From the FDA Drug Label
Stop use and ask a doctor if: • your heartburn continues or worsens • you need to take this product for more than 14 days • you need to take more than 1 course of treatment every 4 months • you get diarrhea • you develop a rash or joint pain
The long term side effects of Ormiloxifene are not directly addressed in the provided drug label.
- The label only mentions conditions under which to stop use and ask a doctor, which may be related to potential side effects, but does not explicitly discuss long-term effects. 1
From the Research
Ormiloxifene can cause several long-term side effects, including menstrual irregularities, ovarian cysts, hormonal effects, weight gain, and rare but serious concerns such as potential effects on bone mineral density and liver function abnormalities, as reported in the most recent study 2.
Common Side Effects
- Menstrual irregularities, such as delayed periods, spotting between periods, and occasionally heavy bleeding
- Ovarian cysts that may develop after months or years of use
- Hormonal effects, including breast tenderness, headaches, and mood changes that may persist with continued use
- Weight gain has been reported in some long-term users
Rare but Serious Concerns
- Potential effects on bone mineral density with prolonged use, though this is less pronounced than with some other hormonal contraceptives
- Isolated reports of liver function abnormalities with extended use
Special Considerations
- Women with a history of blood clotting disorders, liver disease, or certain cancers should avoid long-term use of ormiloxifene
- If experiencing persistent side effects, patients should consult their healthcare provider to discuss alternative options
- Regular follow-up appointments are recommended for women using ormiloxifene long-term to monitor for these potential side effects, as suggested by the study 2 which compared the cost-effectiveness, safety, efficacy, and health-related quality of life of ormeloxifene with medroxyprogesterone acetate in women with non-structural abnormal uterine bleeding.