Adverse reactions : תופעות לוואי

4.8 Undesirable effects
Propranolol is usually well tolerated. In clinical studies the undesired events reported are usually attributable to the pharmacological actions of propranolol.
The following undesired events, listed by body system, have been reported.
The following definitions of frequencies are used:
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          Thrombocytopaenia system disorders
Endocrine disorders      Not known     Hypoglycaemia in neonates, infants, children, elderly patients, patients on haemodialysis,
patients on concomitant antidiabetic therapy,
patients with prolonged fasting and patients with chronic liver disease has been reported, seizure linked to hypoglycaemia
Nervous system           Common        Sleep disturbances, nightmares disorders
Rare          Hallucinations, psychoses, mood changes,
confusion, memory loss, paraesthesia
Very rare     Isolated reports of myasthenia gravis like syndrome or exacerbation of myasthenia gravis have been reported
Eye disorders            Rare          Dry eyes, visual disturbances 

Cardiovascular           Common        Bradycardia, cold extremities, Raynaud's disorders                              phenomenon
Rare          Heart failure deterioration, precipitation of heart block, postural hypotension which may be associated with syncope, exacerbation of intermittent claudication
Respiratory, thoracic    Rare          Bronchospasm may occur in patients with and mediastinal                        bronchial asthma or a history of asthmatic disorders                              complaints, sometimes with fatal outcome Gastrointestinal         Uncommon Gastrointestinal disturbance, such as nausea, disorders                         vomiting, diarrhoea
Skin and                 Rare          Purpura, alopecia, psoriasiform skin reactions, subcutaneous tissue                    exacerbation of psoriasis, skin rashes disorders
General disorders        Common        Fatigue and/or lassitude (often transient) and administration
Rare          Dizziness 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. Cessation of therapy with a beta-blocker should be gradual. In the rare event of intolerance, manifested as bradycardia and hypotension, the drug should be withdrawn and, if necessary, treatment for overdosage instituted.
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