Adverse reactions : תופעות לוואי

4.8         Undesirable effects
For serious undesirable effects in COC users see also section 4.4.

The following adverse drug reactions have been reported during use of YAZ: 
The table below reports adverse reactions by MedDRA system organ classes (MedDRA SOCs).
The frequencies are based on clinical trial data. The most appropriate MedDRA term is used to describe a certain reaction and its synonyms and related conditions.

Adverse drug reactions which have been associated with the use of YAZ as oral contraceptive or in the treatment of moderate acne vulgaris according to the MedDRA system organ classes and MedDRA terms
System Organ Class         common            uncommon             rare                        not known (MedDRA version            (≥1/100 to <1/10) (≥1/1,000 to <1/100) (≥1/10,000 to               (cannot be 9.1)                                                              <1/1,000)                   estimated from the available data)
Infections and                                                       Candidiasis infestations
Blood and lymphatic                                                  Anemia system disorders                                                     Thrombocythemia System Organ Class     common            uncommon             rare                 not known (MedDRA version        (≥1/100 to <1/10) (≥1/1,000 to <1/100) (≥1/10,000 to        (cannot be 9.1)                                                          <1/1,000)            estimated from the available data)
Immune system                                                 Allergic reaction    Hypersensitivity disorders
Exacerbation of symptoms of hereditary and acquired angioedema
Endocrine disorders                                           Endocrine disorder Metabolism and                                                Increased appetite nutrition disorders                                           Anorexia Hyperkalemia
Hyponatremia
Psychiatric disorders Emotional lability   Depression         Anorgasmia Nervousness        Insomnia
Somnolence
Nervous system         Headache            Dizziness          Vertigo disorders                                  Paresthesia        Tremor
Eye disorders                                                 Conjunctivitis Dry eye
Eye disorder
Cardiac disorders                                             Tachycardia Vascular disorders                         Migraine           Phlebitis Varicose vein      Vascular disorder
Hypertension       Epistaxis
Syncope
Venous thrombo- embolism (VTE)
Arterial thrombo- embolism (ATE)
Gastrointestinal       Nausea              Abdominal pain     Abdomen enlarged disorders                                  Vomiting           Gastrointestinal Dyspepsia          disorder
Flatulence         Gastrointestinal
Gastritis          fullness
Diarrhea           Hiatus hernia
Oral candidiasis
Constipation
Dry mouth
Hepatobiliary                                                 Biliary pain disorders                                                     Cholecystitis System Organ Class       common            uncommon             rare                      not known (MedDRA version          (≥1/100 to <1/10) (≥1/1,000 to <1/100) (≥1/10,000 to             (cannot be 9.1)                                                            <1/1,000)                 estimated from the available data)
Skin and                                    Acne                   Chloasma               Erythema subcutaneous tissue                         Pruritus               Eczema                 multiforme disorders                                   Rash                   Alopecia Dermatitis acneiform
Dry skin
Erythema nodosum
Hypertrichosis
Skin disorder
Skin striae
Contact dermatitis
Photosensitive dermatitis
Skin nodule
Musculoskeletal and                         Back pain connective tissue                           Pain in extremity disorders                                   Muscle cramps
Reproductive system Breast pain             Vaginal candidiasis    Dyspareunia and breast disorders Metrorrhagia*          Pelvic pain            Vulvovaginitis Amenorrhea             Breast enlargement     Postcoital bleeding
Fibrocystic breast     Withdrawal bleeding
Uterine / Vaginal      Breast cyst bleeding*              Breast hyperplasia
Genital discharge      Breast neoplasm
Hot flushes            Cervical polyp
Vaginitis              Endometrial atrophy
Menstrual disorder     Ovarian cyst
Dysmenorrhea           Uterine enlargement
Hypomenorrhea
Menorrhagia
Vaginal dryness
Papanicolaou smear suspicious
Libido decreased
General disorders                           Asthenia               Malaise and administration                          Sweating increased site conditions                             Oedema
(Generalized oedema,
Peripheral oedema,
Face oedema)
Investigations                              Weight increase        Weight decrease * bleeding irregularities usually subside during continued treatment


Description of selected adverse reactions
An increased risk of arterial and venous thrombotic and thrombo-embolic events, including myocardial infarction, stroke, transient ischemic attacks, venous thrombosis and pulmonary embolism has been observed in women using CHCs, which are discussed in more detail in section 4.4.


The following serious adverse events have been reported in women using COCs, which are discussed in section 4.4 Special warnings and precautions for use:
-   Venous thromboembolic disorders;
-   Arterial thromboembolic disorders;
-   Hypertension;
-   Liver tumours;
-   Occurrence or deterioration of conditions for which association with COC use is not conclusive: Crohn’s disease, ulcerative colitis, epilepsy, uterine myoma, porphyria, systemic lupus erythematosus, herpes gestationis, Sydenham's chorea, haemolytic uremic syndrome, cholestatic jaundice;
-   Chloasma;
-   Acute or chronic disturbances of liver function may necessitate the discontinuation of COC use until markers of liver function return to normal.


The frequency of diagnosis of breast cancer is very slightly increased among COC users. As breast cancer is rare in women under 40 years of age the excess number is small in relation to the overall risk of breast cancer. Causation with COC use is unknown. For further information, see sections 4.3 and 4.4.

Interactions
Breakthrough bleeding and/or contraceptive failure may result from interactions of other drugs (enzyme inducers) with oral contraceptives (see section 4.5).


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