The most commonly reported adverse drug reactions of patients treated with dydrogesterone in clinical trials of indications without estrogen treatment are vaginal haemorrhage, migraines/headache, nausea, vomiting, abdominal pain, menstrual disorders and breast pain/tenderness.
The following undesirable effects have been observed with the frequencies indicated as follows during clinical trials using dydrogesterone (n=3483) in indications without estrogen treatment, in two company sponsored interventional clinical trials in luteal support as part of an ART treatment using dydrogesterone (n=1036) and from spontaneous reporting. Frequencies are based on the most conservative approach. (See Table 2.)
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Undesirable effects in adolescent population: Based on spontaneous reports and limited clinical trial data, the adverse reaction profile in adolescents is expected to be similar to that seen in adults.
Undesirable effects that are associated with an estrogen-progestogen treatment (see also Precautions and the product information of the estrogen preparation): Breast cancer, endometrial hyperplasia, endometrial carcinoma, ovarian cancer.
Myocardial infarction, coronary artery disease, ischemic stroke.