Who needs progesterone, and who should not take it
Usually needed
Not for, or usually not needed
- Women after a total hysterectomy, who are usually offered estrogen alone [2]
- Women using only low-dose vaginal estrogen, for whom a progestogen is not recommended [3]
- Anyone allergic to peanuts: the FDA-approved capsules contain peanut oil [1]
- Anyone with breast cancer now or in the past, unexplained genital bleeding, liver disease, or a past blood clot, stroke or heart attack [1]
How progesterone protects the uterus
Estrogen makes the lining of the uterus grow. Without a progestogen to balance that growth, the lining can thicken into hyperplasia, which can lead to endometrial cancer. In the three-year PEPI trial of 596 women aged 45 to 64, estrogen alone led to simple hyperplasia in 27.7%, complex hyperplasia in 22.7% and atypical hyperplasia in 11.8%, against 0.8%, 0.8% and 0% on placebo. The groups given estrogen with a progestin, including one on micronized progesterone, had rates like placebo [4].
A 2025 Cochrane review reached the same conclusion: unopposed estrogen probably raises the risk of hyperplasia compared with placebo and with continuous combined therapy, at one year and later [5]. The Menopause Society says that with an adequate progestogen, the risk of endometrial cancer is no higher than in women who take no hormones [6].
The forms
- Micronized progesterone capsules. FDA-approved, as Prometrium® and many generics, in two strengths [7]. The capsules contain peanut oil [1].
- Compounded progesterone. Made by a pharmacy for one patient, for example without peanut oil for someone with a peanut allergy. Not FDA-approved.
- A hormonal IUD. Some physicians use a levonorgestrel IUD to protect the lining instead of capsules; in the US that use is off-label. Read is a Mirena IUD enough progesterone?.
Physicians use either a continuous schedule or a cyclic one, and your physician sets it. Irregular bleeding or spotting was the most common side effect in the trials of an estradiol gel [8], so bleeding you did not expect should always be reported.
How long it takes
- From the startProgesterone starts with your estrogen, not after it. Its job is protection, so you do not feel it working.
- One year and laterThe Cochrane review judged protection of the lining at one year and beyond [5]; the PEPI trial followed women for three years [4].
- OngoingIt continues for as long as you take estrogen for the whole body and have a uterus.
Side effects and risks, in numbers
| Reaction | Progesterone + estrogen | Placebo |
|---|---|---|
| Headache | 31% | 27% |
| Breast tenderness | 27% | 6% |
| Depression | 19% | 12% |
| Dizziness | 15% | 9% |
| Abdominal bloating | 12% | 5% |
| Vaginal discharge | 10% | 3% |
| Hot flashes | 11% | 35% |
- Drowsiness and dizziness. The label warns progesterone may cause short-lived dizziness and drowsiness, so take care driving or using machinery [1]. For what this means for sleep, read does progesterone help sleep?.
- Breast cancer depends on the progestogen. In more than 20 years of Women’s Health Initiative follow-up, estrogen with medroxyprogesterone acetate raised breast cancer incidence (hazard ratio 1.28) and estrogen alone lowered it (0.78) [9]. That trial did not test micronized progesterone.
- Blood clots. In the ESTHER study, micronized progesterone was not linked to clots (odds ratio 0.7), while norpregnane progestins were (3.9) [10]. The Menopause Society says micronized progesterone may be less likely to cause clots than other progestins [6].
What the FDA changed
Prometrium® was the first progestogen-alone product on the FDA’s list of relabeled menopause hormone therapies, on February 12, 2026 [11]. Its current label on DailyMed has no boxed warning [1]. The dated record of the whole change is in the FDA label change tracker.
Is VevaMD’s progesterone FDA-approved?
The progesterone capsules VevaMD’s pharmacies fill come in the same strengths as approved micronized progesterone [7], and a physician can prescribe a compounded version when there is a reason, such as a peanut allergy. The pharmacy has not confirmed in writing which of its capsules are FDA-approved products, so we do not call them FDA-approved. Ask your physician which one you receive.