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.

Very
MedDRA System Organ Class (SOC)                                      Common                    Uncommon          Rare common
Immune system disorders                                                                                          Allergic reaction Metabolism and nutrition disorders                                   Hyperglycemia Psychiatric disorders                                                                          Insomnia Headache
Nervous system disorders
Dizziness
Cardiac disorders                                                    Tachycardia Vascular disorders                                                   Hypotention Hot flush
Gastrointestinal disorders                              Nausea        Vomiting Pruritis
Skin and subcutaneous tissue disorders
Rash
Uterine haemorrage,
Reproductive system and breast disorders
Uterine atony
General disorders and administration site conditions                  Injection site reaction   Pyrexia 
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: 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/