Erythromycin

Hepatic dysfunction, including increased liver enzymes, and hepatocellular and/or cholestatic hepatitis, with or without jaundice reported in patients receiving oral erythromycin products

Prescribing therapy in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to patient and increases risk of development of drug-resistant bacteria

Since erythromycin is principally excreted by the liver, caution should be exercised when erythromycin is administered to patients with impaired hepatic function

Exacerbation of symptoms of myasthenia gravis and new onset of symptoms of myasthenic syndrome reported in patients receiving erythromycin therapy

Infantile hypertrophic pyloric stenosis (IHPS) in infants following erythromycin therapy reported; a possible dose-response effect reported; since erythromycin may be used in the treatment of conditions in infants which are associated with significant mortality or morbidity (such as pertussis or neonatal Chlamydia trachomatis infections), the benefit of therapy needs to be weighed against potential risk of developing IHPS; parents should be informed to contact their physician if vomiting or irritability with feeding occurs

Prolonged or repeated use of erythromycin may result in an overgrowth of nonsusceptible bacteria or fungi; if superinfection occurs, erythromycin should be discontinued, and appropriate therapy instituted

When indicated, incision and drainage or other surgical procedures should be performed in conjunction with antibiotic therapy; observational studies in humans have reported cardiovascular malformations after exposure to drug products containing erythromycin during early pregnancy