Sodium Edecrin Side Effects

Generic Name: ethacrynic acid

Note: This page contains side effects data for the generic drug ethacrynic acid. It is possible that some of the dosage forms included below may not apply to the brand name Sodium Edecrin.

It is possible that some side effects of Sodium Edecrin may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to ethacrynic acid: oral tablet

As well as its needed effects, ethacrynic acid (the active ingredient contained in Sodium Edecrin) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking ethacrynic acid, check with your doctor immediately:

Rare
  • Bleeding gums
  • bloating
  • clay-colored stools
  • constipation
  • darkened urine
  • indigestion
  • itching
  • large, flat, blue or purplish patches in the skin
  • loss of appetite
  • nausea
  • painful knees and ankles
  • pains in stomach, side, or abdomen, possibly radiating to the back
  • pinpoint red spots on skin
  • raised red swellings on the skin, the buttocks, legs, or ankles
  • skin rash
  • unpleasant breath odor
  • vomiting of blood
  • yellow eyes or skin
Incidence not determined
  • Anxiety
  • black, tarry stools
  • blood in urine
  • blurred vision
  • cold sweats
  • coma
  • confusion
  • convulsions (seizures)
  • cool, pale skin
  • cough or hoarseness
  • depression
  • dizziness
  • dry mouth
  • fast heartbeat
  • fever with or without chills
  • flushed, dry skin
  • fruit-like breath odor
  • general feeling of tiredness or weakness
  • headache
  • increased hunger
  • increased thirst
  • increased urination
  • joint pain, stiffness, or swelling
  • lower back, side, or stomach pain
  • nausea
  • nervousness
  • nightmares
  • painful or difficult urination
  • pale skin
  • shakiness
  • shortness of breath
  • slurred speech
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • sweating
  • swelling of the feet or lower legs
  • troubled breathing
  • unexplained weight loss
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vomiting
  • watery and severe diarrhea

If any of the following symptoms of overdose occur while taking ethacrynic acid, get emergency help immediately:

Symptoms of overdose
  • Confusion
  • decreased urination
  • dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
  • increase in heart rate
  • irregular heartbeat
  • muscle cramps or pain
  • numbness, tingling, pain, or weakness in the hands or feet
  • rapid breathing
  • sunken eyes
  • thirst
  • trembling
  • weakness and heaviness of the legs
  • wrinkled skin

Some ethacrynic acid side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

Incidence not determined
  • Continuing ringing or buzzing or other unexplained noise in ears
  • difficulty swallowing
  • fear
  • feeling of constant movement of self or surroundings
  • feeling of fullness in the ears
  • general feeling of discomfort or illness
  • hearing loss
  • mild diarrhea
  • sensation of spinning
  • stomach soreness or discomfort
  • weight loss

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 Sodium 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

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 (the active ingredient contained in Sodium Edecrin) A single case each of acute and fatal gastric ulceration, abdominal pain, and pancreatitis has been associated with ethacrynic acid.

An association between the administration of ethacrynic acid (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.

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 Sodium 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

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 (the active ingredient contained in Sodium Edecrin) (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.

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

Dermatologic

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

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

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.

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.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

Hide
(web5)