Bumetanide side effects: what 26,224 FDA adverse event reports show

Bumetanide · 1,195 reaction terms · 114,919 drug–reaction co-reports · data 2026-09-14

Drug class

Loop Diuretic

FDA label (Established Pharmacologic Class) · compare the class

Who reports

26,224 reports · 77% serious · 4,122 with death outcome · 56% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Bumetanide 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.

FDA label, Indications and Usage

What it is

DESCRIPTION Bumetanide is a loop diuretic available as 0.5 mg, 1 mg and 2 mg tablets for oral administration; each tablet also contains lactose anhydrous, magnesium stearate, microcrystalline cellulose, pregelatinized starch.

FDA label, Description section

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 ).

FDA label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 40 strongest signals

Labeled (related wording) 3Likely indication confounding 1Reporting / coding artifact 3Lab value / disease marker 2Not in label — unassessed 31

What the badges mean

Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 1,155 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Cardiospasm	64	103.4 79.7–134.2ROR 103.7 · χ² 5,648 / p <1e-300	89.2 EB05 72.3 · IC025 +5.3 3/3 methods agree	Not in label — unassessed	serious n=64 · ♀ 100% (drug 56%)	not reported in cached trials
Immunisation	49	101.8 75.6–137.0ROR 101.9 · χ² 4,240 / p <1e-300	87.2 EB05 68.6 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	serious n=49 · ♀ 100% (drug 56%)	not reported in cached trials
Body tinea	55	86.2 65.3–113.9ROR 86.4 · χ² 4,099 / p <1e-300	75.8 EB05 60.5 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	serious n=55 · ♀ 100% (drug 56%) · 100% clinician	not reported in cached trials
Palmoplantar keratoderma	64	77.9 60.2–100.6ROR 78.0 · χ² 4,349 / p <1e-300	69.5 EB05 56.4 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	serious n=64 · ♀ 100% (drug 56%)	not reported in cached trials
Chronic left ventricular failure	27	66.0 44.6–97.7ROR 66.1 · χ² 1,535 / p <1e-300	58.6 EB05 42.3 · IC025 +4.2 3/3 methods agree	Labeled (related wording) related wording	serious n=27	not reported in cached trials
Device wireless communication issue	18	61.9 38.3–99.9ROR 61.9 · χ² 944 / p 2e-207	54.3 EB05 36.3 · IC025 +3.7 3/3 methods agree	Reporting / coding artifact	–	not reported in cached trials
Device maintenance issue	34	51.2 36.2–72.4ROR 51.2 · χ² 1,523 / p <1e-300	46.9 EB05 35.1 · IC025 +4.3 3/3 methods agree	Reporting / coding artifact	serious n=17 · 100% consumer	not reported in cached trials
Venous pressure jugular increased	18	41.1 25.6–65.9ROR 41.1 · χ² 631 / p 1e-139	37.7 EB05 25.2 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=18	not reported in cached trials
Nephrogenic anaemia	228	40.9 35.8–46.7ROR 41.3 · χ² 8,403 / p <1e-300	38.8 EB05 34.8 · IC025 +4.9 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=228	not reported in cached trials
Hyperparathyroidism secondary	112	36.9 30.6–44.6ROR 37.1 · χ² 3,706 / p <1e-300	35.1 EB05 30.0 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious n=111	not reported in cached trials
Hypervolaemia	177	30.6 26.3–35.5ROR 30.8 · χ² 4,844 / p <1e-300	29.4 EB05 25.9 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious n=173	not reported in cached trials
Atrial tachycardia	73	28.6 22.6–36.1ROR 28.7 · χ² 1,850 / p <1e-300	27.5 EB05 22.6 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious n=73 · ♀ 100% (drug 56%)	not reported in cached trials
Dyspnoea paroxysmal nocturnal	25	28.0 18.8–41.7ROR 28.0 · χ² 602 / p 2e-133	26.6 EB05 18.9 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=23	not reported in cached trials
Inhibitory drug interaction	53	27.5 20.9–36.2ROR 27.6 · χ² 1,282 / p 4e-281	26.4 EB05 20.9 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious n=53 · ♀ 100% (drug 56%) · 100% clinician	not reported in cached trials
Cardiorenal syndrome	18	26.0 16.3–41.6ROR 26.0 · χ² 395 / p 4e-88	24.6 EB05 16.4 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious n=18	not reported in cached trials
Acute left ventricular failure	19	23.0 14.6–36.4ROR 23.1 · χ² 368 / p 2e-82	21.9 EB05 14.8 · IC025 +3.1 3/3 methods agree	Labeled (related wording) related wording	serious n=19	not reported in cached trials
Right ventricular failure	198	23.0 20.0–26.5ROR 23.2 · χ² 4,029 / p <1e-300	22.3 EB05 19.8 · IC025 +4.2 3/3 methods agree	Labeled (related wording) related wording	serious PRR 16.7	not reported in cached trials
Pruritus genital	65	22.9 17.9–29.3ROR 23.0 · χ² 1,302 / p 2e-285	22.2 EB05 18.0 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious n=64 · ♀ 100% (drug 56%)	not reported in cached trials
Paracentesis	17	22.6 13.9–36.5ROR 22.6 · χ² 320 / p 8e-72	21.4 EB05 14.0 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious n=17	not reported in cached trials
Catheter site discharge	30	22.4 15.6–32.1ROR 22.4 · χ² 575 / p 3e-127	21.5 EB05 15.8 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious n=23 · ♀ 100% (drug 56%) · 70% consumer	not reported in cached trials
Cor pulmonale	26	22.1 15.0–32.6ROR 22.1 · χ² 489 / p 1e-108	21.2 EB05 15.2 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious n=26	not reported in cached trials
Chronic kidney disease-mineral and bone disorder	29	22.1 15.3–32.0ROR 22.1 · χ² 548 / p 2e-121	21.2 EB05 15.5 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious n=29	not reported in cached trials
Infection susceptibility increased	58	21.7 16.8–28.2ROR 21.8 · χ² 1,097 / p 7e-241	21.1 EB05 16.9 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious n=58 · ♀ 100% (drug 56%) · 100% clinician	not reported in cached trials
Catheter site pruritus	23	21.5 14.2–32.6ROR 21.5 · χ² 418 / p 3e-93	20.6 EB05 14.4 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=17 · ♀ 100% (drug 56%)	not reported in cached trials
Infusion site haemorrhage	84	21.2 17.1–26.4ROR 21.3 · χ² 1,557 / p <1e-300	20.6 EB05 17.2 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=28 · ♀ 82% (drug 56%) · 100% consumer	not reported in cached trials
Cardiac amyloidosis	28	21.1 14.5–30.7ROR 21.1 · χ² 502 / p 1e-111	20.3 EB05 14.7 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious n=28	not reported in cached trials
Orthopnoea	81	20.8 16.7–25.9ROR 20.8 · χ² 1,466 / p <1e-300	20.2 EB05 16.7 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious n=79	not reported in cached trials
Infusion site discharge	43	20.6 15.2–27.8ROR 20.6 · χ² 761 / p 7e-168	19.9 EB05 15.4 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=20 · ♀ 81% (drug 56%) · 100% consumer	not reported in cached trials
Device infusion issue	61	20.4 15.8–26.3ROR 20.4 · χ² 1,076 / p 2e-236	19.8 EB05 15.9 · IC025 +3.7 3/3 methods agree	Reporting / coding artifact	serious n=25 · ♀ 78% (drug 56%) · 85% consumer	not reported in cached trials
Brash syndrome	33	19.9 14.1–28.1ROR 19.9 · χ² 559 / p 7e-124	19.2 EB05 14.3 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious n=33 · 100% clinician	not reported in cached trials
Infusion site infection	53	19.1 14.5–25.1ROR 19.1 · χ² 870 / p 2e-191	18.6 EB05 14.7 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=29 · ♀ 85% (drug 56%) · 100% consumer	NCT03715153: 1/84 (1.2%) on Bumetanide (serious AE)
Rebound acid hypersecretion	71	18.9 14.9–23.9ROR 19.0 · χ² 1,158 / p 3e-254	18.4 EB05 15.1 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious n=71	not reported in cached trials
End stage renal disease	422	18.7 17.0–20.6ROR 19.0 · χ² 6,897 / p <1e-300	18.3 EB05 16.9 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious PRR 13.7	not reported in cached trials
Dilated cardiomyopathy	21	18.4 12.0–28.4ROR 18.5 · χ² 322 / p 3e-72	17.7 EB05 12.0 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious n=21 · 100% clinician	not reported in cached trials
Oxygen consumption increased	51	17.6 13.3–23.2ROR 17.6 · χ² 766 / p 8e-169	17.1 EB05 13.5 · IC025 +3.4 3/3 methods agree	Lab value / disease marker	serious n=43	not reported in cached trials
Chronic respiratory failure	25	17.1 11.5–25.4ROR 17.1 · χ² 356 / p 1e-79	16.4 EB05 11.5 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious n=25	not reported in cached trials
Cardioactive drug level increased	27	16.6 11.3–24.2ROR 16.6 · χ² 371 / p 5e-83	15.9 EB05 11.3 · IC025 +3.0 3/3 methods agree	Lab value / disease marker	serious n=26	not reported in cached trials
Cardiac failure acute	130	15.9 13.4–18.9ROR 16.0 · χ² 1,767 / p <1e-300	15.6 EB05 13.4 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious n=130	not reported in cached trials
Left atrial dilatation	25	15.8 10.7–23.5ROR 15.8 · χ² 326 / p 3e-73	15.2 EB05 10.5 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious n=25	not reported in cached trials
Carotid artery occlusion	70	15.6 12.3–19.7ROR 15.6 · χ² 921 / p 2e-202	15.2 EB05 12.4 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious n=70 · ♀ 100% (drug 56%)	not reported in cached trials

Trial evidence (ClinicalTrials.gov)

✓ Trial adverse-event data found on ClinicalTrials.gov

Largest completed trials with posted results that list Bumetanide as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (1 of 40 signal terms matched).

NCT03715153 — Efficacy and Safety of Bumetanide Oral Liquid Formulation in Children Aged From 2 to Less Than 7 Years Old Wit (N=211, PHASE3; 77 AE terms posted; arms: S95008 - Double-blind Period (Week 0-26); Placebo - Double-blind Period (Week 0-26; S95008/S95008 - Open-Label Extension Per; Placebo/S95008 - Open-Label Extension Pe)

Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Dyspnoea (shortness of breath)	2,649	3.8 3.6–3.9ROR 4.1 · χ² 5,470 / p <1e-300	3.7 EB05 3.6 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 3.3	not reported in cached trials
Fatigue (tiredness)	1,734	1.8 1.7–1.9ROR 1.8 · χ² 619 / p 8e-137	1.8 EB05 1.7 · IC025 +0.8	Labeled adverse reaction exact term	serious PRR 1.9	NCT03715153: 10/107 (9.3%) on Bumetanide; 2/104 (1.9%) control
Death	1,695	1.6 1.5–1.6ROR 1.6 · χ² 367 / p 3e-82	1.6 EB05 1.5 · IC025 +0.6	Outcome field, not a reaction	serious PRR 1.2	not reported in cached trials
Acute kidney injury (sudden kidney damage)	1,692	9.0 8.6–9.4ROR 9.5 · χ² 11,911 / p <1e-300	8.9 EB05 8.5 · IC025 +3.1 3/3 methods agree	Labeled (related wording) related wording	serious PRR 6.6	NCT03715153: 1/84 (1.2%) on Bumetanide (serious AE)
Diarrhoea (diarrhea)	1,577	2.0 1.9–2.1ROR 2.0 · χ² 763 / p 4e-168	2.0 EB05 1.9 · IC025 +0.9	Labeled — boxed warning exact term	serious PRR 1.9	NCT03715153: 1/107 (0.9%) on Bumetanide (serious AE)
Nausea	1,545	1.6 1.5–1.6ROR 1.6 · χ² 326 / p 3e-73	1.6 EB05 1.5 · IC025 +0.6	Labeled — boxed warning exact term	serious PRR 1.6	not reported in cached trials
Dizziness	1,295	2.1 2.0–2.2ROR 2.1 · χ² 741 / p 2e-163	2.1 EB05 2.0 · IC025 +1.0	Labeled — boxed warning exact term	serious PRR 2.1	not reported in cached trials
Headache	1,245	1.6 1.5–1.7ROR 1.6 · χ² 279 / p 6e-63	1.6 EB05 1.5 · IC025 +0.6	Labeled — boxed warning exact term	serious PRR 1.7	NCT03715153: 2/84 (2.4%) on Bumetanide; 6/104 (5.8%) control
Renal failure (kidney failure)	1,139	6.8 6.5–7.3ROR 7.1 · χ² 5,671 / p <1e-300	6.8 EB05 6.5 · IC025 +2.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 5.1	not reported in cached trials
Pneumonia (lung infection)	1,132	2.8 2.6–3.0ROR 2.9 · χ² 1,327 / p 8e-291	2.8 EB05 2.7 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 2.2	not reported in cached trials
Asthenia (weakness)	1,081	2.3 2.2–2.4ROR 2.4 · χ² 805 / p 3e-177	2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious PRR 2.1	not reported in cached trials
Hypotension (low blood pressure)	1,052	4.2 4.0–4.5ROR 4.3 · χ² 2,584 / p <1e-300	4.2 EB05 4.0 · IC025 +2.0 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 3.3	not reported in cached trials
Pain	1,049	1.4 1.3–1.4ROR 1.4 · χ² 104 / p 1e-24	1.4 EB05 1.3 · IC025 +0.3	Labeled adverse reaction exact term	serious PRR 1.2	NCT03715153: 8/107 (7.5%) on Bumetanide; 5/104 (4.8%) control
Cardiac failure congestive	969	9.6 9.1–10.3ROR 10.0 · χ² 7,439 / p <1e-300	9.5 EB05 9.0 · IC025 +3.1 3/3 methods agree	Labeled (related wording) related wording	serious PRR 7.1	not reported in cached trials
Fall	945	2.3 2.1–2.4ROR 2.3 · χ² 682 / p 1e-150	2.3 EB05 2.1 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious PRR 1.9	not reported in cached trials

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

Cardiospasm — n=64, PRR 103.4
Immunisation — n=49, PRR 101.8
Body tinea — n=55, PRR 86.2
Palmoplantar keratoderma — n=64, PRR 77.9
Hyperparathyroidism secondary — n=112, PRR 36.9
Hypervolaemia — n=177, PRR 30.6
Atrial tachycardia — n=73, PRR 28.6
Dyspnoea paroxysmal nocturnal — n=25, PRR 28.0
Inhibitory drug interaction — n=53, PRR 27.5
Pruritus genital — n=65, PRR 22.9

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Bumetanide?

In FDA FAERS, the most frequently co-reported reaction terms for Bumetanide are dyspnoea, fatigue, acute kidney injury, diarrhoea, nausea, dizziness. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Bumetanide have an FDA boxed warning?

Yes. The current FDA label carries a 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 ).

Do FAERS signals prove that Bumetanide causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

FDA label via openFDA (set ID 06745425-e7e7-4413-b9ff-22b121f0ea9a, effective 20260127; matched on openfda.generic_name.exact:"BUMETANIDE")
Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA count= aggregation, field patient.drug.openfda.generic_name.exact, 1,195 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath
ClinicalTrials.gov API v2 (query BUMETANIDE, results-bearing studies sorted by enrollment)

Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.