Erythrocin Side Effects

Please note - some side effects for Erythrocin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Erythrocin - for the Consumer

Erythrocin

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Erythrocin:

Diarrhea; loss of appetite; nausea; stomach pain; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; irregular heartbeat; muscle weakness; reversible hearing loss; severe diarrhea; stomach pain/cramps; yellowing of the skin or eyes.

Erythrocin Side Effects - for the Professional

Erythrocin

The most frequent side effects of oral erythromycin preparations are gastrointestinal and are dose-related. They include nausea, vomiting, abdominal pain, diarrhea and anorexia. Symptoms of hepatitis, hepatic dysfunction and/or abnormal liver function test results may occur.

Onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment.

Erythromycin has been associated with QT prolongation and ventricular arrhythmias, including ventricular tachycardia and torsades de pointes.

Allergic reactions ranging from urticaria to anaphylaxis have occurred. Skin reactions ranging from mild eruptions to erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported rarely.

There have been rare reports of pancreatitis and convulsions.

There have been isolated reports of reversible hearing loss occurring chiefly in patients with renal insufficiency and in patients receiving high doses of erythromycin.

Erythrocin Injection USP

Side effects following the use of intravenous erythromycin are rare. Occasional venous irritation has been encountered, but if the infusion is given slowly, in dilute solution, preferably by continuous intravenous infusion or intermittent infusion in no less than 20 to 60 minutes, pain and vessel trauma are minimized.

Life-threatening episodes of ventricular tachycardia associated with prolonged QT interval (torsades de pointes) have been reported in some patients after intravenous administration of erythromycin lactobionate.

Susceptibility to the development of torsades de pointes arrhythmias, a rare but serious cardiac condition, is related to electrolyte imbalance, hepatic dysfunction, myocardial ischemia, left ventricular dysfunction, idiopathic Q-T prolongation, and concurrent antiarrhythmic therapy.5 Elderly patients exhibit a greater frequency of decreased hepatic function, cardiac function, and of concomitant disease and other drug therapy, and therefore should be monitored carefully during Erythrocin® therapy.

Allergic reactions ranging from urticaria to anaphylaxis have occurred. Skin reactions ranging from mild eruptions to erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported rarely.

There have been isolated reports of reversible hearing loss occurring chiefly in patients with renal insufficiency and in patients receiving high doses of erythromycin.

Elderly patients, particularly those with reduced renal or hepatic function, may also be at increased risk for developing this effect when Erythrocin® doses of 4 grams/day or higher are given.

Side Effects by Body System

General

Side effects of erythromycin may be more likely and more severe in patients with underlying liver disease.

Gastrointestinal

Gastrointestinal side effects are common, especially when the drug is given intravenously. GI side effects include nausea, abdominal pain, diarrhea, and vomiting. Transient elevations of liver function tests and rare cases of hepatitis and pancreatitis have also been reported.

Gastrointestinal adverse effects have rarely included hepatotoxicity, which is independent of dose and usually occur 10 to 20 days after initial administration of drug. Intrahepatic cholestasis has been most commonly reported, but rare cases of fulminant hepatic necrosis, false isolated elevations of serum glutamic and oxaloacetic transaminase (SGOT) enzymes, and pancreatitis without biliary obstruction have also occurred during therapy with erythromycin.

Frequent monitoring of liver function tests during prolonged erythromycin therapy is recommended for patients with liver disease.

Hypersensitivity

Hypersensitivity reactions occur infrequently and have presented as rash, eosinophilia, and fever. Rare cases of Stevens-Johnson syndrome have been associated with erythromycin.

Anaphylaxis associated with erythromycin is rare but has been reported. Some cases of hypersensitivity have also included noninfectious hepatitis.

Dermatologic

Rare cases of generalized, pruritic, maculopapular rashes have been reported.

Dermatologic adverse effects have rarely included skin rash.

Nervous system

Nervous system side effects are rare and include reversible ototoxicity.

Several published reviews have indicated that ototoxicity is associated with erythromycin dosages greater than 4 grams per day, preexisting liver or kidney disease, and advanced age. Recovery generally occurs within two weeks.

Erythromycin has rarely been associated with reproducible exacerbations of myasthenia gravis.

Cardiovascular

Cardiovascular side effects have occurred infrequently and include arrhythmias and hypotension following intravenous administration. The use of IV erythromycin lactobionate has been associated with QTc prolongation in up to 39% of evaluable patients.

Cardiovascular adverse effects have rarely included QT segment prolongation and ventricular arrhythmias such as torsade de pointes. QT prolongation has been reported both in otherwise healthy patients and in patients with a history of heart disease or who were on other potentially arrhythmogenic drugs. Most affected patients were receiving erythromycin intravenously. In a recent retrospective study of 278 consecutive patients who had received IV erythromycin lactobionate, 39% of 49 evaluable patients developed moderate to severe delay in ventricular repolarization (QTc interval >= 500 msec) during treatment. Of the 278 patients, torsade de pointes was observed in one patient (< 0.4%).

One case of erythromycin-related polymorphous ventricular tachycardia reported in a patient treated for pneumonia was characterized by a normal QT interval.

Hematologic

A case of hemolytic anemia has been reported in a patient with severe underlying diseases and erythromycin-associated hepatitis.

Hematologic side effects have included isolated cases of reversible agranulocytosis.

Renal

Renal side effects have included rare cases of interstitial nephritis.

Psychiatric

Psychiatric side effects have included rare reports of recurrent nightmares.

Local

Local adverse effects associated with intravenous erythromycin have included venous irritation. Slow infusion of diluted erythromycin (continuously or intermittently over no less than 20 to 60 minutes) almost invariably alleviates this problem.

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