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ethacrynate sodium

Ethacrynate Sodium is a medication used to treat Ascites, Edema, Heart Failure, Hypertension.

Generic · by Sterimax

Not yet rated· sourced from the FDA label
Rated against independent regulatory sources·Last updated June 7, 2026·How we rate
Verified againstopenFDANIH DailyMedRxClass

Key facts

Active ingredient
Ethacrynate Sodium
Form
Injectable, Powder
Strength
Ethacrynate Sodium EQ 50MG BASE/VIAL
Type
Prescription (Rx)
Brand or generic
Generic
Manufacturer
Sterimax
FDA application
ANDA208663

What is Ethacrynate Sodium?

From the FDA label:Ethacrynic acid is an unsaturated ketone derivative of an aryloxyacetic acid. It is designated chemically as [2,3-dichloro-4-(2-methylene-1-oxobutyl)phenoxy] acetic acid, and has a molecular weight of 303.14. Ethacrynic acid is a white, or practically white, crystalline powder, very slightly soluble in water, but soluble in most organic solvents such as alcohols, chloroform, and benzene. Its empirical formula is C 13 H 12 Cl 2 O 4 and its structural formula is: Ethacrynate sodium, the sodium salt of ethacrynic acid, is soluble in water at 25°C to the extent of about 7 percent. Solutions of the sodium salt are relatively stable at about pH 7 at room temperature for short periods, but as the pH or temperature increases the solutions are less stable. The molecular weight of ethacrynate sodium is 325.12. Its empirical formula is C 13 H 11 Cl 2 NaO 4 and its structural formula is: Intravenous Ethacrynate Sodium is a sterile freeze-dried powder and is supplied in a vial containing: Ethacrynate sodium equivalent to ethacrynic acid - 50 mg Inactive ingredient: Mannitol - 62.5 mg chemicalstructure chemicalstructure1

How to use

Ethacrynate Sodium is sold in more than one form (Injectable and Powder), and each is dosed differently. The instructions below come from the FDA label for application ANDA208663 — follow the label that came with the product you were actually prescribed.

Dosage must be regulated carefully to prevent a more rapid or substantial loss of fluid or electrolyte than is indicated or necessary. The magnitude of' diuresis and natriuresis is largely dependent on the degree of fluid accumulation present in the patient. Similarly, the extent of potassium excretion is determined in large measure by the presence and magnitude of aldosteronism. Oral Use Ethacrynic Acid Tablets USP are available as 25 mg tablets. Dosage: To Initiate Diuresis In Adults : The smallest dose required to produce gradual weight loss (about 1 to 2 pounds per day) is recommended. Onset of diuresis usually occurs at 50 to 100 mg for adults. After diuresis has been achieved, the minimally effective dose (usually, from 50 to 200 mg daily) may be given on a continuous or intermittent dosage schedule. Dosage adjustments are usually in 25 to 50 mg increments to avoid derangement of water and electrolyte excretion. The patient should be weighed under standard conditions before and during the institution of diuretic therapy with this compound: The following schedule may be helpful in determining the smallest effective dose. Day 1 - 50 mg once daily after a meal Day 2 - 50 mg twice daily after meals, if necessary Day 3 - 100 mg in the morning and 50 to 100 mg following the afternoon or evening meal, depending upon response to the morning dose A few patients may require…

Side effects

Gastrointestinal Anorexia, malaise, abdominal discomfort or pain, dysphagia, nausea, vomiting, and diarrhea have occurred. These are more frequent with large doses or after one to three months of continuous therapy. A few patients have had, sudden onset of profuse, watery diarrhea. Discontinue ethacrynate sodium if diarrhea is severe and do not give it again. Gastrointestinal bleeding has occurred in some patients. Rarely, acute pancreatitis has been reported. Metabolic Reversible hyperuricemia and acute gout have been reported. Acute symptomatic hypoglycemia with convulsions occurred in two uremic patients who received doses above those recommended. Hyperglycemia has been reported. Rarely, jaundice and abnormal liver function tests have been reported in seriously ill patients receiving multiple drug therapy, including ethacrynate sodium. Hematologic Agranulocytosis or severe neutropenia has been reported in a few critically ill patients also receiving agents known to produce this effect. Thrombocytopenia has been reported rarely. Henoch-Schӧnlein purpura has been reported rarely in patients with rheumatic heart disease receiving multiple drug therapy, including ethacrynate sodium. Special Senses (see WARNINGS) Deafness, tinnitus and vertigo with a sense of fullness in the ears, and blurred vision have occurred. Central Nervous System Headache, fatigue, apprehension,…

Warnings

Important safety information

The effects of ethacrynic acid on electrolytes are related to its renal pharmacologic activity and are dose dependent. The possibility of profound electrolyte and water loss may be avoided by weighing the patient throughout the treatment period, by careful adjustment of dosage, by initiating treatment with small doses, and by using the drug on an intermittent schedule when possible. When excessive diuresis occurs, the drug should be withdrawn until homeostasis is restored. When excessive electrolyte loss occurs, the dosage should be reduced or the drug temporarily withdrawn. Initiation of diuretic therapy with ethacrynate sodium in the cirrhotic patient with ascites is best carried out in the hospital. When maintenance therapy has been established, the individual can be satisfactorily followed as an outpatient. Ethacrynate sodium should be given with caution to patients with advanced cirrhosis of the liver, particularly those with a history of previous episodes of electrolyte imbalance or hepatic encephalopathy. Like other diuretics it may precipitate hepatic coma and death. Too vigorous a diuresis, as evidenced by rapid and excessive weight loss, may induce an acute hypotensive episode. In elderly cardiac patients, rapid contraction of plasma volume and the resultant hemoconcentration should be avoided to prevent the development of thromboembolic episodes, such as cerebral vascular thromboses and pulmonary emboli which may be fatal. Excessive loss of potassium in patients receiving digitalis glycosides may precipitate digitalis toxicity. Care should also be exercised in patients receiving potassium-depleting steroids. A number of possibly drug-related deaths have occurred in critically ill patients refractory to other diuretics. These generally have fallen into two categories: (1) patients with severe myocardial disease who have been receiving digitalis and presumably developed acute hypokalemia with fatal arrhythmia; (2) patients with severely decompensated hepatic cirrhosis with ascites, with or without accompanying encephalopathy, who were in electrolyte imbalance and died because of intensification of the electrolyte defect. Deafness, tinnitus, and vertigo with a sense of fullness in the ears have occurred, most frequently in patients with severe impairment of renal function. These symptoms have been associated most often with intravenous administration and with doses in excess of those recommended. The deafness has usually been reversible and of short duration (one to 24 hours). However, in some patients the hearing loss has been permanent. A number of these patients were also receiving drugs known to be ototoxic. Ethacrynate sodium may increase the ototoxic potential of other drugs (see PRECAUTIONS, Drug Interactions ). Lithium generally should not be given with diuretics ( see PRECAUTIONS, Drug Interactions ).

Who should not take Ethacrynate Sodium

All diuretics, including ethacrynic acid, are contraindicated in anuria. If increasing electrolyte imbalance, azotemia, and/or oliguria occur during treatment of severe, progressive renal disease, the diuretic should be discontinued. In a few patients this diuretic has produced severe, watery diarrhea. If this occurs, it should be discontinued and not used again. Until further experience in infants is accumulated, therapy with parenteral ethacrynate sodium is contraindicated. Hypersensitivity to any component of this product.

Overdose — what happens if you take too much

Overdosage may lead to excessive diuresis with electrolyte depletion and dehydration. In the event of overdosage; symptomatic and supportive measures should be employed. Correct dehydration, electrolyte imbalance, hepatic coma, and hypotension by established procedures. If required, give oxygen or artificial respiration for respiratory impairment. In the mouse, the oral LD50 of ethacrynic acid is 627 mg/kg and the intravenous LD50 of ethacrynate sodium is 175 mg/kg.

U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.

Interactions

Lithium generally should not be given with diuretics because they reduce its renal clearance and add a high risk of lithium toxicity. Read circulars for lithium preparations before use of such concomitant therapy. Ethacrynate sodium may increase the ototoxic potential of other drugs such as aminoglycoside and some cephalosporin antibiotics. Their concurrent use should be avoided. A number of drugs, including ethacrynic acid, have been shown to displace warfarin from plasma protein; a reduction in the usual anticoagulant dosage may be required in patients receiving both drugs. In some patients, the administration of a non-steroidal anti-inflammatory agent can reduce the diuretic, natriuretic, and antihypertensive effects of loop, potassium-sparing and thiazide diuretics. Therefore, when ethacrynate sodium and non-steroidal anti-inflammatory agents are used concomitantly, the patient should be observed closely to determine if the desired effect of the diuretic is obtained.

May treat (source: NIH RxClass)

Dosage forms

Injectable and Powder

The forms currently marketed in the U.S., per the FDA National Drug Code Directory.

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Frequently asked questions

What does Ethacrynate Sodium treat?
Ethacrynate Sodium (Ethacrynate Sodium) may be used to treat ascites, edema, heart failure, hypertension, chronic kidney failure, liver cirrhosis, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
Is there a coupon or discount for Ethacrynate Sodium?
pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Ethacrynate Sodium. To pay less, Ethacrynate Sodium is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
Who makes Ethacrynate Sodium?
Ethacrynate Sodium is marketed by Sterimax. You can see Sterimax's full profile, rating, and other products on pharmaranks.
Is Ethacrynate Sodium a brand-name or generic drug?
Ethacrynate Sodium is a generic medication; its active ingredient is Ethacrynate Sodium. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
Is Ethacrynate Sodium available over the counter?
No. Ethacrynate Sodium is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
What forms does Ethacrynate Sodium come in?
Ethacrynate Sodium is currently marketed as injectable and powder, per the FDA's National Drug Code Directory.
Is Ethacrynate Sodium FDA-registered?
Ethacrynate Sodium is on record with the U.S. FDA under application number ANDA208663. You can verify this on its official FDA label.
Is Ethacrynate Sodium safe?
There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Ethacrynate Sodium. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
What are the side effects of Ethacrynate Sodium?
Ethacrynate Sodium's side effects are taken directly from its FDA label. From the label: Gastrointestinal Anorexia, malaise, abdominal discomfort or pain, dysphagia, nausea, vomiting, and diarrhea have occurred. These are more frequent with large doses or after one to three months of continuous therapy. A few patients have had, sudden onset of profuse, watery diarrhea.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.

Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.

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