | $0.0636 per tablet 20 mg tablet | No current entry |
| Ethacrynic acid | Heart failure | 8 labelers | $0.807 per tablet 25 mg tablet | No current entry |
| Carvedilol | Heart failure | 41 labelers | $0.0179 per tablet 6.25 mg tablet | No current entry |
| Spironolactone | Heart failure | 38 labelers | $0.0426 per tablet 25 mg tablet | A presentation being discontinued |
| Hydrochlorothiazide | Heart failure | 44 labelers | $0.0115 per tablet 25 mg tablet | A presentation being discontinued |
| Sacubitril and valsartan | Heart failure | 27 labelers | $0.533 per unit 49-51 mg | No current entry |
| Digoxin | Heart failure | 21 labelers | $0.133 per tablet 125 mcg tablet | No 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