Losec Adverse Reactions

The following adverse drug reactions have been identified or suspected in the clinical trials programme for omeprazole and post-marketing. None was found to be dose-related. The reactions are classified according to frequency (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).
Blood and lymphatic system disorders: Rare: Leukopenia, thrombocytopenia, agranulocytosis, pancytopenia.
Immune system disorders: Rare: Hypersensitivity reactions e.g. fever, angioedema and anaphylactic reaction/shock.
Metabolism and nutrition disorders: Rare: Hyponatraemia. Very Rare: Hypomagnesaemia; severe hypomagnesaemia may result in hypocalcaemia. Hypomagnesaemia may also result in hypokalaemia.
Psychiatric disorders: Uncommon: Insomnia. Rare: Agitation, aggression, confusion, depression, 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. Rare: Dry mouth, stomatitis, gastrointestinal candidiasis, microscopic colitis.
Hepatobiliary disorders: Uncommon: Increased liver enzymes. Rare: Hepatitis with or without jaundice, hepatic failure, encephalopathy in patients with pre-existing liver disease.
Skin and subcutaneous tissue disorders: Uncommon: Dermatitis, pruritus, rash, urticaria. Rare: Alopecia, photosensitivity, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), acute generalized exanthematous pustulosis (AGEP), drug rash with eosinophilia and systemic symptoms (DRESS)
Musculoskeletal, connective tissue and bone disorders: Rare: Arthralgia, myalgia, muscular weakness.
Renal and urinary disorders: Rare: Interstitial nephritis.
Reproductive system and breast disorders: Rare: Gynaecomastia.
General disorders and administration site conditions: Uncommon: Malaise. Rare: Increased sweating, peripheral oedema.