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: Very common (≥1/10); 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, anaphylactic reaction/shock.
Metabolism and Nutrition Disorders:
Uncommon: Peripheral oedema.
Not Known: Hypomagnesaemia (see Precautions); severe hypomagnesaemia can correlate with hypocalcaemia.
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.
Not Known: 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:
Common: Administration site reactions*.
Uncommon: Dermatitis, pruritus, rash, urticaria.
Rare: Alopecia, photosensitivity.
Very Rare: Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN).
Musculoskeletal and Connective Tissue Disorders:
Uncommon: Fracture of the hip, wrist or spine (see Precautions).
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.
*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 causal relationship has been established.