pharmacopeia
GET
/api/v1/drug/torsemide
2D structure
1-[[4-(3-methylanilino)-3-pyridinyl]sulfonyl]-3-propan-2-ylurea
SMILES CC1=CC(=CC=C1)NC2=C(C=NC=C2)S(=O)(=O)NC(=O)NC(C)C
InChIKey NGBFQHCMQULJNZ-UHFFFAOYSA-N

Mechanism of action

Sourced from openFDA

Micropuncture studies in animals have shown that torsemide acts from within the lumen of the thick ascending portion of the loop of Henle, where it inhibits the Na + /K + /2Cl – -carrier system. Clinical pharmacology studies have confirmed this site of action in humans, and effects in other segments of the nephron have not been demonstrated.

Sodium Potassium Chloride Symporter

Indications

Sourced from openFDA
  • Torsemide is a loop diuretic indicated for: the treatment of edema associated with heart failure, renal disease or hepatic disease. ( 1.1 ) the treatment of hypertension, to lower blood pressure.ICD-10: I10, I50.9, R60.9

Contraindications

Sourced from openFDA
  • Torsemide is contraindicated in patients with known hypersensitivity to torsemide or to povidone. Torsemide is contraindicated in patients who are anuric.contraindicated

Dosage & administration

Sourced from openFDA

Edema associated with: Heart failure: Initial dose is 10 or 20 mg once daily. Titrate by factors of two; doses above 200 mg have not been studied. ( 2.1 ) Chronic Renal Failure: Initial dose is 20 mg once daily. Titrate by factors of two; doses above 200 mg have not been studied. ( 2.1 ) Hepatic Cirrhosis: Initial dose is 5 or 10 mg once daily. Titrate by factors of two; doses above 40 mg have not been studied. ( 2.1 ) Hypertension: The recommended initial dose is 5 mg once daily. After 4 to 6 weeks, increase to 10 mg once daily, if needed. If 10 mg is insufficient, consider adding another agent. ( 2.2 ) 2.1 Treatment of Edema Edema associated with heart failure The recommended initial dose is 10 mg or 20 mg oral torsemide once daily. If the diuretic response is inadequate, titrate upward by approximately doubling until the desired diuretic response is obtained. Doses higher than 200 mg have not been adequately studied. Edema associated with chronic renal failure The recommended initial dose is 20 mg oral torsemide once daily. If the diuretic response is inadequate, titrate upward by approximately doubling until the desired diuretic response is obtained. Doses higher than 200 mg have not been adequately studied. Edema associated with hepatic cirrhosis The recommended initial dose is 5 mg or 10 mg oral torsemide once daily, administered together with an aldosterone antagonist or a potassium-sparing diuretic. If the diuretic response is inadequate, titrate upward by approximately doubling until the desired diuretic response is obtained.

Warnings & precautions

Sourced from openFDA

Hypotension and worsening renal function: monitor volume status and renal function periodically ( 5.1 ) Electrolyte and metabolic abnormalities: monitor serum electrolytes and blood glucose periodically. ( 5.2 ) Ototoxicity ( 5.3 , 7.6 ) 5.1 Hypotension and Worsening Renal Function Excessive diuresis may cause potentially symptomatic dehydration, blood volume reduction and hypotension and worsening renal function, including acute renal failure particularly in salt-depleted patients or those taking renin-angiotensin aldosterone inhibitors. Worsening of renal function can also occur with concomitant use of nephrotoxic drugs (e.g., aminoglycosides, cisplatin, and NSAIDs). Monitor volume status and renal function periodically. 5.2 Electrolyte and Metabolic Abnormalities Torsemide can cause potentially symptomatic hypokalemia, hyponatremia, hypomagnesemia, hypocalcemia, and hypochloremic alkalosis. Treatment with torsemide can cause an increase in blood glucose levels and hyperglycemia. Asymptomatic hyperuricemia can occur and gout may rarely be precipitated. Monitor serum electrolytes and blood glucose periodically. 5.3 Ototoxicity Tinnitus and hearing loss (usually reversible) have been observed with loop diuretics, including torsemide. Higher than recommended doses, severe renal impairment, and hypoproteinemia, appear to increase the risk of ototoxicity.

Adverse reactions

Sourced from openFDA

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 Avet Pharmaceuticals Inc. at 1-866-901-DRUG (3784) 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 4,000 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. In United States placebo-controlled trials excessive urination occurred in 6.7% of patients compared with 2.2% of patients receiving placebo.

Use in specific populations

Sourced from openFDA

8.1 Pregnancy Risk Summary There are no available data on use of torsemide in pregnant women and the risk of major birth defects or miscarriage. In pregnant rats and rabbits dosed, on a mg/m 2 basis, with 10 and 1.7 times a human dose of 20 mg/day, respectively, there was no fetotoxicity or teratogenicity. However, in pregnant rats and rabbits administered 50 and 6.8 times the human dose, respectively, decreases in body weight, decreased fetal resorption and delayed fetal ossification was observed. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major malformations and miscarriage in clinically recognized pregnancies is 2 to 4%, and 15 to 20%, respectively. Data There was no fetotoxicity or teratogenicity in rats treated with up to 5 mg/kg/day of torsemide (on a mg/kg basis, this is 15 times a human dose of 20 mg/day; on a mg/m 2 basis, the animal dose is 10 times the human dose), or in rabbits, treated with 1.6 mg/kg/day (on a mg/kg basis, 5 times the human dose of 20 mg/kg/day; on a mg/m 2 basis, 1.7 times this dose).

Pharmacokinetics

Sourced from openFDA
Metabolism
Absorption The bioavailability of torsemide tablets is approximately 80%, with small inter-subject variation; the 90% confidence interval is 75% to 89%. The drug is absorbed with little first-pass metabolism, and the serum concentration reaches its peak (C max ) within 1 hour after oral administration.

Overdosage

Sourced from openFDA

The signs and symptoms of overdosage can be anticipated to include those of excessive pharmacologic effect: dehydration, hypovolemia, hypotension, hyponatremia, hypokalemia, hypochloremic alkalosis, and hemoconcentration. Treatment of overdosage should consist of fluid and electrolyte replacement. Laboratory determinations of serum levels of torsemide and its metabolites are not widely available. No data are available to suggest physiological maneuvers (e.g., maneuvers to change the pH of the urine) that might accelerate elimination of torsemide and its metabolites. Torsemide is not dialyzable, so hemodialysis will not accelerate elimination.

Approval history

Sourced from openFDA
  • May 30, 2003ANDAANDA076346Pliva Pharm Ind
  • Mar 1, 2005ANDAANDA076943Hikma
  • May 31, 2005ANDAANDA076894Corepharma
  • Oct 17, 2007ANDAANDA078249Aurobindo Pharma
  • Jan 27, 2009ANDAANDA079234Hetero Labs Ltd Iii
  • Jun 14, 2021NDANDA213218Sarfe Pharms

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
32,002 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Dyspnoea3,40211%
  2. 2Fatigue2,1286.6%
  3. 3Diarrhoea1,9896.2%
  4. 4Nausea1,9786.2%
  5. 5Dizziness1,8835.9%
  6. 6Acute Kidney Injury1,7665.5%
  7. 7Death1,6855.3%
  8. 8General Physical Health Deterioration1,6125.0%
  9. 9Fall1,5604.9%
  10. 10Oedema Peripheral1,5534.9%
  11. 11Headache1,4444.5%
  12. 12Hypotension1,4374.5%
  13. 13Anaemia1,4304.5%
  14. 14Cardiac Failure1,3654.3%
  15. 15Pneumonia1,3204.1%

Literature

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Recent PubMed references pinned to Torsemide as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 51 ClinicalTrials.gov registrations naming Torsemide as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Torsemide work?
Micropuncture studies in animals have shown that torsemide acts from within the lumen of the thick ascending portion of the loop of Henle, where it inhibits the Na + /K + /2Cl – -carrier system. Clinical pharmacology studies have confirmed this site of action in humans, and effects in other segments of the nephron have not been demonstrated.
What is Torsemide used for?
According to FDA labeling, Torsemide carries indications including: Torsemide is a loop diuretic indicated for: the treatment of edema associated with heart failure, renal disease or hepatic disease. ( 1.1 ) the treatment of hypertension, to lower blood pressure.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Torsemide?
Torsemide is classified as Sulfonamides, plain, Loop Diuretic, Sodium Potassium Chloride Symporter Inhibitors, Decreased Blood Pressure, Decreased Intravascular Volume, Increased Diuresis at Loop of Henle, Increased Loop of Henle Ca++ Excretion, Increased Loop of Henle Cl- Excretion, Increased Loop of Henle K+ Excretion, Increased Loop of Henle Mg++ Excretion, Increased Loop of Henle Na+ Excretion.
What are the brand names for Torsemide?
Torsemide is marketed under brand names including Soaanz, Upcard.
What are the contraindications for Torsemide?
Torsemide labeling lists contraindications including: Torsemide is contraindicated in patients with known hypersensitivity to torsemide or to povidone. Torsemide is contraindicated in patients who are anuric.. Always consult the full prescribing information and a clinician.
Note. Data for torsemide is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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