Adverse reactions : תופעות לוואי

4.8           Undesirable effects
In case of an adverse reaction, the dose of Esmolol can be reduced or discontinued.
Most of the adverse reactions observed have been mild and transient. The most important adverse reaction is hypotension.
The following terminologies have been used in order to classify the occurrence of undesirable effects: 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 availabledata) Nervous system disorders
– Common: paraesthesiae, disturbance in attention,dizziness1, somnolence, headache – Uncommon: convulsions, syncope, dysgeusia, speech disorder
Cardiac disorders
– Uncommon: bradycardia, atrioventricular block
– Very rare: sinus arrest, asystole
Eye disorders
– Uncommon: visual impairment
Respiratory, thoracic and mediastinal disorders
– Uncommon: bronchospasm, wheezing, dyspnoea, nasal congestion, pulmonary oedema, rhonchi, rales Gastrointestinal disorders
– Common: nausea, vomiting
– Uncommon: dyspepsia, constipation, mouth dryness,abdominal pain
Renal and urinary disorders
– Uncommon: urinary retention
Skin and subcutaneous tissue disorders
– Very common: diaphoresis
– Uncommon: erythema2, skin discolouration 2
– Very rare: skin necrosis due to extravasation 2
– Not known: psoriasis3
Musculoskeletal and connective tissue disorders
– Uncommon: musculoskeletal pain
Metabolism and nutrition disorders
– Common: anorexia
Vascular disorders
– Very common: hypotension
– Uncommon: peripheral ischaemia, pallor, flushing
– Very rare: thrombophlebitis2
General disorders and administration site conditions
– Common: asthenia, fatigue, injection site reaction, infusion site reaction, infusion site inflammation, infusion site induration – Uncommon: chest pain, oedema2, pain2, infusion site burning, fever and chills Psychiatric disorders:
–      Common: depression, anxiety, confusional state,agitation
–      Uncommon: thinking abnormal
1     Dizziness and diaphoresis are in association with symptomatic hypotension.
2     In association with Injection and Infusion site reactions.
3     Beta-blockers as a drug class can cause psoriasis in some situations or worsen it.
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/