Contents
- Does vaginal estrogen increase risk of cancer and heart disease?
- Does vaginal estrogen raise estrogen levels?
- What we know about the risks and safety of vaginal estrogen
- Is vaginal estrogen associated with endometrial cancer?
- Can you take vaginal estrogen if you have a history of breast cancer?
- What are the side effects associated with vaginal estrogen?
- Next steps
Introduction
If you’re going through menopause or well beyond it, you may be experiencing firsthand the effects of lower levels of the hormone estrogen. Vaginal dryness, pain with sex, UTIs, and urgency are all hallmark symptoms of menopause due to low estrogen, or what's medically termed vaginal atrophy or the genitourinary syndrome of menopause (GSM).
Adding estrogen back to the vulva and vagina can not only bring relief - it can help protect your long-term health and quality of life.
And while a trusted medical provider may have prescribed vaginal estrogen to help treat and prevent your symptoms, you may still have questions about its safety. That’s because what your doctor explained to you might differ from the information you’re reading in the package insert.
In this article, we will dive into the literature, research, and expert opinions on vaginal estrogen so that you can feel informed and educated about your treatment options.
Does vaginal increase risk of cancer and heart disease?
Many women are rightfully concerned about the risk of cancer and heart disease with the use of estrogen products. That's because when you open your box of vaginal estrogen, you’ll read an FDA black box warning label that says estrogens can increase your risk of cancer and heart disease.[1]
However, there is strong consensus among medical professionals that these risks do not apply to vaginal estrogen and that the labeling is inaccurate.
The warning label is based on evidence from a 2002 clinical study of oral estrogen. Importantly, oral estrogen is prescribed in higher doses, while vaginal estrogen is prescribed in lower doses.
In 2018, two large analyses were published that support the safety of vaginal estrogen. Both analyses concluded there is no evidence that vaginal estrogen increases the risk of cancer and heart disease.[2][3]
For years, women's health medical associations have argued that the warning label unnecessarily frightens women.[6] In 2025, the FDA announced it is initiating removal of the black box warning from all menopausal hormone therapy products, including both vaginal estrogen and systemic estrogen.
The Menopause Society supports removal of the warning from vaginal estrogen, noting that the label has previously deterred women from a "safe and effective therapy for a condition that affects most menopausal women". Importantly, the Menopause Society does not support removing the warning from systemic estrogen products (such as the estrogen pill or patch) since those deliver estrogen throughout the entire body at higher doses and do carry some real risks that women should be informed about.
Does vaginal estrogen raise estrogen levels?
Vaginal estrogen is a local therapy and is not shown to raise estrogen levels significantly throughout the body.
When considering treatments for vaginal and urinary health in menopause, it’s key to understand that there are two main types of menopause hormone therapy:
- Systemic hormones are taken as a pill or applied as a patch.
- Local therapy that’s applied to the vagina as a vaginal estrogen cream, vaginal estrogen insert, or vaginal ring.
Systemic hormones are absorbed in the bloodstream and can circulate throughout the entire body - which explains the potential health risks. But vaginal estrogen is applied only to affected areas and generally does not elevate blood estrogen levels beyond what’s considered normal for postmenopausal women.[4][5]
Vaginal estrogen products approved by the FDA
| Brand name | Does data show blood estrogen levels are within normal range? |
|---|---|
| Estrace vaginal cream |  Yes*
|
| Premarin vaginal cream | Yes |
| Yuvafem or Vagifem vaginal insert | Yes |
| Estring vaginal ring | Yes |
While there are possible health risks associated with systemic hormones, the expert opinion of The Menopause Society is that these risks are unlikely when using vaginal estrogen, since there is minimal absorption in the bloodstream.
What do we know about the risks and safety of vaginal estrogen?
Large amounts of clinical data point toward the safety of vaginal estrogen. For example, two large analyses concluded that vaginal estrogen is not shown to increase risk of cancer or heart disease.
According to a 2018 analysis of data from the WHI Observational Study, there was no difference in health risks between people who used vaginal estrogen and people who did not.[3] The findings are consistent with a 2018 analysis of clinical data from another large study called The Nurses’ Health Study.
Health risks of people who use vaginal estrogen compared to people who don’t use vaginal estrogen
| Risk of stroke | No increased risk |
| Risk of invasive breast cancer | No increased risk |
| Risk of colorectal cancer | No increased risk |
| Risk of endometrial cancer | No increased risk |
| Risk of pulmonary embolism/deep vein thrombosis | No increased risk |
| Risk of coronary heart disease | No increased risk |
| Risk of fracture | No increased risk |
| Risk of all-cause mortality | No increased risk |
| Risk of GIE | No increased risk |
Is vaginal estrogen associated with endometrial cancer?
Clinical data shows that vaginal estrogen is not associated with endometrial cancer. But the endometrial safety is not studied in clinical trials beyond one year.
The Menopause Society states that while there is reassuring evidence that vaginal estrogen is not associated with an increased risk of endometrial cancer, more research is needed regarding long-term use.[4]
Regardless of whether you are taking vaginal estrogen, endometrial cancer is rare. But here are some general guidelines:
- You don’t need to be monitored for endometrial cancer if you are using vaginal estrogen.
- Take note of any vaginal bleeding. Vaginal bleeding outside of your menstrual cycle could indicate a serious condition.
- If you experience vaginal bleeding, it should be assessed by a primary care physician or gynecologist.
Can you take vaginal estrogen after breast cancer?
Yes. Women with a history of breast cancer can take vaginal estrogen with approval from their oncologist.
According to a 2021 expert opinion from the American College of Gynecologists published in 2021, women with a history of breast cancer may consider using vaginal estrogen at the lowest effective dose if non-hormonal treatments are not adequate to address symptoms.
Remember, if you wish to try vaginal estrogen, clear it with your oncologist first. Before your appointment, you should prepare to communicate your values, preferences, and symptom severity and then seek to understand the potential risks in your unique case.
What are the side effects associated with vaginal estrogen?
Side effects associated with the use of vaginal estrogen can include vaginal discharge, yeast infection, irritation at the site of application, vaginal bleeding.
Vaginal bleeding should be reported to your doctor for evaluation. Bleeding may be present due to thin and fragile skin. Your doctor can help evaluate if it's something more serious.
Yeast infections or itching and burning can happen as the body adjusts to the healthy benefits of estrogen. But the cream base in the generic estradiol cream can also be irritating. This doesn't mean you should give up on vaginal estrogen. Talk to your doctor about treating any yeast infection and exploring other options with different formulations:
- Our Soothing Estradiol Cream is formulated with soothing ingredients like hyaluronic acid, aloe, and vitamin E.
- We also offer estradiol suppositories 10mcg, an FDA-approved generic vaginal estrogen suppository that's a tiny dissolvable tablet with no cream base.
Vaginal discharge may occur as the body adjusts to absorbing the medication. If the vaginal cream is too messy, talk to your doctor about using your finger to rub in the cream or switching to a suppository form of treatment.
Next steps
While the latest scientific research points to the safety of vaginal estrogen, the information on the product label can understandably cause confusion or fear. Therefore, discussing your symptoms and goals with a trusted medical provider is key.
When it comes to treating vaginal and urinary symptoms from menopause, you have options.
- Moisturizers and lubricants. As an initial solution, you might try vaginal moisturizers or lubricants like coconut oil. These treatments are available over the counter, and can relieve dryness, itching, and discomfort.
- Vaginal estrogen. If you’re not getting relief from moisturizers and lubricants, then it may be time to consider vaginal estrogen. Vaginal estrogen can help reverse vaginal atrophy, restore vaginal moisture, and prevent UTIs. Vaginal estrogen can also help keep the vaginal pH at healthy levels. While vaginal estrogen is available over the counter in countries like the UK, it’s available only as a prescription in the United States.
- Other options. In addition to vaginal estrogen, the FDA has also approved vaginal DHEA, systemic estrogen therapy, and Ospemifene for the treatment of vaginal and urinary symptoms.
Vaginal and urinary symptoms do not get better with time. By taking action now, you can prevent issues like urgency, dryness, and UTIs from worsening. At Interlude, we want you to feel safe and educated about your treatment options. Sexual health is such an important and private topic. We’re making it more approachable so that more women can live pain-free.
