Description
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Side Effect
The most frequently described adverse events against the background of taking a combination of levonorgestrel + ethinyl estradiol are nausea, abdominal pain, weight gain, headache, mood decline, mood changes, breast tenderness, breast swelling. These phenomena occur in ≥1% of patients. Serious adverse events are arterial and venous thromboembolism. Adverse events (according to the MedDRA classification), the connection of which with the intake of COCs has not been confirmed, but has not been refuted, are listed below. From the side of the organ of vision: rarely – intolerance to contact lenses (unpleasant sensations when wearing them). From the gastrointestinal tract: often – nausea, abdominal pain; infrequently – vomiting, diarrhea. From the immune system: rarely – hypersensitivity. From the side of metabolism and eating disorders: infrequently – fluid retention. From the nervous system: often – headache; infrequently – migraine. Mental disorder: often – a decrease in mood, mood swings; infrequently – a decrease in libido; rarely – an increase in libido. From the genitals and breast: often – tenderness of the mammary glands, swelling of the mammary glands; infrequently – hypertrophy of the mammary glands; rarely – discharge from the genital tract, discharge from the mammary glands. From the skin and subcutaneous tissues: infrequently – rash, urticaria; rarely – nodular erythema, erythema multiforme. From the side of the vessels: rarely – venous and arterial thromboembolic complications (estimated frequency according to epidemiological studies in women who have used COCs), which combine such nosological forms as occlusion of peripheral deep veins, thrombosis and thromboembolism / occlusion of pulmonary vessels, thrombosis, embolism and infarction / myocardial infarction / cerebral infarction and stroke, not classified as hemorrhagic. Common disorders: often – an increase in body weight; rarely – a decrease in body weight. The following are adverse events with a very low frequency or delayed development of symptoms that are presumably associated with taking COCs (see also “Contraindications” and “Precautions”). Tumors – In women using COC, the incidence of breast cancer detection is very slightly increased. Since breast cancer is rare in women under 40 years of age, the increase in the incidence of cancer in women using COC is insignificant in relation to the overall risk of breast cancer. A causal relationship with the use of COC has not been identified. – Liver tumors (benign and malignant). Other states – Women with hypertriglyceridemia (increased risk of pancreatitis when using COCs). – Increase in blood pressure. – The onset or deterioration of conditions in which the connection with the use of COCs is not indisputable — jaundice and/ or itching associated with cholestasis; formation of gallstones; porphyria; systemic lupus erythematosus; hemolytic-uremic syndrome; Sydenham chorea; herpes during pregnancy; hearing loss associated with otosclerosis. – Women with hereditary aigioneurotic edema – exogenous estrogens can cause or exacerbate the symptoms of angioedema. – Impaired liver function. – Impaired glucose tolerance or the effect on peripheral insulin resistance. – Crohn’s disease, ulcerative colitis. – Chloasma.
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