pharmacopeia
GET
/api/v1/drug/bumetanide

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 ) .

2D structure
3-(butylamino)-4-phenoxy-5-sulfamoylbenzoic acid
SMILES CCCCNC1=C(C(=CC(=C1)C(=O)O)S(=O)(=O)N)OC2=CC=CC=C2
InChIKey MAEIEVLCKWDQJH-UHFFFAOYSA-N

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Sodium Potassium Chloride Symporter Inhibitors.

Sodium Potassium Chloride Symporter

Indications

Sourced from openFDA
  • 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.ICD-10: I50.9, R60.9

Contraindications

Sourced from openFDA
  • 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.contraindicated

Dosage & administration

Sourced from openFDA

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.

Warnings & precautions

Sourced from openFDA

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.

Adverse reactions

Sourced from openFDA

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.

Use in specific populations

Sourced from openFDA

Pregnancy 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.

Approval history

Sourced from openFDA
  • Feb 28, 1983NDANDA018225Validus Pharms
  • Jan 27, 1995ANDAANDA074441Sagent
  • Apr 24, 1995ANDAANDA074225Heritage Pharma
  • Nov 21, 1996ANDAANDA074700Sandoz
  • Apr 30, 2008ANDAANDA079196West-ward Pharms Int
  • Oct 18, 2017ANDAANDA209724Amneal Pharms Co
  • Jan 23, 2018ANDAANDA209916Upsher Smith Labs
  • Sep 12, 2025NDANDA219500Corstasis Therap

FDA shortages

View JSON

Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.

  • Bumetanide, Injection, .25 mg/1 mL (NDC 0641-6007-10)Active
    Sponsor: Hikma Pharmaceuticals USA, Inc.
    Updated
  • Bumetanide, Injection, .25 mg/1 mL (NDC 0641-6008-10)Active
    Sponsor: Hikma Pharmaceuticals USA, Inc.
    Updated
  • Bumetanide, Injection, .25 mg/1 mL (NDC 25021-321-04)Active
    Sponsor: Sagent Pharmaceuticals · Reason: Demand increase for the drug
    Updated
  • Bumetanide, Injection, .25 mg/1 mL (NDC 25021-321-10)Active
    Sponsor: Sagent Pharmaceuticals · Reason: Demand increase for the drug
    Updated
  • Bumetanide, Injection, .25 mg/1 mL (NDC 65219-570-04)Active
    Sponsor: Fresenius Kabi USA, LLC
    Updated
  • Bumetanide, Injection, .25 mg/1 mL (NDC 65219-572-10)Active
    Sponsor: Fresenius Kabi USA, LLC
    Updated
  • Bumetanide, Injection, 0.25 mg/1 mL (NDC 72205-101-07)Active
    Sponsor: MSN Laboratories Private Limited
    Updated
  • Bumetanide, Injection, 0.25 mg/1 mL (NDC 72205-102-07)Active
    Sponsor: MSN Laboratories Private Limited
    Updated
  • Bumetanide, Injection, 0.25 mg/mL, 10 mL (NDC 72205-102-01)Active
    Sponsor: MSN Laboratories Private Limited
    Updated
  • Bumetanide, Injection, 0.25 mg/mL, 4mL (NDC 72205-101-01)Active
    Sponsor: MSN Laboratories Private Limited
    Updated
  • Bumetanide, Injection, 1 mg/4 mL (0.25 mg/mL) (NDC 83301-0080-2)Active
    Sponsor: Mullan Pharmaceutical Inc.
    Updated
  • Bumetanide, Injection, 2.5 mg/10 mL (0.25 mg/mL) (NDC 83301-0081-2)Active
    Sponsor: Mullan Pharmaceutical Inc.
    Updated

FAERS reports

View JSON
Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
25,625 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Dyspnoea2,57210%
  2. 2Fatigue1,6816.6%
  3. 3Death1,6726.5%
  4. 4Acute Kidney Injury1,6656.5%
  5. 5Diarrhoea1,5165.9%
  6. 6Nausea1,4915.8%
  7. 7Dizziness1,2394.8%
  8. 8Headache1,1844.6%
  9. 9Renal Failure1,1334.4%
  10. 10Pneumonia1,1124.3%
  11. 11Asthenia1,0614.1%
  12. 12Hypotension1,0274.0%
  13. 13Pain1,0274.0%
  14. 14Cardiac Failure Congestive9593.7%
  15. 15Fall9113.6%

Literature

View JSON

Recent PubMed references pinned to Bumetanide as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

View JSON

The 10 most recently updated of 49 ClinicalTrials.gov registrations naming Bumetanide as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Bumetanide work?
Mechanism-of-action class: Sodium Potassium Chloride Symporter Inhibitors.
What is Bumetanide used for?
According to FDA labeling, Bumetanide carries indications including: 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Bumetanide?
Bumetanide is classified as Sulfonamides, plain, Loop Diuretic, Sodium Potassium Chloride Symporter Inhibitors, Decreased Blood Pressure, Decreased Intravascular Volume, Increased Diuresis at Loop of Henle, Increased Loop of Henle Ca++ Excretion, Increased Loop of Henle Cl- Excretion, Increased Loop of Henle K+ Excretion, Increased Loop of Henle Mg++ Excretion, Increased Loop of Henle Na+ Excretion.
What are the brand names for Bumetanide?
Bumetanide is marketed under brand names including Bumex, Enbumyst.
What are the contraindications for Bumetanide?
Bumetanide labeling lists contraindications including: 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.. Always consult the full prescribing information and a clinician.
Note. Data for bumetanide is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

Search pharmacopeia

Search drugs, classes, and ingredients