Adverse reactions : תופעות לוואי

4.8     Undesirable effects

Summary of the safety profile
The most common side effects (1-10% of patients) are headache, abdominal pain, constipation, diarrhoea, flatulence and nausea/vomiting.

Severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP) have been reported in association with omeprazole treatment (see section 4.4).

Tabulated list of 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. Adverse reactions listed below are classified according to frequency and System Organ Class (SOC).
Frequency categories are defined according to the following 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).


SOC/frequency         Adverse reaction

Blood and lymphatic system disorders
Rare:            Leukopenia, thrombocytopenia
Very rare:       Agranulocytosis, pancytopenia
Immune system disorders
Hypersensitivity reactions e.g. fever, angioedema and anaphylactic
Rare: reaction/shock
Metabolism and nutrition disorders
Rare:            Hyponatraemia
Hypomagnesaemia; severe hypomagnesaemia may result in
Not known:       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 mediastinal disorders
Rare:              Bronchospasm
Gastrointestinal disorders
Abdominal pain, constipation, diarrhoea, flatulence, nausea/vomiting, Common: fundic gland polyps (benign)
Rare:              Dry mouth, 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
Alopecia, photosensitivity, acute generalized exanthematous pustulosis Rare:              (AGEP), drug reaction with eosinophilia and systemic symptoms (DRESS)
Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal
Very rare: necrolysis (TEN)
Subacute cutaneous lupus erythematosus (see section 4.4).
Not known:
Musculoskeletal and connective tissue disorders
Uncommon          Fracture of the hip, wrist or spine
Rare:             Arthralgia, myalgia
Very rare:        Muscular weakness
Renal and urinary disorders
Rare:             Interstitial nephritis
Reproductive system and breast disorders
Very rare:        Gynaecomastia
General disorders and administration site conditions
Uncommon:         Malaise, peripheral oedema
Rare:             Increased sweating

Paediatric population

The safety of omeprazole has been assessed in a total of 310 children aged 0 to 16 years with acid- related disease. There are limited long term safety data from 46 children who received maintenance therapy of omeprazole during a clinical study for severe erosive oesophagitis for up to 749 days.
The adverse event profile was generally the same as for adults in short- as well as in long-term treatment. There are no long-term data regarding the effects of omeprazole treatment on puberty and growth.

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