Adverse reactions : תופעות לוואי

4.8 Undesirable effects

Atenolol is well tolerated. In clinical studies, the undesired events reported are usually attributable to its pharmacological actions of atenolol.
The following undesired events, listed by body system, have been reported with the following frequencies: 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) including isolated reports, not known (cannot be estimated from the available data).

System Organ Class                 Frequency                 Undesirable Effect Blood and lymphatic system         Rare                      Purpura, thrombocytopenia disorders
Psychiatric disorders              Uncommon                  Sleep disturbances of the type noted with other beta blockers
Rare                      Mood changes, nightmares,
confusion, psychoses and hallucinations
Not known                 Depression
Nervous system disorders           Rare                      Dizziness, headache, paraesthesia 
Eye disorders                      Rare                      Dry eyes, visual disturbances Cardiac disorders                  Common                    Bradycardia Rare                      Heart failure deterioration,
precipitation of heart block
Vascular disorders                 Common                    Cold extremities Rare                      Postural hypotension which may be associated with syncope, intermittent claudication may be increased if already present, in susceptible patients
Raynaud's phenomenon
Respiratory, thoracic and          Rare                      Bronchospasm may occur in patients mediastinal disorders                                        with bronchial asthma or a history of asthmatic complaints
Gastrointestinal disorders         Common                    Gastrointestinal disturbances Rare                                 Dry mouth

Hepatobiliary disorders            Uncommon                  Elevations of transaminase levels Rare                      Hepatic toxicity including intrahepatic cholestasis
Skin and subcutaneous tissue       Rare                      Alopecia, psoriasiform skin reactions, disorders                                                    exacerbation of psoriasis, skin rashes Not known                 Hypersensitivity reactions, including angioedema and urticaria
Musculoskeletal and                Not known                 Lupus like connective tissue disorders                                  syndrome Reproductive system and            Rare                      Impotence breast disorders
General disorders and              Common                    Fatigue administration site conditions
Investigations                     Very rare                 An increase in ANA (Antinuclear Antibodies) has been observed,
however the clinical relevance of this is not clear

Discontinuance of the drug should be considered if, according to clinical judgement, the well-being of the patient is adversely affected by any of the above reactions.

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