Nexium Adverse Reactions

The following adverse drug reactions have been identified or suspected in the clinical trials programme for esomeprazole and post-marketing. None was found to be dose-related. The reactions are classified according to frequency very common ≥ 1/10; common ≥1/100, <1/10; uncommon ≥1/1,000, <1/100; rare ≥1/10,000, <1/1,000; very rare <1/10,000); not known (cannot be estimated from the available data).
Tablet: Blood and Lymphatic System Disorders: Rare: Leukopenia, thrombocytopenia. Very Rare: Agranulocytosis, pancytopenia.
Immune System Disorders: Rare: Hypersensitivity reactions eg, fever, angioedema and anaphylactic reaction/shock.
Metabolism and Nutrition Disorders: Uncommon: Peripheral oedema. Rare: Hyponatraemia. Not Known: Hypomagnesaemia; severe hypomagnesaemia can correlate with hypocalcaemia.
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: Rare: 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. 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 and Subcutaneous Tissue Disorders: 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. 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.
Granules: General Disorders and Administration Site Conditions: Rare: Malaise, increased sweating.
Respiratory, Thoracic and Mediastinal Disorders: Rare: Bronchospasm.
Blood and Lymphatic System Disorders: Rare: Leukopenia, thrombocytopenia. Very Rare: Agranulocytosis, pancytopenia.
Nervous System Disorders: Common: Headache. Uncommon: Dizziness, paraesthesia, somnolence. Rare: Taste disturbance.
Immune System Disorders: Rare: Hypersensitivity reactions eg, fever, angioedema and anaphylactic reaction/shock.
Skin and Subcutaneous Tissue Disorders: Uncommon: Dermatitis, pruritus, rash, urticaria. Rare: Alopecia, photosensitivity. Very Rare: Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN).
Hepatobiliary Disorders: Uncommon: Increased liver enzymes. Rare: Hepatitis with or without jaundice. Very Rare: Hepatic failure, encephalopathy in patients with preexisting liver disease.
Gastrointestinal Disorders: Common: Abdominal pain, constipation, diarrhoea, flatulence, nausea/vomiting. Uncommon: Dry mouth. Rare: Stomatitis, gastrointestinal candidiasis. Not Known: Microscopic colitis.
Metabolism and Nutrition Disorders: Uncommon: Peripheral oedema. Rare: Hyponatraemia. Not Known: Hypomagnesaemia (see Precautions), severe hypomagnesaemia can correlate with hypocalcemia.
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.
Psychiatric Disorders: Uncommon: Insomnia. Rare: Agitation, confusion, depression. Very Rare: Aggression, hallucinations.
Reproductive System and Breast Disorders: Very Rare: Gynaecomastia.
Eye Disorders: Rare: Blurred vision.
Ear and Labyrinth Disorders: Uncommon: Vertigo.