Adverse reactions : תופעות לוואי

4.8   Undesirable effects

The table below provides a listing of adverse drug reactions with frequency based on all-causality data from Phase 3 clinical studies that evaluated efficacy and safety of DMPA in gynaecology. Those most frequently (>5%) reported adverse drug reactions were dysfunctional uterine bleeding (19%), headache (12%) and nausea (10%).

The following lists of adverse reactions are listed within the organ system classes, under headings of frequency (number of patients expected to experience the reaction), using the following categories:
Very common (≥1/10)
Common (≥1/100 to <1/10);
Uncommon (≥1/1000 to <1/100);
Rare (≥1/10,000 to <1/1000);
Very rare (<1/10,000);
Not known (cannot be estimated from the available data).


System Organ          Very Common          Common            Uncommon         Rare ≥        Very         Frequency Not Class                 ≥1/10            ≥ 1/100 to        ≥ 1/1000 to    1/10,000 to     Rare       Known (cannot be < 1/10            < 1/100       < 1/1000        <           estimated from 1/10,000       available data)
Immune system                                  Drug                                                   Anaphylactic reaction, disorders                                 hypersensitivity                                            Anaphylactoid reaction, Angioedema
Endocrine                                                                                                   Anovulation disorders
Psychiatric                                Depression,
disorders                                   Insomnia,
Nervousness
Nervous system           Headache           Dizziness                                                      Somnolence disorders
Vascular                                                                                                  Embolism and disorders                                                                                                  thrombosis Gastrointestinal             Nausea disorders

Skin and                                  Alopecia, Acne,       Hirsutism                                      Rash subcutaneous                                 Urticaria tissue disorders                              Pruritus
Reproductive           Dysfunctional         Cervical        Galactorrhoea                            Amenorrhoea, Uterine system and            uterine bleeding      discharge,                                                  cervical erosion breast disorders         (irregular,       Breast pain,
increase,            Breast decrease,         tenderness spotting)
General                                    Temperature       Oedema, Fluid disorders and                               elevation,       retention administration                               Fatigue site conditions

System Organ      Very Common         Common         Uncommon         Rare ≥        Very       Frequency Not Class             ≥1/10           ≥ 1/100 to     ≥ 1/1000 to    1/10,000 to     Rare      Known (cannot be < 1/10         < 1/100       < 1/1000        <         estimated from 1/10,000     available data)
Investigations                          Weight                                                 Glucose tolerance increased                                               decreased, Weight decreased


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/