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.


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MedDRA System Organ                 Very common               Common            Uncommon              Rare Class (SOC)

Immune system disorders                                                                    Allergic reaction Metabolism and nutrition                          Hyperglycemia disorders
Psychiatric disorder                                                        Insomnia Nervous system disorders                          Headache,
Dizziness
Cardiac disorders                                 Tachycardia
Vascular disorders                                Hypotension,
Hot flush
Gastrointestinal disorders       Nausea           Vomiting
Skin and subcutaneous                                                       Pruritis, tissue disorders                                                            Rash Reproductive system and                                                                    Uterine haemorrhage, breast disorder                                                                            Uterine atony General disorders and                             Injection site reaction   Pyrexia 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 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/