Summary of the safety profile: Headache, abdominal pain, diarrhoea and nausea are among those adverse reactions that have been most commonly reported in clinical trials (and also from post-marketing use). In addition, the safety profile is similar for different formulations, treatment indications, age groups and patient populations. No dose-related adverse reactions have been identified.
Tabulated list of adverse reactions: The following adverse reactions have been identifies 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 to <1/10; uncommon ≥1/1000 to <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 nutritional disorders: Uncommon: Peripheral oedema.
Not known: Hypomagnesaemia; severe hypomagnesaemia can correlate with hypocalcaemia. Hypomagnesaemia may also be with hypokalemia.
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 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).
Not known: Sub acute cutaneous lupus erythematosus.
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 tare: Interstitial nephritis; in some patients renal failure has been reported concomitantly.
Reproductive system breast disorders: Very rare: Gynaecomastia.
General disorders and administration site conditions: Rare: Malaise, increased sweating.
For suspected Adverse Drug Reactions, report to the FDA: www.fda.gov.ph.
Seek medical attention immediately at the first sigh of Adverse Drug Reaction.