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 drug reactions have been identified 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 >1/1,000 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          Rare         Leukopenia, thrombocytopenia system 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                Rare         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         Uncommon       Dermatitis, pruritus, rash, urticaria tissue disorders              Rare           Alopecia, photosensitivity Very rare      Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis
(TEN), drug reaction with eosinophilia and systemic symptoms (DRESS)
Not known      Subacute cutaneous lupus erythematosus (see section 4.4)
Musculoskeletal and           Uncommon       Fracture of the hip, wrist or spine (see connective tissue                            section 4.4) disorders                     Rare           Arthralgia, myalgia Very rare      Muscular weakness
Renal and urinary             Very rare      Interstitial nephritis; in some patients, disorders                                    renal failure has been reported concomitantly
Reproductive system and       Very rare      Gynaecomastia breast disorders
General disorders and         Rare           Malaise, increased sweating administration site conditions


Reporting of 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