FDA-approved hormone replacement therapy (HRT) products go through rigorous clinical research long before they hit the market. These trials make sure they’re safe and effective for their intended use. And following approval, the FDA stays up to date with each product’s reception, side effects, and changes.

There are also non-FDA-approved HRT products, like compounded bioidentical hormones, which aren’t held to the same standard. Most clinical authorities strongly recommend choosing HRT products with the FDA stamp of approval, though in some cases, your doctor could recommend a compounded option.

Read on as we compare compounded bioidentical hormones versus FDA-approved HRT, what these terms mean, and their efficacy for women managing menopause symptoms.

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What are bioidentical hormones?

Bioidentical hormones share the same chemical structure as the hormones your body produces. Manufacturers commonly include them in HRT formulations (such as bioidentical estrogen and progesterone). 

The term “bioidentical” simply describes the hormone’s structure. It doesn’t indicate anything else, from who manufactured the medication to whether it's been tested. And non-bioidentical, or synthetic, hormones are just as effective.

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Compounded bioidentical hormones vs. FDA-approved HRT: Key differences at a glance

Compounded products are custom-made medications, typically prepared by compounding pharmacies. There are compounded products available on the market that include bioidentical hormones, often referred to as compounded bioidentical hormone therapy (cBHT). This is typically what people refer to as “compounded bioidentical hormones.”

cBHTs, like all compounded medications, involve limited input and oversight from the FDA. In comparison, HRT products that seek FDA approval are held to a higher standard. This is true for products that include bioidentical hormones and those that don’t.

Part of meeting this standard is being subject to the FDA’s pre-market approval process, which looks like this: 

• Discovery and development: In a laboratory, researchers study the medication and seek to understand how it interacts with the body.
• Preclinical research: Before human testing, researchers conduct further laboratory-based studies and examine the medication’s influence on animals. 
• Clinical research: Across three distinct trial phases, researchers systematically test the medication on human patients. 
• FDA review: The FDA reviews all of the data to determine if the medication is safe and effective. 
• FDA post-market safety monitoring: Once the medication is on the market, the FDA maintains oversight and continues to review outcomes. 

Not all FDA-approved products follow these exact steps. For example, certain older HRT medications (like Premarin®) were approved under earlier regulatory frameworks that predate this process. But all FDA-approved HRT products must meet FDA standards as part of ongoing oversight.

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Understanding 3 FDA-approved HRT products

HRT is a category of medications. Each helps restore the hormonal environment, some in different ways than others. Consider these three FDA-approved products for menopause.

1. Vivelle-Dot®

Vivelle-Dot® is a patch that contains a bioidentical form of estrogen, called estradiol. After applying it to your skin (usually the lower abdomen or glutes), it absorbs into the bloodstream, where it carries body-wide effects. For menopause, it’s approved for: 

• Treatment of moderate-to-severe vasomotor symptoms (VMS)
• Treatment of moderate-to-severe symptoms of vulvar and vaginal atrophy
• Prevention of postmenopausal osteoporosis
  

2. Prometrium®

Prometrium® is an oral capsule that contains micronized progesterone, which is identical to the progesterone your body produces. Progesterone limits the endometrial growth, typically caused by estrogen, that can promote endometrial cancer. Prometrium®’s menopause-related approved indication is to prevent endometrial hyperplasia in postmenopausal people who still have a uterus and are receiving conjugated estrogen tablets. 

3. Estrace®

Estrace® delivers estradiol directly to vaginal tissue, where its effects are largely contained to this area. It has just one FDA-approved indication, going hand-in-hand with its targeted action: the treatment of moderate-to-severe symptoms of vulvar and vaginal atrophy.

How effective are compounded bioidentical hormones in HRT products?

A 2020 review by the National Academies of Sciences, Engineering, and Medicine determined that there’s a lack of evidence backing cBHT’s safety and effectiveness. These medications, like all compounded medications, shouldn’t be used unless your doctor or menopause specialist recommends them. 

FDA-approved products paint a different picture. Due to an extensive body of research, The Menopause Society highlights HRT as the most effective treatment for VMS and genitourinary symptoms of menopause. VMS include hot flashes and night sweats, while genitourinary symptoms include:

• Vaginal dryness
• Painful sex
• Urinary urgency
• Painful urination
• Recurrent urinary tract infections

This isn’t an exhaustive list of symptoms. HRT may also offer relief for other common menopause symptoms, such as sleep disturbances and mood instability.

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Understanding the risks: Compounded vs. FDA-approved

When prescribed appropriately, HRT proves safe and effective for many women. But it can cause side effects, including: 

• Diarrhea
• Headaches
• Nausea
• Vaginal bleeding
• Breast tenderness
• Mood instability

These side effects are usually mild and improve with time. 

The side effects of cBHT aren’t as clear-cut. FDA-approved products undergo systematic review, meaning their side effects are thoroughly documented and assessed. Because cBHT involves limited FDA oversight, we can’t understand its side effects to the same extent. 

The risks of compounded HRT products

Here’s why most medical providers approach compounded HRT products with caution: 

• Inconsistent quality control: Compounding pharmacies aren’t held to the same standards as the manufacturers of FDA-approved products. This could lead to oversights and low-quality medication.
• Lack of FDA oversight: The products don’t undergo premarket FDA-approval processes that validate their safety and efficacy. 
• No long-term safety data: Compounded products aren’t subject to rigorous, long-term trials. That means their long-term safety profile is unknown. 
• Varying quality: Because they aren’t standardized, a compounded product’s formulation may differ from what’s being advertised. The same prescription can change from batch to batch. For example, the potency (amount of the active ingredient) of one month’s prescription may differ from the next’s, which can impact treatment. Worse, the active ingredient could be entirely different or missing from the medication.

Additionally, according to the Section 503A of the Federal Food, Drug, and Cosmetic Act, certain compounding pharmacies don’t have to report adverse events to the FDA. This introduces further uncertainty surrounding the real-world safety of these medications. 

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When cBHT may be appropriate 

According to the Endocrine Society, doctors shouldn’t prescribe a compounded product when a suitable FDA-approved medication is available. They should only consider a compounded option if an FDA-approved medication isn’t available or suitable for an individual’s needs. 

Wondering if a compounded product might make sense for you? Have this conversation with your doctor. They’ll guide you on the right path for your body and goals. 

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Accessible evidence-based care, built around your body 

Maven Clinic specialists only prescribe evidence-based, FDA-approved medications. But just because a treatment is FDA-approved doesn't mean it’s automatically right for you. Our team—spanning more than 30 disciplines—looks at your full health picture, placing you on the right path for your body and goals. 

Here’s what this looks like for our patient, Denise: "My in-person doctors are great, but they can't compete with the entire team I can meet with on Maven. I've met with a Wellness Coach, Physical Support coach, OB-GYN, Career Coach, Naturopath, and many more. My daughter calls them my 'entourage' during my Taylor Swift Menopause era.”

Discover our approach to hormone care.