Nexium/Nexium MUPS Adverse Reactions

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. fever, angioedema and anaphylactic reaction/shock.
Metabolism and nutrition disorders: Uncommon: Peripheral oedema. Rare: Hyponatraemia. Very rare: Hypomagnesaemia; severe hypomagnesaemia may result in hypocalcaemia, 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: 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, fundic gland polyps (benign). 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: Uncommon: Dermatitis, pruritus, rash, urticaria. Common: Administration site reactions*. Rare: Alopecia, photosensitivity. Very rare: Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), acute generalized exanthematous pustulosis (AGEP), drug rash with eosinophilia and systemic symptoms (DRESS). Not known: Subacute cutaneous lupus erythematosus (SCLE).
Musculoskeletal, connective tissue and bone 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.
Other possible side effects include Clostridium difficile associated diarrhoea and Vitamin B12 deficiency (with unknown frequency).
Nexium: None was found to be dose-related.
*Administration site reactions have mainly been observed in a study with high-dose exposure over 3 days (72 hours). See Pharmacology: Toxicology: "Preclinical Safety Data" under Actions.
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.