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PlainMeds

What the label lists and what reports show

Torsemide side effects

Torsemide's FDA label: “The most common adverse reaction is excessive urination (6.7%).” FAERS holds 32,925 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 (3,499 reports).

  • Generic listed

Check it at the source: the torsemide FDA label on DailyMed (effective May 8, 2024, Aurobindo Pharma Limited); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

The most common adverse reaction is excessive urination (6.7%).

From the label: adverse reactions, continued

The following risks are discussed in more detail in others sections: Hypotension and Worsening Renal Function [see Warnings and Precautions (5.1) ] Electrolyte and Metabolic Abnormalities [see Warnings and Precautions (5.2) ] Ototoxicity [see Warnings and Precautions (5.3) ] The most common adverse reaction is excessive urination (6.7%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In pre-approval studies, torsemide has been evaluated for safety in approximately 4000 subjects; over 800 of these subjects received torsemide for at least 6 months, and over 380 were treated for more than 1 year. Among these subjects were 564 who received torsemide during United States-based trials in which 274 other subjects received placebo. Discontinuation of therapy due to adverse reactions occurred in 3.5% of United States patients treated with torsemide and in 4.4% of patients treated with placebo. …

Source: FDA drug label, Aurobindo Pharma Limited, effective May 8, 2024 (SPL set 55e88727-864e-4313-860c-31a6ca45168f), via openFDA; the full label on DailyMed

What do FAERS reports show?

32,925 reports list torsemide among the medicines taken, each a report of something that happened, not proof the medicine caused it; 4,435 are coded as a death and 17,727 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 21 reactions below, 3 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

  • Dyspnoea3,499
  • Fatigue2,186
  • Diarrhoea2,062
  • Nausea2,033
  • Dizziness1,933
  • Acute Kidney Injury1,789
  • Death (an outcome recorded in the report)1,720
  • General Physical Health Deterioration1,649
  • Fall1,626
  • Oedema Peripheral1,586
  • Headache1,520
  • Hypotension (named in the label)1,479
  • Anaemia (named in the label)1,444
  • Cardiac Failure1,385
  • Pneumonia1,361
  • Asthenia1,309
  • Cough1,302
  • Vomiting1,268
  • Off Label Use (a use or a product term, not a reaction)1,169
  • Atrial Fibrillation1,168
  • Pain1,121
  • Renal Failure (named in the label)1,111
  • Chronic Kidney Disease1,019
  • Condition Aggravated (a use or a product term, not a reaction)1,011
  • Drug Interaction (a use or a product term, not a reaction)980

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Torsemide: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions