Adverse reactions : תופעות לוואי

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

Tabulated list of adverse reactions
There are adverse reactions that appear twice in the table, as the estimated frequencies differ between indications.

MedDRA System Organ         Very common                                                                            Rare Class                          (<1/10)                   Common                         Uncommon               (1/10,000 to (1/100 to <1/10)              (1/1,000 to <1/100)         <1/1,000) Metabolism and                                                               Hyponatraemia nutrition disorders
Nervous system                              Headache disorders
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      Respiratory      Respiratory distressa            Respiratory distressb            Dyspnoeab and mediastinal            failurea
Pulmonary oedemaa                Pulmonary oedemab disorders
Dyspnoeaa                                         Respiratory failureb Gastrointestinal                            Abdominal pain                   Nausea disorders                                                                    Intestinal ischemia Diarrhoea                        Vomiting
Skin and subcutaneous                                                        Skin necrosis tissue disorders
Pregnancy, puerperium                                                        Uterine hypertonus and perinatal conditions
Uterine ischemia
General disorders and                                                        Injection site necrosis administration site
Chest pain disorders
SOC Infections and                          Sepsis / septic shocka infestations a Applicable to type 1 hepatorenal syndrome. Frequencies are calculated based on the pooled safety population in the OT-0401, REVERSE and CONFIRM clinical trials.
bApplicable to other approved indications apart from type 1 hepatorenal syndrome.


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/