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   Common           Uncommon                  Rare Class                           (<1/10)       (≥1/100 to       (≥1/1,000 to              (≥1/10,000 to <1/10)           <1/100)                   <1/1,000)
Metabolism and nutrition                                       Hyponatraemia disorders

Nervous system disorders                      Headache

Cardiac disorders                             Bradycardia      Atrial fibrillation Ventricular extrasystoles
Tachycardia
Myocardial infarction
Torsade de pointes
Cardiac failure
Cyanosis



Vascular disorders                            Vasoconstriction Hot flush Peripheral ischemia
Pallor
Hypertension


Respiratory, thoracic and      Respiratory    Respiratory      Respiratory distressb Dyspnoeab mediastinal disorders          failurea       distressa        Pulmonary oedemab Dyspnoeaa      Pulmonary        Respiratory failureb oedemaa


Gastrointestinal disorders                    Abdominal pain Nausea
Diarrhoea      Intestinal ischemia
Vomiting

Skin and subcutaneous                                          Skin necrosis tissue disorders

Pregnancy, puerperium and                                       Uterine hypertonus perinatal conditions                                            Uterine ischemia 

General disorders and                                           Injection site necrosis administration site disorders                                   Chest pain 
SOC Infections and                            Sepsis/septic infestations                                  shocka
 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.
b
Applicable 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