Adverse reactions : תופעות לוואי

4.8 Undesirable effects
Possible adverse reactions of atosiban were described for the mother during the use of atosiban in clinical trials. In total 48% of the patients treated with atosiban experienced adverse reactions during the clinical trials. The observed adverse reactions were generally of a mild severity. The most commonly reported adverse reaction in the mother is nausea (14%).

For the newborn, the clinical trials did not reveal any specific adverse reactions of atosiban. The infant adverse reactions were in the range of normal variation and were comparable with both placebo and beta-mimetic group incidences.

The frequency of adverse reactions listed below is defined using the following convention: 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). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
MedDRA System               Very     Common                               Uncommon       Rare Organ Class (SOC)           common

Immune system                                                                            Allergic reaction disorders
Metabolism and                       Hyperglycaemia nutrition disorders
Psychiatric disorders                                                     Insomnia Nervous system                       Headache disorders                            Dizziness
Cardiac disorders                    Tachycardia
Vascular disorders                   Hypotension
Hot flush
Gastrointestinal            Nausea   Vomiting disorders

Skin and                                                                   Pruritis subcutaneous tissue                                                        Rash disorders
Reproductive system                                                                      Uterine haemorrage, and breast disorders                                                                     Uterine atony General                              Injection site reaction              Pyrexia disorders and administration site conditions


Post-marketing experience
Respiratory events like dyspnoea and pulmonary oedema, particularly in association with concomitant administration of other medicinal products with tocolytic activity, like calcium antagonists and beta- mimetics, and/or in women with multiple pregnancy, have been reported post-marketing.

Reporting of suspected adverse reactions:
Reporting suspected adverse reactions after authorization 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/