Edecrin Side Effects

Generic name: ethacrynic acid

Note: This document contains side effect information about ethacrynic acid. Some of the dosage forms listed on this page may not apply to the brand name Edecrin.

Some side effects of Edecrin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to ethacrynic acid: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking ethacrynic acid (the active ingredient contained in Edecrin) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using ethacrynic acid and call your doctor at once if you have any of these serious side effects:

• dry mouth, thirst, nausea, vomiting;

• feeling weak, drowsy, restless, or light-headed;

• fast or uneven heartbeat;

• muscle pain or weakness;

• easy bruising or bleeding, unusual weakness;

• fever, chills, body aches, flu symptoms;

• severe or watery diarrhea;

• blood in your urine or stools;

• coughing up blood or vomit that looks like coffee grounds;

• rapid weight loss;

• hearing loss, feeling of fullness in the ear; or

• jaundice (yellowing of the skin or eyes).

Less serious side effects of ethacrynic acid may include:

• mild diarrhea, stomach pain, loss of appetite;

• trouble swallowing;

• headache; or

• dizziness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to ethacrynic acid: intravenous powder for injection, oral tablet

Nervous system

A cooperative study by the Boston Collaborative Drug Surveillance Program evaluated 32 of 11,526 patients who developed deafness while in the hospital. The incidence of deafness associated with intravenous ethacrynic acid (the active ingredient contained in Edecrin) in this study was 0.7%. No hearing impairment developed in 118 patients who had received the drug by oral administration.

The actual mechanism of ototoxicity is not known, but is believed to be due to inhibition of enzymes that are involved in the endolymph sodium-potassium membrane concentration gradient or to direct effects on the cochlear hair cells. Light microscopic findings in affected cochlea include rupture of endothelial layers and edematous changes of the marginal cells of the stria vascularis.

Nervous system side effects have been associated with ethacrynic acid. Temporary or permanent deafness has been reported in rare cases after intravenous administration of ethacrynic acid. Deafness has been reported even after a single, standard intravenous dose. Ototoxicity is extremely rare after oral administration. Most cases are reported in patients with renal insufficiency.

Renal

Renal side effects including renal loss of urinary sodium, potassium, chloride, and magnesium may develop leading to significant hypokalemic, hypochloremic metabolic alkalosis. Alkalosis can develop in the absence of hypokalemia due to inhibition of bicarbonate secretion and excessive urinary chloride loss.

It is recommended that treated patients be monitored for signs and symptoms of sodium or potassium depletion. These may include weakness, lassitude, muscle hypotonicity, orthostasis, syncope, rising BUN, and signs of "hemoconcentration," such as a rising hematocrit. In some cases, addition of a carbonic anhydrase inhibitor may decrease the risk of metabolic alkalosis and accentuate diuresis. Concomitant potassium therapy is usually needed. A potassium-sparing agent may be coadministered, if indicated, to attenuate urinary potassium losses.

Cardiovascular

Cardiovascular problems may arise from profound ethacrynic acid-induced intravascular volume depletion. Dizziness, orthostasis, or syncope indicate the need to reduce the amount or frequency of the dose. Ethacrynic acid-induced hypokalemia is almost expected, and can predispose some patients to cardiac arrhythmias.

Gastrointestinal

An association between the administration of ethacrynic acid (the active ingredient contained in Edecrin) (EA) and the occurrence of gastrointestinal (GI) bleeding was found during a routine computer monitoring of data in a drug surveillance program. Even after adjustments for diagnosis, age, sex, BUN levels, and heparin therapy, the frequency of GI bleeding among patients receiving EA was higher than in those who received other diuretics.

Gastrointestinal side effects are rare. Nausea, vomiting, diarrhea, and epigastric pain are usually mild and short-lived. A drug surveillance study has found an association between gastrointestinal bleeding and the intravenous administration of ethacrynic acid. A single case each of acute and fatal gastric ulceration, abdominal pain, and pancreatitis has been associated with ethacrynic acid.

Metabolic

Metabolic changes associated with loop diuretics including hyperuricemia, mild glucose intolerance, and hypocalcemia have been reported rarely during ethacrynic acid (the active ingredient contained in Edecrin) therapy. The metabolic and hemodynamic changes associated with ethacrynic acid can induce or exacerbate hepatic encephalopathy, which may be important in patients with significant liver disease.

Hepatic

Hepatic side effects including rare cases of cholestatic jaundice, agranulocytosis, and thrombocytopenia have been reported.

A 25-year-old man with rheumatic heart disease, bacterial endocarditis, and congestive heart failure (CHF) developed elevated serum transaminases and jaundice within two weeks after starting digoxin, ethacrynic acid (EA), and antibiotics. EA alone was discontinued, and the jaundice resolved over the next two weeks. These signs recurred upon rechallenge, and resolved upon discontinuation of the drug. Due to recurrent edema, EA was restarted again. Within seven days the patient developed jaundice, hepatic encephalopathy, and eventually died with CHF. Beside passive venous congestion, the liver, at autopsy, revealed cholestasis and hepatocellular damage.

Dermatologic

Dermatologic problems are rare. Rashes and two cases of Henoch-Schoenlein purpura have been associated with ethacrynic acid (the active ingredient contained in Edecrin)

Of 50 patients with congestive heart failure who were given ethacrynic acid in one study, two developed a necrotizing hemorrhagic lesion of the Henoch-Schonlein type. In both cases, the lesions appeared on the lower extremities two to three weeks after beginning therapy. Histology in one revealed vasculitis involving the arterioles and capillaries. There were no accompanying changes in the platelet count, bleeding time, or clotting times. Each patient was also taking other medications.

Hematologic

A 54-year-old woman with liver cirrhosis, ascites, and hepatic encephalopathy developed a fever and abdominal discomfort associated with a peripheral white blood cell count of 2,200/mm3 and a bone marrow examination consistent with agranulocytosis. The patient's serum did not show leukocyte agglutinins either in the presence or absence of the drug. The patient died of sepsis. Autopsy revealed postnecrotic cirrhosis and ascites. There was no evidence of malignancy or tuberculosis. The patient was also receiving antibiotics, and had previously received thiazide diuretics.

Hematologic side effects including rare cases of fatal agranulocytosis, sometimes with thrombocytopenia, have been associated with ethacrynic acid. Other factors, such as underlying diseases and concomitant medications, make implication of ethacrynic acid difficult in these cases.

Local

Local intravenous site pain and thrombophlebitis are common. If more than one injection is needed, a new intravenous site or use of a central venous catheter is recommended.

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