Important safety information
Progesterone with estrogen. The current FDA prescribing information for Prometrium (progesterone capsules) does not carry a boxed warning. It describes increased risks of blood clots in the legs and lungs, stroke, heart attack and invasive breast cancer in a large study of a different estrogen plus progestin combination, and says the safety and effectiveness of estrogen plus progestogen for preventing heart disease have not been established.
Dizziness and drowsiness. Progesterone capsules may cause dizziness and drowsiness. Take them at bedtime and be careful driving or using machinery. Prometrium capsules contain peanut oil.
Tell your provider if you are allergic to peanuts, have unusual vaginal bleeding, have or have had breast cancer, blood clots, a stroke or heart attack, or liver problems, and if you are pregnant or breastfeeding. Tell your provider about every medication and supplement you take, and before any surgery or bed rest.
The estrogen you take with it has its own safety information, including a boxed warning on endometrial cancer for systemic estrogen used alone, which the FDA kept when it asked for labeling changes on November 10, 2025. Based on the FDA prescribing information for Prometrium (progesterone capsules), revised February 2026. Compounded progesterone capsules are not FDA approved, and the FDA does not review compounded drugs for safety, effectiveness or quality.