Adverse reactions : תופעות לוואי

4.8   Undesirable effects

Summary of the safety profile
The adverse reactions listed below, considered to be possibly or probably related to the administration of argipressin, were reported in 1,588 patients suffering from hypotension following septic shock of which 909 patients have been included in controlled clinical trials.
The most common serious adverse reactions (incidence below 10%) were: Life threatening arrhythmia, mesenteric ischemia, digital ischemia and acute myocardial ischemia.

Tabulated listing of adverse reactions
The adverse reactions that may occur during treatment with Embesin are summarised below and are presented by system organ class and frequency category.
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 available data)

MedDRA system organ         Adverse reaction frequency class (SOC)
Metabolism and              Uncommon: hyponatremia nutrition disorders         Unknown: Water intoxication, diabetes insipidus after discontinuation Nervous system              Uncommon: tremor, vertigo, headache disorders
Cardiac disorders           Common: arrhythmia, angina pectoris, myocardial ischaemia Uncommon: reduced cardiac output, life threatening arrhythmia, cardiac arrest Vascular disorders          Common: peripheral vasoconstriction, necrosis, perioral paleness Respiratory, thoracic       Uncommon: bronchial constriction and mediastinal disorders
Gastrointestinal            Common: abdominal cramps, intestinal ischaemia disorders                   Uncommon: nausea, vomiting, flatulence, gut necrosis Skin and subcutaneous       Common: skin necrosis, digital ischaemia** tissue disorders            Uncommon: sweating, urticaria
General disorders and       Rare: anaphylaxis (cardiac arrest and / or shock) has been observed shortly administration site         after injection of argipressin conditions

Investigations             Uncommon: in two clinical trials some patients with vasodilatory shock showed increased bilirubin and transaminase plasma levels and decreased thrombocyte counts during therapy with argipressin
** Digital ischemia may require surgical intervention in single patients.



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/