PCE Side Effects

Please note - some side effects for PCE may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of PCE - for the Consumer

PCE

Applies to: tablets

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 PCE:

Loss of appetite; mild diarrhea; 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; change in the amount of urine produced; decreased hearing or hearing loss; irregular heartbeat; red, swollen, blistered, or peeling skin; seizures; severe diarrhea; severe stomach pain; stomach cramps; symptoms of liver problems (eg, yellowing of the skin or eyes; pale stools; severe or persistent nausea, vomiting, or loss of appetite; dark urine).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Side Effects by Body System - for Healthcare Professionals

Applies to: compounding powder; injectable powder for injection; oral capsule; oral delayed release capsule; oral delayed release tablet; oral granule for reconstitution; oral suspension; oral tablet; oral tablet, chewable; oral tablet, coated particles

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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