Adverse reactions : תופעות לוואי

4.8.   Undesirable effects

The list of undesirable effects shown below is presented by system organ class, MedDRA preferred term, and frequency using the following frequency conventions:

Rare (≥1/10,000 to <1/1,000)

Not known (cannot be estimated from the available data)
System Organ Class          Frequency                    Adverse reactions Infections and            Rare              Pseudomembranous colitis has been reported infestations                                rarely in association with erythromycin therapy (see section 4.4).
Blood and lymphatic       Not known         Eosinophilia system disorders
Immune system             Not known         Allergic reactions ranging from urticaria and disorders                                   mild skin eruptions to anaphylaxis have occurred
Psychiatric disorders     Not known         Hallucinations
Nervous system            Not known         *Confusion, seizures and vertigo disorders
Eye disorders             Not known         Mitochondrial Optic Neuropathy Ear and labyrinth         Not known         **Deafness, tinnitus disorders
Cardiac disorders         Not known         Cardiac arrest, QTc interval prolongation, torsades de pointes, palpitations and cardiac rhythm disorders including ventricular tachyarrhythmias, ventricular fibrillation
Vascular disorders        Not known         Hypotension
Gastrointestinal          Not known         ***upper abdominal discomfort, nausea, disorders                                   vomiting, diarrhoea, pancreatitis, anorexia, infantile hypertrophic pyloric stenosis.
Hepatobiliary disorders   Not known         Cholestatic hepatitis, jaundice, hepatic dysfunction, hepatomegaly, hepatic failure,
hepatocellular hepatitis (see section 4.4).
Skin and subcutaneous     Not known         Acute generalised exanthematous pustulosis tissue disorders                            (AGEP)
Skin eruptions, pruritus, urticaria, exanthema,
angioedema, Stevens-Johnson syndrome,
toxic epidermal necrolysis, erythema multiforme.
Renal and urinary         Not known         Interstitial nephritis disorders
General disorders and     Not known         Chest pain, fever, malaise administration site conditions
Investigations            Not known         Increased liver enzyme values 


*There have been isolated reports of transient central nervous system side effects; however, a cause and effect relationship has not been established.
**There have been isolated reports of reversible hearing loss occurring chiefly in patients with renal insufficiency or taking high doses.
***The most frequent side effects of oral erythromycin preparations are gastrointestinal and are dose-related.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form: /https://sideeffects.health.gov.il