Torsemide Recall

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Questions & Answers

Side Effects & Adverse Reactions

Hepatic Disease With Cirrhosis and Ascites

Torsemide should be used with caution in patients with hepatic disease with cirrhosis and ascites, since sudden alterations of fluid and electrolyte balance may precipitate hepatic coma. In these patients, diuresis with torsemide (or any other diuretic) is best initiated in the hospital. To prevent hypokalemia and metabolic alkalosis, an aldosterone antagonist or potassium-sparing drug should be used concomitantly with torsemide.


Tinnitus and hearing loss (usually reversible) have been observed after rapid intravenous injection of other loop diuretics and have also been observed after oral torsemide. It is not certain that these events were attributable to torsemide. Ototoxicity has also been seen in animal studies when very high plasma levels of torsemide were induced.

Volume and Electrolyte Depletion

Patients receiving diuretics should be observed for clinical evidence of electrolyte imbalance, hypovolemia, or prerenal azotemia. Symptoms of these disturbances may include one or more of the following: dryness of the mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pains or cramps, muscular fatigue, hypotension, oliguria, tachycardia, nausea, and vomiting. Excessive diuresis may cause dehydration, blood-volume reduction, and possibly thrombosis and embolism, especially in elderly patients. In patients who develop fluid and electrolyte imbalances, hypovolemia, or prerenal azotemia, the observed laboratory changes may include hyper- or hyponatremia, hyper- or hypochloremia, hyper- or hypokalemia, acid-base abnormalities, and increased blood urea nitrogen (BUN). If any of these occur, torsemide should be discontinued until the situation is corrected; torsemide may be restarted at a lower dose.

In controlled studies in the United States, torsemide was administered to hypertensive patients at doses of 5 mg or 10 mg daily. After 6 weeks at these doses, the mean decrease in serum potassium was approximately 0.1 mEq/L. The percentage of patients who had a serum potassium level below 3.5 mEq/L at any time during the studies was essentially the same in patients who received torsemide (1.5%) as in those who received placebo (3%). In patients followed for 1 year, there was no further change in mean serum potassium levels. In patients with congestive heart failure, hepatic cirrhosis, or renal disease treated with torsemide at doses higher than those studied in United States antihypertensive trials, hypokalemia was observed with greater frequency, in a dose-related manner.

In patients with cardiovascular disease, especially those receiving digitalis glycosides, diuretic-induced hypokalemia may be a risk factor for the development of arrhythmias. The risk of hypokalemia is greatest in patients with cirrhosis of the liver, in patients experiencing a brisk diuresis, in patients who are receiving inadequate oral intake of electrolytes, and in patients receiving concomitant therapy with corticosteroids or ACTH.

Periodic monitoring of serum potassium and other electrolytes is advised in patients treated with torsemide.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.


Torsemide tablet is indicated for the treatment of edema associated with congestive heart failure, renal disease, or hepatic disease. Use of torsemide has been found to be effective for the treatment of edema associated with chronic renal failure. Chronic use of any diuretic in hepatic disease has not been studied in adequate and well-controlled trials.

Torsemide tablets are indicated for the treatment of hypertension alone or in combination with other antihypertensive agents.


There is currently no drug history available for this drug.

Other Information

Torsemide is a diuretic of the pyridine-sulfonylurea class. Its chemical name is 1-isopropyl-3-[(4-m-toluidino-3-pyridyl) sulfonyl]urea and its structural formula is:


C16H20N4O3S          M.W. 348.43

Its pKa is 7.1.

Torsemide is a white to off-white crystalline powder. Each torsemide tablet, for oral administration contains 5 mg, 10 mg, 20 mg or 100 mg of torsemide, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate and sodium starch glycolate.

Torsemide Manufacturers

  • Avkare, Inc.
    Torsemide Tablet [Avkare, Inc.]
  • Par Pharmaceutical Inc
    Torsemide Tablet [Par Pharmaceutical Inc]
  • General Injectables And Vaccines, Inc.
    Torsemide Injection [General Injectables And Vaccines, Inc.]
  • General Injectables And Vaccines, Inc.
    Torsemide Injection [General Injectables And Vaccines, Inc.]
  • Cardinal Health
    Torsemide Tablet [Cardinal Health]
  • Ncs Healthcare Of Ky, Inc Dba Vangard Labs
    Torsemide Tablet [Ncs Healthcare Of Ky, Inc Dba Vangard Labs]
  • Physicians Total Care, Inc.
    Torsemide Tablet [Physicians Total Care, Inc.]
  • Qualitest Pharmaceuticals
    Torsemide Tablet [Qualitest Pharmaceuticals]
  • Roxane Laboratories, Inc
    Torsemide Tablet [Roxane Laboratories, Inc]
  • Bryant Ranch Prepack
    Torsemide Tablet [Bryant Ranch Prepack]
  • Pliva, Inc
    Torsemide Tablet [Pliva, Inc]
  • Aurobindo Pharma Limited
    Torsemide Tablet [Aurobindo Pharma Limited]
  • Bryant Ranch Prepack
    Torsemide Tablet [Bryant Ranch Prepack]
  • Camber Pharmaceuticals, Inc.
    Torsemide Tablet [Camber Pharmaceuticals, Inc.]
  • Apotex Corp.
    Torsemide Tablet [Apotex Corp.]
  • American Health Packaging
    Torsemide Tablet [American Health Packaging]
  • Cardinal Health
    Torsemide Tablet [Cardinal Health]
  • Greenstone Llc
    Torsemide Tablet [Greenstone Llc]
  • American Regent, Inc.
    Torsemide Injection, Solution [American Regent, Inc.]
  • Carilion Materials Management
    Torsemide Tablet [Carilion Materials Management]
  • Carilion Materials Management
    Torsemide Tablet [Carilion Materials Management]
  • Cardinal Health
    Torsemide Tablet [Cardinal Health]
  • Avpak
    Torsemide Tablet [Avpak]
  • Citron Pharma Llc
    Torsemide Tablet [Citron Pharma Llc]

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