Menopause Hormone Therapy: FDA-Approved Options and the New Label

The FDA’s consumer page on menopause states the starting point plainly: “there are many different FDA-approved hormones for treatment of the symptoms of menopause” (content current December 14, 2023). The agency’s consumer guide Menopause: Medicines to Help You lists the approved delivery forms as pill, patch, gel, skin spray, injection, vaginal cream, skin cream, vaginal insert, vaginal ring and vaginal tablet.

Systemic estradiol. These products treat symptoms throughout the body. The Climara estradiol patch label (revised December 2023) lists four indications, among them “Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause,” treatment of vulvar and vaginal atrophy symptoms, treatment of hypoestrogenism, and “Prevention of Postmenopausal Osteoporosis.”

Micronized progesterone. Prometrium capsules are “an oral dosage form of micronized progesterone which is chemically identical to progesterone of ovarian origin,” in the label’s own words. They are indicated “for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving conjugated estrogens tablets.” One label detail: “PROMETRIUM Capsules contain peanut oil and is contraindicated in patients allergic to peanuts.”

Combination products. Activella is “an estrogen and progestin combination indicated in a woman with a uterus for” moderate to severe vasomotor symptoms and prevention of postmenopausal osteoporosis (label revised April 2020).

Low-dose vaginal estrogen. These are approved for local symptoms rather than hot flashes. Premarin Vaginal Cream (revised April 2025) is indicated for treatment of atrophic vaginitis and for “Treatment of Moderate to Severe Dyspareunia, a Symptom of Vulvar and Vaginal Atrophy, due to Menopause.” Estring, an estradiol vaginal ring, is indicated for “the treatment of moderate to severe urogenital symptoms due to postmenopausal atrophy of the vagina.”

The category matters before an online visit: the indication, the warnings and the monitoring follow the specific product, not the word “hormones.” Our menopause clinic reviews set out which products each service prescribes.

On November 10, 2025 an HHS fact sheet and an FDA press release carried the same sentence: the agency is “initiating removal of the boxed warnings following a comprehensive review of the scientific literature,” together with “an expert panel in July, and a public comment period.”

The scope was stated in both releases: “The agency is working with companies to update language in product labeling to remove references to risks of cardiovascular disease, breast cancer, and probable dementia.” One warning was carved out: “The FDA is not seeking to remove the boxed warning for endometrial cancer for systemic estrogen-alone products.”

HHS gave its reasoning in the same document, saying women “may be under-utilizing approved therapies that can alleviate menopause symptoms and improve women’s health” because of the warnings, and that “starting HRT within ten years of the onset of menopause can have numerous benefits which for most women outweigh potential risks.” That is the agency’s stated rationale for changing a label, not a finding about any individual, and it does not replace a conversation with a clinician who knows your history.

The paperwork followed three months later. The FDA’s February 12, 2026 press release confirmed that risk statements “related to cardiovascular disease, breast cancer and probable dementia were removed from the ‘boxed warning,’ the agency’s most prominent safety-related warning.” It lists the categories covered:

• “Systemic combination therapy (estrogen and progestogen)”
• “Systemic estrogen-alone therapy”
• “Systemic progestogen-alone therapy for women with a uterus using systemic estrogen”
• “Topical vaginal estrogen therapy”

This is the part that gets lost in headlines. The same release says “29 drug companies have submitted proposed labeling changes” and describes what was approved that day as “This first batch of six products.” It does not name the six, and the rest are still in the queue.

The labels checked for this guide bear that out. Climara (revised December 2023), Activella (revised April 2020), Premarin Vaginal Cream (revised April 2025) and Estring (revised 2009) all still carry the full pre-2026 boxed warning naming endometrial cancer, cardiovascular disorders, probable dementia and breast cancer. Prometrium, which is progesterone only, carries no boxed warning at all.

So read the label of the product you are actually prescribed, and check its revision date: whether the shorter warning has arrived depends on that product, not on the news.

Two prescription drugs are FDA-approved for hot flashes without using hormones. They are often named in the same breath; their labels are not the same.

Fezolinetant (Veozah) was approved on May 12, 2023 as “an oral medication for the treatment of moderate to severe vasomotor symptoms, or hot flashes, caused by menopause.” The current label (revised February 26, 2026) reads: “VEOZAH® is indicated for the treatment of moderate to severe vasomotor symptoms due to menopause.”

There was no boxed warning at approval. On December 16, 2024 the FDA added “a Boxed Warning, our most prominent warning, to highlight the known risk of rare but serious liver injury.” The label’s boxed warning is headed “WARNING: RISKS OF HEPATOTOXICITY” and states that “Hepatotoxicity has occurred with the use of VEOZAH in the postmarketing setting.” Alongside blood work before starting, the FDA’s revised instruction is to “perform follow-up liver blood tests every month for the first three months, and then again at months 6 and 9 of treatment.”

Elinzanetant (Lynkuet) was approved on October 24, 2025. The FDA’s approval letter says “It is approved, effective on the date of this letter, for use as recommended in the enclosed agreed-upon labeling.” Its indication reads: “LYNKUET is indicated for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause.”

Lynkuet carries no boxed warning. Its label instead directs the prescriber to “Perform baseline hepatic laboratory tests to evaluate for hepatic function and injury” before treatment, and to “Perform follow-up evaluations of hepatic transaminase concentration 3 months after initiation of therapy.”

The short version: one of the two carries a boxed warning for liver injury and a monthly-then-periodic testing schedule, the other has no boxed warning and a baseline-plus-three-month check. If a clinic proposes a non-hormonal option, ask which drug it is and what testing its label requires.

Many products sold as “bioidentical hormones” are compounded preparations, mixed to order by a pharmacy. They are not approved by the FDA, and the agency does not review compounded drugs for safety, effectiveness or quality before they are marketed. The FDA’s menopause page puts it directly: the agency “does not have evidence that compounded ‘bioidentical hormones’ are safe and effective.”

The National Academies of Sciences, Engineering, and Medicine reviewed the evidence in 2020 and concluded that “there is insufficient evidence to support the overall clinical utility of cBHT as treatment for menopause and male hypogonadism symptoms.” The same report cautions that “the lack of data should never be interpreted as a marker of safety and/or effectiveness.”

That is a statement about the evidence base, not a claim that these preparations harm people. It does mean the comparison a marketer makes, same hormone and same result, is not one a regulator has checked. We set out the difference in detail in our guide to approved hormones versus compounded preparations.

There is no FDA-approved testosterone product for women in the United States. The FDA’s testosterone information page (last updated June 23, 2026) says approved formulations include “the topical gel, transdermal patch, buccal system (applied to upper gum or inner cheek), and injection,” and that “Testosterone products are FDA-approved only for use in men who lack or have low testosterone levels in conjunction with an associated medical condition.”

The labels match. Vogelxo testosterone gel (revised July 2025) is indicated “for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.” No female indication appears on it.

Testosterone is also a controlled substance, which estrogen and progesterone are not. The DEA lists anabolic steroids such as Depo-Testosterone among its Schedule III examples and describes Schedule III drugs as having “a potential for abuse less than substances in Schedules I or II.” The designation is printed on the product itself: the Vogelxo label is titled “VOGELXO® (testosterone) gel, for topical use, CIII.” A telehealth practice that prescribes it takes on controlled-substance rules that estrogen and progesterone do not carry.

The agency is examining the gap. It held a public meeting on September 17, 2026, “FDA Public Meeting: Testosterone Use In Menopausal Women,” to “examine the current scientific evidence and critical knowledge gaps related to testosterone use in menopausal women,” noting that “Despite growing off-label use of testosterone therapy in menopausal women, critical knowledge gaps remain.” The notice describes future research and “potential drug development,” not an approval.

Until that changes, testosterone prescribed to a woman is either off-label use of a product approved for men, or a compounded preparation. If a clinic offers it, ask which of the two it is and what monitoring comes with it. Off-label and Schedule III are defined in our telehealth terms glossary.

The label is public, free and specific to the product you are being sold. Three steps:

1. Get the exact product name in writing. Brand or active ingredient, strength and form, before you pay.
2. Confirm it is an approved drug. The FDA’s Orange Book “identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA)” and can be searched “by active ingredient, proprietary name, applicant, application number, dosage form” and more. Drugs@FDA and DailyMed, the National Library of Medicine’s label database, carry the current label text.
3. Read two parts of the label. Indications and Usage tells you what the product is approved to treat. The boxed warning, if the product has one, sits at the top. Check the revision date to see whether the shortened 2026 wording has reached that product yet.

Then take a short list into the visit:

• Which exact product are you prescribing, and is it an approved product or a compounded preparation?
• Is it systemic or vaginal-only, and which of my symptoms is it indicated for?
• If I have a uterus, does the plan include a progestogen, and why?
• Does this product’s label still carry the older boxed warning?
• If a non-hormonal drug is proposed, which one, and what liver testing does its label require?
• Are you licensed in my state? HHS says a clinician must “be licensed or legally permitted to practice in the state where the patient is located.”
• What does it cost each month, and is the drug on my insurer’s drug list?

This guide reports labels and agency statements. It is not medical advice; take the questions to a licensed clinician who can see your history. To compare services first, start with our menopause clinics hub, the Midi Health review and the Winona review.