Peprazom/Peprazom IV Adverse Reactions

The following adverse drug reactions have been identified or suspected in the clinical trials programme for esomeprazole administered orally or intravenously and post-marketing when administered orally. The reactions are classified according to frequency: common ≥1/100 to <1/10; uncommon ≥1/1,000 to <1/100; rare ≥1/10,000 to <1/1,000; very rare <1/10,000; not known (cannot be estimated from the available data).
Blood and lymphatic system disorders: Rare: Leukopenia, thrombocytopenia. Very rare: Agranulocytosis, pancytopenia.
Immune system disorders: Rare: Hypersensitivity reactions e.g. fever, angioedema and anaphylactic reaction/shock.
Metabolism and nutrition disorders: Uncommon: Peripheral oedema. Rare: Hyponatraemia. Frequency not known: hypomagnesaemia.
Psychiatric disorders: Uncommon: Insomnia. Rare: Agitation, confusion, depression. Very rare: Aggression, hallucinations.
Nervous system disorders: Common: Headache. Uncommon: Dizziness, paraesthesia, somnolence. Rare: Taste disturbance.
Eye disorders: Uncommon: Blurred vision.
Ear and labyrinth disorders: Uncommon: Vertigo.
Respiratory, thoracic and mediastinal disorders: Rare: Bronchospasm.
Gastrointestinal disorders: Common: Abdominal pain, constipation, diarrhoea, flatulence, nausea/vomiting. Uncommon: Dry mouth. Rare: Stomatitis, gastrointestinal candidiasis. Frequency not known: Microscopic colitis.
Hepatobiliary disorders: Uncommon: Increased liver enzymes. Rare: Hepatitis with or without jaundice. Very rare: Hepatic failure, encephalopathy in patients with pre-existing liver disease.
Skin end subcutaneous tissue disorders: Common: Administration site reactions*. Uncommon: Dermatitis, pruritus, rash, urticaria. Rare: Alopecia, photosensitivity. Very rare: Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN).
Musculoskeletal, connective tissue and bone disorders: Uncommon: Fracture of the hip, wrist or spine myalgia, myalgia. Very rare: Muscular weakness.
Renal and urinary disorders: Very rare: Interstitial nephritis.
Reproductive system and breast disorders: Very rare: Gynaecomastia.
General disorders and administration site conditions: Rare: Malaise, Increased sweating.
^*Administration site reactions have mainly been observed in a study with high-dose exposure over 3 days (72 hours).
Irreversible visual impairment has been reported in isolated cases of critically ill patients who have received omeprazole (the racemate intravenous injection, especially at high doses, but no cause relationship has been established.
Paediatric population: A randomised, open-label, multi-national study was conducted to evaluate the pharmacokinetics of repeated intravenous doses for days of once daily esomeprazole in paediatric patients 0 to 18 year old. A total of 57 patients (8 children in the age group 1-5 years) were included for safety evaluation. The safety results are consistent with the known safety profile of esomeprazole, and no new safety signal were identified.