BUMEX (bumetanide)
BUMEX is indicated for the treatment of Edema; Congestive Heart Failure; Hepatic Disease; Renal Disease; Nephrotic Syndrome.
Details
- Status
- Discontinued
- First Approved
- 1983-02-28
- Routes
- INJECTION, ORAL
- Dosage Forms
- INJECTABLE, TABLET
BUMEX Approval History
What BUMEX Treats
5 indicationsBUMEX is approved for 5 conditions since its original approval in 1983. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Edema
- Congestive Heart Failure
- Hepatic Disease
- Renal Disease
- Nephrotic Syndrome
BUMEX Boxed Warning
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 ) ....
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 ) .
BUMEX Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to BUMEX
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Clinical Trial Registry
17 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03107416 | 17-141 | Ph 1, Ph 2 | active not recruiting | Delivering a Diuretic Into the Liver Artery Followed by Plugging up the Artery to Starve Out Liver Cancer Cells |
| NCT06941415 BUFF | IRB_00186841 | Ph 3 | not yet recruiting | Bumetanide vs. Furosemide in Cirrhosis |
| NCT07005414 | XHEC-C-2025-089 | Ph 2 | completed | Efficacy of Bumetanide in Children With Autism Spectrum Disorder Guided by Peripheral Blood Biomarkers and Machine Learning Models |
| NCT06052163 BumxAD | IRB-69153 | Ph 2 | recruiting | Bumetanide in Patients With Alzheimer's Disease |
| NCT06036914 results posted | 23-005262 | Ph 2 | completed | A Study of Ultra High Dose Diuretics to Treat Heart Failure |
| NCT06465823 | 1042_OPBG_2016 | Ph 2 | recruiting | Efficacy of Bumetanide to Improve Cognitive Functions in Down Syndrome |
| NCT06218199 DART-HA | Dart-HA | Ph 4 | recruiting | Diuretics vs. Afterload Reduction for Treatment of HeartLogic Alerts |
| NCT02947880 BUMAUTEP | I14039 | Ph 2 | withdrawn | Evaluation of the Efficiency of Treatment by BUMETANIDE on Autistic Children With a Known Ethiology |
| NCT03156153 | XH-16-048 | Ph 2 | completed | A Study of Bumetanide for the Treatment of Autism Spectrum Disorders |
| NCT04766177 | autism | Ph 3 | recruiting | Role of Bumetanide in Treatment of Autism |
| NCT00830531 | CURE 07120492 1R01NS066929-01A1 | Ph 1 | completed | Pilot Study of Bumetanide for Newborn Seizures |
| NCT03923933 results posted | DI/19/105-B/03/018 | Ph 2 | completed | Chlortalidone and Bumetanide in Advanced Chronic Kidney Disease: HEBE-CKD Trial |
| NCT02582476 | 120542 | Ph 2 | terminated | Bumetanide in Hypokalaemic Periodic Paralysis |
| NCT00930865 | MB102-057 | Ph 1 | completed | Study to Evaluate the Potential Pharmacokinetic Interaction and Pharmacodynamic Effects on Renal Parameters of Bumetanide (1mg) and Dapagliflozin (10 mg) When Co-administered in Healthy Subjects |
| NCT01434225 NEMO1 | 08NR26 | Ph 1, Ph 2 | completed | NEMO1:NEonatal Seizure Using Medication Off-patent |
| NCT00372762 | R-06-415 | Ph 3 | withdrawn | Bumetanide Versus Furosemide in Heart Failure |
| NCT01078714 BUMEA | RB09-017 | Ph 3 | completed | Efficiency of Bumetanide in Autistic Children |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
BUMEX FDA Label Details
Indications & Usage
FDA Label (PDF)BUMEX is indicated for the treatment of Edema; Congestive Heart Failure; Hepatic Disease; Renal Disease; Nephrotic Syndrome.
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 DO...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.