Adverse reactions : תופעות לוואי

4.8 Undesirable effects
The most commonly reported undesired effects in clinical trials are paleness, increased blood pressure, abdominal pain, nausea, diarrhoea, and headache.

Tabulated list of adverse reactions\

MedDRA System Organ Class       Common                Uncommon                       Rare (1/100 to <1/10)     (1/1,000 to <1/100)           (1/10,000 to <1/1,000) 

Metabolism and nutrition                              Hyponatraemia disorders
Nervous system disorders        Headache
Cardiac disorders               Bradycardia           Atrial fibrillation 
Ventricular extracystoles

Tachycardia


Myocardial infarction
Torsade de pointes

Cardiac failure

Cyanosis


Vascular disorders              Vasoconstriction
Peripheral ischemia

Pallor                Hot flush

Hypertension
Respiratory, thoracic and                             Respiratory distress           Dyspnoea mediastinal disorders
Pulmonary oedema

Respiratory failure
Gastrointestinal disorders      Abdominal pain        Nausea

Intestinal ischemia

Diarrhoea             Vomiting
Skin and subcutaneous tissue                          Skin necrosis disorders
Pregnancy, puerperium and                             Uterine hypertonus perinatal conditions
Uterine ischemia
General disorders and                                 Injection site necrosis administration site disorders                         Chest pain
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/