Adverse reactions : תופעות לוואי

4.8.   Undesirable Effects

Adverse events are described by system organ class and frequency (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) in the table below:

MedDRA
Frequency             Undesirable Effects
System Organ Class
Metabolism and nutrition       Uncommon              Decreased appetite disorders
Psychiatric disorders          Uncommon              Insomnia
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Nervous system disorders             Very common          Migraine, Sinus headache, Headache Uncommon             Dizziness
Cardiac disorders                    Uncommon             Angina pectoris, Tachycardia Respiratory, thoracic and            Uncommon             Dyspnoea mediastinal disorders
Gastrointestinal disorders           Very common          Constipation, Abdominal pain, Abdominal discomfort
Common               Haematochezia, Haemorrhoidal haemorrhage,
Abdominal distention, Dyspepsia, Nausea,
Vomiting, Diarrhoea, Flatulence, Eructation
Uncommon             Peptic ulcer and bleeding, Haemorrhoids,
Impaction
Hepatobiliary disorders              Uncommon             Cholecystitis, Cholelithiasis 
Skin and subcutaneous                Common               Rash tissue disorders                     Uncommon             Urticaria, Dermatitis Musculoskeletal and                  Common               Arthritis, Arthralgia, Back pain, connective tissue disorders                               Musculoskeletal pain, Pain in extremity General disorders and                Common               Fatigue administration site conditions                           Uncommon             Chest pain, Oedema peripheral, Asthenia Investigations                       Uncommon             Alanine aminotransferase increased, Aspartate aminotransferase increased,
Blood alkaline phosphatase increased


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/