Diane-35 Adverse Reactions

Summary of the safety profile: The most commonly reported undesirable effects associated with Diane-35 are nausea, abdominal pain, weight gain, headache, depression, mood swings, breast pain and breast tenderness. They occur in > 1% to < 10% of all users.
There is an increased risk of thromboembolism in all women who use Diane-35 (see Precautions).
Table of undesirable effects: Side effects that have been reported in users of Diane-35, but for which the association has been neither confirmed nor refuted, are: See Table 2.

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Description of selected undesirable effects: An increased risk of arterial and venous thrombotic and thromboembolic events, including myocardial infarction, stroke, transient ischaemic attacks, venous thrombosis and pulmonary embolism, has been observed in women using oestrogen-progestogen combinations, and these are discussed in more detail in Precautions.
The following serious adverse reactions have been reported by women who have used oestrogen-progestogen combinations and are described in Precautions: Venous thromboembolism; Arterial thromboembolism; Hypertension; Hepatic tumours (benign or malignant); Occurrence or deterioration of conditions which have not been conclusively proven to be associated with the use of combined oestrogen-progestogen contraceptives: Crohn's disease, ulcerative colitis, epilepsy, uterine myomas, porphyria, systemic lupus erythematosus, pemphigoid gestationis, Sydenham's chorea, haemolytic-uraemic syndrome, cholestatic jaundice; Chloasma; Acute or chronic liver dysfunction may necessitate the discontinuation of COCs until liver function markers return to normal.
The frequency with which breast cancer is diagnosed is slightly increased in users of oestrogen-progestogen combinations. As breast cancer rarely occurs in women below 40 years of age, the additional risk of developing breast cancer is small in relation to the overall risk. Causality with the use of oestrogen-progestogen combinations is not known. For more information, see Contraindications and Precautions.
If symptoms have significantly worsened recently in women who suffer from hirsutism, the causes of this (androgen-producing tumor, enzyme defect in the adrenal cortex) must be clarified by differential diagnosis.
Interactions: Intermenstrual bleeding and/or contraceptive ineffectiveness may occur as a result of interactions between oestrogen-progestogen combinations and other medicinal products (enzyme-inducing medicines) (see Interactions).
Effect on clinical chemistry normal values: The erythrocyte sedimentation rate can increase without a disease being present. There have also been reports of increased serum copper and serum iron levels, as well as alkaline leukocyte phosphatase activity.
Other metabolic functions: Infrequent disturbances in folic acid and tryptophan metabolism may occur.
Taken regularly, Diane-35 has a contraceptive effect due to its composition. The irregular intake of Diane-35 can lead to irregular menstrual cycles. The regular intake of Diane-35 is very important in preventing both cycle irregularities and pregnancy (because of a possible effect of cyproterone acetate on a developing child).
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.