Evidence review: safety

Evidence review: safety

The studies included in the systematic review and the retrospective chart review do not provide reliable evidence of the risk of adverse effects with erythromycin.

The summaries of product characteristics for erythromycin state that the drug is contraindicated in people with known hypersensitivity, and in those taking certain medications including astemizole, terfenadine, cisapride and pimozide (increased risk of cardiotoxicity), ergotamine and dihydroergotamine (increased risk of ergot toxicity), and simvastatin (increased risk of myopathy and rhabdomyolysis).

Caution is advised when using erythromycin in people with hepatic impairment or in those receiving potentially hepatotoxic agents (hepatic dysfunction has been infrequently reported); those with myasthenia gravis (weakness may be aggravated); and in seriously ill people receiving erythromycin concomitantly with statins (rhabdomyolysis has been reported). The summaries of product characteristics also warn that, as with other broad spectrum antibiotics, pseudomembranous colitis has been rarely reported with erythromycin. Erythromycin may interact with various other medications, including increasing serum concentrations of drugs metabolised by the cytochrome P450 system (including acenocoumarol, carbamazepine, ciclosporin, digoxin, midazolam, omeprazole, phenytoin, sildenafil, tacrolimus, theophylline and valproate). The summaries of product characteristics describe common adverse effects including nausea, abdominal discomfort, vomiting and diarrhoea.

There have been isolated reports of reversible hearing loss occurring with high doses of erythromycin or in people with renal insufficiency.

The following adverse effects have been rarely reported:

  • allergic reactions, including anaphylaxis

  • skin reactions, including erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis

  • hepatitis and hepatic dysfunction

  • cardiac arrhythmias and reports of chest pain and palpitations.

The relevant summaries of product characteristics contain more information on drug interactions and adverse effects of erythromycin.