The following adverse drug reactions have been identified or suspected in the clinical trials program for esomeprazole and post-marketing. None was found to be dose-related. 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).
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.
Uncommon: Insomnia; Rare: Agitation, confusion, depression; Very rare: Aggression, hallucinations.
Nervous System Disorders:
Common: Headache; Uncommon: Dizziness, paraesthesia, somnolence; Rare: Taste disturbance.
Rare: 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.
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.