Dienille Adverse Reactions

There is an increased risk of venous and arterial thromboembolism (e.g. venous thrombosis, pulmonary embolism, stroke, heart attack) for women taking combined oral contraceptives. Certain factors such as smoking, hypertension, disorders of blood clotting and lipid metabolism, severe obesity, varicose veins, advanced phlebitis and thrombosis may increase the risk of venous and arterial thromboembolism. For the most severe side effects in women taking combined oral contraceptives see PRECAUTIONS.
In the next table the undesirable effects of dienogest 2 mg / ethinylestradiol 0.03 mg tablets are listed in order of decreasing frequency. These are the frequencies of side effects observed during clinical tests with dienogest 2 mg / ethinylestradiol 0.03 mg tablets (a total of 3590 women participated in these studies); the appearance of these side effects can be linked to the use of Dienille. Since all the side effects were rarer than 1/10, none of the undesirable effects occurred "very common".
The following classification was used to specify the frequency of side effects: Very common (≥ 1/10), Common (≥1/100 and < 1/10), Uncommon (≥ 1/1,000 and < 1/100), Rare (≥ 1/10,000 and < 1/1,000), Very rare (< 1/10,000), not known (cannot be estimated from the available data).
The following undesirable effects were reported during studies conducted with dienogest 2 mg / ethinylestradiol 0.03 mg Dienille: (See table.)

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In women taking combined oral contraceptives the following undesirable effects have been reported: venous or arterial thromboembolism; hypertension; liver tumors; development or worsening of disorders upon application of combined oral contraceptives, such as Crohn's disease, ulcerative colitis, porphyria, systemic lupus erythematosus, herpes gestationis, Sydenham-chorea, haemolytic uraemic syndrome, cholestatic jaundice; chloasma.
The risk of breast cancer is slightly increased in women taking combined oral contraceptives. However, since the risk of development of breast cancer below the age of 40 is small, the risk of breast cancer is small compared to the total risk. For further information see CONTRAINDICATIONS and PRECAUTIONS.
In women with hereditary angioedema exogenous estrogens may induce or exacerbate symptoms of angioedema.
For further information see CONTRAINDICATIONS and PRECAUTIONS.