Erythromycin

Applies to erythromycin: oral capsule delayed release, oral powder for suspension, oral tablet, oral tablet delayed release, oral tablet enteric coated

Other dosage forms:

• intravenous powder for solution

Along with its needed effects, erythromycin may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking erythromycin:

Rare

• Blistering, peeling, or loosening of the skin
• chills
• cough
• diarrhea
• difficulty with swallowing
• dizziness
• fast heartbeat
• hives or welts, skin rash
• joint or muscle pain
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• red, irritated eyes
• red skin lesions, often with a purple center
• redness of the skin
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• tightness in the chest
• unusual tiredness or weakness

Incidence not known

• Bloating
• bloody or cloudy urine
• chest pain or discomfort
• dark urine
• diarrhea, watery and severe, which may also be bloody
• fainting
• fever
• general tiredness and weakness
• greatly decreased frequency of urination or amount of urine
• hearing loss
• increased thirst
• irregular heartbeat recurrent
• irregular or slow heart rate
• light-colored stools
• nausea
• pain
• stomach cramp or tenderness
• swelling of the feet or lower legs
• unusual weight loss
• upper right abdominal or stomach pain
• vomiting
• yellow eyes and skin

Some side effects of erythromycin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

• Diarrhea (mild)
• loss of appetite
• weight loss

Applies to erythromycin: 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

The most common side effects associated with oral erythromycin were gastrointestinal and were dose-related.

Onset of pseudomembranous colitis symptoms has been reported during or after antibacterial therapy.

Rare (less than 0.1%): Pancreatitis, pancreatitis without biliary obstruction

Frequency not reported: Nausea, abdominal pain, diarrhea, vomiting, anorexia, infantile hypertrophic pyloric stenosis, pseudomembranous colitis, Clostridium difficile associated diarrhea (ranging from mild diarrhea to fatal colitis)

Life-threatening episodes of ventricular tachycardia associated with prolonged QT interval (torsades de pointes) have been reported following IV administration of erythromycin lactobionate.

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 greater than or equal to 500 msec) during treatment. Of the 278 patients, torsade de pointes was observed in one patient (less than 0.4%).

Arrhythmias and hypotension have been reported following IV administration.

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

Frequency not reported: QT prolongation, ventricular arrhythmias, ventricular tachycardia, torsades de pointes, arrhythmias, hypotension, polymorphous ventricular tachycardia

Postmarketing reports: Torsades de pointes

Rare (less than 0.1%): Hepatotoxicity, fulminant hepatic necrosis, false isolated elevations of serum glutamic oxaloacetic transaminase (SGOT) enzymes

Frequency not reported: Hepatic dysfunction (including increased liver enzymes), hepatocellular and/or cholestatic hepatitis (with or without jaundice), transient elevations of liver function tests, hepatitis, abnormal liver function test results, intrahepatic cholestasis

Hepatic dysfunction (including increased liver enzymes) and hepatocellular and/or cholestatic hepatitis (with or without jaundice) have been reported with oral erythromycin.

Frequency not reported: Allergic reactions (ranging from urticaria to anaphylaxis), hypersensitivity reactions (presented as rash, eosinophilia, fever), hypersensitivity with noninfectious hepatitis

Rare (less than 0.1%): Skin rash, maculopapular rashes (generalized, pruritic)

Frequency not reported: Skin reactions (ranging from mild eruptions to erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis)

Rare (less than 0.1%): Convulsions, reversible hearing loss, reversible ototoxicity

Frequency not reported: Exacerbation of myasthenia gravis symptoms, new onset of myasthenic syndrome

Reversible hearing loss was reported primarily in patients with renal dysfunction and in patients receiving high doses of erythromycin.

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

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

Rare (less than 0.1%): Reversible agranulocytosis

Frequency not reported: Hemolytic anemia

Frequency not reported: Interstitial nephritis

Rare (less than 0.1%): Recurrent nightmares

Slow infusion of diluted erythromycin (continuously or intermittently over no less than 20 to 60 minutes) almost invariably alleviated venous irritation.

Rare (less than 0.1%): Venous irritation with IV administration