Retorin Suspension Adverse Reactions

Blood and lymphatic system disorders: Eosinophilia.
Immune system disorders: Allergic reactions ranging from urticaria and mild skin eruptions to anaphylaxis have occurred.
Psychiatric disorders: Hallucinations.
Nervous system disorders: There have been isolated reports of transient central nervous system side effects including confusion, seizures and vertigo; however, a cause and effect relationship has not been established.
Eye disorders: Mitochondrial Optic Neuropathy.
Ear and labyrinth disorders: Deafness, tinnitus.
There have been isolated reports of reversible hearing loss occurring chiefly in patients with renal insufficiency or taking high doses.
Cardiac disorders: QTc interval prolongation, torsades de pointes, palpitations, and cardiac rhythm disorders including ventricular tachyarrhythmias.
Cardiac arrest, ventricular fibrillation (frequency not known).
Vascular disorders: Hypotension.
Gastrointestinal disorders: The most frequent side effects of oral erythromycin preparations are gastrointestinal and are dose-related. The following have been reported: upper abdominal discomfort, nausea, vomiting, diarrhoea, pancreatitis, anorexia, infantile hypertrophic pyloric stenosis.
Pseudomembranous colitis has been rarely reported in association with erythromycin therapy.
Hepatobiliary disorders: Cholestatic hepatitis, jaundice, hepatic dysfunction, hepatomegaly, hepatic failure, hepatocellular hepatitis.
Skin and subcutaneous tissue disorders: Skin eruptions, pruritus, urticaria, exanthema, angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme.
Not known: acute generalised exanthematous pustulosis (AGEP).
Frequency not known: severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS) & acute generalised exanthematous pustulosis (AGEP).
Renal and urinary disorders: Interstitial nephritis.
General disorders and administration site conditions: Chest pain, fever, malaise.
Investigations: Increased liver enzyme values.
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.
Postmarketing Experience: Gastrointestinal Disorders: infantile hypertrophic pyloric stenosis.