Ilosone Side Effects

Generic name: erythromycin

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

Some side effects of Ilosone 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 erythromycin: oral delayed release capsule, oral delayed release tablet, oral granule for reconstitution, oral suspension, oral tablet, oral tablet coated particles

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

Call your doctor at once if you have a serious side effect such as:

• severe dizziness, fainting, fast or pounding heartbeats;

• diarrhea that is watery or bloody;

• hearing problems;

• vomiting or fussiness after eating (in a child taking erythromycin);

• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects of erythromycin may include:

• mild nausea, vomiting, diarrhea, or stomach pain;

• dizziness, headache, feeling tired;

• vaginal itching or discharge; or

• mild itching or skin rash.

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 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

General

The most common side effects associated with oral erythromycin (the active ingredient contained in Ilosone) were gastrointestinal and were dose-related.

Gastrointestinal

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)

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

Cardiovascular

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

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.

Hepatic

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.

Hypersensitivity

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

Dermatologic

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)

Nervous system

Reversible hearing loss was reported primarily in patients with renal dysfunction and in patients receiving high doses of erythromycin (the active ingredient contained in Ilosone)

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.

Rare (less than 0.1%): Convulsions, reversible hearing loss, reversible ototoxicity
Frequency not reported: Exacerbation of myasthenia gravis symptoms, new onset of myasthenic syndrome

Hematologic

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

Renal

Frequency not reported: Interstitial nephritis

Psychiatric

Rare (less than 0.1%): Recurrent nightmares

Local

Slow infusion of diluted erythromycin (the active ingredient contained in Ilosone) (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

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