What the label lists and what reports show
Bumetanide side effects
Bumetanide's FDA label lists its adverse reactions in its own words. FAERS holds 26,259 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is dyspnoea (2,649 reports).
- Generic listed
- Boxed warning
Check it at the source: the bumetanide FDA label on DailyMed (effective September 8, 2025, Validus Pharmaceuticals LLC); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of ENBUMYST ?ENBUMYST may cause serious side effects, including: See " What is the most important information I should know about ENBUMYST? " Worsening kidney function. Your healthcare provider may stop treatment if your kidney function gets worse. Ear damage (ototoxicity) including ringing in the ears (tinnitus) or hearing loss, especially in people with severe kidney problems, taking higher than recommended doses, with low levels of protein in the blood, and when used with certain other medicines. The most common side effects of ENBUMYST include: low levels of fluid in the body headache muscle cramps dizziness low blood pressure nausea abnormal brain functioning in people with certain liver problems Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of ENBUMYST . […]
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
What does the label list?
From the label: adverse reactionsThe most frequent clinical adverse reactions considered probably or possibly related to Bumex 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 Bumex. 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 Bumex 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%). …
Source: FDA drug label, 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?
26,259 reports list bumetanide among the medicines taken, 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. Of the 22 reactions below, 8 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Bumetanide: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions