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 clinical studies that enrolled more than 4200 women who received DMPA for contraception for up to 7 years. Those most frequently (>5%) reported adverse drug reactions were weight increased (69%), weight decreased (25%), headache (16%), nervousness (11%), abdominal pain or discomfort (11%), dizziness (6%), and decrease in libido (6%).

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 Class          Very           Common           Uncommon            Rare ≥ 1/10,000 to < 1/1000 Common          ≥ 1/100 to       ≥ 1/1000 to
≥1/10            < 1/10           < 1/100
Neoplasms Benign,                                                                           Breast cancer Malignant and
Unspecified (Incl. Cysts and Polyps)
Blood and lymphatic                                                                 Anaemia, Blood disorder system disorders
Immune system                                                     Drug               Anaphylactic reaction, disorders                                                    hypersensitivity        Anaphylactoid reaction, Angioedema
Metabolism &                                                    Increased Nutrition Disorder                                               appetite, decreased appetite
Psychiatric disorders      Nervousness      Depression,         Insomnia             Anorgasmia, Emotional Libido                             disturbance, Effective disorder,
decreased                                     Irritability,
Anxiety

System Organ Class      Very          Common           Uncommon             Rare ≥ 1/10,000 to < 1/1000 Common         ≥ 1/100 to       ≥ 1/1000 to
≥1/10           < 1/10           < 1/100
Nervous system           Headache       Dizziness          Seizure,           Migraine, Paralysis, Syncope disorders                                                Somnolence,
Paraesthesia
Ear and Labyrinth                                                                       Vertigo Disorder
Cardiac disorder                                                                     Tachycardia Vascular disorders                                         Hot flush           Embolism and thrombosis, Deep vein thrombosis,
Thrombophlebitis,
Hypertension, Varicose veins
Respiratory, thoracic,                                     Dyspnoea              Pulmonary embolism and mediastinal disorders
Gastrointestinal         Abdominal       Nausea,                                 Rectal haemorrhage, disorders                   pain,       Abdominal                               Gastrointestinal disorder Abdominal      distension discomfort
Hepatobiliary                                           Hepatic function   Jaundice, Hepatic enzyme abnormal disorders                                                  abnormal
Skin and subcutaneous                 Alopecia, Acne,     Hirsutism,           Lipodystrophy acquired*, tissue disorders                           Rash            Urticaria,          Dermatitis, Ecchymosis, Pruritus,           Scleroderma, Skin striae
Chloasma
Musculoskeletal and                     Back pain,                            Arthralgia, Muscle spasms, connective tissue                          Pain in                             Osteoporosis, Osteoporotic disorders                                extremity                                       fractures Reproductive system                       Vaginal        Dysfunctional          Vaginitis, Amenorrhoea, and breast disorders                     discharge,     uterine bleeding       Breast pain, Metrorrhagia, Breast          (irregular,              Menometrorrhagia,
tenderness,         increase,    Menorrhagia,Vulvovaginal dryness,
Dysmenorrhea,         decrease,         Breast atropy, Ovarian cyst,
Genitourinary         spotting,           Premenstrual syndrome,
tract infection    Galactorrhoea          Endometrial hyperplasia,
Pelvic pain,       Breast mass, Nipple exudate
Dyspareunia,        bloody, Vaginal cyst, Breast
Suppressed        enlargement, Lack of return to lactation      fertility, Sensation of pregnancy
General disorders and                  Odema/Fluid        Chest pain        Pyrexia, Fatigue, Injection site administration site                     retention,                        reaction*, Injection site persistent conditions                              Asthenia                            atrophy/indentation/dimpling*, Injection site nodule/lump*,
Injection site pain/tenderness*
Thirst, Dysphonia, VIIth nerve paralysis, Axillary swelling
Investigation              Weight                                         Bone density decreased, Glucose increased,                                                tolerance decreased, Weight                                               Cervical smear abnormal decreased
*ADR identified post-marketing
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/