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 studies (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 identified or suspected in the clinical studies programme for esomeprazole and post-marketing. The reactions are classified according to MedDRA frequency convention: 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).

Common       Uncommon       Rare               Very rare          Not known Blood and                                      leukopenia,        agranulocytosis, lymphatic system                                thrombocytope-     pancytopenia disorders                                       nia
Immune system                                   hypersensitivity

Common        Uncommon        Rare               Very rare        Not known disorders                                           reactions e.g.
fever,
angioedema and anaphylactic reaction/shock
Metabolism and                      peripheral      hyponatraemia                       hypomagne- nutrition disorders                 oedema                                              saemia; severe hypomagne- saemia can correlate with hypocalcae- mia;
hypomagne- saemia may also result in hypokalaem- ia
Psychiatric                         insomnia        agitation,        aggression, disorders                                           confusion,        hallucinations depression
Nervous system        headache      dizziness,      taste disturbance disorders                           paraesthesia,
somnolence
Eye disorders                                       blurred vision
Ear and labyrinth                   vertigo disorders
Respiratory,                                        bronchospasm thoracic and mediastinal disorders
Gastrointestinal      abdominal     dry mouth       stomatitis,                         microscopic disorders             pain,                         gastrointestinal                    colitis constipa-                     candidiasis tion,
diarrhoea,
flatulence,
nausea/ vomiting,
fundic gland polyps
(benign)
Hepatobiliary                       increased      hepatitis with or hepatic failure, disorders                           liver          without jaundice hepatic enzymes                          encephalopathy in patients with pre-existing liver disease
Skin and                            dermatitis,    alopecia,         erythema           Subacute subcutaneous                        pruritus, rash photosensitivity multiforme,         cutaneous tissue disorders                    urticaria                        Stevens-           lupus Common           Uncommon   Rare                Very rare           Not known Johnson             erythematosu syndrome,           s (see section toxic epidermal     4.4).
necrolysis (TEN)
Musculoskeletal                                   arthralgia,         muscular and connective                                    myalgia             weakness tissue disorders
Renal and                                                             Interstitial urinary disorders                                                     nephritis Reproductive                                                          gynaecomastia system and breast disorders
General disorders                                 malaise,
and                                               increased administration                                    sweating site disorders

Reporting of suspected adverse reactions
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/.