Diane-35 Adverse Reactions

cyproterone + ethinylestradiol




Four Star
Full Prescribing Info
Adverse Reactions
There is an increased risk of thromboembolism in all women who use Diane-35 (see Precautions).
This risk can be aggravated by added factors (smoking, hypertension, clotting disorders or disturbances in lipid metabolism, obesity, varicose veins, previous phlebitis and thrombosis), see Precautions.
For further serious side effects, such as liver tumors, cervical and breast cancer, see Precautions.
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.

Click on icon to see table/diagram/image

The following serious adverse reactions have been reported by women who have used Diane-35 and are described in Precautions: Venous thromboembolic disorders; Arterial thromboembolic disorders; Cerebrovascular accidents; Hypertension; Hypertriglyceridaemia; Changes in glucose tolerance or effects on peripheral insulin resistance; Hepatic tumours (benign or malignant); Hepatic dysfunction; Chloasma; Onset or exacerbation of disorders associated with taking COCs, but whose cause has not been clearly established: cholestatic jaundice and/or pruritus, cholelithiasis, porphyria, systemic lupus erythematosus, haemolytic-uraemic syndrome, Sydenham's chorea (chorea minor), herpes gestationis, otosclerosis-related hearing loss, Crohn's disease, ulcerative colitis, cervical cancer; In women with hereditary angioedema, exogenously administered oestrogens can trigger or worsen symptoms of angioedema.
The incidence of breast cancer diagnoses is slightly increased in users of oral contraceptives. As breast cancer rarely occurs in women below 40 years of age, the number of additional breast cancer diagnoses is small in relation to the overall risk of developing breast cancer. For more information, see Contraindications and Precautions.
Effect on breast tissue: Sex hormones affect breast tissue by possibly increasing its susceptibility to other carcinogenic factors. Sex hormones do indeed represent only one among various other possible risk factors unrelated to taking hormonal contraceptives. Epidemiological studies that investigated the possible link between hormonal contraceptives and breast cancer failed to resolve the issue of whether this disease actually does afflict women more frequently prior to middle age who are early, long-term users of oral contraceptives.
Worsening of endogenous depression and epilepsy has also been reported during the use of combined oral contraceptives.
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.
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).
Exclusive offer for doctors
Register for a MIMS account and receive free medical publications worth $768 a year.
Already a member? Sign in
Exclusive offer for doctors
Register for a MIMS account and receive free medical publications worth $768 a year.
Already a member? Sign in