Adverse reactions : תופעות לוואי

4.8    Undesirable effects

Events from clinical trials:

The table below provides a listing of adverse drug reactions with frequency based on all-causality data from clinical studies that enrolled 2053 women who received DMPA-SC for contraception. The most frequently (>5%) reported adverse drug reactions were headache (8.9%), metrorrhagia (7.1%), weight increased (6.9%), amenorrhoea (6.3%) and injection site reactions (any type, 6.1%).

Adverse reactions are listed according to the following categories. These are as follows: 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)

2022-0080695                              Page 7 of 19

Frequency not known (cannot be estimated from the available data)
Events from post-marketing surveillance:
In addition, adverse events of medical significance obtained from post-marketing data with the use of injectable DMPA (IM or SC) are also included in the list below:

System organ       Very common      Common                Uncommon            Rare            Not known class
Neoplasms                                                                     Breast cancer benign,                                                                       (see section malignant and                                                                 4.4) unspecified
(including cysts and polyps)
Immune system                                             Drug                                 Anaphylactic disorders                                                 hypersensitivity                    reaction, (see section 4.4)                   Anaphylactoid reaction,
Angioedema (see section 4.4)
Metabolism and                                            Fluid retention nutrition                                                 (see section disorders                                                 4.4), Increased appetite,
Decreased appetite


Psychiatric                         Depression,           Nervousness, disorders                           Insomnia,             Emotional
Anxiety,              disorder,
Affective             Anorgasmia disorder,
Irritability,
Libido decreased
Nervous system                      Dizziness,            Migraine,                           Seizure disorders                           Headache              Somnolence
Ear and                                                   Vertigo labyrinth disorders
Cardiac                                                   Tachycardia disorders
Vascular                                                  Hypertension                        Pulmonary disorders                                                 (see section                        embolism, 4.4), Varicose                      Embolism and vein, Hot flush                     thrombosis (see section 4.4),
Thrombophlebitis
Gastrointestinal                    Abdominal             Abdominal disorders                           pain, Nausea          distension
Hepatobiliary                                                                                 Jaundice, Hepatic disorders                                                                                     function abnormal (see section 4.4)
Skin and                            Acne                  Alopecia,           Lipodystrophy   Skin striae subcutaneous                                              Hirsutism,          acquired tissue disorders                                          Dermatitis, 
2022-0080695                               Page 8 of 19
                                                        Ecchymosis,
Chloasma,
Rash, Pruritus,
Urticaria
Musculoskeletal                     Back pain,          Arthralgia,                        Osteoporosis, and connective                      Pain in             Muscle spasms                      Osteoporotic tissue disorders                    extremity                                              fractures Reproductive                        Menometrorr         Ovarian cyst, system & breast                     hagia,              Uterine disorders                           Metrorrhagia        haemorrhage
,                   (irregular,
Menorrhagia         increase,
(see section        decrease),
4.4),               Vaginal
Dysmenorrh          discharge,
oea,                Dyspareunia,
Amenorrhea,         Galactorrhoea,
Vaginitis,          Pelvic pain,
Breast pain         Vulvovaginal dryness,
Premenstrual syndrome,
Breast tenderness,
Breast enlargement
General                             Fatigue,             Pyrexia          Asthenia, disorders and                       Injection site                        Injection site administration                      reaction,                             discolouration site conditions                     Injection site persistent atrophy/inde ntation/ dimpling,
Injection site nodule/lump,
Injection site pain/ tenderness
Investigations                       Weight             Bone density      Weight increased           decreased (see    decreased (see
(see section        section 4.4),     section 4.4)
4.4), Smear         Glucose cervix              tolerance abnormal            decreased (see section 4.4),
Hepatic enzyme abnormal

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/