Nexium Adverse Reactions

The following definitions of frequencies are used: Common ≥1/100; Uncommon ≥1/1000 and <1/100; Rare ≥1/10000 and <1/1000; Very rare <1/10000.
The following adverse drug reactions have been identified or suspected in the clinical trials programme for esomeprazole and/or from post-marketing use. None was found to be dose-related.
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. Rare: Hyponatraemia. Very Rare: Hypomagnesaemia; severe hypomagnesaemia may result in hypocalcemia. Hypomagnesaemia may also result in hypokalaemia.
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, diarrhoea, flatulence, nausea/vomiting, constipation. Uncommon: Dry mouth. Rare: Stomatitis, gastrointestinal candidiasis. Very Rare: 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: 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: Rare: Arthralgia, myalgia. Very Rare: Muscular weakness.
Renal and urinary system disorders: Very Rare: Interstitial nephritis.
Reproductive system and breast disorders: Very Rare: Gynaecomastia.
General disorders and administration site conditions: Rare: Malaise, hyperhidrosis.
*Administration site reactions have mainly been observed in a study with high-dose exposure >3 days (72 hours). In the non-clinical program for esomeprazole intravenous formulation there was no evidence of vaso-irritation but a slight tissue inflammatory reaction at the injection site after subcutaneous (paravenous) injection was noted. The non-clinical findings somewhat indicated that the clinical tissue irritation was concentration related.