GoodRx Holdings Inc.

07/26/2024 | Press release | Distributed by Public on 07/26/2024 15:35

Headache, Discharge, and More: 8 Imvexxy Side Effects to Know About

Key takeaways:

  • Imvexxy (estradiol vaginal insert) is a prescription medication that helps reduce pain during sex for women in menopause. It's generally well tolerated.

  • Common Imvexxy side effects include headache, changes to vaginal discharge, and breast tenderness. Some people also experience fluid retention (bloating or swelling) and raised blood pressure with Imvexxy.

  • Imvexxy has a very low risk for serious side effects, such as blood clots, dementia, and breast cancer. These warnings are included on all estrogen-based hormone replacement therapy. But low-dose vaginal estrogens, such as Imvexxy, have the lowest risk for them.

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Imvexxy (estradiol vaginal insert) is a prescription medication that can help reduce pain during sex for women in menopause. It's a form of hormone replacement therapy (HRT). It provides a low dose of the hormone estrogen right where you need it for symptom relief.

Overall, vaginal estrogen products such as Imvexxy are generally well tolerated. But that doesn't mean side effects can't happen.

Imvexxy side effects at a glance

In general, Imvexxy side effects don't happen frequently. In clinical trials, the most common side effects occurred in less than 4% of all participants. And a similar number of people using a placebo (a vaginal insert with no medication) reported these issues. So it's possible they weren't related to Imvexxy.

EXPERT PICKS: WHAT TO READ NEXT
  • Comparing options: Imvexxy is one of several vaginal estrogen products. Read more about the different vaginal estrogen products used for menopause symptoms.

  • How to use Imvexxy: The starting dosage of Imvexxy is more frequent than the dosage you'll use long term. Read more about Imvexxy's typical dosages, plus tips on how to use it.

  • How Imvexxy works: Imvexxy works by raising estrogen levels in and around the vagina. Read more about how Imvexxy relieves certain menopause symptoms.

Mild Imvexxy side effects include:

  • Headache

  • Changes to vaginal discharge

  • Sore or tender breasts

  • Fluid retention (bloating or swelling)

All estrogen-based HRT medications include several rare but serious side effects in their labeling. Some of these are boxed warnings (the FDA's strictest medication warning). Serious risks and side effects listed in Imvexxy's labeling include:

  • Allergic reactions (different from a side effect but can be life-threatening)

  • Raised blood pressure

  • Raised triglyceride levels (fatty cells measured in a cholesterol test)

  • Gallbladder problems

  • Increased or decreased blood calcium levels

  • Vision changes

  • Liver damage

  • Dementia (a boxed warning)

  • Heart attack (a boxed warning)

  • Stroke (a boxed warning)

  • Blood clots in the lungs or legs (a boxed warning)

  • Breast cancer (a boxed warning)

  • Uterine cancer (a boxed warning)

Keep in mind that the FDA requires all estrogen-based HRT to list the serious side effects mentioned above. But as we'll discuss, Imvexxy has a very low risk for causing them. Below, we'll cover 10 Imvexxy side effects in more detail.

1. Headache

Headache was the most common Imvexxy side effect reported in clinical trials. This may be because of changes to hormone levels.

Headaches from Imvexxy should improve over time as your body adjusts to the medication. Staying hydrated and getting enough rest may help relieve and prevent headaches. Occasional use of over-the-counter (OTC) pain relievers, such as acetaminophen (Tylenol) or ibuprofen (Advil, Motrin), can also help. But talk to a healthcare professional before taking an OTC pain medication, as they're not safe for everyone.

2. Vaginal discharge

Increased vaginal discharge is another mild Imvexxy side effect. This typically isn't bothersome enough to make people stop using Imvexxy. Similar to headaches, vaginal discharge changes happen because of shifting hormone levels.

Vaginal discharge is a normal part of a healthy vagina. But when estrogen levels fall during menopause, it's common to have less discharge. Estrogen-based HRT, such as Imvexxy, raises estrogen levels to help relieve menopause symptoms. As a response, your body may start making more discharge again.

If you experience increased vaginal discharge while using Imvexxy, consider taking steps to maintain your vaginal health. Use a mild soap when cleansing, wear 100% cotton underwear, and avoid scented vaginal products. You may also find comfort in wearing a thin, unscented panty liner to absorb vaginal discharge.

If you see blood in your discharge, contact your prescriber. Vaginal bleeding after menopause is never normal. It can be a symptom of a more serious problem, such as uterine cancer.

3. Breast tenderness

Breast tenderness is another possible Imvexxy side effect. Similar to the side effect above, this is likely caused by changing hormone levels.

You may be able to manage breast tenderness at home with OTC pain relievers. Cold compresses and loose-fitting clothing or bras might be helpful, too.

Even though sore breasts are an expected Imvexxy side effect, you should contact your prescriber if it happens to you. In rare cases, breast pain can be a symptom of breast cancer. Your prescriber may want to evaluate you in person if you develop this side effect after starting Imvexxy.

4. Fluid retention

Estrogen-based HRT such as Imvexxy can cause fluid retention. This is because estrogen plays a role in maintaining fluid balance. And using Imvexxy could change this balance. But if you do experience bloating or swelling, know that it's usually mild. It should go away as your body adjusts to Imvexxy.

Make sure your prescriber knows if you have a health condition that raises your risk of retaining fluid, such as heart failure or kidney disease. Imvexxy may not be the right medication for you.

5. Raised blood pressure

A small number of women using Imvexxy have reported a rise in their blood pressure. This wasn't seen in larger clinical trials, though. Keep in mind that it's possible for all estrogen-based HRT to raise blood pressure, but the risk of this side effect is more likely to happen with oral estrogen medications.

If you notice blood pressure increases while using Imvexxy, talk to your prescriber. Depending on your risks, they may ask you to check your blood pressure at home. They may also ask you to stop using Imvexxy.

6. Risk of dementia

Imvexxy carries a boxed warning for dementia. This risk is based on a large study that found a higher risk of dementia for women aged 65 or older who took a certain form of oral estrogen. Since then, the FDA has required all estrogen-based HRT to include this boxed warning. The risk of dementia with vaginal estrogens, such as Imvexxy, hasn't been well studied.

Speak with your prescriber about your risks for dementia when using Imvexxy. For many women, the benefits of using HRT outweighs the risk of dementia. This is especially true if you're 60 years or younger, or if you entered menopause less than 10 years ago.

7. Risk of blood clots, heart attack, and stroke

Imvexxy also includes boxed warnings for a higher risk of blood clots, heart attack, and stroke. Similar to dementia, these cardiovascular warnings are based on a large study that focused on certain oral estrogens. Women in the study who took oral estrogen had a greater risk of these complications. Vaginal estrogens were not included in this study.

Experts believe that the risk of cardiovascular problems is very low for most women using low-dose vaginal estrogens such as Imvexxy. Very little estrogen reaches the bloodstream when you use this form of HRT.

Still, it's a good idea to review your cardiovascular risks with your prescriber when using Imvexxy. They may recommend an alternative if you have a history of blood clots, heart attack, or stroke.

8. Risk of breast or uterine cancer

Imvexxy's boxed warnings also include a higher risk of developing breast or uterine cancer. As with the other boxed warnings, these risks are based on studies of women taking oral estrogen. The FDA requires Imvexxy's manufacturer to include this statement on its labeling.

However, research suggests that low-dose vaginal estrogens such as Imvexxy don't raise the risk of breast or uterine cancer. Since everyone's risks are unique, it's best to discuss these serious side effects with your prescriber. They can let you know if Imvexxy is right for you.

Frequently asked questions

Can Imvexxy cause hair loss?
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Imvexxy isn't known to cause hair loss. But menopause is a common reason for hair thinning. Lower estrogen levels cause hair to be thinner and grow more slowly. Contact your prescriber if you notice large chunks of hair falling out. This isn't a typical Imvexxy side effect nor is it common during menopause.

Can Imvexxy cause a UTI?
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It's unlikely that Imvexxy would cause a urinary tract infection (UTI). But menopause can make you more prone to UTIs. Vaginal estrogens, such as Imvexxy, can actually lower the risk of experiencing them.

Does Imvexxy cause weight gain?
expand_more

No, Imvexxy doesn't cause weight gain. If you notice an increase in body weight shortly after starting Imvexxy, this is most likely fluid retention (bloating). This is temporary and should go away after your body adjusts to the medication.

The bottom line

Common Imvexxy (estradiol vaginal insert) side effects include headache, vaginal discharge changes, and breast tenderness. Some people also experience fluid retention and raised blood pressure. Mild Imvexxy side effects can typically be managed at home and often get better with time.

More severe Imvexxy side effects are rare. They include a higher risk of blood clots, dementia, and breast or uterine cancer. Discuss your risks for these side effects with your prescriber. They can let you know if Imvexxy is right for you.

References

American Cancer Society. (2019). Signs and symptoms of endometrial cancer.

Barad, D. H. (2022). Vaginal discharge. Merck Manuals.

View All References (11)
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Cichowski, S. B. (n.d.). UTIs after menopause: Why they're common and what to do about them. American College of Obstetricians and Gynecologists.

Constantine, G. D., et al. (2019). Endometrial safety of low-dose vaginal estrogens in menopausal women: A systematic evidence review. Menopause.

Craig, M. C., et al. (2005). The Women's Health Initiative Memory Study: Findings and implications for treatment. The Lancet Neurology.

DePolo, J. (2024). Using HRT (hormone replacement therapy). Breastcancer.org.

Kalenga, C. Z., et al. (2023). Association between the route of administration and formulation of estrogen therapy and hypertension risk in postmenopausal women: A prospective population-based study. Hypertension.

Manson, J. E., et al. (2014). Why the product labeling for low-dose vaginal estrogen should be changed. Menopause.

Mayne Pharma LLC (2024). Imvexxy- estradiol insert [package insert].

Stachenfeld, N. S. (2014). Hormonal changes during menopause and the impact on fluid regulation. Reproductive Sciences.

Tan-Kim, J., et al. (2023). Efficacy of vaginal estrogen for recurrent urinary tract infection prevention in hypoestrogenic women. American Journal of Obstetrics and Gynecology.

The Menopause Society. (n.d.). Changes in weight and fat distribution.

Writing Group for the Women's Health Initiative Investigators. (2002). Risks and benefits of estrogen plus progestin in healthy postmenopausal women: Principal results from the Women's Health Initiative randomized controlled trial. JAMA.

GoodRx Health has strict sourcing policies and relies on primary sources such as medical organizations, governmental agencies, academic institutions, and peer-reviewed scientific journals. Learn more about how we ensure our content is accurate, thorough, and unbiased by reading our editorial guidelines.

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