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, <1/10; uncommon >1/1000, <1/100; rare >1/10000, <1/1000; very rare <1/10000); 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. angioedema and anaphylactic reaction/shock.
Metabolism and nutrition disorders:
Uncommon: Peripheral oedema.
Very Rare: Hypomagnesaemia, severe hypomagnesaemia may result in hypocalcaemia.
Hypomagnesaemia may also result in hypokalaemia.
Rare: Agitation, confusion, depression.
Very rare: Aggression, hallucinations.
Nervous system disorders:
Uncommon: Dizziness, paraesthesia, somnolence.
Rare: Taste disturbance.
Uncommon: Blurred vision.
Ear and labyrinth disorders:
Respiratory, thoracic and mediastinal disorders:
Common: Abdominal pain, constipation, diarrhoea, flatulence, nausea/vomiting.
Uncommon: Dry mouth.
Rare: Stomatitis, gastrointestinal candidiasis.
Very rare: Microscopic colitis.
Uncommon: Increased liver enzymes.
Rare: Hepatitis with or without jaundice.
Very rare: Hepatic failure, encephalopathy in patients with pre-existing liver disease.
Skin and subcutaneous tissue disorders:
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:
Rare: Arthralgia, 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.
Infection and Infestation:
Not Known: In hospitalized patients, Clostridium difficile