Adverse reactions : תופעות לוואי

4.8   Undesirable effects
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 medicinal product 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: very common >1/10; 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; not known (cannot be estimated from the available data).



System Organ Class                Frequency        Undesirable Effect Blood and lymphatic system        Rare             Leukopenia, thrombocytopenia disorders                         Very rare        Agranulocytosis, pancytopenia Immune system disorders           Rare             Hypersensitivity reactions e.g. fever, angioedema and anaphylactic reaction/shock


Metabolism and nutrition      Uncommon       Peripheral oedema disorders                     Rare           Hyponatraemia
Not known      Hypomagnesaemia (see section 4.4); severe hypomagnesaemia can correlate with hypocalcaemia. Hypomagnesaemia may also be associated with 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     Rare           Bronchospasm mediastinal disorders
Gastrointestinal disorders    Common         Abdominal pain, constipation, diarrhoea, flatulence, nausea/vomiting, fundic gland polyps (benign)
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         Common         Administration site reactions* tissue disorders              Uncommon       Dermatitis, pruritus, rash, urticaria Rare           Alopecia, photosensitivity
Very rare      Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN)



Not known      Subacute cutaneous lupus erythematosus
(see section 4.4)
Musculoskeletal and                Uncommon       Fracture of the hip, wrist or spine (see section 4.4) connective tissue disorders
Rare           Arthralgia, myalgia
Very rare      Muscular weakness
Renal and urinary disorders         Very rare      Interstitial nephritis: in some patients, renal failure has been reported concomitantly

Reproductive system and             Very rare      Gynaecomastia
 breast disorders
General disorders and               Rare           Malaise, increased sweating administration site conditions

*Administration site reactions have mainly been observed in a study with high-dose exposure over 3 days (72 hours).


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.


Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form: https://sideeffects.health.gov.il/


Paediatric population
A randomised, open-label, multi-national study was conducted to evaluate the pharmacokinetics of repeated intravenous doses for 4 days of once daily esomeprazole in paediatric patients 0 to 18 years old (see section 5.2). A total of 57 patients (8 children in the age group 1– 5 years) were included for safety evaluation. The safety results are 
consistent with the known safety profile of esomeprazole, and no new safety signals were identified.