Duphaston Adverse Reactions

The most commonly reported adverse drug reactions of patients treated with dydrogesterone in clinical trials of indications without estrogen treatment are migraines/headache, nausea, menstrual disorders and breast pain/tenderness.
The following undesirable effects have been observed with the frequencies indicated in Table 2 during clinical trials using dydrogesterone (n=3483) in indications without estrogen treatment and from spontaneous reporting: See Table 2.

Click on icon to see table/diagram/image

LOTUS I study for luteal support as part of an Assisted Reproductive Technology (ART) treatment (see Pharmacology: Pharmacodynamics under Actions): The most frequently reported events were: vaginal hemorrhage, nausea, procedural pain, headache, abdominal pain, and biochemical pregnancy.
The only related treatment emergent adverse event (TEAE) reported in ≥ 2% of subjects in either treatment group was vaginal hemorrhage.
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 Precautions and the product information of the estrogen preparation): Breast cancer, endometrial hyperplasia, endometrial carcinoma, ovarian cancer; venous thromboembolism; myocardial infarction, coronary artery disease, ischemic stroke.