Adverse reactions : תופעות לוואי

4.8   Undesirable effects
The following undesirable effects include all reported side effects following treatment with acetylsalicylic acid, including those following long-term high-dose therapy in rheumatoid arthritis patients. Apart from isolated cases, the incidence figures are based on short-term use of daily doses of not more than 3 g acetylsalicylic acid.

The evaluation of adverse effects is based on the following frequency rates: 
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: Frequency cannot be estimated from the available data.

Blood and lymphatic system disorders:
In rare to very rare cases serious bleeding has been reported, e.g. cerebral bleeding, especially in patients with uncontrolled hypertension and/or simultaneous treatment with anticoagulants, which in isolated cases may be life-threatening.
Haemolysis and haemolytic anaemia have been reported in patients with severe glucose- 6-phosphate dehydrogenase deficiency.
Bleeding, e.g. epistaxis, bleeding of gums, bruising or genitourinary bleeding with possible prolongation of bleeding time (see section 4.4). This effect can persist for 4 to 8 days after use.

Gastrointestinal disorders:
Common:
Gastrointestinal disorders such as heartburn, nausea, vomiting, abdominal pain.
Rare:
Gastrointestinal ulcers, which in very rare cases can lead to perforation.
Gastrointestinal bleeding, which in very rare cases can lead to iron-deficiency anaemia.
Gastrointestinal inflammation.
Not known:
In the event of prior damage to the intestinal mucosa, multiple membranes can form in the intestinal lumen, which may result in subsequent stenosis (particularly with long-term treatment).

Nervous system disorders
Headache, dizziness, impaired hearing, tinnitus and mental confusion can be signs of overdose (see section 4.9).

Skin and subcutaneous tissue disorders:
Uncommon:
Hypersensitivity reactions such as skin reactions.
Rare:
Hypersensitivity reactions such as severe skin reactions (including erythema multiforme exudativum).

Immune system disorders:
Rare:
Hypersensitivity reactions of the respiratory tract, gastrointestinal tract and cardiovascular system, especially in asthmatic patients.
Possible symptoms are: Drop in blood pressure, dyspnoea attacks, rhinitis, nasal congestion, anaphylactic shock or angio-oedema.
      Hepatobiliary disorders:
Very rare:
Elevated hepatic enzyme values.

Renal and urinary disorders:
Renal impairment and acute renal failure have been reported.

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/